(9R)-9-chloro-11-17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10-13-16-trimethyl-6-7-8-11-12-14-15-16-octahydrocyclopenta[a]phenanthren-3-one and Asthma

(9R)-9-chloro-11-17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10-13-16-trimethyl-6-7-8-11-12-14-15-16-octahydrocyclopenta[a]phenanthren-3-one has been researched along with Asthma* in 1661 studies

Reviews

171 review(s) available for (9R)-9-chloro-11-17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10-13-16-trimethyl-6-7-8-11-12-14-15-16-octahydrocyclopenta[a]phenanthren-3-one and Asthma

ArticleYear
[Beclomethasone dipropionate: efficacy and safety of the administration by nebulization.]
    Recenti progressi in medicina, 2022, Volume: 113, Issue:12

    The advent of inhaled corticosteroids (ICS) brought a revolution in the management of asthma, representing now the cornerstone in this pathological condition treatment. Indeed, these drugs have clearly shown to possess a high degree of both efficacy and safety. Beclomethasone dipropionate (BDP) is the first molecule tested in the early 1970s. When administered via nebulizers or pressurized metered-dose inhalers (pMDI), BDP was found to be effective in reducing the symptoms frequency and severity in asthmatic patients, even in those previously treated with low-dose oral corticosteroids. The drug was thus produced to be administered by nebulization or via pMDI. Nebulizers are a practical and efficient tool for administering inhaled drugs in patients of all degree of severity and belonging to all ages, but are especially useful for those unable to utilize other inhaler devices correctly. BDP aerosolization, when generated by modern pneumatic nebulizers, can deliver particles with a mass median aerodynamic diameter (MMAD) value of 2.9-3.7 µm. This ability allows the deposition of the drug in small caliber airways, and considerably reduces the amount of drug deposited in the oropharynx, thus improving this molecule pharmacokinetics. This review aims to analyze the factors influencing the efficacy and safety of ICS, evaluating in detail the characteristics of BDP administered by nebulization.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Beclomethasone; Humans

2022
Extrafine HFA-beclomethasone-formoterol vs. nonextrafine combination of an inhaled corticosteroid and a long acting β2-agonist in patients with persistent asthma: A systematic review and meta-analysis.
    PloS one, 2021, Volume: 16, Issue:9

    Airway inflammation in asthma involves not only the central airways but extends to peripheral airways. Lung deposition may be key for an appropriate treatment of asthma. We compared the clinical effects of extrafine hydrofluoroalkane (HFA)-beclomethasone-formoterol (BDP-F) versus equipotent doses of nonextrafine combination of an inhaled corticosteroid and a long acting β2-agonist (ICS-LABA) in asthma.. We identified eligible studies by a comprehensive literature search of PubMed, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL). Data analysis was performed with the Review Manager 5.3.5 software (Cochrane IMS, 2014).. A total of 2326 patients with asthma from ten published randomized controlled trials (RCTs) were enrolled for analysis. Change from baseline in morning pre-dose peak expiratory flow (PEF), evening pre-dose PEF and forced expiratory volume in one second (FEV1) were detected no significant differences between extrafine HFA-BDP-F and nonextrafine ICS-LABAs (p = 0.23, p = 0.99 and p = 0.23, respectively). Extrafine HFA-BDP-F did not show any greater benefit in forced expiratory flow between 25% and 75% of forced vital capacity (FEF25-75%), the parameter concerning peripheral airways (MD 0.03L/s, p = 0.65; n = 877). There were no substantial differences between interventions in fractional exhaled nitric oxide (FeNO) levels or in its alveolar fraction. The overall analysis showed no significant benefit of extrafine HFA-BDP-F over nonextrafine ICS-LABA in improving Asthma Control Test (ACT) score (p = 0.30) or decreasing the number of puffs of rescue medication use (p = 0.16). Extrafine HFA-BDP-F did not lead to less exacerbations than nonextrafine ICS-LABA (RR 0.61, 95% CI: 0.31 to 1.20; I2 = 0; p = 0.15).. Enrolled RCTs of extrafine HFA-BDP-F have demonstrated no significant advantages over the equivalent combination of nonextrafine ICS-LABA in improving pulmonary function concerning central airways or peripheral airways, improving asthma symptom control or reducing exacerbation rate.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Adult; Aged; Asthma; Beclomethasone; Female; Formoterol Fumarate; Humans; Hydrocarbons, Fluorinated; Male; Middle Aged; Outcome Assessment, Health Care; Publication Bias; Risk; Young Adult

2021
Regular treatment with formoterol and an inhaled corticosteroid versus regular treatment with salmeterol and an inhaled corticosteroid for chronic asthma: serious adverse events.
    The Cochrane database of systematic reviews, 2021, 04-14, Volume: 4

    Asthma is characterised by chronic inflammation of the airways and recurrent exacerbations with wheezing, chest tightness, and cough. Treatment with inhaled steroids and bronchodilators can result in good control of symptoms, prevention of further morbidity, and improved quality of life. However, an increase in serious adverse events with the use of both regular formoterol and regular salmeterol (long-acting beta₂-agonists) compared with placebo for chronic asthma has been demonstrated in previous Cochrane Reviews. This increase was statistically significant in trials that did not randomise participants to an inhaled corticosteroid, but not when formoterol or salmeterol was combined with an inhaled corticosteroid. The confidence intervals were found to be too wide to ensure that the addition of an inhaled corticosteroid renders regular long-acting beta₂-agonists completely safe; few participants and insufficient serious adverse events in these trials precluded a definitive decision about the safety of combination treatments.. To assess risks of mortality and non-fatal serious adverse events in trials that have randomised patients with chronic asthma to regular formoterol and an inhaled corticosteroid versus regular salmeterol and an inhaled corticosteroid.. We searched the Cochrane Airways Register of Trials, CENTRAL, MEDLINE, Embase, and two trial registries to identify reports of randomised trials for inclusion. We checked manufacturers' websites and clinical trial registers for unpublished trial data, as well as Food and Drug Administration (FDA) submissions in relation to formoterol and salmeterol. The date of the most recent search was  24 February 2021.. We included controlled clinical trials with a parallel design, recruiting patients of any age and severity of asthma, if they randomised patients to treatment with regular formoterol versus regular salmeterol (each with a randomised inhaled corticosteroid) and were of at least 12 weeks' duration.. Two review authors independently selected trials for inclusion in the review, extracted outcome data from published papers and trial registries, and applied GRADE rating for the results. We sought unpublished data on mortality and serious adverse events from study sponsors and authors. The primary outcomes were all cause mortality and non-fatal serious adverse events. We chose not to calculate an average result from all the formulations of formoterol and inhaled steroid, as the doses and delivery devices are too diverse to assume a single class effect.. Twenty-one studies in 11,572 adults and adolescents and two studies in 723 children met the eligibility criteria of the review. No data were available for two studies; therefore these were not included in the analysis. Among adult and adolescent studies, seven compared formoterol and budesonide to salmeterol and fluticasone (N = 7764), six compared formoterol and beclomethasone to salmeterol and fluticasone (N = 1923), two compared formoterol and mometasone to salmeterol and fluticasone (N = 1126), two compared formoterol and fluticasone to salmeterol and fluticasone (N = 790), and one compared formoterol and budesonide to salmeterol and budesonide (N = 229). In total, five deaths were reported among adults, none of which was thought to be related to asthma. The certainty of evidence for all-cause mortality was low, as there were not enough deaths to permit any precise conclusions regarding the risk of mortality on combination formoterol versus combination salmeterol. In all, 201 adults reported non-fatal serious adverse events. In studies comparing formoterol and budesonide to salmeterol and fluticasone, there were 77 in the formoterol arm and 68 in the salmeterol arm (Peto odds ratio (OR) 1.14, 95% confidence interval (CI) 0.82 to 1.59; 5935 participants, 7 studies; moderate-certainty evidence). In the formoterol and beclomethasone studies, there were 12 adults in the formoterol arm and 13 in the salmeterol arm with events (Peto OR 0.94, 95% CI 0.43 to 2.08; 1941 participants, 6 studies; moderate-certainty evidence). In the formoterol and mometasone studies, there were 18 in the formoterol arm and 11 in the salmeterol arm (Peto OR 1.02, 95% CI 0.47 to 2.20; 1126 participants, 2 studies; moderate-certainty evidence). One adult in the formoterol and fluticasone studies in the salmeterol arm experienced an event (Peto OR 0.05, 95% CI 0.00 to 3.10; 293 participants, 2 studies; low-certainty evidence). Another adult in the formoterol and budesonide compared to salmeterol and budesonide study in the formoterol arm had an event (Peto OR 7.45, 95% CI 0.15 to 375.68; 229 participants, 1 study; low-certainty evidence). Only 46 adults were reported to have experienced asthma-related serious adverse events. The certainty of the evidence was low to very low due to the small number of events and the absence of independent assessment of causation. The two studies in children compared formoterol and fluticasone to salmeterol and fluticasone. No deaths and no asthma-rel. Overall, for both adults and children, evidence is insufficient to show whether regular formoterol in combination with budesonide, beclomethasone, fluticasone, or mometasone has a different safety profile from salmeterol in combination with fluticasone or budesonide. Five deaths of any cause were reported across all studies and no deaths from asthma; this information is insufficient to permit any firm conclusions about the relative risks of mortality on combination formoterol in comparison to combination salmeterol inhalers. Evidence on all-cause non-fatal serious adverse events indicates that there is probably little to no difference between formoterol/budesonide and salmeterol/fluticasone inhalers. However events for the other formoterol combination inhalers were too few to allow conclusions. Only 46 non-fatal serious adverse events were thought to be asthma related; this small number in addition to the absence of independent outcome assessment means that we have very low confidence for this outcome. We found no evidence of safety issues that would affect the choice between salmeterol and formoterol combination inhalers used for regular maintenance therapy by adults and children with asthma.

    Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Drug Therapy, Combination; Fluticasone; Formoterol Fumarate; Glucocorticoids; Humans; Mometasone Furoate; Randomized Controlled Trials as Topic; Salmeterol Xinafoate

2021
Combination fixed-dose beta agonist and steroid inhaler as required for adults or children with mild asthma.
    The Cochrane database of systematic reviews, 2021, 05-04, Volume: 5

    Asthma affects 350 million people worldwide including 45% to 70% with mild disease. Treatment is mainly with inhalers containing beta₂-agonists, typically taken as required to relieve bronchospasm, and inhaled corticosteroids (ICS) as regular preventive therapy. Poor adherence to regular therapy is common and increases the risk of exacerbations, morbidity and mortality. Fixed-dose combination inhalers containing both a steroid and a fast-acting beta₂-agonist (FABA) in the same device simplify inhalers regimens and ensure symptomatic relief is accompanied by preventative therapy. Their use is established in moderate asthma, but they may also have potential utility in mild asthma.. To evaluate the efficacy and safety of single combined (fast-onset beta₂-agonist plus an inhaled corticosteroid (ICS)) inhaler only used as needed in people with mild asthma.. We searched the Cochrane Airways Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase, ClinicalTrials.gov and the World Health Organization (WHO) trials portal. We contacted trial authors for further information and requested details regarding the possibility of unpublished trials. The most recent search was conducted on 19 March 2021.. We included randomised controlled trials (RCTs) and cross-over trials with at least one week washout period. We included studies of a single fixed-dose FABA/ICS inhaler used as required compared with no treatment, placebo, short-acting beta agonist (SABA) as required, regular ICS with SABA as required, regular fixed-dose combination ICS/long-acting beta agonist (LABA), or regular fixed-dose combination ICS/FABA with as required ICS/FABA. We planned to include cluster-randomised trials if the data had been or could be adjusted for clustering. We excluded trials shorter than 12 weeks. We included full texts, abstracts and unpublished data.. Two review authors independently extracted data. We analysed dichotomous data as odds ratios (OR) or rate ratios (RR) and continuous data as mean difference (MD). We reported 95% confidence intervals (CIs). We used Cochrane's standard methodological procedures of meta-analysis. We applied the GRADE approach to summarise results and to assess the overall certainty of evidence. Primary outcomes were exacerbations requiring systemic steroids, hospital admissions/emergency department or urgent care visits for asthma, and measures of asthma control.. We included six studies of which five contributed results to the meta-analyses. All five used budesonide 200 μg and formoterol 6 μg in a dry powder formulation as the combination inhaler. Comparator fast-acting bronchodilators included terbutaline and formoterol. Two studies included children aged 12+ and adults; two studies were open-label. A total of 9657 participants were included, with a mean age of 36 to 43 years. 2.3% to 11% were current smokers. FABA / ICS as required versus FABA as required Compared with as-required FABA alone, as-required FABA/ICS reduced exacerbations requiring systemic steroids (OR 0.45, 95% CI 0.34 to 0.60, 2 RCTs, 2997 participants, high-certainty evidence), equivalent to 109 people out of 1000 in the FABA alone group experiencing an exacerbation requiring systemic steroids, compared to 52 (95% CI 40 to 68) out of 1000 in the FABA/ICS as-required group. FABA/ICS as required may also reduce the odds of an asthma-related hospital admission or emergency department or urgent care visit (OR 0.35, 95% CI 0.20 to 0.60, 2 RCTs, 2997 participants, low-certainty evidence). Compared with as-required FABA alone, any changes in asthma control or spirometry, though favouring as-required FABA/ICS, were small and less than the minimal clinically-important differences. We did not find evidence of differences in asthma-associated quality of life or mortality. For other secondary outcomes FABA/ICS as required was associated with reductions in fractional exhaled nitric oxide, probably reduces the odds of an adverse event (OR 0.82, 95% CI 0.71 to 0.95, 2 RCTs, 3002 participants, moderate-certainty evidence) and may reduce total systemic steroid dose (MD -9.90, 95% CI -19.38 to -0.42, 1 RCT, 443 participants, low-certainty evidence), and with an increase in the daily inhaled steroid dose (MD 77 μg beclomethasone equiv./day, 95% CI 69 to 84, 2 RCTs, 2554 participants, moderate-certainty evidence). FABA/ICS as required versus regular ICS plus FABA as required There may be little or no difference in the number of people with asthma exacerbations requiring systemic steroid with FABA/ICS as required compared with regular ICS (OR 0.79, 95% CI 0.59 to 1.07, 4 RCTs, 8065 participants, low-certainty evidence), equivalent to 81 people out of 1000 in the regular ICS plus FABA group experiencing an exacerbation requiring systemic steroids, compared to 65 (95% CI 49 to 86) out of 1000 FABA/ICS as required group. The odds of an asthma-related hospital admission. We found FABA/ICS as required is clinically effective in adults and adolescents with mild asthma. Their use instead of FABA as required alone reduced exacerbations, hospital admissions or unscheduled healthcare visits and exposure to systemic corticosteroids and probably reduces adverse events. FABA/ICS as required is as effective as regular ICS and reduced asthma-related hospital admissions or unscheduled healthcare visits, and average exposure to ICS, and is unlikely to be associated with an increase in adverse events. Further research is needed to explore use of FABA/ICS as required in children under 12 years of age, use of other FABA/ICS preparations, and long-term outcomes beyond 52 weeks.

    Topics: Adolescent; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Disease Progression; Drug Combinations; Formoterol Fumarate; Hospitalization; Humans; Nebulizers and Vaporizers; Prednisolone; Quality of Life; Randomized Controlled Trials as Topic; Terbutaline

2021
Effects of inhaled corticosteroids on growth in children with persistent asthma: Impact of drug molecules and delivery devices - An overview of Cochrane reviews.
    Paediatric respiratory reviews, 2019, Volume: 32

    Topics: Administration, Inhalation; Adolescent; Asthma; Beclomethasone; Body Height; Budesonide; Child; Child Development; Child, Preschool; Fluticasone; Glucocorticoids; Humans; Infant; Mometasone Furoate; Pregnenediones

2019
Inhaled corticosteroids in children with persistent asthma: effects of different drugs and delivery devices on growth.
    The Cochrane database of systematic reviews, 2019, 06-10, Volume: 6

    Inhaled corticosteroids (ICS) are the most effective treatment for children with persistent asthma. Although treatment with ICS is generally considered to be safe in children, the potential adverse effects of these drugs on growth remains a matter of concern for parents and physicians.. To assess the impact of different inhaled corticosteroid drugs and delivery devices on the linear growth of children with persistent asthma.. We searched the Cochrane Airways Trials Register, which is derived from systematic searches of bibliographic databases including CENTRAL, MEDLINE, Embase, CINAHL, AMED and PsycINFO. We handsearched respiratory journals and meeting abstracts. We also conducted a search of ClinicalTrials.gov and manufacturers' clinical trial databases, or contacted the manufacturer, to search for potential relevant unpublished studies. The literature search was initially conducted in September 2014, and updated in November 2015, September 2018, and April 2019.. We selected parallel-group randomized controlled trials of at least three months' duration. To be included, trials had to compare linear growth between different inhaled corticosteroid molecules at equivalent doses, delivered by the same type of device, or between different devices used to deliver the same inhaled corticosteroid molecule at the same dose, in children up to 18 years of age with persistent asthma.. At least two review authors independently selected studies and assessed risk of bias in included studies. The data were extracted by one author and checked by another. The primary outcome was linear growth velocity. We conducted meta-analyses using Review Manager 5.3 software. We used mean differences (MDs) and 95% confidence intervals (CIs ) as the metrics for treatment effects, and the random-effects model for meta-analyses. We did not perform planned subgroup analyses due to there being too few included trials.. We included six randomized trials involving 1199 children aged from 4 to 12 years (per-protocol population: 1008), with mild-to-moderate persistent asthma. Two trials were from single hospitals, and the remaining four trials were multicentre studies. The duration of trials varied from six to 20 months.One trial with 23 participants compared fluticasone with beclomethasone, and showed that fluticasone given at an equivalent dose was associated with a significant greater linear growth velocity (MD 0.81 cm/year, 95% CI 0.46 to 1.16, low certainty evidence). Three trials compared fluticasone with budesonide. Fluticasone given at an equivalent dose had a less suppressive effect than budesonide on growth, as measured by change in height over a period from 20 weeks to 12 months (MD 0.97 cm, 95% CI 0.62 to 1.32; 2 trials, 359 participants; moderate certainty evidence). However, we observed no significant difference in linear growth velocity between fluticasone and budesonide at equivalent doses (MD 0.39 cm/year, 95% CI -0.94 to 1.73; 2 trials, 236 participants; very low certainty evidence).Two trials compared inhalation devices. One trial with 212 participants revealed a comparable linear growth velocity between beclomethasone administered via hydrofluoroalkane-metered dose inhaler (HFA-MDI) and beclomethasone administered via chlorofluorocarbon-metered dose inhaler (CFC-MDI) at an equivalent dose (MD -0.44 cm/year, 95% CI -1.00 to 0.12; low certainty evidence). Another trial with 229 participants showed a small but statistically significant greater increase in height over a period of six months in favour of budesonide via Easyhaler, compared to budesonide given at the same dose via Turbuhaler (MD 0.37 cm, 95% CI 0.12 to 0.62; low certainty evidence).. This review suggests that the drug molecule and delivery device may impact the effect size of ICS on growth in children with persistent asthma. Fluticasone at an equivalent dose seems to inhibit growth less than beclomethasone and budesonide. Easyhaler is likely to have less adverse effect on growth than Turbuhaler when used for delivery of budesonide. However, the evidence from this systematic review of head-to-head trials is not certain enough to inform the selection of inhaled corticosteroid or inhalation device for the treatment of children with persistent asthma. Further studies are needed, and pragmatic trials and real-life observational studies seem more attractive and feasible.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Height; Budesonide; Child; Child, Preschool; Fluticasone; Growth; Humans; Metered Dose Inhalers; Randomized Controlled Trials as Topic; Time Factors

2019
Qvar for Treatment of Chronic Asthma.
    American family physician, 2018, 04-15, Volume: 97, Issue:8

    Topics: Administration, Inhalation; Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Respiratory Function Tests; Treatment Outcome

2018
Efficacy and safety of inhaled corticosteroids relative to fluticasone propionate: a systematic review of randomized controlled trials in asthma.
    Expert review of respiratory medicine, 2017, Volume: 11, Issue:10

    Many trials have been published comparing inhaled corticosteroid (ICS) treatments in asthma. However, mixed results necessitate the summarization of available evidence to aid in decision-making. Areas covered: This systematic review evaluated randomized controlled trials (RCTs) that compared the efficacy and safety of inhaled fluticasone propionate (FP) with other ICS including beclomethasone dipropionate (BDP), budesonide (BUD) and ciclesonide (CIC). PubMed was searched and 54 RCTs that fit pre-determined criteria were included. Endpoints evaluated included lung function, asthma symptom control, exacerbation frequency, reliever use, quality of life and steroid-related side effects. Expert commentary: Across all studies, FP was associated with either more favorable or at least similar efficacy and safety, in comparison with BDP or BUD. This observation may be related to FP's higher relative potency and almost negligible oral bioavailability. FP was comparable to CIC for efficacy. However, CIC appeared to have a smaller impact on cortisol levels than FP, which is likely due to CIC's incomplete conversion to active metabolite (des-CIC) and the lower potency of des-CIC compared with FP. Although there were no significant differences in evaluated outcomes after treatment with different ICS in the majority of studies, some observed differences could be explained by their respective pharmacodynamic and pharmacokinetic properties.

    Topics: Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Fluticasone; Glucocorticoids; Humans; Nebulizers and Vaporizers; Pregnenediones; Randomized Controlled Trials as Topic

2017
[Efficacy and safety of beclomethasone dipropionate HFA.]
    Recenti progressi in medicina, 2017, Volume: 108, Issue:11

    Topics: Administration, Inhalation; Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Glucocorticoids; Humans; Nebulizers and Vaporizers

2017
Dilemmas, Confusion, and Misconceptions Related to Small Airways Directed Therapy.
    Chest, 2017, Volume: 151, Issue:6

    During the past decade, there has been increasing evidence that the small airways (ie, airways < 2 mm in internal diameter) contribute substantially to the pathophysiologic and clinical expression of asthma and COPD. The increased interest in small airways is, at least in part, a result of innovation in small-particle aerosol formulations that better target the distal lung and also advanced physiologic methods of assessing small airway responses. Increasing the precision of drug deposition may improve targeting of specific diseases or receptor locations, decrease airway drug exposure and adverse effects, and thereby increase the efficiency and effectiveness of inhaled drug delivery. The availability of small-particle aerosols of corticosteroids, bronchodilators, or their combination enables a higher total lung deposition and better peripheral lung penetration and provides added clinical benefit, compared with large-particle aerosol treatment. However, a number of questions remain unanswered about the pragmatic approach relevant for clinicians to consider the role of small airways directed therapy in the day-to-day management of asthma and COPD. We thus have tried to clarify the dilemmas, confusion, and misconceptions related to small airways directed therapy. To this end, we have reviewed all studies on small-particle aerosol therapy systematically to address the dilemmas, confusion, and misconceptions related to small airways directed therapy.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Bronchioles; Bronchodilator Agents; Disease Management; Drug Combinations; Dry Powder Inhalers; Equipment Design; Fluocinolone Acetonide; Formoterol Fumarate; Glucocorticoids; Humans; Inhalation Spacers; Metered Dose Inhalers; Nebulizers and Vaporizers; Particle Size; Pregnenediones; Pressure; Pulmonary Disease, Chronic Obstructive

2017
Inhaled beclometasone dipropionate/formoterol fumarate extrafine fixed combination for the treatment of asthma.
    Expert review of respiratory medicine, 2016, Volume: 10, Issue:5

    Inhaled therapy is often considered the cornerstone of asthma management and international guidelines recommend combination therapy of inhaled corticosteroids (ICS) and long-acting-beta2-agonists (LABA) in a large proportion of asthmatic patients. The effectiveness of ICS/LABA is dependent on the correct choice of device and proper inhalation technique, this influences drug delivery and distribution along the bronchial tree, including the most peripheral airways. The fixed combination of beclometasone dipropionate/formoterol fumarate (BDP/FF) is the only extrafine formulation available in pressurized metered dose inhaler (pMDI) and in dry powder inhaler (DPI). Here, we focus on the recent significant advances regarding BDP/FF fixed combination for the treatment of asthma.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Combinations; Dry Powder Inhalers; Formoterol Fumarate; Humans; Metered Dose Inhalers; Treatment Outcome

2016
Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and children.
    The Cochrane database of systematic reviews, 2016, Jun-07, Issue:6

    People with asthma may experience exacerbations or "attacks" during which their symptoms worsen and additional treatment is required. Written action plans may advocate doubling the dose of inhaled steroids in the early stages of an asthma exacerbation to reduce the severity of the attack and to prevent the need for oral steroids or hospital admission.. To compare the clinical effectiveness and safety of increased versus stable doses of inhaled corticosteroids (ICS) as part of a patient-initiated action plan for home management of exacerbations in children and adults with persistent asthma.. We searched the Cochrane Airways Group Specialised Register, which is derived from searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) to March 2016. We handsearched respiratory journals and meeting abstracts.. We included randomised controlled trials (RCTs) that compared increased versus stable doses of ICS for home management of asthma exacerbations. We included studies of children or adults with persistent asthma who were receiving daily maintenance ICS.. Two review authors independently selected trials, assessed quality and extracted data. We contacted authors of RCTs for additional information.. This review update added three new studies including 419 participants to the review. In total, we identified eight RCTs, most of which were at low risk of bias, involving 1669 participants with mild to moderate asthma. We included three paediatric (n = 422) and five adult (n = 1247) studies; six were parallel-group trials and two had a cross-over design. All but one study followed participants for six months to one year. Allowed maintenance doses of ICS varied in adult and paediatric studies, as did use of concomitant medications and doses of ICS initiated during exacerbations. Investigators gave participants a study inhaler containing additional ICS or placebo to be started as part of an action plan for treatment of exacerbations.The odds of treatment failure, defined as the need for oral corticosteroids, were not significantly reduced among those randomised to increased ICS compared with those taking their usual stable maintenance dose (odds ratio (OR) 0.89, 95% confidence interval (CI) 0.68 to 1.18; participants = 1520; studies = 7). When we analysed only people who actually took their study inhaler for an exacerbation, we found much variation between study results but the evidence did not show a significant benefit of increasing ICS dose (OR 0.84, 95% CI 0.54 to 1.30; participants = 766; studies = 7). The odds of having an unscheduled physician visit (OR 0.96, 95% CI 0.66 to 1.41; participants = 931; studies = 3) or acute visit (Peto OR 0.98, 95% CI 0.24 to 3.98; participants = 450; studies = 3) were not significantly reduced by an increased versus stable dose of ICS, and evidence was insufficient to permit assessment of impact on the duration of exacerbation; our ability to draw conclusions from these outcomes was limited by the number of studies reporting these events and by the number of events included in the analyses. The odds of serious events (OR 1.69, 95% CI 0.77 to 3.71; participants = 394; studies = 2) and non-serious events, such as oral irritation, headaches and changes in appetite (OR 2.15, 95% CI 0.68 to 6.73; participants = 142; studies = 2), were neither increased nor decreased significantly by increased versus stable doses of ICS during an exacerbation. Too few studies are available to allow firm conclusions on the basis of subgroup analyses conducted to investigate the impact of age, time to treatment initiation, doses used, smoking history and the fold increase of ICS on the magnitude of effect; yet, effect size appears similar in c. Current evidence does not support increasing the dose of ICS as part of a self initiated action plan to treat exacerbations in adults and children with mild to moderate asthma. Increased ICS dose is not associated with a statistically significant reduction in the odds of requiring rescue oral corticosteroids for the exacerbation, or of having adverse events, compared with a stable ICS dose. Wide confidence intervals for several outcomes mean we cannot rule out possible benefits of this approach.

    Topics: Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Chronic Disease; Disease Progression; Humans; Randomized Controlled Trials as Topic

2016
High-dose beclometasone dipropionate/formoterol fumarate in fixed-dose combination for the treatment of asthma.
    Therapeutic advances in respiratory disease, 2016, Volume: 10, Issue:5

    The high-strength formulation of extrafine beclometasone dipropionate/formoterol fumarate (BDP/Form) 200/6 µg has been developed to step up inhaled corticosteroid treatment, without increasing the dose of the bronchodilator, in patients who are not controlled with previous therapies. Two clinical studies have evaluated efficacy of high-strength BDP/Form as compared with another high-dose fixed combination and BDP monotherapy. Overall, data show that BDP/Form 200/6 μg improves lung function and has beneficial effects on symptoms, use of rescue medication and asthma control, with an acceptable safety profile comparable with that of high-dose fluticasone propionate/salmeterol. Therefore, BDP/Form 200/6 μg could be considered as an effective and safe treatment for patients with asthma who are not adequately controlled with high doses of inhaled corticosteroid monotherapy or medium doses of inhaled corticosteroid/long-acting β2-agonist combinations.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Dose-Response Relationship, Drug; Drug Combinations; Formoterol Fumarate; Humans

2016
Comparing the efficacy and safety of salmeterol/fluticasone pMDI versus its mono-components, other LABA/ICS pMDIs and salmeterol/fluticasone Diskus in patients with asthma.
    Expert opinion on drug delivery, 2015, Volume: 12, Issue:6

    Pressurized metered dose inhalers (pMDIs) are evolving to be a very effective drug delivery option in patients with airway diseases. They offer comparable lung deposition and reduced oropharyngeal deposition similar with the dry powder inhalers. As recommended by the Global Initiative for Asthma guidelines, the ideal maintenance treatment for asthma is a combination of long acting β2-agonists (LABAs) and inhaled corticosteroids (ICSs). One of the available LABA/ICS combinations is the salmeterol/fluticasone propionate combination (SFC) and a plethora of evidence supports its clinical efficacy and safety.. This article focuses on the SFC hydrofluroalkane pMDI and compares the efficacy and tolerability with salmeterol and fluticasone given individually, and with other fixed-dose combinations namely formoterol/fluticasone, formoterol/beclometasone and formoterol/mometasone furoate, all delivered via pMDI. Also discussed is the efficacy and tolerability of the SFC delivered via a pMDI, as compared to the SFC via Diskus.. pMDIs play an important role in inhalation therapy given the low price, low maintenance and convenience of use. LABA/ICS combinations are the preferred choice of medication for asthma treatment and will remain the mainstay for the decades to come. In our opinion, pMDI should be the choice of device to administer LABA/ICS maintenance therapy, as it is already being used by the patients for reliever therapy, which may eventually improve patient adherence and compliance.

    Topics: Albuterol; Androstadienes; Asthma; Beclomethasone; Drug Combinations; Dry Powder Inhalers; Ethanolamines; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Glucocorticoids; Humans; Lung; Metered Dose Inhalers; Mometasone Furoate; Pregnadienediols

2015
Long-acting muscarinic antagonists (LAMA) added to inhaled corticosteroids (ICS) versus higher dose ICS for adults with asthma.
    The Cochrane database of systematic reviews, 2015, Jul-21, Issue:7

    Long-acting muscarinic antagonists (LAMA), a class of drugs with proven effectiveness in chronic obstructive pulmonary disease (COPD), are being considered as an add-on option for adults with asthma whose condition is uncontrolled on inhaled corticosteroids (ICS). It is important to assess the safety and efficacy of LAMA add-on as an alternative to the prolonged use of higher doses of ICS, which are known to cause undesirable side effects in some people.. To compare the effects of adding a LAMA to any dose of ICS versus increasing the dose of ICS, for uncontrolled asthma in adults.. We searched the Cochrane Airways Group Specialised Register (CAGR) from its inception in 1995 to April 2015, imposing no restriction on language of publication. We also handsearched trial registries, reference lists of primary studies and existing reviews, as well as manufacturers' websites.. We looked for parallel or cross-over randomised controlled trials lasting at least 12 weeks, in which adults whose asthma was not well controlled on ICS alone were randomised to treatment with LAMA add-on to ICS or with an increased dose of ICS. Trials were excluded if patients were taking long-acting beta2-agonists during the study period.. Two review authors independently screened the searches and extracted data from studies meeting all the inclusion criteria. We used Covidence to manage duplicate screening, data extraction and risk of bias judgements, and to form a consensus where discrepancies arose. We used standard methods expected by The Cochrane Collaboration.The pre-specified primary outcomes were exacerbations requiring a course of oral corticosteroids (OCS), effects on quality of life and serious adverse events.. One cross-over randomised controlled trial met the inclusion criteria. The trial was performed in 210 patients with moderate to severe asthma and compared the use of the LAMA tiotropium bromide with double dose beclomethasone (an ICS) using a cross-over design and 14-week treatment periods.Compared with people taking a double dose of ICS, fewer people taking a LAMA add-on had an exacerbation requiring treatment with OCS (odds ratio (OR) 0.57, 95% confidence interval (CI) 0.22 to 1.43) or an exacerbation resulting in emergency department admission (OR 0.49, 95% CI 0.09 to 2.77), but the confidence intervals for both outcomes did not exclude the possibility that double dose ICS was more effective. Serious adverse events and exacerbations requiring hospitalisation occurred in similarly low numbers of people taking each treatment, but confidence intervals were too wide to suggest that the two treatment options were equivalent.Asthma-related quality of life was similar in both treatment groups (mean difference (MD) in change from baseline 0.10, 95% CI - 0.07 to 0.27). Those taking LAMA add-on scored slightly better on a scale measuring asthma control than those increasing their ICS dose (MD in change from baseline - 0.18, 95% CI - 0.34 to - 0.02), although the difference was clinically small. Evidence was deemed low quality for both quality of life and asthma control.There was moderate-quality evidence that participants' trough forced expiratory volume in one second (FEV1) was 100 mL better when taking LAMA add-on than with increased ICS dose (MD in change from baseline 0.10, 95% CI 0.03 to 0.17).. Only one randomised trial was found, comparing tiotropium add-on to increased dose beclomethasone. Differences between the treatments were too small or imprecise to understand whether adding a LAMA to ICS is safer or more effective than increasing the dose of ICS, and there is a possibility of carry-over effects due to the study's cross-over design. LAMA add-on may lead to more improvement in lung function (FEV1) than an increased dose of ICS.The results of this review, alongside pending results from related reviews assessing the use of LAMA against other treatments, will help to define the role of these drugs in asthma management, and this review should be updated as results from future trials emerge. Studies assessing the role of LAMA add-on should be longer and include a double-ICS treatment arm so that the results can be interpreted in the context of the guideline-recommended treatment options that are available to physicians.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cross-Over Studies; Humans; Muscarinic Antagonists; Randomized Controlled Trials as Topic; Tiotropium Bromide

2015
Addition of long-acting beta2-agonists to inhaled corticosteroids for chronic asthma in children.
    The Cochrane database of systematic reviews, 2015, Nov-24, Issue:11

    Long-acting beta2-agonists (LABA) in combination with inhaled corticosteroids (ICS) are increasingly prescribed for children with asthma.. To assess the safety and efficacy of adding a LABA to an ICS in children and adolescents with asthma. To determine whether the benefit of LABA was influenced by baseline severity of airway obstruction, the dose of ICS to which it was added or with which it was compared, the type of LABA used, the number of devices used to deliver combination therapy and trial duration.. We searched the Cochrane Airways Group Asthma Trials Register until January 2015.. We included randomised controlled trials testing the combination of LABA and ICS versus the same, or an increased, dose of ICS for at least four weeks in children and adolescents with asthma. The main outcome was the rate of exacerbations requiring rescue oral steroids. Secondary outcomes included markers of exacerbation, pulmonary function, symptoms, quality of life, adverse events and withdrawals.. Two review authors assessed studies independently for methodological quality and extracted data. We obtained confirmation from trialists when possible.. We included in this review a total of 33 trials representing 39 control-intervention comparisons and randomly assigning 6381 children. Most participants were inadequately controlled on their current ICS dose. We assessed the addition of LABA to ICS (1) versus the same dose of ICS, and (2) versus an increased dose of ICS.LABA added to ICS was compared with the same dose of ICS in 28 studies. Mean age of participants was 11 years, and males accounted for 59% of the study population. Mean forced expiratory volume in one second (FEV1) at baseline was ≥ 80% of predicted in 18 studies, 61% to 79% of predicted in six studies and unreported in the remaining studies. Participants were inadequately controlled before randomisation in all but four studies.There was no significant group difference in exacerbations requiring oral steroids (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.70 to 1.28, 12 studies, 1669 children; moderate-quality evidence) with addition of LABA to ICS compared with ICS alone. There was no statistically significant group difference in hospital admissions (RR 1.74, 95% CI 0.90 to 3.36, seven studies, 1292 children; moderate-quality evidence)nor in serious adverse events (RR 1.17, 95% CI 0.75 to 1.85, 17 studies, N = 4021; moderate-quality evidence). Withdrawals occurred significantly less frequently with the addition of LABA (23 studies, 471 children, RR 0.80, 95% CI 0.67 to 0.94; low-quality evidence). Compared with ICS alone, addition of LABA led to significantly greater improvement in FEV1 (nine studies, 1942 children, inverse variance (IV) 0.08 L, 95% CI 0.06 to 0.10; mean difference (MD) 2.99%, 95% CI 0.86 to 5.11, seven studies, 534 children; low-quality evidence), morning peak expiratory flow (PEF) (16 studies, 3934 children, IV 10.20 L/min, 95% CI 8.14 to 12.26), reduction in use of daytime rescue inhalations (MD -0.07 puffs/d, 95% CI -0.11 to -0.02, seven studies; 1798 children) and reduction in use of nighttime rescue inhalations (MD -0.08 puffs/d, 95% CI -0.13 to -0.03, three studies, 672 children). No significant group difference was noted in exercise-induced % fall in FEV1, symptom-free days, asthma symptom score, quality of life, use of reliever medication and adverse events.A total of 11 studies assessed the addition of LABA to ICS therapy versus an increased dose of ICS with random assignment of 1628 children. Mean age of participants was 10 years, and 64% were male. Baseline mean FEV1 was ≥ 80% of predicted. All trials e. In children with persistent asthma, the addition of LABA to ICS was not associated with a significant reduction in the rate of exacerbations requiring systemic steroids, but it was superior for improving lung function compared with the same or higher doses of ICS. No differences in adverse effects were apparent, with the exception of greater growth with the use of ICS and LABA compared with a higher ICS dose. The trend towards increased risk of hospital admission with LABA, irrespective of the dose of ICS, is a matter of concern and requires further monitoring.

    Topics: Adolescent; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Chronic Disease; Disease Progression; Drug Therapy, Combination; Ethanolamines; Female; Formoterol Fumarate; Humans; Male; Randomized Controlled Trials as Topic; Salmeterol Xinafoate

2015
NEXThaler, an innovative dry powder inhaler delivering an extrafine fixed combination of beclometasone and formoterol to treat large and small airways in asthma.
    Expert opinion on drug delivery, 2014, Volume: 11, Issue:9

    Airway inflammation and remodelling in asthma occur in the large airways and also in the small airways. The small airways are those < 2 mm in diameter and are significant sites of chronic asthmatic inflammation. It is important, therefore, to target the small as well as the large airways in any strategy for effective treatment of this disease.. The present review deals with the recently developed fixed dose drug combination of beclometasone dipropionate/formoterol fumarate that emits extrafine particles when delivered from an innovative dry powder inhaler (DPI), NEXThaler®. The aim is to present the technical and clinical aspects of aerosolized drug delivery to the lungs.. The data show that the NEXThaler DPI is an efficient device for the management of persistent asthma. The evaluation of the inhalation profiles through the NEXThaler DPI demonstrates that device activation and consistent dose delivery occurs at patient achievable inhalation flow rates, and supports the broad utility of the NEXThaler DPI in patients with asthma. Overall, all the effectiveness, efficiency and satisfaction outcomes demonstrate the NEXThaler DPI is easy to use.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Combinations; Drug Delivery Systems; Dry Powder Inhalers; Ethanolamines; Formoterol Fumarate; Humans; Lung; Particle Size

2014
Inhaled corticosteroids in children with persistent asthma: effects on growth.
    The Cochrane database of systematic reviews, 2014, Jul-17, Issue:7

    Treatment guidelines for asthma recommend inhaled corticosteroids (ICS) as first-line therapy for children with persistent asthma. Although ICS treatment is generally considered safe in children, the potential systemic adverse effects related to regular use of these drugs have been and continue to be a matter of concern, especially the effects on linear growth.. To assess the impact of ICS on the linear growth of children with persistent asthma and to explore potential effect modifiers such as characteristics of available treatments (molecule, dose, length of exposure, inhalation device) and of treated children (age, disease severity, compliance with treatment).. We searched the Cochrane Airways Group Specialised Register of trials (CAGR), which is derived from systematic searches of bibliographic databases including CENTRAL, MEDLINE, EMBASE, CINAHL, AMED and PsycINFO; we handsearched respiratory journals and meeting abstracts. We also conducted a search of ClinicalTrials.gov and manufacturers' clinical trial databases to look for potential relevant unpublished studies. The literature search was conducted in January 2014.. Parallel-group randomised controlled trials comparing daily use of ICS, delivered by any type of inhalation device for at least three months, versus placebo or non-steroidal drugs in children up to 18 years of age with persistent asthma.. Two review authors independently performed study selection, data extraction and assessment of risk of bias in included studies. We conducted meta-analyses using the Cochrane statistical package RevMan 5.2 and Stata version 11.0. We used the random-effects model for meta-analyses. We used mean differences (MDs) and 95% CIs as the metrics for treatment effects. A negative value for MD indicates that ICS have suppressive effects on linear growth compared with controls. We performed a priori planned subgroup analyses to explore potential effect modifiers, such as ICS molecule, daily dose, inhalation device and age of the treated child.. We included 25 trials involving 8471 (5128 ICS-treated and 3343 control) children with mild to moderate persistent asthma. Six molecules (beclomethasone dipropionate, budesonide, ciclesonide, flunisolide, fluticasone propionate and mometasone furoate) [corrected] given at low or medium daily doses were used during a period of three months to four to six years. Most trials were blinded and over half of the trials had drop out rates of over 20%.Compared with placebo or non-steroidal drugs, ICS produced a statistically significant reduction in linear growth velocity (14 trials with 5717 participants, MD -0.48 cm/y, 95% CI -0.65 to -0.30, moderate quality evidence) and in the change from baseline in height (15 trials with 3275 participants; MD -0.61 cm/y, 95% CI -0.83 to -0.38, moderate quality evidence) during a one-year treatment period.Subgroup analysis showed a statistically significant group difference between six molecules in the mean reduction of linear growth velocity during one-year treatment (Chi² = 26.1, degrees of freedom (df) = 5, P value < 0.0001). The group difference persisted even when analysis was restricted to the trials using doses equivalent to 200 μg/d hydrofluoroalkane (HFA)-beclomethasone. Subgroup analyses did not show a statistically significant impact of daily dose (low vs medium), inhalation device or participant age on the magnitude of ICS-induced suppression of linear growth velocity during a one-year treatment period. However, head-to-head comparisons are needed to assess the effects of different drug molecules, dose, inhalation device or patient age. No statistically significant difference in linear growth velocity was found between participants treated with ICS and controls during the second year of treatment (five trials with 3174 participants; MD -0.19 cm/y, 95% CI -0.48 to 0.11, P value 0.22). Of two trials that reported linear growth velocity in the third year of treatment, one trial involving 667 participants showed similar growth velocity between the budesonide and placebo groups (5.34 cm/y vs 5.34 cm/y), and another trial involving 1974 participants showed lower growth velocity in the budesonide group compared with the placebo group (MD -0.33 cm/y, 95% CI -0.52 to -0.14, P value 0.0005). Among four trials reporting data on linear growth after treatment cessation, three did not describe statistically significant catch-up growth in the ICS group two to four months after treatment cessation. One trial showed accelerated li. Regular use of ICS at low or medium daily doses is associated with a mean reduction of 0.48 cm/y in linear growth velocity and a 0.61-cm change from baseline in height during a one-year treatment period in children with mild to moderate persistent asthma. The effect size of ICS on linear growth velocity appears to be associated more strongly with the ICS molecule than with the device or dose (low to medium dose range). ICS-induced growth suppression seems to be maximal during the first year of therapy and less pronounced in subsequent years of treatment. However, additional studies are needed to better characterise the molecule dependency of growth suppression, particularly with newer molecules (mometasone, ciclesonide), to specify the respective role of molecule, daily dose, inhalation device and patient age on the effect size of ICS, and to define the growth suppression effect of ICS treatment over a period of several years in children with persistent asthma.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Child, Preschool; Fluocinolone Acetonide; Fluticasone; Growth; Growth Disorders; Humans; Mometasone Furoate; Patient Dropouts; Pregnadienediols; Pregnenediones

2014
Inhaled corticosteroids in children with persistent asthma: dose-response effects on growth.
    The Cochrane database of systematic reviews, 2014, Jul-17, Issue:7

    Inhaled corticosteroids (ICS) are the first-line treatment for children with persistent asthma. Their potential for growth suppression remains a matter of concern for parents and physicians.. To assess whether increasing the dose of ICS is associated with slower linear growth, weight gain and skeletal maturation in children with asthma.. We searched the Cochrane Airways Group Specialised Register of trials (CAGR) and the ClinicalTrials.gov website up to March 2014.. Studies were eligible if they were parallel-group randomised trials evaluating the impact of different doses of the same ICS using the same device in both groups for a minimum of three months in children one to 17 years of age with persistent asthma.. Two review authors ascertained methodological quality independently using the Cochrane Risk of bias tool. The primary outcome was linear growth velocity. Secondary outcomes included change over time in growth velocity, height, weight, body mass index and skeletal maturation.. Among 22 eligible trials, 17 group comparisons were derived from 10 trials (3394 children with mild to moderate asthma), measured growth and contributed data to the meta-analysis. Trials used ICS (beclomethasone, budesonide, ciclesonide, fluticasone or mometasone) as monotherapy or as combination therapy with a long-acting beta2-agonist and generally compared low (50 to 100 μg) versus low to medium (200 μg) doses of hydrofluoroalkane (HFA)-beclomethasone equivalent over 12 to 52 weeks. In the four comparisons reporting linear growth over 12 months, a significant group difference was observed, clearly indicating lower growth velocity in the higher ICS dose group of 5.74 cm/y compared with 5.94 cm/y on lower-dose ICS (N = 728 school-aged children; mean difference (MD)0.20 cm/y, 95% confidence interval (CI) 0.02 to 0.39; high-quality evidence): No statistically significant heterogeneity was noted between trials contributing data. The ICS molecules (ciclesonide, fluticasone, mometasone) used in these four comparisons did not significantly influence the magnitude of effect (X(2) = 2.19 (2 df), P value 0.33). Subgroup analyses on age, baseline severity of airway obstruction, ICS dose and concomitant use of non-steroidal antiasthmatic drugs were not performed because of similarity across trials or inadequate reporting. A statistically significant group difference was noted in unadjusted change in height from zero to three months (nine comparisons; N = 944 children; MD 0.15, 95% CI -0.28 to -0.02; moderate-quality evidence) in favour of a higher ICS dose. No statistically significant group differences in change in height were observed at other time points, nor were such differences in weight, bone mass index and skeletal maturation reported with low quality of evidence due to imprecision.. In prepubescent school-aged children with mild to moderate persistent asthma, a small but statistically significant group difference in growth velocity was observed between low doses of ICS and low to medium doses of HFA-beclomethasone equivalent, favouring the use of low-dose ICS. No apparent difference in the magnitude of effect was associated with three molecules reporting one-year growth velocity, namely, mometasone, ciclesonide and fluticasone. In view of prevailing parents' and physicians' concerns about the growth suppressive effect of ICS, lack of or incomplete reporting of growth velocity in more than 86% (19/22) of eligible paediatric trials, including those using beclomethasone and budesonide, is a matter of concern. All future paediatric trials comparing different doses of ICS with or without placebo should systematically document growth. Findings support use of the minimal effective ICS dose in children with asthma.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Dose-Response Relationship, Drug; Fluticasone; Growth; Growth Disorders; Humans; Mometasone Furoate; Pregnadienediols; Pregnenediones; Randomized Controlled Trials as Topic

2014
Interventions for managing asthma in pregnancy.
    The Cochrane database of systematic reviews, 2014, Oct-21, Issue:10

    Asthma is the most common respiratory disorder complicating pregnancy, and is associated with a range of adverse maternal and perinatal outcomes. There is strong evidence however, that the adequate control of asthma can improve health outcomes for mothers and their babies. Despite known risks of poorly controlled asthma during pregnancy, a large proportion of women have sub-optimal asthma control, due to concerns surrounding risks of pharmacological agents, and uncertainties regarding the effectiveness and safety of different management strategies.. To assess the effects of interventions (pharmacologic and non-pharmacologic) for managing women's asthma in pregnancy on maternal and fetal/infant outcomes.. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (2 June 2014) and the Cochrane Airways Group's Trials Register (4 June 2014).. Randomised and quasi-randomised controlled trials comparing any intervention used to manage asthma in pregnancy, with placebo, no intervention, or an alternative intervention. We included pharmacological and non-pharmacological interventions (including combined interventions). Cluster-randomised trials were eligible for inclusion (but none were identified). Cross-over trials were not eligible for inclusion.We included multi-armed trials along with two-armed trials. We also included studies published as abstracts only.. At least two review authors independently assessed trial eligibility and quality and extracted data. Data were checked for accuracy.. We included eight trials in this review, involving 1181 women and their babies. Overall we judged two trials to be at low risk of bias, two to be of unclear risk of bias, and four to be at moderate risk of bias.Five trials assessed pharmacological agents, including inhaled corticosteroids (beclomethasone or budesonide), inhaled magnesium sulphate, intravenous theophylline, and inhaled beclomethasone verus oral theophylline. Three trials assessed non-pharmacological interventions, including a fractional exhaled nitric oxide (FENO)-based algorithm versus a clinical guideline-based algorithm to adjust inhaled corticosteroid therapy, a pharmacist-led multi-disciplinary approach to management versus standard care, and progressive muscle relaxation (PMR) versus sham training.The eight included trials were assessed under seven separate comparisons. Pharmacological interventionsPrimary outcomes: one trial suggested that inhaled magnesium sulphate in addition to usual treatment could reduce exacerbation frequency in acute asthma (mean difference (MD) -2.80; 95% confidence interval (CI) -3.21 to -2.39; 60 women). One trial assessing the addition of intravenous theophylline to standard care in acute asthma did not report on exacerbations (65 women). No clear difference was shown in the risk of exacerbations with the use of inhaled beclomethasone in addition to usual treatment for maintenance therapy in one trial (risk ratio (RR) 0.36; 95% CI 0.13 to 1.05; 60 women); a second trial also showed no difference, however data were not clearly reported to allow inclusion in a meta-analysis. No difference was shown when inhaled beclomethasone was compared with oral theophylline for maintenance therapy (RR 0.88; 95% CI 0.59 to 1.33; one trial, 385 women). None of these trials reported on neonatal intensive care admissions.. inhaled magnesium sulphate in acute asthma was shown to improve lung function measures (one trial, 60 women); intravenous theophylline in acute asthma was not associated with benefits (one trial, 65 women). No clear differences were seen with the addition of inhaled corticosteroids to routine treatment in three trials (374 women). While inhaled beclomethasone, compared with oral theophylline, significantly reduced treatment discontinuation due to adverse effects in one trial (384 women), no other differences were observed, except for higher treatment adherence with theophylline. Four of the five trials did not report on adverse effects. Non-pharmacological interventionsPrimary outcomes: in one trial, the use of a FENO-based algorithm was shown to significantly reduce asthma exacerbations (RR 0.61; 95% CI 0.41 to 0.90; 220 women); and a trend towards fewer neonatal hospitalisations was observed (RR 0.46; 95% CI 0.21 to 1.02; 214 infants). No exacerbations occurred in one trial assessing pharmacist-led management; this approach did not reduce neonatal intensive care admissions (RR 1.50; 95% CI 0.27 to 8.32; 58 infants). One trial (64 women) assessing PMR did not report on exacerbations or neonatal intensive care admissions.. the use of a FENO-based algorithm to adjust therapy led to some improvements in quality of life scores, as well as more frequent use of inhaled corticosteroids and long-acting β-agonists, and less frequent use of short-acting β-agonists (one trial, 220 women). The FENO-based algorithm was associated with fewer infants with recurrent episodes of bronchiolitis in their first year of life, and a trend towards fewer episodes of croup for infants. Pharmacist-led management improved asthma control scores at six months (one trial, 60 women); PMR improved lung function and quality of life measures (one trial, 64 women). No other differences between comparisons were observed.. Based on eight included trials, of moderate quality overall, no firm conclusions about optimal interventions for managing asthma in pregnancy can be made. Five trials assessing pharmacological interventions did not provide clear evidence of benefits or harms to support or refute current practice. While inhaled magnesium sulphate for acute asthma was shown to reduce exacerbations, this was in one small trial of unclear quality, and thus this finding should be interpreted with caution. Three trials assessing non-pharmacological interventions provided some support for the use of such strategies, however were not powered to detect differences in important maternal and infant outcomes. While a FENO-based algorithm reduced exacerbations, the effects on perinatal outcomes were less certain, and thus widespread implementation is not yet appropriate. Similarly, though positive effects on asthma control were shown with PMR and pharmacist-led management, the evidence to date is insufficient to draw definitive conclusions.In view of the limited evidence base, further randomised trials are required to determine the most effective and safe interventions for asthma in pregnancy. Future trials must be sufficiently powered, and well-designed, to allow differences in important outcomes for mothers and babies to be detected. The impact on health services requires evaluation. Any further trials assessing pharmacological interventions should assess novel agents or those used in current practice. Encouragingly, at least five trials have been identified as planned or underway.

    Topics: Adrenal Cortex Hormones; Algorithms; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Magnesium Sulfate; Muscle Relaxation; Nitric Oxide; Pregnancy; Pregnancy Complications; Randomized Controlled Trials as Topic; Theophylline

2014
[Progress of research on pressurized metered dose inhalers].
    Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases, 2013, Volume: 36, Issue:3

    Topics: Administration, Inhalation; Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Chemistry, Pharmaceutical; Ethanolamines; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Metered Dose Inhalers; Particle Size; Pressure; Pulmonary Disease, Chronic Obstructive

2013
Nebulized corticosteroids in asthma and COPD. An Italian appraisal.
    Respiratory care, 2012, Volume: 57, Issue:7

    Inhaled corticosteroids (ICSs) are the mainstay of anti-inflammatory treatment in subjects with asthma and COPD. This review evaluates the role of nebulizers as an alternative to inhalers for delivering ICSs in asthma and COPD. I selected 16 randomized, placebo-controlled, blinded, long-term studies, mostly carried out in asthma (n = 14) and COPD. Nebulized budesonide has been demonstrated to be effective and safe in children ages 1-8 years, and, with less evidence, in infants and adults with asthma. Other investigations, with the addition of in vitro and in vivo comparison studies, have shown that nebulized beclomethasone, fluticasone, and flunisolide are effective alternatives to nebulized budesonide in asthma and COPD. Efficient delivery of nebulized ICSs requires that the nebulizer system, the nebulized drug formulation, and the inhaling subject interact properly. The practices of mixing nebulized ICSs with bronchodilators and using nebulized ICSs in acute settings are promising, but require further confirmations, and at present cannot be recommended. I conclude that nebulizers may be considered as an effective alternative to inhalers for delivering ICSs and can be recommended to asthmatic and COPD subjects who are unwilling or unable to use inhalers. Newer formulations could possibly offer a relevant advance for a more efficient nebulization of ICSs.

    Topics: Administration, Inhalation; Androstadienes; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Equipment Design; Fluocinolone Acetonide; Fluticasone; Glucocorticoids; Humans; Nebulizers and Vaporizers; Pulmonary Disease, Chronic Obstructive

2012
Airway obstruction lability helps distinguish levels of disease activity in asthma.
    Respiratory medicine, 2012, Volume: 106, Issue:4

    Classifying disease activity in asthma relies on clinical and physiological variables, but these variables do not capture all aspects of asthma that distinguish levels of disease activity. We used data from two pivotal trials of montelukast in asthma to classify disease activity as "high" or "low". We performed a principal component analysis (PCA) of disease activity using 21 efficacy outcome variables, including several novel derived outcome variables reflecting clinical and airway obstruction lability. Then we performed discriminant analysis (DA) based on disease activity classification. PCA revealed 6 factors (daytime asthma control, nighttime-predominant asthma control, airway obstruction, exacerbations, clinical lability, airway obstruction lability) that explained 76% of the variance between outcome variables. Although airway obstruction lability (comprising both diurnal variability in peak expiratory flow and diurnal variability in β-agonist use) accounted for only 6% of the explained variance in PCA, in DA it was more accurate (canonical coefficient 0.75) than traditional measures of asthma severity such as obstruction (-0.54) and daytime control (-0.56) in distinguishing between high and low disease activity. We conclude that airway obstruction lability, a parameter not typically captured in clinical trials, may contribute to more complete assessment of asthma disease activity and may define an emerging clinical target of future therapy.

    Topics: Acetates; Adolescent; Adrenergic beta-Agonists; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Circadian Rhythm; Clinical Trials, Phase III as Topic; Cyclopropanes; Drug Administration Schedule; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Leukotriene Antagonists; Male; Middle Aged; Peak Expiratory Flow Rate; Quinolines; Randomized Controlled Trials as Topic; Severity of Illness Index; Sulfides; Treatment Outcome; Young Adult

2012
Inhaled corticosteroid and long-acting β2-agonist pharmacological profiles: effective asthma therapy in practice.
    Respiratory medicine, 2012, Volume: 106 Suppl 1

    Fixed-dose combinations of inhaled corticosteroids (ICSs) and long-acting β2-agonists (LABAs) have been used to manage asthma for several years. They are the preferred therapy option for patients who do not achieve optimal control of their asthma with low-dose ICS monotherapy. In Europe, four ICS/LABA products are commercially available for asthma maintenance therapy (fluticasone propionate/formoterol fumarate, fluticasone propionate/salmeterol xinafoate, budesonide/formoterol fumarate and beclometasone dipropionate/formoterol fumarate), and other combinations are likely to be developed over the next few years (e.g. mometasone/formoterol fumarate, fluticasone furoate/vilanterol, mometasone/indacaterol). Data from randomized, controlled, clinical trials do not demonstrate a clear overall efficacy difference among ICS/LABA combinations approved for asthma therapy. Conversely, pharmacological data indicate that there may be certain advantages to using one ICS or LABA over another because of the specific pharmacodynamic and pharmacokinetic profiles associated with particular treatments. This review article summarizes the pharmacological characteristics oft he various ICSs and LABAs available for the treatment of asthma, including the potential for ICS and LABA synergy, and gives an insight into the rationale for the development of the latest ICS/LABA combination approved for asthma maintenance therapy.

    Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Drug Combinations; Drug Therapy, Combination; Ethanolamines; Evidence-Based Medicine; Fluticasone; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Glucocorticoids; Humans; Nebulizers and Vaporizers; Randomized Controlled Trials as Topic; Salmeterol Xinafoate; Time Factors; Treatment Outcome

2012
Inhaled corticosteroid therapy with nebulized beclometasone dipropionate.
    Pulmonary pharmacology & therapeutics, 2010, Volume: 23, Issue:3

    Inhaled corticosteroids (ICS) are the most effective anti-inflammatory agents for the management of chronic persistent asthma and are therefore recommended as first-line antiasthmatic therapy in children and adults. In various settings, the administration of ICS via nebulizer rather than hand-held inhaler (HHI) may have certain advantages, as many patients with HHI fail to use these devices properly or efficiently. In particular, young children, the elderly, the acutely ill, and those with restricted dexterity may be unable to coordinate inhalation with actuation of the device or to generate sufficient inspiratory flow to operate breath-actuated devices effectively. Compliance with nebulized therapy may also be better than that with a pressurized metered-dose inhaler (pMDI) plus spacer. Systematic reviews conclude that there is no significant difference in clinical effects between nebulizers and HHI. Performance and clinical effect of nebulization are influenced by several technical aspects such as the nebulizer-drug combination, nebulizer type, output and lung deposition. Among the currently available ICS, nebulized beclometasone dipropionate (BDP) has been in clinical use for more than 35 years, and has demonstrated marked clinical efficacy and a favorable tolerability profile in children and adults with chronic persistent asthma. The clinical efficacy of nebulized beclometasone is discussed in the present review using data from 13 published studies, which included a total of 1250 patients. Three multicenter, randomized, double-blind studies showed that nebulized BDP is as effective as BDP via pMDI plus spacer in a 2:1 dose ratio. Controlled trials involving 497 adults and children demonstrated similar clinical efficacy between nebulized BDP and either nebulized fluticasone propionate or nebulized budesonide. In all these trials, treatment-related adverse effects were generally uncommon, most were mild-to-moderate in severity, and most were associated with the respiratory system. Meta-analyses show that BDP, like other inhaled corticosteroids, has no major influence on patient height, urinary cortisol concentration, or bone metabolism, thus suggesting the absence of growth retardation or any marked effect on adrenal function or the hypothalamic-pituitary-adrenal axis when used in the approved dose range. Overall, nebulized BDP appears to have a particularly important place in asthma therapy: as a general alternative to HHIs (e.g. in patients with poor H

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Age Factors; Anti-Inflammatory Agents; Asthma; Beclomethasone; Clinical Trials as Topic; Forced Expiratory Volume; Humans; Nebulizers and Vaporizers; Patient Education as Topic; Patient Satisfaction; Practice Guidelines as Topic

2010
Addition of long-acting beta2-agonists to inhaled corticosteroids versus same dose inhaled corticosteroids for chronic asthma in adults and children.
    The Cochrane database of systematic reviews, 2010, May-12, Issue:5

    Long-acting inhaled ss(2)-adrenergic agonists (LABAs) are recommended as 'add-on' medication to inhaled corticosteroids (ICS) in the maintenance therapy of asthmatic adults and children aged two years and above.. To quantify in asthmatic patients the safety and efficacy of the addition of LABAs to ICS in patients insufficiently controlled on ICS alone.. We identified randomised controlled trials (RCTs) through electronic database searches (the Cochrane Airways Group Specialised Register, MEDLINE, EMBASE and CINAHL), bibliographies of RCTs and correspondence with manufacturers until May 2008.. We included RCTs if they compared the addition of inhaled LABAs versus placebo to the same dose of ICS in children aged two years and above and in adults.. Two review authors independently assessed studies for methodological quality and extracted data. We obtained confirmation from the trialists when possible. The primary endpoint was the relative risk (RR) of asthma exacerbations requiring rescue oral corticosteroids. Secondary endpoints included pulmonary function tests (PFTs), rescue beta2-agonist use, symptoms, withdrawals and adverse events.. Seventy-seven studies met the entry criteria and randomised 21,248 participants (4625 children and 16,623 adults). Participants were generally symptomatic at baseline with moderate airway obstruction despite their current ICS regimen. Formoterol or salmeterol were most frequently added to low-dose ICS (200 to 400 microg/day of beclomethasone (BDP) or equivalent) in 49% of the studies. The addition of a daily LABA to ICS reduced the risk of exacerbations requiring oral steroids by 23% from 15% to 11% (RR 0.77, 95% CI 0.68 to 0.87, 28 studies, 6808 participants). The number needed to treat with the addition of LABA to prevent one use of rescue oral corticosteroids is 41 (29, 72), although the event rates in the ICS groups varied between 0% and 38%. Studies recruiting adults dominated the analysis (6203 adult participants versus 605 children). The subgroup estimate for paediatric studies was not statistically significant (RR 0.89, 95% CI 0.58 to 1.39) and includes the possibility of the superiority of ICS alone in children.Higher than usual dose of LABA was associated with significantly less benefit. The difference in the relative risk of serious adverse events with LABA was not statistically significant from that of ICS alone (RR 1.06, 95% CI 0.87 to 1.30). The addition of LABA led to a significantly greater improvement in FEV(1) (0.11 litres, 95% 0.09 to 0.13) and in the proportion of symptom-free days (11.88%, 95% CI 8.25 to 15.50) compared to ICS monotherapy. It was also associated with a reduction in the use of rescue short-acting ss(2)-agonists (-0.58 puffs/day, 95% CI -0.80 to -0.35), fewer withdrawals due to poor asthma control (RR 0.50, 95% CI 0.41 to 0.61), and fewer withdrawals due to any reason (RR 0.80, 95% CI 0.75 to 0.87). There was no statistically significant group difference in the risk of overall adverse effects (RR 1.00, 95% 0.97 to 1.04), withdrawals due to adverse health events (RR 1.04, 95% CI 0.86 to 1.26) or any of the specific adverse health events.. In adults who are symptomatic on low to high doses of ICS monotherapy, the addition of a LABA at licensed doses reduces the rate of exacerbations requiring oral steroids, improves lung function and symptoms and modestly decreases use of rescue short-acting ss(2)-agonists. In children, the effects of this treatment option are much more uncertain. The absence of group difference in serious adverse health events and withdrawal rates in both groups provides some indirect evidence of the safety of LABAs at usual doses as add-on therapy to ICS in adults, although the width of the confidence interval precludes total reassurance.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Chronic Disease; Drug Therapy, Combination; Ethanolamines; Formoterol Fumarate; Humans; Randomized Controlled Trials as Topic; Salmeterol Xinafoate

2010
Inter-country variations in anti-asthmatic drug prescriptions for children. Systematic review of studies published during the 2000-2009 period.
    European journal of clinical pharmacology, 2010, Volume: 66, Issue:9

    The objective of this study was to analyse inter-and intra-country quantitative and qualitative differences in anti-asthmatic prescriptions to children and adolescents.. A literature search was performed in EMBASE and MEDLINE to identify pharmaco-epidemiological studies published from January 1, 2000 to December 31, 2008 in which anti-asthmatic prescription prevalence in out-hospital children was measured. A meta-analytic weighted average and 95% confidence intervals of prescription prevalences were calculated using a random-effect(s) model. Inter- and intra-country quantitative and, where possible, qualitative prescribing patterns were compared and assessed.. Twelve studies were identified (ten from Europe, one from Canada and one from the USA), but epidemiological indicators varied widely, and only eight were suitable for meta-analysis. The data from these studies revealed inter-country quantitative differences in prescription prevalences in the overall population

    Topics: Acetates; Adolescent; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Canada; Child; Cromolyn Sodium; Cyclopropanes; Drug Prescriptions; Ethanolamines; Europe; Fluocinolone Acetonide; Fluticasone; Humans; Italy; Prevalence; Quinolines; Salmeterol Xinafoate; Sulfides; United States

2010
Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and children.
    The Cochrane database of systematic reviews, 2010, Dec-08, Issue:12

    Written action plans providing guidance in the early treatment of asthma exacerbations have traditionally advocated doubling of inhaled corticosteroids (ICS) as one of the first steps in treatment.. To compare the clinical effectiveness of increasing the dose of ICS versus keeping the usual maintenance dose as part of a patient-initiated action plan at the onset of asthma exacerbations.. We searched the Cochrane Airways Group Specialised Register (last search October 2009) which is derived from searches of CENTRAL, MEDLINE, EMBASE and CINAHL, as well as handsearched respiratory journals and meeting abstracts.. Randomised controlled trials (RCTs) that compared the strategy of increasing the daily dose of ICS to continuing the same ICS dose in the home management of asthma exacerbations in children or adults with persistent asthma on daily maintenance ICS.. Two review authors independently selected trials, assessed quality and extracted data. We contacted authors of RCTs for additional information.. Five RCTs (four parallel-group and one cross-over) involving a total of 1250 patients (28 children and 1222 adults) with mild to moderate asthma were included. The mean daily baseline ICS dose was 555 mcg (range 200 mcg to 795 mcg) and the mean daily ICS dose achieved following increase was 1520 mcg (range 1000 mcg to 2075 mcg), in CFC beclomethasone dipropionate equivalents. Three parallel-group studies in adults (two doubling and one quadrupling; mean achieved daily dose of 1695 mcg with a range of 1420 to 2075 mcg), involving 1080 patients contributed data to the primary outcome. There was no significant reduction in the need for rescue oral corticosteroids when patients were randomised to the increased ICS compared to stable maintenance dose groups (OR 0.85, 95% CI 0.58 to 1.26). There was no significant difference in the overall risk of non-serious adverse events associated with the increased ICS dose strategy, but the wide confidence interval prevents a firm conclusion. No serious adverse events were reported.. There is very little evidence from trials in children. In adults with asthma on daily maintenance ICS, a self-initiated ICS increase to 1000 to 2000 mcg/day at the onset of an exacerbation is not associated with a statistically significant reduction in the risk of exacerbations requiring rescue oral corticosteroids. More research is needed to assess the effectiveness of increased ICS doses at the onset of asthma exacerbations (particularly in children).

    Topics: Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Chronic Disease; Disease Progression; Humans; Randomized Controlled Trials as Topic

2010
Efficacy of inhaled corticosteroids in infants and preschoolers with recurrent wheezing and asthma: a systematic review with meta-analysis.
    Pediatrics, 2009, Volume: 123, Issue:3

    To compare the efficacy of inhaled corticosteroids in infants and preschoolers with recurrent wheezing or asthma.. Randomized, prospective, controlled trials published January 1996 to March 2008 with a minimum of 4 weeks of inhaled corticosteroids versus placebo were retrieved through Medline, Embase, and Central databases. The primary outcome was wheezing/asthma exacerbations; secondary outcomes were withdrawal caused by wheezing/asthma exacerbations, changes in symptoms score, pulmonary function (peak expiratory flow and forced expiratory volume in 1 second), or albuterol use.. Of eighty-nine studies identified, 29 (N = 3592 subjects) met the criteria for inclusion. Patients who received inhaled corticosteroids had significantly less wheezing/asthma exacerbations than those on placebo (18.0% vs 32.1%); posthoc subgroup analysis suggests that this effect was higher in those with a diagnosis of asthma than wheeze but was independent of age (infants versus preschoolers), atopic condition, type of inhaled corticosteroid (budesonide metered-dose inhaler versus fluticasone metered-dose inhaler), mode of delivery (metered-dose inhaler versus nebulizer), and study quality (Jadad score: <4 vs >/=4) and duration (<12 vs >/=12 weeks). In addition, children treated with inhaled corticosteroids had significantly fewer withdrawals caused by wheezing/asthma exacerbations, less albuterol use, and more clinical and functional improvement than those on placebo.. Infants and preschoolers with recurrent wheezing or asthma had less wheezing/asthma exacerbations and improve their symptoms and lung function during treatment with inhaled corticosteroids.

    Topics: Adrenal Cortex Hormones; Androstadienes; Asthma; Beclomethasone; Budesonide; Child, Preschool; Fluticasone; Humans; Infant; Lung Volume Measurements; Metered Dose Inhalers; Practice Guidelines as Topic; Randomized Controlled Trials as Topic; Respiratory Sounds; Secondary Prevention

2009
Addition of long-acting beta-agonists to inhaled corticosteroids for chronic asthma in children.
    The Cochrane database of systematic reviews, 2009, Jul-08, Issue:3

    Long-acting ss(2)- agonists (LABA) in combination with inhaled corticosteroids (ICS) are increasingly prescribed in asthmatic children.. To compare the safety and benefit of adding LABA to ICS with the same or an increased dose of ICS in children with persistent asthma.. We searched the Cochrane Airways Group Asthma Trials Register (May 2008).. We included randomised controlled trials testing the combination of LABA and ICS versus the same or an increased dose of ICS for minimum of at least 28 days in children and adolescents with asthma. The main outcome was the rate of exacerbations requiring rescue oral steroids. Secondary outcomes included pulmonary function, symptoms, adverse events, and withdrawals.. Studies were assessed independently by two review authors for methodological quality and data extraction. Confirmation was obtained from the trialists when possible.. A total of 25 trials representing 31 control-intervention comparisons were included in the review randomising 5572 children. Most of the participants were inadequately controlled on current ICS dose. We assessed the addition of LABA to the same dose of ICS and to an increased dose of ICS:(1) The addition of LABA to ICS was compared to same dose ICS, namely 400 mcg/day of beclomethasone or less in 16 of the 24 studies. The mean age of participants was 10 years and males accounted for 64% of the study populations. The mean FEV(1) at baseline was 80% of predicted or above in 10 studies; FEV(1) 61% to 79% of predicted in eight studies; and unreported in the remaining study. Participants were inadequately controlled before randomisation in all but seven studies. Compared to ICS alone, the addition of LABA to ICS was not associated with a significant reduction in exacerbations requiring oral steroids (seven studies, RR 0.92 95% CI 0.60 to 1.40). Compared to ICS alone, there was a significantly greater improvement in FEV1 with the addition of LABA (nine studies; 0.08 Litres, 95% CI 0.06 to 0.11) but no statistically significant group differences in symptom-free days, hospital admission, quality of life, use of reliever medication, and adverse events. Withdrawals occurred significantly less frequently with the addition of LABA.(2) A total of seven studies assessed the addition of LABA to ICS therapy compared with an increased dose of ICS randomising 1021 children. The mean age of participants was 8 years with 67% of males. The baseline mean FEV(1) was 80% of predicted or above in 2 of the 3 studies reporting this characteristic. All trials enrolled participants who were inadequately controlled on a baseline dose equivalent to 400 mcg/day of beclomethasone or less. There was no group significant difference in the risk of an exacerbation requiring oral steroids with the combination of LABA and ICS compared to a double dose of ICS (two studies, RR 1.5 95% CI 0.65 to 3.48). The increased risk of hospital admission with combination therapy was also not statistically significant (RR 2.21 95% CI 0.74 to 6.64). Compared to double dose ICS, use of LABA was associated with a significantly greater improvement in morning PEF (four studies; MD 7.55 L/min 95% CI: 3.57 to 11.53) and evening PEF L/min (three studies, MD 5.5 L/min; 95% CI 1.21 to 9.79), but there were insufficient data to aggregate data on FEV(1), symptoms, rescue reliever use, and quality of life. There was no s. In children with persistent asthma, the addition of LABA to ICS was not associated with a significant reduction in the rate of exacerbations requiring systemic steroids, but was superior for improving lung function compared to the same dose of ICS. Similarly, compared to a double dose ICS, the combination of LABA and ICS did not significantly increase the risk of exacerbations requiring oral steroids, but was associated with a significantly greater improvement in PEF and growth. The possibility of an increased risk of rescue oral steroids and hospital admission with LABA therapy needs to be further examined.

    Topics: Adolescent; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Drug Therapy, Combination; Ethanolamines; Female; Formoterol Fumarate; Humans; Male; Salmeterol Xinafoate

2009
Dose-response relationship of inhaled corticosteroids and cataracts: a systematic review and meta-analysis.
    Respirology (Carlton, Vic.), 2009, Volume: 14, Issue:7

    The risk of cataracts associated with the long-term use of inhaled corticosteroids (ICS) is poorly recognized, yet may be of major public health importance. The aim of this study was to determine the dose-response relationship of ICS use and risk of cataracts in adults.. A systematic review and meta-analysis was performed of case-control studies of cataracts and ICS use, which included at least two doses of ICS and in which the number of cases and controls using each dose of ICS was reported. The primary outcome variable was risk of cataracts.. Four case-control studies were identified, with a total of 46 638 cases and 146 378 controls. There was a significant relationship between the risk of cataracts and ICS dose, with a random effects pooled odds ratio for risk of cataracts per 1000 microg increase in daily beclomethasone dipropionate dose of 1.25 (95% CI: 1.14-1.37).. The risk of cataracts was increased by approximately 25% for each 1000 microg per day increase in the dose of beclomethasone dipropionate or equivalent. These findings reinforce the importance of prescribing within the therapeutic dose-response range for ICS in asthma and the need to determine the dose-response relationship for the efficacy of ICS in COPD. Screening for the presence of cataracts could usefully be undertaken in older subjects with asthma and COPD, particularly current or ex-smokers.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Asthma; Beclomethasone; Cataract; Dose-Response Relationship, Drug; Humans; Pulmonary Disease, Chronic Obstructive; Risk Factors

2009
[Do fixed combinations increase effectiveness in asthma bronchiale?].
    Deutsche medizinische Wochenschrift (1946), 2009, Volume: 134 Suppl 10

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Dose-Response Relationship, Drug; Drug Combinations; Ethanolamines; Fluticasone; Forced Expiratory Volume; Formoterol Fumarate; Humans; Middle Aged; Peak Expiratory Flow Rate; Randomized Controlled Trials as Topic; Salmeterol Xinafoate; Treatment Outcome

2009
Particle size of inhaled corticosteroids: does it matter?
    The Journal of allergy and clinical immunology, 2009, Volume: 124, Issue:6 Suppl

    A question with respect to asthma therapy revolves around the issue of whether better efficacy occurs with an ultrafine-particle inhaled corticosteroid because of better lung deposition into the distal airways. This article reviews particle size and delivery devices of different steroids, clinical outcomes of small- versus large-particle steroids, and the issue of pharmacoeconomics.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Beclomethasone; Clinical Trials as Topic; Dose-Response Relationship, Drug; Humans; Particle Size; Treatment Outcome

2009
Inhaled BDP/formoterol extra-fine combination. Evidence and future perspectives.
    Pneumologie (Stuttgart, Germany), 2009, Volume: 63 Suppl 2

    The combination of inhaled corticosteroids (ICS) and long acting Beta-2 agonists (LABA) represents the mainstay of current treatment of moderate to severe persistent asthma. Corticosteroids and LABA combine the main pillars of asthma therapy--inhibition of inflammation and bronchodilation--and they may potentiate each other when they simultaneously reach the pharmacological target. A new extra-fine formulation containing the combination of inhaled beclometasone (BDP) and formoterol (F) (with the non polluting HFA-Hydrofluoroalkane-134a as propellant) is now available on the market. The extra-fine formulation increases the deposition into the peripheral airways and a greater proportion of the inhaled compound reaches the pharmacological target. Thus, the dose of ICS can be decreased and the risk-benefit profile improves. The efficacy and tolerance of BDP/F extra-fine combination has been documented in randomized clinical trials into which patients with moderate to severe asthma were included. These trials confirmed that the new extra-fine combination is as effective as the other fixed combinations.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Drug Therapy, Combination; Ethanolamines; Evidence-Based Medicine; Forecasting; Formoterol Fumarate; Humans

2009
[One point message of JGL2006 (children)--level of severity and control].
    Arerugi = [Allergy], 2008, Volume: 57, Issue:5

    Topics: Administration, Inhalation; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Fluticasone; Glucocorticoids; Humans; Japan; Pediatrics; Practice Guidelines as Topic; Severity of Illness Index

2008
Dose-response relationship for risk of non-vertebral fracture with inhaled corticosteroids.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2008, Volume: 38, Issue:9

    To determine the strength of association between the dose of inhaled corticosteroids (ICS) and risk of non-vertebral fracture in adults.. A systematic review and meta-analysis of case-control studies of non-vertebral fractures in adults, in which at least two doses of ICS were reported as the dose of beclomethasone dipropionate (BDP) or equivalent.. Five case-control studies were identified, with a total of 43 783 cases and 259 936 controls. There was an association between the risk of non-vertebral fracture and increasing dose of BDP. The random-effects odds ratio of relative risk for a non-vertebral fracture was 1.12 (95% confidence interval 1.00-1.26) per 1000 microg increase in the daily dose of BDP or equivalent.. In older adults, the relative risk of non-vertebral fractures increases by about 12% for each 1000 microg/day increase in the dose of BDP or equivalent. The magnitude of this risk was considerably less than other common risk factors for fracture in the older adult.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Beclomethasone; Case-Control Studies; Dose-Response Relationship, Drug; Fractures, Bone; Humans; Risk

2008
Inhaled beclometasone dipropionate/formoterol extra-fine fixed combination in the treatment of asthma: evidence and future perspectives.
    Expert opinion on pharmacotherapy, 2008, Volume: 9, Issue:3

    Combinations of a long-acting beta(2)-agonist (LABA) and an inhaled corticosteroid (ICS) are effective and safe options in asthma management.. To review available data on a recently developed combination of beclometasone dipropionate (BDP) and formoterol (F) given via a pressurized metered-dose inhaler.. Published data on preclinical and clinical studies were reviewed.. In the treatment of asthma, BDP/F was shown to be at least as effective and well-tolerated as other available combinations of ICS and LABA with the advantage of a better cost effectiveness, and more effective in improving asthma control than BDP and formoterol given via separate inhalers. The extra-fine BDP/F combination appears to be a valuable therapeutic option in the management of asthma.

    Topics: Administration, Inhalation; Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Drug Combinations; Ethanolamines; Formoterol Fumarate; Humans; Metered Dose Inhalers; Particle Size

2008
Ciclesonide versus other inhaled steroids for chronic asthma in children and adults.
    The Cochrane database of systematic reviews, 2008, Apr-16, Issue:2

    Inhaled corticosteroids (ICS) are an integral part of asthma management, and act as an anti-inflammatory agent in the airways of the lung. These agents confer both significant benefit in terms of symptom management and improvement in lung function, but may also cause harm in terms of local and systemic side-effects. Ciclesonide is a novel steroid that is metabolised to its active component in the lung, making it a potentially useful for reducing local side effects.. To assess the efficacy and adverse effects of ciclesonide relative to those of other inhaled corticosteroids in the management of chronic asthma.. We searched the Cochrane Airways Group register of trials with pre-defined terms. Additional searches of PubMed and Clinicalstudyresults.org were undertaken. The literature searches for this review are current up to June 2007.. Randomised parallel or crossover studies were eligible for the review. We included studies comparing ciclesonide with other steroids both at nominally equivalent dose or lower doses of ciclesonide.. Two review authors independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials.. Twenty one trials involving 7243 participants were included. Equal daily doses of ciclesonide and beclomethasone (BDP) or budesonide (BUD) gave similar results for peak expiratory flow rates (PEF), although forced vital capacity (FVC) was higher with ciclesonide. Data on forced expired volume in one second (FEV1) were inconsistent. Withdrawal data and symptoms were similar between treatments. Compared with the same dose of fluticasone (FP), data on lung function parameters (FEV1, FVC and PEF) did not differ significantly. Paediatric quality of life score favoured ciclesonide. Candidiasis was less frequent with ciclesonide, although other side-effect outcomes did not give significant differences in favour of either treatment. When lower doses of ciclesonide were compared to BDP or BUD, the difference in FEV1 did not reach significance but we cannot exclude a significant effect in favour of BDP/BUD. Other lung function outcomes did not give significant differences between treatments. Paediatric quality of life scores did not differ between treatments. Adverse events occurred with similar frequency between ciclesonide and BDP/BUD. Comparison with FP at half the nominal dose was undertaken in three studies, which indicated that FEV1 was not significantly different, but was not equivalent between the treatments (per protocol: -0.05 L 95% confidence intervals -0.11 to 0.01).. The results of this review give some support to ciclesonide as an equivalent therapy to other ICS at similar nominal doses. The studies assessed low doses of steroids, in patients whose asthma required treatment with low doses of steroids. At half the dose of FP and BDP/BUD, the effects of ciclesonide were more inconsistent The effect on candidiasis may be of importance to people who find this to be problematic. The role of ciclesonide in the management of asthma requires further study, especially in paediatric patients. Further assessment against FP at a dose ratio of 1:2 is a priority.

    Topics: Administration, Inhalation; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Chronic Disease; Fluticasone; Humans; Pregnenediones; Randomized Controlled Trials as Topic

2008
[Fluticasone propionate in children and infants with asthma].
    Archives de pediatrie : organe officiel de la Societe francaise de pediatrie, 2007, Volume: 14, Issue:4

    The known efficacy of fluticasone propionate in adults, comparable at half-dosage of corticosteroids has been validated by the market authorization (MA) and by the national and international guidelines for beclomethasone. This could be partly explained by its pharmacological properties, affinity for glucocorticosteroid receptors, lung deposition and lipophilicity. The limited systemic adverse events is due to its low bioavailability, optimal hepatic clearance, high plasma protein binding. The efficacy in asthmatic children has been confirmed in clinical studies showing a "plateau" efficacy between 100 and 200 microg/d for the majority of children. Most children are controlled by such dosages: the added value of increasing posology on asthma control exists but is small. A high off-label posology does not allow more quickly asthma control and therefore is not justified. A twice daily dosing is more efficient, particularly for initiation of maintenance therapy, than a once daily dosing. A literature survey confirms that, at MA recommended daily doses in children (100-200 microg), fluticasone propionate has no clinically significant effect either on hypothalamic-pituitary-adrenal (HPA) axis (basal function or stimulation tests), bone or growth velocity. However, high daily doses (higher to 500 microg/day) for long periods expose to systemic adverse effects with measurable consequences on growth rate, bone density (decreasing biochemical makers of bone formation) and HPA function. Several cases of adrenal insufficiency that may have led to acute adrenal crisis have been reported in 4- to 10-year-old children receiving fluticasone propionate in doses between 500 to 2000 microg daily. In case of surgery or infection, a preventive treatment of adrenal insufficiency with hydrocortisone should be proposed for children treated for more than 6 months with such high daily doses. Such children need definitely an advice from paediatricians specialized in chest diseases as well as in endocrinology. It is important to recall that the clinical benefit of daily doses of inhaled corticosteroids higher than recommended is low and that the good use of inhaled corticosteroids particularly in children lays on the careful search of the minimal efficient daily doses.

    Topics: Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biological Availability; Bronchodilator Agents; Child; Child, Preschool; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Fluticasone; Humans; Infant; Practice Guidelines as Topic

2007
The properties of inhaled corticosteroids: similarities and differences.
    Primary care respiratory journal : journal of the General Practice Airways Group, 2007, Volume: 16, Issue:3

    Inhaled corticosteroids remain the most important therapy for chronic asthma in both adults and children. As all inhaled corticosteroids act by binding to a common glucocorticoid receptor there is little evidence of any real difference in clinical efficacy between the different inhaled corticosteroids. The main potential differences are in their propensity to cause side effects. Local side effects such as a hoarse voice do occur in a proportion of adults and there is some limited evidence that ciclesonide may cause less local side effects. In adults there is little evidence for clinically important systemic side effects from doses of inhaled steroids below 800 mcg/day (beclomethasone equivalent). Above this dose a proportion of patients may show some adrenocortical suppression, though it is unlikely to be of clinical importance. Data on bone mineral density and fracture rates is discrepant, but an overview would suggest that below 800 mcg/day there is no increase in fracture risk whereas above this dose there might be an increased fracture risk. The properties of ciclesonide would suggest that it has less propensity for systemic side effects, but large long term studies are needed to confirm this. In children using inhaled steroids at above-licensed doses reductions in short-term growth can occur, but there is little evidence for reductions in long-term growth at normal doses. At above-licensed doses, biochemical adrenocortical suppression can occur with some unusual but documented cases of clinical Addisonian crisis. Limited evidence in paediatric age groups would suggest that ciclesonide may have some advantage although it is not as yet licensed in all countries for paediatric use. Data on differences in side effects between normal and asthmatic patients, and between asthmatic patients with near-normal lung function compared to those with impaired lung function, indicate that inhaled corticosteroids (particularly fluticasone) are absorbed more in those with normal lung function; this strongly supports stepping down the inhaled steroid dose when asthma is controlled - as is recommended in asthma guidelines.

    Topics: Administration, Inhalation; Adrenal Glands; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bone and Bones; Dose-Response Relationship, Drug; Glucocorticoids; Growth; Hoarseness; Humans; Nebulizers and Vaporizers; Practice Guidelines as Topic; Pregnenediones

2007
Hypothalamic-pituitary-adrenal axis suppression in asthmatic children on inhaled corticosteroids (Part 2)--the risk as determined by gold standard adrenal function tests: a systematic review.
    Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2007, Volume: 18, Issue:6

    The evidence for hypothalamic-pituitary-adrenal axis (HPA) suppression by inhaled corticosteroids (ICS) was found to be conflicting. Reviewers have not distinguished between gold standard and basal adrenal function tests. The utility of the latter is limited by physiological and pathological variability as well as by methodological concerns. The risk of HPA suppression in asthmatic children and adolescents treated with ICS, as determined by gold standard adrenal function tests, needs to be established. A systematic review of the literature from January 1973 to July 2005 was performed. The Medline and Cochrane databases were searched, the reference lists of retrieved articles were inspected and pharmaceutical companies were approached. Randomized-controlled trials, cohort and case-control studies designed to detect HPA suppression caused by ICS, diagnosed by the insulin tolerance test (ITT) or the metyrapone test, performed on asthmatics of all ages not on oral steroids, were included and assessed for methodological quality. Of the 22 identified studies only four met the criteria for inclusion. All of these were published before 1988 and only one was methodologically sound. The cohort study showed that the baseline risk for HPA suppression is 0% while the absolute risk is 100% in asthmatic children treated with a beclomethasone dipropionate metered dose inhaler at a dose of 250-600 mug/m(2)/day for 6-42 months. As suggested by other observations these results could be generalized to other ICS. They may be of clinical significance especially if children are subjected to stress. Further research is needed to establish the cumulative dose for all ICS at which HPA suppression will be precipitated. Guidelines for future trials are suggested.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adrenal Insufficiency; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Humans; Hypothalamo-Hypophyseal System; Pituitary-Adrenal Function Tests; Pituitary-Adrenal System; Reproducibility of Results; Research Design; Risk Assessment; Treatment Outcome

2007
Fluticasone versus beclomethasone or budesonide for chronic asthma in adults and children.
    The Cochrane database of systematic reviews, 2007, Oct-17, Issue:4

    Beclomethasone dipropionate (BDP) and budesonide (BUD) are commonly prescribed inhaled corticosteroids for the treatment of asthma. Fluticasone propionate (FP) is newer agent with greater potency in in-vitro assays.. To compare the efficacy and safety of Fluticasone to Beclomethasone or Budesonide in the treatment of chronic asthma.. We searched the Cochrane Airways Group trial register (January 2007) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997 to 2006).. Randomised trials in children and adults comparing Fluticasone to either Beclomethasone or Budesonide in the treatment of chronic asthma.. Two reviewers independently assessed articles for inclusion and methodological quality. One reviewer extracted data. Quantitative analyses were undertaken using RevMan analyses 1.0.1.. Seventy-one studies (14,602 participants) representing 74 randomised comparisons met the inclusion criteria. Methodological quality was fair. Dose ratio 1:2: FP produced a significantly greater end of treatment FEV1 (0.04 litres (95% CI 0 to 0.07 litres), end of treatment and change in morning PEF, but not change in FEV1 or evening PEF. This applied to all drug doses, age groups, and delivery devices. No difference between FP and BDP/BUD were seen for trial withdrawals. FP led to fewer symptoms and less rescue medication use. When given at half the dose of BDP/BUD, FP led to a greater likelihood of pharyngitis. There was no difference in the likelihood of oral candidiasis. Plasma cortisol and 24 hour urinary cortisol was measured frequently but data presentation was limited. Dose ratio 1:1: FP produced a statistically significant difference in morning PEF, evening PEF, and FEV1 over BDP or BUD. The effects on exacerbations were mixed. There were no significant differences incidence of hoarseness, pharyngitis, candidiasis, or cough.. Fluticasone given at half the daily dose of beclomethasone or budesonide leads to small improvements in measures of airway calibre, but it appears to have a higher risk of causing sore throat and when given at the same daily dose leads to increased hoarseness. There are concerns about adrenal suppression with Fluticasone given to children at doses greater than 400 mcg/day, but the randomised trials included in this review did not provide sufficient data to address this issue.

    Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Fluticasone; Humans; Randomized Controlled Trials as Topic

2007
Comparative improvement of asthma symptoms and expiratory flows after corticosteroid treatment: a method to assess the effect of corticosteroids on large vs. small airways?
    Respiratory medicine, 2006, Volume: 100, Issue:3

    The magnitude of improvement of respiratory symptoms (RS) and expiratory flows (EF) following corticosteroid treatment may vary from one asthmatic patient to another. The distribution of ratio of improvement of the above parameters was assessed in 937 patients with asthma of variable severity who took part in three clinical trials comparing the effects of chlorofluorocarbon-propelled beclomethasone dipropionate (CFC-BDP) with similar (n:316) or half-doses (n:581) of extrafine hydrofluoroalkane-propelled (HFA-BDP) on asthma control. We calculated the ratio of improvement of shortness of breath, wheezing, sleep disturbance, cough, and chest tightness over the following physiological parameters: forced expiratory volume in 1s (FEV1), FEF(25/75%), morning peak expiratory flow, and FVC, from the baseline value to the last set of measures in the study, while on the study medication. We hypothesized that the ratio of RS/EF would have a normal distribution and would be higher with extrafine HFA-BDP compared with CFC-BDP, which has a larger particle size, when FEV1 is used, as it mostly assesses large airways. Ratios of improvement were normally distributed for both drugs and no significant shift in its distribution curve was found for HFA-BDP. The ratio of changes in FEF(25/75%)/FEV1 was similar in the two groups. In conclusion, the ratio of improvement of RS/EF is normally distributed over a narrow range, showing a generally good correlation between improvements in EF and symptoms in asthma; it was, however, similar for the two BDP molecules tested. This may suggest that this ratio is not useful for evaluating the effect of corticosteroids on small airways, or that extrafine HFA-BDP acts at the level of large- to moderate-caliber airways to produce most of its beneficial effect.

    Topics: Administration, Inhalation; Adult; Aerosol Propellants; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chlorofluorocarbons; Female; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Male; Middle Aged; Randomized Controlled Trials as Topic; Respiratory Function Tests

2006
Holding chambers versus nebulisers for inhaled steroids in chronic asthma.
    The Cochrane database of systematic reviews, 2006, Jan-25, Issue:1

    Inhaled corticosteroids are available in the form of a suspension for nebulisation, although the role of this mode of therapy in the treatment of chronic asthma is still unclear.. To assess the efficacy and safety of inhaled corticosteroids delivered via nebuliser versus holding chamber for the treatment of chronic asthma.. We searched the Cochrane Airways Group Trial Register (1999) and reference lists of articles. We contacted the authors of studies and pharmaceutical companies for additional studies and hand-searched the British Journal of Clinical Research, European Journal of Clinical Research and major respiratory society meeting abstracts (1997-1999). Date of last search August 2005.. Randomised controlled trials comparing nebuliser to holding chamber in the delivery of inhaled corticosteroids for the treatment of chronic asthma. All age groups of patients were considered. Two reviewers assessed articles for inclusion; two reviewers independently assessed included studies for methodological quality.. One reviewer extracted data; authors were contacted to clarify missing information. Quantitative analyses were undertaken using Review Manager 4.1 with MetaView 3.1.. Two studies were selected for inclusion (63 subjects), both concerned adults. An additional small study including 14 children was identified for the 2005 update. Methodological quality was variable. Due to design differences it was not appropriate to pool the studies. The single high quality study compared budesonide 2000-8000 mcg delivered via Pari Inhalier Boy jet nebuliser with inspiration-only inhalation to budesonide 1600 mcg via large volume spacer. The nebuliser delivery led to higher morning peak expiratory flow values (25 L/min p<0.01), higher evening values (30L/min, p<0.01), lower rescue beta2 agonist use and symptom scores compared to the holding chamber delivery.. Budesonide in high dose delivered by the particular nebuliser used in the only double-blinded study that could be included in this review was more effective than budesonide 1600 mcg via a large volume spacer. However, it is not clear whether this was an effect of nominal dose delivered or delivery system. Cost, compliance and patient preference are important determinants of clinical effectiveness that still require further assessment. Future studies are needed to evaluate the relative effectiveness of inhaled corticosteroids delivered by different combinations of nebuliser/compressor compared to holding chamber. Moreover, further studies assessing these delivery methods are needed in infants and pre-school children, as these are groups that are likely to be considered for treatment with nebulised corticosteroids.

    Topics: Administration, Topical; Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Drug Delivery Systems; Glucocorticoids; Humans; Nebulizers and Vaporizers; Randomized Controlled Trials as Topic

2006
Allergic airway inflammation and beta-adrenoceptor dysfunction.
    Cell biochemistry and biophysics, 2006, Volume: 44, Issue:1

    A reduced response to beta-adrenoceptor agonists has been reported in airways of asthmatic subjects. Mechanisms for beta-adrenoceptor dysfunction are (1) inactivation or downregulation of beta-adrenoceptors by specific agonists (homologous desensitization) or by inflammatory mediations (heterologous desensitization), (2) inactivation or downregulation of second messengers of beta-adrenoceptor pathway. Studies from our laboratory have shown that allergen challenge of passively sensitized human bronchi causes a beta-adrenoceptor dysfunction as a result of reduced activity of the receptor-coupled Gs protein. The dysfunction was prevented by leukotriene-receptor antagonists or a cell membrane stabilizer, but not by an antihistimine or indomethacin, suggesting a central role of leukotrienes released from resident inflammatory cells in its genesis. Furthermore, the beta-adrenoceptor response and Gs protein function after allergen exposure were restored by short-term (3 h) incubation with beclomethasone dipropionate, suggesting an effect independent of gene transcription. Restoration of the intracellular beta-adrenoceptor effector pathway may contribute to the efficacy of corticosteroids in the acute treatment of asthma.

    Topics: Adrenergic beta-Agonists; Allergens; Asthma; Beclomethasone; Humans; In Vitro Techniques; Leukotriene Antagonists; Models, Biological; Muscle Contraction; Muscle Relaxation; Muscle, Smooth; Receptors, Adrenergic, beta

2006
[Longitudinal growth in children with asthma treated with inhaled glucocorticoids].
    Ugeskrift for laeger, 2006, Feb-27, Volume: 168, Issue:9

    Randomised, double-blind studies with a knemometer have shown that the risk of inhaled glucocorticoid-induced growth suppression depends on dose, administration regimen, delivery device and specific glucocorticoid. Dry-powder beclomethasone dipropionate, 300-400 microg daily, and budesonide, 400 microg daily, suppress height growth rate by 20-25% during the first year of treatment, whereas lower doses of budesonide and fluticasone propionate do not affect growth rate. Available assessments of final height are flawed by poor compliance rates. Children with asthma on continuous treatment with inhaled glucocorticoids should have their height measured at six-month intervals. In the case of growth deviation, they should be referred for evaluation.

    Topics: Administration, Inhalation; Anthropometry; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Height; Bronchodilator Agents; Budesonide; Child; Dose-Response Relationship, Drug; Glucocorticoids; Growth; Humans; Leg; Randomized Controlled Trials as Topic

2006
Fluticasone versus HFA-beclomethasone dipropionate for chronic asthma in adults and children.
    The Cochrane database of systematic reviews, 2006, Apr-19, Issue:2

    The relative efficacy of fluticasone (FP) and beclomethasone (BDP) propelled with CFCs has been well established. The potency of HFA-BDP is thought to have been improved with new propellant and some studies suggest that it may equipotent at half the dose of CFC propelled-BDP. There is a need to revisit this question in the light of a potentially more potent new non-CFC propellant.. To determine the relative efficacy of FP and HFA-propelled BDP in chronic asthma.. The Cochrane Airways Group Specialised Register was searched using pre-specified terms. Searches were current as of January 2006.. Randomised controlled trials were eligible for inclusion in the review. We compared either CFC or HFA-propelled FP with HFA-propelled BDP. We made a distinction between HFA-BDP and HFA-BDP extra fine, which dispenses smaller particles of drug, leading to different, usually more peripheral distribution in the airways. Any inhaler device was considered, and there was no restriction on studies with or without spacers. We included studies which assessed HFA-BDP given via either pMDI, breath-actuated MDI, or DPI.. Two reviewers independently assessed studies for inclusion in the review. Data were extracted and entered in to RevMan 4.2 using standard meta-analytical techniques with predefined criteria for exploring statistical heterogeneity.. Eight studies (1260 participants) met the inclusion criteria of the review. One study was conducted in children. Study reporting quality was fair, but all studies were of short duration (three to twelve weeks). Only studies assessing HFA-BDP extra fine in comparison with FP were identified. Lung function was not significantly different between extra fine BDP and FP when compared at the same dose in parallel studies, change in FEV1: 0.04 litres (95% CI -0.03 to 0.11 litres; three studies, 659 adults); change in am PEF: -0.69 litres (95% CI -11.21 to 9.83 litres; two studies, 364 adults). Individual studies reported non-significant findings in symptom scores and quality of life questionnaires. There was no significant difference between FP and HFA-BDP in the risk of study withdrawal, dysphonia or when data were reported as any adverse event.. There was no significant difference between FP and extra fine HFA-BDP on FEV(1) or peak flow at a dose ratio of 1:1. However, the number of studies and width of the confidence intervals in the analyses do not exclude a clinically meaningful difference between these two drugs. Difficulty in the successful manipulation of the devices studied may be a barrier to the widespread use of MDIs. One paediatric study was included in the review, so extrapolation of the findings of this review to children is limited. Further longer term studies in adults and children with moderate and severe asthma are required.

    Topics: Administration, Inhalation; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child; Chronic Disease; Fluticasone; Humans; Nebulizers and Vaporizers; Randomized Controlled Trials as Topic

2006
Inhaled ciclesonide versus inhaled budesonide or inhaled beclomethasone or inhaled fluticasone for chronic asthma in adults: a systematic review.
    BMC family practice, 2006, Jun-05, Volume: 7

    Ciclesonide is a new inhaled corticosteroids licensed for the prophylactic treatment of persistent asthma in adults. Currently beclomethasone dipropionate, budesonide and fluticasone propionate are the most commonly prescribed inhaled corticosteroids for the treatment of asthma but there has been no systematic review comparing the effectiveness and safety ciclesonide to these agents. We therefore aimed to systematically review published randomised controlled trials of the effectiveness and safety of ciclesonide compared to alternative inhaled corticosteroids in people with asthma.. We performed literature searches on MEDLINE, EMBASE, PUBMED, the COCHRANE LIBRARY and various Internet evidence sources for randomised controlled trials or systematic reviews comparing ciclesonide to beclomethasone or budesonide or fluticasone in adult humans with persistent asthma. Data was extracted by one reviewer.. Five studies met the inclusion criteria. Methodological quality was variable. There were no trials comparing ciclesonide to beclomethasone. There was no significant difference between ciclesonide and budesonide or fluticasone on the following outcomes: lung function, symptoms, quality of life, airway responsiveness to a provoking agent or inflammatory markers. However, the trials were very small in size, increasing the possibility of a type II error. One trial demonstrated that the combined deposition of ciclesonide (and its active metabolite) in the oropharynx was 47% of that of budesonide while another trial demonstrated that the combined deposition of ciclesonide (and its active metabolite) in the oropharynx was 53% of that of fluticasone. One trial demonstrated less suppression of cortisol in overnight urine collection after ciclesonide compared to fluticasone (geometric mean fold difference = 1.5, P < 0.05) but no significant difference in plasma cortisol response.. There is very little evidence comparing CIC to other ICS, restricted to very small, phase II studies of low power. These demonstrate CIC has similar effectiveness and efficacy to FP and BUD (though equivalence is not certain) and findings regarding oral deposition and HPA suppression are inconclusive. There is no direct comparative evidence that CIC causes fewer side effects since none of the studies reported patient-based outcomes.

    Topics: Administration, Inhalation; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Chronic Disease; Fluticasone; Humans; Pregnenediones; Randomized Controlled Trials as Topic

2006
The dose-response characteristics of inhaled corticosteroids when used to treat asthma: an overview of Cochrane systematic reviews.
    Respiratory medicine, 2006, Volume: 100, Issue:8

    Inhaled corticosteroids form the cornerstone of treatment for most patients with asthma. A range of compounds are available with a wide range of prescribable doses. In this overview, we summarize the findings from a number of Cochrane systematic reviews that have examined the relative benefits of different doses of beclometasone dipropionate, budesonide and fluticasone propionate when used to treat children and adults. The key findings are that all inhaled corticosteroids demonstrate a dose-response relationship for efficacy measures, but most of the benefit in mild-to-moderate severity disease is gained in the low-to-moderate dose range of each drug. In this group, high doses of fluticasone lead to small improvements in measures of control at the expense of a steep increase in the incidence of oral side-effects. In patients with severe disease who are dependent on oral steroids, there may be appreciable benefit in reducing oral steroids from very high compared with high doses of fluticasone.

    Topics: Administration, Inhalation; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Dose-Response Relationship, Drug; Evidence-Based Medicine; Fluticasone; Forced Expiratory Volume; Humans; Peak Expiratory Flow Rate; Treatment Outcome

2006
Managing asthma in the 21st century: role of pharmacogenetics.
    Pediatric annals, 2006, Volume: 35, Issue:9

    As discussed above, pharmacogenetics offers the opportunity to ascertain associations between genetic variability and response (both salutary and adverse) to various asthma medications. Although there have been multiple asthma pharmacogenetic studies, the field of pharmacogenetics is still in its infancy. As this field advances, it is estimated that an increasing proportion of individual variation in responses to pharmacotherapy will be predictable based on associations with particular genetic polymorphisms or patterns of polymorphisms. These associations hold out the promise of being able to individualize pharmacotherapy by providing specific therapy to those most likely to respond, while avoiding therapy in those most likely to suffer adverse effects. Currently, only the pharmacogenetic effects of position 16 of the beta-adrenergic receptor appear to be of sufficient magnitude to affect asthma therapy, but further understanding of the mechanism of this association as well as prospective replication with long-acting beta-agonists is still required to bring pharmacogenetics into the clinical arena. Most other pharmacogenetic effects are likely to be of smaller magnitude or, as with 5-LO or CRHR1 polymorphisms, less common. Thus, ultimately, we most likely will use "panels" of polymorphisms to calculate the relative risk-benefit ratio of a particular therapeutic course for an individual patient. It is hoped that, within the next decade, pharmacogenetic information will allow us to treat those who can benefit most from particular asthma medications and to avoid toxicity by administering medications to those unlikely to experience toxicity. If pharmacogenetics fulfills its promise, then not only will we be able to administer corticosteroids and other therapies to pediatric patients with asthma who are most likely to respond or to those least likely to experience adverse effects but we also will be able to introduce or develop drugs for asthma that would otherwise have been held back due to potential toxicity in a subset of patients.

    Topics: Acetates; Adrenergic beta-Agonists; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cyclopropanes; Genotype; Humans; Pharmacogenetics; Polymorphism, Single Nucleotide; Quinolines; Receptors, Adrenergic, beta; Sulfides

2006
[Biotherapies for the treatment of asthma: are they the treatment of the future?].
    Revue des maladies respiratoires, 2006, Volume: 23, Issue:4 Pt 2

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Animals; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Beclomethasone; Biological Therapy; Child; Controlled Clinical Trials as Topic; Disease Models, Animal; Eosinophilia; Etanercept; Forecasting; Glucocorticoids; Haplorhini; Humans; Hypereosinophilic Syndrome; Immunoglobulin E; Immunoglobulin G; Immunosuppressive Agents; Interleukin-5; Omalizumab; Receptors, Tumor Necrosis Factor; Time Factors; Tumor Necrosis Factor-alpha

2006
Inhaled corticosteroids in the treatment of respiratory allergy: safety vs. efficacy.
    Jornal de pediatria, 2006, Volume: 82, Issue:5 Suppl

    Review the molecular mechanisms of action, efficacy, and potential side effects associated with inhaled corticosteroids (ICS) in children with persistent asthma.. Articles in English from MEDLINE. The following terms were used: corticosteroids, inhaled corticosteroids, asthma, children, beclomethasone, fluticasone, budesonide, ciclesonide, growth, adrenal insufficiency, bone mineral density, and oral candidiasis. Treatment guidelines, review articles, controlled trials, meta-analyses, and systematic reviews evaluating the efficacy and the adverse events of treatment with ICS were selected.. In vivo and in vitro studies show that the available ICS have different pharmacokinetic and pharmacodynamic properties that result in different action potentials. ICS also differ as to the systemic and local side effects. The bioavailability of these products is essential in order to determine the incidence of side effects. In general, ICS are capable of controlling asthma, reducing the number of exacerbations, medical consultations, hospitalizations, and the need of oral corticosteroid (applications) bursts. Improvement can also be seen in pulmonary function, especially in patients with recent onset asthma. The most documented adverse effect is transitory decrease of growth rate.. ICS are the main anti-inflammatory agent used to treat persistent asthma. When administered in low doses, they seem to be safe and effective. Patient monitoring allows for early detection of possible side effects associated with ICS.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Androstadienes; Anti-Allergic Agents; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biological Availability; Bone and Bones; Bone Density; Budesonide; Child; Child Development; Fluticasone; Humans; Pregnenediones; Treatment Outcome

2006
Inhaled beclomethasone versus placebo for chronic asthma.
    The Cochrane database of systematic reviews, 2005, Jan-25, Issue:1

    Inhaled beclomethasone dipropionate (BDP) has been, together with inhaled budesonide, the mainstay of anti-inflammatory therapy for asthma for many years. A range of new prophylactic therapies for asthma is becoming available and BDP has been reformulated using a hydrofluoroalkane-134a (HFA) propellant which is free from chlorofluorocarbon (CFC).. The objectives of this review were to: (1) Compare the efficacy of BDP with placebo with both CFC and HFA propellants in the treatment of chronic asthma. (2) Explore the possibility that a dose response relationship exists for BDP in the treatment of chronic asthma. (3) To provide the best estimate of the efficacy of BDP as a benchmark for evaluation of newer asthma therapies.. Electronic searches were current as of January 2003.. Randomised parallel group design trials for a minimum period of four weeks, in children and adults comparing CFC-BDP or HFA-BDP with placebo in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality.. One reviewer extracted data; authors were contacted to clarify missing information. We analysed data with RevMan Analyses 1.0.2.. 60 studies recruiting 6542 participants met the inclusion criteria. CFC-BDP (57 studies): In non-oral steroid treated patients, at doses of 400 mcg/day or less CFC-BDP produced significant improvements from baseline in a number of efficacy measures compared with placebo, including forced expiratory volume in one second (FEV1) 360 ml (95% CI 260 to 460); FEV1 (% predicted) WMD 12.41% (95% CI 8.18 to 16.64) and morning peak expiratory flow rate (am PEF) WMD 35.95 L/min (95% CI 27.85 to 44.04). BDP also led to reductions in rescue beta-2 agonist use compared with placebo of -2.32 puffs/d (95% CI -2.55 to -2.09) and reduced the relative risk (RR) of trial withdrawal due to an asthma exacerbation 0.25 (95% CI 0.12 to 0.51). Subgroup analyses based on treatment duration provide support to the proposal that a treatment period of greater than four weeks is required to realise a fuller treatment effect. In oral steroid treated patients BDP led to significantly greater reductions in oral prednisolone use WMD -4.91 mg/d (95% CI -5.88 to -3.94 mg/d) and greater likelihood of withdrawing oral steroid treatment RR 8.02 (95% CI 3.23 to 19.92). HFA-BDP (3 studies): In non-oral steroid-treated patients, HFA-BDP was significantly more effective than placebo in improving FEV1, morning and evening PEF, FEF25 to 75%, reduced asthma symptoms and beta2-agonists daily consumption. Significant effects for such outcomes were apparent after six weeks of treatment. In oral steroid treated patients, HFA-BDP improved significantly FEV1 and am PEF. The summary estimates for these outcomes suggested a high level of heterogeneity, and divergent aims of the studies may contribute to the variation we observed. Limited data on adverse events were reported.. This review has quantified the efficacy of CFC-BDP and HFA-BDP in the treatment of chronic asthma and strongly supports its use. Current asthma guidelines recommend titration of dose to individual patient response, but the published data provide little support for dose titration above 400 mcg/d in patients with mild to moderate asthma. There are insufficient data to draw any conclusions concerning dose-response in people with severe asthma.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Chronic Disease; Dose-Response Relationship, Drug; Drug Monitoring; Humans; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic

2005
Inhaled fluticasone versus inhaled beclomethasone or inhaled budesonide for chronic asthma in adults and children.
    The Cochrane database of systematic reviews, 2005, Apr-18, Issue:2

    Beclomethasone dipropionate (BDP) and budesonide (BUD) are commonly prescribed inhaled corticosteroids for the treatment of asthma. Fluticasone propionate (FP) is newer agent with greater potency in in-vitro assays.. To compare the efficacy and safety of Fluticasone to Beclomethasone or Budesonide in the treatment of chronic asthma.. We searched the Cochrane Airways Group trial register (January 2004) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997 to 2003).. Randomised trials in children and adults comparing Fluticasone to either Beclomethasone or Budesonide in the treatment of chronic asthma.. Two reviewers independently assessed articles for inclusion and methodological quality. One reviewer extracted data. Quantitative analyses were undertaken using RevMan analyses 1.0.1.. Fifty six studies (12, 119 participants) met the inclusion criteria. Methodological quality was variable. Dose ratio 1:2: FP produced a significantly greater FEV1 (0.14 litres, 95% Confidence Interval (CI) 0.06 to 0.22), morning PEF (11.10 L/min, 95%CI 3.12 to 19.09 L/min) and evening PEF (9.31 L/min, 95%CI 5.12 to 13.5 L/min). This applied to all drug doses, age groups, and delivery devices. No difference between FP and BDP/BUD were seen for trial withdrawals. Symptoms and rescue medication use were widely reported but few trials provided sufficient data for analysis. When given at half the dose of BDP/BUD, FP led to a greater likelihood of pharyngitis. There was no difference in the likelihood of oral candidiasis. Plasma cortisol and 24 hour urinary cortisol was measured frequently but data presentation was limited. Dose ratio 1:1: FP produced a statistically significant difference in am PEF (9.58 L/min (95% CI 5.20 to 13.97)), pm PEF (7.41 L/min (95% CI 2.61 to 12.22)), and FEV1 (0.09 L (0.02 to 0.17)). The effects on exacerbations were mixed. There was an increase in the incidence of hoarseness, but no significant difference in pharyngitis, candidiasis, or cough.. Fluticasone given at half the daily dose of beclomethasone or budesonide leads to small improvements in measures of airway calibre, but it appears to have a higher risk of causing hoarseness when given at the same daily dose. Future studies should attempt to establish the relative efficacy of inhaled steroids delivered with CFC-free propellants.

    Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Humans; Randomized Controlled Trials as Topic

2005
Pharmacokinetic and pharmacodynamic properties of inhaled beclometasone dipropionate delivered via hydrofluoroalkane-containing devices.
    Clinical pharmacokinetics, 2005, Volume: 44, Issue:8

    Inhaled corticosteroids have a key role in the treatment of asthma and chronic obstructive pulmonary disease. In recent times, beclometasone dipropionate has been reformulated in pressurised metered dose inhalers (pMDIs), using hydrofluoroalkanes (HFAs) as a propellant. Extensive toxicological testing has shown that HFA-propellants are well tolerated. Among the reformulated beclometasone dipropionate-containing pMDIs, only the characteristics of the two Qvar formulations have been thoroughly explored. Compared to the reference beclometasone dipropionate formulation, the mass median aerodynamic diameter of the Qvar formulations are substantially smaller (1.1 vs 4.0 microm), whereas that of Modulite averages 2.6 microm. Scintigraphic and pharmacokinetic studies indicate a higher lung deposition for both the Qvar and the Beclazone formulations, compared with reference beclometasone dipropionate formulation. Since the 2- to 3-fold increase in pulmonary deposition results in a 2.6- to 3-fold difference in relative efficacy for Qvar, half the dose of the reference beclometasone dipropionate formulation has been currently recommended in adult patients with asthma, a recommendation that is supported by a large number of clinical trials. Conversely, the design of the studies conducted to compare the efficacy of Qvar with fluticasone propionate and budesonide does not allow establishing their equivalence on a milligram per milligram basis. Good studies on the bioequivalence between the reference beclometasone dipropionate formulation and the Modulite or Beclazone formulations are not available.

    Topics: Administration, Inhalation; Aerosol Propellants; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Therapeutic Equivalency

2005
Inhaled corticosteroids for non-specific chronic cough in children.
    The Cochrane database of systematic reviews, 2005, Oct-19, Issue:4

    Cough in isolation of other clinical features is known as non-specific cough, which has been defined as non-productive cough in the absence of identifiable respiratory disease or any known aetiology. In children with non-specific cough the possibility of asthma being the underlying disorder is often raised (so called cough variant asthma). The proponents of cough variant asthma suggest a therapeutic trial of medications usually used to treat asthma.. To determine the efficacy of inhaled corticosteroids in non-specific cough in children over the age of two years.. Searches were conducted on Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE. Searches were current as of March 2004.. All randomised (randomised and quasi-randomised) controlled clinical trials in which an inhaled corticosteroid (beclomethasone (BDP), fluticasone (FP), triamcinalone (TAA) or any other corticosteroid) were given for cough in children over two years of age were included. Two review authors independently assessed articles for inclusion and methodological quality.. Data from trials was extracted by both review authors and entered into the Cochrane Collaboration software program RevMan Analyses 1.0.2.. Two trials met the inclusion criteria (123 participants). One compared inhaled beclomethasone dipropionate (400 micrograms per day) with placebo and the other compared fluticasone propionate (2 mg per day for 3 days followed by 1 mg per day for 11 days) with placebo. Both studies used metered dose inhalers via a spacer. With the lower dose of inhaled corticosteroid there was no significant difference between the beclomethasone and placebo groups. With the higher dose there was a significant improvement in nocturnal cough frequency after two weeks in children presenting with persistent nocturnal cough. However, a significant but smaller improvement was also seen with placebo.. In one study beclomethasone dipropionate (400 micrograms per day) was no different from placebo in reducing the frequency of cough measured objectively or scored subjectively. There might be a small improvement with very high-dose inhaled corticosteroid but the clinical impact of this is unlikely to beneficial.

    Topics: Adrenal Cortex Hormones; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Cough; Fluticasone; Humans; Randomized Controlled Trials as Topic

2005
Fluticasone versus HFA-beclomethasone dipropionate for chronic asthma in adults and children.
    The Cochrane database of systematic reviews, 2005, Oct-19, Issue:4

    The relative efficacy of fluticasone (FP) and beclomethasone (BDP) propelled with CFCs has been well established. The potency of HFA-BDP is thought to have been improved with new propellant and some studies suggest that it may equipotent at half the dose of CFC propelled-BDP. There is a need to revisit this question in the light of a potentially more potent new non-CFC propellant.. To determine the relative efficacy of FP and HFA-propelled BDP in chronic asthma.. The Cochrane Airways Group Specialised Register was searched using pre-specified terms. Searches were current as of March 2005.. Randomised controlled trials were eligible for inclusion in the review. We compared either CFC or HFA-propelled FP with HFA-propelled BDP. We made a distinction between HFA-BDP and HFA-BDP extra fine, which dispenses smaller particles of drug, leading to different, usually more peripheral distribution in the airways. Any inhaler device was considered, and there was no restriction on studies with or without spacers. We included studies which assessed HFA-BDP given via either pMDI, breath-actuated MDI, or DPI.. Two reviewers independently assessed studies for inclusion in the review. Data were extracted and entered in to RevMan 4.2 using standard meta-analytical techniques with predefined criteria for exploring statistical heterogeneity.. Seven studies (1230 participants) met the inclusion criteria of the review. One study was conducted in children. Study reporting quality was fair, but all studies were of short duration (three to twelve weeks). Only studies assessing HFA-BDP extra fine in comparison with FP were identified. Lung function was not significantly different between extra fine BDP and FP when compared at the same dose in parallel studies, change in FEV1: 0.04 litres (95% CI -0.03 to 0.11 litres; three studies, 659 adults); change in am PEF: -0.69 litres (95% CI -11.21 to 9.83 litres; two studies, 364 adults). Individual studies reported non-significant findings in symptom scores and quality of life questionnaires. There was no significant difference between FP and HFA-BDP in the risk of study withdrawal, dysphonia or when data were reported as any adverse event.. There was no significant difference between FP and extra fine HFA-BDP on FEV(1) or peak flow at a dose ratio of 1:1. However, the number of studies and width of the confidence intervals in the analyses do not exclude a clinically meaningful difference between these two drugs. Difficulty in the successful manipulation of the devices studied may be a barrier to the widespread use of MDIs. One paediatric study was included in the review, so extrapolation of the findings of this review to children is limited. Further longer term studies in adults and children with moderate and severe asthma are required.

    Topics: Administration, Inhalation; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child; Chronic Disease; Fluticasone; Humans; Randomized Controlled Trials as Topic

2005
Are outcomes the same with all dry powder inhalers?
    International journal of clinical practice. Supplement, 2005, Issue:149

    Most clinicians and patients would intuitively say that the inhaler device used influences the outcome achieved in asthma. However, it is important to have objective evidence to support or refute this view. Systematic reviews have suggested that there is no difference in clinical effectiveness between dry powder inhalers and metered-dose inhalers. However, the studies included in the review were randomised clinical trials and not studies based on real-life clinical practice. In the real world, the efficacy of products as determined in a specified and well-monitored population is only one aspect of product performance--patient characteristics and behaviour are critical. Observational studies in real-world primary care settings suggest that the choice of inhaler device has an important impact on asthma outcomes. The IMS Mediplus database has now been used to compare outcomes among patients receiving initial maintenance therapy with beclometasone dipropionate administered via different dry powder inhalers. Patients using the DISKHALER dry powder inhaler used significantly less short-acting beta(2)-agonist than those using the ROTAHALER dry powder inhaler. This suggests a difference in the level of asthma control with the different devices, even when the same chemical entity is delivered. Real-world studies suggest, therefore, that outcomes are not always the same with all dry powder inhalers. This indicates the need for further studies to investigate the impact of inhaler device choice and the impact of switching between devices.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Bronchodilator Agents; Humans; Nebulizers and Vaporizers; Powders; Randomized Controlled Trials as Topic; Treatment Outcome

2005
[Inhaled corticosteroid therapy in adults with asthma. Current evidences].
    Recenti progressi in medicina, 2005, Volume: 96, Issue:10

    Different international guidelines recommend the early introduction of inhaled corticosteroids (ICS) and their regular use to gain clinical and functional control of persistent asthma. There is now evidence that the starting dose of all ICS is lower than previously regarded. Initial moderate ICS doses appear to be more effective than an initial low ICS dose. The lowest effective dose should always be seeked by a step-down procedure. More than 90% of benefit is achieved by approximately a daily regular dose of 200 microg of fluticasone or 400 microg of beclomethasone or budesonide. The beneficial effects of increasing the dose of ICS alone appear to be modest in most cases. Intermittent ICS therapy has been successfully used in the long term treatment of mild asthma. In general, twice-daily administration of ICS provides greater therapeutic benefit than a once-daily regimen in moderate asthma. When asthma control has been obtained, a once-daily regimen can be tried. In clinical practice, this has the potential advantage of increasing patients' compliance. Chlorofluorocarbon-free formulations of old ICS have also remarkably improved their clinical efficacy mainly through an increased peripheral deposition pattern. Despite some limitations due to poor response in neutrophilic asthma and to potential systemic side effects, ICS will certainly be the cornerstone of asthma therapy even the next future.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Drug Therapy, Combination; Fluticasone; Humans

2005
Once-daily inhaled corticosteroids for the treatment of asthma.
    Current opinion in pulmonary medicine, 2004, Volume: 10, Issue:1

    Inhaled corticosteroids (ICS) are the mainstay of asthma therapy. Although compliance to this type of medication is often suboptimal and once-daily dosing can help to improve adherence to the treatment, the clinical implications of such a mode of administration should be determined.. This review summarizes the recent studies on comparative efficacy of once-versus twice-daily administration of ICS, in light of previous reports.. Although twice-daily administration of ICS is often better to optimize asthma parameters, in many patients, asthma can be sufficiently controlled by a once-daily regimen of most ICS. An increased frequency of dosing seems preferable if asthma becomes uncontrolled or is severe, although this requires further study. A therapeutic trial should, however, be done to ensure that asthma control is adequate. Comparative long-term effects of such a strategy on inflammatory and remodeling parameters remain to be determined, as does the proportion of patients who can adequately control their asthma with once-daily administration of the various ICS available.

    Topics: Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Fluticasone; Glucocorticoids; Humans; Mometasone Furoate; Pregnadienediols; Treatment Outcome

2004
Impact of long-term inhaled corticosteroid therapy on bone mineral density: results of a meta-analysis.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2004, Volume: 92, Issue:2

    The impact of long-term inhaled corticosteroid (ICS) therapy on bone mineral density (BMD) is poorly understood.. To evaluate the impact of long-term ICS use on BMD.. Random-effects meta-analysis. Published and unpublished literature were identified by searches of MEDLINE and EMBASE databases and consultation with experts. Studies reporting BMD among adult asthma and chronic obstructive pulmonary disease (COPD) patients using ICS and non-ICS controls were identified. Studies selected for review included at least 1 year of follow-up. Two independent reviewers evaluated studies; data from those meeting specified inclusion criteria were abstracted for inclusion in the meta-analysis.. Fourteen (5.3%) of 266 reviewed studies met specified inclusion criteria. Sufficient data were available to perform meta-analysis on 3 measures for ICS-using patients (lumbar, femoral neck, and major trochanter BMD) and 1 measure (lumbar BMD) for non-ICS-using controls. Using current National Asthma Education and Prevention Program definitions, the majority of studies (12 of 14) included patients receiving moderate to high doses of ICSs. Among ICS users, annual changes from baseline in lumbar, femoral neck, and major trochanter BMD (-0.23%, -0.17%, and +1.46%, respectively) were not statistically significant. Mean changes in lumbar BMD were also not significantly different from controls (-0.02%). Further, annual changes in lumbar BMD were not statistically significant for subgroups of patients with asthma or COPD.. Long-term use of ICSs in patients with asthma or COPD was not associated with significant changes in BMD.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bone Density; Budesonide; Fluticasone; Humans; Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trials as Topic; Triamcinolone Acetonide

2004
[Recent study on pathogenesis of bronchial asthma and the therapeutic strategy].
    Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine, 2004, Mar-10, Volume: 93, Issue:3

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Albuterol; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchi; Bronchial Diseases; Bronchial Hyperreactivity; Bronchitis; Constriction, Pathologic; Drug Therapy, Combination; Eosinophilia; Glucocorticoids; Humans; Salmeterol Xinafoate; Theophylline

2004
Inhaled fluticasone versus inhaled beclomethasone or inhaled budesonide for chronic asthma.
    The Cochrane database of systematic reviews, 2004, Issue:2

    Beclomethasone dipropionate (BDP) and budesonide (BUD) are commonly prescribed inhaled corticosteroids for the treatment of asthma, Fluticasone propionate (FP) is newer agent with greater potency in in-vitro assays.. To compare the efficacy and safety of Fluticasone to Beclomethasone or Budesonide in the treatment of chronic asthma.. We searched the Cochrane Airways Group trial register (January 2003) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997 to 2003).. Randomised trials in children and adults comparing Fluticasone to either Beclomethasone or Budesonide in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality.. One reviewer extracted data. Quantitative analyses were undertaken using RevMan analyses 1.0.1.. 48 studies (11,479 participants) met the inclusion criteria. Methodological quality was variable. When compared at a FP:BUD/BDP dose ratio of 1:2, fluticasone produced a significantly greater FEV1 (Weighted Mean Difference (WMD) 0.11 litres, 95% Confidence Interval (CI) 0.01 to 0.20 litres), morning PEF (WMD 13 L/min, 95%CI 5 to 22 L/min) and evening PEF (WMD 11 L/min, 95%CI 1 to 20 L/min). This applied to all drug doses, age groups, and delivery devices, although subgroup analyses suggested that the relative benefit of FP may be greater in more severe patients treated with higher doses of inhaled corticosteroid. No difference between fluticasone and beclomethasone or budesonide were seen for trial withdrawals (Peto OR 0.76, 95%CI 0.53 to 1.09). Symptoms and rescue medication use were widely reported but few trials provided sufficient data for analysis. A higher likelihood of pharyngitis (Peto Odds Ratio 2.16; 95% CI 1.43 to 3.24) was apparent when patients were treated with fluticasone at twice the dose of BDP/BUD, although there was unexplained heterogeneity in this effect between trials. There was no difference in the likelihood of oral Candidiasis. Plasma cortisol and 24 hour urinary cortisol were measured frequently but data presentation was limited.. Fluticasone given at half the daily dose of beclomethasone or budesonide leads to small improvements in measures of airway calibre, but it appears to have a higher risk of causing side-effects when given at the same daily dose.

    Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Fluticasone; Humans; Randomized Controlled Trials as Topic

2004
High dose versus low dose inhaled corticosteroid as initial starting dose for asthma in adults and children.
    The Cochrane database of systematic reviews, 2004, Issue:2

    Inhaled corticosteroids (ICS) form the basis of maintenance therapy in asthma and their efficacy is well established. However, the optimal starting dose of ICS is not clearly established. Recent reviews demonstrate a relatively flat efficacy curve for ICS and increasing side effects with increasing ICS doses. High doses are frequently prescribed and there are now reports of significant side effects occurring with high dose ICS use. These issues demonstrate the need to establish the optimal starting dose of ICS in asthma.. To establish the optimal starting dose of ICS by evaluating the efficacy of initial high dose ICS with low dose ICS in subjects with asthma, not currently on ICS.. We searched the Cochrane Airways Group trials register and reference lists of articles. Date of last search: January 2003. Randomised controlled trials of two different doses of the same ICS in adults and children with asthma with no concomitant ICS or OCS.. Trial quality was assessed and data were extracted independently by two reviewers. Study authors were contacted for confirmation. Trials were analysed according to the following ICS dose comparisons: step down vs constant dose ICS (n=7); high vs moderate (n=11); high vs low (n=9); moderate vs low (n=11); fold change in dose (all studies).. 31 papers reporting the results of 26 trials were included in the review. For studies that compared a step down approach to a constant moderate/low ICS dose, there were no significant differences in lung function, symptoms, rescue medications or asthma control between the two treatment approaches. Significant but clinically small improvements in percent predicted FEV(1) ( WMD 5.32, 95% CI 0.65 to 9.99) and non significant improvements in the change in morning PEF were found for high dose ICS compared to moderate dose ICS. There were no significant differences in efficacy between high and low dose ICS. For moderate dose ICS, compared to low dose ICS, there were significant improvements in the change in morning PEF l/min from baseline (WMD 11.14, 95% CI 1.34 to 20.93) and nocturnal symptoms (SMD -0.29, 95% CI -0.53 to -0.06 ). Commencing ICS at double or quadruple a base moderate or low dose had no greater effect than commencing with the base dose. Several studies reported greater improvement in airway hyperresponsiveness for high dose ICS.. For patients with asthma who require ICS, commencing with a moderate dose ICS is equivalent to commencing with a high dose ICS and down-titrating. The small significant benefits of commencing with a high ICS dose are not of sufficient clinical benefit to warrant its use when compared to moderate or low dose ICS. Initial moderate ICS dose appears to be more effective than initial low ICS dose. High dose ICS may be more effective than moderate or low dose ICS for airway hyperresponsiveness. There is no benefit in doubling or quadrupling ICS in subjects with stable asthma.

    Topics: Administration, Inhalation; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Fluticasone; Humans; Randomized Controlled Trials as Topic

2004
The efficacy and safety of QVAR (hydrofluoroalkane-beclometasone diproprionate extrafine aerosol) in asthma (part 1): an update of clinical experience in adults.
    International journal of clinical practice, 2004, Volume: 58, Issue:7

    In 1999, a robust dose-finding study showed that the chlorofluorocarbon (CFC) -free formulation of beclometasone dipropionate (BDP), QVAR (hydrofluoroalkane-134a BDP), produced equivalent asthma control to CFC-BDP at approximately half the daily dose in adults. Since then, a wealth of clinical and pharmaco-vigilance studies have been undertaken to confirm these results and establish dose-potency ratios with other inhaled corticosteroids (ICS). This review summarises the results of studies performed by the manufacturer that have been published since the last comprehensive review of the efficacy and safety of QVAR in 2000. Long-term comparisons with CFC-BDP have confirmed the durability of the 2:1 daily dosing ratio of CFC-BDP:QVAR in adults. Clinical comparisons with other ICS in both symptomatic and asymptomatic patients have established dose-potency ratios of 2: 1 for budesonide:QVAR and 1:1 for fluticasone:QVAR. Furthermore, QVAR has been associated with benefits on asthma symptomatology and quality of life, compared with other ICS that probably arises from its peripheral deposition in the lung.

    Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Fluticasone; Forced Expiratory Volume; Humans; Hydrocarbons, Fluorinated; Multicenter Studies as Topic; Peak Expiratory Flow Rate; Randomized Controlled Trials as Topic; Treatment Outcome; Vital Capacity

2004
[Clinical study on bronchial asthma and leukotriene antagonists].
    Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine, 2004, Dec-10, Volume: 93, Issue:12

    Topics: Administration, Inhalation; Administration, Oral; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Clinical Trials as Topic; Drug Administration Schedule; Drug Therapy, Combination; Glucocorticoids; Humans; Inflammation Mediators; Leukotriene Antagonists; Leukotrienes; Membrane Proteins; Patient Compliance; Practice Guidelines as Topic; Receptors, Leukotriene; Severity of Illness Index

2004
[Effectiveness and safety of fluticasone propionate in therapy of children suffering from asthma. Part I. Mechanisms of actions and clinical effectiveness of treatment in children with asthma].
    Polski merkuriusz lekarski : organ Polskiego Towarzystwa Lekarskiego, 2004, Volume: 17 Suppl 2

    The introduction of inhaled corticosteroids (ICS) has been a milestone in asthma therapy. According to current guidelines ICS are the first line drug in chronic anti-inflammatory therapy. The purpose of first part of this publication is to present updated knowledge on mechanisms of anti-inflammatory action as well as some pharmacokinetics and pharmacodynamics data about commonly used ICS, especially fluticasone propionate (FP) and two others: budesonide (BUD), beclomethasone dipropionate (BDP). Some differences between mentioned drugs have been found concerning systemic activity and safety of therapy. Fluticasone propionate is twice as active as the BUD and BDP. First results of therapy are seen 1-2 week after administration. Fluticasone propionate, more lipophilic than other steroids, has also high glucocorticoid receptor affinity and specificity, high topical anti-inflammatory activity and low systemic bioavailability. Systemic availability of FP depends on absorption from respiratory system. Oral bioavailability can be neglected because of almost total inactivation in liver during first pass. Fluticasone propionate has some features of dissociated steroids which means predominance of transrepression over transactivation--beneficial from safety point of view. Clinical efficacy of FP in chronic asthma therapy in children was confirmed in many studies. It significantly reduces the symptoms and exacerbations of asthma. There is a close correlation between FP use and lung function tests. The therapy with FP decreases bronchial hyperreactivity and the use of systemic steroids and rescue medication. The beneficial action of fluticasone propionate in asthma is due its anti-inflammatory properties within the airways (decreasing levels of direct and indirect markers of airways inflammations are observed).

    Topics: Administration, Inhalation; Adolescent; Age Factors; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biological Availability; Budesonide; Child; Child, Preschool; Drug Administration Schedule; Female; Fluticasone; Glucocorticoids; Humans; Infant; Infant, Newborn; Male; Peak Expiratory Flow Rate; Randomized Controlled Trials as Topic; Treatment Outcome

2004
Long-term management of asthma.
    Indian journal of pediatrics, 2003, Volume: 70, Issue:1

    Long-term management of asthma includes identification and avoidance of precipitating factors of asthma, pharmacotherapy and home management plan. Common precipitating factors include viral upper respiratory infections, exposure to smoke, dust, cold food and cold air. Avoidance of common precipitating factors has been shown to help in better control of asthma. Pharmacotherapy is the main stay of treatment of asthma. Commonly used drugs for better control of asthma are long and short acting bronchodilators, mast cell stabilizers, inhaled steroids, theophylline and steroid sparing agents. After assessment of severity most appropriate medications are selected. For mild episodic asthma the medications are short acting beta agonists as and when required. For mild persistent asthma: as and when required bronchodilators along with a daily maintenance treatment in form of low dose inhaled steroids or cromolyn or oral theophylline or leukotriene antagonists are required. Moderate persistent asthma should be treated with inhaled steroids along with long acting beta agonists for symptom control. For severe persistent asthma the recommended treatment includes inhaled steroids, long acting beta agonists with or without theophylline. If symptoms are not well controlled, a minimal dose of oral prednisolone preferably on alternate days may be needed in few patients. Patients should be followed up every 8-12 weeks. On each follow up visit patients should be examined by a doctor, compliance to medications should be checked and actual inhalation technique is observed. Depending on the assessment, medications may be decreased or stepped up. For exercise induced bronchoconstriction: cromolyn, short or long acting beta agonists or leukotriene antagonists may be used. In children with seasonal asthma, maintenance treatment according to assessed severity should be started 2 weeks in advance and continued throughout the season. These patients should be reassessed after discontinuing the treatment. Parents should be given a written plan for management of acute exacerbation at home.

    Topics: Administration, Inhalation; Albuterol; Allergens; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child; Child, Preschool; Cromolyn Sodium; Drug Therapy, Combination; Glucocorticoids; Humans; Immunotherapy; Patient Education as Topic

2003
Anti-inflammatory treatment for recurrent wheezing in the first five years of life.
    Pediatric pulmonology, 2003, Volume: 35, Issue:4

    Medications identified for the treatment of recurrent wheezing in preschool children by the Expert Panel Report of the NHLBI Guidelines for the Diagnosis and Management of Asthma include inhaled corticosteroids, chromones, theophylline, and leukotriene pathway modifiers. However, these various agents differ in their mechanism, extent of action on the airway inflammatory process, and degree of clinical efficacy. Inhaled corticosteroids can control symptoms in many young children with even severe persistent wheezing, but data on their long-term safety when administered in preschool-age children are scarce. There is some information on the uninterrupted use of inhaled corticosteroids in school-age children and the absence of an adverse effect on ultimate adult height. Despite laboratory evidence of adrenal suppression in some studies, few pediatric cases of clinical adrenal insufficiency have been reported. Low-dose inhaled corticosteroid (<400 mcg/day for beclomethasone), which is adequate for controlling mild persistent symptoms, is generally safe. Chromones have a remarkable safety profile, but they are most effective for symptoms of mild severity. Promising data have been published on the efficacy and safety of leukotriene pathway modifiers when used in young children with persistent symptoms. It is uncertain whether early introduction and long-term administration of inhaled corticosteroids prevent development of irreversible airway obstruction. Nevertheless, they may be especially useful for patients with moderate to severe disease in whom other agents (chromones or leukotriene pathway modifiers) will most likely fail to control symptoms. Pediatr Pulmonol. 2003; 35:241-252.

    Topics: Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child, Preschool; Cromolyn Sodium; Glucocorticoids; Humans; Infant; Leukotriene Antagonists; Recurrence; Respiratory Sounds; Theophylline

2003
Inhaled corticosteroids effects on bone in asthmatic and COPD patients: a quantitative systematic review.
    Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2003, Volume: 14, Issue:3

    Deleterious effect of oral corticosteroids on bone has been well documented, whereas this remains debated for inhaled ones (ICS). Our objectives were to analyze the effects of ICS on bone mineral density, fracture risk and bone markers. We performed an exhaustive systematic research of all controlled trials potentially containing pertinent data, peer-reviewed by a dedicated WHO expert group, and comprehensive meta-analyses of the data. Inclusion criteria were ICS, and BMD/markers/fractures in asthma/chronic obstructive pulmonary diseases (COPD) and healthy patients. Analyses were performed in a conservative fashion using professional dedicated softwares and stratified by outcome, study design and ICS type. Results were expressed as standardized mean difference/effect size (ES), relative risk (RR) or odds ratio (OR), depending on study design and outcome units. Publication bias was investigated. Twenty-three trials were reviewed; 11 papers fit the inclusion criteria and were assessed for the main analysis. Quality scores for the randomized controlled trials (RCTs) were 80%, 71% for the prospective cohort studies, and 78% for the retrospective cohort and cross-sectional studies. We globally assessed ICS effects on BMD and found deleterious effects: ES=0.61 ( p=0.001) for healthy subjects, and ES=0.27 ( p<0.001) for asthma/COPD patients. For these patients, this effect was 0.21 ( p<0.01) at the lumbar spine, and 0.26 ( p<0.001) at the hip or femoral neck. A single study evaluated the impact of ICS on hip fracture and reported an increased OR of 1.6 (1.24; 2.03). Lumbar fracture rate differences did not reach the level of statistical significance: 1.87 (0.5; 6.94). Osteocalcin and PICP were decreased and ICTP, pyridinoline and deoxypyridinoline levels were not significantly affected. Budesonide (BUD) appeared to be the ICS inducing the less deleterious effects on bone, followed by beclomethasone dipropionate (BDP) and triamcinolone (TRI). Publication bias investigation provided non-significant results. In our meta-analyses, BUD at a mean daily dose (SD) of 686 microg (158 microg), BDP at 703 microg (123 microg) and TRI at 1,000 microg (282 microg) were found to affect bone mineral density and markers in patients suffering from the two major respiratory diseases. These findings could have practical implication in the long-term management of asthmatic and COPD patients.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bone and Bones; Bone Density; Budesonide; Fluticasone; Fractures, Bone; Humans; Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trials as Topic; Triamcinolone Acetonide

2003
Fluticasone and beclometasone: what are their effects on children's growth?
    British journal of community nursing, 2003, Volume: 8, Issue:5

    Fear of growth retardation may account for the underuse of inhaled corticosteroids in children with asthma, despite compelling evidence of their effectiveness. This fear may be reduced with newer agents with lower oral bioavailability if their theoretical advantage of fewer systemic adverse effects than the standard treatment of inhaled beclometasone is realized in practice. This review aims to determine if one of the newer agents, inhaled fluticasone, has less effect on the growth of pre-pubertal asthmatic children than inhaled beclometasone. The outcome measure was growth velocity. Two double blind, randomized controlled trials were identified. In one of the studies the mean growth velocity in the fluticasone group was 0.7 cm/year greater than in the beclometasone group. In the second, smaller study the mean growth velocity in the fluticasone group was 0.8 cm/year greater. There is therefore some evidence that fluticasone has less (if any) adverse effect on growth.

    Topics: Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Fluticasone; Growth Disorders; Humans

2003
Considering therapeutic options in the real world.
    The Journal of allergy and clinical immunology, 2003, Volume: 112, Issue:5 Suppl

    When choosing a drug regimen, physicians can rely on two models: their own clinical experience and results from clinical trials. Both options have problems. Overall, patients with persistent asthma symptoms often have improved outcomes with the use of long-term controller medications on a daily basis to prevent exacerbations of symptoms. Inhaled corticosteroids (ICSs) are generally recognized as being the most effective treatment for the underlying inflammatory characteristics of asthma. However, despite adequate dosing, some patients with persistent asthma remain symptomatic while taking an ICS. Therefore, it may be beneficial to administer combination therapy with an ICS and a long-acting beta-agonist (LABA) in this subset of asthma patients. Another anti-inflammatory choice for persistent asthma is the leukotriene receptor antagonist (LTRA), either as monotherapy or in combination with an ICS. Regardless of what treatment regimen a physician chooses to prescribe, the choice of medication depends on many factors, including patient preference, physician comfort with the regimen, and cost.

    Topics: Adolescent; Adrenergic beta-Agonists; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Drug Therapy, Combination; Humans; Leukotriene Antagonists; Middle Aged; Randomized Controlled Trials as Topic; Treatment Outcome

2003
Fluticasone versus beclomethasone or budesonide for chronic asthma.
    The Cochrane database of systematic reviews, 2002, Issue:1

    Beclomethasone dipropionate (BDP) and budesonide (BUD) are commonly prescribed inhaled corticosteroids for the treatment of asthma, Fluticasone propionate (FP) is newer agent with greater potency in in-vitro assays.. To compare the efficacy and safety of Fluticasone to Beclomethasone or Budesonide in the treatment of chronic asthma.. We searched the Cochrane Airways Group Trial Register (1999) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997-1999).. Randomised trials in children and adults comparing Fluticasone to either Beclomethasone or Budesonide in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality.. One reviewer extracted data. Quantitative analyses where undertaken using Review Manager 4.0.3 with Metaview 3.1.. 42 studies (>10,000 patients) met the inclusion criteria. Methodological quality was variable. When compared at a FP:BUD/BDP dose ratio of 1:2, fluticasone produced a significantly greater FEV1 (Weighted Mean Difference (WMD) 0.11 litres, 95% Confidence Interval (CI) 0.01, 0.20 litres), morning PEF (WMD 13 L/min, 95%CI 5, 22 L/min) and evening PEF (WMD 11 L/min, 95%CI 1, 20 L/min). This applied to all drug doses, age groups, and delivery devices, although subgroup analyses suggested that the relative benefit of FP may be greater in more severe patients treated with higher doses of inhaled corticosteroid. No difference between fluticasone and beclomethasone or budesonide were seen for trial withdrawals (Peto OR 0.77, 95%CI 0.54, 1.10). Symptoms and rescue medication use were widely reported but few trials provided sufficient data for analysis. A higher likelihood of pharyngitis (Peto Odds Ratio 2.16; 95% CI 1.42, 3.28) was apparent when patients were treated with fluticasone at twice the dose of BDP/BUD, although was unexplained heterogeneity in this effect between trials. There was no difference in the likelihood of oral Candidiasis. Plasma cortisol and 24 hour urinary cortisol were measured frequently but data presentation was limited.. Fluticasone given at half the daily dose of beclomethasone or budesonide leads to small improvements in measures of airway calibre, but it appears to have a higher risk of causing side-effects when given at the same daily dose.

    Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Fluticasone; Humans; Randomized Controlled Trials as Topic

2002
Inhaled beclomethasone versus budesonide for chronic asthma.
    The Cochrane database of systematic reviews, 2002, Issue:1

    Beclomethasone dipropionate (BDP) and budesonide (BUD) are used widely in the treatment of chronic asthma. The two drugs have different in vitro pharmacokinetic characteristics. It is unclear whether this translates into clinically significant differences in efficacy or safety when treating children and adults with chronic asthma.. To assess clinical outcomes in studies which have compared inhaled BDP and BUD in the treatment of chronic asthma.. We searched the Cochrane Airways Group Trial Register (1999) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997-1999).. Prospective, randomised trials comparing BDP to BUD in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality.. One reviewer extracted data; authors were contacted to clarify missing information. Quantitative analyses where undertaken using Review Manager 4.0.3 with Metaview 3.1.. 24 studies met the criteria for inclusion (1174 subjects). Methodological quality was variable. A meta-analysis of crossover studies did not demonstrate a significant difference between BDP and BUD for FEV1, morning PEF, evening PEF, asthma symptoms or rescue beta2 agonist use, over a dose range of 400 to 1000 mcg/d. The majority of crossover trials had significant design flaws related to a lack of washout and/or failure to exclude carryover effects so the results must be viewed with caution. A single crossover study with adequate washout showed that BUD 400 mcg/d delivered via Turbohaler dry powder inhaler (DPI) may be more effective than BDP 400 mcg/d delivered via Rotahaler DPI in reducing histamine bronchial hyper-responsiveness: Weighted Mean Difference (WMD) 0.43 log10 PC20 FEV1 (95% Confidence Intervals (CI) 0.05, 0.81 log10 PC20 FEV1). A meta-analysis of two parallel group, dose down-titration studies (231 patients) showed that less BUD delivered via a Turbohaler DPI was required to maintain control in adults asthmatics compared to BDP delivered via metered dose inhaler with or without a spacer: WMD 444 mcg/d (95% CI 332, 556 mcg/d).. There is limited high quality randomised controlled trial data comparing the relative efficacy of BDP and BUD. Current guidelines (BTS 1997, GINA 1995, NHLBI 1997) assume BDP and BUD to have equal efficacy, such that for each defined level of asthma severity, the recommended doses BDP and BUD are the same. Although there is some data to suggest that BUD via Turbohaler is more effective than BDP via either Rotahaler or MDI (with and without spacer), these comparisons are confounded by use of different delivery devices, and are not sufficient to warrant a change in guideline recommendations.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Humans; Randomized Controlled Trials as Topic

2002
Beclomethasone at different doses for chronic asthma (review).
    The Cochrane database of systematic reviews, 2001, Issue:1

    Beclomethasone dipropionate (BDP) is available in a wide range of daily doses for the treatment of long-term asthma.. To assess the evidence for a dose response relationship for BDP in the treatment of long-term asthma.. We searched the Cochrane Airways Group trial register, Cochrane Controlled Trials Register (The Cochrane Library issue 1 1999) and references lists of articles. Authors and Glaxo Wellcome UK were contacted to identify eligible studies. We also hand searched the proceeding from relevant respiratory society meetings, the British Journal of Clinical Research and the European Journal of Clinical Research for studies.. Prospective, randomised trials comparing two or more daily doses of BDP in patients over the age of two years with long-term asthma.. Trials were selected for inclusion and scored for quality by two reviewers. Data were extracted by one reviewer. Authors were contacted to clarify details of study design and retrieve missing data.. 11 trials involving 1614 subjects were included. Methodological quality was variable. Studies rarely gave a clear indication of the degree of asthma control at baseline. Less than two-fold to five-fold dose differences were assessed by different studies. The results are reported as weighted mean differences (WMD) with 95% confidence limits (95% CI). The number of trials (N) contributing to each outcome is stated. In non-oral steroid treated asthmatics a small advantage of BDP 800 mcg/d over 400 mcg/d was apparent for improvement in morning peak expiratory flow rate (PEFR) compared to baseline, WMD 11 L/min (95% CI 4 to 19 L/min) N=2; improvement in forced expired volume in one second (FEV1) compared to baseline, WMD 9 ml (95% CI 3 to 140) N=1; and reduction in night-time symptom score compared to baseline, WMD 0.13 (95% CI 0.04 to 0.22) N=1. Studies that assessed BDP 1000 v 500 mcg/d and BDP 1600 v 400 mcg/d demonstrated significant advantage of higher dose over lower dose for histamine bronchial hyper-responsiveness (BHR) and percentage improvement in FEV1 compared to baseline. No differences between higher and lower daily doses of BDP were apparent for daytime symptoms, withdrawals due to asthma exacerbation, oropharyngeal side effects or measures of hypothalamo-pituitary-adrenal (HPA) function. No difference in prednisolone sparing effect was apparent when comparing high dose and low dose BDP in oral corticosteroid (OCS) dependent patients.. BDP appears to demonstrate a shallow dose response effect in long-term asthma for a small number of efficacy outcomes over range of daily doses from 400 mcg/d to 1600 mcg/d, although the clinical significance of the improvements afforded by higher doses is questionable.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Dose-Response Relationship, Drug; Humans; Prospective Studies; Randomized Controlled Trials as Topic; Treatment Outcome

2001
Inhaled corticosteroids reduce growth. Or do they?
    The European respiratory journal, 2001, Volume: 17, Issue:2

    The class label warning in the United States for inhaled corticosteroids (ICS's) states that these drugs may reduce growth velocity in children. In this paper, the evidence for this warning is reviewed from a clinical point of view. Children with asthma tend to grow slower than their healthy peers during the prepubertal years because they go into puberty at a later age. However, asthmatic children do achieve a (near) normal adult height. In randomized controlled clinical trials, the use of inhaled beclomethasone, budesonide and fluticasone is associated with a reduced growth during the first months of therapy, in the order of magnitude of approximately 0.5-1.5 cm x yr(-1). It is, however, unlikely that such an effect continues or persists because accumulating evidence shows that asthmatic children, even when they have been treated with ICS for years, attain normal adult height. Individual rare cases have been reported, however, where ICS use was associated with clinically relevant growth suppression. Inhaled corticosteroids are the most effective therapy available for maintenance treatment of childhood asthma. Fear of reduced growth velocity is based on exceptional cases and not on group data. It should, therefore, not be a reason to withhold or withdraw such highly effective treatment in children with asthma.

    Topics: Administration, Inhalation; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biological Availability; Bronchodilator Agents; Budesonide; Child; Dose-Response Relationship, Drug; Fluticasone; Glucocorticoids; Growth; Humans

2001
Holding chambers versus nebulisers for inhaled steroids in chronic asthma.
    The Cochrane database of systematic reviews, 2001, Issue:2

    Inhaled corticosteroids are available in the form of a suspension for nebulisation, although the role of this mode of therapy in the treatment of chronic asthma is still unclear.. To assess the efficacy and safety of inhaled corticosteroids delivered via nebuliser versus holding chamber for the treatment of chronic asthma.. We searched the Cochrane Airways Group Trial Register (1999) and reference lists of articles. We contacted the authors of studies and pharmaceutical companies for additional studies and hand-searched the British Journal of Clinical Research, European Journal of Clinical Research and major respiratory society meeting abstracts (1997-1999).. Randomised controlled trials comparing nebuliser to holding chamber in the delivery of inhaled corticosteroids for the treatment of chronic asthma. All age groups of patients were considered. Two reviewers assessed articles for inclusion; two reviewers independently assessed included studies for methodological quality.. One reviewer extracted data; authors were contacted to clarify missing information. Quantitative analyses were undertaken using Review Manager 4.1 with MetaView 3.1.. Two studies were selected for inclusion (63 subjects), both concerned adults. Methodological quality was variable. Due to design differences it was not appropriate to pool the studies. The single high quality study compared budesonide 2000-8000 mcg delivered via Pari Inhalier Boy jet nebuliser with inspiration-only inhalation to budesonide 1600 mcg via large volume spacer. The nebuliser delivery led to higher morning peak expiratory flow values (25 L/min p<0.01), higher evening values (30L/min, p<0.01), lower rescue beta2 agonist use and symptom scores compared to the holding chamber delivery.. Budesonide in high dose delivered by the particular nebuliser used in the only double-blinded study that could be included in this review was more effective than budesonide 1600 mcg via a large volume spacer. However, it is not clear whether this was an effect of nominal dose delivered or delivery system. Cost, compliance and patient preference are important determinants of clinical effectiveness that have not been assessed. Future studies are needed to evaluate the relative effectiveness of inhaled corticosteroids delivered by different combinations of nebuliser/compressor compared to holding chamber. Moreover, further studies assessing these delivery methods are needed in infants and pre-school children, as these are groups that are likely to be considered for treatment with nebulised corticosteroids.

    Topics: Administration, Topical; Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Drug Delivery Systems; Fluticasone; Glucocorticoids; Humans; Nebulizers and Vaporizers; Randomized Controlled Trials as Topic

2001
Dose-response relation of inhaled fluticasone propionate in adolescents and adults with asthma: meta-analysis.
    BMJ (Clinical research ed.), 2001, Aug-04, Volume: 323, Issue:7307

    To examine the dose-response relation of inhaled fluticasone propionate in adolescents and adults with asthma.. Meta-analysis of placebo controlled, randomised clinical trials that presented data on at least one outcome measure of asthma and that used at least two different doses of fluticasone.. Medline, Embase, and GlaxoWellcome's internal clinical study registers.. FEV(1), morning and evening peak expiratory flow, night awakenings, beta agonist use, and major exacerbations.. Eight studies, with 2324 adolescents and adults with asthma, met the inclusion criteria. Data on doses of >500 microg/day were limited. The dose-response curve for the raw data began to reach a plateau at around 100-200 microg/day and peaked by 500 microg/day. A negative exponential model for the data, without meta-analysis, indicated that 80% of the benefit at 1000 microg/day was achieved at doses of 70-170 microg/day and 90% by 100-250 microg/day. A quadratic meta-regression showed that the maximum achievable efficacy was obtained by doses of around 500 microg/day. The odds ratio for patients remaining in a study at a dose of 200 microg/day, compared with higher doses, was 0.73 (95% confidence interval 0.49 to 1.08). Comparison of the standardised difference in FEV(1 )for an inhaled dose of 200 microg/day against higher doses showed a difference in FEV(1) of 0.13 of a standard deviation (-0.02 to 0.29).. In adolescent and adult patients with asthma, most of the therapeutic benefit of inhaled fluticasone is achieved with a total daily dose of 100-250 microg, and the maximum effect is achieved with a dose of around 500 microg/day. However, these findings were limited by the lack of data on individual patients and by the paucity of dose-response studies that included doses of >500 microg/day.

    Topics: Administration, Inhalation; Adolescent; Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Fluticasone; Glucocorticoids; Humans; Male; Odds Ratio; Randomized Controlled Trials as Topic

2001
Improved asthma control after changing from low-to-medium doses of other inhaled corticosteroids to low-dose fluticasone propionate.
    MedGenMed : Medscape general medicine, 2001, Jun-08, Volume: 3, Issue:3

    To evaluate the efficacy and safety of changing from low-to-medium doses of other inhaled corticosteroids to low-dose fluticasone propionate.. Data from 11 randomized, double-blind, parallel-group trials in adults (>= 12 years; n = 1453; % predicted FEV1 = 42% to 89%) and 4 trials in children (4-11 years; n = 161; % predicted FEV1 = 50% to 112%) with chronic asthma were retrospectively analyzed. Symptomatic adults (n = 1181) treated with low-to-medium doses of beclomethasone dipropionate (168-672 mcg/day), triamcinolone acetonide (400-1200 mcg/day), or flunisolide (>=1000 mcg/day) were switched to low-dose fluticasone propionate (176 or 200 mcg daily) for 6-26 weeks. Patients (n = 272) remaining on low-dose beclomethasone dipropionate (336 mcg daily) served as controls. Pediatric patients previously treated with low doses of triamcinolone acetonide (4-8 puffs/day), or low-to-medium doses of beclomethasone dipropionate (4-8 puffs/day) or flunisolide (2-6 puffs/day), were changed to low-dose fluticasone propionate (100 mcg daily) for 12-52 weeks.. Improvements in FEV1, morning and evening peak expiratory flow (PEF), rescue albuterol use, asthma symptom scores, and symptom-free days were significantly greater in adults who changed from low-to-medium doses of beclomethasone dipropionate or triamcinolone acetonide to low-dose fluticasone propionate (P <.001). Regardless of the degree of asthma severity, these improvements were 1.5- to 4-fold greater in adult patients changed to low-dose fluticasone propionate vs those remaining on low-dose beclomethasone dipropionate. Significant improvements in lung function, albuterol use, and asthma symptoms (P <=.002) were also seen in pediatric patients who changed from beclomethasone dipropionate, flunisolide, or triamcinolone acetonide to a much lower dose of an inhaled corticosteroid (100 mcg fluticasone propionate daily). Drug-related adverse events were low in adults and children, and were comparable among adults receiving low-dose fluticasone propionate or beclomethasone dipropionate.. Results indicate that patients with persistent asthma can change from other inhaled corticosteroids to a lower dose of fluticasone propionate and still maintain or improve asthma control.

    Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Fluocinolone Acetonide; Fluticasone; Glucocorticoids; Humans; Randomized Controlled Trials as Topic; Triamcinolone Acetonide

2001
What's new: newly approved drugs for children.
    Pediatrics in review, 2001, Volume: 22, Issue:10

    Topics: Adolescent; Age Factors; Albuterol; Androstadienes; Anticonvulsants; Asthma; Atovaquone; Attention Deficit Disorder with Hyperactivity; Beclomethasone; Carbamazepine; Child; Delayed-Action Preparations; Diabetes Mellitus, Type 1; Drug Approval; Drug Combinations; Drug Delivery Systems; Drug Therapy; Epilepsies, Partial; Fluticasone-Salmeterol Drug Combination; HIV Protease Inhibitors; Humans; Insulin; Insulin Glargine; Insulin, Long-Acting; Lopinavir; Methylphenidate; Naphthoquinones; Nebulizers and Vaporizers; Oxcarbazepine; Pediatrics; Proguanil; Pyrimidinones; Ritonavir; United States

2001
Long-acting inhaled beta(2)-agonist therapy in asthma.
    American journal of respiratory and critical care medicine, 2001, Sep-15, Volume: 164, Issue:6

    Topics: Administration, Topical; Adrenergic beta-Agonists; Adult; Age Factors; Albuterol; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Drug Interactions; Drug Therapy, Combination; Ethanolamines; Fluticasone; Formoterol Fumarate; Glucocorticoids; Humans; Meta-Analysis as Topic; Polymorphism, Genetic; Randomized Controlled Trials as Topic; Receptors, Adrenergic, beta-2; Receptors, Glucocorticoid; Respiratory Therapy; Salmeterol Xinafoate; Time Factors

2001
Systematic review of clinical effectiveness of pressurised metered dose inhalers versus other hand held inhaler devices for delivering corticosteroids in asthma.
    BMJ (Clinical research ed.), 2001, Oct-20, Volume: 323, Issue:7318

    To determine the clinical effectiveness of pressurised metered dose inhalers (with or without spacer) compared with other hand held inhaler devices for the delivery of corticosteroids in stable asthma.. Systematic review of randomised controlled trials.. Cochrane Airways Group trials database (Medline, Embase, Cochrane controlled clinical trials register, and hand searching of 18 relevant journals), pharmaceutical companies, and bibliographies of included trials.. All trials in children or adults with stable asthma that compared a pressurised metered dose inhaler with any other hand held inhaler device delivering the same inhaled corticosteroid.. 24 randomised controlled trials were included. Significant differences were found for forced expiratory volume in one second, morning peak expiratory flow rate, and use of drugs for additional relief with dry powder inhalers. However, either these were within clinically equivalent limits or the differences were not apparent once baseline characteristics had been taken into account. No significant differences were found between pressurised metered dose inhalers and any other hand held inhaler device for the following outcomes: lung function, symptoms, bronchial hyper-reactivity, systemic bioavailability, and use of additional relief bronchodilators.. No evidence was found that alternative inhaler devices (dry powder inhalers, breath actuated pressurised metered dose inhalers, or hydrofluoroalkane pressurised metered dose inhalers) are more effective than the pressurised metered dose inhalers for delivery of inhaled corticosteroids. Pressurised metered dose inhalers remain the most cost effective first line delivery devices.

    Topics: Adult; Androstadienes; Asthma; Beclomethasone; Candidiasis, Oral; Child; Fluticasone; Glucocorticoids; Hoarseness; Humans; Hydrocortisone; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Randomized Controlled Trials as Topic; Treatment Outcome

2001
[Inhaled corticosteroids: first-line therapy in asthma].
    Nihon rinsho. Japanese journal of clinical medicine, 2001, Volume: 59, Issue:10

    The pathology of asthma has clarified that the inflammatory process in the pulmonary airways of the asthmatic patients determines asthma symptom activity primarily. Among the anti-inflammatory agents currently available to treat asthma, glucocorticoids are the most effective, and the topically active agents, inhaled corticosteroids (ICS) are the most efficient. In Japan, two ICS are commercially available: beclomethasone dipropionate (BDP) and fluticasone propionate(FP). Both agents have been widely used and their clinical efficacy (BDP vs FP at half the microgram dose of the BDP) are largely comparable. In order to bring asthmatic patients maximal benefits of the ICS, enhancing treatment compliance and giving educations (including how to use the ICS) are mandatory. New ICS, which have better drug delivery and be topically more potent, will be available.

    Topics: Administration, Inhalation; Administration, Topical; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Clinical Trials as Topic; Fluticasone; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Patient Education as Topic; Pregnenediones

2001
[Recent advance in inhaled corticosteroid therapy].
    Nihon rinsho. Japanese journal of clinical medicine, 2001, Volume: 59, Issue:10

    Inhaled corticosteroid therapy against bronchial asthma has developed rapidly and remarkably during last 10 years. The significance of this therapy has been established in a lot of international guidelines for asthma management. Early intervention, which developed from the concept of step-down therapy, is new therapeutic approach to prevent the remodeling of airway walls deemed as the major cause of irreversible airflow limitation which makes patient chronic and refractory asthmatics. It is comprehensive therapeutic approach which include not only early diagnosis, early intensive corticosteroid therapy, but also environment intervention and enough patient education. In addition to this new therapeutic strategy, we will describe about add-on effect of long-acting beta-2 agonists, theophylline, and leukotriene receptor antagonist.

    Topics: Administration, Inhalation; Administration, Topical; Adrenergic beta-Agonists; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Clinical Trials as Topic; Drug Therapy, Combination; Fluticasone; Glucocorticoids; Humans; Leukotriene Antagonists; Practice Guidelines as Topic; Theophylline

2001
[Inhaled corticosteroid therapy in childhood asthma].
    Nihon rinsho. Japanese journal of clinical medicine, 2001, Volume: 59, Issue:10

    Asthma has been recognized as a chronic inflammatory disorder of the airway. The early use of antiinflammatory agents, one of which is inhaled corticosteroids, is advocated in the treatment of chronic asthma. Beclomethasone dipropionate (BDP) is effective in childhood asthma. CD4 T-cell activation correlate with the values of the coefficient variation (CV) of peak expiratory flow (PEF) in asthmatic patients, suggesting that CV of PEF is a good marker for assessing not only the variability of airway obstruction but also the degree of airway inflammation. PEF monitoring is useful for better controlling asthma, because some patients treated with inhaled corticosteroid may still remain undertreated.

    Topics: Administration, Inhalation; Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; CD4-Positive T-Lymphocytes; Child; Chronic Disease; Cromolyn Sodium; Humans; Lymphocyte Activation; Monitoring, Physiologic; Peak Expiratory Flow Rate

2001
Chronic asthma.
    BMJ (Clinical research ed.), 2001, Oct-27, Volume: 323, Issue:7319

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Albuterol; Asthma; Beclomethasone; Chronic Disease; Drug Therapy, Combination; Glucocorticoids; Humans; Indoles; Leukotriene Antagonists; Phenylcarbamates; Randomized Controlled Trials as Topic; Sulfonamides; Tosyl Compounds

2001
[Changes in metered dose inhaler propellants].
    Revue des maladies respiratoires, 2000, Volume: 17, Issue:1

    The understanding of the damaging effect of chlorofluorocarbons (CFCs) on the stratospheric ozone has led to international agreements calling for the total phase-out of CFC production. The banning of CFCs in pressurized metered dose inhalers used in airways disorders has been postponed on a temporary basis until replacement propellants have been identified. Hydrofluoroalkanes HFA-134a and HFA-227 have been shown to have no ozone damaging potential and to be safe. However, HFAs cannot simply be substituted for CFCs in inhalers of identical design. Their use has required changes in many aspects of the drug formulation, inhaler design and manufacture. This, in turn, has provided at least to some pharmaceutical companies an opportunity to assess and enhance the performances of new inhalers. The new products are neither technically nor pharmacologically identical to their CFC-based counterparts. Some of them have now completed clinical trials and the transition has already started: by the end of 1998, 2 short acting beta-agonist HFA-based inhalers and a corticosteroid HFA-based inhaler have reached the marketplace in France.

    Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Aerosol Propellants; Animals; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Chlorofluorocarbons; Humans; Hydrocarbons, Fluorinated; Respiratory Therapy

2000
Beclomethasone for asthma in children: effects on linear growth.
    The Cochrane database of systematic reviews, 2000, Issue:2

    Inhaled steroids play a central role in the management of childhood asthma. There is concern about their side effects, especially on growth. However asthma may also cause growth retardation. Growth rates are not stable, so randomised controlled parallel group studies are needed to assess the impact of inhaled steroids on growth. This review is confine to one inhaled steroid, beclomethasone, that is known to have significant levels of systemic absorption.. To determine whether inhaled beclomethasone cause significant delay in the linear growth of children with asthma.. The Cochrane Airways Group asthma register was searched. Bibliographies from included studies, and known reviews were searched for additional citations. Personal contact with colleagues and researchers working in the field of asthma were made to identify potentially relevant trials.. Randomized, controlled trials comparing the effects of beclamethasone to non-steroidal medication (placebo or non-steroidal therapy) on the linear growth of children with asthma.. Data related to the clinical outcome "change in growth" were extracted by two reviewers working independently. One hundred and fifty-nine citations were identified by the search strategy and bibliography review. Three studies met the inclusion criteria. All used beclomethasone 200 mcg twice daily delivered by dry powder Diskhaler to treat children with mild-moderate asthma. Study duration was 7-12 months. In all three studies, a significant decrease in linear growth occurred in children treated with beclomethasone compared to those receiving placebo or non-steroidal asthma therapy. The average decrease, calculated through meta-analysis, was -1.54 cm per year (95% CI -1.15, -1.94).. In children with mild-moderate asthma, beclomethasone 200 mcg twice daily caused a decrease in linear growth of -1.54 cm per year. These studies lasted a maximum of 54 weeks, so it remains unclear whether the decrease in growth is sustained or whether it reverses with 'catch up' after therapy is discontinued. We are unable to comment on growth effects of other inhaled steroids that have potentially less systemic effects. If inhaled steroids are required to control a child's asthma, we recommend using the minimum dose that effectively controls the child's asthma and closely following growth.

    Topics: Age Factors; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child Development; Growth; Humans

2000
Meta-analysis of increased dose of inhaled steroid or addition of salmeterol in symptomatic asthma (MIASMA).
    BMJ (Clinical research ed.), 2000, May-20, Volume: 320, Issue:7246

    To examine the benefits of adding salmeterol compared with increasing dose of inhaled corticosteroids.. Systematic review of randomised, double blind clinical trials. Independent data extraction and validation with summary data from study reports and manuscripts. Fixed and random effects analyses.. EMBASE, Medline, and GlaxoWellcome internal clinical study registers.. Efficacy and exacerbations.. Among 2055 trials of treatment with salmeterol, there were nine parallel group trials of >/=12 weeks with 3685 symptomatic patients aged >/=12 years taking inhaled steroid in primary or secondary care. Compared with response to increased steroids, in patients receiving salmeterol morning peak expiratory flow was greater at three months (difference 22.4 (95% confidence interval 15.0 to 30.0) litre/min, P<0.001) and six months (27.7 (19.0 to 36.4) litre/min, P<0.001). Forced expiratory volume in one second (FEV(1)) was also increased at three months (0.10 (0.04 to 0.16) litres, P<0.001) and six months (0.08 (0.02 to 0.14) litres, P<0.01), as were mean percentage of days and nights without symptoms (three months: days-12% (9% to 15%), nights-5% (3% to 7%); six months: days-15% (12% to 18%), nights-5% (3% to 7%); all P<0.001) and mean percentage of days and nights without need for rescue treatment (three months: days-17% (14% to 20%), nights-9% (7% to 11%); six months: days-20% (17 to 23%), nights-8% (6% to 11%); all P<0.001). Fewer patients experienced any exacerbation with salmeterol (difference 2.73% (0.43% to 5.04%), P=0. 02), and the proportion of patients with moderate or severe exacerbations was also lower (2.42% (0.24% to 4.60%), P=0.03).. Addition of salmeterol in symptomatic patients aged 12 and over on low to moderate doses of inhaled steroid gives improved lung function and increased number of days and nights without symptoms or need for rescue treatment with no increase in exacerbations of any severity.

    Topics: Adrenergic beta-Agonists; Albuterol; Asthma; Beclomethasone; Drug Administration Schedule; Drug Therapy, Combination; Forced Expiratory Volume; Glucocorticoids; Humans; Peak Expiratory Flow Rate; Randomized Controlled Trials as Topic; Salmeterol Xinafoate; Treatment Outcome

2000
[Influence of inhaled glucocorticoids on bone mineral density and bone metabolism].
    Revista panamericana de salud publica = Pan American journal of public health, 2000, Volume: 7, Issue:4

    Inhaled glucocorticoids (IGs) are today the first-line treatment for bronchial asthma. The systemic effects of inhaled glucocorticoids, such as suppressing the hypothalamic-pituitary-adrenal axis, are generally less than those with oral glucocorticoids. However, there is a long-term risk of adverse effects on bone. The objective of this piece was to review the published data on the effects of IGs on bone metabolism markers and bone mineral density in adults and in pediatric patients. The reviewed studies do not provide uniform results. Nevertheless, in general they suggest that IGs can affect metabolism and bone mineral density, especially: 1) when high doses are administered (more than 400 micrograms/day in children and more than 800 micrograms/day in adults), 2) in pediatric patients, in whom growth in stature can also be affected, 3) in patients whose intake of calcium and vitamin D is inadequate, and 4) in postmenopausal women not undergoing hormone replacement therapy. In general, at therapeutically equivalent doses, beclomethasone has a greater deleterious effect on bone than does budesonide, which in turn has more of an effect than does fluticasone. In addition to the obvious precaution of using the lowest effective dose, other proposed preventive measures include: 1) adequate instruction on the use of aerosols, 2) the use of large volume spacer devices, 3) rinsing the mouth after administering IGs, and 4) dietary adjustments or supplements in order to ensure an adequate intake of calcium and vitamin D.

    Topics: Administration, Inhalation; Administration, Oral; Administration, Topical; Adolescent; Adult; Age Factors; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bone and Bones; Bone Density; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Clinical Trials as Topic; Female; Glucocorticoids; Humans; Infant; Middle Aged; Time Factors

2000
The effect of inhaled steroids on the linear growth of children with asthma: a meta-analysis.
    Pediatrics, 2000, Volume: 106, Issue:1

    To determine whether inhaled steroid therapy causes delayed linear growth in children with asthma.. Medline (1966-1998), Embase (1980-1998), and Cinahl (1982-1998) databases and bibliographies of included studies were searched for randomized, controlled trials of inhaled steroid therapy in children with asthma that evaluated linear growth.. Studies were included if they met the following criteria: subjects 0 to 18 years of age with the clinical diagnosis of asthma; subjects randomized to inhaled beclomethasone, budesonide, flunisolide, fluticasone, or triamcinolone versus a nonsteroidal inhaled control for a minimum of 3 months; single- or double-blind; and outcome convertible to linear growth velocity. English- and non-English-language trials were included.. Data were extracted using a priori guidelines. Methodologic quality was assessed independently by both authors. Outcome was extracted as linear growth velocity.. Included trials were subgrouped by inhaled steroid. The beclomethasone subgroup, with 4 studies and 450 subjects, showed a decrease in linear growth velocity of 1.51 cm/year (95% confidence interval: 1.15,1.87). The fluticasone subgroup, with 1 study and 183 subjects, showed a decrease in linear growth velocity of.43 cm/year (95% confidence interval:.01,.85). Sensitivity analysis in the beclomethasone subgroup, which evaluated study quality, mode of medication delivery, control medication, and statistical model, showed similar results.. This meta-analysis suggests that moderate doses of beclomethasone and fluticasone in children with mild to moderate asthma cause a decrease in linear growth velocity of 1.51 cm/year and.43 cm/year, respectively. The effects of inhaled steroids when given for >54 weeks, or on final adult height, remain unknown.

    Topics: Administration, Inhalation; Adolescent; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Body Height; Budesonide; Child; Child, Preschool; Fluocinolone Acetonide; Fluticasone; Growth; Humans; Infant; Infant, Newborn; Steroids; Triamcinolone

2000
An overview of the clinical efficacy of HFA-BDP in asthma.
    Respiratory medicine, 2000, Volume: 94 Suppl D

    Topics: Administration, Topical; Aerosol Propellants; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chemistry, Pharmaceutical; Glucocorticoids; Humans; Hydrocarbons, Fluorinated

2000
The comparative safety/efficacy ratio of HFA-BDP.
    Respiratory medicine, 2000, Volume: 94 Suppl D

    As has been discussed in the previous sections of the Supplement, the improved physical characteristics of HFA-BDP extrafine aerosol spray allow BDP to be delivered more efficiently into the large, medium and small airways. This improved delivery has allowed the dose of HFA-BDP to be reduced compared to CFC-BDP and budesonide, whilst maintaining equipotency with fluticasone. However, unlike fluticasone, HFA-BDP does not show a propensity for blood or tissue accumulation when administered with a 12-h dosing interval. Standard tests for assessing effects on the HPA-axis indicate that HFA-BDP extrafine aerosol has a favourable systemic bioactivity profile. Even up to the recommended dose of 800 microg day(-1) HFA-BDP (the highest recommended maximum dose), there appear to be no clinically relevant systemic side effects associated with HFA-BDP (Fig. 8). Thus, viewing the data as a whole, it would seem that, compared to CFC-BDP and alternative inhaled corticosteroids, HFA-BDP in a dose of up to 800 microg day(-1) exhibits a favourable therapeutic ratio.

    Topics: Administration, Topical; Aerosol Propellants; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chemistry, Pharmaceutical; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Risk Assessment

2000
A comparison of HFA-BDP Autohaler with budesonide Turbuhaler in asthma control of adult patients with mild to moderately severe disease.
    Respiratory medicine, 2000, Volume: 94 Suppl D

    Topics: Administration, Topical; Adult; Aerosol Propellants; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Chemistry, Pharmaceutical; Clinical Trials as Topic; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Nebulizers and Vaporizers

2000
HFA-BDP and its implications for the quiet zone.
    Respiratory medicine, 2000, Volume: 94 Suppl D

    Topics: Administration, Topical; Aerosol Propellants; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchi; Bronchography; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Tomography, X-Ray Computed

2000
The relative clinical effectiveness of HFA-BDP and fluticasone propionate in asthma.
    Respiratory medicine, 2000, Volume: 94 Suppl D

    Topics: Administration, Topical; Aerosol Propellants; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chemistry, Pharmaceutical; Fluticasone; Glucocorticoids; Humans; Hydrocarbons, Fluorinated

2000
Inhaled beclomethasone versus placebo for chronic asthma.
    The Cochrane database of systematic reviews, 2000, Issue:4

    Inhaled beclomethasone diproprionate (BDP) has been, together with inhaled budesonide, the mainstay of anti-inflammatory therapy for asthma for many years. A range of new prophylactic therapies for asthma is becoming available and BDP is now frequently used as the reference treatment against which these newer agents are being compared.. The objectives of this review were to: a) Compare the efficacy of BDP with placebo in the treatment of chronic asthma. b) Explore the possibility that a dose response relationship exists for BDP in the treatment of chronic asthma. c) To provide the best estimate of the efficacy of BDP as a benchmark for evaluation of newer asthma therapies.. We searched the Cochrane Airways Group Trial Register (1999) and reference lists of articles. We contacted trialists and Glaxo Wellcome for additional studies and searched abstracts of major respiratory society meetings (1997-1999).. Randomised trials in children and adults comparing BDP to placebo in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality.. One reviewer extracted data; authors were contacted to clarify missing information. Quantitative analyses where undertaken using Review Manager (Revman) 4.0.3 with Metaview 3.1.. 52 studies were selected for inclusion (3459 subjects). The studies were generally of high methodological quality. In non-oral steroid treated patients, BDP produced significant improvements in a number of efficacy measures compared to placebo including FEV1 weighted mean difference (WMD) 340ml (95% CI 190-500ml); FEV1 (% predicted) WMD 6% (95% CI 0.4 to 11.5%) and morning PEFR WMD 50 L/min (95% CI 8 to 92 L/min). BDP also led to reductions in rescue beta2 agonist use compared to placebo WMD 1.75 puffs/d (95% CI 1.4 to 2.4 puffs/d) and reduced the likelihood of trial withdrawal due to asthma exacerbation relative risk (RR) 0.26 (95% CI 0.15 to 0.43). In oral steroid treated patients BDP led to significantly greater reductions in oral prednisolone use WMD 5 mg/d (95% CI 4 to 6 mg/d) and a higher likelihood of discontinuing oral prednisolone RR 0.54 (95% CI 0.43 to 0.67). There was little evidence for a clincially worthwhile dose response effect, but few studies recruited patients with more severe asthma.. This review has quantified the efficacy of BDP in the treatment of chronic asthma and strongly supports its use. Current asthma guidelines recommend titration of dose to individual patient response, but the published data provide little support for dose titration above 400 mcg/d in patients with mild to moderate asthma. There are insufficient data to draw any conclusions concerning dose-response in patients with severe disease.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Chronic Disease; Dose-Response Relationship, Drug; Drug Monitoring; Humans; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic

2000
[Corticosteroid therapy of asthma].
    Presse medicale (Paris, France : 1983), 2000, Sep-16, Volume: 29, Issue:16

    BRONCHIAL INFLAMMATION AND GLUCOCORTICOIDS: Bronchial inflammation plays an important role in asthma and contributes to bronchoconstriction, hypersecretion and bronchial hyperreactivity. Glucocorticoids are the gold standard treatment in asthma affecting most of the components involved in bronchial inflammation. Inhaled steroids are recommended early in most countries.. The molecular and cellular mechanisms of glucocorticoids action are still better understood. However, it remains difficult to evaluate individual sensitivity when initiating treatment. Glucocorticoids have an effect on all inflammatory cells and bronchial structure cells. They bind to cytoplasmic receptors and then the complex links to DNA, inducing or inhibiting gene transcription in the target cell. DIFFERENT GLUCOCORTICOID SENSITIVITY: Very few patients are totally insensitive to the effect of glucocorticoids and require specific explorations for an identification. Although individual variability in corticosensitivity is similar in asthmatic patients and in the general population, the underlying mechanisms remain to be fully elucidated. The difference observed between responders and non-responders is not clearly identified and their definitions must be fully adapted.

    Topics: Administration, Inhalation; Administration, Topical; Adrenal Cortex Hormones; Adult; Age Factors; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchi; Child; Glucocorticoids; Humans; Maximal Expiratory Flow-Volume Curves; Receptors, Glucocorticoid

2000
Efficacy and safety overview of a new inhaled corticosteroid, QVAR (hydrofluoroalkane-beclomethasone extrafine inhalation aerosol), in asthma.
    The Journal of allergy and clinical immunology, 2000, Volume: 106, Issue:6

    Chlorofluorocarbon (CFC)-containing inhalers are gradually being phased out and replaced with hydrofluoroalkane (HFA)-based alternatives. The reformulation provided the opportunity to improve the inhalation technology and physical characteristics of corticosteroid formulations. QVAR contains HFA-beclomethasone dipropionate (HFA-BDP) with the steroid in solution rather than suspension, which, in combination with improved inhaler technology, produces an extrafine aerosol with a mass median aerodynamic diameter of 1.1 microm (smaller than the 3.5-4.0 microm found with CFC-BDP). It was predicted and demonstrated that the smaller particle size of QVAR would be deposited in the lung to a greater extent than that found with CFC-BDP, particularly in the small airway, a major site of inflammation. Increased lung deposition of QVAR permits a reduction in dosage relative to CFC-BDP. Clinical evidence confirms that adult and elderly patients required approximately half the dose of QVAR to achieve the same degree of asthma control as with CFC-BDP. In long-term assessments, patients taking CFC-BDP could be switched to QVAR at half the daily dose without exacerbation of their asthma symptoms. QVAR was associated with a low overall incidence of side effects and, at the maximum recommended dose of 640 microg/d, caused no more adrenal suppression than 672 microg/d CFC-BDP.

    Topics: Administration, Inhalation; Aerosol Propellants; Aerosols; Asthma; Beclomethasone; Humans; Hydrocarbons, Fluorinated; Therapeutic Equivalency

2000
The 1997 Asthma Management Guidelines and therapeutic issues relating to the treatment of asthma. National Heart, Lung, and Blood Institute.
    Chest, 1999, Volume: 115, Issue:1

    In 1997, the National Heart, Lung, and Blood Institute released the Second Expert Panel Report on the Guidelines for the Diagnosis and Management of Asthma as a follow-up to the first report issued in 1991. Implementation of the recommendations from this report could have a potentially huge impact on care and treatment of asthma in the United States. Even though the Guidelines are expansive, there are some areas related to the pharmacologic component that warrant further discussion and clarification. These are: (1) safety and efficacy of available asthma medications, (2) clinical efficacy comparisons of inhaled corticosteroids, (3) comparative risks among inhaled corticosteroids, and (4) expectations of different delivery systems used with inhaled corticosteroids.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Therapy, Combination; Humans; United States

1999
Asthma and pregnancy.
    Lancet (London, England), 1999, Apr-10, Volume: 353, Issue:9160

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Steroids

1999
Systemic adverse effects of inhaled corticosteroid therapy: A systematic review and meta-analysis.
    Archives of internal medicine, 1999, May-10, Volume: 159, Issue:9

    To appraise the data on systemic adverse effects of inhaled corticosteroids.. A computerized database search from January 1, 1966, through July 31, 1998, using MEDLINE, EMBASE, and BIDS and using appropriate indexed terms. Reports dealing with the systemic effects of inhaled corticosteroids on adrenal gland, growth, bone, skin, and eye, and reports on pharmacology and pharmacokinetics were reviewed where appropriate. Studies were included that contained evaluable data on systemic effects in healthy volunteers as well as in asthmatic children and adults. A statistical meta-analysis using regression was performed for parameters of adrenal suppression in 27 studies.. Marked adrenal suppression occurs with high doses of inhaled corticosteroid above 1.5 mg/d (0.75 mg/d for fluticasone propionate), although there is a considerable degree of interindividual susceptibility. Meta-analysis showed significantly greater potency for dose-related adrenal suppression with fluticasone compared with beclomethasone dipropionate, budesonide, or triamcinolone acetonide, whereas prednisolone and fluticasone propionate were approximately equivalent on a 10:1-mg basis. Inhaled corticosteroids in doses above 1.5 mg/d (0.75 mg/d for fluticasone propionate) may be associated with a significant reduction in bone density, although the risk for osteoporosis may be obviated by post-menopausal estrogen replacement therapy. Although medium-term growth studies showed suppressive effects with 400-microg/d beclomethasone dipropionate, there was no evidence to support any significant effects on final adult height. Long-term, high-dose inhaled corticosteroid exposure increases the risk for posterior subcapsular cataracts, and, to a much lesser degree, the risk for ocular hypertension and glaucoma. Skin bruising is most likely to occur with high-dose exposure, which correlates with the degree of adrenal suppression.. All inhaled corticosteroids exhibit dose-related systemic adverse effects, although these are less than with a comparable dose of oral corticosteroids. Metaanalysis shows that fluticasone propionate exhibits greater dose-related systemic bioactivity compared with other available inhaled corticosteroids, particularly at doses above 0.8 mg/d. The long-term systemic burden will be minimized by always trying to achieve the lowest possible maintenance dose that is associated with optimal asthmatic control and quality of life.

    Topics: Administration, Inhalation; Administration, Topical; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bone and Bones; Budesonide; Dose-Response Relationship, Drug; Eye; Fluticasone; Glucocorticoids; Growth; Humans; Prednisolone; Skin; Triamcinolone

1999
[Inhalation corticosteroids and the growth of asthmatic children].
    Nederlands tijdschrift voor geneeskunde, 1999, Oct-09, Volume: 143, Issue:41

    During therapy with inhaled corticosteroids (ICS) of asthmatic children studies examining growth over several weeks using a knemometer showed a dose-dependent reduction of lower leg growth. During maintenance treatment with beclomethasone 400 micrograms/day for several months the growth of asthmatic children was reduced by approximately 1 cm/year compared with contemporaries who had not been treated with this substance. No such growth retardation was found in studies on long-term therapy with budesonide (400-800 micrograms/day) or fluticasone (100-200 micrograms/day). However, differences between ICS are difficult to establish or to exclude, since the systemic availability may vary, due for instance to the properties of the inhaler and the individual inhaling technique. It appears that most children with asthma treated with ICS perform a catch-up growth so that they reach a normal height as young adults. Since growth retardation if any mostly occurs during the first three months of the treatment, growth of asthmatic children must be monitored carefully. When growth is reduced by > 0.25 standard deviation score within 1 year, the use of ICS needs to be reconsidered. This decision can best be made by a paediatrician or after consulting one.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Height; Budesonide; Child; Child Development; Child, Preschool; Dose-Response Relationship, Drug; Fluticasone; Humans

1999
[Modes of administration of inhaled corticosteroids in mild to moderate persistent asthma].
    Revue des maladies respiratoires, 1999, Volume: 16, Issue:5

    Inhaled corticosteroids are the treatment of choice for asthma. However, poor compliance by patients is one of the principal difficulties forced by clinicians. Thus, it seems important to propose the minimal daily number of doses. This study has compared the various modes of administration of inhaler corticosteroids and was carried out in patients with mild to moderate persistent asthma. Thus, comparing two to four doses per day shows an identical efficacy if the dose is less than 800 micrograms per day. At higher doses only two studies have been carried out and there are discordant results. The studies compare two doses versus one single dose per day and equally disagree with numerous works in favor of a single daily dose. In the single study carried out for at least twelve months the twice daily dose was the most effective. Thus it seems reasonable to suggest a single dose for mild persistent asthmatics. For moderate persistent asthmatics the choice between a single or twice daily dose would depend on the therapeutic compliance of the patient.

    Topics: Administration, Inhalation; Administration, Topical; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Fluocinolone Acetonide; Humans; Placebos; Randomized Controlled Trials as Topic; Time Factors; Triamcinolone Acetonide

1999
Clinical experience with fluticasone propionate in asthma: a meta-analysis of efficacy and systemic activity compared with budesonide and beclomethasone dipropionate at half the microgram dose or less.
    Respiratory medicine, 1998, Volume: 92, Issue:1

    The relative clinical efficacy and systemic effects of different inhaled corticosteroids is controversial. To obtain further information on this matter, the authors have performed meta-analysis of seven trials comparing fluticasone propionate (FP) with budesonide (Bud), and seven trials comparing FP with beclomethasone dipropionate (BDP) for the treatment of asthma of all severities in adult and paediatric patients. In all cases, the drugs were compared at clinically equivalent doses, i.e. FP was given at half (or less) the microgram dose. The total number of patients was 1980 (1000 treated with FP 200-800 micrograms day-1 and 980 with Bud 400-1600 micrograms day-1), and 1584 patients in the second analysis (780 treated with FP 200-1000 micrograms day-1 and 804 with BDP 400-2000 micrograms day-1). FP significantly improved mean morning peak expiratory flow rate (PEFR) compared with Bud, with an overall difference of +11 l min-1. Analysis of serum cortisols showed no differences between FP and Bud treatment at low doses, but at higher dosages, and overall, significant differences in favour of FP were observed. In the second meta-analysis, no significant differences in PEFR were observed between FP and BDP in any of the seven individual studies or in the pooled analysis. Analysis of serum cortisols showed a similar trend to the previous analysis, however, no overall difference in serum cortisol results were seen between FP and BDP. In conclusion, the pooled analysis shows that FP at half the dose (or less) is more effective than Bud and as effective as BDP in improving PEFR; in addition, these improvements were achieved with a reduction in cortisol suppression compared with BUD and with no greater degree of cortisol suppression compared with BDP. This demonstrates, in patients with asthma, that FP has an improved efficacy to safety ratio compared with older inhaled corticosteroids.

    Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Child; Drug Administration Schedule; Fluticasone; Humans; Hydrocortisone; Peak Expiratory Flow Rate

1998
[Current status on the treatment of asthma--special reference to anti-inflammatory drug therapy].
    Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine, 1998, Mar-10, Volume: 87, Issue:3

    Topics: Administration, Inhalation; Anti-Allergic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Cromolyn Sodium; Delayed-Action Preparations; Humans; Monitoring, Physiologic; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Practice Guidelines as Topic; Theophylline

1998
Improved delivery of inhaled steroids to the large and small airways.
    Respiratory medicine, 1998, Volume: 92 Suppl A

    The reformulation of asthma medications with non-ozone depleting propellants such as hydrofluoroalkane-134a (HFA) has provided the opportunity to apply new knowledge and inhaler technology to improve significantly the delivery of aerosol drugs to the respiratory tract. Beclomethasone dipropionate (BDP), the most commonly prescribed inhaled corticosteroid for asthma therapy, is effective therapy; however currently available chlorofluorocarbon (CFC)-BDP metered dose inhalers typically deliver no more than 10% of the inhaled drug to the lungs with the remainder deposited in the oropharynx. Compared with an average particle size of 3.5-4.0 microns for CFC-BDP, the new HFA-BDP formulation has an average particle size of 1.1 microns and a respirable fraction of approximately 60%. The lung deposition of 99mTc-radiolabelled HFA-BDP has been investigated in healthy volunteers and patients with asthma. Results showed that the HFA-BDP formulation reverses the pattern of distribution seen with CFC-BDP products, delivering most of the dose of inhaled steroid directly to the lungs rather than to the oropharynx and gut where it may lead to unwanted side-effects. As such, HFA-BDP is likely to achieve equivalent efficacy to existing CFC-BDP formulations with lower doses and with reduced potential for local adverse effects.

    Topics: Administration, Inhalation; Aerosol Propellants; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchi; Drug Delivery Systems; Humans; Hydrocarbons, Fluorinated; Lung; Nebulizers and Vaporizers; Particle Size; Pulmonary Alveoli; Radionuclide Imaging; Technetium

1998
Effect of changing the fine particle mass of inhaled beclomethasone dipropionate on intrapulmonary deposition and pharmacokinetics.
    Respiratory medicine, 1998, Volume: 92 Suppl A

    Reformulation of beclomethasone dipropionate (BDP) in the chlorofluorocarbon (CFC)-free propellant hydrofluoroalkane-134a (HFA) gave the opportunity to produce a solution formulation that provides a greater total mass of fine drug particles than the current CFC suspension metered dose inhaler (MDI). The HFA-BDP MDI was studied in three pharmacokinetic trials in asthmatic patients. Serum levels of BDP plus metabolites [total beclomethasone (total BOH) assay] were used to test whether the increased fine particle mass of HFA-BDP would result in improved intrapulmonary deposition and subsequent differences in serum profiles. Serum levels, maximum serum concentrations and area under the serum concentration-time curves of total BOH following both single and multiple doses of HFA-BDP were similar to those obtained with approximately twice the dose of CFC-BDP. The observed lower bioavailability of CFC-BDP compared with HFA-BDP could be explained if most of each inhaled dose from the CFC-BDP MDI was swallowed and absorbed from the gastrointestinal tract, while most of each inhaled dose from the HFA-BDP MDI was absorbed from the lungs. Deposition studies have confirmed this explanation. These results suggest that asthmatic patients can be treated with lower total daily doses of drug from HFA-BDP extrafine aerosol than from CFC-BDP.

    Topics: Administration, Inhalation; Adolescent; Adult; Aerosol Propellants; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chlorofluorocarbons; Cross-Over Studies; Drug Administration Schedule; Female; Humans; Hydrocarbons, Fluorinated; Lung; Male; Middle Aged; Particle Size; Randomized Controlled Trials as Topic

1998
Comparative physicochemical and pharmacokinetic profiles of inhaled beclomethasone dipropionate and budesonide.
    Respiratory medicine, 1998, Volume: 92 Suppl B

    The physicochemical and pharmacokinetic characteristics of BDP and budesonide are somewhat different, but the overall result is that both are well suited for use as inhaled corticosteroids. Both BDP and budesonide are metabolized primarily by the liver, with one of the metabolites of BDP, 17-BMP, having greater receptor affinity than either the parent compound or budesonide, which has no active metabolites. BDP has a lower water solubility than either 17-BMP or budesonide, which have similar water solubilities. Budesonide has lower oral bioavailability than BDP; however, it is generally reported to have a longer plasma half-life than either BDP or 17-BMP. The physicochemical and pharmacokinetic profiles of inhaled BDP and budesonide provide both compounds with a favourable ratio of topical to systemic effects and support their well-established role in the treatment of asthma. The device used to deliver an inhaled corticosteroid influences the lung deposition of the drug and selection of the device should be made with an understanding of the particular advantages and disadvantages of the device for each individual patient.

    Topics: Absorption; Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Drug Delivery Systems; Humans; Liver; Lung; Nebulizers and Vaporizers; Structure-Activity Relationship

1998
Efficacy of inhaled beclomethasone dipropionate and budesonide in the treatment of asthma.
    Respiratory medicine, 1998, Volume: 92 Suppl B

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Drug Administration Schedule; Drug Delivery Systems; Humans; Randomized Controlled Trials as Topic

1998
Effect of inhaled beclomethasone dipropionate and budesonide on adrenal function, skin changes and cataract formation.
    Respiratory medicine, 1998, Volume: 92 Suppl B

    Topics: Administration, Inhalation; Adrenal Glands; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Cataract; Child; Drug Administration Schedule; Humans; Randomized Controlled Trials as Topic; Skin

1998
Effect of inhaled beclomethasone dipropionate and budesonide on growth in children with asthma.
    Respiratory medicine, 1998, Volume: 92 Suppl B

    Topics: Administration, Inhalation; Administration, Topical; Adolescent; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Body Height; Budesonide; Child; Child, Preschool; Glucocorticoids; Humans; Infant; Randomized Controlled Trials as Topic; Time Factors

1998
Comparative review of the effects of inhaled beclomethasone dipropionate and budesonide on bone.
    Respiratory medicine, 1998, Volume: 92 Suppl B

    Topics: Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biomarkers; Bone and Bones; Bone Density; Budesonide; Child; Female; Humans; Male; Middle Aged; Osteocalcin

1998
Inhaled glucocorticosteroids in childhood asthma.
    Indian pediatrics, 1998, Volume: 35, Issue:9

    Topics: Administration, Inhalation; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Child, Preschool; Dose-Response Relationship, Drug; Humans; Infant; Severity of Illness Index

1998
Targeting inhaled steroids.
    International journal of clinical practice. Supplement, 1998, Volume: 96

    Asthma is a disease of the entire respiratory tract and successful asthma therapy requires drug delivery throughout the large and small airways. The most commonly prescribed inhaled corticosteroid for the treatment of asthma is beclomethasone dipropionate (BDP) delivered by a metered-dose inhaler (MDI) containing chlorofluorocarbons (CFCs). CFC-BDP MDIs produce relatively large particles and when used optimally deposit less than 10% of the dose in the lungs, primarily in the large airways, with more than 90% being deposited in the oropharynx. The new hydrofluoroalkane (HFA)-BDP inhaler developed by 3M Pharmaceuticals (Qvar) delivers a particle size of approximately 1.1 microns. Animal and mechanical models predict more than 50% lung deposition with this formulation. Clinical results, with radiolabelled Qvar in patients with asthma and volunteers, have demonstrated that 50-60% of the dose is deposited throughout the airways with approximately 30% being deposited in the oropharynx. 3M Pharmaceuticals have developed the breath-actuated Autohaler which provides the same lung deposition as an optimally used Qvar MDI by automatically delivering the drug very early in the inhalation. Neither device routinely requires the use of a spacer.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Humans; Nebulizers and Vaporizers; Steroids

1998
Improvements in delivery with an extra fine beclomethasone aerosol.
    International journal of clinical practice. Supplement, 1998, Volume: 96

    The reformulation of beclomethasone dipropionate (BDP) in a chlorofluorocarbon (CFC)-free propellant, hydrofluoroalkane (HFA), has resulted in improved delivery of medication to the large and small airways, the target site of action of anti-asthmatic therapy. It is hypothesised that this improved delivery of BDP to the airways will translate into improved clinical efficacy in comparison with the previous CFC formulation. This paper reviews the results of three large-scale clinical trials that were designed to test this hypothesis by comparing the efficacy of various doses of Qvar (3M Pharmaceuticals' HFA-BDP formulation) with CFC-BDP in asthmatic patients. It was found that the dose-response relationship of Qvar is shifted to the left compared with CFC-BDP, such that equivalent improvements in asthma control are seen with half the daily dose of Qvar compared with the CFC formulation.

    Topics: Administration, Inhalation; Aerosols; Anti-Asthmatic Agents; Asthma; Beclomethasone; Clinical Trials as Topic; Drug Delivery Systems; Humans

1998
[Asthma therapy: combination of topical glucocorticosteroids and theophylline].
    Medizinische Klinik (Munich, Germany : 1983), 1997, Volume: 92 Suppl 5

    In addition to its bronchodilatory effects, theophylline has anti-inflammatory and immunomodulatory effects. Since theophylline and corticosteroids act via different molecular mechanisms, they may be used in combination. Two recently completed trials have demonstrated that with respect to asthma control the combination of inhaled steroid (400 - 800 microg/d) plus theophylline is at least as effective as doubling the dose of inhaled steroid in patients who remain symptomatic on a dosage of 400 - 800 microg daily.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Albuterol; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Multicenter Studies as Topic; Peak Expiratory Flow Rate; Randomized Controlled Trials as Topic; Salmeterol Xinafoate; Theophylline

1997
[Management of adult asthma].
    Arerugi = [Allergy], 1997, Volume: 46, Issue:12

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Administration Schedule; Humans; Practice Guidelines as Topic; Steroids

1997
Issues in the use of inhaled glucocorticoids. The Asthma Clinical Research Network.
    American journal of respiratory and critical care medicine, 1996, Volume: 153, Issue:6 Pt 1

    Topics: Administration, Inhalation; Administration, Topical; Adrenal Glands; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Dose-Response Relationship, Drug; Fluocinolone Acetonide; Fluticasone; Glucocorticoids; Growth; Humans; Osteoporosis; Pregnenediones; Triamcinolone Acetonide

1996
[Recent view on drug therapy of bronchial asthma].
    Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine, 1996, Mar-10, Volume: 85, Issue:3

    Topics: Adrenergic beta-Agonists; Anti-Inflammatory Agents; Asthma; Beclomethasone; Betamethasone; Bronchodilator Agents; Humans; Isoproterenol; Peak Expiratory Flow Rate; Prednisolone; Theophylline

1996
[Steroid inhalation therapy of asthma].
    Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine, 1996, Feb-10, Volume: 85, Issue:2

    Topics: Administration, Inhalation; Anti-Inflammatory Agents; Asthma; Beclomethasone; Humans

1996
Inhaled glucocorticoids: new developments relevant to updating of the asthma management guidelines.
    Respiratory medicine, 1996, Volume: 90, Issue:7

    Topics: Absorption; Administration, Topical; Adolescent; Adult; Aerosols; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Child; Drug Administration Schedule; Fluticasone; Glucocorticoids; Humans; Infant; Practice Guidelines as Topic; Pregnenediones; Risk Factors

1996
Do patients with COPD benefit from treatment with inhaled corticosteroids?
    The European respiratory journal, 1996, Volume: 9, Issue:10

    Topics: Administration, Inhalation; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchodilator Agents; Budesonide; Follow-Up Studies; Forced Expiratory Volume; Forecasting; Glucocorticoids; Humans; Lung Diseases, Obstructive; Peak Expiratory Flow Rate; Pregnenediones; Randomized Controlled Trials as Topic; Smoking; Vital Capacity

1996
[Bronchial asthma as an inflammation and the use of inhaled steroid].
    Nihon rinsho. Japanese journal of clinical medicine, 1996, Volume: 54, Issue:11

    Recently, bronchial asthma has been widely recognized as a chronic inflammatory disorder of the airways. In the course of inflammation, many kinds of inflammatory cells such as lymphocytes, especially Th2 lymphocytes, mast cells, eosinophills, bronchial epithelial cells interact each other by so-called cytokine network. Bronchial hyperreactivity, which is a characteristic phenomenon in bronchial asthma, is induced as a result of bronchial inflammation. According to the inflammation theory of pathogenesis of bronchial asthma, anti-inflammatory treatment using inhaled corticosteroid is recommended as the first choice of asthma therapy. Bronchial biopsy proved decrease of the number of infiltrating inflammatory cells such as T lymphocytes, eosinophils and mast cells in the bronchial submucosal tissue after inhaled steroid treatment. Improvement of bronchial reactivity after inhaled steroid therapy was also reported. Recently, a certain group of so-called steroid resistant asthma has been known and the mechanism of it is now under investigation.

    Topics: Administration, Inhalation; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchi; Bronchial Diseases; Bronchial Hyperreactivity; Cytokines; Eosinophils; Humans; Inflammation; Inflammation Mediators; Mast Cells; T-Lymphocytes

1996
[Inhaled corticosteroid therapy in long-term management of adult asthma].
    Nihon rinsho. Japanese journal of clinical medicine, 1996, Volume: 54, Issue:11

    Bronchial asthma is no longer considered a condition with isolated, acute episodes of bronchoconstriction. Rather, asthma is now understood to be a chronic inflammatory disorder of the airways. Therefore anti-inflammatory agents and, more specifically, inhaled corticosteroids are at present the most effective controllers in long-term treatment and prevention of asthma. Asthma is highly variable, so precise classification of severity is needed for management. Asthma therapy recommended in guidelines follows a stepwise approach in which the level of therapy is increased (step up) as the severity of asthma increased and therapy decreased (step down) once control is achieved and sustained. In this stepwise approach, inhaled corticosteroid is a key drug and establishment of the dosage of inhaled corticosteroid is most important.

    Topics: Administration, Inhalation; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chronic Disease; Female; Humans; Japan; Practice Guidelines as Topic; Severity of Illness Index; Societies, Medical; World Health Organization

1996
[Inhaled corticosteroid in out-patient management of asthma].
    Nihon rinsho. Japanese journal of clinical medicine, 1996, Volume: 54, Issue:11

    In 1988, we started to change our treatment policy, away from a polypharmaceutical approach including oral bronchodilators and oral anti-allergic agents available in Japan, toward an inhalation therapy including inhaled corticosteroids and inhaled beta-agonist. A marked decline in the number of asthma admission and death from asthma started coincidentally with the increased use of inhaled corticosteroid which were followed by the decreased use of inhaled beta-agonists and oral anti-asthma agents. The intensification of patient education mainly consisting of emphasizing on better understanding of benefits of inhalation therapy and a self-management is likely to play an important role in enhancing a protective effects of inhaled corticosteroids. Despite some limitations of inhaled corticosteroids, such as poorer dose response in elderly asthmatics and/or patients with severe disease, further introduction of guide-line treatment will result in a measurable improvement on asthma control.

    Topics: Administration, Inhalation; Anti-Inflammatory Agents; Asthma; Beclomethasone; Humans; Patient Education as Topic; Quality of Life; Self Administration

1996
[Problems of inhaled steroid therapy in children with asthma].
    Nihon rinsho. Japanese journal of clinical medicine, 1996, Volume: 54, Issue:11

    Inhaled steroid therapy has become a most popular anti-inflammatory medication in asthmatic children. However, overreliance on inhaled steroids should not mislead the treatment of asthma because the best way to prevent asthmatic symptoms is the identification and control of triggers such as allergens and non-specific irritants. We should weigh the merits against adverse effects and make a correct decision to use inhaled steroids in each asthmatic child. Since the effectiveness of inhaled steroids mainly depends on the correct performance of inhalation therapy, we must educate patients and their family to develop a good partnership in asthma management as emphasized in every guideline.

    Topics: Administration, Inhalation; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Family; Female; Humans; Male; Patient Education as Topic

1996
[High dose inhaled steroid therapy--usefulness and limitation].
    Nihon rinsho. Japanese journal of clinical medicine, 1996, Volume: 54, Issue:11

    Our data indicate that 1800 micrograms of per day is more effective than 1400 micrograms/day at the beginning of long-term management of severe asthma in adults whose symptoms are not controlled with the combination of 800 approximately 900 micrograms/day BDP and bronchodilators. Therapy with a higher dose (at least 1600 micrograms/day) of inhaled steroid is more useful and should be promptly began to treat severe asthma. Oral steroid therapy for long-term management should be introduced to mostly severe case after high dose inhaled BDP therapy reveals to be failure.

    Topics: Administration, Inhalation; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chronic Disease; Female; Humans; Hydrocortisone; Male; Middle Aged; Peak Expiratory Flow Rate

1996
[A comparison of the pharmacological actions between DSCG (disodium cromoglycate) and BDP (beclomethasone dipropionate) in the treatment of bronchial asthma].
    Nihon rinsho. Japanese journal of clinical medicine, 1996, Volume: 54, Issue:11

    Effects and actions of DSCG and corticosteroids in the airways could not essentially evaluated at the same situation, before the inhaled BDP had been used. Each of the drugs have been shown to reduce both immediate and late phase responses in experimentally induced asthma, exercise induced bronchospasm, and bronchial hypersensitivity to histamine especially after the prolonged pretreatment of BDP. DSCG probably targets nonspecifically the surfaces of relevant cells including mast cells and eosinophils, but BDP are known to act specifically and/or nonspecifically on the gene transcription in the various types of cells including eosinophils, lymphocytes, and resident cells. Many informations on the systemic side effects of BDP will be still required.

    Topics: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; Bronchial Hyperreactivity; Cromolyn Sodium; Eosinophils; Humans; Inflammation Mediators; Mast Cells; Transcription, Genetic

1996
[A role of inhaled disodium cromoglycate in child asthma].
    Nihon rinsho. Japanese journal of clinical medicine, 1996, Volume: 54, Issue:11

    Inhalation of disodium clomoglycate (DSCG) is main therapy for childhood asthma in Japan. Regular inhalation of both DSCG and beta 2 stimulant is recommended for the treatment of severe asthma in the guideline which was made in 1993. Characteristic of childhood asthma such as retardation of growth and exercise-induced asthma is considered as an important view point in Japanese pediatric field. On the other hand inhalation of beclomethasone dipropionate (BDP) is used for the treatment of adult-hood asthma in Japan and WHO global storategy. In the future new treatment will be developed using both DSCG and BDP.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Age of Onset; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; Child; Cromolyn Sodium; Drug Combinations; Humans

1996
[The clinical usefulness of the combined use of inhaled beta 2-agonist and inhaled steroid in asthma].
    Nihon rinsho. Japanese journal of clinical medicine, 1996, Volume: 54, Issue:11

    Treatment with inhaled steroid has become increasingly important in asthma. However there are also many patients with asthma whose symptoms are uncontrolled by beclomethasone dipropionate (BDP) alone. For these patients we have tried the regular use of inhaled procaterol or inhaled fenoterol with BDP, and some of these patients have got good control. Recent studies show that, in patients whose asthma is inadequately controlled with BDP, better control can be achieved by adding inhaled long-acting beta 2-agonist rather than by doubling the dose of BDP. In the near future inhaled long-acting beta 2-agonist will be possible for clinical use in our country, and the combined use of it and BDP as preventive therapy will be the mainstay of treatment for patients with moderate-to-severe asthma.

    Topics: Adrenergic beta-Agonists; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Controlled Clinical Trials as Topic; Delayed-Action Preparations; Double-Blind Method; Drug Therapy, Combination; Female; Fenoterol; Humans; Procaterol

1996
Evolving role of theophylline for treatment of chronic childhood asthma.
    The Journal of pediatrics, 1995, Volume: 127, Issue:2

    Topics: Adrenergic beta-Agonists; Asthma; Beclomethasone; Bronchodilator Agents; Child; Clinical Trials as Topic; Cromolyn Sodium; Humans; Metaproterenol; Randomized Controlled Trials as Topic; Theophylline

1995
[Beclomethasone dipropionate, budesonide and flunisolide in the treatment of bronchial asthma (a review of the literature and the authors' own research)].
    Terapevticheskii arkhiv, 1995, Volume: 67, Issue:3

    Inhalation corticosteroids (beclometasone dipropionate, budesonide, flunisolide) proved effective against bronchial asthma (BA) and safe as they induce no severe systemic side effects. Of these three drugs side effects arise most frequently in administration of beclometasone dipropionate, least frequently of flunisolide. These inhalation corticosteroids are indicated both in non-steroid-dependent and steroid-dependent BA to reduce the dose of oral steroids or, if possible, for their complete discontinuation. Flunisolide is the most potent and effective of all inhalation corticosteroids used in current practice.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Dose-Response Relationship, Drug; Drug Evaluation; Fluocinolone Acetonide; Humans; Pregnenediones; Prodrugs

1995
[Steroid inhalation therapy of bronchial asthma].
    Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine, 1995, Dec-10, Volume: 84, Issue:12

    Topics: Administration, Inhalation; Anti-Inflammatory Agents; Asthma; Beclomethasone; Clinical Trials as Topic; Humans

1995
A meta-analysis of the effect of oral and inhaled corticosteroids on growth.
    The Journal of allergy and clinical immunology, 1994, Volume: 93, Issue:6

    This analysis summarizes studies comparing attained heights with expected heights of children with asthma treated with inhaled or oral corticosteroids. The possible moderating effects of treatment duration, and dosage and asthma severity are also examined. A preliminary database of 95 articles rendered 21 includable studies representing 810 patients with asthma, which yielded 29 tests of the corticosteroid-growth effect. Statistical integration of the results of these studies revealed a significant but small tendency for corticosteroid therapy in general to be associated with diminished final height (Z = 2.328, p = 0.01, mean r = -0.023). However, this effect varied for the specific drugs under consideration. As expected, significant weak growth impairment was observed for prednisone (Z = 2.137, p = 0.0164, mean r = -0.295) and "other oral corticosteroids" (Z = 9.107, p = 2.44E-18, mean r = -0.260). On the other hand, a significant moderate tendency was observed for inhaled beclomethansone dipropionate therapy to be associated with attaining normal stature (Z = 7.395, p = 2.17E-13, mean r = +0.432). There was no statistical evidence for beclomethasone dipropionate therapy to be associated with growth impairment at higher doses, for longer therapy durations, or among patients with more severe asthma. This meta-analytic integration indicates that available studies of inhaled beclomethasone dipropionate therapy do not show an association between its use and the adverse effect of diminished stature.

    Topics: Administration, Inhalation; Administration, Oral; Adrenal Cortex Hormones; Age Factors; Asthma; Beclomethasone; Child; Growth; Humans

1994
[Clinical efficacy and side effects of inhalation corticosteroids in asthma].
    Nederlands tijdschrift voor geneeskunde, 1994, Jul-09, Volume: 138, Issue:28

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Glucocorticoids; Growth; Humans; Longitudinal Studies; Osteoporosis; Pregnenediones

1994
[Glucocorticosteroid therapy in bronchial asthma].
    Nihon rinsho. Japanese journal of clinical medicine, 1994, Volume: 52, Issue:3

    Corticosteroid inhibits airway inflammation associated with eosinophils and lymphocytes in bronchial asthma. Asthma severity is classified according to symptoms, airflow obstruction (PEF) and treatment requirement. Step 1: A patient has mild asthma. Inhaled corticosteroid, beclomethasone dipropionate (BDP), is used not to exceed 200 micrograms a day. Step 2: A patient has moderate asthma. The primary therapy is 200-400 micrograms of BDP a day. Step 3: If the patient experiences exacerbations, 400 to 1000 micrograms of BDP a day are required. Step 4: A patient has severe asthma. Oral corticosteroid and/or 800-1600 micrograms of BDP are available. Intravenous corticosteroid therapy for acute exacerbation of asthma is applied for patients who have moderate or severe exacerbation. Corticosteroids are currently the most effective anti-inflammatory drugs for the treatment of asthma. Corticosteroids, however, have many sort of adverse effects. Adverse effects of inhaled corticosteroids are less than those of oral corticosteroid except for local effects. Use of spacer and gargle after the inhalation are recommended to reduce the local adverse effects.

    Topics: Administration, Inhalation; Administration, Oral; Asthma; Beclomethasone; Glucocorticoids; Humans; Injections, Intravenous; Prednisolone

1994
Evolution of asthma treatments.
    Annals of allergy, 1993, Volume: 71, Issue:3

    The treatment of asthma has undergone dramatic changes in the past two decades. These changes stem from the marked increase in our understanding of the pathophysiology of asthma as well as from the availability of potent and effective therapeutic agents. This review discusses the current treatment of asthma considered from a pathophysiologic perspective, focusing on the roles of specific and symptomatic approaches. Specific therapies are aimed at the underlying processes causing asthma, with the goal of reducing symptoms and the need for concomitant medication. Choices include allergen avoidance, immunotherapy, inhaled cromolyn or nedocromil, and inhaled or oral corticosteroids. Symptomatic therapies that control the symptoms of asthma without affecting the underlying causes are used alone or to provide coverage in the period before specific therapies take effect. Here the options are beta agonists, theophylline, and anticholinergic agents. This article weighs the advantages and disadvantages of each of the principal therapies and discusses today's major controversies, including the link between beta-agonist use and asthmatic deaths, theophylline toxicity, and the efficacy of immunotherapy.

    Topics: Albuterol; Asthma; Beclomethasone; Humans

1993
[Use of inhaled beclomethasone dipropionate in adult asthma].
    Presse medicale (Paris, France : 1983), 1992, Oct-03, Volume: 21, Issue:32

    Beclomethasone dipropionate has now been used for more than 10 years during which our knowledge of how to use inhaled corticosteroids has gradually improved: high dose initial treatment followed by progressive reduction down to the minimum effective dosage; administration in 2 daily doses when the asthma is stable and 4 daily doses in case of instability; mild and transient undesirable effects, often minimized by a correct use of the inhaler; effectiveness assessed from bronchial hyper-reactivity and respiratory function tests, reduction or avoidance of oral corticosteroid therapy, or results of association with other treatments, and in particular bronchodilators. When exactly should inhaled corticosteroid therapy should be started and how long should it be pursued are controversial points, but an early and prolonged treatment must probably be recommended.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Asthma; Beclomethasone; Bronchial Hyperreactivity; Candidiasis, Oral; Drug Therapy, Combination; Humans; Pituitary-Adrenal System

1992
[Isolated cough and bronchial asthma].
    Revue de pneumologie clinique, 1991, Volume: 47, Issue:2

    Over an 18-month period 31 patients (27 female and 4 male) were referred to the ENT department of our clinic for a 1-month to 14-year history of isolated non-productive cough. As ENT examination, including posterior rhinoscopy, was normal, these patients were sent to the pneumology department. Physical examination and X-ray films of the chest were negative, and the patients did not take an angiotensin converting enzyme inhibitor that could have induced this cough. Inhalation of acetylcholine lowered vital capacity by 32 +/- 14% and forced expiratory volume by 34 +/- 16%, a test which is the hallmark of bronchial hyperreactivity. Three patients were atopic. We believe that this cough can be the only manifestation of bronchial asthma. In these patients, cough was suppressed or strongly attenuated by the inhalation, 5 times a day, of salbutamol 200 mg puffs and beclomethasone dipropionate 250 mcg. In addition, the atopic patients were prescribed 10 puffs of sodium cromoglycate per day. Complaints of isolated non-productive cough must always suggest that possibility of bronchial asthma, and a bronchial provocation test must be performed to confirm this diagnosis.

    Topics: Adolescent; Adult; Aged; Albuterol; Asthma; Beclomethasone; Bronchial Provocation Tests; Chronic Disease; Cough; Cromolyn Sodium; Female; Humans; Hypersensitivity, Immediate; Male; Middle Aged

1991
[Mechanism of the development and management of a chronic state of allergic diseases--bronchial asthma].
    Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine, 1991, Mar-10, Volume: 80, Issue:3

    Topics: Allergens; Animals; Asthma; Beclomethasone; Bronchodilator Agents; Chronic Disease; Histamine Antagonists; Humans

1991
[Topical intranasal cortisone therapy].
    Recenti progressi in medicina, 1991, Volume: 82, Issue:4

    Owing to improvements made during the last 15 years in the pathophysiological and pharmacological research, many new corticosteroids have been successfully experimented. They have high activity on the target organ and they are suitable for long term therapies since they have not any systemic and/or local side effects. Nowadays the topical intranasal corticosteroid therapy is indispensable for allergic rhinitis treatment and it is very useful for many nasal and bronchopulmonary diseases (some chronic rhinitis, nasal polyposis, bronchial asthma, chronic obstructive bronchopulmonary diseases). The authors use their personal experience and carefully review the literature to describe the general aspects (pharmacology, pharmacokinetics, toxicology, side effects and contraindications) and to analyze the single drugs currently used in Italy and abroad. Finally, they compare the efficacy of each topical intranasal glucocorticoid among themselves and with other drugs.

    Topics: Administration, Intranasal; Adrenal Cortex Hormones; Adult; Asthma; Beclomethasone; Budesonide; Child; Fluocinolone Acetonide; Humans; Hydrocortisone; Lung Diseases, Obstructive; Pregnenediones; Rhinitis

1991
Anaphylactoid reaction to intravenous hydrocortisone sodium succinate: a case report and literature review.
    The Medical journal of Australia, 1991, Feb-04, Volume: 154, Issue:3

    Reports of corticosteroid sensitivity reactions are rare in the medical literature. We report an anaphylactoid reaction to hydrocortisone sodium succinate given intravenously which occurred on two occasions during treatment of a patient for asthma. Intradermal testing with a wide range of steroid preparations gave positive results with hydrocortisone sodium succinate, methylprednisolone sodium succinate, methylprednisolone sodium succinate and methylprednisolone acetate. No reactions occurred to dexamethasone sodium phosphate administered intravenously, prednisolone given orally or beclomethasone dipropionate by inhalation. Results of a radioallergosorbent test (RAST) were negative for hydrocortisone sodium succinate.

    Topics: Administration, Inhalation; Adult; Anaphylaxis; Asthma; Beclomethasone; Dexamethasone; Humans; Hydrocortisone; Injections, Intravenous; Intradermal Tests; Male; Recurrence; Skin Tests

1991
[Application of inhalation steroids in children].
    Tijdschrift voor kindergeneeskunde, 1990, Volume: 58, Issue:1

    Topics: Administration, Inhalation; Administration, Topical; Adrenal Cortex Hormones; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Child; Glucocorticoids; Humans; Pregnenediones

1990
[Long-term efficacy of high-dose aerosol corticotherapy in the treatment of severe asthma].
    Revue de pneumologie clinique, 1988, Volume: 44, Issue:6

    Forty-five patients with severe, poorly controlled asthma, including 23 corticosteroid-dependent patients, were treated with a preparation of beclomethasone dipropionate aerosol delivering 250 mcg per puff. The daily dose ranged from 1000 to 2000 mcg. The mean follow-up period was 14 +/- 7 months, and 11 patients have now been followed up for more than 2 years. Forty-two patients were improved, and total withdrawal of continuous steroid therapy could be achieved in 13 cases. Treatment remained effective in long term use, provided a minimum of 1000 mcg/day was given. However, despite clinical improvement the obstructive syndrome persisted in 65% of the patients.

    Topics: Administration, Inhalation; Aerosols; Asthma; Beclomethasone; Female; Humans; Male; Middle Aged; Time Factors

1988
Inhaled high-dose beclomethasone in chronic asthma.
    The New Zealand medical journal, 1987, May-27, Volume: 100, Issue:824

    The effects of high-dose inhaled beclomethasone dipropionate were studied retrospectively in 123 asthma patients who were inadequately controlled on standard doses of beclomethasone dipropionate, or who required oral corticosteroids to control their asthma. High-dose beclomethasone dipropionate was administered by aerosol which delivered 250 micrograms beclomethasone dipropionate per metered dose. Thirty-one percent of the steroid-dependent patients (n = 65) were able to stop maintenance oral steroid after the introduction of beclomethasone dipropionate 250 and a further 48% were able to reduce their daily dosage. The mean reduction in daily maintenance prednisone was 5.2 mg. Comparing a six month period before and during treatment with beclomethasone dipropionate 250, asthma control was improved in 69% of all patients. This was accompanied by a 53% reduction in the number of acute attacks requiring supplementary courses of oral corticosteroid and a 70% reduction in admissions to hospital. Prior to beclomethasone dipropionate 250, 21% of the steroid-dependent patients were maintained on alternate day prednisone whereas after the introduction of beclomethasone dipropionate 250, 44% of those 45 still requiring continuous prednisone were maintained on an alternate-day regimen.

    Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Chronic Disease; Drug Evaluation; Female; Humans; Male; Middle Aged; Prednisone; Retrospective Studies; Substance-Related Disorders

1987
Control of asthma by aerosols.
    The New England journal of medicine, 1986, Oct-02, Volume: 315, Issue:14

    Topics: Adrenergic Agonists; Aerosols; Asthma; Beclomethasone; Bronchodilator Agents; Humans; Parasympatholytics; Prednisone; Sympathomimetics

1986
[Corticosteroid therapy in childhood asthma].
    Harefuah, 1986, Mar-16, Volume: 110, Issue:6

    Topics: Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Child; Female; Glucocorticoids; Humans; Infant, Newborn; Pregnancy; Pregnancy Complications

1986
An appraisal of the influence of dose frequency on the antiasthmatic activity of inhaled corticosteroids.
    Annals of allergy, 1985, Volume: 55, Issue:1

    Topics: Administration, Intranasal; Adrenal Cortex Hormones; Asthma; Beclomethasone; Betamethasone; Budesonide; Drug Administration Schedule; Fluocinolone Acetonide; Humans; Pregnenediones; Triamcinolone Acetonide

1985
The present status of steroid aerosols.
    The Journal of the Association of Physicians of India, 1985, Volume: 33, Issue:11

    Topics: Administration, Intranasal; Administration, Oral; Adult; Aerosols; Animals; Asthma; Beclomethasone; Betamethasone; Betamethasone Valerate; Child; Dogs; Female; Humans; Prednisolone; Pregnancy

1985
Immunologic aspects of asthma.
    Clinics in chest medicine, 1984, Volume: 5, Issue:4

    Asthma often, but not always, is the result of an IgE-mediated allergic reaction to an airborne antigen. The chain of biochemical reactions is now fairly well defined. These reactions generate an immediate smooth muscle bronchoconstriction and a late inflammation 4 to 24 hours later. This article describes the most important allergens in the community, home and workplace, and discusses procedures for diagnosis and management.

    Topics: Allergens; Antigens; Asthma; Beclomethasone; Bronchial Provocation Tests; Cromolyn Sodium; Desensitization, Immunologic; Histamine Release; Humans; Immunoglobulin E; Skin Tests

1984
Personal observations on the use of inhaled corticosteroid drugs for chronic asthma.
    European journal of respiratory diseases, 1984, Volume: 65, Issue:5

    Topically active inhaled corticosteroid (IC) drugs are highly effective for chronic asthma. Formalized conceptions of "high, low or safe" dosages of these drugs may be less appropriate than one of "optimal dosage". It seems reasonable to formulate a specific goal of treatment, and then fit dosage to the individual needs and tolerances of the patient rather than to a conventionalized "safe" limit, based on averaged data from different and perhaps quite dissimilar subjects. The studies reviewed here illustrate some principles applicable to the effective use of IC drugs.

    Topics: Aerosols; Asthma; Beclomethasone; Budesonide; Candidiasis, Oral; Dose-Response Relationship, Drug; Drug Administration Schedule; Glossitis; Glucocorticoids; Humans; Hypothalamo-Hypophyseal System; Pituitary-Adrenal System; Prednisone; Pregnenediones; Respiratory Therapy; Risk; Time Factors; Voice Disorders

1984
Beclomethasone dipropionate. A reappraisal of its pharmacodynamic properties and therapeutic efficacy after a decade of use in asthma and rhinitis.
    Drugs, 1984, Volume: 28, Issue:2

    Inhaled beclomethasone dipropionate is now well established in the management of asthma. Studies conducted over the last decade, and since the drug was previously reviewed in the Journal, have confirmed that inhaled beclomethasone dipropionate 400 to 800 micrograms daily can reduce the need for oral maintenance corticosteroids in the majority of asthmatic patients requiring such therapy, and that increasing the dosage to 2000 micrograms daily may provide additional clinical benefit in some patients unresponsive to usual therapeutic dosages. Follow-up over a period of several years has confirmed that the initial response to inhaled beclomethasone can be maintained in most patients. Recent studies indicate that beclomethasone dipropionate 400 micrograms daily is equally effective when administered in 2 or 4 divided doses in patients with stable asthma, but it is likely that the lower frequency of administration will be less effective when the asthma is unstable. Recent studies have established the usefulness and good tolerability of intranasal beclomethasone dipropionate in the treatment of perennial and seasonal rhinitis, where the drug has been shown to be more effective than intranasal sodium cromoglycate and similar in efficacy to flunisolide. Nasal polyps decrease in size during continuous treatment with intranasal beclomethasone dipropionate, but enlarge again during periods of respiratory infection. After a decade of treatment with inhaled and intranasal beclomethasone dipropionate, there is no evidence that the drug damages the tracheobronchial lining or the nasal mucosa. Thus, the initial promise of beclomethasone dipropionate has been fulfilled. It has had an important role in asthma therapy over the past decade, which will continue into the future.

    Topics: Adrenal Glands; Aerosols; Asthma; Beclomethasone; Bronchi; Drug Therapy, Combination; Glucocorticoids; Humans; Immunity; Kinetics; Nasal Mucosa; Rhinitis

1984
[Development of new steroid preparations and their clinical applications].
    Nihon rinsho. Japanese journal of clinical medicine, 1984, Volume: 42, Issue:11

    Topics: Administration, Topical; Aerosols; Anti-Inflammatory Agents; Arthritis, Rheumatoid; Asthma; Beclomethasone; Dexamethasone; Fluprednisolone; Glucocorticoids; Humans; Hydrocortisone; Injections, Intra-Articular; Prednisolone; Rhinitis; Skin Diseases; Triamcinolone Acetonide

1984
[Use of bekotid in the treatment of bronchial asthma].
    Sovetskaia meditsina, 1983, Issue:2

    Topics: Aerosols; Asthma; Beclomethasone; Clinical Trials as Topic; Humans; Hydroxycorticosteroids

1983
Asthma in childhood.
    The Journal of allergy and clinical immunology, 1983, Volume: 72, Issue:5 Pt 2

    Asthma is defined as an obstructive disease of the pulmonary airways resulting from spasm of airway muscle, increased mucus secretion, and inflammation. The airways of asthmatic individuals are hyperresponsive to a variety of stimuli including cold air, atmospheric irritants, pharmacologically active chemicals, various drugs, and hyperventilation. The fundamental abnormality underlying the hyperresponsiveness appears to be genetically determined; two theories explaining the abnormality have received the most attention. One theory suggests that asthma is due to abnormal beta-adrenergic receptor-adenylate cyclase function with decreased adrenergic responsiveness. An alternate theory proposes that increased cholinergic activity in the airway is the fundamental defect in the disease. The true prevalence of asthma has been difficult to determine owing to uncertainties regarding the definition of the disease. Prevalence in various populations of children ranged from 1.37% to 11.4% or higher. Most studies report a preponderance of asthma in boys over girls, with ratios varying from 1.3:1 to 3.3:1. Risk factors for the disease include a history of atopy, acute lower respiratory tract disease, parental cigarette smoking, and bronchiolitis or croup. The spectrum of asthma is that of an illness beginning early in life and persisting, in some cases, through adulthood. Signs of the disease may be apparent in the first 2 yr of life and are often associated with viral respiratory infections. Disproportionate narrowing of peripheral airways and decreased static elastic recoil properties of the lung predispose infants and young children to asthma. During midchildhood there is a tendency toward improvement, with continued improvement during adolescence. The goal of management of the child with asthma is to reduce symptoms sufficiently so that the child can regularly attend school, engage in play activities, and sleep through the night uninterrupted, while avoiding unacceptable levels of adverse drug effects. Nonpharmacologic management includes both avoidance of environmental irritants and behavioral approaches to overcome emotional precipitants that lead to attacks. Pharmacologic treatment includes the use of four classes of drugs: (1) adrenergics, (2) theophylline, (3) cromolyn, and (4) corticosteroids. The prognosis of asthma in childhood is good. Although airway activity may remain abnormal for indefinite periods of time, most children reach a state where they are virt

    Topics: Adolescent; Asthma; Beclomethasone; Behavior Therapy; Child; Child, Preschool; Cromolyn Sodium; Epinephrine; Humans; Prednisolone; Prednisone; Prognosis; Risk; Terbutaline; Theophylline; Tobacco Smoke Pollution

1983
[Preventive treatment of asthma due to exertion in children: comparative study of 4 drugs].
    La Pediatria, 1981, Dec-31, Volume: 89, Issue:4

    Topics: Albuterol; Asthma; Asthma, Exercise-Induced; Atropine Derivatives; Beclomethasone; Child; Cromolyn Sodium; Humans; Ipratropium; Male

1981
Steroids in allergic disease.
    The Medical clinics of North America, 1981, Volume: 65, Issue:5

    From the experience above, it may be concluded that corticosteroid therapy in allergic disease has become more effective than ever before. The expected variations in usage of new important pharmacologic agents is seen with special clarity in the use of corticosteroids. The wide acclaim for the "miracle drug of the 1950's", which followed penicillin of the 1940's, soon gave away to anguish about side-effects that threatened to abolish its use entirely in the late 1950's. The 1960's brought alternate day therapy for chronic usage and recognition that short term usage was relatively safe. The 1970's saw proliferation of topically active steroids similar to those so important to the practice of Dermatology in the previous decade. Results in treating asthma and nasal diseases have been excellent and extensive research for adverse effects has been largely unrevealing.

    Topics: Administration, Intranasal; Adrenal Cortex Hormones; Asthma; Beclomethasone; Cataract; Cushing Syndrome; Humans; Hypersensitivity; Hypersensitivity, Immediate; Long-Term Care; Nasal Polyps; Osteonecrosis; Osteoporosis; Prednisone; Rhinitis; Sleep Initiation and Maintenance Disorders; Stress, Physiological

1981
Corticosteroids in asthma: inhaled or oral?
    Drugs, 1980, Volume: 20, Issue:1

    Topics: Administration, Oral; Aerosols; Asthma; Beclomethasone; Cortisone; Cromolyn Sodium; Drug Administration Schedule; Glucocorticoids; Humans; Prednisolone; Theophylline

1980
[Results and prospects of using becotid in bronchial asthma and other allergic diseases].
    Sovetskaia meditsina, 1980, Issue:8

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Bronchitis; Child; Clinical Trials as Topic; Double-Blind Method; Humans; Placebos; Respiratory Hypersensitivity; Rhinitis, Allergic, Seasonal; Time Factors

1980
New drug therapy for asthma.
    Comprehensive therapy, 1978, Volume: 4, Issue:4

    Topics: Asthma; Atropine; Beclomethasone; Cromolyn Sodium; Humans; Isoproterenol; Metaproterenol; Receptors, Adrenergic, beta; Terbutaline; Theophylline; Triamcinolone Acetonide

1978
Newer medications to aid treatment of asthma.
    Annals of allergy, 1977, Volume: 39, Issue:2

    The selective beta-2 adrenergic bronchodilator preparations should be considered the medications for the first line of defense in the treatment of the average asthmatic patient. Theophylline and derivatives of theophylline are the second line of defense. Cromolyn sodium, atropine and derivatives, corticosteroids and other selected agents follow, depending on the individual case and the circumstances involved.

    Topics: Adrenal Cortex Hormones; Adrenergic alpha-Agonists; Adrenergic beta-Agonists; Aminophylline; Asthma; Atropine; Beclomethasone; Bronchodilator Agents; Cromolyn Sodium; Epinephrine; Humans; Ipratropium; Isoproterenol; Metaproterenol; Physical Exertion; Prostaglandins; Terbutaline; Theophylline; Triamcinolone Acetonide

1977
[Long-term treatment with corticoids in respiratory disorders].
    Revue de l'Institut d'hygiene des mines, 1977, Volume: 32, Issue:2

    In a first chapter the author reviews the mechanisms of action of corticoids in respiratory diseases. Moreover the causes and the prevalence of unwanted side-effects are discussed. The advantages of synthetic glucocorticoids with short half-life time in pneumology are stressed. In the following chapters, the rationale of long-term corticoid treatments of asthma, in non allergic obstructive chronic lung diseases, in sarcoidosis and in the thoracic localisations of some collagen diseases is presented in detail. Regarding the treatment of asthma the author discusses the advantages of the alternate-day therapy, the use of corticoids in aerosols and the ratioale of ACTH. The usefulness of alternate-day therapy in sarcoidosis is also advocated.

    Topics: Adrenocorticotropic Hormone; Aerosols; Asthma; Beclomethasone; Bronchitis; Chemical Phenomena; Chemistry; Chronic Disease; Collagen Diseases; Glucocorticoids; Humans; Lung Diseases, Obstructive; Respiratory Tract Diseases; Sarcoidosis; Time Factors

1977
Asthma: therapy old and new.
    The Medical clinics of North America, 1977, Volume: 61, Issue:6

    Topics: Asthma; Beclomethasone; Bronchi; Cromolyn Sodium; Glucocorticoids; Humans; Parasympatholytics; Sympathomimetics; Theophylline

1977
Treatment of asthma with cromolyn and corticosteroids.
    Cutis, 1976, Volume: 17, Issue:6

    Topics: Administration, Topical; Adrenal Cortex Hormones; Adrenal Glands; Adult; Asthma; Beclomethasone; Child; Cromolyn Sodium; Drug Therapy, Combination; Humans

1976
[Drug therapy of bronchial asthma].
    La Clinica terapeutica, 1975, Feb-28, Volume: 72, Issue:4

    Topics: Adrenocorticotropic Hormone; Adult; Asthma; Atropine; Beclomethasone; Child; Cromolyn Sodium; Epinephrine; Histamine; Histamine H1 Antagonists; Humans; Immunosuppressive Agents; Isoproterenol; Theophylline

1975
The place of a new aerosol steroid, beclomethasone dipropionate, in the management of childhood asthma.
    Pediatric clinics of North America, 1975, Volume: 22, Issue:1

    Topics: Adrenal Glands; Adrenal Insufficiency; Aerosols; Asthma; Beclomethasone; Candidiasis, Oral; Child; Child, Preschool; Drug Evaluation; Growth; Humans; Hydrocortisone; Methylprednisolone

1975
Treatment of asthma. Recent advances.
    New York state journal of medicine, 1974, Volume: 74, Issue:8

    Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Aerosols; Asthma; Beclomethasone; Cromolyn Sodium; Humans; Isoproterenol; Respiratory Therapy; Triamcinolone Acetonide

1974
Asthma: current concepts.
    Pediatric clinics of North America, 1974, Volume: 21, Issue:4

    Topics: Adolescent; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Carboxylic Acids; Child; Child, Preschool; Cromolyn Sodium; Cyclic AMP; Cyclic GMP; Humans; Hypertension, Pulmonary; Immunoglobulin E; Metaproterenol; Phenols; Prostaglandins; Pulmonary Atelectasis; Pulmonary Edema; Radiography; Respiratory Function Tests; Terbutaline; Tetrazoles; Xanthenes

1974
Conference on the scientific basis of respiratory therapy. Aerosol therapy. Steroid and antibiotic aerosols.
    The American review of respiratory disease, 1974, Volume: 110, Issue:6 Pt 2

    Topics: Aerosols; Airway Obstruction; Anti-Bacterial Agents; Asthma; Bacteria; Bacterial Infections; Beclomethasone; Carbenicillin; Child; Clinical Trials as Topic; Colistin; Corticosterone; Dexamethasone; Gentamicins; Humans; Hydrocortisone; Kanamycin; Lung Diseases, Fungal; Placebos; Polymyxins; Respiratory Therapy; Triamcinolone Acetonide

1974
Beclomethasone in childhood asthma.
    Archives of disease in childhood, 1973, Volume: 48, Issue:9

    Topics: Administration, Topical; Adrenocorticotropic Hormone; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Child, Preschool; Glucocorticoids; Humans; Methylprednisolone; Prednisolone

1973

Trials

679 trial(s) available for (9R)-9-chloro-11-17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10-13-16-trimethyl-6-7-8-11-12-14-15-16-octahydrocyclopenta[a]phenanthren-3-one and Asthma

ArticleYear
The effect of beclomethasone-formoterol
    The European respiratory journal, 2023, Volume: 61, Issue:6

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Bronchiectasis; Cough; Double-Blind Method; Formoterol Fumarate; Humans

2023
Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.
    The New England journal of medicine, 2022, 04-21, Volume: 386, Issue:16

    Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations.. In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 μg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed.. Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI, 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI, 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups.. Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.).

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Black or African American; Glucocorticoids; Hispanic or Latino; Humans; Quality of Life; Surveys and Questionnaires; Symptom Flare Up

2022
Determinants of response to inhaled extrafine triple therapy in asthma: analyses of TRIMARAN and TRIGGER.
    Respiratory research, 2020, Oct-29, Volume: 21, Issue:1

    A number of single-inhaler triple therapies are being developed for asthma, including the extrafine formulation of beclometasone dipropionate (BDP), formoterol fumarate (FF), and glycopyrronium (G). Given asthma is a heterogenous disease, we investigated whether the clinical response to the addition of the long-acting muscarinic antagonist component within inhaled triple therapy was impacted by a range of clinical characteristics.. These were pre-specified and post-hoc sub-group analyses of TRIMARAN and TRIGGER, which were double-blind, 52-week studies comparing medium-strength (100/6/10 µg; TRIMARAN) and high-strength (200/6/10 µg; TRIGGER) BDP/FF/G with the respective BDP/FF strengths in adults with uncontrolled asthma and a history of ≥ 1 exacerbation. Co-primary endpoints were pre-dose forced expiratory volume in 1 s (FEV. Baseline clinical characteristics (pre-specified analyses) had no consistent effect on the lung function improvements with BDP/FF/G. For the exacerbation endpoints, sub-groups with higher reversibility gained greatest relative benefit from BDP/FF/G versus BDP/FF. In post-hoc analyses with patients sub-grouped by screening blood eosinophil values, in TRIMARAN the greatest relative effect of BDP/FF/G versus BDP/FF on the lung function endpoints was in the ≤ 300 cells/µL group; in TRIGGER, eosinophil levels did not markedly influence the relative efficacy of BDP/FF/G versus BDP/FF. Eosinophil levels did not influence relative efficacy on moderate-to-severe or severe exacerbations.. Overall, the relative efficacy of extrafine BDP/FF/G versus BDP/FF was not influenced by a range of clinical characteristics. However, some patient sub-groups gained additional benefit from BDP/FF/G for certain endpoints. In particular, for exacerbations the relative efficacy of BDP/FF/G was greater in more reversible patients. Trial registration ClinicalTrials.gov: TRIMARAN, NCT02676076 (registered February 8, 2016, https://clinicaltrials.gov/ct2/show/NCT02676076?term=NCT02676076&draw=2&rank=1 ,); TRIGGER, NCT02676089 (registered February 8, 2016, https://clinicaltrials.gov/ct2/show/NCT02676089?term=NCT02676089&draw=2&rank=1 ).

    Topics: Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Bronchodilator Agents; Double-Blind Method; Drug Therapy, Combination; Female; Formoterol Fumarate; Glycopyrrolate; Humans; Male; Middle Aged; Muscarinic Antagonists; Treatment Outcome

2020
Time to onset of improvements in Quality of Life from Temperature-controlled Laminar Airflow (TLA) in severe allergic asthma.
    Respiratory medicine, 2019, Volume: 147

    Allergen avoidance is important in allergic asthma management. Nocturnal treatment with Temperature-controlled Laminar Airflow (TLA; Airsonett. Asthma Quality of Life Questionnaire (AQLQ) scores were collected in a previous study. TTO of improvements in Quality of Life was analysed for difference (TLA-placebo) in Area-under-Curve using backwards deletion from 12, 9, 6, 3 down to 1 month for the AQLQ total score, the four individual domains and specifically the sleep question.. Patients with uncontrolled asthma on GINA step 4 (n = 87)) reported a statistically significant and clinically relevant (≥0.5 point) improvement in total AQLQ score (0.57; p = 0.009) after 3 months treatment for TLA over placebo. The shortest TTO was within 1 month for the environmental domain (0.68; p = 0.016) and the sleep question (0.771; p = 0.037). TTO for the emotional and symptom domains was 3 months (0.66; p = 0.020 and 0.64; p = 0.014 respectively) and for the activity domain 6 months (0.47; p = 0.036).. Nocturnal avoidance of allergens using TLA provided a statistically significant and clinically relevant improvement in total AQLQ score within 3 months in patients in the GINA 4 + ACT<18 group. Questions related to sleep quality may provide the first signal of response already within a month after commencing treatment.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Air Movements; Allergens; Asthma; Beclomethasone; Environment, Controlled; Exhalation; Female; Humans; Hypersensitivity; Inflammation; Male; Nitric Oxide; Quality of Life; Severity of Illness Index; Sleep; Temperature; Time Factors

2019
Comparative efficacy and tolerability of beclomethasone/formoterol and fluticasone/salmeterol fixed combination in Taiwanese asthmatic patients.
    Journal of the Formosan Medical Association = Taiwan yi zhi, 2018, Volume: 117, Issue:12

    The study was designed to compare the efficacy and tolerability of a fixed combination of extra-fine beclomethasone and formoterol, with the fixed combination fluticasone and salmeterol in Taiwanese asthmatic patients.. This was a phase III, multicentre, randomized, two-arm parallel groups, controlled study. Patients with moderate to severe asthma were randomized to a 12-week treatment with either beclomethasone 100 mcg plus formoterol 6 mcg (BDP/F) or fluticasone 125 mcg plus salmeterol 25 mcg (FP/S), both delivered 2 inhalations twice daily. The efficacy and tolerability of these two combinations were compared.. The BDP/F combination is comparable in efficacy and tolerability to FP/S combination in Taiwanese asthmatic patients, with the advantage of rapid onset of improvement of FVC, consistent with the faster improvement of pulmonary hyperinflation with BDP/F.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Double-Blind Method; Female; Fluticasone-Salmeterol Drug Combination; Forced Expiratory Volume; Formoterol Fumarate; Humans; Linear Models; Male; Middle Aged; Severity of Illness Index; Taiwan

2018
Randomized trial to assess the efficacy and safety of beclomethasone dipropionate breath-actuated inhaler in patients with asthma.
    Allergy and asthma proceedings, 2018, Mar-09, Volume: 39, Issue:2

    Breath-actuated inhalers (BAI) eliminate the need for the hand-breath coordination required with standard metered-dose inhalers (MDI).. To evaluate the efficacy and safety of beclomethasone dipropionate (BDP) administered via BAI.. This 6-week, phase III, double-blind study included patients aged ≥12 years with persistent asthma. During the single-blind run-in, patients discontinued asthma medications and received twice-daily placebo BAI or MDI. At randomization, BAI patients received BDP BAI 320 μg/day, BDP BAI 640 μg/day, or placebo BAI, and MDI patients received BDP MDI 320 μg/day or placebo MDI. Assessments included standardized baseline-adjusted trough morning forced expiratory volume in 1 second (FEV1) area under the effect curve from 0 to 6 weeks (AUEC[0-6 wk]) (obtained by clinic-based spirometry; the primary end point), morning peak expiratory flow (PEF), trough daily morning FEV1 (obtained by handheld spirometry), withdrawals, and tolerability.. Of 425 patients randomized, most were white (81%) and female (61%). BDP BAI 320 and 640 μg/day significantly improved FEV1 AUEC(0-6 wk) versus placebo (p < 0.001). The BDP BAI treatment groups exhibited significantly improved morning PEF and daily morning FEV1 versus placebo (p < 0.001). Similar treatment effects were demonstrated for BDP MDI (p < 0.001). Fewer patients withdrew due to worsening asthma while taking BDP BAI 320 μg/day (n = 1), BDP BAI 640 μg/day (n = 0), and BDP MDI 320 μg/day (n = 1) versus placebo (n = 10). BDP BAI was well tolerated.. BDP BAI demonstrated significant improvements in pulmonary function versus placebo, with results similar to BDP MDI. The safety profile of BDP BAI was comparable to BDP MDI, with no new safety signals.The study was registered on ClinicalTrials.gov (NCT02513160), www.clinicaltrials.gov.

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Asthma; Beclomethasone; Child; Double-Blind Method; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Respiration; Respiratory Function Tests; Treatment Outcome; Young Adult

2018
Home-made spacer as an auxiliary device in administration of beclomethasone via pressurized metered dose inhaler for asthma control. A randomized controlled pragmatic trial.
    Respiratory medicine, 2017, Volume: 126

    Holding chambers or spacers can enhance the efficacy of pressurized metered dose inhalers (pMDI) in delivering inhaled medications, as they reduce the need for hand-breath coordination and improve lower airways deposition. Nevertheless, their cost can be high for patients in low-income countries.. To compare asthma control achieved with beclomethasone-dipropionate administered through a hydrofluoroalkane-driven pMDI (BDp-pMDI) coupled to a home-made spacer (HmS) or to a valved commercial spacer (VCS) as auxiliary devices.. Sixty-three patients with poorly controlled asthma that had a BDp-pMDI prescription were randomized to use the inhaler coupled to a HmS made of 500 ml plastic bottles (Group HmS, n = 32) or to a VCS (Group VCS, n = 31) for 60 days. All were given training sessions. Asthma control was assessed through the Asthma Control Test (ACT) and forced expiratory volume in the first second (FEV1), both measured before, and 30 and 60 days after treatment began.. Both groups showed significant improvement in ACT scores after 30 and 60 days compared to baseline values (an increase of 7 and 7.8 points for the HmS group and 5.9 and 7.0 points for the VCS group, respectively, p < 0.001). There was no statistically significant difference in ACT scores between groups at any observation time (P = 0.261). FEV1 showed the same behavior.. A similar level of asthma control was achieved with beclomethasone-dipropionate administered through a pMDI whether the inhaler was coupled to the HmS or VCS. These results are significant for asthma control planning strategies in low-income communities. (Trial Register Number: RBR-5x4dc9).

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Brazil; Equipment Design; Female; Forced Expiratory Volume; Humans; Male; Metered Dose Inhalers; Middle Aged; Treatment Outcome; Young Adult

2017
Efficacy and safety of beclomethasone dipropionate breath-actuated or metered-dose inhaler in pediatric patients with asthma.
    Allergy and asthma proceedings, 2017, Sep-14, Volume: 38, Issue:5

    Breath-actuated inhalers (BAI) eliminate the need for hand-breath coordination and, therefore, simplify the delivery of inhaled medication.. To evaluate the efficacy and safety of beclomethasone dipropionate BAI and metered-dose inhaler (MDI) versus placebo in pediatric patients ages 4-11 years with persistent asthma.. In this double-blind, double-dummy, phase III study, 628 children with persistent asthma were randomly assigned (1:1:1:1:1) to twice-daily beclomethasone dipropionate (BAI 80 μg/day, BAI 160 μg/day, MDI 80 μg/day, or MDI 160 μg/day) or to placebo. Efficacy over 12 weeks was assessed by spirometry, peak expiratory flow (PEF) measurements and other clinical end points. The primary efficacy end point was the baseline-adjusted trough morning percent predicted forced expiratory volume in 1 second (PPFEV1) area under the effect curve from 0 to 12 weeks (AUEC[0-12 weeks]).. PPFEV1 AUEC(0-12 weeks) showed numerical improvements from baseline in the BAI 80 μg/day and BAI 160 μg/day groups and MDI 80 μg/day and MDI 160 μg/day groups; however, these improvements were not significant versus placebo for any group after hierarchical testing was applied. Consistent improvements were noted in the active treatment groups versus placebo for the weekly average trough morning and evening PEFs, and with BAI 80 μg/day versus placebo for rescue albuterol/salbutamol use and the total daily asthma symptom score. Most patients indicated that the BAI device was easy or very easy to use. Adverse events were comparable across the groups; the incidence of oral candidiasis ranged from 0.8 to 3.2%.. Although the primary efficacy end point was not demonstrated, consistent improvements in PEF and other clinical end points were observed with beclomethasone dipropionate BAI, particularly at the 80 μg/day dose. These clinical benefits, combined with the need for better symptom control in children with asthma, supported the development of beclomethasone dipropionate BAI.

    Topics: Age Factors; Asthma; Beclomethasone; Child; Child, Preschool; Female; Humans; Male; Metered Dose Inhalers; Nebulizers and Vaporizers; Respiratory Function Tests; Time Factors; Treatment Outcome

2017
Evaluation of beclomethasone dipropionate (80 and 160 micrograms/day) delivered
    Allergy and asthma proceedings, 2017, Nov-08, Volume: 38, Issue:6

    Breath-actuated inhalers (BAI) may simplify the delivery of inhaled medications compared with other devices.. To evaluate the efficacy and safety of beclomethasone dipropionate BAI versus matching placebo in adolescent and adult patients with persistent asthma.. This phase III, 12-week, double-blind study enrolled patients with asthma aged ≥12 years who were previously treated with a stable dose of inhaled corticosteroid or noncorticosteroid therapy. After a run-in period of 14 to 21 days, patients were randomly assigned in a 1:1:1 ratio to beclomethasone dipropionate BAI 80 or 160 micrograms/day (40 or 80 micrograms twice daily) or placebo BAI. The primary end point was the standardized baseline-adjusted trough morning forced expiratory volume in 1 second (FEV1) area under the effect curve from time 0 to 12 weeks (AUEC[0-12 weeks]). Secondary end points included peak expiratory flow, rescue medication use, asthma symptoms, and the time to withdrawal due to meeting predefined criteria for worsening asthma. Additional end points evaluated quality of life, instructions for use, and safety.. The full analysis and the safety sets included 270 and 273 patients, respectively. Patients who received beclomethasone dipropionate BAI 80 or 160 micrograms/day had significant improvements in FEV1 AUEC(0-12 weeks) versus placebo (p ≤ 0.001). Improvements in secondary end points were also apparent in patients who received beclomethasone dipropionate BAI 80 or 160 micrograms/day compared with placebo. Patients who received beclomethasone dipropionate BAI 80 or 160 micrograms/day had greater increases in Asthma Quality of Life Questionnaire scores versus placebo patients at week 12. Of 98 patients who participated in the instructions-for-use substudy, 87 (88.8%) used the inhaler successfully on their first attempt. Treatment was generally safe and well tolerated.. Beclomethasone dipropionate BAI 80 and 160 micrograms/day were effective and well-accepted treatments in patients with asthma, with safety comparable to beclomethasone dipropionate delivered via a metered-dose inhaler.Clinical trial NCT02040779, www.clinicaltrials.gov.

    Topics: Adolescent; Adult; Aged; Asthma; Beclomethasone; Child; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Metered Dose Inhalers; Middle Aged; Nebulizers and Vaporizers; Young Adult

2017
Extrafine compared to non-extrafine particle inhaled corticosteroids in smokers and ex-smokers with asthma.
    Respiratory medicine, 2017, Volume: 130

    Smoking is as prevalent in asthmatics as in the general population. Asthmatic smokers benefit less from inhaled corticosteroids (ICS) than non-smoking asthmatics, possibly due to more smoking-induced small airways disease. Thus targeting small airways may be important in treating asthmatic (ex-)smokers. We hypothesized that extrafine particle ICS improve small airways function more than non-extrafine particle ICS in asthmatic (ex-)smokers.. We performed an open-label, randomized, three-way cross-over study comparing extrafine beclomethasone (HFA-QVAR) to non-extrafine beclomethasone (HFA-Clenil) and fluticasone (HFA-Flixotide) in 22 smokers and 21 ex-smokers with asthma (?5 packyears).. Similar effectiveness in improving small airways function was found for extrafine and non-extrafine particle ICS treatment for asthmatic smokers and ex-smokers.

    Topics: Adenosine Monophosphate; Administration, Inhalation; Adrenal Cortex Hormones; Adult; Airway Remodeling; Asthma; Beclomethasone; Bronchial Provocation Tests; Cross-Over Studies; Female; Fluticasone; Forced Expiratory Volume; Humans; Male; Middle Aged; Particle Size; Respiratory Function Tests; Smokers; Treatment Outcome

2017
Asthma phenotypes: do cough and wheeze predict exacerbations in persistent asthma?
    The European respiratory journal, 2017, Volume: 50, Issue:6

    Little is known of the long-term symptom profile in uncontrolled asthma and whether symptoms can predict distinct phenotypes. The primary objective of these analyses was to assess diurnal profile of cough and wheeze in an uncontrolled asthma population. Secondary outcomes were to examine how these symptom profiles influence response to treatment.Twice-daily electronically recorded data from 1701 patients were examined in relation to the population demographics. Reliever treatment with salbutamol was then compared with extra-fine beclometasone/formoterol maintenance and reliever therapy (MART). Exacerbation frequency was then correlated with the symptom profile.Symptoms were commoner in older patients with an increased body mass index. In most patients, reported cough and wheeze were closely correlated (r=0.73). Two phenotypes of cough- and wheeze-predominant patients were identified; the former were overweight, older females and the latter older males. Diurnal symptoms of cough and wheeze were similarly attenuated by both therapies. MART reduced exacerbation frequency by a third compared with salbutamol, and this effect was greatest in patients with fewest reported symptoms.While cough and wheeze are highly correlated in uncontrolled asthma, some patients predominantly have cough whereas others wheeze. Symptoms and exacerbation frequency appear poorly associated, suggesting an alternative pathophysiology. MART may be the preferred option in those with fewest symptoms.

    Topics: Adrenergic beta-2 Receptor Agonists; Adult; Age Distribution; Aged; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cough; Disease Progression; Female; Formoterol Fumarate; Humans; Incidence; Male; Middle Aged; Phenotype; Regression Analysis; Respiratory Sounds; Severity of Illness Index; United Kingdom

2017
Knemometry is more sensitive to systemic effects of inhaled corticosteroids in children with asthma than 24-hour urine cortisol excretion.
    The Journal of allergy and clinical immunology, 2017, Volume: 140, Issue:2

    Pharmacodynamic assessment of the systemic effect of inhaled corticosteroids (ICSs) is often done by measuring 24-hour urine free cortisol (UFC) excretion. Knemometry assessing short-term lower-leg growth rate (LLGR) is a more rarely used alternative.. The primary aim of this study was to compare the sensitivity of LLGR and 24-hour UFC excretion for evaluating systemic exposure to ICSs in prepubertal children with asthma. The secondary aim was to evaluate factors influencing the precision of LLGR calculated by the traditional 1 leg nonparametric method versus a new 2 leg parametric method.. The study evaluated 60 children with mild asthma aged 5 to 12 years participating in a randomized controlled trial of ICSs with longitudinal concomitant assessments of LLGR and 24-hour UFC excretion. The sensitivity of the safety assessments was analyzed by comparing LLGR and 24-hour UFC in the placebo run-in period with values in the ICS treatment period by using paired t tests. Factors with a potential influence on LLGR were analyzed by means of ANOVA and the Levene test of homogeneity.. The mean LLGR was significantly reduced during the ICS versus placebo run-in periods: 0.18 mm/wk (SD, 0.55 mm/wk) versus 0.45 mm/wk (SD, 0.39 mm/wk), with a mean difference of 0.27 mm/wk (95% CI, 0.05-0.48 mm/wk; P = .02). In contrast, there was no difference in 24-hour UFC excretion: 6.91 nmol/mmol (SD, 4.67 nmol/mmol) versus 7.58 nmol/mmol (SD, 6.17 nmol/mmol), with a mean difference of 0.67 nmol/mmol (95% CI, -1.13 to 2.48 nmol/mmol; P = .46). We observed no significant difference in parametric determined LLGR caused by the child's age or sex, investigator, or season of measurement, whereas some differences were observed for the nonparametric LLGR.. These findings suggest that knemometry is a more sensitive pharmacodynamic measure of systemic effects of ICSs than 24-hour UFC excretion and that a parametric determination of LLGR increases the sensitivity of the method. These findings should be considered by legislative authorities in the future.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child Development; Child, Preschool; Female; Humans; Hydrocortisone; Leg; Male

2017
Safety and efficacy of beclomethasone dipropionate delivered by breath-actuated or metered-dose inhaler for persistent asthma.
    Allergy and asthma proceedings, 2016, Volume: 37, Issue:5

    Breath-actuated inhalers (BAI) have been developed to simplify the delivery of inhaled medication.. To evaluate the safety and efficacy of beclomethasone dipropionate hydrofluoroalkane BAI and metered-dose inhaler (MDI) versus placebo in patients who previously used a mid- to high-dose inhaled corticosteroid or inhaled corticosteroid/long-acting beta agonist for persistent asthma.. This phase III study included five treatment groups: placebo, and four beclomethasone dipropionate groups (BAI 320 μg/day, BAI 640 μg/day, MDI 320 μg/day, and MDI 640 μg/day). Efficacy over 12 weeks was assessed by spirometry, peak flow measurements, and other clinical end points. Safety was assessed by adverse events.. Baseline-adjusted trough morning forced expiratory volume in 1 second area under the effect curve from time 0 to 12 weeks (primary end point) was increased in the BAI 320 and BAI 640 μg/day groups and the MDI 640 μg/day group versus placebo (not significant). Clinically important improvements were noted in morning and evening peak expiratory flow and decreased rescue medications. More patients who received placebo than patients in active treatment groups withdrew due to meeting the stopping criteria for worsening asthma. Patients in the active treatment groups experienced a greater decrease in asthma symptoms than patients in the placebo group. Quality of life and Asthma Control Test scores improved in the active treatment groups compared with the placebo group (p ≤ 0.0074). The most common adverse events (>5% in any group) were oral candidiasis and upper respiratory tract infection.. Clinical benefits for patients who used BAI 320 and 640 μg/day and MDI 640 μg/day were demonstrated. The safety profiles of BAI 320 and 640 μg/day were comparable with that of the MDI. These benefits and the continued need for better symptom control among patients with asthma support the continued development of this controller medication. ClinicalTrials.gov identifier NCT02031640.

    Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Female; Humans; Male; Metered Dose Inhalers; Middle Aged; Respiratory Function Tests; Retreatment; Risk Factors; Time Factors; Treatment Outcome; Young Adult

2016
Comparison of clinical effects of beclomethasone dipropionate & budesonide in treatment of children with mild persistent asthma: A double-blind, randomized, controlled study.
    The Indian journal of medical research, 2016, Volume: 144, Issue:2

    Various inhaled corticosteroids (ICSs) are available to control the symptoms of asthma. Although beclomethasone dipropionate (BDP) and budesonide (BUD) are one of the oldest ICSs, their wide availability and low cost make them attractive options in developing countries. Due to lack of consensus on which of the two drugs is better for controlling mild persistent asthma, we undertook this study to compare the efficacy of these two drugs by measuring the change in percentage predicted forced expiratory volume in one second (FEV 1 ) from baseline in children with mild persistent asthma.. A double-blind, randomized, parallel group study was conducted in children 7-15 yr of age with newly diagnosed asthma. Of the 85 cases of mild persistent asthma, 42 received BUD while 43 received BDP at a dose of 400 µg/day using pressurized metered-dose inhaler with valved spacer for two months. The outcomes measured were change in FEV 1 , symptom scores and side effects.. There was a significant (P < 0.05) improvement in FEV 1 in BUD group (98.43 ± 4.63%) than in BDP group (95.65 ± 5.66%) at the end of two months of treatment. The mean symptom scores in BUD group (0.28 ± 1.22) and BDP group (0.43 ± 1.52) were comparable after two months. No side effects were seen in either group.. FEV 1 was significantly greater in BUD group than BDP group. Improvement in symptoms and incidence of side effects were similar. Our findings indicate that both BDP and BUD can be used effectively in the management of children with mild persistent asthma. [CTRI No: CTRI/2013/03/003495].

    Topics: Administration, Inhalation; Adolescent; Asthma; Beclomethasone; Budesonide; Child; Dose-Response Relationship, Drug; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male

2016
High strength extrafine pMDI beclometasone/formoterol (200/6 μg) is effective in asthma patients not adequately controlled on medium-high dose of inhaled corticosteroids.
    BMC pulmonary medicine, 2016, 12-09, Volume: 16, Issue:1

    A high strength of beclomethasone/formoterol fumarate (BDP/FF) in a pressurised metered dose inhaler (pMDI), which contains extrafine BDP (200 μg/actuation) and FF (6 μg/actuation) has been developed to treat those asthmatics who are not adequately controlled on previous treatments.. A 12-week, randomized, double-blind, parallel group study was performed to compare the efficacy and safety of pMDI BDP/FF 200/6 (two actuations bid) with BDP 100 μg (four actuation bid) in a population of 376 randomized adult asthmatics not adequately controlled with high dose of inhaled corticosteroids (ICS) or medium dose of ICS plus long acting β. The primary endpoint [change from baseline over the entire treatment period in average pre-dose morning peak expiratory flow (PEF)] demonstrated the superiority of BDP/FF over BDP monotherapy, with an adjusted mean difference of 19 L/min, which is above the minimal important clinical difference reported for this parameter. Overall, BDP/FF and BDP showed a similar improvement of symptom-based parameters and of the use of rescue medication after 3-month treatment. The safety profile of the two drugs was comparable, although BDP monotherapy, but not BDP/FF, slightly reduced the levels of serum cortisol.. The study proved that pMDI BDP/FF 200/6 μg was superior to BDP alone in improving lung function with comparable safety profiles. Therefore it may be considered as an effective treatment for adults with asthma not adequately controlled with high dose of ICS monotherapy or medium dose of ICS/LABA combinations.. ClinicalTrials.gov: NCT01577082 , date 06/04/2012.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Female; Forced Expiratory Volume; Formoterol Fumarate; Humans; Italy; Male; Metered Dose Inhalers; Middle Aged; Patient Safety; Severity of Illness Index; Treatment Outcome; Young Adult

2016
The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size.
    Pulmonary pharmacology & therapeutics, 2015, Volume: 30

    Asthma guidelines recommend prescription of inhaled corticosteroids at a reduced dosage in children compared to older patients in order to minimize the systemic exposure and risk of unwanted side effects. In children, pressurized metered dose inhalers (pMDI) are recommended in combination with a valved holding chamber (VHC) to overcome the problem of coordinating inhalation with actuation. However, the influence of age and body size on the systemic exposure of drugs to be administered via a pMDI with VHC is still not fully elucidated. Therefore, we aimed to compare the systemic exposure to the active ingredients of a fixed combination of beclometasone-dipropionate/formoterol-fumarate administered via pMDI with VHC in children, adolescents and adults.. The pharmacokinetics of formoterol and beclometasone-17-monopropionate (active metabolite of beclometasone-dipropionate) was evaluated over 8 h from three studies, each performed in a different age and body size group. Children (7-11 years, n = 20), adolescents (12-17 years, n = 29) and adults (≥18 years, n = 24) received a single dose of beclometasone/formoterol (children: 200 μg/24 μg, adolescents and adults: 400 μg/24 μg) via pMDI with AeroChamber Plus™.. The systemic exposure in children in comparison to adolescents was equivalent for formoterol while it was halved for beclometasone-17-monopropionate in accordance with the halved dose of beclometasone administered in children (90% CIs within 0.8-1.25 for formoterol and 0.4-0.625 for beclometasone-17-monopropionate). The systemic exposure to beclometasone-17-monopropionate and formoterol was equivalent between adolescents and adults.. The systemic exposure to the active ingredients of a fixed dose combination of beclometasone/formoterol administered via pMDI with AeroChamber Plus™ correlates with the nominal dose independently of patient age and body size. Thus, dose reduction in relation to age when using a pMDI with VHC may be unnecessary for reducing the systemic exposure in children.

    Topics: Administration, Inhalation; Adolescent; Adult; Age Factors; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Dose-Response Relationship, Drug; Drug Combinations; Ethanolamines; Female; Formoterol Fumarate; Humans; Male; Metered Dose Inhalers; Middle Aged; Young Adult

2015
The effect of beclometasone dipropionate/formoterol extra-fine fixed combination on the peripheral airway inflammation in controlled asthma.
    Journal of aerosol medicine and pulmonary drug delivery, 2015, Volume: 28, Issue:2

    Suppression of small airway inflammation may contribute to achieving asthma control. We aimed to evaluate the additional effect of beclometasone dipropionate/formoterol (BDP/F) hydrofluoroalkane (HFA) pressurized metered dose inhaler (pMDI) (BDP/F-HFA 100/6 μg pMDI) on airway inflammation and functional parameters in asthma cases, who were optimally controlled by maintenance therapy.. Ninety-five controlled asthmatic patients were included. They were grouped as Group 1 [budesonide/formoterol 320/9 μg dry powder inhaler (DPI)] and Group 2 (fluticasone/salmeterol 500/50 μg DPI) according to the combination they used. Then Group 3 was established by random selection from these two groups, and BDP/F-HFA 100/6 μg pMDI treatment was prescribed. All patients were evaluated in the beginning of the study and were re-evaluated at the end of a 3-week treatment period by spirometry, exhaled nitric oxide (eNO) levels, and small airway functional indices, namely, Sacin and Scond values.. There was no significant statistical difference in terms of age, height, weight, disease duration, symptoms, and spirometric parameters between the groups. There was a significant decrease in eNO levels in asthma cases who were on BDP/F-HFA therapy (p=0.001). A significant improvement in Sacin values at the end of the treatment period was observed in cases treated with BDP/F-HFA (p=0.001), indicating that inflammation was suppressed in peripheral airways.. These results emphasize that asthma treatment has mainly focused on the strategy to keep the disease under control; maintaining optimal functional level might be underestimated. BDP/F-HFA may have an additional favorable effect on the peripheral airway inflammation in the controlled asthma.

    Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Adult; Aerosols; Anti-Asthmatic Agents; Asthma; Beclomethasone; Breath Tests; Bronchodilator Agents; Drug Combinations; Dry Powder Inhalers; Female; Formoterol Fumarate; Glucocorticoids; Humans; Lung; Male; Middle Aged; Particle Size; Powders; Recovery of Function; Spirometry; Time Factors; Treatment Outcome

2015
Extrafine beclomethasone/formoterol combination via a dry powder inhaler (NEXThaler(®)) or pMDI and beclomethasone monotherapy for maintenance of asthma control in adult patients: A randomised, double-blind trial.
    Pulmonary pharmacology & therapeutics, 2015, Volume: 30

    The fixed combination of extrafine beclomethasone dipropionate and formoterol fumarate (BDP/FF) pMDI (Foster(®)) is approved for treatment of adult asthmatic patients. In order to provide an alternative drug delivery system for BDP/FF to physicians and patients, a dry powder inhaler (NEXThaler(®)) has been developed, capable to deliver extrafine particles to the lungs and therefore improve the dosing of the drugs, especially in patients with poor hand-breath coordination.. This trial was performed to compare efficacy and safety of extrafine BDP/FF NEXThaler(®) with extrafine BDP/FF pMDI or non-extrafine BDP DPI alone in adult patients with controlled asthma.. In this 8-week randomised, double-blind, parallel-group trial, patients were randomized to receive either extrafine BDP/FF NEXThaler(®) 100/6 μg bid, extrafine BDP/FF 100/6 μg pMDI bid or non-extrafine BDP DPI 100 μg bid. The primary efficacy variable was change from baseline to the entire 8-week randomised treatment period in average pre-dose morning PEF.. The ITT population comprised 754 patients. Extrafine BDP/FF NEXThaler(®) was non-inferior (pre-defined margin: -15 L/min) relative to extrafine BDP/FF pMDI (mean difference: -1.84; 95% CI: -6.73, 3.05) in terms of the primary efficacy variable, change from baseline in average pre-dose morning PEF. Statistical superiority of both extrafine BDP/FF formulations over non-extrafine BDP DPI was demonstrated for the primary efficacy variable (providing evidence of assays sensitivity of the trial), ACQ score and percentage of rescue medication use-free days. No significant safety signals were observed.. NEXThaler(®) is an effective and well-tolerated delivery device for treatment of patients with asthma who need a regular treatment.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Dry Powder Inhalers; Ethanolamines; Female; Formoterol Fumarate; Humans; Male; Metered Dose Inhalers; Middle Aged; Particle Size; Treatment Outcome; Young Adult

2015
Effects of beclomethason/formoterol and budesonide/formoterol fixed combinations on lung function and airway inflammation in patients with mild to moderate asthma--an exploratory study.
    Pulmonary pharmacology & therapeutics, 2015, Volume: 31

    Asthma is a chronic inflammatory airway disease of the whole bronchial tree. In this exploratory study we investigated the effects of beclomethasone/formoterol (becl/form) and budesonide/formoterol (bud/form) fixed combinations on lung function and airway inflammation in patients with mild to moderate asthma.. 22 adult patients with asthma (mean FEV1 91.6% pred.) were recruited to this prospective phase IV, double-blind, double-dummy, two-way cross-over, single-centre, randomised study. After a 7 days run-in period with bud 200 μg bid patients were randomised to receive 4 weeks of becl/form (100/6 μg) bid in a pressurised metered dose inhaler or bud/form (160/4.5 μg) bid administered via dry powder inhaler. We measured spirometry, bodyplethysmography, impulse oscillometry, nitric oxide (NO) and its alveolar fraction (CAlv), and assessed sputum cellularity.. CAlv significantly decreased after 4 weeks of treatment in each treatment period. The adjusted geometric mean (log transformed data, end of treatment vs. baseline) was 0.942 ppb (95% CI: 0.778-1.141 ppb) for becl/form and 0.903 ppb (95% CI: 0.741-1.099 ppb) for bud/form. Impulse oscillometry revealed a significant decrease in mean Delta R5-R20 of -0.033 kPa * L(-1) * sec(-1) for becl/form (95% CI: -0.064 to -0.002) and of -0.048 033 kPa * L(-1) * sec(-1) for bud/form (95% CI: -0.079 to -0.017). Other parameters of lung function and NO showed numerically small and in most cases statistically non-significant changes.. In patients with mild to moderate asthma pre-treated with inhaled corticosteroids, the use of ICS/LABA formulations led to improvements of CAlv and Delta R5-R20 indicating that these parameters might be helpful to further assess the effects of inhaled ICS/LABA combinations on lung function and airway inflammation.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide, Formoterol Fumarate Drug Combination; Cross-Over Studies; Double-Blind Method; Drug Combinations; Female; Formoterol Fumarate; Humans; Inflammation; Male; Patient Compliance; Prospective Studies; Respiratory Function Tests; Severity of Illness Index; Sputum

2015
Atorvastatin in combination with inhaled beclometasone modulates inflammatory sputum mediators in smokers with asthma.
    Pulmonary pharmacology & therapeutics, 2015, Volume: 31

    Statins have pleiotropic immunomodulatory effects that may be beneficial in the treatment of asthma. We previously reported that treatment with atorvastatin improved asthma symptoms in smokers with asthma in the absence of a change in the concentration of a selection of sputum inflammatory mediators.. To determine the effects of atorvastatin alone and in combination with inhaled corticosteroid on a range of sputum cytokines, chemokines and growth factors implicated in the pathogenesis of asthma, and their association with asthma control questionnaire (ACQ) and/or asthma quality of life questionnaire (AQLQ) scores.. Sputum samples were analysed from a sub-group of 39 smokers with mild to moderate asthma recruited to a randomised controlled trial comparing atorvastatin (40 mg/day) versus placebo for four weeks, followed by inhaled beclometasone (400 μg/day) for a further four weeks. Induced sputum supernatant fluid was analysed (Luminex or biochemical analyses) for concentrations of 35 mediators.. Sputum mediator concentrations were not reduced by inhaled beclometasone alone. Atorvastatin significantly reduced sputum concentrations of CCL7, IL-12p70, sCD40L, FGF-2, CCL4, TGF-α and MMP-8 compared with placebo and, when combined with inhaled beclometasone, reduced sputum concentrations of MMP-8, IL-1β, IL-10, MMP-9, sCD40L, FGF-2, IL-7, G-CSF and CCL7 compared to ICS alone. Improvements in ACQ and/or AQLQ scores with atorvastatin and ICS were associated with decreases in G-CSF, IL-7, CCL2 and CXCL8.. Short-term treatment with atorvastatin alone or in combination with inhaled beclometasone reduces several sputum cytokines, chemokines and growth factors concentrations unresponsive to inhaled corticosteroids alone, in smokers with asthma.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Atorvastatin; Beclomethasone; Chemokines; Cytokines; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Inflammation Mediators; Male; Middle Aged; Quality of Life; Severity of Illness Index; Sputum

2015
Pharmacokinetics and pharmacodynamics of an extrafine fixed pMDI combination of beclometasone dipropionate/formoterol fumarate in adolescent asthma.
    British journal of clinical pharmacology, 2015, Volume: 80, Issue:3

    The aim was to investigate the pharmacokinetics and pharmacodynamics of an extrafine pressurized metered-dose inhaler (pMDI) fixed combination of beclometasone dipropionate (BDP)/formoterol fumarate (FF) in adolescent and adult asthma.. This was a three-way crossover study, on 30 asthmatic adolescents receiving BDP/FF pMDI with or without a valved holding chamber (VHC) or a free licenced combination of BDP pMDI and FF pMDI plus a parallel arm of 30 asthmatic adults receiving BDP/FF pMDI. All patients received a single dose of BDP and FF of 400 µg and 24 µg, for each treatment, respectively. Assessments were performed over 8 hours.. In adolescents, the 90% confidence intervals (CIs) for the systemic exposure (AUC(0,t)) geometric mean ratio of the fixed combination with or without VHC vs. the free combination were within the bioequivalence range 0.80-1.25, both for beclometasone-17-monopropionate (B17MP, the active metabolite of BDP) and formoterol. Pharmacodynamic variables for plasma potassium and glucose, pulse rate and pulmonary function in adolescents were equivalent between treatments, 95% CI within 0.9, 1.09. The upper level of 90% CIs for AUC(0,t) geometric mean ratio adolescents : adults of B17MP and formoterol after treatment with BDP/FF pMDI was lower than 1.25, 90% CI 0.78, 1.04 and 0.86, 1.17, respectively.. In adolescents the pharmacodynamics and the overall systemic exposure to the active ingredients of an extrafine fixed combination of BDP/FF pMDI with or without a VHC was equivalent to that of a free licenced combination of pMDIs of established safety and efficacy profiles. The systemic exposure in adolescents was not higher than in adults. These results support the indication for use of inhaled corticosteroid/long acting β2 -adrenoceptor agonist pMDIs in adolescents at the same dosage as in adults.

    Topics: Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Area Under Curve; Asthma; Beclomethasone; Cross-Over Studies; Drug Combinations; Formoterol Fumarate; Humans; Metered Dose Inhalers; Treatment Outcome

2015
The Combined Impact of Exhaled Nitric Oxide and Sputum Eosinophils Monitoring in Asthma Treatment: A Prospective Cohort Study.
    Current pharmaceutical design, 2015, Volume: 21, Issue:32

    Inhaled corticosteroids (ICS) treatment for asthma control is generally focused on lung function and symptoms, but inadequately correlated with airway inflammation.. To compare asthma control in a group of patients whose treatment was based on fraction of exhaled nitric oxide (FENO) and sputum eosinophils (intervention group) with a group in whom treatment was based on clinical score (control group). Study design and primary outcome: Randomized parallel-group longitudinal 24-month study including 5 visits every 6 months. A combination of asthma exacerbation rate and symptom score at 24 months was the primary outcome.. Fourteen patients with eosinophilic asthma per group were included.. In the intervention group, exacerbation rate/patient/year was reduced at 12 months (0.82) (-73%) and, to a greater extent at 24 months (0.5) (-84%) compared with baseline (3.21, p<0.01). In the control group, a significant reduction in exacerbation rate/patient/year was only observed between month 12 (3.0) and 24 (2.0, -33%, p<0.01). At 24 months, exacerbation rate was lower (-75%) in the intervention (0.5) than in the control group (2.0, p<0.05). Compared with baseline, mean symptom scores at 24 months were reduced in both groups (intervention group: -72%; control group: - 60%), but were lower in the intervention (8.1±1.0, p<0.05; -27%) than in the control group (11±2.6). ICS dose gradually increased in both groups throughout the study, with no between-group differences.. Compared with conventional strategy, longitudinal monitoring of FENO and sputum eosinophils improves eosinophilic asthma control in terms of reduced symptoms and exacerbations without additional increase e in ICS treatment.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Asthma; Beclomethasone; Cohort Studies; Eosinophils; Exhalation; Female; Humans; Leukocyte Count; Longitudinal Studies; Male; Monitoring, Physiologic; Nitric Oxide; Prospective Studies; Respiratory Function Tests; Single-Blind Method; Sputum; Treatment Outcome

2015
The effect of body posture during medication inhalation on exercise induced bronchoconstriction in asthmatic children.
    Respiratory medicine, 2015, Volume: 109, Issue:10

    Inhaling medication in a standard body posture leads to impaction of particles in the sharp angle of the upper airway. Stretching the upper airway by extending the neck in a forward leaning body posture may improve pulmonary deposition. A single dose of inhaled corticosteroids (ICS) offers acute, but moderate protection against exercise induced bronchoconstriction (EIB). This study investigated whether inhaling a single dose of ICS in a forward leaning posture improves this protection against EIB.. 32 Asthmatic children, 5-16 years, with EIB (Median fall in FEV1 or FEV0.5 30.9%) performed two exercise challenge tests (ECT's) with spirometry in a single blinded cross-over trial design. Children inhaled a single dose of 200 μg beclomethasone dipropionate (BDP) 4 h before the ECT, once in the standard posture and once with the neck extended in a forward leaning posture. Spirometry was also performed before the inhalation of the single dose of BDP.. Inhalation of BDP in both body postures provided similar protection against EIB (fall in FEV1 or FEV0.1 in standard posture 16.7%; in forward leaning posture 15.1%, p = 0.83). Inhaling ICS in a forward leaning posture significantly delayed EIB compared to inhaling in the standard posture (respectively 2.5 min ± 1.0 min vs. 1.6 min ± 0.8 min; difference 0.9 min (95CI 0.25; 1.44 min); p = 0.01).. Inhalation of a single dose BDP in both the forward leaning posture and the standard posture provided effective and similar protection against EIB in asthmatic children, but the forward leaning posture resulted in a delay of EIB.. NTR3432 (www.trialregister.nl).

    Topics: Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Asthma; Asthma, Exercise-Induced; Beclomethasone; Bronchoconstriction; Child; Child, Preschool; Cross-Over Studies; Exercise Test; Female; Forced Expiratory Volume; Heart Rate; Humans; Male; Posture; Respiratory Function Tests; Spirometry

2015
Roflumilast for asthma: Efficacy findings in non-placebo-controlled comparator and dosing studies.
    Pulmonary pharmacology & therapeutics, 2015, Volume: 35 Suppl

    Roflumilast, a phosphodiesterase-4 inhibitor, has an established place in the treatment of chronic obstructive pulmonary disease. Its potential role as a treatment for asthma is unclear.. We report the results from seven double-blind, parallel group, phase II or III studies designed to compare roflumilast with two anti-inflammatory treatments, beclomethasone dipropionate (BDP) and montelukast, in patients with asthma.. The studies of 6-12 week duration were conducted at 309 sites in Europe, North America, South Africa and Australia from 1998 to 2005. Data from 3802 patients, aged 12-70 years who received either roflumilast 100 μg, 250 μg or 500 μg once daily, BDP 400 μg or 500 μg twice daily, or 10 mg montelukast once daily was analyzed. Primary endpoints were mean change and time averaged excess area under the curve in forced expiratory volume in one second (FEV1) over the duration of the study. Secondary endpoints included change in forced vital capacity and peak expiratory flow, asthma symptoms and the concomitant use of rescue medication.. Roflumilast was non-inferior to BDP and montelukast and consistently increased FEV1. Use of rescue medication and all asthma symptom scores decreased significantly with all treatments, but no statistically significant between-group differences were observed. Secondary lung function endpoints generally supported the conclusions of the primary outcome measure.. Roflumilast improves FEV1 and asthma symptoms in patients with mild to moderate asthma, and is non-inferior compared with both BDP and montelukast. It deserves further study as a potentially effective anti-inflammatory treatment for asthma.

    Topics: Acetates; Adolescent; Adult; Aged; Aminopyridines; Asthma; Beclomethasone; Benzamides; Child; Cyclopropanes; Double-Blind Method; Forced Expiratory Volume; Humans; Middle Aged; Phosphodiesterase 4 Inhibitors; Quinolines; Sulfides; Young Adult

2015
Roflumilast for asthma: Efficacy findings in placebo-controlled studies.
    Pulmonary pharmacology & therapeutics, 2015, Volume: 35 Suppl

    The role of roflumilast as a potential asthma treatment is not yet fully understood. A series of placebo-controlled trials were undertaken in order to investigate the safety and efficacy of roflumilast in asthma.. To evaluate the efficacy of roflumilast in nine randomized proof-of-concept, placebo-controlled monotherapy and combination therapy phase II and III clinical studies performed between 1997 and 2005.. The studies were conducted at sites in Europe, North and South America, Africa, Australasia and Asia and study length varied from 4 to 24 weeks. Data were analyzed from 4873 patients, 12-70 years of age, of whom 2668 received roflumilast. At randomization patients had a forced expiratory flow (FEV1) of 45-90%. Roflumilast was investigated at doses of 125, 250 and 500 μg versus placebo. In two studies, 500 μg roflumilast was added on top of standard therapy with inhaled corticosteroids (ICS), 250 μg fluticasone propionate, or 400 μg beclomethasone dipropionate (BDP). Improvement in FEV1 from baseline was the primary endpoint in seven studies. Key secondary endpoints included asthma symptom scores and time to first severe exacerbation.. Roflumilast consistently improved FEV1 across the nine studies compared with placebo, reaching statistical significance in three studies. When given in addition to ICS, roflumilast provided additional improvements in FEV1 which was statistically significant for 500 μg roflumilast/400 μg BDP versus placebo/400 μg BDP.. Together these studies show that roflumilast has potential as an effective anti-inflammatory therapy for the treatment of asthma. Additional beneficial effects are observed when given in combination with ICS, which warrant further investigation. All studies were funded by Takeda. Trial registration numbers available on ClinicalTrials.gov: NCT00073177, NCT00076076, NCT00163527.

    Topics: Adolescent; Adult; Aged; Aminopyridines; Asthma; Beclomethasone; Benzamides; Child; Cyclopropanes; Double-Blind Method; Forced Expiratory Volume; Humans; Middle Aged; Phosphodiesterase 4 Inhibitors; Quality of Life; Young Adult

2015
Lack of long-term effects of high-dose inhaled beclomethasone for respiratory syncytial virus bronchiolitis: a randomized placebo-controlled trial.
    The Pediatric infectious disease journal, 2014, Volume: 33, Issue:1

    Previously, we showed that high-dose early initiated inhaled corticosteroids during respiratory syncytial virus bronchiolitis partially and transiently prevents subsequent recurrent wheeze. Here, we study treatment effect on lung function at age 6.. This is a 6-year follow-up report of a randomized placebo-controlled trial, in which 185 infants hospitalized for respiratory syncytial virus bronchiolitis were treated with early initiated, high-dose inhaled beclomethasone (n = 86) or placebo (n = 99) for 3 months. The primary outcome was forced expiratory volume in 1 second as percentage predicted. Secondary outcomes were bronchial hyperresponsiveness, physician-diagnosed asthma, hay fever and eczema. Possible toxicity was assessed by linear growth measurements.. At age 6, no significant differences were found in mean forced expiratory volume in 1 second percentage predicted between beclomethasone-treated and placebo-treated patients (91.4 vs. 93.4, mean difference 2.05 (95% confidence interval: -1.98 to 6.08). The proportion of bronchial hyperresponsiveness, physician-diagnosed asthma, parent reported hay fever and eczema was comparable between groups. There were no differences in linear growth.. Early initiated prolonged treatment with high-dose inhaled beclomethasone during hospitalization for respiratory syncytial virus infection during infancy did not improve the long-term respiratory outcome, but was safe.

    Topics: Administration, Inhalation; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchiolitis; Child; Child, Preschool; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Humans; Male; Respiratory Syncytial Virus Infections

2014
A clinical pharmacology study of fixed vs. free combination of inhaled beclometasone dipropionate and formoterol fumarate dry powder inhalers in asthmatic adolescents.
    British journal of clinical pharmacology, 2014, Volume: 78, Issue:5

    Topics: Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biological Availability; Cross-Over Studies; Drug Combinations; Drug Therapy, Combination; Dry Powder Inhalers; Ethanolamines; Female; Formoterol Fumarate; Humans; Male; Patient Compliance

2014
The inverse agonist propranolol confers no corticosteroid-sparing activity in mild-to-moderate persistent asthma.
    Clinical science (London, England : 1979), 2014, Volume: 127, Issue:11

    The murine asthma model shows that switching off airway β2 receptors with an inverse agonist may confer anti-inflammatory effects as well as corticosteroid-sparing activity. We have assessed for any corticosteroid-sparing effects of propranolol, an inverse agonist, added to low-dose inhaled corticosteroid (ICS) compared with higher dose ICS. A randomized double-blind placebo-controlled cross-over trial in mild-to-moderate persistent asthmatic patients was performed. After a run-in (2 weeks) on hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) at 100 μg/day (HFA-BDP100), patients received randomized treatments (4 weeks) with propranolol at 80 mg/day plus HFA-BDP at 100 μg/day compared with placebo plus HFA-BDP at 400 μg/day (HFA-BDP400). Propranolol was up-titrated to 80 mg/day over the initial 2 weeks. Tiotropium was co-administered until 5 days before each histamine challenge (the primary outcome). Sixteen patients completed the study [mean age, 38 years; forced expiratory volume in 1 s (FEV1), 86.4%; histamine provocative concentration causing a 20% fall in FEV1 (PC20), 1.39 mg/ml; ICS dose, 406 μg/day]. Histamine PC20 was unchanged by adding propranolol to HFA-BDP100 compared with baseline (HFA-BDP100) {0.17 doubling dilution (dd) difference [95% confidence interval (CI): -0.58 to 0.92]}, but there was a significant improvement with HFA-BDP400 compared with both baseline [1.05 dd (95% CI: 0.43-1.66); P=0.02], and propranolol+HFA-BDP100 [0.88 dd (95% CI: 0.45-1.30); P=0.006]. Significant improvements were also observed with HFA-BDP400 for exhaled nitric oxide, blood eosinophils, serum eosinophilic cationic protein and asthma quality-of-life questionnaire symptoms compared with propranolol+HFA-BDP100. Salbutamol recovery post-challenge was partially blunted by propranolol (median prolongation 5 min; P=0.002). Domiciliary evening FEV1 also fell with propranolol+HFA-BDP100 [mean reduction from baseline 0.22 litres (95% CI: 0.10-0.34); P=0.012], whereas Asthma Control Questionnaire remained unchanged. In conclusion, the inverse agonist propranolol produced no improvements when given with low-dose ICS, whereas further significant improvements in airway hyper-responsiveness and inflammation were demonstrated with higher dose ICS. Thus, propranolol does not confer corticosteroid-sparing activity in persistent asthma.

    Topics: Adult; Asthma; Beclomethasone; Bronchial Provocation Tests; Creatinine; DNA-Binding Proteins; Double-Blind Method; Eosinophilia; Female; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Male; Nuclear Proteins; Potassium; Propranolol; Transcription Factors

2014
Systemic exposure to inhaled beclometasone/formoterol DPI is age and body size dependent.
    Respiratory medicine, 2014, Volume: 108, Issue:8

    Prescription of inhaled corticosteroids to children with asthma is recommended at half the nominal dose of adults in order to reduce the risk of systemic side effects. However, there is a lack of pharmacokinetic trials supporting such dose reduction regimens. Therefore, we aimed to compare the systemic exposure to the active ingredients of a fixed dose combination of beclometasone-dipropionate (BDP) and formoterol after dry powder inhaler (DPI) administration in children, adolescents and adults.. The pharmacokinetic profiles of formoterol and beclometasone-17-monopropionate (B17MP; active metabolite of BDP) were evaluated over 8 h from two independent studies comprising children (6-11yrs, n = 27), adolescents (12-17 yrs, n = 28) and adults (≥18 yrs, n = 30) receiving a single, fixed dose of BDP/formoterol (children: 200 μg/24 μg, adolescents and adults: 400 μg/24 μg) via DPI.. The systemic exposure (AUC) for children versus adults was almost doubled for formoterol and similar for B17MP despite the halved BDP dose administered in children. In adolescents the AUC for formoterol and B17MP were approximately one third higher than in adults for both compounds. Upon normalization for the BDP/formoterol dose in the three populations the AUC and peak concentration (C(max)) correlated inversely with age and body surface area of the patients (r ≤ -0.53; p < 0.0001).. The systemic exposure to the active ingredients of BDP/formoterol administered as DPI correlates inversely with age and body size suggesting that dry powder dosage regimens should be adjusted for age and body size to avoid high systemic drug levels in children.

    Topics: Administration, Inhalation; Adolescent; Adult; Age Factors; Aged; Analysis of Variance; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Size; Child; Cross-Over Studies; Ethanolamines; Forced Expiratory Volume; Formoterol Fumarate; Half-Life; Humans; Metered Dose Inhalers; Middle Aged; Young Adult

2014
Irreversible acinar airway abnormality in well controlled asthma.
    Respiratory medicine, 2014, Volume: 108, Issue:11

    Even in stable asthma patients, acinar ventilation distribution can be abnormal, and we aimed to specifically maximize its reversibility by switching patients from a standard inhaled corticosteroid (iCS) to a fine particle iCS formulation.. For this prospective double-blind double-dummy randomized study, 66 stable asthma patients under maintenance iCS (equivalent budesonide ≤ 800 μg/day) were screened for abnormal baseline acinar ventilation heterogeneity (Sacin). After a 3-week run-in period, 35 eligible patients were randomized to fine particle beclomethasone (HFA-BDP; Qvar Autohaler) or to budesonide (DPI-BUD; Pulmicort Turbohaler). Asthma Control Test (ACT) score and various lung function indices reflecting the small airways were obtained at baseline, after 6 and 12 weeks.. Thirty one patients [age:52 ± 17(SD) years; FEV1:76 ± 19(SD)%pred] completed the study (DPI-BUD:n = 16; HFA-BDP:n = 15). After 6 and 12 weeks, there were no significant changes in acinar or conductive ventilation heterogeneity, nor in mid-expiratory flow, RV/TLC, closing capacity, impulse oscillometry indices (resistance, reactance), bronchial NO production or alveolar NO, in either treatment arm. Asthma control was maintained in both arms.. In stable asthma patients with small airways dysfunction under maintenance therapy, there is a residual functional abnormality in the lung periphery which is probably not eosinophilic in origin and cannot be normalized with the iCS formulations under study. ISRCTN17195095.

    Topics: Acinar Cells; Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Particle Size; Prospective Studies; Vital Capacity

2014
Stepping-across controlled asthmatic patients to extrafine beclometasone/formoterol combination.
    Pulmonary pharmacology & therapeutics, 2013, Volume: 26, Issue:5

    Asthma management focuses on achieving and maintaining asthma control. Few studies have assessed whether complete and sustained asthma control is maintained in clinical practice after stepping-across ICS/LABA fixed combinations. Aim of this double-blind, double-dummy, randomized, parallel group, controlled study was to demonstrate clinical equivalence between equipotent doses of extrafine beclometasone/formoterol (BDP/F) pMDI and fluticasone/salmeterol (FP/S) Diskus® in maintaining lung function and asthma control.. A total of 416 asthmatic patients already controlled with FP/S 500/100 μg/day (Diskus®, pMDI or separate inhalers) were randomized to a 12-week treatment with extrafine BDP/F 400/24 μg/day pMDI or FP/S 500/100 μg/day Diskus®. Pre-dose 1-s forced expiratory volume (FEV(1)) was the primary efficacy variable; secondary variables included asthma control questionnaire (ACQ-7) and FEV(1)0-1 h area under the curve (FEV(1)AUC(0-1h)). Safety was assessed through adverse events monitoring and vital signs.. After 12 weeks of treatment, pre-dose FEV(1) did not differ between treatments (difference between means 0.01 L; 95% CI -0.03-0.06 L) with no significant changes from baseline in both groups (p = 0.726 and p = 0.783 in BDF/F arm and FP/S, respectively). ACQ-7 score showed that control was maintained after stepping-across to extrafine BDP/F. FEV(1)AUC(0-1h) was significantly higher in BDP/F arm at the beginning (p = 0.004) and at the end of the 12-week treatment period (p = 0.019). No safety issues were reported in both groups.. Patients previously controlled with FP/S in any device formulation can effectively step-across to extrafine BDP/F pMDI, maintaining lung function and asthma control with a 5-min onset of action.

    Topics: Administration, Inhalation; Adult; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Drug Combinations; Ethanolamines; Female; Fluticasone-Salmeterol Drug Combination; Forced Expiratory Volume; Formoterol Fumarate; Humans; Male; Middle Aged; Particle Size; Respiratory Function Tests; Time Factors; Treatment Outcome

2013
Real life clinical study design supporting the effectiveness of extra-fine inhaled beclomethasone/formoterol at the level of small airways of asthmatics.
    Pulmonary pharmacology & therapeutics, 2013, Volume: 26, Issue:6

    In an attempt to establish how treatment with inhaled extra-fine beclomethasone/formoterol (I-EF-BDP/F) formulation differs from other combinations of inhaled corticosteroid (ICS) and long acting beta-agonist (LABA), we studied lung function and markers of airway inflammation upon switching to the extra-fine formulation and after 8 weeks of treatment with it.. We carried out a real-life clinical observation of undercontrolled asthmatic patients switched over from dry powder inhalers of fluticasone/salmeterol and budesonide/formoterol to I-EF-BDP/F (Foster(®), Chiesi Farmaceutici S.p.A., Italy). The effects of 8-weeks of treatment were documented by means of visual analog scale (VAS), quality of life by Asthma Quality of Life Questionnaire (AQLQ), spirometry and markers of airway or systemic inflammation: exhaled breath temperature (EBT), blood eosinophils (Eos), and high sensitivity C-reactive protein (CRP). Before/after treatment differences between forced vital capacity percent of predicted (%FVC), a simple indicator of small airways involvement, were calculated and subjects were ranked accordingly to reflect the magnitude of the therapeutic response. Subjects above the 75th percentile (n = 15), "top responders", were then compared with those below the 25th percentile (n = 15) "poor responders".. On average, the 59 patients completing the study (mean age ± SD 51 ± 12 years, 38 women) had significant improvement in VAS and QLQ scores at the end of the treatment period (49.1 ± 2.4 vs. 73.1 ± 2.05 and 146.1 ± 2.7 vs. 176.7.1 ± 3.4 respectively, P < 0.001), but not in the inflammatory indicators (EBT, CRP and Eos). However, when comparing the "top responders" with the "poor responders", significant improvement in these inflammatory indicators was observed: EBT significantly decreased from 34.04/mean/± 0.30/s.e.m./[°C] to 33.57 ± 0.33, P = 0.003, Eos in blood fell from 381.7 ± 91.2 [cells/μL] to 244.2 ± 43.2, P = 0.02. Before/after treatment differences in hsCRP decreased significantly in the top responders compared with the poor responders (Mann-Whitney test, P = 0.04).. Asthmatic subjects who had the most improvement in FVC after transition to I-EF-BDP/F from other combined ICS/LABA preparations also demonstrated a significant decrease in some indicators of airway/systemic inflammation. These results support the notion that I-EF-BDP/F exerts an effect also at the level of the small airways through a reduction of the level of air trapping. Patients in whom inflammation of the small airways plays an important clinical role are the ones to derive most benefit from this small airways tailored treatment. However, improved compliance due to the "promise of a new drug" effect should also be considered as contributing to the treatment results.

    Topics: Administration, Inhalation; Adult; Albuterol; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; C-Reactive Protein; Drug Combinations; Ethanolamines; Female; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Humans; Inflammation; Male; Middle Aged; Particle Size; Quality of Life; Spirometry; Statistics, Nonparametric; Treatment Outcome

2013
Stepping down from high dose fluticasone/salmeterol to extrafine BDP/F in asthma is cost-effective.
    Respiratory medicine, 2013, Volume: 107, Issue:10

    GINA guideline recommends stepping down treatment of asthma patients where control is achieved. The aim of this analysis was to estimate the costs and health outcomes associated with step down of controlled patients on high dose fluticasone/salmeterol (FP/S 1000/100 μg daily) to either medium dose FP/S (500/100 μg) dry powder or extrafine beclometasone/formoterol (BDP/F 400/24 μg) pMDI in three European countries.. A patient-level simulation Markov model was constructed to enable the simulation of three comparative arms (FP/S 1000/100, FP/S 500/100, BDP/F 400/24). Transition probabilities and healthcare resources consumption were derived from a multinational clinical trial comparing BDP/F 400/24 μg vs. FP/S 500/100 μg as step down therapy in asthma. Direct costs and health state utilities were sourced from public source and published literature. The analysis was conducted from a health system perspective, based on six months horizon. Probabilistic sensitivity analyses were conducted.. The ICER (Incremental Cost-Effectiveness Ratio) associated with high dose dry powder FP/S 1000/100 μg vs. extrafine BDP/F 400/24 μg was above 70,000 GBP and 200,000 €/QALY (Quality Adjusted Life Years). An ICER of 29,000 GBP/QALY and above 30,000 €/QALY was associated with medium dose dry powder FP/S 500/100 μg vs. BDP/F 400/24 μg.. It was found that maintaining controlled patients on high dose FP/S is not cost-effective. Extrafine BDP/F 400/24 μg daily can be considered to be a cost-effective option in the countries analyzed to maintain control of asthmatic patients stepped down from high dose FP/S 1000/100 μg daily dry powder or suspension formulations.

    Topics: Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cost-Benefit Analysis; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Combinations; Drug Costs; Ethanolamines; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Health Care Costs; Humans; Markov Chains; Models, Econometric; Netherlands; Quality-Adjusted Life Years; Spain; United Kingdom

2013
Beclometasone-formoterol as maintenance and reliever treatment in patients with asthma: a double-blind, randomised controlled trial.
    The Lancet. Respiratory medicine, 2013, Volume: 1, Issue:1

    According to international treatment guidelines, inhaled rapid-acting β2 agonists should be used for the control of symptoms in patients with asthma. We compared the efficacy and safety of an extrafine combination inhaler containing a corticosteroid (beclometasone) plus a rapid-onset, long-acting β2 agonist (formoterol) with a short-acting β2 agonist (salbutamol) as reliever strategies in patients taking beclometasone-formoterol combination as maintenance treatment.. In a double-blind trial undertaken in 183 centres in 14 European countries over 48 weeks, patients (aged ≥18 years) with asthma that was not fully controlled, with a forced expiratory volume in 1 s (FEV1) of at least 60% predicted, had a 2-week run in. During this period, patients were treated with a combination of beclometasone 100 μg and formoterol 6 μg per one inhalation twice daily plus salbutamol 100 μg as required delivered by use of a pressurised metered-dose inhaler. They were then randomly assigned in a 1:1 ratio with a computer-generated randomisation list to receive beclometasone 100 μg plus formoterol 6 μg or salbutamol 100 μg as reliever in addition to maintenance with beclometasone 100 μg plus formoterol 6 μg twice daily. Primary outcome was the time to first severe exacerbation (admission to hospital or visit to emergency department, or use of systemic steroids for ≥3 consecutive days). Secondary outcomes were number of severe exacerbations (events per 100 patients per year), time to and number of mild exacerbations, additional exacerbation variables, lung function, symptom scores, and asthma control. Analysis was by intention to treat. The study is registered with ClinicalTrials.gov, number NCT00861926.. 1714 patients were randomly assigned to the as-needed beclometasone-formoterol (n=857) and as-needed salbutamol groups (n=857), and 1701 were analysed (852 and 849, respectively). 326 severe exacerbations were reported by 251 patients during the study, and 99 versus 152 patients had at least one exacerbation during the 48 weeks, respectively. Compared with beclometasone-formoterol plus salbutamol as needed, beclometasone-formoterol for both maintenance and reliever treatment significantly increased the time to first exacerbation (209 days vs 134 days) by 75 days, with a 36% reduction in risk (hazard ratio 0·64 [95% CI 0·49 to 0·82]; p=0·0005), and the estimated probability was 12% and 18%, respectively (p=0·0003). The number of days with mild asthma exacerbations was also lower with as-needed beclometasone-formoterol than with as-needed salbutamol (56·04 days per patient per year vs 65·11 days per patient per year; 0·86 [0·76 to 0·98]; p=0·021). From the run-in period to week 48, both treatments improved symptoms (mean change -1·59 [-1·94 to -1·25] in the as-needed beclometasone-formoterol group vs -1·44 [-1·78 to -1·10] in the as-needed salbutamol group, difference -0·15 [-0·60 to 0·30]; p=0·507), percentage of asthma control days (9·5% [7·3 to 11·8] vs 10·9% [8·7 to 13·1], respectively, -1·4 [-4·3 to 1·6]; p=0·359), use of reliever (-0·29 [-0·38 to -0·20] vs -0·27 [-0·36 to -0·19], respectively, -0·02 [-0·13 to 0·10]; p=0·794), and lung function (FEV1, 0·090 [0·060 to 0·120] vs 0·090 [0·060-0·120], respectively, 0·001 [-0·040 to 0·040]; p=0·969), and were well tolerated (patients with serious adverse events, 32 [4%] and 41 [5%], respectively).. Our results lend support to the use of the combination of a single inhaled corticosteroid plus a rapid-onset, long-acting β2 agonist for maintenance and relief in patients with moderate to severe asthma and provide encouraging data for the formulation of beclometasone-formoterol for this use.. Chiesi Farmaceutici.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Aged, 80 and over; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Drug Combinations; Ethanolamines; Female; Forced Expiratory Volume; Formoterol Fumarate; Humans; Male; Middle Aged; Treatment Outcome; Young Adult

2013
Pharmacokinetic comparison of inhaled fixed combination vs. the free combination of beclomethasone and formoterol pMDIs in asthmatic children.
    British journal of clinical pharmacology, 2013, Volume: 75, Issue:4

    The fixed combination of beclomethasone (BDP) and formoterol pressurized metered dose inhaler (pMDI) (Foster®, Chiesi Farmaceutici) is being developed in the lower strength (BDP/formoterol: 50/6 μg) to provide an appropriate dosage for children with asthma. The aim of this work was to investigate the systemic bioavailability of beclomethasone-17-monoproprionate (B17MP, the active metabolite of BDP) and formoterol after single inhalation of Foster® pMDI 50/6 μg vs. the free combination of BDP and formoterol pMDIs in asthmatic children.. Children aged 5-11 years old inhaled BDP 200 μg and formoterol 24 μg as fixed vs. free combination in an open label, randomized, two way crossover single dose study. Blood was collected pre-dose up to 8 h post-dose for pharmacokinetic evaluation (AUC(0,t), AUC(0,∞), AUC(0,0.5 h, Cmax , tmax , t1/2 ). Pharmacodynamics included heart rate, plasma potassium, urinary glucose and cortisol excretion. Peak expiratory flow and adverse events were monitored.. Twenty subjects were evaluable. The systemic exposure of B17MP and formoterol administered as fixed combination did not exceed the free combination: B17MP AUC(0,t) (pg ml(-1)  h) ratio test : reference (90% CI), 0.81 (0.697, 0.948) and formoterol AUC(0,t) (pg ml(-1)  h) ratio test : reference 0.97 (0.85, 1.10). All pharmacokinetic and pharmacodynamic end points showed non-superiority in favour of the test drug. One adverse event (vertigo) occurred but was not considered treatment-related.. BDP and formoterol pharmacokinetic and pharmacodynamic effects are non-superior after administration of the two actives as fixed vs. the free combination in 5-11-year-old asthmatic children.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biological Availability; Child; Child, Preschool; Drug Combinations; Drug Therapy, Combination; Ethanolamines; Female; Formoterol Fumarate; Glucose; Heart Rate; Humans; Hydrocortisone; Male; Metered Dose Inhalers; Peak Expiratory Flow Rate; Potassium

2013
Effect of nebulized beclomethasone on airway inflammation and clinical status of children with allergic asthma and rhinitis: a randomized, double-blind, placebo-controlled study.
    International archives of allergy and immunology, 2013, Volume: 161, Issue:1

    We aimed to evaluate the therapeutic effect of nebulized beclomethasone dipropionate (nBDP) on both allergic asthma and rhinitis. In a randomized, double-blind, placebo-controlled study, 40 children (mean age 10.7 ± 2.1 years) with allergic asthma and rhinitis received either nBDP (daily dose of 800 µg, administered twice daily) or placebo for 4 weeks (with a face mask), after a 2-week run-in period of clinical assessment. Nasal and oral fractional exhaled nitric oxide (FeNO) measurements together with pulmonary function tests, nasal and oral exhaled breath condensate (EBC) collection for pH and interleukin-5 (IL-5) measurements as well as nasal and bronchial symptom scores were obtained at baseline and after 4-week treatment. A significant improvement in oral FeNO, oral and nasal EBC IL-5 and nasal EBC pH was observed in the nBDP group when comparing the values with baseline, together with an improvement in symptom score of the visual analogue scale, nasal obstruction, sneezing, rhinorrhea, breathing difficulty, cough, wheezing and sleep disturbance (nBDP end treatment vs. baseline, Wilcoxon signed-rank test). nBDP was more effective than placebo (ANCOVA test) in improving [difference Δ = response after treatment at the last visit (active or placebo) - value at baseline] nasal pH, oral IL-5, oral FeNO, forced expiratory volume in 1 s, forced expiratory volume in 1 s/forced vital capacity, peek expiratory flow, visual analogue scale, breathing difficulty, cough, wheezing and sleep disturbance scores. No differences were observed between the nBDP and the placebo group for symptom score of rhinitis. nBDP is a useful treatment for airway inflammation and clinical status in children with concomitant allergic asthma and rhinitis.

    Topics: Administration, Inhalation; Adolescent; Adrenergic beta-2 Receptor Agonists; Anti-Asthmatic Agents; Asthma; Beclomethasone; Breath Tests; Child; Double-Blind Method; Female; Humans; Immunoglobulin E; Interleukin-5; Male; Nebulizers and Vaporizers; Nitric Oxide; Pilot Projects; Respiratory Function Tests; Rhinitis, Allergic, Perennial

2013
The novel TLR-9 agonist QbG10 shows clinical efficacy in persistent allergic asthma.
    The Journal of allergy and clinical immunology, 2013, Volume: 131, Issue:3

    Allergen-specific TH2 responses contribute to the development of allergic asthma. Their increase may be due to a reduced early exposure to environmental pathogens, which induces a TH1 response, and thereby suppresses the allergic TH2 response. QbG10 (bacteriophage Qbeta-derived virus-like particle with CpG-motif G10 inside), a novel Toll-like receptor 9 agonist packaged into virus-like particles, was designed to stimulate the immune system toward a TH1-mediated protective response.. We examined clinical efficacy, safety, and tolerability of QbG10 with patient-reported and objective clinical outcome parameters in patients with mild-to-moderate persistent allergic asthma.. In this proof-of-concept parallel-group, double-blind, randomized trial, 63 asthmatic patients followed conversion to a standardized inhaled steroid and were treated with 7 injections of either QbG10 or placebo. Incorporating a controlled steroid withdrawal, the effects on patient-reported (day- and nighttime asthma symptoms, salbutamol usage, and 7-item-Asthma Control Questionnaire scores) and objective clinical outcome measures (FEV1, fraction of exhaled nitric oxide, and blood eosinophils) were assessed over 12 weeks (ClinicalTrials.gov number, NCT00890734).. All patient-reported parameters improved overall between week 0 and 12 in QbG10-treated patients (n = 33) despite steroid withdrawal, compared with deteriorations observed under placebo (n = 30, P < .05). At week 12, two thirds of the QbG10-treated patients had their asthma "well controlled" (Asthma Control Questionnaire score ≤0.75) compared with one third under placebo. FEV1 had worsened to a clinically significant extent in patients on placebo, while it remained stable in QbG10 patients. Adverse events were mostly injection site reactions occurring after QbG10 administration.. Treatment with QbG10 may contribute to continued asthma control during steroid reduction in patients on moderate or high-dose inhaled steroids.

    Topics: Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Immunoglobulin E; Male; Middle Aged; Nitric Oxide; Oligonucleotides; Toll-Like Receptor 9; Young Adult

2013
Systemic activity of inhaled beclomethasone dipropionate: a double-blind comparison of volume spacers.
    Acta paediatrica (Oslo, Norway : 1992), 2012, Volume: 101, Issue:2

    To which extent volume spacers may influence systemic activity of inhaled beclomethasone dipropionate (BDP) has not been evaluated.. To assess whether the AeroChamber Plus™ spacer is equivalent to the Volumatic™ spacer for administration of inhaled hydroflouroalkane 134a propelled BDP in terms of lower leg growth rate (LLGR).. Prepubertal children with mild asthma (n = 26, aged 6-14 years) were included in a 3-time periods of 2 weeks duration randomized double-blind cross-over study with a single-blind placebo run-in and two washout periods. LLGR was measured with the knemometer. Interventions were inhaled BDP hydroflouroalkane 134a pressurized metered dose inhaler 100 μg and 200 μg b.i.d. with the AeroChamber Plus and 200 μg b.i.d. with the Volumatic spacer.. Beclomethasone dipropionate 200 μg b.i.d. from the AeroChamber Plus was non-inferior to BDP 200 b.i.d. from the Volumatic spacer as the lower margin of confidence interval of the difference between treatments (-0.18 to 0.13 mm/week) was greater than the prespecified lower limit for non-inferiority (-0.20 mm/week). UFC/creatinine data showed no statistically significant variations.. The systemic activity of BDP, via the Volumatic™, and AeroChamber Plus™ spacers is similar. The AeroChamber Plus spacer may be used in children without risk of increasing systemic activity of BDP.

    Topics: Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Cross-Over Studies; Double-Blind Method; Female; Humans; Leg; Male; Nebulizers and Vaporizers; Treatment Outcome

2012
The role of the small airways in the clinical expression of asthma in adults.
    The Journal of allergy and clinical immunology, 2012, Volume: 129, Issue:2

    The clinical relevance of increased ventilation heterogeneity, a marker of small-airways disease, in asthmatic patients is unclear. Ventilation heterogeneity is an independent determinant of airway hyperresponsiveness (AHR), improves with bronchodilators and inhaled corticosteroids (ICSs), and worsens during exacerbations, but its relationship to asthma control is unknown.. We sought to determine the association between ventilation heterogeneity and current asthma control before and after ICS treatment.. Adult subjects with asthma had lung function and asthma control (5-item Asthma Control Questionnaire [ACQ-5 score] ≥1.5 = poorly controlled, ACQ-5 score ≤0.75 = well controlled) measured at baseline. A subgroup with AHR had repeat measurements after 3 months of high-dose ICS treatment. The indices of ventilation heterogeneity in the regions of the lung where gas transport occurs predominantly through convection (ventilation heterogeneity in convection-dependent airways [Scond]) and through diffusion (ventilation heterogeneity in diffusion-dependent airways [Sacin]) were derived by using the multiple-breath nitrogen washout technique.. At baseline (n = 105), subjects with poorly controlled asthma had worse FEV(1), fraction of exhaled nitric oxide measured at 200 mL/s (Feno), Scond, and Sacin values. In the treatment group (n = 50) spirometric, Feno, residual volume (RV)/total lung capacity (TLC), AHR, and Scond values significantly improved. Asthma control also improved (mean ACQ-5 score, 1.3-0.7; P < .0001). The change in ACQ-5 score correlated with changes in Feno (r(s) = 0.31, P = .03), Sacin (r(s) = 0.32, P = .02), and Scond (r(s) = 0.41, P = .003) values. The independent predictors of a change in asthma control were changes in Scond and Sacin values (model r(2) = 0.20, P = .005).. Current asthma control is associated with markers of small-airways disease. Improvements in ventilation heterogeneity with anti-inflammatory therapy are associated with improvements in symptoms. Sensitive measures of small-airway function might be useful in monitoring the response to therapy in asthmatic subjects.

    Topics: Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Female; Humans; Male; Nitric Oxide; Plethysmography; Skin Tests; Spirometry

2012
Adherence rate to beclomethasone dipropionate and the level of asthma control.
    Respiratory medicine, 2012, Volume: 106, Issue:3

    There are only a few studies assessing the relationship between adherence rate to ICS, as assessed by electronic monitoring, and the level of asthma control in childhood. The present study was carried out to examine the relationship between adherence to beclomethasone diproprionate (BDP) as well as other factors related to poor asthma control. In this prospective cohort study, 102 steroid naïve randomly selected subjects with persistent asthma, aged 5-14 years were prescribed 500-750 μg daily of BDP-CFC and followed during one year. Adherence to BDP was measured electronically in the 4th, 8th and 12th months of study. The level of asthma control was classified as either controlled or uncontrolled instead of the current three categories recommended by the Global Initiative for Asthma (GINA). Mean adherence rate was higher in patients with controlled asthma during follow-up, but went down from 60.4% in the 4th month to 49.8% in the 12th month (p = 0.038). Conversely, among patients with uncontrolled asthma, the mean adherence rate decreased from 43.8% to 31.2% (p = 0.001). Multivariate analysis showed that the level of asthma control was independently associated to the adherence rate in all follow-up visits (p-values equal or lower than 0.005). The level of asthma control was directly proportional to adherence rate. Our results suggest that a BDP daily dose by 300 μg seems to be enough to attain control over mild and moderate persistent asthma, including exercise induced asthma.

    Topics: Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Asthma; Beclomethasone; Brazil; Child; Child, Preschool; Drug Administration Schedule; Drug Monitoring; Female; Follow-Up Studies; Humans; Male; Medication Adherence; Prospective Studies; Socioeconomic Factors; Treatment Outcome

2012
Real-life effectiveness of extrafine beclometasone dipropionate/formoterol in adults with persistent asthma according to smoking status.
    Respiratory medicine, 2012, Volume: 106, Issue:6

    The efficacy and safety of extrafine beclomethasone dipropionate 100 μg/formoterol 6 μg (BDP/F HFA) pressurized metered dose inhaler (pMDI) in patients with moderate-to-severe persistent asthma, has been demonstrated in randomised controlled trials (RCTs). The aim of this prospective observational study was to assess real-life effectiveness in terms of asthma control in smoking (most of the time excluded from RCTs) and non-smoking asthmatics.. Adult patients with persistent asthma, in whom treatment with an inhaled corticosteroid/long-acting β(2)-agonist (ICS/LABA) combination is indicated, were included. Pulmonary function (FEV1%pred or PEF absolute value), Asthma Control Questionnaire (ACQ) and asthma control according to GINA criteria were measured at baseline as well as 2-8 months and >8-14 months after treatment initiation with BDP/F HFA.. Overall, 619 patients were enrolled by 97 investigators. In the effectiveness cohort (N = 568), at baseline, smoking asthmatics (N = 123) had higher ACQ6 (p < 0.0001) and lower asthma control (p = 0.021) than non-smoking asthmatics. Treatment with BDP/F HFA pMDI was associated with significant (p < 0.0001) improvements in pulmonary function (+7.1% in FEV1% pred), ACQ6 (-1.32) and GINA asthma control (improvement of control in 49.8% of patients). Importantly, the same treatment benefits were observed in former or current smokers compared with non-smoking asthmatics. There was a reduction in the dose of ICS from 489 ± 192 μg BDP extrafine equivalents at baseline to 265 ± 125 μg after one year. The drug was well-tolerated.. This prospective cohort study demonstrates the real-life effectiveness and safety of BDP/F HFA in adult asthma patients, including smokers, in normal clinical practice.

    Topics: Adrenergic beta-2 Receptor Agonists; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Combinations; Ethanolamines; Female; Forced Expiratory Volume; Formoterol Fumarate; Glucocorticoids; Humans; Male; Metered Dose Inhalers; Middle Aged; Peak Expiratory Flow Rate; Prospective Studies; Smoking; Treatment Outcome

2012
Step-down from high dose fixed combination therapy in asthma patients: a randomized controlled trial.
    Respiratory research, 2012, Jun-25, Volume: 13

    Asthma guidelines suggest that therapy can be reduced once asthma is controlled. Despite these recommendations, asthmatic patients are seldom stepped down in clinical practice, and questions remain about when and how to reduce asthma therapy. The purpose of the present study was to evaluate lung function and asthma control in patients who were stepped down from the highest recommended dose of inhaled corticosteroid/long acting β2 agonist combination therapy.. This was a prospective, randomised, controlled, two-arm parallel group study. Asthmatic patients who were fully controlled with a high daily dose (1000/100 μg) of fluticasone/salmeterol were randomly assigned to 6 months of open-label treatment with either 500/100 μg fluticasone/salmeterol Diskus daily or 400/24 μg extrafine beclomethasone/formoterol pMDI daily. The primary outcome was the change in morning peak expiratory flow (PEF) values between baseline and the end of treatment. The secondary outcomes included asthma control and exacerbation frequency.. Four hundred twenty-two patients were included in the analysis. The PEF values remained above 95% of the predicted values throughout the study. The end-study morning PEF rates showed equivalence between the groups (difference between means, 2.49 L/min; 95% CI, -13.43 to 18.42). No changes from baseline were detected in PEF and forced expiratory volume in 1 second measured at the clinics, in the symptom scores or in the use of rescue medication. Asthma control was maintained in 95.2% of the patients at 6 months. No significant differences between the groups were detected in any other parameter, including exacerbation frequency and adverse events.. Stepping down patients whose asthma is controlled with the highest recommended dose of fluticasone/salmeterol to either 500/100 μg fluticasone/salmeterol daily or 400/24 μg extra-fine beclomethasone/formoterol daily provides comparable maintenance of lung function and asthma control.. clinicaltrials.gov NCT00497237.

    Topics: Adolescent; Adult; Aged; Albuterol; Androstadienes; Asthma; Beclomethasone; Bronchodilator Agents; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Female; Fluticasone-Salmeterol Drug Combination; Humans; Male; Middle Aged; Prospective Studies; Young Adult

2012
Relief of methacholine-induced bronchospasm with extrafine beclomethasone dipropionate/formoterol in comparison with salbutamol in asthma.
    Pulmonary pharmacology & therapeutics, 2012, Volume: 25, Issue:5

    Short-acting beta2-agonists like salbutamol and terbutaline are used as rescue medications for acute bronchoconstriction and relief of symptoms due to their rapid onset of action. The aim of this study was to assess whether inhaled beclomethasone dipropionate (BDP)/formoterol fumarate (FF) combination in extrafine formulation is non-inferior to salbutamol in the speed of reverting methacholine-induced bronchoconstriction and symptoms.. Fifty-six asthmatic patients were examined in a multicentre, randomised, double blind, double dummy, active treatment and placebo controlled three period cross-over study. On three different days, a single dose of BDP/FF 100/6 μg in pressurised metered-dose inhaler (pMDI) extrafine formulation or salbutamol 200 μg pMDI or placebo was inhaled after FEV(1) had dropped by 30-45% with methacholine challenge.. The median time to recovery of FEV(1) to 85% of baseline was similar for BDP/FF and salbutamol (3.66 and 2.15 min, respectively), but significantly longer for placebo (21.1 min). The planned analysis on adjusted mean time to recovery showed that the difference from methacholine-induced bronchoconstriction between BDP/FF and salbutamol was 3.82 min (95% confidence interval: -0.85 to 8.5), therefore greater than 3 min supposed in the study design. The difference between BDP/FF and salbutamol was not clinically significant. The two active treatments were also comparable in terms of the relief of symptoms (as assessed by the Borg dyspnoea scale).. BDP/FF combination has a fast onset of action, similar to that of salbutamol, and may represent a good alternative as rescue medication in asthmatic patients.

    Topics: Adult; Albuterol; Asthma; Beclomethasone; Bronchial Spasm; Cross-Over Studies; Double-Blind Method; Drug Therapy, Combination; Ethanolamines; Female; Forced Expiratory Volume; Formoterol Fumarate; Humans; Male; Methacholine Chloride; Middle Aged

2012
Sensitivity of impulse oscillometry and spirometry in beta-blocker induced bronchoconstriction and beta-agonist bronchodilatation in asthma.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2012, Volume: 109, Issue:6

    Impulse oscillometry (IOS) provides an alternative method of assessing pulmonary function to conventional spirometry.. To compare the sensitivities of IOS and spirometry in assessing bronchoconstriction to propranolol and bronchodilation with salbutamol.. A post-hoc analysis of a randomized placebo-controlled crossover study was performed. Patients with mild-to-moderate persistent stable asthma taking 1,000 μg/day or less beclomethasone dipropionate equivalent received 10 or 20 mg of oral propranolol followed by histamine challenge, with recovery to nebulized salbutamol (5 mg). Spirometry and IOS were measured before and 2 hours after beta-blocker, post histamine, and 20 minutes post-salbutamol. Pre versus post percent change (95%CI) values were compared, and standardized response means (SRM) were calculated to assess the "signal to noise" of each test.. Thirteen participants (mean age, 34 years) completed the protocol. Eleven participants received 20 mg of propranolol; 2 received 10 mg, because this dose caused more than 10% decrease in forced expiratory volume in 1 second (FEV(1)) on the test-dose algorithm. All IOS indices (R5, R5-R20, AX, RF) showed significant worsening of airways resistance or reactance to propranolol. FEV(1) but not FEF25-75 showed significant deterioration after beta-blocker (mean percent change, 4.6% and 6.2%). The magnitude of change was consistently higher for parameters of IOS, with the largest change being observed with R5 and RF (mean percent change, 30.8% and 39.4%). The SRMs for IOS outcomes were better than for spirometry. All measures of lung function showed significant bronchodilator response, with the best SRMs seen in R5 and RF.. IOS is a more sensitive response outcome than spirometry with respect to bronchoconstriction to oral propranolol and bronchodilatation after salbutamol in patients with mild to moderate asthma.

    Topics: Adrenergic beta-Agonists; Adrenergic beta-Antagonists; Adult; Airway Resistance; Albuterol; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchoconstriction; Bronchodilator Agents; Cross-Over Studies; Female; Histamine; Humans; Lung; Male; Middle Aged; Oscillometry; Propranolol; Respiratory Function Tests; Spirometry; Treatment Outcome; Young Adult

2012
Use of beclomethasone dipropionate as rescue treatment for children with mild persistent asthma (TREXA): a randomised, double-blind, placebo-controlled trial.
    Lancet (London, England), 2011, Feb-19, Volume: 377, Issue:9766

    Daily inhaled corticosteroids are an effective treatment for mild persistent asthma, but some children have exacerbations even with good day-to-day control, and many discontinue treatment after becoming asymptomatic. We assessed the effectiveness of an inhaled corticosteroid (beclomethasone dipropionate) used as rescue treatment.. In this 44-week, randomised, double-blind, placebo-controlled trial we enrolled children and adolescents with mild persistent asthma aged 5-18 years from five clinical centres in the USA. A computer-generated randomisation sequence, stratified by clinical centre and age group, was used to randomly assign participants to one of four treatment groups: twice daily beclomethasone with beclomethasone plus albuterol as rescue (combined group); twice daily beclomethasone with placebo plus albuterol as rescue (daily beclomethasone group); twice daily placebo with beclomethasone plus albuterol as rescue (rescue beclomethasone group); and twice daily placebo with placebo plus albuterol as rescue (placebo group). Twice daily beclomethasone treatment was one puff of beclomethasone (40 μg per puff) or placebo given in the morning and evening. Rescue beclomethasone treatment was two puffs of beclomethasone or placebo for each two puffs of albuterol (180 μg) needed for symptom relief. The primary outcome was time to first exacerbation that required oral corticosteroids. A secondary outcome measured linear growth. Analysis was by intention to treat. This study is registered with clinicaltrials.gov, number NCT00394329.. 843 children and adolescents were enrolled into this trial, of whom 288 were assigned to one of four treatment groups; combined (n=71), daily beclomethasone (n=72), rescue beclomethasone (n=71), and placebo (n=74)-555 individuals were excluded during the run-in, according to predefined criteria. Compared with the placebo group (49%, 95% CI 37-61), the frequency of exacerbations was lower in the daily (28%, 18-40, p=0·03), combined (31%, 21-43, p=0·07), and rescue (35%, 24-47, p=0·07) groups. Frequency of treatment failure was 23% (95% CI 14-43) in the placebo group, compared with 5·6% (1·6-14) in the combined (p=0·012), 2·8% (0-10) in the daily (p=0·009), and 8·5% (2-15) in the rescue (p=0·024) groups. Compared with the placebo group, linear growth was 1·1 cm (SD 0·3) less in the combined and daily arms (p<0·0001), but not the rescue group (p=0·26). Only two individuals had severe adverse events; one in the daily beclomethasone group had viral meningitis and one in the combined group had bronchitis.. Children with mild persistent asthma should not be treated with rescue albuterol alone and the most effective treatment to prevent exacerbations is daily inhaled corticosteroids. Inhaled corticosteroids as rescue medication with albuterol might be an effective step-down strategy for children with well controlled, mild asthma because it is more effective at reducing exacerbations than is use of rescue albuterol alone. Use of daily inhaled corticosteroid treatment and related side-effects such as growth impairment can therefore be avoided.. National Heart, Lung and Blood Institute.

    Topics: Administration, Inhalation; Adolescent; Albuterol; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child; Child, Preschool; Disease Progression; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Kaplan-Meier Estimate; Male; Prednisone

2011
Lung function changes in asthmatic children treated with HFA-BDP.
    Pediatric pulmonology, 2011, Volume: 46, Issue:9

    Asthma guidelines suggest that normal or near normal lung function should be one of the goals for good asthma control. Therefore, children with chronic persistent asthma and reduced peripheral airway function were assessed after the replacement of conventional inhaled corticosteroids (ICS) with an extrafine aerosol formulation, hydrofluoroalkane-134a beclomethoasone diproprionate (HFA-BDP).. Lung function and clinical details were studied in children with moderate persistent asthma who regularly attended the pediatric pulmonary outpatient clinic at Kosair Children's Hospital, Louisville, Kentucky, USA.. A total of 20 children, 7 girls and 13 boys, with stable asthma but reduced forced expiratory flows between 25% and 75% of vital capacity (FEF(25-75) ) were included in the study.. After the initial assessment, each subject was switched from conventional ICS to HFA-BDP. All other medications remained the same. Reassessment of lung function and clinical status was performed at least 3 weeks after the intervention.. FEF(25-75) increased from a mean of 50.75% to 68.85% predicted (P < 0.001). Forced expiratory volume in 1 sec (FEV(1)) also increased significantly from 84.6% to 93.8% predicted (P = 0.001). No changes asthma symptoms were observed.. Compared to conventional ICS, the use of HFA-BDP in asthmatic children significantly improves airflow in both the large and the peripheral airways without loss of asthma control.

    Topics: Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Chronic Disease; Female; Humans; Hydrocarbons, Fluorinated; Lung; Male; Respiratory Function Tests; Retrospective Studies

2011
Effects of short-term treatment with atorvastatin in smokers with asthma--a randomized controlled trial.
    BMC pulmonary medicine, 2011, Apr-07, Volume: 11

    The immune modulating properties of statins may benefit smokers with asthma. We tested the hypothesis that short-term treatment with atorvastatin improves lung function or indices of asthma control in smokers with asthma.. Seventy one smokers with mild to moderate asthma were recruited to a randomized double-blind parallel group trial comparing treatment with atorvastatin (40 mg per day) versus placebo for 4 weeks. After 4 weeks treatment inhaled beclometasone (400 μg per day) was added to both treatment arms for a further 4 weeks. The primary outcome was morning peak expiratory flow after 4 weeks treatment. Secondary outcome measures included indices of asthma control and airway inflammation.. At 4 weeks, there was no improvement in the atorvastatin group compared to the placebo group in morning peak expiratory flow [-10.67 L/min, 95% CI -38.70 to 17.37, p = 0.449], but there was an improvement with atorvastatin in asthma quality of life score [0.52, 95% CI 0.17 to 0.87 p = 0.005]. There was no significant improvement with atorvastatin and inhaled beclometasone compared to inhaled beclometasone alone in outcome measures at 8 weeks.. Short-term treatment with atorvastatin does not alter lung function but may improve asthma quality of life in smokers with mild to moderate asthma.. Clinicaltrials.gov identifier: NCT00463827.

    Topics: Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Atorvastatin; Beclomethasone; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Forced Expiratory Volume; Heptanoic Acids; Humans; Male; Peak Expiratory Flow Rate; Pyrroles; Quality of Life; Smoking; Surveys and Questionnaires; Treatment Outcome

2011
Short-term lower leg growth in 5- to 11-year-old asthmatic children using beclomethasone dipropionate inhalers with chlorofluorocarbon or hydrofluoroalkane propellants: a 9-week, open-label, randomized, crossover, noninferiority study.
    Clinical therapeutics, 2011, Volume: 33, Issue:8

    Beclomethasone dipropionate-hydrofluoroalkane (BDP-HFA) is a non-chlorofluorocarbon (CFC)-propelled metered dose inhaler. Data is needed to support the registration of BDP-HFA in pediatric populations for countries in the European Union.. The aim of the study was to assess short-term lower leg growth in children with asthma during treatment with BDP-HFA 100 μg BID compared with BDP-CFC 200 μg BID.. Children with asthma were included in this open-label, randomized, crossover study with 2-week run-in, active treatment, and washout periods. Lower leg length was measured every second week. As a secondary outcome parameter, 24-hour urine was collected for assessment of free cortisol. Interventions were inhaled BDP-HFA 100 μg BID with AeroChamber Plus spacer and BDP-CFC 200 μg BID with Volumatic spacer.. In 63 patients with asthma aged 5 to 11 years, BDP-HFA 100 μg BID was noninferior to BDP-CFC 200 μg BID, as the lower margin of CI (-0.03 to 0.10 mm/wk) of the estimated difference (0.03 mm/wk) was greater than the prespecified lower limit for noninferiority of -0.12 mm/wk. Mean (SD) lower leg growth rate during run-in, BDP-HFA 100 μg BID, and BDP-CFC 200 μg BID was 0.36 (0.17), 0.27 (0.21), and 0.23 (0.18) mm/wk, respectively (BDP-HFA estimate of difference, -0.09 [95% CI, -0.16 to -0.03 mm/wk; P < 0.01]; BDP-CFC estimate of difference, -0.13 [95% CI, -0.19 to -0.06 mm/wk; P < 0.001]). No statistically significant differences were seen in urinary free cortisol assessments. Eight and 6 mild to moderate adverse events in 10 children were reported during treatment with BDP-HFA and BDP-CFC, respectively. One event in each group was judged to be probably related to the study medication; no others were judged to be related.. No statistically significant differences were found in lower leg growth between BDP-HFA 100 μg BID with AeroChamber Plus spacer and BDP-CFC 200 μg BID with Volumatic spacer during 2-week treatment. Evidence of differences in systemic activity between the treatments was not found. EudraCT registration: 2007-007455-14.

    Topics: Administration, Inhalation; Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Chlorofluorocarbons; Cross-Over Studies; Female; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Leg; Male; Metered Dose Inhalers; Treatment Outcome

2011
Short term efficacy of nebulized beclomethasone in mild-to-moderate wheezing episodes in pre-school children.
    Italian journal of pediatrics, 2011, Aug-22, Volume: 37

    Few data are available on the usefulness of short term treatment with low-medium dose of inhaled corticosteroids (ICS) in pre-school children with wheezing exacerbations.. To compare the efficacy of one week treatment with 400 μg b.i.d. nebulized beclomethasone dipropionate (BDP), plus nebulized 2500 μg prn salbutamol (BDP group), versus nebulized b.i.d. placebo, plus nebulized prn 2500 μg salbutamol (placebo group), a post-hoc analysis was performed on data obtained in 166 pre-school children with multiple-trigger wheezing, recruited during an acute wheezing episode.. The percentage of symptom-free days (SFDs) was significantly higher in the BDP group (54.7%) than in the placebo group (40.5%; p = 0.012), with a 35% relative difference. Day-by-day analysis showed that the percentage of SFDs was already higher in the BDP group after 2 days (7.4%), the difference reaching statistical significance at day 6 (12.3%; p = 0.035). Cough score was also reduced in the BDP group (0.11) as compared with the placebo group (0.39; p = 0.048), the difference reaching statistical significance after 5 days of treatment (0.18 and 0.47 respectively; p = 0.047). The mean number of nebulizations per day of prn salbutamol was lower in the BDP group as compared to the placebo group (0.26 and 0.34, respectively), but the difference was not significant (p = 0.366). There were no differences in positive effects of BDP treatment between children with and without risk factors for asthma.. A 1-week treatment with nebulized BDP and prn salbutamol is effective in increasing SFDs and improving cough in children with wheezing, providing a clinical rationale for the short term use of ICS in episodic wheeze exacerbations in pre-school children.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child, Preschool; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Infant; Male; Nebulizers and Vaporizers; Respiratory Sounds; Severity of Illness Index; Treatment Outcome

2011
Rapid effects of extrafine beclomethasone dipropionate/formoterol fixed combination inhaler on airway inflammation and bronchoconstriction in asthma: a randomised controlled trial.
    BMC pulmonary medicine, 2011, Dec-21, Volume: 11

    The dose-dependent anti-inflammatory effects of a recent fixed combination of extrafine beclomethasone dipropionate/formoterol (BDP/F) were investigated using non-invasive markers of inflammation, exhaled nitric oxide (NO) and adenosine monophosphate (AMP) provocative challenge. The aim was to assess the onset of the anti-inflammatory action of low and high doses and evaluate the suitability of non-invasive assessments to demonstrate dose response.. Steroid naïve adult out-patients with mild asthma, sensitive to AMP with baseline exhaled NO > 25 parts per billion entered a double-blind, placebo-controlled, 3-way, cross-over study. Patients were randomised to low dose (1 actuation) or high dose (4 actuations) extrafine BDP/F 100/6 μg, or placebo administered twice daily on Days 1 and 2 and once in the morning on Day 3 of each period. Exhaled NO was measured pre-dose on Day 1, then 2 and 4 hours post-administration on Day 3. The AMP challenge was performed 4 hours post-administration on Day 3 and forced expiratory volume in 1 second (FEV1, L) was measured from 0 to 4 hours post-dose on Day 1. Endpoints were NO at 2 and 4 hours, AMP challenge at 4 hours after the fifth dose on Day 3 and FEV1 area under the curve from 0 to 4 h post-dose on Day 1. Analysis of covariance was performed for NO and FEV1 and analysis of variance for AMP challenge.. Eighteen patients were randomised and completed the study. Exhaled NO was significantly lower for both doses of extrafine BDP/F versus placebo at 2 and 4 hours (high dose LS mean difference: -22.5 ppb, p < 0.0001 and -20.5 ppb, p < 0.0001; low dose: -14.1 ppb, p = 0.0006 and -12.1 ppb, p = 0.0043) with a significant dose response (p = 0.0342 and p = 0.0423). Likewise, AMP challenge revealed statistically significant differences between both doses of extrafine BDP/F and placebo (high dose LS mean difference: 4.8 mg/mL, p < 0.0001; low dose: 3.7 mg/mL, p < 0.0001), and a significant dose response (p = 0.0185). FEV1 was significantly improved versus placebo for both doses (high dose LS mean difference: 0.2 L, p = 0.0001; low dose: 0.2 L p = 0.0001), but without a significant dose response.. The fixed combination inhaler of extrafine BDP/F has early dose-dependent anti-inflammatory effects with a rapid onset of bronchodilatation in mild asthmatic patients.. ClinicalTrials.gov: NCT01343745.

    Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchoconstriction; Bronchodilator Agents; Cross-Over Studies; Double-Blind Method; Drug Combinations; Ethanolamines; Female; Forced Expiratory Volume; Formoterol Fumarate; Humans; Metered Dose Inhalers; Middle Aged; Treatment Outcome; Young Adult

2011
Childhood evaluation of salmeterol tolerance--a double-blind randomized controlled trial.
    Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2010, Volume: 21, Issue:2 Pt 1

    Long acting beta(2)-agonists (LABA) are widely used in children with asthma. Data from adults suggest that there is tachyphylaxis particularly to the bronchoprotective effects of LABA. There are no data in children. To determine whether LABA are subject to tachyphylaxis in school-aged children. Children were eligible for participation if they remained symptomatic on 400 microg of beclometasone dipropionate equivalent/day. Participants undertook a 4-wk run in period with open-label fluticasone 100 microg BD via Diskus. Children were then randomized to receive fluticasone 100 microg BD or salmeterol/fluticasone 50/100 microg BD via Diskus in a double-blind manner. Children underwent spirometry, cold air challenge and salbutamol reversibility testing at baseline, 4 and 8 wk. 37/42 children completed the study. There were significant improvements in basal FEV1 (% predicted) in the salmeterol/fluticasone group (n = 21) (+6.4% (95% CI: 2.4-10.5) p = 0.0033) but not in the fluticasone group (n = 16) [+1.2 (95% CI: -3.4 to 5.8) p = 0.5900]. There was a non-significant reduction in fall in FEV1 provoked by cold air in both groups. There was a significant lessening in the acute salbutamol response after 8 wk in the salmeterol/fluticasone group [-11.4% (95% CI: -17.6 to -5.2) p = 0.0010] but not in the fluticasone group [-1.6% (95% CI: -9.8 to 6.6) p = 0.6827]. Salmeterol/fluticasone therapy significantly improves basal FEV(1) in asthmatic children however, there is negligible additional bronchoprotection by week 4 of treatment and there is significant attenuation of salbutamol responsiveness when compared with fluticasone alone. Some of this reduction in salbutamol response may relate to the concurrent improvements in baseline lung function.

    Topics: Adrenergic beta-Agonists; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Female; Fluticasone; Forced Expiratory Volume; Humans; Male; Salmeterol Xinafoate; Tachyphylaxis; Treatment Outcome

2010
The effect of active and passive household cigarette smoke exposure on pregnant women with asthma.
    Chest, 2010, Volume: 137, Issue:3

    The article was designed to estimate the effect of active and passive household cigarette smoke exposure on asthma severity and obstetric and neonatal outcomes in pregnant women with asthma.. We used a secondary observational analysis of pregnant women with mild and moderate-severe asthma enrolled in a prospective observational cohort study of asthma in pregnancy and a randomized clinical trial (RCT) comparing inhaled beclomethasone and oral theophylline. A baseline questionnaire detailing smoking history and passive household smoke exposure was given to each patient. Smoking status was confirmed in the RCT using cotinine levels. Data on asthma severity and obstetric and neonatal outcomes were collected and analyzed with respect to self-reported tobacco smoke exposure. Kruskal-Wallis and Pearson chi(2) statistics were used to test for significance.. A total of 2,210 women were enrolled: 1,812 in the observational study and 398 in the RCT. Four hundred and eight (18%) women reported current active smoking. Of the nonsmokers, 790 (36%) women reported passive household smoke exposure. Active smoking was associated with more total symptomatic days (P < .001) and nights of sleep disturbance (P < .001). Among the newborns of active smokers, there was a greater risk of small for gestational age < 10th percentile (P < .001), and a lower mean birth weight (P < .001). There were no differences in symptom exacerbation or outcome between nonsmokers with and without passive household cigarette smoke exposure.. Among pregnant women with asthma, active but not passive smoking is associated with increased asthma symptoms and fetal growth abnormalities.

    Topics: Administration, Inhalation; Administration, Oral; Adult; Asthma; Beclomethasone; Disease Progression; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Infant, Newborn; Maternal Exposure; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Prospective Studies; Severity of Illness Index; Smoking; Surveys and Questionnaires; Theophylline; Tobacco Smoke Pollution; Young Adult

2010
Shared treatment decision making improves adherence and outcomes in poorly controlled asthma.
    American journal of respiratory and critical care medicine, 2010, Mar-15, Volume: 181, Issue:6

    Poor adherence to asthma controller medications results in poor treatment outcomes.. To compare controller medication adherence and clinical outcomes in 612 adults with poorly controlled asthma randomized to one of two different treatment decision-making models or to usual care.. In shared decision making (SDM), nonphysician clinicians and patients negotiated a treatment regimen that accommodated patient goals and preferences. In clinician decision making, treatment was prescribed without specifically eliciting patient goals/preferences. The otherwise identical intervention protocols both provided asthma education and involved two in-person and three brief phone encounters.. Refill adherence was measured using continuous medication acquisition (CMA) indices-the total days' supply acquired per year divided by 365 days. Cumulative controller medication dose was measured in beclomethasone canister equivalents. In follow-up Year 1, compared with usual care, SDM resulted in: significantly better controller adherence (CMA, 0.67 vs. 0.46; P < 0.0001) and long-acting beta-agonist adherence (CMA, 0.51 vs. 0.40; P = 0.0225); higher cumulative controller medication dose (canister equivalent, 10.9 vs. 5.2; P < 0.0001); significantly better clinical outcomes (asthma-related quality of life, health care use, rescue medication use, asthma control, and lung function). In Year 2, compared with usual care, SDM resulted in significantly lower rescue medication use, the sole clinical outcome available for that year. Compared with clinician decision making, SDM resulted in: significantly better controller adherence (CMA, 0.67 vs. 0.59; P = 0.03) and long-acting beta-agonist adherence (CMA, 0.51 vs. 0.41; P = 0.0143); higher cumulative controller dose (CMA, 10.9 vs. 9.1; P = 0.005); and quantitatively, but not significantly, better outcomes on all clinical measures.. Negotiating patients' treatment decisions significantly improves adherence to asthma pharmacotherapy and clinical outcomes. Clinical trials registered with www.clinicaltrials.gov (NCT00217945 and NCT00149526).

    Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Cromolyn Sodium; Decision Making; Female; Follow-Up Studies; Humans; Male; Middle Aged; Patient Compliance; Patient Education as Topic; Patient Participation; Patient Satisfaction; Physician-Patient Relations; Quality of Life; Respiratory Function Tests; Surveys and Questionnaires; Theophylline; Treatment Outcome

2010
Lung deposition of BDP/formoterol HFA pMDI in healthy volunteers, asthmatic, and COPD patients.
    Journal of aerosol medicine and pulmonary drug delivery, 2010, Volume: 23, Issue:3

    When inhaling medication, it is essential that drug particles are delivered to all sites of lung inflammation, including the peripheral airways. The aim of this study was to assess the lung deposition and lung distribution of beclomethasone dipropionate (BDP)/formoterol (100/6 microg), both dissolved in hydrofluoroalkane (HFA) and delivered by pressurized metered dose inhaler (pMDI) in healthy subjects, asthmatic, and chronic obstructive pulmonary disease (COPD) patients, to investigate how the in vitro characteristics of the formulation translate into the in vivo performance in diseases with different airway obstruction.. Healthy volunteers (n = 8), persistent asthmatics (n = 8), and patients with stable COPD (n = 8) completed this open-label, single-dose parallel-group study. Each patient received one single treatment of four puffs of (99 m)Tc-labeled BDP/formoterol formulation. The correlation between particle size distribution of radioactivity and of the drugs in the radiolabeled formulation was validated. Intra- and extrapulmonary deposition, amount of exhaled drug, and the central to peripheral ratio (C/P) were calculated immediately after inhalation. Patients' lung function and pharmacokinetic parameters were also assessed up to 24 h post-dose.. The average lung deposition of BDP/formoterol was 34.08 +/- 9.30% (relative to nominal dose) in healthy subjects, 30.86 +/- 8.89% in asthmatics, and 33.10 +/- 8.90% in COPD patients. Extrathoracic deposition was 53.48% +/- 8.95, 57.64% +/- 9.92 and 54.98% +/- 7.01, respectively. C/P ratios of 1.42 +/- 0.32 in healthy subjects, 1.96 +/- 0.43 in asthmatics, and 1.94 +/- 0.69 for COPD patients confirmed drug distribution to all regions of the lungs. Forced expiratory volume in 1 sec (FEV(1)) increased in all groups after BDP/formoterol inhalation, but was more evident in the patient groups. No significant correlation between baseline lung function and drug deposition was observed. Formoterol, BDP, and beclomethasone 17 monopropionate (B17MP) plasma profiles were comparable between groups.. Inhalation of BDP/formoterol HFA (100/6 microg) produces high and homogeneous deposition of BDP and formoterol in the airways, regardless of pathophysiological condition.

    Topics: Administration, Inhalation; Adult; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Case-Control Studies; Drug Combinations; Ethanolamines; Female; Forced Expiratory Volume; Formoterol Fumarate; Humans; Lung; Male; Metered Dose Inhalers; Middle Aged; Particle Size; Pulmonary Disease, Chronic Obstructive; Respiratory Function Tests; Tissue Distribution

2010
Effects of extra-fine inhaled beclomethasone/formoterol on both large and small airways in asthma.
    Allergy, 2010, Volume: 65, Issue:7

    Airway inflammation in asthma involves both large and small airways, and the combination of inhaled corticosteroids (ICS) and long acting beta-2 agonists (LABA) is the mainstay of therapy. Available inhaled combinations differ in terms of drug delivery to the lung and the ability to reach small airways.. To evaluate whether treatment with an extra-fine inhaled combination provides additional effects vs a nonextra-fine combination on airway function.. After a 1- to 4-week run-in period, patients with asthma were randomized to a double blind, double dummy, 12-week treatment with either extra-fine beclomethasone/formoterol (BDP/F) 400/24 microg daily or fluticasone propionate/salmeterol (FP/S) 500/100 microg daily. Methacholine (Mch) bronchoprovocation challenge and single breath nitrogen (sbN2) test were performed.. Thirty patients with asthma (15 men), mean age 43, mean forced expiratory volume in the first second (FEV(1)) 71.4% of predicted, were included. A significant increase (P < 0.01) versus baseline was observed in predose FEV(1) in both BDP/F and FP/S groups (0.37 +/- 0.13 l and 0.36 +/- 0.12 l, respectively). PD(20)FEV(1) Mch improved significantly from 90.42 (+/-30.08) microg to 432.41 (+/-122.71) microg in the BDP/F group (P = 0.01) but not in the FP/S group. A trend toward improvement vs baseline was observed for BDP/F in closing capacity (CC), whereas no differences were recorded in other sbN(2) test parameters.. The findings of this pilot study suggest that an extra-fine inhaled combination for the treatment of asthma has beneficial effects on both large and small airways function as expressed by Mch and sbN(2) tests.

    Topics: Administration, Inhalation; Adult; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchi; Bronchioles; Chemistry, Pharmaceutical; Double-Blind Method; Drug Combinations; Ethanolamines; Female; Fluticasone-Salmeterol Drug Combination; Forced Expiratory Volume; Formoterol Fumarate; Humans; Male; Metered Dose Inhalers; Pilot Projects; Respiratory Function Tests

2010
Economic evaluation of BDP/formoterol fixed vs two single inhalers in asthma treatment.
    Allergy, 2010, Volume: 65, Issue:9

    Asthma treatment costs are substantial, the largest proportion being incurred by medications. Combination therapy with inhaled corticosteroids (ICS) and long-acting beta(2)-agonists (LABA) is recommended in patients not adequately controlled by ICS alone. Aim of this study was to compare costs and health outcomes of a fixed ICS-LABA combination of beclomethasone dipropionate (BDP) and formoterol fumarate (FF) vs the same drugs delivered via separate inhalers in Germany.. A cost-minimization analysis, a cost-effectiveness analysis, as well as a threshold analysis were undertaken. Efficacy results were obtained from a recent clinical trial. Cost inputs include medical costs, physician costs, and hospital admission costs. Medical costs, health outcomes, and treatment costs were also varied to assess their impact on results.. Beclomethasone dipropionate/FF fixed combination was less costly compared to BDP + FF delivered as separate inhalers, costs totaling euro 525 and euro 637, respectively, over a 24-week treatment period. The incremental cost-effectiveness ratio was euro-9.77 per additional day free of asthma symptoms. Equal cost-effectiveness ratios would still be obtained at a price of the fixed combination increased by 3.4-fold.. A cost-minimization analysis as well as a cost-effectiveness analysis for Germany based on different product price calculations show that BDP/FF fixed combination is superior to BDP + FF delivered via separate inhalers.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cost-Benefit Analysis; Drug Combinations; Ethanolamines; Female; Formoterol Fumarate; Germany; Health Care Costs; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Treatment Outcome; Young Adult

2010
Effects of beclomethasone and factors related to asthma on the growth of prepubertal children.
    Respiratory medicine, 2010, Volume: 104, Issue:7

    Few studies on the concomitant effects of beclomethasone dipropionate and asthma-related factors on the growth of prepubertal asthmatic children have been published to date. In this prospective long-term 'real-life' cohort study we recruited 82 prepubertal steroid-naïve asthmatic patients aged 3 + years, excluding those with birth weight lower than 2500 g, malnutrition, and other concurrent chronic diseases. Height/age and weight/age Z scores were calculated every three months. Random effects multivariate longitudinal data analysis was used to adjust height/age and weight/age Z scores with independent variables. Among the studied patients, 63.4% were male, aged 4.7 + or - 1.5 years, 68.3% suffered from severe persistent asthma and had normal values for height/age and weight/age Z scores at enrolment. They were followed for 5.2 years (range 2.3-6.1) and used a mean daily beclomethasone dipropionate dose of 351.8 mcg (range 137.3-1140.0). Height/age and weight/age Z scores were not affected by either duration of treatment or doses of beclomethasone dipropionate up to 500 mcg, 750 mcg and higher than 750 mcg (p-values > 0.17). The multivariate analysis final model showed that severe persistent asthma was associated to lower height for age Z score (p = 0.04), whereas hospitalizations because of acute asthma (before and during follow-up) were associated (p = 0.02) to lower weight for age Z score. Growth parameters were not affected by the use of beclomethasone dipropionate.

    Topics: Administration, Inhalation; Anthropometry; Anti-Asthmatic Agents; Asthma; Beclomethasone; Brazil; Child; Child, Preschool; Female; Follow-Up Studies; Growth; Humans; Male; Multivariate Analysis; Prospective Studies; Time Factors

2010
Beclomethasone dipropionate blunts allergen-induced early increase in urinary LTE4.
    European journal of clinical investigation, 2010, Volume: 40, Issue:6

    The inhibitory effect of corticosteroids (CS) on the secretions of cysteinyl-leukotrienes (Cys-LTs) in asthma is controversial. The aim of this study was to evaluate the effect of CS on allergen-induced increase in urinary leukotriene E4 (uLTE4) during early (EAR) and late (LAR) asthmatic responses in mild untreated asthmatics.. Nine subjects with mild untreated allergic asthma performed two allergen challenges, after 1-week treatment with beclomethasone dipropionate (BDP, 500 microg b.i.d) or placebo. Forced Expiratory Volume in one second 1 (FEV1) was monitored to assess EAR and LAR, and uLTE4 was measured before and during EAR and LAR.. After placebo, uLTE4 increased significantly during EAR, but not during and after LAR, in comparison with baseline values. Beclomethasone dipropionate induced a significant attenuation of the uLTE4 increase during EAR, in comparison with placebo, in association with a good protection of LAR (P = 0.002) and a mild protection of EAR (P = 0.07).. Beclomethasone dipropionate blunts the early increase in uLTE4 excretion due to allergen challenge, in association with a significant effect on the severity of LAR. These data support the hypothesis that inhaled CS may inhibit the allergen-induced release of cys-LTs in asthma.

    Topics: Administration, Inhalation; Adult; Allergens; Asthma; Beclomethasone; Chromatography, High Pressure Liquid; Cross-Over Studies; Double-Blind Method; Female; Glucocorticoids; Humans; Leukotriene E4; Male; Spirometry; Time Factors; Young Adult

2010
Acute additive effect of montelukast and beclomethasone on AMP induced bronchoconstriction.
    Respiratory medicine, 2010, Volume: 104, Issue:10

    Bronchial hyperresponsiveness to 5-adenosine mono-phosphate (AMP) is a marker of airway inflammation. Inhaled corticosteroids and antileukotrienes are used as anti-inflammatory drugs for the treatment of asthma. To find out if these two drugs exert their protection in an additive fashion, we compared the effects of acute treatment with inhaled beclomethasone (BDP) and montelukast (ML), alone or in combination, on methacholine and AMP induced bronchoconstriction. 15 asthmatic patients undertook methacholine and AMP challenges at baseline and after receiving ML or BDP, alone or in combination, in a randomized, double-blind, double-dummy placebo-controlled, crossover design. BDP pretreatment significantly increased the AMP PC(20) value (68.34+/-15.9mg/mL) as compared to placebo (22.87+/-5.7mg/mL). Combined treatment, BDP plus ML, afforded a further significant increase of AMP PC(20) (154.57+/-55.0mg/mL) as compared to each single treatment. The significant protection exerted by combined treatment as compared to each single active treatment was also demonstrated by the change of AMP PC(20) doubling dose as compared to placebo and each single active treatment. Our findings suggest that these two agents exert their acute additive protection against AMP induced bronchoconstriction acting on distinct inflammatory pathways and their combined use might provide greater protection against inflammatory response elicited by AMP than either drug alone.

    Topics: Acetates; Administration, Inhalation; Adolescent; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Bronchoconstriction; Cross-Over Studies; Cyclopropanes; Double-Blind Method; Drug Synergism; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Male; Quinolines; Sulfides; Treatment Outcome; Young Adult

2010
Validity of measurement of two specific biomarkers for the assessment of small airways inflammation in asthma.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2010, Volume: 47, Issue:4

    Small airways inflammation in asthma has been supposed to contribute to instability of the disease and therapy resistance. This study was designed to determine the validity of measurement of N(epsilon)-(carboxymethyl)lysine (CML) levels in induced sputum and alveolar concentrations of nitric oxide (NO) for the assessment of small airways inflammation in asthma.. The authors measured CML levels in induced sputum and the bronchial flux (Jno) and alveolar concentration (C(alv)) of NO in 37 asthmatic patients and 15 normal controls. After initial analysis, all asthmatics were randomly assigned to receive inhaled fluticasone propionate (FP; 400 microg/day, n = 21) or hydrofluoroalkane-beclomethasone dipropionate (HFA-BDP; 400 microg/day, n = 16) for 12 weeks. And then the determination of exhaled NO level and sputum induction was performed after the treatment period.. CML levels in induced sputum were significantly higher in asthmatics than in normal controls (median [interquartile range], asthmatics: 53.0 [44.8-64.3] microg/ml, normal controls: 22.0 [14.8-28.3] microg/ml; p < .01). Similarly, Jno and C(alv) were also higher in asthmatics. Moreover, CML level was closely correlated with C(alv) but not with Jno in asthmatics (r = .47, p = .005). Jno was significantly correlated with forced expiratory volume in one second/forced vital capacity (FEV(1)/FVC), and CML level and C(alv) were correlated with forced expiratory flow between 25% and 75% of FVC (FEF(25-75)), an index of small airways obstruction. After FP treatment, the decrease in CML level and Calv were very small. In contrast, these levels were markedly decreased after HFA-BDP treatment. Moreover, even after FP or HFA-BDP treatment, CML level was significantly correlated with C(alv).. This novel, noninvasive technique of measurement of CML levels in induced sputum and C(alv) may prove to be important not only in the evaluation of small airways inflammation but also in helping us move toward a better understanding of the roles of the small airways in the pathogenesis of asthma.

    Topics: Adult; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biomarkers; Bronchi; Female; Fluticasone; Humans; Inflammation; Lysine; Male; Middle Aged; Nitric Oxide; Pulmonary Alveoli; Reproducibility of Results; Sputum

2010
A pediatric asthma management program in a low-income setting resulting in reduced use of health service for acute asthma.
    Allergy, 2010, Volume: 65, Issue:11

    The effectiveness of pediatric asthma management programs in reducing health services utilization during exacerbations in developing countries is not widely studied. This study was carried out to assess the effectiveness of an asthma management program to reduce the overall health services utilization by acute asthma in children and adolescents.. In this historical population-based real-life cohort study, we selected 582 patients with asthma aged 4-15 living in deprived areas in the town of Itabira, Brazil, of which 470 cases were assisted by the asthma management program and 112 were controls. The end point was the first physician-diagnosed asthma exacerbation occurring after study enrollment and within 12 months after admission. All 470 cases received a written plan about exacerbation self-management, including the use of inhaled albuterol at home. Three hundred and seventeen out of 470 cases (67.4%) were also treated with beclomethasone diproprionate (BDP).. Both groups were comparable regarding gender, age group, and place of residence. At the end of the study, only 5% of cases vs 34% of controls did seek health services because of acute asthma (P < 0.01). Statistical difference also remained when comparing the 112 controls with the 153 cases not treated with com BDP (Hazard Ratio = 0.04, 95% CI, 0.01-0.14, P < 0.01).. Results have demonstrated the effectiveness of the pediatric asthma management program in reducing dependence on the health services for acute asthma. Effectiveness was also observed in subjects with no use of BDP.

    Topics: Acute Disease; Adolescent; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Brazil; Child; Child, Preschool; Cohort Studies; Female; Health Services; Humans; Male; Patient Education as Topic; Poverty; Self Care

2010
Tiotropium bromide step-up therapy for adults with uncontrolled asthma.
    The New England journal of medicine, 2010, Oct-28, Volume: 363, Issue:18

    Long-acting beta-agonist (LABA) therapy improves symptoms in patients whose asthma is poorly controlled by an inhaled glucocorticoid alone. Alternative treatments for adults with uncontrolled asthma are needed.. In a three-way, double-blind, triple-dummy crossover trial involving 210 patients with asthma, we evaluated the addition of tiotropium bromide (a long-acting anticholinergic agent approved for the treatment of chronic obstructive pulmonary disease but not asthma) to an inhaled glucocorticoid, as compared with a doubling of the dose of the inhaled glucocorticoid (primary superiority comparison) or the addition of the LABA salmeterol (secondary noninferiority comparison).. The use of tiotropium resulted in a superior primary outcome, as compared with a doubling of the dose of an inhaled glucocorticoid, as assessed by measuring the morning peak expiratory flow (PEF), with a mean difference of 25.8 liters per minute (P<0.001) and superiority in most secondary outcomes, including evening PEF, with a difference of 35.3 liters per minute (P<0.001); the proportion of asthma-control days, with a difference of 0.079 (P=0.01); the forced expiratory volume in 1 second (FEV1) before bronchodilation, with a difference of 0.10 liters (P=0.004); and daily symptom scores, with a difference of -0.11 points (P<0.001). The addition of tiotropium was also noninferior to the addition of salmeterol for all assessed outcomes and increased the prebronchodilator FEV1 more than did salmeterol, with a difference of 0.11 liters (P=0.003).. When added to an inhaled glucocorticoid, tiotropium improved symptoms and lung function in patients with inadequately controlled asthma. Its effects appeared to be equivalent to those with the addition of salmeterol. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT00565266.).

    Topics: Administration, Inhalation; Adult; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Cholinergic Antagonists; Cross-Over Studies; Double-Blind Method; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Peak Expiratory Flow Rate; Salmeterol Xinafoate; Scopolamine Derivatives; Tiotropium Bromide

2010
[Efficacy and safety of a beta2-agonist-combination in patients with bronchial asthma--a clinical practice surveillance study].
    MMW Fortschritte der Medizin, 2010, Jan-14, Volume: 151 Suppl 4

    Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Antagonists; Adult; Aged; Airway Obstruction; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Administration Schedule; Drug Combinations; Ethanolamines; Female; Formoterol Fumarate; Germany; Humans; Lung Volume Measurements; Male; Metered Dose Inhalers; Middle Aged

2010
[Cost effectiveness of BDP/formoterol fixed vs. two single inhalers in the treatment of bronchial asthma].
    MMW Fortschritte der Medizin, 2010, Oct-14, Volume: 152 Suppl 3

    Topics: Adolescent; Adrenergic beta-2 Receptor Agonists; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cost Savings; Delayed-Action Preparations; Double-Blind Method; Drug Combinations; Drug Costs; Ethanolamines; Female; Formoterol Fumarate; Germany; Humans; Male; Metered Dose Inhalers; Middle Aged; National Health Programs; Young Adult

2010
Factors related to lower adherence rates to inhaled corticosteroids in children and adolescents: a prospective randomized cohort study.
    Journal of tropical pediatrics, 2009, Volume: 55, Issue:1

    Asthma morbidity is high, partly due to low adherence to inhaled corticosteroids (ICS). This study aims to assess rates and factors related to low adherence to ICS over time in asthmatic children and adolescents.. A concurrent cohort study was carried out for 24 months in 168 randomly selected patients suffering from persistent moderate asthma. All of them were given beclomethasone dipropionate (BDP) free of charge. Adherence rates were verified by pharmacy records (doses filled/doses prescribed). A multivariate analysis evaluated factors related with low adherence rates.. Overall adherence rates were 72.5, 58.6 and 61.1% in the 4th, 12th and 24th months of follow-up, respectively. Factors associated to adherence rates <70% were: mother's schooling level (p = 0.03), replacement of the caregiver (p = 0.03), prescription greater than two puffs/day (p = 0.005), absence of rhinosinusitis (p = 0.002) and age under 7 years (p = 0.04). Only the number of consultations lower than two in a 4-month period was associated to a lower adherence rate in all study periods (p = 0.02).. Adherence rates decreased over time, even in patients who had received the medication free of charge, and factors related to lower adherence changed during the follow-up. Results have shown that adherence had a dynamic pattern and its determinants should be re-evaluated continuously. Only the number of consultations was associated to a lower adherence rate in all periods, pointing out that health programs must recognize and facilitate the access of patients needing special care, which can contribute for better adherence and reducing asthma morbidity.

    Topics: Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Asthma; Beclomethasone; Brazil; Child; Child, Preschool; Female; Glucocorticoids; Humans; Infant; Male; Medication Adherence; Multivariate Analysis; Prospective Studies; Treatment Outcome

2009
Lung function and asthma control with beclomethasone and formoterol in a single inhaler.
    Respiratory medicine, 2009, Volume: 103, Issue:1

    Lung deposition is crucial for asthma treatment. However, there is no study comparing the potential role of lung co-deposition of combination therapy (inhaled corticosteroid and long-acting beta2 agonist) in the same inhaler. In moderate to severe asthmatics, an extra-fine hydrofluoroalkane combination of beclomethasone dipropionate and formoterol given via a single pressurised metered-dose inhaler (pMDI) was compared with beclomethasone dipropionate chlorofluorocarbon (CFC) pMDI and formoterol dry powder inhaler (DPI) given via separate inhalers.. In a double-blind, double-dummy, 24-week randomised clinical trial, 645 patients with moderate to severe asthma uncontrolled by regular treatment with inhaled corticosteroids received regular treatment with extra-fine fixed combination beclomethasone dipropionate 200 microg/formoterol 12 microg bid, or beclomethasone dipropionate (500 microg bid) via CFC pMDI and formoterol (12 microg bid) via DPI, or beclomethasone dipropionate (500 microg bid) via CFC pMDI. The primary outcome was morning peak expiratory flow (PEF). Secondary outcomes included lung function measured at clinic, asthma symptoms and control, exacerbations.. Beclomethasone dipropionate/formoterol combination via single inhaler or via separate inhalers improved morning PEF. However, the combination via single inhaler was more effective than given via separate inhalers for asthma control. Both combination treatments were superior to beclomethasone dipropionate alone in improving lung function and asthma control. All treatments were well tolerated.. In patients with moderate to severe asthma, beclomethasone dipropionate/formoterol in a single inhaler was as effective as beclomethasone dipropionate plus formoterol and superior to beclomethasone dipropionate alone in improving lung function. For the first time with a single inhaler, beclomethasone dipropionate/formoterol was significantly superior to separate components for asthma control.

    Topics: Administration, Inhalation; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Ethanolamines; Female; Formoterol Fumarate; Humans; Hydrocortisone; Male; Metered Dose Inhalers; Middle Aged; Peak Expiratory Flow Rate; Treatment Outcome

2009
Effect of low-dose theophylline plus beclometasone on lung function in smokers with asthma: a pilot study.
    The European respiratory journal, 2009, Volume: 33, Issue:5

    Smoking is common in asthma and is associated with worse asthma control and a reduced therapeutic response to corticosteroids. The present authors hypothesised that treating smokers with asthma with low-dose theophylline added to inhaled corticosteroids would enhance steroid sensitivity and thereby improve lung function and symptoms. In a double-blind, parallel group exploratory trial, 68 asthmatic smokers were randomised to one of three treatments for 4 weeks: inhaled beclometasone (200 microg day(-1)), theophylline (400 mg day(-1)) or both treatments combined. Outcome measures included change in lung function and Asthma Control Questionnaire (ACQ) scores. At 4 weeks, theophylline added to inhaled beclometasone produced an improvement in peak expiratory flow (39.9 L min(-1), 95% confidence intervals (CI) 10.9-68.8) and ACQ score (-0.47, 95% CI -0.91- -0.04) and a borderline improvement in pre-bronchodilator forced expiratory volume in one second (mean difference 165 mL, 95% CI -13-342) relative to inhaled corticosteroid alone. Theophylline alone improved the ACQ score (-0.55, 95% CI -0.99- -0.11), but not lung function. In the present pilot study, the combination of low-dose theophylline and inhaled beclometasone produced improvements in both lung function and symptoms in a group of smokers with asthma. Larger trials are required to extend and confirm these findings.

    Topics: Administration, Inhalation; Administration, Oral; Adolescent; Adult; Analysis of Variance; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Pilot Projects; Prospective Studies; Respiratory Function Tests; Smoking; Statistics, Nonparametric; Theophylline; Treatment Outcome

2009
Increased levels of angiopoietin-2 in induced sputum from smoking asthmatic patients.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2009, Volume: 39, Issue:9

    Active cigarette smoking has detrimental effects on asthma morbidity and severity. Angiopoietin-1 has been shown to protect the microvessels against plasma leakage, whereas angiopoietin-2 enhances vascular permeability and subsequently induces airway mucosal oedema. Therefore, it is recently thought that angiopoietin-2 may contribute to the pathophysiology of asthma.. To determine whether angiopoietin-2 levels in the airways are associated with clinical profiles in smoking asthmatics.. We measured angiopoietin-1 and -2 levels in induced sputum in 35 normal controls (18 non-smokers and 17 smokers) and 49 asthmatics (24 non-smokers and 25 smokers) before and after inhaled beclomethasone dipropionate (BDP: 800 microg/day) therapy for 12 weeks.. Angiopoietin-1 and -2 levels in induced sputum were significantly higher in asthmatics than in normal controls. Moreover, angiopoietin-2 levels were significantly higher in smoking asthmatics than in non-smoking asthmatics (P=0.0001). The airway vascular permeability index was also higher in smoking asthmatics than in non-smoking asthmatics. Moreover, the angiopoietin-2 level was positively correlated with the airway vascular permeability index (non-smoking asthmatics: r=0.87, P<0.001, smoking asthmatics: r=0.64, P=0.002). After BDP therapy, angiopoietin-1 levels were significantly decreased in non-smoking asthmatics, smoking-cessation asthmatics, and active-smoking asthmatics. In contrast, angiopoietin-2 levels did not differ from before to after BDP therapy in non-smoking asthmatics and active-smoking asthmatics. However, its levels were significantly decreased from before to after BDP therapy in smoking-cessation asthmatics (P=0.002). Although forced expiratory volume in 1 s (FEV(1))/forced vital capacity (FVC) before BDP therapy was comparable in all subgroups, this parameter after BDP therapy was significantly lower in active-smoking asthmatics than in non-smoking and smoking-cessation asthmatics. Moreover, the reduction in angiopoietin-2 levels after BDP therapy in smoking-cessation asthmatics was significantly correlated with an improvement in FEV(1)/FVC.. Angiopoietin-2 levels were elevated in the airways of smoking asthmatics, and its levels were associated with impaired airway responses.

    Topics: Adult; Angiopoietin-1; Angiopoietin-2; Anti-Asthmatic Agents; Asthma; Beclomethasone; Capillary Permeability; Edema; Female; Forced Expiratory Volume; Humans; Male; Respiratory Mucosa; Smoking; Smoking Cessation; Sputum

2009
The usefulness of inspiratory flow rate during inhalation corticosteroid therapy in asthma.
    Respiration; international review of thoracic diseases, 2009, Volume: 78, Issue:4

    The recently released handheld In-Check device can be used to measure the peak inspiratory flow rate (PIF) of patients and is reportedly useful in determining whether the PIF is sufficient for using inhaler devices. In this study, we evaluated the effects of instructions for the use of the device and of the device type based on measurements of the PIF in asthma.. One hundred and thirty-five asthmatic patients who used a fluticasone propionate Diskus (FP-DK) or a budesonide Turbuhaler (BUD-TH) were studied.. The PIF was measured by the In-Check device. For patients without a sufficient PIF of 50 l/min, instructions for the use of the device were given, and the device was changed to hydrofluoroalkan-beclomethasone dipropionate (HFA-BDP).. A significant correlation between the PIF and peak expiratory flow rate (p < 0.0001) was found. In 10 patients in whom the PIF did not increase to >50 l/min after instructions, the device was changed to HFA-BDP, which resulted in significant improvements in lung function in terms of the forced expiratory volume in 1 s (p = 0.018), peak expiratory flow (p = 0.038) and the maximum expiratory flow rates at 50% (p = 0.018) and 25% (p = 0.011).. Measurement of the PIF by the In-Check device is useful in the clinical management of asthma, to provide an appropriate device so as to improve lung function.

    Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Androstadienes; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Female; Fluticasone; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Inhalation; Male; Middle Aged; Respiratory Function Tests

2009
Effect of inhaled corticosteroids on small airways in asthma: investigation using impulse oscillometry.
    Pulmonary pharmacology & therapeutics, 2009, Volume: 22, Issue:4

    Small airways appear to have an important role in asthma. Hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) has ultrafine particles and accordingly greater deposition in the small airways than chlorofluorocarbon (CFC)-BDP. Impulse oscillometry systems (IOS), a new and non-invasive measure of pulmonary function, can examine the resistance of total (R5), large (R20), and small airways (R5-R20) separately, and low-frequency reactance area (AX), also considered a measure of small airways dysfunction.. Mild-to-moderate asthmatics who were inhaled corticosteroid naïve were randomized to receive 200 mcg HFA-BDP bid (n 1/4 26) or 400 mcg CFC-BDP bid (n 1/4 12) for 12 weeks in an open-label manner. Following baseline measurements, IOS and spirometry were repeated every 4 weeks, and methacholine challenge to separately assess airway sensitivity and airway reactivity and lung volumes at 12 weeks.. Moderate correlations were found between R5-R20 or AX and spirometry and lung volume indices of small airways, and between R20 and peak expiratory flow at baseline. The two groups did not significantly differ in baseline clinical or functional parameters. At 12 weeks, all IOS indices improved in the HFA-BDP group, whereas all but R5-R20 improved with CFC-BDP. R5-R20 and AX progressively improved with HFA-BDP; these changes achieved statistical significance at 12 weeks versus the CFC-BDP group. Other IOS and spirometry indices failed to show such trends. HFA-BDP significantly attenuated methacholine airway sensitivity; the degree of this attenuation strongly correlated with R5-R20 and AX baseline values, and with improvement of AX with treatment.. HFA-BDP is an effective treatment of small airways in asthma. Prolonged treatment provides a progressive effect over time, which is associated with an attenuation of airway responsiveness.

    Topics: Adrenal Cortex Hormones; Adult; Airway Resistance; Asthma; Beclomethasone; Chlorofluorocarbons; Double-Blind Method; Female; Humans; Hydrocarbons, Fluorinated; Lung Volume Measurements; Male; Methacholine Chloride; Middle Aged; Muscarinic Agonists; Nebulizers and Vaporizers; Oscillometry; Respiratory Function Tests; Respiratory System; Spirometry

2009
A randomized study comparing the effect of loratadine added to montelukast with montelukast, loratadine, and beclomethasone monotherapies in patients with chronic asthma.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2009, Volume: 46, Issue:5

    Loratadine added to montelukast has been suggested to improve endpoints of asthma.. This study investigated the additive effects of concomitant montelukast and loratadine when compared with montelukast, loratadine, and inhaled beclomethasone monotherapies in asthma. Methods. Patients (N = 406) were 15 to 65 years of age with a forced expiratory volume in 1 second (FEV(1))-predicted of 50% to 85%, FEV(1) reversibility > or = 15%, and a minimal level of daytime symptoms and beta -agonist use. This three-part 2X2 crossover-study consisted of two double-blind 6-week treatment periods where patients were administered once daily oral montelukast 10 mg, loratadine 10 mg, montelukast 10 mg + loratadine 10 mg, or twice daily inhaled beclomethasone 200 mu g. A subsequent 48-week extension study compared montelukast + loratadine with beclomethasone. The primary endpoint was the percentage change from baseline in FEV(1).. Over 6 weeks of double-blind treatment, significant improvements (p < 0.05) in the primary endpoint of FEV(1) were seen for montelukast + loratadine versus loratadine (least-square mean percentage-point difference of 5.8%), beclomethasone versus montelukast + loratadine (2.35%), montelukast versus loratadine (5.94%), and beclomethasone versus montelukast (4.65%); a numerical improvement (p = 0.054) was seen for montelukast + loratadine versus montelukast (1.60%). Significant improvements for montelukast + loratadine versus montelukast were seen in some secondary endpoints (evening peak expiratory flow, nocturnal asthma symptom score, nocturnal awakenings, and asthma-specific quality of life) but not others. Significant improvements in most endpoints except daytime asthma symptoms score were seen for montelukast + loratadine versus loratadine. In the extension study, both montelukast + loratadine and beclomethasone improved several endpoints. All treatments were generally comparable in the percentage of patients with clinical and laboratory adverse experiences.. In this study, the addition of loratadine to montelukast produced a small numerical, but not statistically significant, improvement in FEV(1) and, in general, no consistent improvement in other asthma endpoints. No improvement of montelukast + loratadine versus beclomethasone was seen in any endpoint.

    Topics: Acetates; Adolescent; Adult; Aged; Anti-Allergic Agents; Asthma; Beclomethasone; Chronic Disease; Cross-Over Studies; Cyclopropanes; Double-Blind Method; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Loratadine; Male; Middle Aged; Quality of Life; Quinolines; Sulfides; Young Adult

2009
Quadrupling the dose of inhaled corticosteroid to prevent asthma exacerbations: a randomized, double-blind, placebo-controlled, parallel-group clinical trial.
    American journal of respiratory and critical care medicine, 2009, Oct-01, Volume: 180, Issue:7

    Asthma exacerbations are unpredictable, disruptive, and frightening, and are therefore important to prevent.. We investigated whether a policy of quadrupling the dose of inhaled corticosteroid when asthma control starts to deteriorate reduces asthma exacerbations requiring treatment with oral corticosteroids.. A total of 403 people with asthma were given a self-management plan and randomized to take an active or placebo corticosteroid inhaler in addition to their usual asthma treatment when their PEF fell by 15% on 2 consecutive days or by 30% on 1 day. The study inhalers provided a quadrupling or no change in corticosteroid dose.. Eighteen of 197 (9%) and 29 of 203 (14%) participants had an exacerbation of asthma requiring treatment with oral corticosteroids in the active and placebo groups, respectively, giving a risk ratio of 0.64 (95% confidence interval, 0.37-1.11, P = 0.11). Of the 94 participants who started the study inhaler far fewer required treatment with oral corticosteroids in the active compared with the placebo group: 12 of 56 (21%) in the active group and 19 of 38 (50%) in the placebo group, giving a risk ratio of 0.43 (95% confidence interval, 0.24-0.78, P = 0.004).. Although our primary outcome did not reach statistical significance, quadrupling the dose of inhaled corticosteroid when asthma control starts to deteriorate appears to reduce acute exacerbations of asthma and deserves further investigation. Clinical trial registered with www.controlled-trials.com (ISRCTN 46018181).

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Metered Dose Inhalers; Middle Aged; Respiratory Function Tests; Treatment Outcome

2009
Long-term safety of mometasone furoate administered via a dry powder inhaler in children: Results of an open-label study comparing mometasone furoate with beclomethasone dipropionate in children with persistent asthma.
    BMC pediatrics, 2009, Jul-13, Volume: 9

    To assess the long-term pediatric safety of 2 doses of mometasone furoate administered via a dry powder inhaler (MF-DPI) for mild-to-moderate persistent asthma and compare them with that of beclomethasone dipropionate administered via a metered dose inhaler (BDP-MDI) in the treatment of persistent asthma. Both MF-DPI doses tested are twice the approved pediatric dosage of 100 microg once-daily (QD) for children aged 4-11 years.. Children (N = 233) aged 4-11 years were randomized to 52 weeks of treatment with MF-DPI 200 microg QD AM, MF-DPI 100 microg twice daily (BID), or BDP-MDI 168 microg BID. Patients had used inhaled corticosteroids (ICSs) daily for > or = 30 days before the screening visit and were on stable ICS doses for > or = 2 weeks before screening. The primary safety variable was the incidence of adverse events. Secondary safety variables were laboratory tests (including cortisol concentrations), vital signs, and physical examination.. The incidence of adverse events was similar in all 3 treatment groups. The most frequently reported adverse event was upper respiratory tract infection, reported by 47%-49% of the MF-DPI-treated patients and 51% of the BPD-treated patients. Most adverse events were considered unrelated to study drug. The most frequently reported related adverse events were headache (MF-DPI 200 microg QD AM, 8%; MF-DPI 100 microg BID, 4%; BDP-MDI 168 microg BID, 2%) and oral candidiasis (4% in each treatment group). No clinically relevant changes in laboratory values, including plasma cortisol, vital signs, or physical examinations were noted in any treatment group.. Both MF-DPI doses were well tolerated, with no unusual or unexpected adverse events or safety concerns, and had a similar adverse event profile to that of BDP-MDI 168 microg BID.

    Topics: Administration, Inhalation; Anti-Allergic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Child, Preschool; Humans; Hydrocortisone; Mometasone Furoate; Nebulizers and Vaporizers; Powders; Pregnadienediols

2009
Regular vs prn nebulized treatment in wheeze preschool children.
    Allergy, 2009, Volume: 64, Issue:10

    International guidelines recommend regular treatment with inhaled glucocorticoids for children with frequent wheezing; however, prn inhaled bronchodilator alone or in combination with glucocorticoid is also often used in practice. We aimed to evaluate whether regular nebulized glucocorticoid plus a prn bronchodilator or a prn nebulized bronchodilator/glucocorticoid combination is more effective than prn bronchodilator alone in preschool children with frequent wheeze.. Double-blind, double-dummy, randomized, parallel-group trial. After a 2-week run-in period, 276 symptomatic children with frequent wheeze, aged 1-4 years, were randomly assigned to three groups for a 3-month nebulized treatment: (1) 400 microg beclomethasone bid plus 2500 microg salbutamol prn; (2) placebo bid plus 800 microg beclomethasone/1600 microg salbutamol combination prn; (3) placebo bid plus 2500 microg salbutamol prn. The percentage of symptom-free days was the primary outcome measure. Secondary outcomes included symptom scores, use of relief medication and exacerbation frequency.. As compared with prn salbutamol (61.0 +/- 24.83 [SD]), the percentage of symptom-free days was higher with regular beclomethasone (69.6%, SD 20.89; P = 0.034) but not with prn combination (64.9%, SD 24.74). Results were no different in children with or without risk factors for developing persistent asthma. The effect of prn combination was no different from that of regular beclomethasone on the primary and on several important secondary outcomes.. Regular inhaled glucocorticoid is the most effective treatment for frequent wheezing in preschool children. However, prn bronchodilator/glucocorticoid combination might be an alternative option, but it requires further study.

    Topics: Administration, Inhalation; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child, Preschool; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Infant; Male; Nebulizers and Vaporizers; Respiratory Sounds; Treatment Outcome

2009
Effect of beta2-adrenergic receptor polymorphism on response to longacting beta2 agonist in asthma (LARGE trial): a genotype-stratified, randomised, placebo-controlled, crossover trial.
    Lancet (London, England), 2009, Nov-21, Volume: 374, Issue:9703

    Some studies suggest that patients with asthma who are homozygous for arginine at the 16th amino acid position of the beta2-adrenergic receptor (B16 Arg/Arg) benefit less from treatment with longacting beta2 agonists and inhaled corticosteroids than do those homozygous for glycine (B16 Gly/Gly). We investigated whether there is a genotype-specific response to treatment with a longacting beta2 agonist in combination with inhaled corticosteroid.. In this multicentre, randomised, double-blind, placebo-controlled trial, adult patients with moderate asthma were enrolled in pairs matched for forced expiratory volume in 1 s and ethnic origin, according to whether they had the B16 Arg/Arg (n=42) or B16 Gly/Gly (n=45) genotype. Individuals in a matched pair were randomly assigned by computer-generated randomisation sequence to receive inhaled longacting beta2 agonist (salmeterol 50 microg twice a day) or placebo given in a double-blind, crossover design for two 18-week periods. Open-label inhaled corticosteroid (hydrofluoroalkane beclometasone 240 microg twice a day) was given to all participants during the treatment periods. The primary endpoint was morning peak expiratory flow (PEF). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00200967.. After 18 weeks of treatment, mean morning PEF in Arg/Arg participants was 21.4 L/min (95% CI 11.8-31.1) higher when participants were assigned to receive salmeterol than when assigned to receive placebo (p<0.0001). In Gly/Gly participants, morning PEF was 21.5 L/min (11.0-32.1) higher when participants were assigned to receive salmeterol than when assigned to receive placebo (p<0.0001). The improvement in PEF did not differ between genotypes (difference [Arg/Arg-Gly/Gly] -0.1, -14.4 to 14.2; p=0.99). In Gly/Gly participants, methacholine PC20 (20% reduction in forced expiratory volume in 1 s; a prespecified secondary outcome) was 2.4 times higher when participants were assigned to salmeterol than when assigned to placebo (p<0.0001). Responsiveness to methacholine did not differ between salmeterol and placebo in Arg/Arg participants (p=0.87). The 2.5 times higher genotype-specific difference in responsiveness to methacholine was significant (1.32 doubling dose difference between genotypes, 0.43-2.21, p=0.0038). Seven Arg/Arg participants (placebo, n=5; salmeterol, n=2) and six Gly/Gly participants (placebo, n=3; salmeterol, n=3) had an asthma exacerbation. Five serious adverse events were reported, one each during the pre-match and run-in phases on open-label inhaled corticosteroid, two during double-blind treatment with salmeterol/inhaled corticosteroid, and one during double-blind treatment with placebo/inhaled corticosteroid. None of the serious events was asthma-related or related to study drugs or procedures.. In asthma patients with B16 Arg/Arg and B16 Gly/Gly genotypes, combination treatment with salmeterol and inhaled corticosteroid improved airway function when compared with inhaled corticosteroid therapy alone. These findings suggest that patients should continue to be treated with longacting beta2 agonists plus moderate-dose inhaled corticosteroids irrespective of B16 genotype. Further investigation is needed to establish the importance of the genotype-specific difference in responsiveness to methacholine.. National Institutes of Health.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Albuterol; Asthma; Beclomethasone; Cross-Over Studies; Double-Blind Method; Female; Genotype; Glucocorticoids; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Polymorphism, Genetic; Receptors, Adrenergic, beta-2; Salmeterol Xinafoate; Treatment Outcome

2009
Comparison of the anti-inflammatory effects of extra-fine hydrofluoroalkane-beclomethasone vs fluticasone dry powder inhaler on exhaled inflammatory markers in childhood asthma.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2008, Volume: 100, Issue:6

    Extra-fine hydrofluoroalkane-beclomethasone differs from other inhaled corticosteroids by its fine aerosol characteristics. Therefore, extra-fine hydrofluoroalkane-beclomethasone may be particularly useful for treating peripheral airway inflammation in asthma.. To analyze the anti-inflammatory effects of extra-fine hydrofluoroalkane-beclomethasone vs fluticasone dry powder inhaler (DPI) in asthmatic children by measuring bronchial and alveolar nitric oxide (NO) and inflammatory markers in exhaled breath condensate (EBC).. In a 6-month crossover study, 33 children aged 6 to 12 years with moderate persistent asthma were randomly treated with extra-fine hydrofluoroalkane-beclomethasone (200 microg daily via an Autohaler) and fluticasone DPI (200 microg daily via a Diskus). The primary outcome variables were alveolar NO concentration and bronchial NO flux. The secondary outcome variables were levels of inflammatory markers in EBC, lung function indices, symptoms, exacerbations, and adverse effects. All the variables were recorded at baseline and after each treatment period.. Mean +/- SE alveolar NO concentration and bronchial NO flux were comparable after treatment with hydrofluoroalkane-beclomethasone vs fluticasone DPI (4.7 +/- 0.5 vs 4.3 +/- 0.5 ppb, P = .55, and 1,124.3 +/- 253.6 vs 1,029.1 +/- 195.5 pL/s, P = .70, respectively). In addition, levels of inflammatory markers in EBC, lung function indices, and symptoms did not differ between treatments. Patients used fewer beta2-agonists during the last 2 weeks of hydrofluoroalkane-beclomethasone treatment.. The anti-inflammatory effects of hydrofluoroalkane-beclomethasone are similar to those of fluticasone DPI in children with moderate persistent asthma.

    Topics: Administration, Inhalation; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biomarkers; Breath Tests; Child; Cross-Over Studies; Dinoprost; Female; Fluticasone; Forced Expiratory Volume; Humans; Hydrocarbons, Fluorinated; Hydrogen Peroxide; Inflammation; Interleukins; Male; Nitrates; Nitric Oxide; Nitrites; Prospective Studies; Treatment Outcome; Vital Capacity

2008
Intranasal corticosteroid administration reduces nonspecific bronchial hyperresponsiveness and improves asthma symptoms.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2008, Volume: 45, Issue:9

    Rhinitis and asthma are currently recognized as manifestations of a single syndrome, the chronic allergic respiratory syndrome. Nearly all individuals with asthma have rhinitis, and severe rhinitis has been associated with worse outcomes in asthma patients. Intranasal treatment has been reported to be beneficial for the lower airways.. This was a randomized, double-blind, placebo-controlled study. The objective was to evaluate the effects that treatment with intranasal beclomethasone dipropionate (BDP; 400 microg/d) has on nasal and bronchial symptoms, as well as on lung function test results and bronchial responsiveness to histamine in patients with allergic rhinitis and asthma. We evaluated 33 patients, divided into two groups: treatment (n = 17); and placebo (n = 16). Over the course of the 125-day study period, each patient reported daily rhinitis and asthma symptoms, as well as the need for additional medication. All patients were submitted to spirometry and histamine challenge at baseline and at each subsequent evaluation (on days 50 and 75).. In comparison with the patients in the placebo group, those in the BDP treatment group presented significantly fewer nasal symptoms on day 50 and fewer asthma symptoms on day 75 (p < 0.01 for both); required rescue medications less often; and presented a significantly lower degree of bronchial responsiveness to histamine on day 75 (p < 0.01).. In this study, intranasal BDP was effective in treating rhinitis as well as asthma. The benefits for the lower airways were observed only after prolonged treatment and might be better evaluated through nonspecific bronchial challenge.

    Topics: Administration, Intranasal; Adolescent; Adult; Asthma; Beclomethasone; Bronchial Hyperreactivity; Double-Blind Method; Female; Glucocorticoids; Histamine; Humans; Male; Respiratory Function Tests; Rhinitis; Young Adult

2008
A randomized, controlled trial to investigate the effect of ciclesonide and beclomethasone dipropionate on eye lens opacity.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2008, Volume: 45, Issue:10

    Inhaled corticosteroids (ICS) are recommended first-line therapy for the treatment of persistent asthma. However, reports from observational studies have suggested that the use of ICS may be associated with systemic adverse events, such as glaucoma and cataract (opacity of the lens) formation.. To compare two ICS over 1 year regarding the formation/progression of lenticular opacities in patients with asthma.. Adults (>or=18 years of age) with moderate-to-severe asthma were randomized to ciclesonide 640 micro g/day (n = 785) or beclomethasone dipropionate 640 micro g/day (n = 783) in a multinational, double-blind, active-controlled, parallel-group study. The primary endpoint was the occurrence of a positive Class I grading shift (increase [worsening] in Lens Opacities Classification System [LOCS] III score of >or= 0.5 for nuclear opalescence, >or= 0.8 for cortical opacification, or >or= 0.5 for posterior subcapsular opacification, or cataract surgery) in either eye at any visit over the 12-month, double-blind treatment period.. Mean changes (+/- standard error) in nuclear opalescence and cortical and posterior subcapsular opacification were small and similar between groups (ciclesonide 640 micro g/day: 0.10 +/- 0.02, 0.07 +/- 0.02 and 0.04 +/- 0.01, respectively; beclomethasone dipropionate 640 micro g/day: 0.11 +/- 0.02, 0.09 +/- 0.02 and 0.03 +/- 0.01, respectively). Class I shifts were observed in 34.3% versus 36.8% of ciclesonide-treated and beclomethasone dipropionate-treated patients, respectively. Ciclesonide 640 micro g/day was non-inferior to beclomethasone dipropionate 640 micro g/day regarding Class I shifts (risk ratio of ciclesonide to beclomethasone dipropionate, 0.940 [95% confidence interval, 0.820-1.077]); the 95% confidence interval upper bound was lower than the pre-specified non-inferiority bound of 1.333 (p < 0.0001), thereby excluding the possibility of higher risk ratio values.. Mean changes in LOCS III scores were very small in both groups. Treatment with ciclesonide 640 micro g/day or beclomethasone dipropionate 640 micro g/day for 1 year has a minimal impact on lenticular opacities development and/or progression.

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Allergic Agents; Asthma; Beclomethasone; Cataract; Double-Blind Method; Female; Glucocorticoids; Humans; Lens, Crystalline; Male; Middle Aged; Pregnenediones; Young Adult

2008
[Therapeutic efficacy and follow-up study of inhaled corticosteroids vs. oral montelukast in treatment of cough variant asthma].
    Zhonghua er ke za zhi = Chinese journal of pediatrics, 2008, Volume: 46, Issue:2

    To compare the effects of inhaled corticosteroids (ICS) and oral leukotriene modifier (LTM) montelukast on the prognosis of children with cough variant asthma (CVA), and to identify the related risk factors for the development of classic asthma in children with CVA.. Eighty-four children with CVA (2 - 6 yrs) were randomized to receive inhaled beclomethasone dipropionate 200 microg/d through pressurized metered-dose inhaler (MDI) plus spacer with mask or oral montelukast 5 mg, once at bedtime for 6 months, then followed by 18 months observation period after the end of the study medication.. There was no significant difference in antitussive days between the two groups (ICS group: 14 +/- 9 days, LTM group: 13 +/- 9 days, Z = 1.12, P = 0.25). Wheezing developed in 7.1% of the children in ICS group during 24 months follow-up period, which was significantly lower than that in LTM group (33.3%, chi2 = 8.92, P = 0.003). The prevalence of eczema or allergic rhinitis was higher in children who developed wheezing than those who did not develop wheezing (eczema: 47.1% vs. 19.4%, chi(2) = 4.16, P = 0.042; allergic rhinitis: 58.8% vs. 31.3%, chi2 = 4.40, P = 0.036). Logistic regression analysis confirmed that eczema and allergic rhinitis were risk factors for wheezing development in children with CVA, the odds ratio was 7.668 and 3.855 respectively (P < 0.05 for all). But administration of ICS was negatively correlated with the development of wheezing by an odds ratio of 0.128 (P = 0.008).. Children with CVA may progress to classic asthma; eczema and allergic rhinitis are two risk factors for wheezing development in children with CVA. Both ICS and LTM are effective antitussive treatment, but ICS may be more effective than LTM on preventing the progression of CVA to classic asthma.

    Topics: Acetates; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Cough; Cyclopropanes; Female; Follow-Up Studies; Humans; Male; Quinolines; Risk Factors; Sulfides; Treatment Outcome

2008
A randomised controlled trial of the Buteyko technique as an adjunct to conventional management of asthma.
    Respiratory medicine, 2008, Volume: 102, Issue:5

    To assess the effectiveness of a non-pharmacological intervention in patients with asthma on conventional therapy including inhaled corticosteroid.. A randomised controlled trial of the Buteyko technique in a group of adults with asthma. The control group was trained by a physiotherapist in breathing and relaxation techniques.. A single centre associated with a University-based asthma programme.. Asthma control, defined by a composite score based on the Canadian asthma consensus report 6 months after completion of the intervention.. Both groups showed substantial and similar improvement and a high proportion with asthma control 6 months after completion of the intervention. In the Buteyko group the proportion with asthma control increased from 40% to 79% and in the control group from 44% to 72%. In addition the Buteyko group had significantly reduced their inhaled corticosteroid therapy compared with the control group (p=0.02). None of the other differences between the groups at 6 months were significant.. Six months after completion of the interventions, a large majority of subjects in each group displayed control of their asthma with the additional benefit of reduction in inhaled corticosteroid use in the Buteyko group. The Buteyko technique, an established and widely recognised intervention, or an intensive programme delivered by a chest physiotherapist appear to provide additional benefit for adult patients with asthma who are being treated with inhaled corticosteroid.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Breathing Exercises; Bronchodilator Agents; Chi-Square Distribution; Female; Humans; Male; Middle Aged; Physical Therapy Modalities; Treatment Outcome

2008
Tolerability of high cumulative doses of the HFA modulite beclomethasone dipropionate/formoterol combination inhaler in asthmatic patients.
    Pulmonary pharmacology & therapeutics, 2008, Volume: 21, Issue:3

    The corticosteroid beclomethasone dipropionate (BDP) has been formulated with the long acting beta agonist formoterol (BDP/formoterol 100 microg/6 microg, Foster) in a single inhaler using Modulite technology. We have investigated the acute tolerability of high, cumulative doses of BDP/formoterol compared to formoterol alone and placebo. This was a double blind, 3-way cross-over comparison of 10 puffs of BDP/formoterol 100 microg/6 microg or formoterol 6 microg or placebo during maintenance treatment with BDP/formoterol two puffs per day. Pharmacokinetics over 12h during maintenance treatment was measured on day 7. High cumulative doses were then administered on three separated days. Eighteen patients with asthma were recruited (mean FEV(1) 65% predicted). The primary endpoint was serum potassium over the 12h period after high doses. QTc, blood pressure and heart rate over 12h, and plasma lactate and glucose over 3h following dosing were assessed. Formoterol caused a significantly greater decrease in serum potassium than BDP/formoterol or placebo (difference in mean minimum concentrations; 0.11 and -0.15 mmol/l, respectively, p<0.05 for both comparisons). No significant differences in serum potassium parameters were found between BDP/formoterol and placebo. QTc, plasma lactate and vital signs values observed with the combination were not statistically different from those with formoterol alone. For glucose, the mean maximum increase after formoterol treatment was 0.4 mmol/l (p<0.01 compared to placebo), while BDP/formoterol treatment caused a maximum increase of 0.7 mmol/l (p<0.01 compared to formoterol and placebo). The active metabolite of BDP is beclomethasone-17-monopropriate (B17MP), which reached Cmax at 0.25 h, with an elimination half-life of 3.7 h. Formoterol also reached Cmax at 0.25 h, and concentrations were measurable up to 12 h. High doses of BDP/formoterol did not significantly reduce serum potassium, while formoterol alone did to a greater extent. The BDP/formoterol combination was well tolerated, and exhibited a safety profile generally similar to formoterol alone when administered in high doses to stable asthmatic patients.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Blood Glucose; Blood Pressure; Cross-Over Studies; Double-Blind Method; Drug Combinations; Electrocardiography; Ethanolamines; Female; Formoterol Fumarate; Half-Life; Heart Function Tests; Heart Rate; Humans; Lactic Acid; Male; Middle Aged; Potassium

2008
Once-daily inhaled glucocorticosteroid administration in controlled asthma patients.
    Pulmonary pharmacology & therapeutics, 2008, Volume: 21, Issue:4

    Inhaled glucocorticosteroids are usually administered in two equal daily doses. To simplify the method of treatment, once-daily administration has been used. However, little information regarding whether once-daily treatment can sufficiently control airway inflammation is available. We aimed to investigate whether once-daily administration of inhaled glucocorticosteroids can control airway inflammation.. Twenty-four well-controlled asthma patients were enrolled in a randomized crossover trial to compare the efficacies of once-daily and twice-daily administration of inhaled glucocorticosteroids. Initially, the patients were randomly assigned to receive either once-daily or twice-daily administration for 16 weeks. After an 8-week washout period, patients who originally received twice-daily administration were assigned to once-daily administration for 16 weeks and vice versa. We assessed the changes in the forced expiratory volume in 1s, morning and evening peak expiratory flows, asthma symptoms, health-related quality of life and fractional exhaled nitric oxide levels.. Patients with once-daily administration showed the same level of clinical control and lung functions as patients receiving twice-daily administration. There was no difference in the fractional exhaled nitric oxide levels between the beginning and end of the twice-daily treatment (35.69 and 33.23ppb, respectively). In contrast, the fractional exhaled nitric oxide level was significantly higher at the end of the once-daily treatment (33.87 and 39.38ppb, respectively, p< 0.001).. Although once-daily administration is sufficient for clinical control of asthma, it might not control airway inflammation sufficiently.

    Topics: Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Breath Tests; Budesonide; Cross-Over Studies; Drug Administration Schedule; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Nitric Oxide; Quality of Life

2008
Hydrofluoroalkane-beclomethasone dipropionate effectively improves airway eosinophilic inflammation including the distal airways of patients with mild to moderate persistent asthma as compared with fluticasone propionate in a randomized open double-cross
    Allergology international : official journal of the Japanese Society of Allergology, 2008, Volume: 57, Issue:3

    To evaluate whether hydrofluoroalkane-beclomethasone dipropionate (HFA-BDP) controls eosinophilic inflammation, including that in the distal airways, more effectively than fluticasone propionate (FP) Diskus.. Fifty patients with well-controlled mild to moderate persistent asthma using FP for more than 6 months were randomly assigned to FP and HFA-BDP groups, and the treatment regimens of the two groups were switched twice between FP and HFA-BDP in a double cross-over manner at 3-month intervals after 2-week washout periods. Evidence of eosinophilic inflammation in blood and induced sputum samples was assessed, together with pulmonary function testing and an Asthma-related Quality of Life Questionnaire (AQLQ) survey after each treatment period.. The peripheral blood differential eosinophil count and sputum levels of eosinophil cationic protein (ECP) showed reciprocal changes during the study periods in both groups. The blood differential eosinophil count was significantly lower during the HFA-BDP than during the FP treatment period in both the FP (p = 0.004) and the HFA-BDP (p = 0.020) group. The late-phase induced sputum ECP level was significantly decreased during the HFA-BDP treatment period in both the FP (p = 0.016) and the HFA-BDP group (p = 0.023). The significant elevation of surfactant protein D values in the late-phase sputum observed in both groups indicated that late-phase sputum was obtained mainly from proximal peripheral airways. Both symptom and activity limitation domains of the AQLQ in the HFA-BDP group significantly increased after switching from FP to HFA-BDP. There were no significant changes in pulmonary function indices in either group at any time during the study.. HFA-BDP improved residual eosinophilic inflammation in asthmatic airways, including distal airways, more effectively than FP.

    Topics: Adult; Aged; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cross-Over Studies; Eosinophil Cationic Protein; Eosinophilia; Female; Fluticasone; Humans; Leukocyte Count; Male; Middle Aged; Quality of Life; Sputum

2008
Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma.
    The European respiratory journal, 2007, Volume: 29, Issue:4

    The present study was designed to compare the fixed combination of beclomethasone and formoterol in a hydrofluoroalkane Modulite (Chiesi Farmaceutici, Parma, Italy) pressurised metered-dose inhaler (pMDI), with a combination of budesonide and formoterol administered via a Turbuhaler (AstraZeneca, Lund, Sweden) dry powder inhaler (DPI). This was a phase III, multinational, multicentre, double-blind, double-dummy, randomised, two-arm parallel groups, controlled study design. After a 2-week run-in period, 219 patients with moderate-to-severe asthma were randomised to a 12-week treatment with beclomethasone 200 microg plus formoterol 12 microg b.i.d. delivered via a pMDI or budesonide 400 microg plus formoterol 12 microg b.i.d. delivered via a DPI. The analysis of noninferiority on primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups. A statistically significant improvement from baseline in lung function, symptoms and rescue medication use was observed in both groups at all time-points. No differences were observed between treatments in either rate of asthma exacerbations or frequency of adverse events. The new fixed combination of beclomethasone and formoterol in hydrofluoroalkane Modulite pressurised metered-dose inhaler is equivalent to the marketed combination of budesonide and formoterol in terms of efficacy and tolerability profile.

    Topics: Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Ethanolamines; Female; Formoterol Fumarate; Humans; Male; Metered Dose Inhalers; Middle Aged; Peak Expiratory Flow Rate; Time Factors; Treatment Outcome

2007
Combined mediator blockade or topical steroid for treating the unified allergic airway.
    Allergy, 2007, Volume: 62, Issue:1

    Asthma and allergic rhinitis are manifestations of a single unified allergic airway, for which the best treatment is uncertain.. To compare the anti-inflammatory efficacy in the unified allergic airway of combined oral mediator antagonism and combined topical steroid.. Subjects with asthma and perennial allergic rhinitis entered a randomized double blind crossover study comparing montelukast 10 mg and cetirizine 10 mg to extra-fine inhaled beclomethasone 400 mcg/day and intranasal beclomethasone 200 mcg/day, each taken once daily for 2 months, after 2-week placebo washouts. Measurements were made after each washout and randomized treatment, comprising: methacholine PC20, exhaled and nasal nitric oxide, blood eosinophils and eosinophilic cationic protein, symptoms, lung and nasal function tests.. Seventeen patients completed per protocol. For PC20 and exhaled nitric oxide, only combined topical steroid produced improvements (P < 0.005) from placebo baseline. Combined steroid was superior by a 0.93 (95% CI 0.14-0.93, P < 0.05) doubling dilution difference for PC20 and a 0.99 (95% CI 0.9-15.1, P < 0.01) doubling difference for exhaled nitric oxide. Both treatments attenuated eosinophils and eosinophilic cationic protein, and reduced nasal symptoms (P < 0.05). Only steroid improved nasal nitric oxide (P=0.05) and asthma symptoms (P < 0.05). Neither treatment affected lung or nasal function tests.. Combined topical steroid and combined mediator antagonism both attenuated systemic inflammation in the unified allergic airway, but only the former reduced bronchial and nasal inflammatory markers. The relevance of this to exacerbations and airway remodelling needs to be defined.

    Topics: Acetates; Administration, Topical; Adolescent; Adult; Aged; Anti-Allergic Agents; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cetirizine; Cross-Over Studies; Cyclopropanes; Double-Blind Method; Drug Administration Routes; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Quinolines; Rhinitis, Allergic, Perennial; Sulfides

2007
Air trapping in mild and moderate asthma: effect of inhaled corticosteroids.
    The Journal of allergy and clinical immunology, 2007, Volume: 119, Issue:3

    Air trapping reflects small airway obstruction in asthma and can be assessed quantitatively by high-resolution computed tomography (HRCT). Hydrofluoroalkane-beclomethasone dipropionate (HFA-BDP) is deposited across all sizes of airways, including the small ones. However, its long-term effect on air trapping remains unknown in uncontrolled asthma.. To compare the effect of inhaled corticosteroids of different particle size - HFA-BDP and fluticasone propionate (FP) - on lung attenuation in mild-to-moderate uncontrolled asthma.. A randomized study was performed to analyze the effect of HFA-BDP (400 microg/d) or FP (500 microg/d) given over a period of 3 months to patients with uncontrolled mild-to-moderate asthma. HRCT was performed with spirometric gating, and lung attenuation was measured at residual volume and at pulmonary total capacity. The difference between inspiratory and expiratory attenuation was calculated as an air trapping index.. Twenty-five out of 58 patients had abnormal air trapping and could be included in the study. Lung attenuation significantly diminished in the posterior zones of the lung after a 3-month treatment with HFA-BDP or FP, but the difference between the groups was not significant. Adjusted mean variations of the air trapping index from baseline to treatment completion were 34.3 (11.2, 57.3) and 27.3 (6.4, 48.2) for the HFA-BDP and FP groups, respectively. However, the reduction of air trapping area was more pronounced in the group treated with HFA-BDP.. Inhaled corticosteroids decrease air trapping in uncontrolled asthma regardless of their particle size.. In mild-to-moderate asthma, air trapping assessed by HRCT may be a new outcome related to the control of the disease.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Airway Obstruction; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchospirometry; Female; Humans; Lung; Male; Particle Size; Tomography, X-Ray Computed; Treatment Outcome

2007
Smoking affects response to inhaled corticosteroids or leukotriene receptor antagonists in asthma.
    American journal of respiratory and critical care medicine, 2007, Apr-15, Volume: 175, Issue:8

    One-quarter to one-third of individuals with asthma smoke, which may affect response to therapy and contribute to poor asthma control.. To determine if the response to an inhaled corticosteroid or a leukotriene receptor antagonist is attenuated in individuals with asthma who smoke.. In a multicenter, placebo-controlled, double-blind, double-dummy, crossover trial, 44 nonsmokers and 39 light smokers with mild asthma were assigned randomly to treatment twice daily with inhaled beclomethasone and once daily with oral montelukast.. Primary outcome was change in prebronchodilator FEV(1) in smokers versus nonsmokers. Secondary outcomes included peak flow, PC(20) methacholine, symptoms, quality of life, and markers of airway inflammation. Despite similar FEV(1), bronchodilator response, and sensitivity to methacholine at baseline, subjects with asthma who smoked had significantly more symptoms, worse quality of life, and lower daily peak flow than nonsmokers. Adherence to therapy did not differ significantly between smokers and nonsmokers, or between treatment arms. Beclomethasone significantly reduced sputum eosinophils and eosinophil cationic protein (ECP) in both smokers and nonsmokers, but increased FEV(1) (170 ml, p = 0.0003) only in nonsmokers. Montelukast significantly increased a.m. peak flow in smokers (12.6 L/min, p = 0.002), but not in nonsmokers.. In subjects with mild asthma who smoke, the response to inhaled corticosteroids is attenuated, suggesting that adjustments to standard therapy may be required to attain asthma control. The greater improvement seen in some outcomes in smokers treated with montelukast suggests that leukotrienes may be important in this setting. Larger prospective studies are required to determine whether leukotriene modifiers can be recommended for managing asthma in patients who smoke.

    Topics: Acetates; Adult; Asthma; Beclomethasone; Cross-Over Studies; Cyclopropanes; Double-Blind Method; Female; Glucocorticoids; Humans; Leukotriene Antagonists; Male; Quality of Life; Quinolines; Respiratory Function Tests; Smoking; Sulfides; Treatment Outcome

2007
The Predicting Response to Inhaled Corticosteroid Efficacy (PRICE) trial.
    The Journal of allergy and clinical immunology, 2007, Volume: 119, Issue:1

    Although guidelines recommend anti-inflammatory therapy for persistent asthma, recent studies suggest that 25% to 35% of patients with asthma may not improve lung function with inhaled corticosteroids.. To evaluate potential biomarkers of predicting short-term (6-week) response to inhaled corticosteroid with subsequent evaluation of responders and nonresponders to asthma control over a longer interval (16 additional weeks).. Eighty-three subjects with asthma off steroid were enrolled in this multicenter study. Biomarkers and asthma characteristics were evaluated as predictors of inhaled corticosteroid response over a 6-week trial for changes in FEV(1) and methacholine PC(20). After this, an additional 4-month trial evaluated asthma control.. Although multiple baseline predictors had significant correlations with improvements for short-term inhaled steroid success, the only strong correlations (r >or= +/- 0.6) were albuterol reversibility (r = 0.83; P < .001), FEV(1)/forced vital capacity (r = -0.75; P < .001), and FEV(1) % predicted (r = -0.71; P < .001). Dividing the subjects in the short-term inhaled steroid trial into responders (>5% FEV(1) improvement) and nonresponders (

    Topics: Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biomarkers; Clinical Trials as Topic; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Treatment Outcome

2007
Beclometasone dipropionate extrafine aerosol versus fluticasone propionate in children with asthma.
    Respiratory medicine, 2007, Volume: 101, Issue:7

    Beclometasone dipropionate (BDP) extrafine is a hydrofluoroalkane-based, chlorofluorocarbon (CFC)-free inhalation aerosol. This study was conducted to determine whether BDP extrafine and CFC-fluticasone proprionate (FP) aerosols were equivalent in terms of efficacy and tolerability in children with symptomatic mild-to-moderate asthma. Male and female patients (aged 5-12 yr) with an asthma diagnosis for > or =3 months, peak expiratory flow (PEF) > or =60% of predicted normal and suboptimal asthma control were randomised to double-blind treatment with BDP extrafine 200 microg day(-1) (n=139) or CFC-FP 200 microg day(-1) (n=141) for up to 18 weeks. After 6 and 12 weeks, study medication was 'stepped down' to 100 and 50 microg day(-1), respectively, if patients had achieved good asthma control. Patients with poor asthma control discontinued from the study and those with intermediate control continued in the study but did not undergo a dose reduction. The estimated treatment difference in morning PEF% predicted at 6 weeks was -1.9% (90% CI -4.9, 1.0). There was a trend towards a greater increase in forced vital capacity (% predicted) in the BDP extrafine group (5.3 versus 0.4%; p=0.084). A 'step-down' in therapy to 100 microg day(-1) was possible in 36% and 42% of patients in the BDP extrafine and CFC-FP groups, respectively, at 6 weeks. Both drugs were well tolerated. BDP extrafine and CFC-FP aerosols were equally effective at improving asthma control in children with mild-to-moderate asthma at the same daily dose.

    Topics: Administration, Inhalation; Aerosols; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child; Child, Preschool; Double-Blind Method; Drug Administration Schedule; Female; Fluticasone; Humans; Male; Quality of Life; Respiratory Mechanics; Treatment Outcome

2007
Eosinophilic airway inflammation and exacerbations of COPD: a randomised controlled trial.
    The European respiratory journal, 2007, Volume: 29, Issue:5

    Evidence suggests that eosinophilic airway inflammation is important in the pathogenesis of severe chronic obstructive pulmonary disease (COPD) exacerbations. The present authors tested the hypothesis that a management strategy that aims to reduce sputum eosinophil counts is associated with a reduction in exacerbations of COPD. A total of 82 patients with COPD were randomised into two groups. One group was treated according to traditional guidelines (British Thoracic Society (BTS) group) and the other (sputum group) was treated with the additional aim of minimising eosinophilic airway inflammation, assessed using the induced sputum eosinophil count. The primary outcome was exacerbations, which were categorised as mild, moderate or severe. The frequency of severe exacerbations per patient per year was 0.5 and 0.2 in the BTS and sputum groups, respectively (mean reduction 62%). The majority of this benefit was confined to patients with eosinophilic airway inflammation. There was no difference in the frequency of mild and moderate exacerbations. The average daily dose of inhaled or oral corticosteroids during the trial did not differ between the groups. Out of 42 patients in the sputum group, 17 required regular oral corticosteroids to minimise eosinophilic airway inflammation. A management strategy that aims to minimise eosinophilic airway inflammation, as well as symptoms, is associated with a reduction in severe exacerbations of chronic obstructive pulmonary disease.

    Topics: Aged; Aged, 80 and over; Analysis of Variance; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Eosinophilia; Female; Glucocorticoids; Humans; Inflammation; Male; Middle Aged; Nebulizers and Vaporizers; Pulmonary Disease, Chronic Obstructive; Respiratory Function Tests; Sputum; Treatment Outcome

2007
Zileuton added to low-dose inhaled beclomethasone for the treatment of moderate to severe persistent asthma.
    Respiratory medicine, 2007, Volume: 101, Issue:6

    To assess the therapeutic effects of oral zileuton tablets combined with low-dose beclomethasone compared to doubling the dose of beclomethasone, in improving lung function and reducing asthma symptoms.. Randomized, active-control, double-blind, parallel, multi-center study of zileuton (400 or 600 mg QID)+200 microg beclomethasone dipropionate (BDP) BID versus placebo+BDP 400 microg BID in asthmatics with baseline FEV(1) percent predicted values between 40% and 80% following a single-blind ICS (BDP 200 microg BID) 2-week run-in. During the 3-month double-blind treatment period, assessments included safety, daytime and nighttime symptoms, acute asthma exacerbations, beta(2)-agonist use, AM and PM peak expiratory flow (PEF) and FEV(1).. The addition of a 5-lipoxygenase (5-LO) inhibitor added to a low-dose of BDP showed no significant difference in FEV(1) compared to doubling the dose of BDP. FEV(1) improved in all 3 treatment groups, with mean increases of 10% with zileuton 600 mg QID+BDP 200 microg BID, 12% with zileuton 400mg QID+BDP 200 microg BID, and 11% with BDP 400 microg BID by study end. Within each treatment group, there were significant improvements in asthma symptoms and AM and PM PEF compared to baseline. No significant differences were observed between groups with regards to salbutamol use, acute asthma exacerbations, the requirement for oral/parenteral corticosteroids and adverse clinical events.. The addition of a 5-LO inhibitor added to low-dose beclomethasone may be an alternative to higher-doses of ICS in patients unable to achieve sufficient asthma control on low-dose ICS therapy.

    Topics: Adolescent; Adult; Aged; Anti-Asthmatic Agents; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; Double-Blind Method; Drug Therapy, Combination; Forced Expiratory Volume; Glucocorticoids; Humans; Hydroxyurea; Middle Aged; Peak Expiratory Flow Rate; Severity of Illness Index; Single-Blind Method

2007
Asthma control during the year after bronchial thermoplasty.
    The New England journal of medicine, 2007, Mar-29, Volume: 356, Issue:13

    Bronchial thermoplasty is a bronchoscopic procedure to reduce the mass of airway smooth muscle and attenuate bronchoconstriction. We examined the effect of bronchial thermoplasty on the control of moderate or severe persistent asthma.. We randomly assigned 112 subjects who had been treated with inhaled corticosteroids and long-acting beta2-adrenergic agonists (LABA) and in whom asthma control was impaired when the LABA were withdrawn to either bronchial thermoplasty or a control group. The primary outcome was the frequency of mild exacerbations, calculated during three scheduled 2-week periods of abstinence from LABA at 3, 6, and 12 months. Airflow, airway responsiveness, asthma symptoms, the number of symptom-free days, use of rescue medication, and scores on the Asthma Quality of Life Questionnaire (AQLQ) and the Asthma Control Questionnaire (ACQ) were also assessed.. The mean rate of mild exacerbations, as compared with baseline, was reduced in the bronchial-thermoplasty group but was unchanged in the control group (change in frequency per subject per week, -0.16+/-0.37 vs. 0.04+/-0.29; P=0.005). At 12 months, there were significantly greater improvements in the bronchial-thermoplasty group than in the control group in the morning peak expiratory flow (39.3+/-48.7 vs. 8.5+/-44.2 liters per minute), scores on the AQLQ (1.3+/-1.0 vs. 0.6+/-1.1) and ACQ (reduction, 1.2+/-1.0 vs. 0.5+/-1.0), the percentage of symptom-free days (40.6+/-39.7 vs. 17.0+/-37.9), and symptom scores (reduction, 1.9+/-2.1 vs. 0.7+/-2.5) while fewer puffs of rescue medication were required. Values for airway responsiveness and forced expiratory volume in 1 second did not differ significantly between the two groups. Adverse events immediately after treatment were more common in the bronchial-thermoplasty group than in the control group but were similar during the period from 6 weeks to 12 months after treatment.. Bronchial thermoplasty in subjects with moderate or severe asthma results in an improvement in asthma control. (ClinicalTrials.gov number, NCT00214526 [ClinicalTrials.gov].).

    Topics: Adrenergic beta-Agonists; Adult; Asthma; Beclomethasone; Bronchi; Bronchial Hyperreactivity; Bronchoscopy; Catheter Ablation; Female; Follow-Up Studies; Forced Expiratory Volume; Glucocorticoids; Humans; Hyperthermia, Induced; Male; Middle Aged; Muscle, Smooth; Peak Expiratory Flow Rate; Quality of Life

2007
Pharmacokinetics of inhaled monodisperse beclomethasone as a function of particle size.
    British journal of clinical pharmacology, 2007, Volume: 64, Issue:3

    For optimal efficacy, antiasthma drugs should be delivered to the desired region in the airways. To date, the optimal particle size for steroids in adults is not known. The aim of the study was to evaluate the pulmonary bioavailability for inhaled beclomethasone dipropionate (BDP) aerosols of different particle sizes.. In a randomized single-blind crossover trial, 10 mild asthmatic patients inhaled monodisperse BDP aerosols with mass median aerodynamic diameters (MMADs) of 1.5, 2.5 and 4.5 microm. Gastrointestinal absorption was blocked by activated charcoal. Plasma concentrations of 17-beclomethasone monopropionate (17-BMP) were measured by liquid chromatography plus mass spectrometry.. Aerosols with MMADs of 1.5 microm, 2.5 microm, and 4.5 microm gave mean maximum concentrations (C(max)) of 17-BMP of 475 pg ml(-1), 1300 pg ml(-1), and 1161 pg ml(-1), respectively. The area under the curve (AUC) values of 17-BMP for MMADs of 1.5 microm, 2.5 microm, and 4.5 microm were 825 pg ml(-1) h, 2629 pg ml(-1) h, and 2276 pg ml(-1) h, respectively. The mean terminal half-time of 17-BMP for all three aerosol sizes was around 1.5 h.. Monodisperse BDP aerosols with a MMAD of 1.5 microm gave two-three fold lower values for C(max) and AUC than those with MMADs of 2.5 and 4.5 microm.

    Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Anti-Asthmatic Agents; Area Under Curve; Asthma; Beclomethasone; Biological Availability; Cross-Over Studies; Female; Humans; Male; Middle Aged; Particle Size; Single-Blind Method

2007
Rescue use of beclomethasone and albuterol in a single inhaler for mild asthma.
    The New England journal of medicine, 2007, May-17, Volume: 356, Issue:20

    Treatment guidelines recommend the regular use of inhaled corticosteroids for patients with mild persistent asthma. We investigated whether the symptom-driven use of a combination of beclomethasone dipropionate and albuterol (also known as salbutamol) in a single inhaler would be as effective as the regular use of inhaled beclomethasone and superior to the as-needed use of inhaled albuterol.. We conducted a 6-month, double-blind, double-dummy, randomized, parallel-group trial. After a 4-week run-in, patients with mild asthma were randomly assigned to receive one of four inhaled treatments: placebo twice daily plus 250 microg of beclomethasone and 100 microg of albuterol in a single inhaler as needed (as-needed combination therapy); placebo twice daily plus 100 microg of albuterol as needed (as-needed albuterol therapy); 250 microg of beclomethasone twice daily and 100 microg of albuterol as needed (regular beclomethasone therapy); or 250 microg of beclomethasone and 100 microg of albuterol in a single inhaler twice daily plus 100 microg of albuterol as needed (regular combination therapy). The primary outcome was the morning peak expiratory flow rate.. In 455 patients with mild asthma who had a forced expiratory volume in 1 second of 2.96 liters (88.36% of the predicted value), the morning peak expiratory flow rate during the last 2 weeks of the 6-month treatment was higher (P=0.04) and the number of exacerbations during the 6-month treatment was lower (P=0.002) in the as-needed combination therapy group than in the as-needed albuterol therapy group, but the values in the as-needed combination therapy group were not significantly different from those in the groups receiving regular beclomethasone therapy or regular combination therapy. The cumulative dose of inhaled beclomethasone was lower in the as-needed combination therapy group than in the groups receiving regular beclomethasone therapy or regular combination therapy (P<0.001 for both comparisons).. In patients with mild asthma, the symptom-driven use of inhaled beclomethasone (250 microg) and albuterol (100 microg) in a single inhaler is as effective as regular use of inhaled beclomethasone (250 microg twice daily) and is associated with a lower 6-month cumulative dose of the inhaled corticosteroid. (ClinicalTrials.gov number, NCT00382889 [ClinicalTrials.gov].).

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Drug Combinations; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate

2007
Differential anti-inflammatory effects of large and small particle size inhaled corticosteroids in asthma.
    Allergy, 2007, Volume: 62, Issue:6

    Extra-fine particle formulations of hydrofluoroalkane-134a beclometasone dipropionate (HFA-BDP) exhibit clinical effects comparable with conventional particle formulations of chlorofluorocarbon beclometasone dipropionate (CFC-BDP) at half the dose. There is little data comparing their effects on inflammation. We have evaluated the effects of HFA-BDP and CFC-BDP on pulmonary and systemic markers of asthmatic inflammation.. A double-blind randomized crossover trial was undertaken comparing the anti-inflammatory effects of HFA-BDP (100 and 400 microg/day) and CFC-BDP (200 and 800 microg/day). Treatment with montelukast was evaluated as add-on to the higher dose of BDP.. Compared with baseline after withdrawal of usual asthma therapy, 100 microg of HFA-BDP significantly attenuated serum eosinophilic cationic protein levels (0.61-fold change, 95% CI 0.49-0.77; a 39% reduction, P < 0.001), but 200 microg of CFC-BDP did not (0.87-fold change, 95% CI 0.63-1.23; P = 1). A dose of 800 microg of CFC-BDP and 400 microg of HFA-BDP led to reductions in exhaled nitric oxide (0.57-fold change, 95% CI 0.44-0.73; a 43% reduction, P < 0.001 and 0.65-fold change, 95% CI 0.47-0.91; a 35% reduction, P = 0.008, respectively); and peripheral eosinophils (-74 cells/microl, 95% CI -146 to -2; P = 0.020 and -77 cells/microl, 95% CI -140 to -14; P = 0.012, respectively). Montelukast further reduced exhaled nitric oxide (0.81-fold change, 95% CI 0.66-0.98; P = 0.028) with 400 microg HFA-BDP and eosinophils (-44 cells/microl, 95% CI -80 to -8; P = 0.012) with 800 microg CFC-BDP, but not vice versa.. Chlorofluorocarbon beclometasone dipropionate and HFA-BDP have differential effects on pulmonary and systemic inflammation, which dictate the additive effects of montelukast.

    Topics: Acetates; Administration, Inhalation; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chemistry, Pharmaceutical; Chlorofluorocarbons; Cyclopropanes; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Eosinophils; Humans; Hydrocarbons, Fluorinated; Inflammation; Nitric Oxide; Particle Size; Quinolines; Sulfides

2007
An in vivo and in vitro comparison of inhaled steroid delivery via a novel vortex actuator and a conventional valved holding chamber.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2007, Volume: 98, Issue:5

    Valved holding chambers improve delivery of inhaled corticosteroids to the lung but are bulky in design. A novel compact vortex actuator device has therefore been developed.. To compare the in vitro and in vivo performance of a novel compact vortex actuator (the Neohaler [NH]) vs a conventional small-volume valve holding chamber (the AeroChamber Plus [AP].. Seventeen asthmatic patients completed the study per protocol, receiving 4 weeks each of 100 microg/d (50-microg formulation) or 400 microg/d (100-microg formulation) of hydrofluoroalkane beclomethasone dipropionate via the NH or AP devices in a randomized crossover, double-blind, double-dummy, placebo-controlled design. The doubling dilution (dd) shift in methacholine provocation concentration that caused a decrease in forced expiratory volume in 1 second of 20% (primary outcome) was used to evaluate anti-inflammatory effects and adrenal function to measure systemic exposure. The fine particle (<4.7 tm) dose was evaluated using an Andersen Cascade Impactor.. A total of 100 microg of hydrofluoroalkane beclomethasone dipropionate via the NH and AP produced 0.95-dd (95% confidence interval [CI], 0.44-1.45; P = .006) and 0.45-dd (95% CI, -0.16 to 1.06; P = .83) improvements from baseline in methacholine provocation concentration that caused a decrease in forced expiratory volume in 1 second of 20%, respectively, with no statistically significant difference between devices: 0.50 dd (95% CI, -0.25 to 1.24; P = .18). At 400 microg/d, 1.08-dd (95% CI, 0.49-1.67; P = .006) and 0.85-dd (95% CI, 0.32-1.39; P = .02) improvements were found for the NH and AP, respectively, with a 0.23-dd difference (95% CI, -0.28 to 0.74; P = .36) between devices. No adrenal suppression occurred with either device. The in vitro fine particle dose was 39.1 microg for the NH and 39.0 microg for the AP with the 100-microg formulation and 26.0 g and 25.2 microg, respectively, with the 50-microg formulation.. Delivering hydrofluoroalkane beclomethasone dipropionate via the NH and AP attenuates asthmatic airway inflammation to a comparable degree and produces a similar in vitro fine particle dose profile.

    Topics: Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cross-Over Studies; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Hydrocarbons, Fluorinated; Male; Middle Aged; Nebulizers and Vaporizers

2007
Once daily nebulized beclomethasone is effective in maintaining pulmonary function and improving symptoms in asthmatic children.
    Monaldi archives for chest disease = Archivio Monaldi per le malattie del torace, 2007, Volume: 67, Issue:1

    Compliance with long-term inhaled therapy in asthma is often poor, but it is likely to be improved with a simplified administration, once daily. The present study was designed to assess whether, in childhood asthma, a single dose of nebulized beclomethasone dipropionate once daily was as effective and safe as the same total daily dose administered twice daily.. Asthmatic children, not treated with inhaled steroids for at least a month preceding the study and using short-acting bronchodilators more than once a week were enrolled in a double-blind, double dummy, randomised, multicentric study. After a two week run-in period on nebulised twice daily 400 mcg beclomethasone dipropionate, patients were randomly assigned to twelve weeks of treatment with 800 mcg nebulised beclomethasone dipropionate daily, either in single dose (o.d. group) or divided into two 400 mcg doses (b.i.d. group).. 65 children (mean age 8.6 years, mean FEV1 81% of predicted), were valuable for intention to treat. During the run-in period, a significant improvement in FEV1, FVC, morning and evening PEF values and clinical scores was observed. Children then entered the randomised trial: 32 were included in the o.d. group and 33 in the b.i.d. group. During the twelve week treatment period, the observed improvement in pulmonary function parameters was maintained in both treatment groups. Morning and evening PEF showed a progressive slight increase as well as PEF diurnal variability showed a progressive reduction in the two treatment groups during the whole study period without reaching statistical significance. Moreover, in both treatment groups a similar progressive increase in symptom free nights and days and in the percentage of children achieving total asthma symptoms control was detected. Finally, no significant changes in urinary cortisol/creatinine ratio were observed throughout the study period and between groups.. A daily dose of 800 mcg of beclomethasone, administered for twelve weeks with a nebuliser either once or twice daily provide similar efficacy in maintaining pulmonary function and symptoms of asthmatic children, with a good tolerability profile.

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Circadian Rhythm; Creatinine; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Hydrocortisone; Male; Nebulizers and Vaporizers; Patient Compliance; Peak Expiratory Flow Rate; Spirometry; Treatment Outcome; Vital Capacity

2007
Efficacy and safety of once-daily inhaled ciclesonide in adults with mild to moderate asthma: a double-blind, placebo-controlled study.
    Respirology (Carlton, Vic.), 2007, Volume: 12, Issue:4

    Inhaled corticosteroids are recommended as first-line therapy for the management of asthma, although side-effects may limit their use. Ciclesonide, a novel pro-drug inhaled corticosteroid, exerts potent and prolonged local anti-inflammatory effects in the lungs, and is considered to have an improved safety and tolerability profile. The aim of this study was to evaluate the efficacy and safety of ciclesonide in adult patients with mild to moderate asthma.. A placebo-controlled, multicentre, randomized, double-blind, parallel-group study was conducted. During the 4-week baseline period, patients were given 400 microg/day of beclomethasone dipropionate in a chlorofluorocarbon formulation. After the baseline period, 311 patients were given once-daily 100, 200 or 400 microg of ciclesonide or placebo for an 8-week treatment period without the use of a spacer. The primary efficacy variable was morning PEF.. Changes in the morning PEF (least squares mean) at the end of the study were 4.23 L/min (P < 0.001) in the 100 microg group, 3.75 L/min (P < 0.001) in the 200 microg group, -0.40 L/min (P < 0.001) in the 400 microg group, as compared with -24.95 L/min in the placebo group. In the ciclesonide groups, the PEF remained at the same level as the baseline period. No large differences were observed between the placebo group and the ciclesonide groups regarding safety.. Once-daily administration of ciclesonide at doses of 100, 200 or 400 microg was shown to be effective in adult patients with mild to moderate asthma. Ciclesonide is considered to have favourable safety profiles and be well tolerated.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Allergic Agents; Anti-Asthmatic Agents; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Least-Squares Analysis; Male; Pregnenediones; Spirometry; Vital Capacity

2007
Efficacy and safety of inhaled ciclesonide compared with chlorofluorocarbon beclomethasone dipropionate in adults with moderate to severe persistent asthma.
    Respirology (Carlton, Vic.), 2007, Volume: 12, Issue:4

    Inhaled corticosteroids are recognized as first-line therapy in the management of asthma; however, their use may be limited by systemic and local side-effects. Ciclesonide, a novel pro-drug inhaled corticosteroid, is activated in the lungs and is expected to have less systemic and local side-effects. This study evaluated the efficacy and safety of ciclesonide in hydrofluoroalkane (HFA) compared with beclomethasone dipropionate (BDP) in a chlorofluorocarbon (CFC) formulation in adult patients with moderate to severe asthma.. This was a multicentre, randomized, open-label, parallel-group comparative study. The patients were given 800 microg/day of CFC-BDP in the four-week baseline period. After the baseline period, 319 patients were randomly allocated into three groups which, respectively, received HFA-ciclesonide 400 microg/day (without a spacer), HFA-ciclesonide 800 microg/day (without spacer) and CFC-BDP 800 microg/day (with spacer) for the eight-week treatment period. The primary efficacy variable was morning PEF.. The morning PEF increased by 16.02 L/min in the 400 microg HFA-ciclesonide group, 23.98 L/min in the 800 microg HFA-ciclesonide group and 5.91 L/min in the 800 microg CFC-BDP group. Better outcomes were achieved by the use of 800 microg/day of HFA-ciclesonide compared with 800 microg/day of CFC-BDP (P = 0.001). There was no difference in adverse events between the groups.. In adult patients with moderate to severe asthma, 800 microg/day of HFA-ciclesonide was significantly more effective than 800 microg/day of CFC-BDP. Ciclesonide at doses of 400 microg/day and 800 microg/day was safe and well tolerated.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Allergic Agents; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Hydrocarbons, Fluorinated; Male; Middle Aged; Pregnenediones

2007
[A multicenter, open-label, randomized comparison of suppressive effects on asthmatic inflammation of lower airways and improved effects on health-related QOL between HFA-BDP and fluticasone propionate].
    Arerugi = [Allergy], 2007, Volume: 56, Issue:6

    It is important to evaluate the effects of hydrofluoroalkane-beclomethasone dipropionate (HFA-BDP), which shows predominant deposition in the lower airways, on asthmatic inflammation in the lower airways and the Quality of Life (QOL) of asthma patients, as compared with those of fluticasone propionate (FP) Diskus.. Seventy-seven adult patients with mild persistent or more severe asthma who were being treated with FP for >/=3 months were randomly assigned to the HFA-BDP group and continued FP group. The differential count of eosinophils in the peripheral blood, the serum cortisol levels, and pulmonary function parameters were measured before the study and at 3 months after the start of the study treatment. The improvements in the Asthma Quality of Life Questionnaire (AQLQ) scores were also compared. Sputum samples collected by the induced expectoration method (inhalation of 10% saline for 15 min) were divided into the early-phase sputum samples obtained within 15 minutes of the inhalation and the late-phase sputum samples obtained later than 15 minutes after the inhalation, and the eosinophil count and eosinophil cationic protein (ECP) levels were measured.. In the HFA-BDP group (N=40), the differential count of eosinophils in the peripheral blood was significantly decreased as compared with that in the FP group (p=0.009), and the scores in all the domains of the AQLQ and the percentage improvement of the total score were significantly better as compared with those in FP group (p=0.033). The eosinophil count in the late-phase sputum samples (p=0.022) as well as the ECP level in the sputum samples showed more pronounced decreases in the HFA-BDP group as compared with those in the FP group. On the other hand, no significant changes were detected in the pulmonary function values.. Use of the HFA-BDP preparation can more effectively suppress residual inflammation in the lower airways and significantly improve the QOL as compared with use of the FP preparation of asthma patients. Examination of induced sputum samples allows detection of changes in the peripheral airways that cannot be detected by pulmonary function testing.

    Topics: Administration, Inhalation; Aerosol Propellants; Aged; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Fluticasone; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Middle Aged; Quality of Life

2007
Is there any point in a corticosteroid treatment of intermittent asthma?
    TheScientificWorldJournal, 2007, Jul-03, Volume: 7

    International guidelines advocate the early introduction of inhaled corticosteroids (ICS) in all types of persistent asthma. Our study was undertaken to assess the effects of ICS on bronchial hyperresponsiveness (BHR) as a hallmark of inflammation, and to assess the symptoms, the use of rescue medications, and the parameters of lung function in patients with mild intermittent asthma. The patients with intermittent asthma (n = 85) were randomly allocated to a treatment with ICS, beclomethasone dipropionate 250 microg/day and short-acting beta2 agonists salbutamol as needed (Group A, n = 45) or to a treatment with only short-acting beta2 agonists as needed (Group B, n = 40) during the 6-month treatment period. At the end of the study, in Group A, we found a statistically significant decrease of BHR (PD20 0.98 vs. 2.07) (p < 0.001), diurnal peak expiratory flow (PEF) variability (17.9 vs. 13.8) (p < 0.001), symptom scores (0.63 vs. 0.30) (p < 0.001), and used rescue medication (p < 0.001), while the parameters of lung function remained unchanged except for forced expiratory volume in 1 sec (FEV1), which had a statistically significant increase (3.58 vs. 3.66) (p < 0.001). In Group B, there was a statistically significant decrease of lung function parameters FEV1 (3.80 vs. 3.71) (p < 0.001), forced vital capacity (FVC) (4.43 vs. 4.37) (p < 0.001), FEV1/FVC (88.2 vs. 85.3) (p < 0.05), PEF (8.05 vs. 7.51) (p < 0.01), PEF variability (17.85 vs. 18.33) (p < 0.001), increased BHR (PD20 1.04 vs. 0.62) (p < 0.05), and symptom scores (0.46 vs. 0.62) (p < 0.01), as well as the use of rescue medication during the day (p < 0.001). Early introduction of low doses of ICS may be more beneficial than beta2 agonists alone in patients with intermittent asthma.

    Topics: Adrenal Cortex Hormones; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Combinations; Female; Humans; Male; Treatment Outcome

2007
Swimming and persons with mild persistant asthma.
    TheScientificWorldJournal, 2007, Aug-17, Volume: 7

    The aim of our study was to analyze the effect of recreational swimming on lung function and bronchial hyperresponsiveness (BHR) in patients with mild persistent asthma. This study included 65 patients with mild persistent asthma, who were divided into two groups: experimental group A (n = 45) and control group B (n = 20). Patients from both groups were treated with low doses of inhaled corticosteroids (ICS) and short-acting beta2 agonists salbutamol as needed. Our program for patients in group A was combined asthma education with swimming (twice a week on a 1-h basis for the following 6 months). At the end of the study, in Group A, we found a statistically significant increase of lung function parameters FEV1 (forced expiratory volume in 1 sec) (3.55 vs. 3.65) (p < 0.01), FVC (forced vital capacity) (4.27 vs. 4.37) (p < 0.05), PEF (peak expiratory flow) (7.08 vs. 7.46) (p < 0.01), and statistically significant decrease of BHR (PD20 0.58 vs. 2.01) (p < 0.001). In Group B, there was a statistically significant improvement of FEV1 3.29 vs. 3.33 (p < 0.05) and although FVC, FEV1/FVC, and PEF were improved, it was not significant. When Groups A and B were compared at the end of the study, there was a statistically significant difference of FVC (4.01 vs. 4.37), FEV1 (3.33 vs. 3.55), PEF (6.79 vs.7.46), and variability (p < 0.001), and statistically significantly decreased BHR in Group A (2.01 vs. 1.75) (p < 0.001). Engagement of patients with mild persistent asthma in recreational swimming in nonchlorinated pools, combined with regular medical treatment and education, leads to better improvement of their parameters of lung function and also to more significant decrease of their airway hyperresponsiveness compared to patients treated with traditional medicine.

    Topics: Adrenergic beta-Agonists; Adult; Albuterol; Asthma; Beclomethasone; Bronchial Hyperreactivity; Female; Histamine; Humans; Hypersensitivity, Immediate; Male; Patient Education as Topic; Respiratory Function Tests; Swimming

2007
Beclomethasone/formoterol vs fluticasone/salmeterol inhaled combination in moderate to severe asthma.
    Allergy, 2007, Volume: 62, Issue:10

    Recommended treatment for moderate to severe asthma is the combination of an inhaled corticosteroid and a long-acting beta(2)-agonist. The present study was designed to compare a new fixed combination of extrafine beclomethasone and formoterol, with the fixed combination fluticasone and salmeterol.. This was a phase III, multinational, multicentre, double-blind, randomized, two-arm parallel groups, controlled study. After a 2-week run-in period, 228 patients with moderate to severe asthma were randomized to a 12-week treatment with either beclomethasone 100 microg plus formoterol 6 microg or fluticasone 125 microg plus salmeterol 25 microg, both delivered two inhalations b.i.d. via a pressurized metered dose inhaler.. The analysis of noninferiority on the primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups (difference -3.32 l/min; 95% CI -17.92 to 11.28). A significant improvement from baseline in lung function, symptom score and rescue medication use was observed in both groups at all time points. Beclomethasone plus formoterol combination showed a significantly faster onset of bronchodilation when compared with fluticasone plus salmeterol with the difference maintained for up to 1 h postdosing. No differences were observed between treatments in the rate of asthma exacerbations, frequency of adverse events and overnight urinary cortisol/creatinine ratio.. The new combination of extrafine beclomethasone plus formoterol is not inferior to the marketed combination of fluticasone and salmeterol in terms of efficacy and tolerability, with the advantage of a faster onset of bronchodilation. ( ClinicalTrials.gov number, NCT00394368).

    Topics: Adult; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Drug Combinations; Ethanolamines; Female; Fluticasone; Formoterol Fumarate; Humans; Male; Metered Dose Inhalers; Middle Aged; Peak Expiratory Flow Rate; Salmeterol Xinafoate; Severity of Illness Index; Time Factors

2007
A study to evaluate safety and efficacy of mepolizumab in patients with moderate persistent asthma.
    American journal of respiratory and critical care medicine, 2007, Dec-01, Volume: 176, Issue:11

    Accumulation of eosinophils in the bronchial mucosa of individuals with asthma is considered to be a central event in the pathogenesis of asthma. In animal models, airway eosinophil recruitment and airway hyperresponsiveness in response to allergen challenge are reduced by specific targeting of interleukin-5. A previous small dose-finding study found that mepolizumab, a humanized anti-interleukin-5 monoclonal antibody, had no effect on allergen challenge in humans.. To investigate the effect of three intravenous infusions of mepolizumab, 250 or 750 mg at monthly intervals, on clinical outcome measures in 362 patients with asthma experiencing persistent symptoms despite inhaled corticosteroid therapy (400-1,000 mug of beclomethasone or equivalent).. Multicenter, randomized, double-blind, placebo-controlled study.. Morning peak expiratory flow, forced expiratory volume in 1 second, daily beta(2)-agonist use, symptom scores, exacerbation rates, and quality of life measures. Sputum eosinophil levels were also measured in a subgroup of 37 individuals. Mepolizumab was associated with a significant reduction in blood and sputum eosinophils in both treatment groups (blood, P < 0.001 for both doses; sputum, P = 0.006 for 250 mg and P = 0.004 for 750 mg). There were no statistically significant changes in any of the clinical end points measured. There was a nonsignificant trend for decrease in exacerbation rates in the mepolizumab 750-mg treatment group (P = 0.065).. Mepolizumab treatment does not appear to add significant clinical benefit in patients with asthma with persistent symptoms despite inhaled corticosteroid therapy. Further studies are needed to investigate the effect of mepolizumab on exacerbation rates, using protocols specifically tailored to patients with asthma with persistent airway eosinophilia.

    Topics: Administration, Inhalation; Adrenergic Agonists; Adrenergic beta-2 Receptor Agonists; Adult; Anti-Asthmatic Agents; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Double-Blind Method; Eosinophils; Female; Forced Expiratory Volume; Humans; Injections, Intravenous; Male; Middle Aged; Peak Expiratory Flow Rate; Quality of Life; Severity of Illness Index; Sputum; Treatment Failure

2007
Ciclesonide and beclomethasone dipropionate coadministration: effect on cortisol in perennial allergic rhinitis.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2007, Volume: 44, Issue:8

    Coexisting asthma and allergic rhinitis (AR) are often treated with both intranasal and inhaled corticosteroids. This study investigated whether intranasal ciclesonide 200 microg once daily has an additional effect on cortisol suppression when coadministered with inhaled hydrofluoroalkane-beclomethasone dipropionate (HFA-BDP). Adult patients (n = 150) with perennial AR received HFA-BDP 320 microg twice daily and placebo once daily during a run-in period. Patients were then randomized to ciclesonide or placebo and HFA-BDP (43 days). A single 2-mg dose of dexamethasone was administered on the last treatment day. Plasma cortisol decreased by 67.8 microg x h/dL (p < 0.001) during the run-in period. When ciclesonide was added, the change in mean plasma cortisol was similar for ciclesonide and placebo (8.5 microg x h/dL and 1.0 microg x h/dL, respectively). Dexamethasone decreased mean plasma cortisol (p < 0.001), demonstrating that further cortisol suppression was possible. This study suggests that intranasal ciclesonide can be used with an inhaled corticosteroid without increased cortisol suppression.

    Topics: Administration, Inhalation; Administration, Intranasal; Adolescent; Adult; Anti-Allergic Agents; Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Middle Aged; Patient Compliance; Pituitary-Adrenal System; Pregnenediones; Rhinitis, Allergic, Perennial

2007
Efficacy and safety of once or twice daily inhalation of extrafine HFA beclomethasone dipropionate in patients with mild to moderate asthma.
    Journal of physiology and pharmacology : an official journal of the Polish Physiological Society, 2007, Volume: 58 Suppl 5, Issue:Pt 1

    The relatively new chlorofluorocarbon-free solution preparation of beclomethasone dipropionate in hydrofluoroalkane (HFA-BDP) (Qvar, 3M Pharmaceuticals) generates an extra fine aerosol with a smaller particle size (mean mass aerodynamic diameter of 1.1 microm), drug deposition in the lung is more uniformly distributed, thus improving efficacy even at a low dose. This might be also important for the use of a new fixed combination containing HFA-BDP plus formoterol in one inhaler for basic therapy and for an as-need application. Further, inhalation once a day might considerably enhance patients' adherence to maintenance therapy. The aim of this study was to test clinical efficacy and safety of twice daily inhalation (b.i.d.) vs. once daily inhalation (o.d.). In a double-blind, randomised, multicenter, parallel-group study, the efficacy and safety of 200 microg HFA-BDP o.d. (evenings) was compared with 100 microg HFA-BDP b.i.d., and with placebo. The trial included 201 patients with mild to moderately severe asthma. FEV1 was the primary endpoint and treatment duration was eight weeks. The improvement of FEV1 (20.4% o.d. vs. 12.9% b.i.d. vs. 7.9% placebo) was comparable in the two BDP groups. Both were more effective than placebo (P=0.014). The efficacy of o.d. dose was also equivalent to b.i.d. dose in secondary endpoints (peak flow, beta2-sympathomimetic drug use, asthma symptom score, and nocturnal awakenings). The treatment was well tolerated. A single evening dose (200 microg HFA-BDP) is as equivalently effective as the twice daily inhalation (2x100 microg HFA-BDP) in mild to moderate asthma.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Aerosol Propellants; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chemistry, Pharmaceutical; Double-Blind Method; Drug Administration Schedule; Female; Forced Expiratory Volume; Germany; Humans; Hydrocarbons, Fluorinated; Male; Middle Aged; Powders; Severity of Illness Index; Treatment Outcome

2007
Beclomethasone dipropionate attenuates airways hyperresponsiveness to neurokinin A and histamine in asthma.
    Respiratory medicine, 2006, Volume: 100, Issue:6

    Inhaled corticosteroids (ICS) are the most effective anti-inflammatory agents available for the treatment of asthma but they produce only modest effects on airway inflammation and non-specific bronchial hyperresponsiveness (BHR). However, little is known about the possibility that treatment with ICS might cause additional protection on BHR to inhaled tachykinins such as neurokinin A (NKA).. Therefore, we compared the effects of beclomethasone dipropionate (BDP) on the degree of BHR to inhaled histamine and NKA in a double-blind, controlled, cross-over study of asthmatic patients.. Patients attended the laboratory before and after each 6 weeks treatment period to undertake concentration-response studies with histamine and NKA. Bronchial responsiveness to both funs was expressed as the provocative concentration producing a 20% decrease in FEV(1) from baseline (PC(20)).. BDP therapy attenuated the constrictor response to both agonists to a similar degree, their geometric mean (range) PC(20) values increasing from 0.47 (0.21-1.41) mg/ml to 2.43 (0.51-4.50) mg/ml (P<0.01, post-salb vs. post-BDP treatment) and from 101.7 (27.3-356.1) microg/ml to 666.7 (151.5-1,000) microg/ml (P<0.01, post-salb vs. post-BDP treatment) for histamine and NKA, respectively.. Airway responsiveness to histamine and NKA is reduced by BDP to the same extent. As a result of these findings, provocation with NKA is unlikely to provide additional useful information in the assessment of airway inflammation in asthma.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Albuterol; Analysis of Variance; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Female; Histamine; Humans; Male; Neurokinin A; Statistics, Nonparametric

2006
Corticosteroid sparing effects of vitamin C and magnesium in asthma: a randomised trial.
    Respiratory medicine, 2006, Volume: 100, Issue:1

    The study aims to assess the a priori hypothesis that regular supplementation with vitamin C or magnesium will permit a reduction in the corticosteroid dose required to maintain asthma control in adults.. We invited all participants recruited from primary care centres who completed a parallel-group, randomised, placebo-controlled, 16-week supplementation trial of 1g/day vitamin C or 450 mg/day magnesium to continue and participate in a structured corticosteroid reduction protocol over 10 weeks.. A total of 92 participants (29 vitamin C, 31 magnesium and 32 placebo) entered the study. Assuming no reduction in corticosteroid dose in the 10 who subsequently withdrew, the geometric mean reductions in inhaled corticosteroid dose achieved with vitamin C, magnesium and placebo were 49, 13 and 11 microg, respectively. Relative to placebo, the unadjusted effect of vitamin C was significant, and remained at borderline significance after adjustment for baseline corticosteroid dose (relative reduction ratio=4.03, 95% CI 0.95 to 17.1, P=0.06).. We conclude that while vitamin C supplements may have modest corticosteroid sparing effects and hence the potential to reduce exposure to their side effects, magnesium supplements have no effect on the inhaled corticosteroid dose required to maintain asthma control.

    Topics: Administration, Inhalation; Adolescent; Adult; Ascorbic Acid; Asthma; Beclomethasone; Double-Blind Method; England; Female; Glucocorticoids; Humans; Magnesium; Male; Middle Aged; Vitamins

2006
Comparison of roflumilast, an oral anti-inflammatory, with beclomethasone dipropionate in the treatment of persistent asthma.
    Allergy, 2006, Volume: 61, Issue:1

    Roflumilast is an oral, once-daily phosphodiesterase 4 inhibitor with anti-inflammatory activity in development for the treatment of asthma. Roflumilast was compared with inhaled beclomethasone dipropionate (BDP) in patients with asthma.. In a double blind, double-dummy, randomized, noninferiority study, 499 patients (forced expiratory volume in 1 s [FEV1] = 50-85% predicted) received roflumilast 500 microg once daily or BDP 200 microg twice daily (400 microg/day) for 12 weeks. Lung function and adverse events were monitored.. Roflumilast and BDP significantly improved FEV1 by 12% (270 +/- 30 ml) and 14% (320 +/- 30 ml), respectively (P < 0.0001 vs baseline). Roflumilast and BDP also significantly improved forced vital capacity (FVC) (P < 0.0001 vs baseline). There were no significant differences between roflumilast and BDP with regard to improvement in FEV1 and FVC. Roflumilast and BDP showed small improvements in median asthma symptom scores (-0.82 and -1.00, respectively) and reduced rescue medication use (-1.00 and -1.15 median puffs/day, respectively; P < 0.0001 vs baseline). These small differences between roflumilast and BDP were not considered clinically relevant. Both agents were well tolerated.. Once daily, oral roflumilast 500 microg was comparable with inhaled twice-daily BDP (400 microg/day) in improving pulmonary function and asthma symptoms, and reducing rescue medication use in patients with asthma.

    Topics: Administration, Inhalation; Administration, Oral; Adolescent; Adult; Aged; Aminopyridines; Anti-Inflammatory Agents; Asthma; Beclomethasone; Benzamides; Child; Cyclopropanes; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Forced Expiratory Volume; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Probability; Respiratory Function Tests; Risk Assessment; Severity of Illness Index; Statistics, Nonparametric; Treatment Outcome

2006
Influence of body mass index on the response to asthma controller agents.
    The European respiratory journal, 2006, Volume: 27, Issue:3

    The incidence of asthma has been positively associated with obesity. Asthma comprises diverse "phenotypes" reflecting heterogeneity in a number of characteristics, including response to therapy. The present authors examined whether body mass index (BMI) influenced the response to placebo, as well as to two asthma controller medications. A post hoc analysis was performed, pooling data from four double-blind, placebo-controlled studies randomising 3,073 moderate asthmatic adults to montelukast (n=1,439), beclomethasone (n=894) or placebo (n=740). The primary end point was asthma control days; other end points were forced expiratory volume in one second, beta-agonist use and nocturnal awakening. Analyses were conducted using BMI classification into normal (<25.0 kg.m-2; 52% of patients), overweight (25-29.9 kg.m-2; 32%) and obese (>or=30.0 kg.m-2; 16%) categories, as well as BMI as a continuous variable. The treatment groups were balanced for BMI, demographic characteristics and parameters of asthma control. The placebo response for all end points was generally lower with increasing BMI. Similarly, the response to the inhaled corticosteroid decreased, whereas the response to the leukotriene antagonist remained stable. In conclusion, post hoc data from the present study suggested that body mass index may influence the natural history of asthma control (as reflected by response to placebo) and may differentially influence response to the two active agents, warranting explicit testing in future prospective studies.

    Topics: Acetates; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Mass Index; Cyclopropanes; Double-Blind Method; Female; Humans; Male; Middle Aged; Quinolines; Sulfides; Treatment Outcome

2006
Effects of hydrofluoroalkane and dry powder-formulated corticosteroids on sputum inflammatory markers in asthmatic patients.
    Canadian respiratory journal, 2006, Volume: 13, Issue:2

    Inhaled corticosteroids are powerful drugs that can suppress airway inflammation in asthmatic patients. Deposition of most of the inhaled corticosteroid occurs mainly in the central airways. However, a new hydrofluoroalkane formulation of beclomethasone dipropionate (HFA-BDP) is preferentially deposited in the distal airways. Inflammatory characteristics of induced sputum have been shown to differ in samples collected early after sputum induction compared with later.. To compare the effects of HFA-BDP and budesonide in a dry powder inhaler (DPI-BUD) on inflammatory cells and inflammatory cytokine expression in early and late induced sputa compared with placebo.. Seventeen patients with mild, intermittent bronchial asthma were randomly assigned to two treatment groups: eight patients received HFA-BDP and nine patients received DPI-BUD. Each patient was treated with one of the active treatments and placebo (for four weeks), with a two-week washout interval in between. Inflammatory cells and expression of interleukin (IL)-4 and IL-5 were measured in early and late induced sputa before and after active treatment, as well as before and after placebo treatment using immunocytochemistry and in situ hybridization.. Compared with placebo, eosinophils were significantly reduced in both early and late induced sputa after HFA-BDP treatment (P<0.05), whereas DPI-BUD had a significant effect only on early induced sputum. Both HFA-BDP and DPI-BUD decreased IL-4 expression in early and late induced sputa, but the effect was more prominent with HFA-BDP. IL-5 expression was reduced in both early and late induced sputa after HFA-BDP treatment. DPI-BUD significantly decreased IL-5 expression in early but not in late induced sputum. The number of lymphocytes was not altered by either treatment.. HFA-BDP reduced eosinophilic inflammation and T helper 2-type cytokine expression in both early and late induced sputa, whereas the effect of DPI-BUD on inflammation was predominantly demonstrated in early induced sputum.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Aerosol Propellants; Algorithms; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biomarkers; Budesonide; Cytokines; Double-Blind Method; Eosinophils; Female; Humans; Hydrocarbons, Fluorinated; Lymphocytes; Male; Powders; Sputum

2006
A comparison of 2 extrafine hydrofluoroalkane-134a-beclomethasone formulations on methacholine hyperresponsiveness.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2006, Volume: 96, Issue:3

    Small airways inflammation is a recognized pathologic component of asthma, and it is postulated that the observed airway-wall remodeling in small airways could be due to uncontrolled inflammation in airways that are not penetrated by conventional inhaled corticosteroids. Thus, extrafine particle formulations of inhaled corticosteroids are of clinical interest.. To compare 2 extrafine solution hydrofluoroalkane-134a formulations of beclomethasone dipropionate (Beclate and Qvar).. Fifteen asthmatic patients (mean +/- SEM forced expiratory volume in 1 second [FEV1], 2.62 +/- 0.21 L; provocative concentration of methacholine causing a 20% decrease in FEV1 [PC20], 1.06 +/- 0.58) were randomized to completion in a placebo-controlled, double-blind, crossover manner to receive Beclate or Qvar at doses of 100 or 400 microg/d for 2 weeks, with a 1-week washout period before each randomized treatment. Methacholine hyperresponsiveness was the primary outcome measure.. The 2 formulations were equivalent in terms of predefined equivalence limits of +/- 1 doubling dilution for PC20 at both doses: -0.25 (95% confidence interval [CI], -0.77 to 0.27) doubling dilution difference between the 100-microg doses and a 0.26 (95% CI, -0.29 to 0.82) doubling dilution difference between the 400-microg doses for the difference between Beclate and Qvar, respectively. Both formulations, at either dose, produced a statistically significant (P < .05) reduction in mean exhaled nitric oxide levels: 400 microg/d of Beclate, 14.1 ppb (95% CI, 5.6 to 22.6 ppb); and 400 microg/d of Qvar, 14.2 ppb (95% CI, 6.0 to 22.4 ppb). The higher doses produced a statistically significant (P < .05) reduction in early morning urinary cortisol-creatinine ratio (geometric mean fold suppression: Beclate, 1.48 [95% CI, 1.16 to 1.89]; and Qvar, 1.42 [95% CI, 1.12 to 1.79]). Both formulations significantly improved peak expiratory flow, FEV1, and forced expiratory flow between 25% and 75% of forced vital capacity at the higher doses (P < .05).. Beclate and Qvar were equivalent for all primary and secondary outcome measures.

    Topics: Adolescent; Adult; Aerosol Propellants; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchi; Bronchial Provocation Tests; Bronchoconstrictor Agents; Creatine; Female; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Male; Methacholine Chloride; Middle Aged; Nitric Oxide; Spirometry; Therapeutic Equivalency; Treatment Outcome

2006
Linear growth in prepubertal asthmatic children treated with montelukast, beclomethasone, or placebo: a 56-week randomized double-blind study.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2006, Volume: 96, Issue:6

    Antileukotrienes and inhaled corticosteroids are asthma controller agents widely used in the treatment of pediatric asthma.. To evaluate the effects of montelukast and beclomethasone on linear growth in prepubertal asthmatic children for 1 year.. This was a 30-center study of boys (6.4-9.4 years old) and girls (6.4-8.4 years old) at Tanner stage I with mild, persistent asthma. After a placebo run-in period, 360 patients were randomized in equal ratios to double-blind, double-dummy treatment with 5 mg of montelukast, 200 microg of beclomethasone twice daily (positive control), or placebo for 56 weeks; 90% of the patients completed the study. The primary end point was linear growth velocity, measured using a stadiometer.. Linear growth rates were similar between the montelukast and placebo groups; the mean difference for the year was 0.03 cm. The mean growth rate with beclomethasone was significantly less than with placebo (-0.78 cm) or montelukast (0.81 cm) (P < .001 for both). Median percentage of days with beta-agonist use was greater with placebo (14.58%) vs montelukast (10.55%) or beclomethasone (6.65%) (P < .05 for all). More patients used oral corticosteroid rescue with placebo (34.7%) than with montelukast (25.0%) or beclomethasone (23.5%). An imbalance in bone marker levels was seen with beclomethasone but not with montelukast.. In prepubertal asthmatic children, montelukast did not affect linear growth, whereas the growth rate with beclomethasone was significantly decreased during 1 year of treatment.

    Topics: Acetates; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Height; Child; Cyclopropanes; Double-Blind Method; Female; Humans; Leukotriene Antagonists; Male; Quinolines; Sulfides

2006
The use of patch formulation of tulobuterol, a long-acting beta2-adrenoreceptor agonist, in the treatment of severe pediatric asthma.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2006, Volume: 96, Issue:6

    Topics: Administration, Cutaneous; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Asthma; Beclomethasone; Bronchodilator Agents; Child; Drug Therapy, Combination; Humans; Peak Expiratory Flow Rate; Terbutaline

2006
The functional benefit of anti-inflammatory aerosols in the lung periphery.
    The Journal of allergy and clinical immunology, 2006, Volume: 118, Issue:2

    The target of anti-inflammatory therapy in asthma is thought to be situated, at least partly, in the lung periphery, and inhaled steroid aerosols are being engineered to reach it. However, the potential effect of such aerosols cannot be fully evaluated by conventional lung function tests because these are insensitive to peripheral lung structure.. A prospective cohort study was conducted to investigate whether ultrafine steroid aerosols can elicit a response in the lung periphery, using a validated multibreath washout technique that can distinguish acinar from conductive lung zone function.. In 30 stable patients with asthma with a wide range of disease severity (FEV(1) 27% to 108% predicted), we assessed conductive and acinar airway function abnormality at baseline, with patients on a standard dry powder steroid aerosol and after switching them to an ultrafine steroid aerosol.. Only in those patients with abnormal acinar airway function at baseline (n = 16) did acinar heterogeneity show a consistent improvement after switching to an ultrafine steroid aerosol; the improvement was also correlated with baseline acinar heterogeneity (r = -0.67; P = .007). Although all patients with asthma also presented conductive airway abnormality at baseline, no changes were observed in this lung zone with the switch to the ultrafine aerosol (P > .1).. Among stable patients with asthma, those with acinar lung zone abnormality at baseline have the potential to receive functional benefit from an ultrafine steroid aerosol. Clinical studies comparing the efficacy of steroid aerosols targeted to the deep lung should at least include a measurement of peripheral lung zone function.. A new noninvasive measure of small airways function reveals why, and for which particular patients with asthma, small steroid aerosol particles can be of therapeutic use.

    Topics: Adolescent; Adult; Aerosol Propellants; Aerosols; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Female; Humans; Hydrocarbons, Fluorinated; Lung; Male; Middle Aged; Nebulizers and Vaporizers; Particle Size; Powders; Spirometry

2006
Does the combination of inhaled steroids with long acting beta2 agonists decrease the risk for osteoporosis? A 1-year prospective follow-up study.
    Rheumatology international, 2006, Volume: 27, Issue:2

    Combination of inhaled corticosteroids (ICS) with long acting beta2 agonists has been used increasingly in the treatment of moderate-severe asthma, however there is indefinitive data about their effect on bone loss. The aim of this study was to compare the effects of treatment with single ICS and combination of ICS with long acting beta2 agonists (combination therapy) on BMD and biomarkers of bone metabolism in adult patients with asthma over 1 year period. Forty-three patients with asthma were enrolled. Patients were separated into two groups according to their use of asthma drugs: single ICS or combination therapy (ICS plus long-acting inhaled beta2-agonist). Change in bone mineral density (BMD) and biochemical markers of bone metabolism were measured at baseline and at the end of 1 year. Mean ages and basal BMD of patients did not differ between the two groups (P > 0.05). The decrease in BMD was higher in the single ICS group than the combination therapy group, however there was no significant difference between them (P > 0.05). One year change (%) in BMD and biochemical markers of bone metabolism were not different between two groups (P > 0.05). In conclusion, use of ICS-in the range of doses used- does not seem to have an effect on the change of BMD. However, our data indicate a nonsignificant trend towards reducing bone loss with the use of combination therapy. Future studies are needed to provide definitive evidence for this trend to allow us suggesting combination therapy for minimizing bone loss.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Albuterol; Androstadienes; Asthma; Beclomethasone; Bone Density; Bone Resorption; Budesonide; Drug Therapy, Combination; Ethanolamines; Female; Fluticasone; Formoterol Fumarate; Humans; Male; Middle Aged; Osteoporosis; Salmeterol Xinafoate

2006
Usefulness of HFA-BDP for adult patients with bronchial asthma: randomized crossover study with fluticasone.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2006, Volume: 43, Issue:7

    In this randomized crossover study, 22 adult patients with moderate-to-severe persistent bronchial asthma were assigned to one of two groups. Patients in group 1 were administered fluticasone dry powder inhaler (DPI) for 8 weeks followed by a 2-week washout period, then hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) for 8 weeks. After a further 2-week washout, they were again administered fluticasone DPI for 8 weeks. Patients in group 2 were assigned HFA-BDP followed by fluticasone PII and finally HFA-BDP over the same time periods. In both groups, no significant difference was observed in use of beta2-agonists and symptom score between the treatment periods; however, markers of pulmonary function were significantly higher when on HFA-BDP versus fluticasone DPI. Significant increases of morning peak expiratory flow (PEF) (p < 0.01), forced expiratory volume in 1 second (FEV1.0) (p < 0.01), V50 (p < 0.05), and V25 (p < 0.01) were observed at 18 weeks in group 1, whereas there were significant decreases of V50 (p < 0.05) at 18 weeks in group 2. No significant difference was noted in circulating eosinophil count and serum ECP between the 2 treatments; however, ECP in induced sputum and nitric oxide in expired gas were significantly lower (p < 0.05 and < 0.01, respectively) when on HFA-BDP versus fluticasone DPI. HFA-BDP might be delivered to small airways more effectively than fluticasone DPI.

    Topics: Adrenergic beta-Agonists; Adult; Aerosol Propellants; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Cross-Over Studies; Drug Combinations; Drug Therapy, Combination; Female; Fluticasone; Humans; Hydrocarbons, Fluorinated; Male; Medical Records; Metered Dose Inhalers; Middle Aged; Particle Size; Peak Expiratory Flow Rate

2006
Usefulness of QVAR for the treatment of bronchial asthma--with and without use of an inhalation device.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2006, Volume: 43, Issue:8

    The treatment of bronchial asthma with QVAR (hydrofluoroalkane-134a BDP; 3M Pharmaceuticals, St. Paul, MN, USA) is usually conducted without an inhalation assistance device. However, Japanese patients who experience difficulty in coordinating activation with inspiration of inhaled steroid drugs are instructed on the use of such a device. We therefore examined the necessity of using an inhalation assistance device (INSPIR-EASE, IE) and its effect on quality of life (QOL) in the treatment of patients with bronchial asthma taking QVAR. Hence, lung function and QOL associated with taking QVAR plus IE or QVAR alone were examined by a cross-over method in 44 bronchial asthma patients (STEP 2 or 3) over 20 years of age. In all patients, lung function tests conducted 12 weeks after start of treatment indicated significant improvements of forced expiratory volume in 1 second (FEV1) with QVAR alone compared with QVAR plus IE (p < 0.05). In patients less than 70 years of age, significant improvements of forced vital capacity (FVC) and nitric oxide (NO) were also observed with QVAR alone compared with QVAR plus IE (p < 0.05). Examination of QOL the Living with Asthma Questionnaire indicated that medication usage was significantly improved with QVAR alone compared with QVAR plus IE. Significant improvement of FEV1 was observed with QVAR alone compared with QVAR plus IE, and additionally in patients less than 70 years of age improvement of FVC and NO was also marked. This study confirmed the usefulness of QVAR alone in patients with bronchial asthma.

    Topics: Activities of Daily Living; Adult; Aerosols; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cross-Over Studies; Dose-Response Relationship, Drug; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Nitric Oxide; Quality of Life; Treatment Outcome; Vital Capacity

2006
Short-term growth and adrenal function in children with asthma treated with inhaled beclomethasone dipropionate hydrofluoroalkane-134a.
    Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2006, Volume: 17, Issue:8

    Inhaled beclomethasone dipropionate (BDP) with the propellant hydrofluoroalkane-134a (HFA) has been designed to be equivalent in terms of safety to chlorofluorocarbon (CFC)-formulated metered dose inhalers (MDI). The aim was to assess whether BDP HFA MDI 100 microg twice daily was equivalent to BDP CFC MDI 100 microg twice daily in terms of effects on short-term lower leg growth rate (LLGR) and measures of hypothalamic-pituitary-adrenal (HPA) function. The study consisted of a randomized double-blind cross-over trial with three active, a run-in and two wash-out periods each consisting of 2 wk. The place of study was a secondary referral outpatient clinic. The subjects involved were 14 boys and 10 girls with asthma, aged 7-12 yr. They were all administered BDP HFA 100 microg, BDP CFC 100 microg and 200 microg twice daily. The outcome measures included LLGR and 24-h urine-free cortisol (UFC) and total cortisol metabolites (TCM). Mean (SD) LLGR during run-in and BDP HFA 100 microg, BDP CFC 100 microg and 200 microg twice daily periods were 0.43 (0.23), 0.09 (0.29), 0.10 (0.45) and 0.08 (0.27) mm/wk. The one-sided 97.5% confidence interval for the difference in LLGR between BDP HFA 100 microg and BDP CFC 100 microg was 0.24, thus, below the predefined criterion of 0.20 mm/week. Inter-period comparisons of active treatments showed no differences between means of LLGR, UFC or TCM. Though non-inferiority between BDP HFA and CFC 100 microg twice daily in terms of effects on LLGR was not found, equivalence was suggested by comparisons of LLGR during run-in and active treatments and by HPA function measures.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Chlorofluorocarbons; Chlorofluorocarbons, Methane; Cross-Over Studies; Double-Blind Method; Female; Humans; Hydrocarbons, Fluorinated; Hypothalamo-Hypophyseal System; Leg; Male; Pituitary-Adrenal System; Treatment Outcome

2006
Efficacy of low and high dose inhaled corticosteroid in smokers versus non-smokers with mild asthma.
    Thorax, 2005, Volume: 60, Issue:4

    Cigarette smokers with asthma are insensitive to short term inhaled corticosteroid therapy, but efficacy when given for a longer duration at different doses is unknown.. Ninety five individuals with mild asthma were recruited to a multicentre, randomised, double blind, parallel group study comparing inhaled beclomethasone in doses of 400 microg or 2000 microg daily for 12 weeks in smokers and non-smokers. The primary end point was the change in morning peak expiratory flow (PEF). Secondary end points included evening PEF, use of reliever inhaler, number of asthma exacerbations, spirometric parameters, and asthma control score.. After 12 weeks of inhaled beclomethasone there was a considerable difference between the morning PEF measurements of smokers and non-smokers with asthma (-18 (95% CI -35 to -1), adjusted p = 0.035). Among those receiving 400 microg daily there was a difference between the mean (95% CI) morning PEF (l/min) in smokers and non-smokers (-25 (95% CI -45 to -4), adjusted p = 0.019) and in the number of asthma exacerbations (6 v 1 in smokers and non-smokers, respectively, p = 0.007). These differences were reduced between smokers and non-smokers receiving 2000 microg inhaled beclomethasone daily.. Compared with non-smokers, smokers with mild persistent asthma are insensitive to the therapeutic effect of low dose inhaled corticosteroid treatment administered for a 12 week period. The disparity of the response between smokers and non-smokers appears to be reduced with high dose inhaled corticosteroid. These findings have important implications for the management of individuals with mild asthma who smoke.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Forced Expiratory Volume; Humans; Middle Aged; Smoking; Vital Capacity

2005
Soluble CD23 and interleukin-1 receptor antagonist in human asthmatics following antigen challenge.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2005, Volume: 42, Issue:1

    Two postulated intrinsic anti-inflammatory mechanisms in asthma include the low affinity IgE receptor, or CD23, and interleukin 1 receptor antagonist (IL-1ra). We investigated the role these mediators play in the asthmatic response by measuring local levels in human asthmatics before and after segmental allergen challenge and examined the effect of inhaled corticosteroids on soluble CD23 and IL-1ra levels. Ten subjects underwent bronchoscopy at baseline and 24 hours after antigen challenge. Prior to challenge and every 12 hours afterward subjects received beclomethasone 252 microg or placebo. Fluid was analyzed for sCD23 and IL-1ra using ELISA immunoassays. Eosinophil percentages significantly increased at 24 hours following antigen challenge. sCD23 levels were generally undetectable at baseline and increased significantly following antigen challenge. IL-1ra levels increased 28-fold in the late-phase response. Beclomethasone significantly reduced the late-phase eosinophil percentage at 24 hours compared with placebo but did not attenuate late-phase sCD23 or IL-1ra levels. Our data showed a significant rise in the levels of two mediators thought to play an important role in the attenuation of the asthmatic response. The finding that steroid treatment did not enhance these levels suggests that this may be an independent approach to asthma therapy that should be investigated.

    Topics: Adolescent; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Provocation Tests; Cross-Over Studies; Double-Blind Method; Enzyme-Linked Immunosorbent Assay; Eosinophils; Female; Humans; Male; Middle Aged; Receptors, IgE; Receptors, Interleukin-1

2005
Comparison of inhaled corticosteroid combined with theophylline and double-dose inhaled corticosteroid in moderate to severe asthma.
    Respirology (Carlton, Vic.), 2005, Volume: 10, Issue:2

    Recent studies have found that theophylline exerts anti-inflammatory and immunomodulatory effects. This study was performed to compare the efficacy of inhaled corticosteroids (ICS) combined with slow-release theophylline (SRT) with that of double-dose ICS in asthma control, anti-inflammatory activity and safety.. In a randomized, open, parallel, control trial, 41 patients with asthma were randomly treated with either beclomethasone dipropionate 500 microg b.i.d. (BDP group) or a combination of BDP 250 microg b.i.d and SRT 0.2 g b.i.d. (SRT/BDP group) for 6 weeks. At the start and at the end of treatment, lung function testing and sputum induction were performed, and plasma cortisol levels were measured. Sputum was analyzed for cell differential counts and the interleukin (IL)-5 level. Patients kept a record of peak expiratory flow (PEF), symptom score, and beta2-agonist use.. Significant increases in the morning and the evening PEF and FEV1 were observed (P < 0.05), together with an obvious reduction in symptom score and beta2-agonist use (P < 0.01). Significant decreases in the percentage eosinophils and IL-5 level in induced sputum also occurred (P < 0.05). However, there was no difference between the two groups for all these parameters. There was no significant change in the plasma cortisol level for either group.. Both ICS combined with SRT and double-dose ICS had the same effect on asthma control, improving symptoms and ameliorating lung function. Both therapies had similar anti-airway inflammatory effects and therapeutic safety. Combining SRT with ICS may allow a reduction in ICS dose when treating asthma.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Bronchodilator Agents; Dose-Response Relationship, Drug; Drug Therapy, Combination; Eosinophils; Female; Glucocorticoids; Headache; Hoarseness; Humans; Hydrocortisone; Interleukin-5; Male; Middle Aged; Peak Expiratory Flow Rate; Respiratory Function Tests; Severity of Illness Index; Theophylline; Treatment Outcome

2005
Improvement of asthma control with beclomethasone extrafine aerosol compared to fluticasone and budesonide.
    Respiratory medicine, 2005, Volume: 99, Issue:6

    Qvar Autohaler efficacy on asthma control, assessed with E. Juniper asthma control questionnaire (ACQ), was compared with fluticasone and budesonide. An open randomized study, stratified (2:1) on the intake of long-acting beta2-mimetics (LAbeta2), was performed in patients with moderate to severe poorly controlled asthma (defined by at least one nocturnal discomfort in the last 5 days or a mean of 2 puffs of short-acting beta2-mimetics in the last 7 days or exercise dyspnea) despite treatment with beclomethasone < or = 1000 microg/day (or equivalent). 460 patients received Qvar Autohaler 800 microg/day (n = 149), fluticasone Diskus 1000 microg/day (n = 149) or budesonide Turbuhaler 1600 microg/day (n = 162) during 12 weeks. Asthma control improved in all groups, with no difference between groups. For patients treated with LAbeta2 (n = 286) a significantly greater improvement of the ACQ score was obtained with Qvar Autohaler versus fluticasone (1.0 +/- 1.0 vs. 0.6 +/- 0.9; P = 0.019), but not versus budesonide (0.9 +/- 0.9). Pulmonary function test improvements were similar in the 3 groups. The significant improvement in asthma control in patients receiving LAbeta2 suggests potential advantages for extrafine aerosols as part of anti-inflammatory treatment optimization.

    Topics: Administration, Inhalation; Adult; Aerosols; Albuterol; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Drug Administration Schedule; Drug Therapy, Combination; Ethanolamines; Female; Fluticasone; Formoterol Fumarate; Humans; Leukotriene Antagonists; Male; Metered Dose Inhalers; Middle Aged; Particle Size; Peak Expiratory Flow Rate; Respiratory Function Tests; Salmeterol Xinafoate

2005
Effects of HFA- and CFC-beclomethasone dipropionate on the bronchial response to methacholine (MCh) in mild asthma.
    Respiratory medicine, 2005, Volume: 99, Issue:7

    Metered inhalers using chlorofluorocarbon (CFC) propellents have been gradually replaced by new devices that use hydrofluoroalkanes (HFAs) as their propellents, which are less harmful to the environment. This reformulation led to a substantial improvement of the previous technologies applied to inhalation devices and of the physical characteristics of drugs delivered. In particular, inhaled corticosteroids, such as beclomethasone dipropionate (BDP) which is of fundamental importance in the long-term management of bronchial asthma, took advantage of this reformulation. Unlike the preparation beclomethasone dipropionate and chlorofluorocarbon (BDP-CFC) which was a suspension, that of beclomethasone dipropionate and a hydrofluoroalkane (BDP-HFA) is a solution and produces an aerosol with a mean aerodynamic particle size of 1.1 microm, which is much smaller than the particle size of 3.5-4.0 microm, obtained with the BDP-CFC. The particles of BDP-HFA can then deposit in the lungs in a larger amount, and particularly in the more peripheral airways where the inflammatory process starts in the case of bronchial asthma. A 12-week use of BDP-HFA ensured a significant better control of the bronchial response to methacholine (MCh) than the corresponding use of BDP-CFC for the same duration. The therapeutic performance of BDP-HFA proved much higher and allowed the substantial reduction of the therapeutic daily dose for the clinical asthma management, being the increased and more peripheral deposition of BDP-HFA is presumed to play a crucial role.

    Topics: Administration, Inhalation; Adult; Aerosol Propellants; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchi; Bronchoconstrictor Agents; Chlorofluorocarbons; Cross-Over Studies; Double-Blind Method; Female; Humans; Hydrocarbons, Fluorinated; Male; Metered Dose Inhalers; Methacholine Chloride; Middle Aged; Respiratory Function Tests

2005
Successful withdrawal of inhaled corticosteroids in childhood asthma.
    Respirology (Carlton, Vic.), 2005, Volume: 10, Issue:3

    Although inhaled corticosteroids are useful and effective in the prophylaxis of childhood asthma, there is a dearth of information regarding the duration of treatment. The present study was undertaken to assess the possibility of successful withdrawal of inhaled corticosteroids in childhood asthma following good control of the disease.. The study was carried out at the Asiri Hospital, Colombo, Sri Lanka and was a prospective observational clinical study. The participants were consecutive children with documented moderately severe and severe asthma seen over a period of 4 years from January 1990 and followed up to December 2003. Patients were allocated randomly to receive either beclomethasone dipropionate or budesonide. Initial dose of the selected drug was 300, 400 or 600 microg/day, depending on the child's age. After a period of stabilization, the dose was reduced from the starting dose to a maintenance level of 200, 300 or 400 microg/day, respectively. Once sustained control had been maintained for a period ranging from 9 to 18 months, gradual withdrawal was attempted. The dosage was reduced by 50-100 microg each time, at intervals of 3 months. Long-term follow up was maintained following withdrawal of inhaled corticosteroids. Breakthrough wheezing, acute severe attacks, hospitalization for wheezing and absence from school were used to assess the response.. Eighty-six children were recruited into the study. Eighty children responded well. The initial period on a high dose of corticosteroid was 8.4 months (range 4-12 months) and the average period of maintenance dosing was 11.7 months (range 9-18 months). The average time taken for withdrawal was 12.6 months (range 9-18 months). Successful withdrawal was achieved in 73 children. In this group, the mean total duration of treatment was 27.4 months (range 20-44 months). Up to December 2003, the subjects had been observed for an average period of 97.1 months (range 86-121 months) following withdrawal of inhaled corticosteroids. Of the 73 children in whom corticosteroids were withdrawn, 57 (78%) have remained well without any episodes of wheezing, and 14 (19%) have had mild episodes of wheezing that were easily controlled by bronchodilators. No patient needed hospitalization, long-term treatment or systemic corticosteroids. In two (3%) patients, it was necessary to restart inhaled corticosteroids because of troublesome recurrences.. It is possible to gradually withdraw inhaled corticosteroids in a significant proportion of asthmatic children once good control has been sustained on a maintenance dose for a considerable period.

    Topics: Administration, Inhalation; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Child; Child, Preschool; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Glucocorticoids; Humans; Infant; Male; Observation; Prospective Studies; Time Factors; Treatment Outcome

2005
Effects of mometasone furoate dry powder inhaler and beclomethasone dipropionate hydrofluoroalkane and chlorofluorocarbon on the hypothalamic-pituitary-adrenal axis in asthmatic subjects.
    Chest, 2005, Volume: 128, Issue:1

    Mometasone furoate dry powder inhaler (MF-DPI) [400 mug] is an inhaled corticosteroid (ICS) that is effective in the treatment of asthma. MF-DPI has a low potential for suppression of the hypothalamic-pituitary-adrenal (HPA) axis at its clinical dose. The effect of MF-DPI, 400 microg qd, on the HPA axis was compared to that of beclomethasone dipropionate (BDP) using hydrofluoroalkane (HFA) and chlorofluorocarbon (CFC) propellants via metered-dose inhalers (MDIs) twice daily.. This randomized, third-party blind, parallel-group study compared the effects of MF-DPI 400 mug one puff qd in the morning (n = 18), HFA-BDP 200 microg two puffs MDI bid (n = 18), and CFC-BDP 400 microg two puffs MDI bid (n = 17) for 14 days on the area under the 24-h serum cortisol concentrations curve (AUC(0-24)) and on total 24-h urinary free cortisol excretion in mild asthmatic subjects. Effects on morning/evening peak expiratory flow (PEF) and on inhaled albuterol use were also assessed. Adverse events that occurred during or > or = 30 days after the study were recorded.. The mean decrease from baseline in the serum cortisol concentrations AUC(0-24) in the MF-DPI group was significantly less than in either the HFA-BDP (p = 0.024) or the CFC-BDP (p = 0.011) groups. Decreases in serum cortisol concentrations AUC(0-24) in the two BDP groups did not differ from one another. The MF-DPI group trended toward higher morning and evening PEF than either BDP group. Treatment-associated adverse events were reported by seven subjects in the MF-DPI group, vs one subject in the HFA-BDP and three subjects in the CFC-BDP groups; these were mild, and no subject discontinued treatment due to an adverse event.. Fourteen days of treatment with MF-DPI 400 microg qd was associated with a significantly lesser decrease in the serum cortisol concentrations AUC(0-24) compared with HFA-BDP 200 microg MDI or CFC-BDP 400 microg MDI bid.

    Topics: Administration, Inhalation; Adolescent; Adult; Aerosol Propellants; Aged; Analysis of Variance; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Area Under Curve; Asthma; Beclomethasone; Chlorofluorocarbons; Creatinine; Female; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Hypothalamo-Hypophyseal System; Infant, Newborn; Male; Middle Aged; Mometasone Furoate; Pituitary-Adrenal System; Pregnadienediols

2005
Hydrofluoroalkane-134A beclomethasone or chlorofluorocarbon fluticasone: effect on small airways in poorly controlled asthma.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2005, Volume: 42, Issue:4

    Inflammation in asthma extends into the small airways (< 2 mm diameter). Most inhaled corticosteroids are suspensions with a particle size > 2 mm. Therefore, inflammation in the small airways of patients with asthma may not be adequately treated with these preparations. Some inhaled corticosteroids, on the other hand, are compounded with alcohol, resulting in a solution producing an aerosol that has a mean particle diameter of < 2 mm. This study was designed to compare the addition of equivalent amounts of two inhaled corticosteroids (one a suspension and one a solution) to the treatment of patients with asthma, which was uncontrolled despite treatment with moderate to high doses of inhaled corticosteroids and usually additional controller medications. The study was performed with 30 patients, > or = 18 years of age. Subjects were randomized in a single-blind fashion to receive, in addition to their current asthma therapy, either CFC-FP 220 microg each morning and 110 microg each evening (n = 10) or HFA-BDP 160 mcg twice daily (n = 20). Pre- and postbronchodilator spirometry, single breath nitrogen washout for closing volume and residual volume by plethysmography were assessed before and after 3 months of therapy. In the subjects who received HFA-BDP, the ratio of closing volume (CV) to vital capacity (VC) and residual volume (RV) decreased significantly (p = 0.0214 and 0.0433, respectively), whereas forced expiratory flow over 25-75% of the vital capacity (FEF25-75%), forced expiratory volume in 1 second (FEV1), and morning peak flow improved significantly (p = 0.0014, 0.0184, and 0.0321). Improvements from baseline of CV, CV/VC, and postbronchodilator FEF25-75%, were statistically significant in the HFA-BDP group compared with the CFC-FP group (p = 0.0049, 0.0194, and 0.0355, respectively). These preliminary findings suggest that the addition of HFA-BDP, compared with CFC-FP in patients with poorly controlled asthma despite receiving moderate to high doses of inhaled steroids, has a greater effect on parameters reflecting small airway patency presumably secondary to reduction in inflammation.

    Topics: Administration, Inhalation; Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchi; Bronchodilator Agents; Chlorofluorocarbons; Drug Administration Schedule; Drug Therapy, Combination; Female; Fluticasone; Humans; Hydrocarbons, Fluorinated; Male; Middle Aged; Pharmaceutical Solutions; Pulmonary Ventilation; Single-Blind Method; Suspensions

2005
Deposition of corticosteroid aerosol in the human lung by Respimat Soft Mist inhaler compared to deposition by metered dose inhaler or by Turbuhaler dry powder inhaler.
    Journal of aerosol medicine : the official journal of the International Society for Aerosols in Medicine, 2005,Fall, Volume: 18, Issue:3

    Fourteen mild-to-moderate asthmatic patients completed a randomized four-way crossover scintigraphic study to determine the lung deposition of 200 microg budesonide inhaled from a Respimat Soft Mist Inhaler (Respimat SMI), 200 microg budesonide inhaled from a Turbuhaler dry powder inhaler (Turbuhaler DPI, used with fast and slow peak inhaled flow rates), and 250 microg beclomethasone dipropionate inhaled from a pressurized metered dose inhaler (Becloforte pMDI). Mean (range) whole lung deposition of drug from the Respimat SMI (51.6 [46-57]% of the metered dose) was significantly (p < 0.001) greater than that from the Turbuhaler DPI used with both fast and slow inhaled flow rates (28.5 [24-33]% and 17.8 [14-22]%, respectively) or from the Becloforte pMDI (8.9 [6-12]%). The deposition pattern within the lungs was more peripheral for Respimat SMI than for Turbuhaler DPI. The results of this study showed that Respimat SMI deposited corticosteroid more efficiently in the lungs than either of two widely used inhaler devices, Turbuhaler DPI or Becloforte pMDI.

    Topics: Adult; Aerosols; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Cross-Over Studies; Equipment Design; Female; Forced Expiratory Volume; Humans; Lung; Male; Metered Dose Inhalers; Middle Aged; Nebulizers and Vaporizers; Radiopharmaceuticals; Technetium

2005
Effect of treating allergic rhinitis with corticosteroids in patients with mild-to-moderate persistent asthma.
    Chest, 2005, Volume: 128, Issue:5

    Rhinitis and asthma are considered to be synchronic or sequential forms of the same allergic syndrome. Treating the inflammation associated with allergic rhinitis influences the control of asthma. However, few studies have investigated the effect of treating perennial rhinitis on persistent asthma and vice versa. We determined the effects of inhaled or topical nasal beclomethasone dipropionate (BDP) administered separately or in combination on the control of asthma and bronchial hyperresponsiveness (BHR) in patients with the rhinitis/asthma association.. A double-blind, parallel, three-group study.. Outpatient clinic of Pulmonary Division/Heart Institute (InCor) and the Division of General Internal Medicine, University of Sao Paulo Medical School, Sao Paulo, Brazil.. Seventy-four patients with mild-to-moderate asthma and allergic rhinitis (median age, 25 years).. Patients received nasal or inhaled BDP separately or in combination for 16 weeks after a 2-week placebo run-in period.. Nasal and pulmonary symptoms, as well as pulmonary function and BHR, were compared among the three groups after 4 weeks and 16 weeks of treatment. Patients in all three groups demonstrated a progressive and significant decrease in nasal and pulmonary symptoms, which started after 4 weeks (p < 0.05) and continued through the end of treatment (p < 0.001). Clinical improvement was similar and parallel in the three groups. Asthma-related morbidity, evaluated by quantifying absence from work, emergency department visits, and nighttime awakenings, also decreased in the three groups (p < 0.05).. Failure to consider treatment of rhinitis as essential to asthma management might impair clinical control of asthma. Furthermore, these data suggest that asthma and rhinitis in some patients can be controlled by the exclusive use of nasal medication.

    Topics: Adolescent; Adult; Asthma; Beclomethasone; Bronchial Hyperreactivity; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Multivariate Analysis; Rhinitis, Allergic, Perennial

2005
Influence of particle size and patient dosing technique on lung deposition of HFA-beclomethasone from a metered dose inhaler.
    Journal of aerosol medicine : the official journal of the International Society for Aerosols in Medicine, 2005,Winter, Volume: 18, Issue:4

    The objective of this study was to determine the lung delivery of HFA-134a-beclomethasone dipropionate (HFA-BDP) from a breath-activated inhaler (QVAR Autohaler) compared with proper and improper press and breathe (QVAR P&B) metered dose inhaler (MDI) technique. The hypothesis was that that the smaller particles of BDP from HFA-BDP would stay suspended longer in the inspiratory air of patients and thus reduce the deleterious effects of inhaler discoordination. The study was an open label, four period, cross-over design. Asthmatic patients (n = 7) with a history of asthma symptoms, an FEV-1 of >70% of predicted normal, and a history of reversibility to a beta-agonist of >or=12% were utilized. BDP was radiolabeled with technetium-99m and delivered from the QVAR Autohaler or QVAR P&B device in patients trained to reproducibly utilize coordinated and discoordinated P&B MDI technique. Patients using Autohaler MDI exhibited 60% lung deposition of BDP. Patients using coordinated technique with the P&B MDI exhibited 59% lung deposition. Patients trained to consistently actuate the P&B MDI before inhaling exhibited 37% lung deposition. Patients trained to consistently actuate the P&B MDI late in the inspiration (i.e., 1.5 sec into a 3-sec inspiration) exhibited 50% lung deposition. In conclusion, the breath-activated Autohaler automatically provided optimal BDP lung deposition of 60%. Patients with good P&B MDI technique also received optimal lung deposition of 59%. The degree of lung deposition was decreased as patients demonstrated poor inhaler technique. However patients with poor technique still received a large lung dose of BDP (i.e., >or=37%) compared with lung deposition values of 4-7% for CFC-BDP MDIs previously published and confirmed in this study.

    Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Cross-Over Studies; Drug Delivery Systems; Female; Humans; Lung; Male; Metered Dose Inhalers; Middle Aged; Particle Size; Scintillation Counting; Technetium

2005
Doubling the dose of inhaled corticosteroid to prevent asthma exacerbations: randomised controlled trial.
    Lancet (London, England), 2004, Jan-24, Volume: 363, Issue:9405

    Asthma self-management plans that include doubling the dose of inhaled corticosteroid when the condition deteriorates improve asthma control. Whether doubling the dose of corticosteroid in isolation is effective is unknown. We undertook a randomised controlled trial to investigate the effects of doubling the dose of inhaled corticosteriods when asthma deteriorates.. 390 individuals with asthma who were at risk of an exacerbation monitored their morning peak flow and asthma symptoms for up to 12 months. When peak flow or symptoms started to deteriorate, participants added an active or placebo corticosteroid inhaler to their usual corticosteroid for 14 days to produce a doubling or no change in dose. The primary outcome was the number of individuals starting oral prednisolone in each group.. During 12 months, 207 (53%) started their study inhaler and 46 (12%) started prednisolone--22 (11%) of 192 and 24 (12%) of 198 in the active and placebo groups, respectively. The risk ratio for starting prednisolone was therefore 0.95 (95% CI 0.55-1.64, p=0.8).. We recorded little evidence to support the widely recommended intervention of doubling the dose of inhaled corticosteroid when asthma control starts to deteriorate.

    Topics: Acute Disease; Administration, Inhalation; Administration, Oral; Adrenal Cortex Hormones; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Male; Metered Dose Inhalers; Middle Aged; Prednisolone; Treatment Outcome

2004
Effect of caffeine ingestion on exhaled nitric oxide measurements in patients with asthma.
    American journal of respiratory and critical care medicine, 2004, May-01, Volume: 169, Issue:9

    Exhaled nitric oxide (FENO) measurements may be influenced by a number of confounding factors. Reports have offered conflicting evidence as to whether caffeine consumption increases or decreases FENO. In this study we aimed to confirm whether caffeine ingestion affects FENO in patients with asthma. On two separate days, 20 patients with asthma (10 steroid-naive and 10 steroid-treated) received a standard cup of either caffeinated or noncaffeinated coffee (15 g) (control) in a randomized, double-blind, cross-over manner. FENO measurements were obtained at baseline, and 30, 60, 120, and 180 minutes after ingestion. Serum caffeine levels were also measured at 0 and 60 minutes. No significant changes in FENO occurred after caffeine compared with the control. We conclude that caffeinated foods and beverages are unlikely to acutely influence FENO in subjects with asthma, and protocols for laboratory measurement do not need to take this factor into account.

    Topics: Administration, Oral; Adolescent; Adult; Aged; Analysis of Variance; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bias; Breath Tests; Caffeine; Confounding Factors, Epidemiologic; Cross-Over Studies; Double-Blind Method; Feeding Behavior; Forced Expiratory Volume; Humans; Metabolic Clearance Rate; Middle Aged; Nitric Oxide; Sensitivity and Specificity; Time Factors

2004
[Clinical evaluation of tulobuterol patch in patients with mild or moderate persistent bronchial asthma-effects of long-term treatment on airway inflammation and hypersensitivity].
    Nihon Kokyuki Gakkai zasshi = the journal of the Japanese Respiratory Society, 2004, Volume: 42, Issue:2

    The tulobuterol transdermal therapeutic system (TTS) is the world's first commercially available transdermal preparation of tulobuterol, a beta-2 stimulant, that can maintain effective blood tulobuterol levels for 24 hours when applied once daily. In the present study, a total of 36 adult patients with mildly persistent (Step 2) or moderately persistent (Step 3) bronchial asthma 19 who were using inhalational steroids and 17 who were not used tulobuterol TTS for one year and underwent measurement of peak expiratory flow (PEF) once daily. Peripheral eosinophil count, serum eosinophil cationic protein (ECP) level and airway responsiveness (Dmin) were evaluated at 6 months and 1 year after the start of the study. PEF exhibited significant improvements at 6 months and 1 year in patients treated with or without inhalational steroids, while serum ECP was improved significantly only in the patients on inhalational steroids. Patients not using inhalational steroids exhibited no significant exacerbation of Dmin at either 6 months or 1 year: One-year treatment with tulobuterol TTS did not appear to cause tachyphylaxis. The significant improvements in Dmin at 6 months and 1 year in the patients using inhalational steroids suggested that inhalational steroids offer beneficial effects in controlling airway inflammation. Tulobuterol TTS is considered quite beneficial in improving quality of life (QOL) in patients with bronchial asthma because its incidence of adverse effects including palpitations and shivering is significantly lower than those of oral preparations, because of its remarkable improvement of pulmonary function and symptoms of airway obstruction without increasing airway responsiveness even after repeated use, and because it is simple to use and offers excellent clinical efficacy.

    Topics: Administration, Cutaneous; Administration, Inhalation; Adrenergic beta-Agonists; Aged; Androstadienes; Asthma; Beclomethasone; Bronchial Hyperreactivity; Delayed-Action Preparations; Drug Therapy, Combination; Female; Fluticasone; Humans; Inflammation; Male; Middle Aged; Peak Expiratory Flow Rate; Quality of Life; Severity of Illness Index; Terbutaline; Time Factors; Treatment Outcome

2004
Randomized trial of inhaled beclomethasone dipropionate versus theophylline for moderate asthma during pregnancy.
    American journal of obstetrics and gynecology, 2004, Volume: 190, Issue:3

    This study was undertaken to compare the efficacy of inhaled beclomethasone dipropionate to oral theophylline for the prevention of asthma exacerbation(s) requiring medical intervention.. A prospective, double-blind, double placebo-controlled randomized clinical trial of pregnant women with moderate asthma was performed.. There was no significant difference (P=.554) in the proportion of asthma exacerbations among the 194 women in the beclomethasone cohort (18.0%) versus the 191 in the theophylline cohort (20.4%; risk ratio [RR]=0.9, 95% CI=0.6-1.3). The beclomethasone cohort had significantly lower incidences of discontinuing study medications caused by side effects (RR=0.3, 95% CI=0.1-0.9; P=.016), and proportion of study visits with forced expiratory volume expired in 1 second (FEV1) less than 80% predicted (0.284+/-0.331 vs 0.284+/-0.221, P=.039). There were no significant differences in treatment failure, compliance, or proportion of peak expiratory flow rate less than 80% predicted. There were no significant differences in maternal or perinatal outcomes.. The treatment of moderate asthma with inhaled beclomethasone versus oral theophylline resulted in similar rates of asthma exacerbations and similar obstetric and perinatal outcomes. These results favor the use of inhaled corticosteroids for moderate asthma during pregnancy because of the improved FEV1 and because theophylline had more side effects and requires serum monitoring.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Odds Ratio; Pregnancy; Pregnancy Complications; Severity of Illness Index; Theophylline; Treatment Outcome

2004
Safety and efficacy of HFA-134a beclomethasone dipropionate extra-fine aerosol over six months.
    Canadian respiratory journal, 2004, Volume: 11, Issue:2

    To compare the systemic safety and efficacy of hydrofluoroalkane beclomethasone dipropionate (HFA-BDP) extra-fine aerosol 800 microg/day with chlorofluorocarbon (CFC)-BDP 1500 microg/day.. Six-month, randomized, parallel-group, double-blind, double-dummy study.. Patients (n=141) with moderate to severe asthma adequately controlled by CFC-BDP 1000 microg/day to 2000 microg/day.. Patients received CFC-BDP 1500 microg/day during a two-week run-in period and were then randomized to either HFA-BDP (n=70) or CFC-BDP (n=71).. Similar proportions of HFA-BDP and CFC-BDP patients had a 24 h urinary free cortisol values below the reference range at month 6 (15% versus 25%, P=0.35). Measures of adrenocorticotrophic hormone stimulation and morning plasma cortisol levels were also similar in each group. The frequency of skin bruising and oral candidiasis was low for both treatments. No change in intraocular pressure was reported for either treatment. Pulmonary function was similar in both groups; however, the onset of the first asthma exacerbation or increased asthma symptoms tended to be earlier for CFC-BDP than for HFA-BDP (P=0.076); 27% of CFC-BDP patients reported increased asthma symptoms, compared with 14% of HFA-BDP patients (P=0.095).. HFA-BDP 800 microg/day has a systemic adverse event profile comparable to that of CFC-BDP 1500 microg/day, and further control of asthma symptoms may be achieved after a switch from CFC-BDP 1500 microg/day to HFA-BDP 800 microg/day.

    Topics: Administration, Inhalation; Adolescent; Adult; Aerosol Propellants; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chlorofluorocarbons; Double-Blind Method; Drug Administration Schedule; Female; Headache; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Male; Respiratory Tract Infections; Treatment Outcome

2004
Exhaled nitric oxide in children with asthma receiving Xolair (omalizumab), a monoclonal anti-immunoglobulin E antibody.
    Pediatrics, 2004, Volume: 113, Issue:4

    To evaluate the effect of a humanized monoclonal antibody to immunoglobulin E, omalizumab (Xolair, Novartis Pharmaceuticals, East Hanover, NJ; Genentech Inc, South San Francisco, CA), on airway inflammation in asthma, as indicated by the fractional concentration of exhaled nitric oxide (FE(NO)), a noninvasive marker of airway inflammation. Xolair was approved recently by the US Food and Drug Administration for moderate-to-severe allergic asthma in adolescents and adults.. As an addendum at 2 sites to a randomized, multicenter double-blind, placebo-controlled trial, FE(NO) was assessed in children with allergic asthma over 1 year. There were 3 consecutive study periods: 1) stable dosing of inhaled beclomethasone dipropionate (BDP) when the dose was optimized (period of 16 weeks); 2) inhaled steroid-reduction phase (period of 12 weeks), during which BDP was tapered if subjects remained stable; and 3) open-label extension phase, during which subjects receiving placebo were switched to active omalizumab (period of 24 weeks). The primary outcome was area under the FE(NO) versus time curve (AUC) for adjusted FE(NO), defined as the ratio of FE(NO) at each time point compared with the value at baseline.. Twenty-nine subjects participated and were randomized to omalizumab (n = 18) and placebo (n = 11) treatment groups in a 2:1 ratio dictated by the main study. There was a significant difference for age, resulting in a difference in absolute forced expiratory volume in 1 second but no difference in asthma severity based on the forced expiratory volume in 1 second percentage predicted. Baseline BDP dose was comparable between groups, as were baseline values of mean FE(NO) (active: 38.6 +/- 25.6 ppb; placebo: 52.7 +/- 52.9 ppb). The degree of BDP dose reduction during the steroid-reduction and open-label phases was equivalent between the omalizumab and placebo-treated groups; subjects in the omalizumab- and placebo-treated groups had reduced their BDP dose by an average of 51% and 60%, respectively, at the end of the steroid-reduction phase and by 68% and 94%, respectively, by the end of the open-label period. In the active and placebo groups, 44% and 27% and 75% and 73% of subjects had stopped use of inhaled corticosteroids at the end of the steroid-reduction and open-label phases, respectively. There was no significant difference between the active and placebo groups during the steroid-stable phase for AUC of adjusted nitric oxide (1.31 +/- 1.511 vs 1.45 +/- 0.736). However, during the steroid-reduction phase, the variability of adjusted FE(NO) in the placebo-treated group was greater than that of the omalizumab-treated group at most visits, with a significant difference between groups for AUC of adjusted nitric oxide (0.88 +/- 0.69 vs 1.65 +/- 1.06). FE(NO) fell from 82.1 +/- 55.6 ppm at the end of the steroid-reduction phase to 33.3 +/- 21.6 ppb at the end of the open-label period in the placebo group who were placed on active omalizumab. This decrease occurred while the mean dose of BDP remained very low. Analysis of FE(NO) over 52 weeks of omalizumab treatment in the active group demonstrated that there was a significant reduction from baseline to the end of the open-label period (41.9 +/- 29.0 to 18.0 +/- 21.8 ppb) despite a high degree of steroid reduction.. In this preliminary study based on FE(NO), a noninvasive marker of airway inflammation, treatment with omalizumab may inhibit airway inflammation during steroid reduction in children with allergic asthma. The degree of inhibition of FE(NO) was similar to that seen for inhaled corticosteroids alone, suggesting an antiinflammatory action for this novel therapeutic agent in asthma. This is in keeping with recent evidence that omalizumab inhibits eosinophilic inflammation in induced sputum and endobronchial tissue.

    Topics: Anti-Asthmatic Agents; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Beclomethasone; Breath Tests; Child; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Immunoglobulin E; Male; Nitric Oxide; Omalizumab

2004
Predicting response to omalizumab, an anti-IgE antibody, in patients with allergic asthma.
    Chest, 2004, Volume: 125, Issue:4

    To determine baseline characteristics predictive of response to omalizumab, an anti-IgE antibody, in patients with allergic asthma.. Pooled analysis of two multicenter, double-blind, randomized, placebo-controlled phase III studies with omalizumab.. One thousand seventy allergic asthma patients symptomatic despite moderate-to-high doses (mean, 725 micro g/d) of inhaled beclomethasone dipropionate (BDP).. Omalizumab (n = 542) or placebo (n = 528) were administered at a 4-weekly subcutaneous dose of at least 0.016 mg/kg/IgE (IU/mL) for 16 weeks in addition to stable BDP therapy.. Univariate logistic regression was performed to explore baseline variables predictive of best response. Various aspects of response (reduced symptom scores, reduced usage of rescue medication, improved lung function, improved quality of life [QoL]) were explored as well as a composite definition of response (response in at least one of these four aspects with no asthma exacerbation during 16 weeks of treatment). Time to onset of response as well as the ability to predict eventual response were also determined for the composite definition of response. A consistent pattern of predictive covariates was seen over all definitions of response (except for QoL). For the composite definition, a history of emergency asthma treatment in the past year was the factor most predictive (p = 0.015) of best response on active treatment (response rate for those with such history was 67% for omalizumab and 42% for placebo; for those without a history the response rates were 63% and 54%, respectively). Another factor predictive of best response on active treatment was high BDP dose (p = 0.037; response rate for those treated with >or= 800 micro g/d was 65% for omalizumab and 40% for placebo; for those treated with < 800 micro g/d, the response rates were 63% and 55%, respectively). A low FEV(1) was also predictive (p = 0.072; response rates for those with FEV(1) or= 65% predicted, the response rates were 67% and 53%, respectively). Seventy-six percent of patients had at least one of these factors. This subgroup showed odds of being a responder (composite definition) 2.25 times higher (95% confidence interval, 1.68 to 3.01) than placebo. Some 38% of patients treated with omalizumab showed a response (composite definition) at the first evaluation time point at 4 weeks, increasing to 64% at week 16 (vs 48% for placebo; p < 0.001). Among omalizumab responders at 16 weeks, only 61% had responded at 4 weeks whereas 87% had responded at 12 weeks.. Patients who benefit most when omalizumab is administered as add-on therapy are those receiving high doses of BDP, those with a history of frequent emergency asthma treatment, and those with poor lung function. Patients should be treated with omalizumab for a minimum duration of 12 weeks.

    Topics: Adolescent; Adult; Aged; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Beclomethasone; Child; Double-Blind Method; Female; Forced Expiratory Volume; Forecasting; Humans; Immunoglobulin E; Male; Middle Aged; Omalizumab; Respiratory Hypersensitivity; Treatment Outcome

2004
Effect of short-term treatment with inhaled corticosteroid on airway wall thickening in asthma.
    The American journal of medicine, 2004, Jun-01, Volume: 116, Issue:11

    Computed tomography studies demonstrate thickening of the asthmatic airway wall and its relation to disease severity. We evaluated the effect of inhaled corticosteroid on this phenomenon.. Cross-sectional images of the right upper lobe apical segmental bronchus were obtained by helical computed tomography in 45 corticosteroid-naïve patients with persistent asthma and 28 healthy controls. Airway wall thickness was measured as airway wall area normalized to body surface area. Computed tomography, pulmonary function, and serum levels of eosinophil cationic protein were examined before and after treatment with beclomethasone (800 microg/d for 12 weeks).. Before treatment, airway wall thickness was greater in asthma patients than in controls (P <0.0001). After treatment, it decreased by 11% (P <0.001) but remained high (P <0.0001 vs. control); the serum level of eosinophil cationic protein decreased, and airflow obstruction was reduced, but not to the level in controls. The decrease in wall thickness was associated with a decrease in the serum level of eosinophil cationic protein (r = 0.39, P = 0.009) and an increase in the forced expiratory volume in 1 second (r = 0.45, P = 0.003) and was inversely related to disease duration at entry (r = -0.38, P = 0.009). Post-treatment wall thickness was related to disease duration (r = 0.45, P = 0.003) and remaining airflow obstruction.. Wall thickening of asthmatic central airways responds partially to inhaled corticosteroid therapy and may reflect an overall reduction in airway inflammation. "Unresponsive components," possibly involving structural changes, may increase in the absence of inhaled corticosteroid treatment, potentially leading to chronic airflow obstruction.

    Topics: Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Blood Proteins; Drug Administration Schedule; Eosinophil Granule Proteins; Female; Follow-Up Studies; Glucocorticoids; Humans; Lung; Male; Middle Aged; Respiratory Function Tests; Respiratory Mucosa; Ribonucleases; Time Factors; Tomography, X-Ray Computed

2004
Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma.
    Allergy, 2004, Volume: 59, Issue:7

    Patients with poorly controlled asthma have greater morbidity and mortality. This study evaluated the efficacy and tolerability of omalizumab in patients with poorly controlled, moderate-to-severe allergic asthma.. This was a randomized, open-label, multicentre, parallel-group study. A total of 312 patients (12-73 years) receiving >/=400 microg/day (adolescent) or >/=800 microg/day (adult) inhaled beclomethasone dipropionate, or equivalent were included. Patients received best standard care (BSC) with or without omalizumab [at least 0.016 mg/kg/IgE (IU/ml) every 4 weeks] for 12 months.. The annualized mean number of asthma deterioration-related incidents was reduced from 9.76 with BSC alone (n = 106) to 4.92 per patient-year with omalizumab (n = 206) (P < 0.001). Mean clinically significant asthma exacerbation rates were 2.86 and 1.12 per patient-year, respectively (P < 0.001). Omalizumab-treated patients (41.4%) required rescue medication <1 day/week compared with 20.7% for BSC alone (P < 0.001). Omalizumab improved absolute forced expiratory volume in 1 s (FEV(1)) compared with BSC alone (2.48 and 2.28 l, respectively; P < 0.05) and reduced symptom scores relative to BSC alone (decrease of 6.5 and 0.7 respectively; P < 0.001). Omalizumab was well-tolerated.. Omalizumab administered as add-on therapy to BSC benefits patients with poorly controlled, moderate-to-severe allergic asthma.

    Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aged; Anti-Asthmatic Agents; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Beclomethasone; Child; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Immunoglobulin E; Leukotriene Antagonists; Male; Middle Aged; Omalizumab; Severity of Illness Index; Survival Analysis; Time Factors; Treatment Outcome

2004
Simultaneous treatment of asthma and allergic rhinitis.
    Pediatric pulmonology, 2004, Volume: 38, Issue:3

    Asthma and allergic rhinitis (AR) form a well-recognized comorbidity. This study aims at assessing the efficacy of nasally inhaled beclomethasone dipropionate (BDP) in their simultaneous treatment. A randomized controlled trial was conducted with 78 allergic rhinitis and asthma patients aged 5-17 years. Seventy-five individuals completed the study. During 8 weeks, 38 subjects received BDP-CFC aerosol (>or= 500 mcg/day) exclusively via nasal inhalation through a facemask attached to a plastic valved spacer. The control group (37 patients) received 200 mcg/day of aqueous intranasal beclomethasone plus oral inhalation of BDP-CFC (>or= 500 mcg/day) through a mouthpiece connected to the same spacer. Primary outcomes analyzed in order to assess the response to treatment were clinical scoring for allergic rhinitis and measurements of nasal inspiratory peak flow (NIPF). AR clinical scoring and NIPF did not differ in the two groups at admission or at nearly all follow-up visits. Nasal inhalation of beclomethasone dipropionate provides AR symptom relief while maintaining control of asthma by delivering it to the lungs. Therefore, this therapeutic strategy might be considered for patients suffering from this comorbidity, especially in low-resource countries, since it is less expensive than the conventional treatment.

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Comorbidity; Female; Humans; Male; Respiratory Function Tests; Rhinitis, Allergic, Perennial; Treatment Outcome

2004
Comparison of patient preference and ease of teaching inhaler technique for Pulmicort Turbuhaler versus pressurized metered-dose inhalers.
    Journal of aerosol medicine : the official journal of the International Society for Aerosols in Medicine, 2004,Summer, Volume: 17, Issue:2

    A multicenter, randomized, open-label, crossover study with two 4-week evaluation periods compared patient preference and ease of teaching correct inhaler technique for Pulmicort Turbuhaler versus pressurized metered-dose inhalers (pMDIs). Patients 18 to 65 years of age with stable, mild to moderate asthma, who required or were eligible for inhaled corticosteroid therapy, were randomized to treatment sequences consisting of 4-week evaluation periods with Pulmicort Turbuhaler (budesonide inhalation powder) two puffs (400 microg) bid and one of three inhaled corticosteroids via pMDI: Aerobid-M (flunisolide) four puffs (1 mg) bid, Flovent (fluticasone propionate) two puffs (440 microg) bid, or Vanceril Double Strength (beclomethasone dipropionate) five puffs (420 microg) bid. Patients indicated device preference at study end and completed the Patient Device Experience Assessment (PDEA) questionnaire after each evaluation period. Ease of teaching, time required to master use of the device, percentage of patients demonstrating mastery on the first attempt, and the number of attempts required to demonstrate mastery were assessed. Despite previous use of pMDIs by most patients, Pulmicort Turbuhaler was significantly preferred (p < 0.001) and required significantly less time to master than pMDIs (p < 0.001). Median times to device mastery were 3.67 min for Pulmicort Turbuhaler versus 5.33 min for pMDIs. Patients rated Pulmicort Turbuhaler significantly better than pMDIs on PDEA ease of use (p = 0.0005) and overall satisfaction (p < 0.0001) single-item scales and all four multi-item scales (pharyngeal symptoms, oral sensation, operational use, and inhaler attributes; p < 0.05). Overall, patients preferred Pulmicort Turbuhaler over pMDIs and required less time to be taught how to correctly use Turbuhaler trade mark.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cross-Over Studies; Female; Follow-Up Studies; Humans; Inhalation Spacers; Male; Metered Dose Inhalers; Middle Aged; Nebulizers and Vaporizers; Patient Compliance; Patient Education as Topic; Patient Satisfaction; Probability; Statistics, Nonparametric; Treatment Outcome

2004
Effects of high-dose inhaled fluticasone propionate on the hypothalamic-pituitary-adrenal axis in asthmatic patients with severely impaired lung function.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2004, Volume: 93, Issue:3

    The effects of high-dose fluticasone propionate therapy on dynamic cortisol stimulation in severe asthma are unknown.. To evaluate the human corticotropin-releasing factor (hCRF)-stimulated plasma cortisol response to fluticasone propionate therapy in severe asthmatic patients with impaired airway caliber (forced expiratory volume in 1 second [FEV1] < 60% of predicted) and in control subjects.. Ten severe asthmatic patients (mean FEV1, 47% of predicted) and 10 controls (mean FEV1, 104% of predicted) received fluticasone propionate, 2,000 microg/d, via a 750-mL primed spacer for 2 weeks. Plasma cortisol levels before and after hCRF stimulation and overnight 10-hour urinary cortisol excretion corrected for creatinine concentration (OUCC) were measured at baseline after washout and 12 hours after the last dose of fluticasone propionate.. Baseline values before fluticasone propionate use were not significantly different in asthmatic patients vs controls for plasma cortisol before and after hCRF stimulation and OUCC. Comparing values at baseline vs after fluticasone propionate use, there was no significant suppression of plasma cortisol levels before (378.2 vs 357.4 nmol/L) or after (510.5 vs 507.9 nmol/L) hCRF stimulation or OUCC (8.2 vs 7.5 nmoL/mmoL) in asthmatic patients. In controls, all outcomes were significantly suppressed comparing values before vs after fluticasone propionate therapy: plasma cortisol levels before (423.5 vs 200.2 nmol/L; P = .002) and after (503.5 vs 291.1 nmol/L; P = .001) hCRF stimulation and OUCC (6.5 vs 2.4 nmol/mmol; P = .002).. Patients with severe persistent asthma and impaired airway caliber seem to be protected from developing systemic adverse effects with high-dose fluticasone propionate therapy, as evaluated by basal and dynamic measures of hypothalamic-pituitary-adrenal axis activity.

    Topics: Adult; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Blood Proteins; Breath Tests; Creatinine; Dose-Response Relationship, Drug; Drug Therapy, Combination; Eosinophil Granule Proteins; Ethanolamines; Female; Fluticasone; Forced Expiratory Volume; Formoterol Fumarate; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Metered Dose Inhalers; Nitric Oxide; Peak Expiratory Flow Rate; Pituitary-Adrenal System; Ribonucleases; Salmeterol Xinafoate; Theophylline

2004
A single blinded randomised trial to compare the efficacy and safety of once daily budesonide (400microg) administered by turbuhaler with beclomethasone dipropionate (400microg) given twice daily through a metered-dose inhaler in patients with mild to mod
    African journal of medicine and medical sciences, 2004, Volume: 33, Issue:2

    The study compared clinical efficacy and safety of beclomethasone dipropionate (BDP) given at a dose of 400microg in the mornings and evenings and delivered via pressurised metered dose inhaler (pMDI) with budesonide given via a dry-powder, inspiratory flow driven device at a daily dose of 400microg in the evening. The study was conducted as a week screening. 8-week open comparative clinical trial. At the commencement of the therapy, the baseline characteristics of the patients randomised into the two drug groups were comparable. Efficacy was assessed by changes in symptoms, number of times beta2-agonist was used and results of pulmonary function tests (PEF and FEV1) while safety was assessed by adverse event experiences. At the end of the study, 24 patients (12 in each group) were evaluated. Both drugs were effective in reducing asthma symptoms and frequency of beta2-agonist usage, as well as improving the lung function tests (FEV1 and PEF). However, budesonide given via Turbuhaler provided better effects in all parameters. The drugs were well tolerated and no adverse event was noticed in any of the patients. We therefore concluded that budesonide Turbuhaler administered once daily at a dose of 400microg is more efficacious than beclomethasone 400microg twice daily administered via pressurized metered dose inhaler.

    Topics: Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Drug Administration Schedule; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Single-Blind Method; Treatment Outcome

2004
Distribution of therapeutic response in asthma control between oral montelukast and inhaled beclomethasone.
    The European respiratory journal, 2003, Volume: 21, Issue:1

    The distribution of responses in study populations provides a novel method of comparing the benefit of two treatments. This 6-week, randomised, placebo-controlled, double-blind study compared the effectiveness of oral montelukast with inhaled beclomethasone in chronic asthma by assessing the distribution and overlap of patient responses to therapy, as measured by a clinical outcome (asthma control days). A total of 730 adult patients with asthma, age 15-65 yrs, with a forced expiratory volume in one second (FEV1) at baseline of 50-85% of predicted and > or = 15% improvement in FEV1 after inhaled beta-agonist were enrolled. After a 2-week placebo run-in period, patients were randomly allocated to receive montelukast (10 mg once daily), inhaled beclomethasone (200 microg twice daily) or placebo. The primary end-point (per cent of asthma control days) was compared between treatments as the overlap in the response distributions. The overlap of the distribution of responses between the montelukast and beclomethasone groups was 89% for per cent asthma control days and 96% for change from baseline in FEV1. The mean (+/-SD) per cent asthma control days in the montelukast and beclomethasone groups was significantly higher than that in the placebo group (placebo 40.0+/-35.8, montelukast 50.7+/-37.1, beclomethasone 57.9+/-36.1). The mean differences between montelukast and placebo, beclomethasone and placebo, and montelukast and beclomethasone were significant. The mean per cent change (+/-SD) from baseline in FEV1 was 12.1+/-18.7 and 13.9+/-20.8 in the montelukast and beclomethasone groups, respectively, and significantly greater than that in the placebo group (6.4+/-20.1); there was no significant difference between the montelukast and beclomethasone groups in mean values or response distribution. There was also no difference among treatment groups in the frequency of adverse experiences. A comparison of the response distribution is an important approach to comparing therapies; montelukast and beclomethasone provided similar response distributions for the end-point of per cent asthma control days over a 6-week treatment period.

    Topics: Acetates; Administration, Inhalation; Administration, Oral; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cyclopropanes; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Quinolines; Spirometry; Sulfides; Time Factors

2003
The response of two different dosages of beclometasone dipropionate suspension for nebulization versus a standard dose of beclometasone dipropionate via a metered-dose inhaler on bronchoprovocation testing in adults with asthma.
    Respiratory medicine, 2003, Volume: 97 Suppl B

    The objective of this double-blind, randomized, placebo-controlled, parallel-group study was to compare the pharmacodynamic effects and safety of beclometasone dipropionate (BDP) given by nebulization or metered-dose inhalation in adult patients with asthma. Following a 1-week run-in period, 40 patients, aged 18-60 years, with intermittent bronchial asthma were randomized to one of four treatment groups for 3 weeks (n = 10 in each group): beclometasone dipropionate (BDP) suspension for nebulization 1,600 microg day(-1) b.i.d. via a nebulizer, BDP suspension for nebulization 3,200 microg day(-1) b.i.d. via a nebulizer, BDP 800 microg day(-1) b.i.d. via a metered-dose inhaler (MDI) plus spacer, or placebo. At study end, comparable effects were reported for all active treatment groups on the primary pharmacodynamic endpoint of FEV1 in response to methacholine bronchial provocation testing, with a statistically significant improvement shown in the BDP 3,200 microg day(-1) suspension for nebulization group compared with pre-treatment for other parameters, including FEV1 and peak expiratory flow rates. All treatments were comparable. All treatments were equally well tolerated. No significant effects on cortisol levels were reported in any of the treatment groups.

    Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Provocation Tests; Dose-Response Relationship, Drug; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Metered Dose Inhalers; Middle Aged; Peak Expiratory Flow Rate

2003
Comparison of the efficacy and safety of beclometasone dipropionate suspension for nebulization and beclometasone dipropionate via a metered-dose inhaler in paediatric patients with moderate to severe exacerbation of asthma.
    Respiratory medicine, 2003, Volume: 97 Suppl B

    Nebulization simplifies the administration of effective inhaled medications to young asthmatics who experience hand-to-lung co-ordination problems and inspiratory difficulties associated with metered-dose and dry-powder inhalers, respectively. The objective of this double-blind, double-dummy multicentre, randomized, parallel-group study was to compare the efficacy and safety of corticosteroids given by nebulization or metered-dose inhalation in paediatric patients with exacerbation of asthma. Following a 24-h run-in period, 151 patients, aged 6-16years, with moderate to severe exacerbation of asthma were randomized to one of two treatment groups for 4 weeks: beclometasone dipropionate (BDP) suspension for nebulization 1,600 microg day(-1) b.i.d. given via a nebulizer (n = 75), or BDP spray 800 microg day(-1) b.i.d. given via a metered-dose inhaler (MDI) plus spacer (BDP MDI) (n = 76). Superimposable and statistically significant improvements over baseline were noted at study end for the two treatment groups in the various efficacy parameters evaluated (pulmonary function tests, asthma symptoms scores, and the use of rescue salbutamol). The primary efficacy endpoint was the morning pulmonary expiratory flow rate (PEFR). In the BDP nebulization group, mean morning PEFR increased statistically significantly from 233.2 +/- 86.31 min(-1) to 322.0 +/- 101.81 min(-1), while in the BDP MDI group the increase was from 222.9 +/- 87.31 min(-1) to 314.9 +/- 96.61 min(-1). Moreover, an additional 4-week treatment period at half doses, completed by 26 patients, demonstrated that improvements were maintained or further enhanced. The two treatments were equally well tolerated. A total of 25 and 26 patients in the BDP nebulization and BDP MDI groups, respectively reported adverse events during the treatment period, and these were generally mild. In conclusion, the results of this study demonstrate that BDP suspension for nebulization 1,600 microg day(-1) given via a nebulizer and BDP spray 800 microg day(-1) given via an MDI plus spacer are equally effective, with an acceptable safety and tolerability profile, when used in paediatric patients with moderate to severe asthma exacerbation.

    Topics: Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Metered Dose Inhalers; Patient Satisfaction

2003
Comparison of the efficacy and safety of high doses of beclometasone dipropionate suspension for nebulization and beclometasone dipropionate via a metered-dose inhaler in steroid-dependent adults with moderate to severe asthma.
    Respiratory medicine, 2003, Volume: 97 Suppl B

    Nebulization for the administration of high doses of inhaled corticosteroids can benefit steroid-dependent asthmatics. The objective of this double-blind, double-dummy, multicentre, randomized, parallel-group study was to compare the efficacy and safety of high-dose corticosteroids given by nebulization or metered-dose inhalation in adult patients with asthma. Following a 2-week run-in period, 124 patients, aged 18-70 years, with moderate to severe asthma treated with high-dose inhaled steroids were randomized to one of two treatment groups for 12 weeks: beclometasone dipropionate (BDP) suspension for nebulization 3,000-4,000 microgday(-1) b.i.d. given via a nebulizer (n = 63), or BDP spray 1,500-2000 microgday(-1) b.i.d. given via a metered-dose inhaler (MDI) plus spacer (BDP MDI) (n = 61). Comparable improvements over baseline, which were statistically significant in most cases, were reported at study end for the two treatment groups in the various efficacy parameters evaluated (pulmonary function tests, clinical symptoms scores, and the use of rescue salbutamol). The primary efficacy endpoint was morning pulmonary expiratory flow rate (PEFR). For the intent-to-treat population, in the BDP nebulization group mean morning PEFR increased statistically significantly from 308.7 +/- 107.81 min(-1) to 3 19.2 +/- 104.01 min(-1) while in the BDP MDI group the increase was from 301.5 +/- 94.71 min(-1) to 309.3 +/- 86.71 min(-1). The two treatments were equally well tolerated.A total of 19 patients in each group reported adverse events during the treatment period, and these were generally mild-moderate in severity. In conclusion, the results of this study demonstrate that BDP suspension for nebulization 3,000-4,000 microg day(-1) given via a nebulizer and BDP spray 1,500-2,000 microg day(-1) given via an MDI plus spacer are equally effective, with an acceptable safety and tolerability profile, when used in steroid-dependent adult patients with moderate to severe asthma.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Metered Dose Inhalers; Middle Aged; Patient Satisfaction; Peak Expiratory Flow Rate; Vital Capacity

2003
Comparison of the efficacy and safety of nebulized beclometasone dipropionate and budesonide in severe persistent childhood asthma.
    Respiratory medicine, 2003, Volume: 97 Suppl B

    Inhaled steroids are recommended for long-term control of asthma, but their use may be limited in young children because of difficulties in using the associated inhaler device. The use of nebulizers may help to overcome this issue, without compromising therapeutic efficacy or safety. This 14-week, multicentre, randomized, controlled, open-label, parallel-group study compared the efficacy and safety of nebulized corticosteroids in paediatric patients (aged 6 months to 6 years) with severe persistent asthma. Beclometasone dipropionate (BDP) 800 microgday(-1) suspension for nebulization and budesonide (BUD) 750 microg day(-1) given by nebulization in a twice-daily regimen, and when used in addition to the usual maintenance therapy, resulted in comparable clinical efficacy across all parameters. The primary efficacy endpoint was the number of patients who did not experience any major exacerbation, this being 40.4% and 51.7% in the BDP and BUD groups respectively in the ITT population (P = 0.28), and the mean number of global exacerbations (major plus minor) decreased respectively by -37.5% in the BDP group and -23.3% in the BUD group. Both treatments were also associated with marked reductions in the number of nights with wheezing and the number of days of oral steroid use. Moreover, the two treatment groups had a similar adverse-event incidence and profile. Only 11 adverse events were reported, and no serious adverse events were related to treatment. Urinary cortisol and the time course of height and weight were unaffected by both treatments, and BDP was confirmed to have a neutral effect on bone metabolism. In conclusion, this study demonstrates that both BDP 800 microg day(-1) suspension for nebulization and BUD 750 microgday(-1) administered by nebulization are effective, with an acceptable safety profile, for treatment of severe persistent asthma in infants and young children.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Female; Humans; Infant; Male; Nebulizers and Vaporizers; Treatment Outcome

2003
Comparison of the efficacy of beclometasone dipropionate and fluticasone propionate suspensions for nebulization in adult patients with persistent asthma.
    Respiratory medicine, 2003, Volume: 97 Suppl B

    The use of nebulization for the administration of inhaled steroids plays an important role in asthma patients who are unable to use pressurized aerosol or dry-powder inhalers effectively. Moreover, the type of nebulizer used may affect how much drug is delivered to the lungs. The objective of this multinational, multicentre, randomized, active-controlled, parallel-group study was to compare the efficacy and safety of nebulized corticosteroids in adult patients with chronic asthma. Following a 1-week placebo run-in period, 205 patients, aged 18-65 years, with moderate persistent asthma were randomized to one of two treatment groups for 12 weeks: beclometasone dipropionate (BDP) suspension for nebulization 2,400 microg day(-1) b.i.d. (n = 103), or fluticasone propionate (FP) suspension for nebulization 2,000 microg day(-1) b.i.d. (n = 102), both administered by a jet nebulizer Comparable efficacy in controlling asthma was demonstrated by the two treatments at study end, as evident when evaluating various efficacy parameters (pulmonary function tests, asthma exacerbations and symptoms, and the use of rescue salbutamol). The primary efficacy endpoint was the variation in the pulmonary expiratory flow (PEF) at treatment end over the baseline visit. For the intent-to-treat population, in the BDP group mean PEF values increased statistically significantly from 5.2 +/- 1.31 s(-1) to 5.7 +/- 1.61 s(-1), while in the FP group the increase was from 5.2 +/- 1.21 s(-1) to 5.8 +/- 1.81 s(-1). Mean PEF values as per cent of predicted also increased in a statistically significant way, from 71% to 77.1 % in the BDP group, and from 70.1% to 76.9% in the FP group. The two treatments were equally well tolerated.A total of 23 and 32 patients in the BDP and FP groups, respectively, reported adverse events during the treatment period, and these were generally mild. In conclusion, the results of this study demonstrate that BDP 2,400 microg day(-1) and FP 2,000 microg day(-1), both suspensions for nebulization administered via a jet nebulizer, are equally effective, with an acceptable safety and tolerability profile, when used in adult patients with moderate persistent asthma.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Analysis of Variance; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chronic Disease; Female; Fluticasone; Forced Expiratory Volume; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Vital Capacity

2003
Internet-enabled interactive multimedia asthma education program: a randomized trial.
    Pediatrics, 2003, Volume: 111, Issue:3

    To determine whether health outcomes of children who have asthma can be improved through the use of an Internet-enabled interactive multimedia asthma education program.. Two hundred twenty-eight children with asthma visiting a pediatric pulmonary clinic were randomly assigned to control and intervention groups. Children and caregivers in both groups received traditional patient education based on the National Asthma Education and Prevention Program. Intervention group participants received additional self-management education through the Interactive Multimedia Program for Asthma Control and Tracking. Pediatric Asthma Care Knowledge Survey, Pediatric Asthma Caregiver's Quality of Life Questionnaire, asthma symptom history, spirometry, and health services utilization data were collected at the initial visit and at 3 and 12 months.. Interactive Multimedia Program for Asthma Control and Tracking significantly increased asthma knowledge of children and caregivers, decreased asthma symptom days (81 vs 51 per year), and decreased number of emergency department visits (1.93 vs 0.62 per year) among the intervention group participants. The intervention group children were also using a significantly lower average daily dose of inhaled corticosteroids (434 vs 754 micro g [beclomethasone equivalents]) at visit 3. Asthma knowledge of all 7- to 17-year-old children correlated with fewer urgent physician visits (r = 0.37) and less frequent use of quick-relief medicines (r = 0.30).. Supplementing conventional asthma care with interactive multimedia education can significantly improve asthma knowledge and reduce the burden of childhood asthma.

    Topics: Adolescent; Adult; Asthma; Beclomethasone; Caregivers; Child; Computer-Assisted Instruction; Emergency Service, Hospital; Female; Glucocorticoids; Health Education; Humans; Internet; Male; Multimedia; Outcome Assessment, Health Care; Patient Education as Topic; Program Evaluation; Quality of Life; Self Care

2003
Salbutamol and/or beclomethasone diproprionate in asthma.
    Indian journal of pediatrics, 2003, Volume: 70, Issue:2

    Acute severe exacerbation of asthma is potentially life threatening and requires critical assessment and appropriate therapy. Now a days, steroids are often combined with bronchodilators for the treatment of bronchial asthma. Therefore, the present study was undertaken to compare effectiveness of beclomethasone diproprionate-salbutamol combination versus salbutamol alone by MDI (with or without spacer) in acute asthma.. A total of 57 paediatric patients (5-12 years) with acute attack of bronchial asthma attending emergency department of Indira Gandhi Medical College and Hospital was randomised to receive salbutamol (100 microg/puff) alone or with BDP (50 microg/puff) by metered dose inhaler with or without spacer. All baseline investigations were repeated one hour after the therapy.. Clinical parameters indicative of severity of asthma improved statistically in all treatment groups. The increase in PEFR was better with MDI-S+B with spacer as compared to other groups, though it failed to reach statistical significance. The fall in serum potassium level is significantly more with MDI-S+B group when spacer was not used. No serious adverse effects were observed in any of the treatment groups.. Metered dose inhalation of BDP-salbutamol combination with spacer provides better recovery whereas fall in serum potassium with MDI-S+B suggests use of spacer and monitoring of serum potassium during treatment.

    Topics: Administration, Inhalation; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Female; Humans; Male; Metered Dose Inhalers; Peak Expiratory Flow Rate

2003
Creatininuria in asthmatic children treated with a combination of glucocorticoid and beta-agonist.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2003, Volume: 40, Issue:1

    We examined whether a combination of glucocorticoids and beta-agonists inhaled by asthmatics had an influence on the metabolism of L-arginine, an amino acid involved in the production of urea, creatinine, and NO that is known to play a significant role in asthma. After lung function tests, we assayed nitrates, urea, and creatinine and determined urinary osmolality in urine samples taken from groups of 129 children (10+/-3 years old) with mild-to-moderate asthma treated with different regimens of drugs. No significant differences in urinary urea levels were noted between the groups. On the other hand, the children treated by the combination of glucocorticoid and beta-agonist (n = 52) had a higher level of urinary creatinine (+40%, P < .001, and a higher creatinine/urea ratio (C/U) expressed as % mass= 5.98 +/- 2.44, P < .001) than did the untreated children (n = 43, C/U = 4.03 +/- 1.24), those treated with glucocorticoid (n = 23, C/U = 4.01 +/- 1.32) or beta-agonist alone (n = 11, C/U = 4.09 +/- 1.01) or control children of the same age (n = 20, C/U = 4.81 +/- .90). Children treated with beta-agonist alone had the lowest mean levels of urinary nitrates (P < .05). The children in group 1 whose C/U ratio was above 6 (n = 24) had a higher FVC (P < .02) and FEV1 (not significant (NS)). However, an overly high C/U may also be indicative of a deleterious influence on the biosynthesis of NO from arginine. Further investigations will be required to determine whether there is a relationship between C/U ratios and lung function parameters, and whether the urinary C/U ratio could be employed as a simple and noninvasive parameter for assessment of treatment in asthmatics.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Creatinine; Drug Therapy, Combination; Ethanolamines; Female; Formoterol Fumarate; Glucocorticoids; Humans; Male; Nitrates; Osmolar Concentration; Salmeterol Xinafoate; Terbutaline; Urea

2003
Stepping down inhaled corticosteroids in asthma: randomised controlled trial.
    BMJ (Clinical research ed.), 2003, May-24, Volume: 326, Issue:7399

    To determine whether the dose of inhaled corticosteroids can be stepped down in patients with chronic stable asthma while maintaining control.. One year, randomised controlled, double blind, parallel group trial.. General practices throughout western and central Scotland.. 259 adult patients with asthma receiving regular treatment with inhaled corticosteroids at high dose (mean dose 1430 microg beclomethasone dipropionate).. Participants were allocated to receive either no alteration to their dose of inhaled corticosteroid (control) or a 50% reduction in their dose if they met criteria for stable asthma (stepdown).. Comparison of asthma exacerbation rates, asthma related visits to general practice and hospital, health status measures, and corticosteroid dosage between the two groups.. The proportions of subjects with asthma exacerbations were not significantly different (stepdown 31%, control 26%, P=0.354). Similarly, the numbers of visits to general practice or hospital and the disease specific and generic measures of health status over the one year period were not significantly different. On average the stepdown group received 348 microg (95% confidence interval 202 microg to 494 microg) of beclomethasone dipropionate less per day than the controls (a difference of 25%), with no difference in the annual dose of oral corticosteroids between the two treatment regimens.. By adopting a stepdown approach to the use of inhaled steroids at high doses in asthma a reduction in the dose can be achieved without compromising asthma control.

    Topics: Administration, Inhalation; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chronic Disease; Double-Blind Method; Health Status; Humans; Middle Aged; Treatment Outcome

2003
Comparative bronchial vasoconstrictive efficacy of inhaled glucocorticosteroids.
    The European respiratory journal, 2003, Volume: 21, Issue:6

    The vasoconstrictive efficacies of glucocorticosteroids (GS) are usually compared by the McKenzie skin-blanching test and taken as an index of relative potency. The rationale for the present study was to transpose the McKenzie test to the airway and to compare the airway vascular effects of three inhaled GS: beclomethasone dipropionate (BDP), fluticasone propionate (FP) and budesonide (BUD), in healthy subjects and patients with mild stable asthma. A soluble, inert gas-uptake method was used to measure airway blood flow (Qaw). Baseline mean+/-SD Qaw normalised for anatomical dead space was 53.1+/-1.4 microL x min(-1) x mL(-1) in healthy subjects (n=10) and 67.8+/-3 microL x min(-1) x mL(-1) in asthmatics (n=10). All GS caused a transient decrease in Qaw. The magnitude of the vasoconstriction was greater in asthmatics. The relative vasoconstrictive effect of BDP, FP and BUD was 1, 1.9, and 2.7, respectively, in asthmatics and 1, 3.3 and 3.0, respectively, in healthy subjects, as assessed by the dose required to decrease Qaw by 20%, from the baseline, 30-min postdrug inhalation. Therefore, measuring airway blood flow may be a useful, site-specific parameter to assess the tissue bioavailability and vasoconstrictive efficacy of inhaled glucocorticosteroids.

    Topics: Administration, Inhalation; Adolescent; Adult; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchi; Budesonide; Dose-Response Relationship, Drug; Female; Fluticasone; Humans; Male; Middle Aged; Reference Values; Regional Blood Flow; Severity of Illness Index; Vasoconstriction

2003
Distribution of technetium-99m-labelled QVAR delivered using an Autohaler device in children.
    The European respiratory journal, 2003, Volume: 21, Issue:6

    QVAR, an extrafine hydrofluoroalkane/beclomethasone dipropionate formulation, has been shown to double lung deposition in adults. The aim of the present study was to assess the total body deposition and distribution of technetium-99m-labelled (99mTc) QVAR in children after inhalation via an Autohaler. Sixteen male asthmatic children (5-14 yrs) inhaled labelled drug (<4 MBq 99mTc; 100 microg beclomethasone dipropionate) via an Autohaler within 30 min after salbutamol (200 microg) administration. Simultaneous anterior and posterior planar scintigraphic scans (120 s acquisition time) were collected after inhalation of labelled drug. Mean+/-SD lung deposition of labelled drug (attenuation-corrected; percentage of ex-actuator dose) was 36.9+/-9.2, 46.5+/-11.6 and 54.1+/-10.7% in children aged 5-7, 8-10 and 11-14 yrs, respectively. Combined oropharyngeal and gastrointestinal deposition was 59.7+/-8.2, 48.9+/-12.3 and 40.3+/-11.8%. Lung deposition positively correlated with the forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). Gastrointestinal dose negatively correlated with the FEV1, FVC, height and age. In older children (11-14 yrs), lung deposition was almost identical to that reported in adults using QVAR. In children aged 5-10 yrs, lung deposition using QVAR was greater than the levels measured using other commercial aerosol delivery systems. Oropharygeal and gastrointestinal deposition was inversely related to age.

    Topics: Administration, Inhalation; Adolescent; Age Factors; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Humans; Hydrocarbons, Fluorinated; In Vitro Techniques; Male; Metered Dose Inhalers; Radionuclide Imaging; Reproducibility of Results; Severity of Illness Index; Technetium

2003
[Effects of H1 blocker and inhaled corticosteroids on asthmatic patients with allergic rhinitis].
    Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases, 2003, Volume: 26, Issue:3

    To evaluate the therapeutic effects of H(1) blocker in combination with low dose inhaled corticosteroid on allergic asthma.. A multi-center, double blind, randomized, placebo control study was conducted in 67 patients with mild to moderate allergic asthma. Patients were randomized to receive either Loratadine 10 mg or placebo twice a day on the basis of inhaled beclomethasone dipropionate (400 microg/d for 14 days, then reduced to 200 microg/d) for 5.3 +/- 1.3 months. Symptom scores of asthma, frequencies of episode of rhinitis and common cold and doses of inhaled Salbutamol as rescue drug were recorded. Bronchial hyperresponsiveness (PD(20) FEV(1) in response to Histamine) and serum ICAM-1 and VCAM-1 were measured before and after the treatment.. After treatment, there was much better improvement in symptom score (2.4 +/- 0.9 vs 3.1 +/- 0.9, P < 0.01), symptomatic days due to rhinitis (4.0 +/- 1.2 d/week vs 1.9 +/- 0.9 d/week, P < 0.001), episode of common cold symptom (0.8 +/- 0.5 time vs 1.1 +/- 0.4 time, P < 0.001), average doses of inhaled beta(2) agonist as rescue medication (2.6 +/- 0.9 puff/week vs 3.7 +/- 0.8 puff/week, P < 0.001) and bronchial responsiveness (P < 0.05) in Loratadine group as compared with the control group. However, there was no significant change in serum ICAM-1 and VCAM-1 levels after treatment in both groups (P > 0.05).. On the basis of low dose inhaled corticosteroid, orally administered Loratadine significantly improves the therapeutic efficacy of asthma in patients with allergic asthma and rhinitis.

    Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Double-Blind Method; Female; Histamine H1 Antagonists, Non-Sedating; Humans; Intercellular Adhesion Molecule-1; Loratadine; Male; Middle Aged; Rhinitis, Allergic, Perennial; Vascular Cell Adhesion Molecule-1

2003
Rapid effect of inhaled steroids on nocturnal worsening of asthma.
    Thorax, 2003, Volume: 58, Issue:7

    Inhaled steroids are the most commonly used anti-inflammatory agents for asthma and are increasingly recognised as having a more rapid onset of action than was previously thought. We have investigated the effect of a single dose of inhaled steroid on nocturnal worsening of asthma.. Ten patients with steroid naive moderate asthma and nocturnal asthma participated in a randomised, double blind, placebo controlled, crossover trial. Participants spent three nights in the laboratory, one week apart. On each night they underwent spirometric testing at 16.00 hours and received one of the three treatments (placebo, beclomethasone 1000 micro g, or fluticasone 1000 micro g) delivered by metered dose inhaler. Spirometric tests were repeated at 04.00 hours the following morning.. Following placebo administration the mean (SE) overnight fall in FEV(1) was 0.65 (0.27) l compared with -0.02 (0.13) l following fluticasone (p=0.019) and 0.23 (0.12) l following beclomethasone (p=0.048 v placebo).. A single dose of inhaled steroid (within the therapeutic range) reduced the fall in FEV(1) in patients with nocturnal asthma when administered at 16.00 hours. Nocturnal worsening of asthma is a useful model for testing inhaled steroid activity in a single night study.

    Topics: Administration, Inhalation; Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Cross-Over Studies; Double-Blind Method; Female; Fluticasone; Forced Expiratory Volume; Humans; Male; Middle Aged

2003
Oral candidiasis associated with inhaled corticosteroid use: comparison of fluticasone and beclomethasone.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2003, Volume: 90, Issue:6

    Inhaled steroids such as fluticasone propionate and beclomethasone dipropionate play a central role in the treatment of bronchial asthma. Fluticasone exhibits excellent clinical effectiveness; however, oral adverse effects can occur.. To compare the frequency of oral candidiasis in asthmatic patients treated with fluticasone and beclomethasone, to evaluate the effect of gargling with amphotericin B, and to measure the inhalation flow rate on candidiasis.. The study consisted of 143 asthmatic patients who were treated with inhaled steroids, 11 asthmatic patients not treated with inhaled steroids, and 86 healthy volunteers. Quantitative fungal culture was performed by aseptically obtaining a retropharyngeal wall swab from these patients. Patients with positive results were treated with gargling using a 1:50 dilution amphotericin B solution. In asthmatic patients treated with fluticasone, the inhalation flow rate was measured using an inspiratory flow meter.. The amount of Candida spp. was significantly greater in asthmatic patients taking inhaled steroids compared with those who were not. It was also significantly greater in patients with oral symptoms than asymptomatic patients and significantly greater in asthmatic patients treated with fluticasone than in those treated with beclomethasone. Although the presence of Candida did not correlate with the inhaled dose of beclomethasone, it did increase with the dose of fluticasone. Gargling with amphotericin B was effective in most asthmatic patients with candidiasis. Candidiasis was not due to inappropriate flow rates during inhalation of steroids.. Fungal culture of a retropharyngeal wall swab may be useful for predicting the risk of developing oral candidiasis in asthmatic patients treated with inhaled steroids. The amount of isolated Candida was significantly greater in asthmatic patients treated with fluticasone than in those treated with beclomethasone. Attention to dosage is required as the amount of Candida increased with dose of fluticasone. Gargling with a 1:50 dilution of amphotericin B is effective in treating oral candidiasis of asthmatic patients treated with inhaled steroids.

    Topics: Administration, Inhalation; Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Amphotericin B; Androstadienes; Anti-Inflammatory Agents; Antifungal Agents; Asthma; Beclomethasone; Candidiasis, Oral; Dose-Response Relationship, Drug; Drug Hypersensitivity; Female; Fluticasone; Glucocorticoids; Humans; Japan; Male; Middle Aged; Regression Analysis; Statistics as Topic; Treatment Failure

2003
Formoterol (Foradil) and medium-high doses of inhaled corticosteroids are more effective than high doses of corticosteroids in moderate-to-severe asthma.
    Pulmonary pharmacology & therapeutics, 2003, Volume: 16, Issue:5

    This double-blind, randomised, multi-centre, parallel-group study compared the effect of adding Foradil (formoterol fumarate) to existing medium-high doses of inhaled corticosteroids (ICS) with that of doubling the dose of ICS in patients with sub-optimally controlled asthma. After a run-in period, 203 patients with moderate-to-severe asthma who remained symptomatic despite treatment with 500 microg beclomethasone twice daily, were randomised to receive either 12 microg formoterol twice daily (Foradil Aerolizer), Novartis) in addition to beclomethasone 500 microg twice daily, or beclomethasone 1000 microg twice daily and placebo for 12 weeks. The primary efficacy variable was mean morning pre-medication peak expiratory flow (PEF) during the last seven days of treatment. The difference in PEF between treatments was 27.78 l/min in favour of the formoterol/beclomethasone combination (95% CI 13.42, 42.14 l/min, p=0.0002, intention-to-treat population). Significant differences in the urinary cortisol/creatinine ratio between treatment groups at 12 weeks (p=0.001) indicated suppression of the hypothalamic-pituitary-adrenal axis in the patients on beclomethasone 1000 microg twice daily. The addition of formoterol 12 microg twice daily to beclomethasone in patients with asthma who were poorly controlled with beclomethasone 500 microg twice daily was more effective than doubling the ICS dose and resulted in less suppression of the hypothalamic-pituitary-adrenal axis.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Asthma; Australia; Beclomethasone; Drug Administration Schedule; Drug Therapy, Combination; Ethanolamines; Formoterol Fumarate; Humans; Male; Middle Aged

2003
Improvement in health-related quality of life with fluticasone propionate compared with budesonide or beclomethasone dipropionate in adults with severe asthma.
    Respirology (Carlton, Vic.), 2003, Volume: 8, Issue:3

    Changes in health-related quality of life (HRQoL) were evaluated in adults with severe asthma following inhaled corticosteroid treatment with high-dose beclomethasone dipropionate or budesonide (BDP/BUD) and compared with fluticasone propionate taken at approximately half the dose of BDP/BUD.. HRQoL was assessed as part of an open, multicentre, randomized, parallel-group study in Australia evaluating the safety and efficacy of switching to fluticasone propionate (FP) 1000-2000 micro g/day (n = 67) compared with remaining on BDP/BUD >/=1750 micro g/day (n = 66) for 6 months. Patients completed two HRQoL questionnaires, the Asthma Quality of Life Questionnaire (AQLQ) and the Medical Outcomes Study Short Form-36 (SF-36), at baseline and at weeks 12 and 24. A change in AQLQ score of >/=0.5 was considered to be clinically meaningful.. There were significant improvements in HRQoL with FP on four of the eight dimensions on the SF-36 (i.e. physical functioning, general health, role-emotional, and mental health), while there were no significant improvements in HRQoL in the BDP/BUD group. Overall, patients in the FP group experienced significantly greater improvement (P < 0.001) in AQLQ scores at weeks 12 and 24 compared with the BDP/BUD group. On the individual domains of the AQLQ, there were significant treatment differences (P < 0.01) in favour of FP in three of the four domains (activity limitations [0.92], symptoms [0.73], and emotional function [1.02]). Mean differences between groups for overall score and these three domains were also clinically meaningful.. Patients with severe asthma who received FP (at approximately half the dose of BDP/BUD) experienced statistically significant, as well as clinically meaningful, improvements in their HRQoL.

    Topics: Adult; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Female; Fluticasone; Humans; Male; Quality of Life; Surveys and Questionnaires; Treatment Outcome

2003
Evaluation of long-term safety of the anti-IgE antibody, omalizumab, in children with allergic asthma.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2003, Volume: 91, Issue:2

    To evaluate the long-term effects of the anti-IgE antibody omalizumab in children with asthma.. This was a 28-week, double-blind, randomized, placebo-controlled trial with a 24-week open-label extension. In the core trial 225 children (ages 6 to 12 years) with moderate-to-severe allergic asthma requiring inhaled beclomethasone dipropionate (BDP) received omalizumab every 2 or 4 weeks, and 109 received placebo. BDP dosage was stable for weeks 1 to 16, then reduced during weeks 17 to 24 using strict safety criteria. The lowest dose for optimal asthma control was maintained for 4 more weeks. During the 24-week extension, all patients (n = 309) received open-label omalizumab in addition to other asthma medications. One-year safety data were analyzed.. The incidence of adverse events in patients treated with omalizumab for 52 weeks was similar to those treated for 28 weeks in the core trial, which was generally comparable with placebo. In the 52-week omalizumab group, upper respiratory tract infection and headache were the most frequently reported adverse events (47.1% and 42.7%, respectively). Eleven patients (4.9%) reported urticaria, which resolved spontaneously or with antihistamine, except for 1 patient who was discontinued because of severe urticaria. No anaphylactic reactions or adverse events suggestive of serum sickness or immune complex formation occurred. No anti-omalizumab antibodies were detected in any of the children. There is no evidence that new or more serious adverse events occur with long-term omalizumab treatment.. Long-term treatment with omalizumab is safe and well tolerated in children with allergic asthma.

    Topics: Anti-Asthmatic Agents; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Beclomethasone; Child; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Immunoglobulin E; Injections, Subcutaneous; Longitudinal Studies; Male; Omalizumab; Platelet Count

2003
Assessment of inhaled BDP-dose dependency of exhaled nitric oxide and local and serum eosinophilic markers in steroids-naive nonatopic asthmatics.
    Allergy, 2003, Volume: 58, Issue:10

    The aim of the present study was to assess the dose-dependency from inhaled steroids of changes of airways inflammation [eosinophils count and eosinophil cationic protein (ECP)] measures in induced sputum and in serum, as well as that of exhaled nitric oxide. Twenty steroid-naive patients with nonatopic asthma of mild to moderate degree [forced expiratory volume in 1 s (FEV1) = 70% of predicted] and with negative response to the standard tests for allergy were selected; after a 1-week run-in period they were randomized to receive a 12-week treatment period of inhaled beclomethasone dipropionate dry powder given with the Pulvinal inhaler (Clenil P, Chiesi Farmaceutici S.p.A., Parma, Italy) in two different dose regimens, 400 microg bid (high dose) or 200 microg bid (low dose), over a double blind, parallel groups design. The following outcome measures were assessed in baseline and after 1, 6 and 12 weeks of treatment: FEV1 (l), eosinophils count in sputum (%), is ECP (microg/l), serum eosinophils count (%), serum ECP (microg/l) and exhaled NO (ppb). The results showed that all the considered parameters improved in both groups: the increase over baseline of FEV1 and the decrease of NO were significant at any time in the high-dose group and only at week 12 in the low-dose group (NS between groups), whereas the markers of eosinophilic activity showed more consistent reductions in the high-dose than in the low-dose group when measured in induced sputum (P < 0.05 between groups after 6 and 12 weeks for eosinophils count and after 12 weeks for ECP). Decreases over baseline of markers measured in serum were more rapid in the high-dose group, without differences between groups. A marked trend towards a negative correlation was found between FEV1 and ECP, (r = -0.72, P < 0.05), between FEV1 and eosinophils in sputum (r = -0.31, NS) and between FEV1 and exhaled NO (r = -0.38, NS), all of them only in the high-dose group. The results of the study demonstrate that changes of levels of eosinophilic activity in the airways are dependent from the daily dose of inhaled steroids when measured in induced sputum and that the local assessment can therefore represent a practical and noninvasive method to monitor the extent of airways inflammation.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Biomarkers; Blood Proteins; Dose-Response Relationship, Drug; Eosinophil Granule Proteins; Eosinophils; Exhalation; Female; Humans; Male; Middle Aged; Nitric Oxide; Pulmonary Eosinophilia; Ribonucleases; Sputum

2003
Adrenal function as assessed by low-dose adrenocorticotropin hormone test before and after switching from inhaled beclomethasone dipropionate to inhaled fluticasone propionate.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2003, Volume: 40, Issue:5

    Low-dose adrenocorticotropin hormone (ACTH) tests (0.5 microg/L 73 m2) were done before and after switching from inhaled beclomethasone dipropionate to inhaled fluticasone propionate in 12 patients 33-77 years old who had mild-to-severe asthma to compare the effects of these drugs on adrenal function. Low-dose ACTH tests were performed after the subjects had received inhaled beclomethasone dipropionate (200-900 microg/day) for at least 12 wk. Treatment was then switched to inhaled fluticasone propionate (200-600 microg/day) for at least 12 wk, and a second low-dose ACTH test was done. Pulmonary function was assessed on the basis of peak expiratory flow rate (PEFR, % of predicted value). After switching treatment, the daily dose of inhaled corticosteroid decreased by about 40%. Basal serum cortisol and ACTH levels were similar with both treatments. The adrenal response, as assessed by incremental rise in the serum cortisol level (peak minus basal) after ACTH challenge, improved significantly (5.6-7.9 microg/dL, p < 0.01) after switching to fluticasone. All three patients who had lower serum cortisol levels during beclomethasone treatment than during fluticasone treatment showed improvement in both the peak cortisol level and the incremental rise in cortisol. Mean morning and evening PEFRs significantly increased after switching from beclomethasone to fluticasone (morning: 71.2 to 76.0%, p < 0.01; evening: 67.3 to 72.1%, both p < 0.05). The diurnal variation of PEFR significantly decreased from 10.9% to 8.3% after switching treatment (p < 0.01). We conclude that switching from beclomethasone to fluticasone reduces the risk of adrenal dysfunction associated with inhaled steroids and improves pulmonary function.

    Topics: Administration, Inhalation; Adrenal Insufficiency; Adrenocorticotropic Hormone; Adult; Aged; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Female; Fluticasone; Humans; Hydrocortisone; Male; Middle Aged; Peak Expiratory Flow Rate; Pituitary-Adrenal Function Tests

2003
[Clinical effects of long-term administration of pranlukast, a leukotriene receptor antagonist, on adult patients with bronchial asthma].
    Nihon Kokyuki Gakkai zasshi = the journal of the Japanese Respiratory Society, 2003, Volume: 41, Issue:10

    Eighty-one adult patients with bronchial asthma who suffered asthmatic episodes in spite of treatment with 400 mg/day of BDP were placed on pranlukast therapy for 4 weeks. Group I, which showed a 5% or greater increase in PEFR, continued oral pranlukast medication for an additional two years. Those patients who did not show an increase of 5% or greater in PEFR after 4 weeks of pranlukast therapy were instructed to continue the medication for another year. Group II, which exhibited a 5% or greater increase in PEFR after a one-year period continued medication for one more year. Medication was suspended for Group III, which failed to show improvement in PEFR after one year, and the group was placed under observation for the following year. Group I improved significantly in PEFR and exhibited a reduction in the frequency of b2 inhalation, the number of night visits to a medical facility, the amount of steroids inhaled, and the quantity of oral steroids given at regular intervals; and the Group I peripheral eosinophil count, serum ECP level, and FEV1.0 ameliorated. After one year, Group II also showed significant improvement in PEFR and a reduction in both the peripheral eosinophil count and the serum ECP level. This group's PEFR continued to improve after two years. One year after medication was suspended, Group III showed a significant increase in the number of night visits to a medical facility and a rise in the serum ECP level. These findings indicated the efficacy of pranlukast.

    Topics: Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biomarkers; Blood Proteins; Chromones; Drug Therapy, Combination; Eosinophil Granule Proteins; Eosinophils; Female; Humans; Leukocyte Count; Leukotriene Antagonists; Male; Middle Aged; Peak Expiratory Flow Rate; Ribonucleases; Treatment Outcome

2003
Effect of inhalation of salbutamol, beclomethasone dipropionate & ipratropium bromide on mucociliary clearance in some patients with chronic stable bronchial asthma.
    The Indian journal of medical research, 2003, Volume: 117

    Asthma is now regarded as an inflammatory disease and bronchial inflammation may disrupt mucociliary function. Inhaled drugs may act by improving mucociliary function. The aim of the study was to investigate the effect of salbutamol, ipratropium bromide and beclomethasone on mucociliary clearance in patients with chronic stable asthma and to compare the efficacy of these drugs on mucociliary clearance.. Ten patients with chronic stable asthma were enrolled in the study, but two patients did not complete the study. Patients with bronchial asthma were chosen on clinical grounds. (99m)Tc phytate radioaerosol generated through a nebulizer, was given to each patient on four days. After each administration the radioactivity over the thorax was constantly measured in sequential frame mode for 120 min. Radioactivity in the thorax was also measured after 24 h. A base-line pulmonary function test with reversibility was obtained. Salbutamol, ipratropium bromide, beclomethasone dipropionate and placebo inhalation were given randomly to each patient on four days.. The mean age of patients (n = 8) was 36 +/- 9.3 yr and mean duration of symptoms was 5 +/- 6.6 yr. There was no visual impression that mucociliary clearance was enhanced with any of the drugs. The time activity curves did not show any visually recognisable change in slope. In only one patient the curve tended to show a steeper slope with ipratropium inhalation. In the rest of the patients the curves showed no difference at all with medication when compared with placebo. All the quantitative indices analyzed by two-way ANOVA at the end of one and two hours were comparable for the three test drugs and placebo. None of the three test drugs demonstrated statistically significant mucociliary clearance effect compared with placebo. However, the temporal difference in airways clearance efficiency (ACE) was significant with beclomethasone and ipratropium bromide.. Inhalation of any of the three drugs tested did not produce any immediate improvement in mucociliary clearance as compared to placebo in patients with stable bronchial asthma suggesting the need for further studies using higher doses of drugs for longer duration in a large sample.

    Topics: Administration, Inhalation; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Humans; Ipratropium; Middle Aged; Mucociliary Clearance; Placebos; Radionuclide Imaging

2003
A randomized controlled trial using the school for anti-inflammatory therapy in asthma.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2003, Volume: 40, Issue:7

    This study investigated the impact of providing low-dose inhaled corticosteroids (ICS) at school or at home to asthmatic inner city children over a 14-week period, compared with the existing community standard. Eight elementary schools in the Dallas Independent School District with a high incidence of asthma located in predominantly urban African-American communities were randomly assigned to one of four groups. The treatment arms were school-based delivery of inhaled steroids, home-based delivery of inhaled steroids, and home-based delivery of inhaled steroids with school-based asthma education, and the control group was no change in current therapy. Fifty students were objectively diagnosed with mild, persistent asthma and participated in the study. Students in the treatment arms received beclomethasone (42 mcg/puff) 4 puffs, twice a day, either at school or at home. Students in the control, "community standard of care" group received no additional medical intervention. Higher peak flows for the treatment groups were seen in the first week and maintained throughout the study (P = .047). By week 5 significant differences were found in frequency of bronchodilator use (P = .025), episodes of nocturnal awakening with asthma symptoms (P = .022), and visits to the primary health care provider (P = .022). Treatment groups rated their asthma as "better than the week before" more frequently than the control group (P = .001). Delivering ICS in school is associated with improved asthma control than when anti-inflammatory medication was delivered to children with asthma in a home-based setting, and both are superior when compared with a control, "community standard of care" group in which no additional medical intervention occurred.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Glucocorticoids; Humans; Patient Education as Topic; School Health Services; Urban Health

2003
Hydrofluoroalkane-134a beclomethasone as a dominant economic asthma therapy.
    Respiratory medicine, 2003, Volume: 97, Issue:12

    Inhaled corticosteroids for asthma treatment have become mainstay of therapy for patients with persistent asthma. Numerous inhaled corticosteroids are available but to date no prospective cost-effectiveness studies have been reported using exclusively US patients and costs. The purpose of this study was to examine the cost-effectiveness of HFA-bectomethasone (QVAR) compared to CFC-beclomethasone (Vanceril) using data from a year-long prospective randomized, open label, parallel multicenter trial. Eligibility criteria required patients to have been on a stable dose of CFC-BDP prior to enrollment. Patients were randomized to either HFA-BDP at approximately half their previous daily dose of CFC-BDP or to continue CFC-BDP Effectiveness data, in terms of symptom-free days (SFDs), were used in a cost-effectiveness analysis conducted from the viewpoint of managed care. Patients receiving HFA-BDP reported a greater increase (median = 22.1) in the number of SFDs than those receiving CFC-BDP (median = 14.3) (P = 0.03). Total costs of care were less for patients taking HFA-BDP (median = dollars 668) compared to CFC-BDP (median = dollars 977). The median incremental cost-effectiveness ratio was dollars -5.77 (95% CI: dollars -68.08 to dollars -4.08). The results of this analysis indicate that HFA-BDP was a dominant therapy (more effective, less costly) compared to CFC-BDP.

    Topics: Administration, Inhalation; Adult; Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chlorofluorocarbons; Cost-Benefit Analysis; Drug Costs; Female; Forced Expiratory Volume; Health Resources; Humans; Hydrocarbons, Fluorinated; Male

2003
Add-on effects of suplatast tosilate in bronchial asthma patients treated with inhaled corticosteroids.
    Lung, 2003, Volume: 181, Issue:4

    Th2 cytokines play an important role in the pathogenesis of asthma. In the present study, we investigated the effect of suplatast tosilate, a selective Th2 cytokine inhibitor, on asthma control, in terms of subjective symptoms and pulmonary function in patients treated with inhaled corticosteroids. Thirty-eight patients with bronchial asthma being treated with inhaled corticosteroids were given suplatast tosilate (100 mg three times daily) for 12 weeks, in a multicenter setting. During the study period, other medications were continued. Morning and evening peak expiratory flow, asthma symptoms, blood eosinophil count and serum IgE levels were monitored. Suplatast tosilate treatment was associated with a significant improvement in mean morning peak expiratory flow (from 295 L/min to 348 L/min, P < 0.01) and evening peak expiratory flow (from 313 L/min to 357 L/min, P < 0.01). The mean daily variation in peak expiratory flow was significantly reduced (from 11.6% to 7.3%, P < 0.01) by suplatast tosilate treatment. The greatest improvement in peak expiratory flow was observed in patients whose blood eosinophil counts were decreased by suplatast tosilate treatment. Treatment with suplatast tosilate improved pulmonary function in patients with bronchial asthma. Our results suggest the therapeutic effects observed may occur through suppression of eosinophilic inflammation.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Arylsulfonates; Asthma; Beclomethasone; Cytokines; Histamine Antagonists; Humans; Peak Expiratory Flow Rate; Sulfonium Compounds; Th2 Cells

2003
[A fixed combination of fluticasone and salmeterol permits better control of asthma than a beclomethasone dipropionate and montelukast combination].
    European annals of allergy and clinical immunology, 2003, Volume: 35, Issue:9

    It is now recommended to add an inhaled long-acting beta 2-agonist, or as an alternative, to add a leukotriene-antagonist, in patients whose asthma is insufficiently controlled with an inhaled corticosteroid alone. A randomised, multicentre, open-label, parallel-group study was carried out in 246 patients of at least 15 years, whose asthma was not adequately controlled with a medium dose of an inhaled corticosteroid. They received either fluticasone/salmeterol combination 250/50 micrograms one inhalation twice daily or CFC beclomethasone dipropionate 250 micrograms two puffs twice daily plus montelukast 10 mg in the evening for 12 weeks. The mean morning PEFR (main criterion) was significantly (p = 0.017) more improved with fluticasone/salmeterol (+44.2 L/min) than with beclomethasone dipropionate plus montelukast (+31.0 L/min). Other outcomes showed significantly better improvements (p 0.022 Pound) with fluticasone/salmeterol than with beclomethasone plus montelukast. The two treatments were well tolerated. Fluticasone/salmeterol provided a better asthma control than beclomethasone dipropionate plus montelukast in patients insufficiently controlled with an inhaled corticosteroid alone.

    Topics: Acetates; Administration, Inhalation; Adult; Aerosols; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Cyclopropanes; Drug Combinations; Female; Fluticasone; Humans; Leukotriene Antagonists; Male; Middle Aged; Peak Expiratory Flow Rate; Powders; Prospective Studies; Quinolines; Salmeterol Xinafoate; Sulfides; Treatment Outcome

2003
Relationship between changes in quality of life and measures of lung function and bronchial hyper-responsiveness during high-dose inhaled corticosteroid treatment in uncontrolled asthma.
    American journal of respiratory medicine : drugs, devices, and other interventions, 2003, Volume: 2, Issue:5

    To examine the relationship between changes in quality of life and measures of lung function and bronchial hyper-responsiveness (BHR) during treatment with high-dose inhaled corticosteroids in patients with uncontrolled asthma.. Thirty patients with uncontrolled asthma currently receiving inhaled corticosteroids (median dose 550 microg/day) were treated with beclomethasone dipropionate (BDP) dry powder 2000 microg/day for 4 weeks. Patients completed the Asthma Quality of Life Questionnaire (AQLQ), underwent bronchial challenge with methacholine and spirometry, and made entries in asthma diary cards at baseline and after treatment with beclomethasone dipropionate.. The mean change in overall AQLQ score improved significantly (p < 0.05) during the 4-week period by 0.57 (95% CI 0.29-0.84, p < 0.05), representing a minimal important difference, with similar improvements in individual domains. Change in overall AQLQ score correlated significantly with FEV(1) (p < 0.001), forced mid-expiratory flow between 25-75% of vital capacity (FEF(25-75)) [p < 0.05] and morning PEF (p < 0.05), but not with methacholine PD(20) i.e. the provocative dose of methacholine causing a 20% fall in FEV(1).. Quality-of-life scores related to changes in lung function but not BHR during short-term high-dose inhaled corticosteroid therapy for uncontrolled asthma.

    Topics: Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Bronchial Hyperreactivity; Dose-Response Relationship, Drug; Glucocorticoids; Humans; Lung; Middle Aged; Quality of Life; Respiratory Function Tests

2003
Buteyko Breathing Technique for asthma: an effective intervention.
    The New Zealand medical journal, 2003, Dec-12, Volume: 116, Issue:1187

    To assess the impact of the Buteyko Breathing Technique (BBT) on medication use in asthma.. A blinded randomised controlled trial comparing BBT with control was conducted in 38 people with asthma aged between 18 and 70. Participants were followed for six months following the intervention. Medication use and indices of ventilatory function were recorded.. No significant change in FEV1 (forced expiratory volume in one second) was recorded in either group. The BBT group exhibited a reduction in inhaled steroid use of 50% and beta2-agonist use of 85% at six months from baseline. In the control group inhaled steroid use was unchanged and beta2-agonist use was reduced by 37% from baseline. Investigator contact between the two groups was equal. There were no adverse events recorded in either group.. BBT is a safe and efficacious asthma management technique. BBT has clinical and potential pharmaco-economic benefits that merit further study.

    Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Adult; Aged; Asthma; Beclomethasone; Combined Modality Therapy; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Respiratory Therapy; Single-Blind Method

2003
Salmeterol decreases eosinophilic cationic protein and rescue medication in patients inhaling beclomethasone dipropionate: preliminary study in mild and moderate asthma in Trinidad, West Indies.
    International journal of clinical pharmacology research, 2003, Volume: 23, Issue:2-3

    Activated eosinophils play a critical role in asthma pathogenesis, and eosinophil cationic protein (ECP) is a useful indicator of inflammation. Inhaled corticosteroids and long-acting beta2-agonists (LABA) effectively control asthma symptoms and improve airway function. Salmeterol's anti-inflammatory efficacy as add-on therapy to inhaled corticosteroids has not been evaluated in Caribbean populations. We investigated nine non-smoking subjects (three men and six women; mean age: +/- SE, 50.7 +/- 3.82 years) with stable mild and moderate persistent asthma who were inhaling > or = 500 microg beclomethasone dipropionate (BDP) daily. This was a with-in-patient controlled laboratory blind study performed over 8 weeks. Patients received BDP for 2 weeks, add-on salmeterol 100 microg in weeks 3-6 and BDP alone in weeks 7-8. Patients recorded daily morning and night symptoms. Morning peak expiratory flow rate was measured on entry to the study and with sputum ECP at the end of weeks 2, 4, 6 and 8. Salmeterol together with BDP decreased sputum ECP from a pretreatment median value of 897.84 microg/l to 628.38 microg/l after 4 weeks, and ECP continued to decrease even after salmeterol withdrawal. Both drugs decreased the frequency of rescue medication use by approximately 50% and increased the median number of days per week without rescue salbutamol from 0 to 3 days. Salmeterol's bronchoprotective effect was maximal after 4 weeks and was sustained after its withdrawal. In conclusion, this study, performed in Trinidadian asthmatics, used ECP as a surrogate marker of bronchial inflammation and supports the recent Salmeterol Multi-center Asthma Research Trial (SMART) data recommending add-on salmeterol therapy to adequate anti-inflammatory medication such as inhaled corticosteroids for optimal asthma management. Further studies are required to evaluate the anti-inflammatory efficacy and possible tolerance to salmeterol in Caribbean patients.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biomarkers; Blood Proteins; Eosinophil Granule Proteins; Eosinophils; Female; Humans; Male; Middle Aged; Outpatients; Ribonucleases; Salmeterol Xinafoate; Treatment Outcome; Trinidad and Tobago

2003
Switching from conventional to extrafine aerosol beclomethasone dipropionate therapy in children: a 6-month, open- label, randomized trial.
    The Journal of allergy and clinical immunology, 2002, Volume: 110, Issue:1

    In adults with asthma, hydrofluoralkane-134a beclomethasone dipropionate (HFA-BDP) extrafine aerosol provides equivalent asthma control at half the daily dose of conventional chlorofluorocarbon (CFC)-BDP.. We sought to compare the efficacy and tolerability of switching from CFC-BDP to HFA-BDP at half the daily dose in children with stable asthma.. This 6-month, open-label, randomized, multicenter study enrolled 520 children aged 5 to 11 years with well-controlled asthma receiving inhaled CFC-BDP or budesonide 200 to 800 microg/d x. (Four hundred fifty-two patients were using doses within the recommended range of 200-400 microg and were analyzed separately.) During a 4-week run-in period, patients used CFC-BDP plus a spacer (CFC-BDP+S) at approximately the same dose as they were using before study entry. Patients were then randomized in a 1:3 ratio to continue on CFC-BDP+S or switch to HFA-BDP Autohaler at half the daily dose.. The change from baseline in morning peak expiratory flow was significantly greater in patients receiving 100-200 microg of HFA-BDP compared with those receiving 200-400 microg of CFC-BDP+S at weeks 7 to 8 (8.5 and 0.4 L/min, respectively; P =.014), with continuing improvement in both groups over 6 months (12.2 and 12.4 L/min, respectively, at month 6). There were no significant differences between treatments in mean change from baseline in FEV(1), percentage of days or nights without asthma symptoms, and daily beta-agonist use over the 6-month treatment period. The proportion of patients who had one or more asthma exacerbations, the incidence of adverse events, and the percentage change from baseline in 24-hour urinary free cortisol levels were similar in the 2 treatment groups.. This study confirms that asthma control can be well maintained in children when switching from CFC-BDP+S to an HFA-BDP Autohaler at doses as low as 100 to 200 microg/d.

    Topics: Administration, Inhalation; Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Chlorofluorocarbons; Drug Administration Schedule; Female; Humans; Hydrocarbons, Fluorinated; Male; Patient Compliance; Treatment Outcome

2002
Effects of adding either a leukotriene receptor antagonist or low-dose theophylline to a low or medium dose of inhaled corticosteroid in patients with persistent asthma.
    Chest, 2002, Volume: 122, Issue:1

    To evaluate the effect of adding zafirlukast or low-dose theophylline to a beclomethasone dipropionate (BDP) extra-fine hydrofluoroalkane aerosol on bronchial hyperresponsiveness as the primary outcome variable.. Twenty-four patients with mild-to-moderate asthma were studied using a randomized crossover design with the following three treatment blocks: (1) beclomethasone, 100 microg/d, alone for the first 2 weeks followed by 400 microg/d alone for the next 2 weeks; (2) beclomethasone, 100 microg/d, followed by 400 microg/d, with the addition of zafirlukast, 20 mg bid; (3) beclomethasone, 100 microg/d, followed by 400 microg/d, with the addition of theophylline, 200 to 300 mg bid. Measurements were made after 2 and 4 weeks of each treatment and at pretreatment baseline.. The mean trough plasma theophylline concentration was 6.7 mg/L, coinciding with the anti-inflammatory target range (ie, 5 to 10 mg/L). The provocative dose of methacholine causing a 20% fall in FEV(1) (as doubling dose difference from baseline) was significantly (p < 0.05) greater with beclomethasone, 100 microg, plus zafirlukast (1.1 doubling dose) but not with beclomethasone, 100 microg, plus theophylline (0.7 doubling dose) compared to beclomethasone, 100 microg alone (0.4 doubling dose), but not compared to beclomethasone, 400 microg alone (1.1 doubling dose). There were also significant (p < 0.05) differences between beclomethasone, 100 microg, plus zafirlukast (but not BDP, 100 microg, plus theophylline) vs beclomethasone, 100 microg, alone in terms of nitric oxide level, midexpiratory phase of forced expiratory flow, and peak expiratory flow. There were no further significant improvements observed with the addition of zafirlukast or theophylline to beclomethasone, 400 microg.. A leukotriene receptor antagonist, but not low-dose theophylline, conferred significant additive anti-inflammatory effects to therapy with a low-dose inhaled corticosteroid but not to that with a medium dose of an inhaled corticosteroid. Thus, optimizing the dose of inhaled corticosteroid as monotherapy would seem to be the logical first step, which is in keeping with current guidelines.

    Topics: Administration, Inhalation; Administration, Oral; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Child; Cross-Over Studies; Drug Administration Schedule; Female; Humans; Indoles; Leukotriene Antagonists; Male; Middle Aged; Phenylcarbamates; Respiratory Function Tests; Sulfonamides; Theophylline; Tosyl Compounds

2002
Hypogammaglobulinemia in steroid-dependent asthmatics correlates with the daily dose of oral prednisolone.
    International archives of allergy and immunology, 2002, Volume: 128, Issue:3

    Steroid-induced adverse effects including suppression of humoral immunity should be considered in steroid-dependent severe asthma. Only a few studies have determined the exact steroid dose that could potentially suppress humoral immunity in asthmatics.. Randomly selected 100 adult asthmatics treated with inhaled beclomethasone dipropionate (BDP) were classified into three groups based on the dose of steroid to determine the serum IgG, IgA and IgM levels by radioimmunoassay. Relationships between serum immunoglobulin levels and the daily dose and duration of oral prednisolone (PSL) therapy were examined.. None of the patients on inhaled corticosteroid alone had hypogammaglobulinemia. Patients on oral PSL at a dose >12.5 mg/day for at least 1 year had low serum IgG. There was no significant correlation between the duration of oral PSL therapy and serum IgG.. Oral PSL can potentially suppress humoral immunity in severe asthma. In asthmatics, hypogammaglobulinemia could develop in those on a daily dose of PSL >12.5 mg, but is independent of the duration of such treatment. No suppression of humoral immunity was noted on inhaled corticosteroid therapy alone, either at low or high dose.

    Topics: Administration, Inhalation; Administration, Oral; Adult; Agammaglobulinemia; Anti-Inflammatory Agents; Asthma; Beclomethasone; Drug Therapy, Combination; Female; Humans; Immunoglobulins; Male; Middle Aged; Prednisolone; Time Factors

2002
Long-term observations of the clinical course after step down of corticosteroid inhalation therapy in adult chronic asthmatics: correlation with serum levels of eosinophil cationic protein.
    Respirology (Carlton, Vic.), 2002, Volume: 7, Issue:3

    Symptoms often deteriorate in well-controlled asthmatics after a step down in inhaled beclomethasone dipropionate (iBDP) therapy if the serum concentration of eosinophil cationic protein (sECP) is high. This deterioration is significantly abrogated by pranlukast, a leukotriene receptor antagonist, or by seratrodast, a thromboxane A2 receptor antagonist. However, these results were based on short-term (less than 6 months) observations.. We studied 35 well-controlled adult asthmatics. We assigned the patients into different groups according to their sECP levels before the step down: (i) group A, sECP < 25 microg/L; (ii) group B, sECP > or = 25 microg/L; and (iii) group C, sECP > or = 25 microg/L but patients treated with pranlukast or seratrodast. We began the study with a step down in iBDP therapy (initial step down), then followed the clinical course of the asthma for 2 years. During the study period, we decreased, increased or maintained the iBDP dose on the basis of the stepwise approach described in the National Institutes of Health guidelines. We monitored the time and frequency of exacerbation and evaluated the iBDP dose required to control the asthma symptoms.. The rates of exacerbation after the step down were high in groups A and B. In group A, the conditions were again qualified for the step down in all patients, but this was not the case for most group B patients. From 15 to 21 months after the initial step down, the average dose of iBDP required to control symptoms was significantly higher in group B than in group A patients (P = 0.0127-0.0373). The exacerbation rate in group C after 12 months tended to be lower than in the other two patient groups (P = 0.0743). In group C, the average dose of iBDP from 9 to 24 months after the initial step down was significantly lower than before the step down (P < 0.0001) and was not significantly different from the mean dose of iBDP in groups A or B.. High sECP in well-controlled asthma may indicate the necessity for a higher iBDP dose over a long period than when the sECP concentration is not high. Even if sECP is high, pranlukast or seratrodast help to prevent exacerbation of asthma and enable successful step down in iBDP therapy for at least 2 years thereafter.

    Topics: Adult; Aged; Analysis of Variance; Asthma; Beclomethasone; Benzoquinones; Blood Proteins; Chromones; Chronic Disease; Drug Therapy, Combination; Eosinophil Granule Proteins; Female; Glucocorticoids; Heptanoic Acids; Humans; Leukotriene Antagonists; Male; Middle Aged; Prognosis; Prospective Studies; Prostaglandin Antagonists; Respiratory Mechanics; Ribonucleases; Statistics, Nonparametric

2002
The cost effectiveness of chlorofluorocarbon-free beclomethasone dipropionate in the treatment of chronic asthma: a cost model based on a 1-year pragmatic, randomised clinical study.
    PharmacoEconomics, 2002, Volume: 20, Issue:10

    To compare the cost effectiveness of hydrofluoroalkane 134a-beclomethasone dipropionate (HFA-BDP; Qvar) [corrected] with chlorofluorocarbon-beclomethasone dipropionate (CFC-BDP) in patients with chronic stable asthma previously receiving CFC-BDP, from the perspective of a healthcare provider.. Cost-effectiveness analysis based on a 12-month pragmatic, randomised, parallel group, open-label clinical trial assessing safety and efficacy of HFA-BDP at approximately half the dose of CFC-BDP in patients with stable asthma.. International, multicentre study at 57 study sites in the US, UK, The Netherlands, and Belgium. Healthcare costs were calculated for UK-based healthcare [in 1999 as pounds (pounds sterling)].. Patients (n = 473) > or =12 years of age with currently stable asthma that had been stable (i.e. no exacerbations requiring oral corticosteroid use in the last 4 weeks) for at least the preceding month.. Average and incremental cost-effectiveness ratios based upon symptom-free days, improvement in health-related quality of life, and total and drug-only direct healthcare costs.. Patients in the HFA-BDP group experienced a significantly higher percentage of symptom-free days than patients in the CFC-BDP group by the end of the study period (42.4 vs 20.0%; p = 0.006). A greater percentage of patients in the HFA-BDP group had a clinically significant improvement in health-related quality of life than in the CFC-BDP group [35.3 (n = 116/329) vs 16.1% (n = 18/112)]. Total per patient healthcare costs were similar between the two groups. The average cost per symptom-free day per patient was 1.36 pounds sterling for HFA-BDP and 1.81 pounds sterling for CFC-BDP based on total healthcare costs. The incremental cost per symptom-free day for using HFA-BDP instead of CFC-BDP was negative, indicating that HFA-BDP is a dominant strategy and may be a cost-saving intervention compared with CFC-BDP. A sensitivity analysis varying both cost and outcome parameters further supported this finding for most scenarios tested. The cost to achieve a clinically significant improvement in health-related quality of life over the study period was 13.24 pounds sterling per improved patient per week for HFA-BDP and 29.38 pounds sterling per patient per week for CFC-BDP.. These findings indicate that HFA-BDP is a cost-effective intervention when compared with CFC-BDP in this group of patients with stable asthma. In the majority of scenarios HFA-BDP provides more effective asthma control at a similar cost to CFC-BDP.

    Topics: Asthma; Beclomethasone; Chlorofluorocarbons; Chronic Disease; Cost-Benefit Analysis; Humans; Hydrocarbons, Fluorinated; Prospective Studies; Quality of Life; Treatment Outcome

2002
Comparison of anti-inflammatory and clinical effects of beclomethasone dipropionate and salmeterol in moderate asthma.
    The European respiratory journal, 2002, Volume: 20, Issue:1

    Inhaled corticosteroids and long-acting beta2-agonists effectively control asthma symptoms and improve airway function. The effects of beclomethasone were compared with those of salmeterol on markers of eosinophilic inflammation in induced sputum in steroid-naive asthmatic subjects with moderate asthma. Fifteen moderate asthmatics were treated with either beclomethasone dipropionate (500 microg b.i.d.) or salmeterol (50 microg b.i.d.) for 4 weeks, according to a randomised, double-blind, parallel-group study design. All patients underwent spirometry, methacholine test, sputum induction, and blood sampling before and after 2 and 4 weeks of treatment. They also recorded daily symptoms and peak expiratory flow (PEF). Sputum eosinophils, eosinophil cationic protein (ECP) and eosinophil protein X (EPX), and blood eosinophils, as well as the forced expiratory volume in one second (FEV1) and morning PEF, significantly improved after beclomethasone but not after salmeterol. PEF variability, the symptom score and rescue beta2-agonist use significantly improved after both treatments, although the improvement in the symptom score tended to be greater after beclomethasone. After 2 and 4 weeks of beclomethasone treatment, both serum ECP and EPX decreased. With salmeterol, only serum EPX decreased, after 4 weeks. Bronchial hyperresponsiveness to methacholine did not change after either treatment. The authors conclude that beclomethasone, but not salmeterol, substantially improves airway inflammation in asthma. Beclomethasone also had an overall greater clinical effect, although the improvement in symptoms and peak expiratory flow variability was similar after both treatments.

    Topics: Adrenergic beta-Agonists; Adult; Albuterol; Anti-Inflammatory Agents; Asthma; Beclomethasone; Blood Proteins; Double-Blind Method; Eosinophil Granule Proteins; Eosinophils; Female; Humans; Inflammation Mediators; Leukocyte Count; Male; Middle Aged; Respiratory Function Tests; Ribonucleases; Salmeterol Xinafoate; Severity of Illness Index; Sputum

2002
Omalizumab provides long-term control in patients with moderate-to-severe allergic asthma.
    The European respiratory journal, 2002, Volume: 20, Issue:1

    The ability of omalizumab, an anti-immnoglobulin-E agent, to maintain long-term disease control in patients with moderate-to-severe allergic asthma was investigated in a 24-week double-blind extension to a 28-week core trial. During the extension, 483 of the initial 546 patients were maintained on randomised treatment and the lowest sustainable dose of beclomethasone dipropionate (BDP) as established during the steroid-reduction phase of the core trial. The use of concomitant asthma medication was permitted and investigators were allowed to adjust the BDP dose or switch patients from BDP to other asthma medications if deemed necessary. More omalizumab-treated patients (33.5%) than placebo-treated patients (13.5%) were able to complete the extension period without requiring inhaled corticosteroid treatment. The mean BDP equivalent dose throughout the extension was lower in the omalizumab group (25 microg x day(-1)) than in the placebo group (43 microg x day(-1)). Disease control was sustained in 76% of omalizumab patients compared with 59.4% of placebo patients free from an asthma exacerbation during the extension period. Compared with placebo, fewer patients in the omalizumab group used other concomitant asthma medication during the extension. Treatment with omalizumab was well tolerated and the incidence of adverse events was similar between groups. In conclusion, these results suggest that omalizumab is a promising new agent for the long-term control of allergic asthma.

    Topics: Adolescent; Adult; Aged; Anti-Asthmatic Agents; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Beclomethasone; Child; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Hypersensitivity; Male; Middle Aged; Omalizumab; Severity of Illness Index; Time Factors; Treatment Outcome

2002
Early asthma control and maintenance with eformoterol following reduction of inhaled corticosteroid dose.
    Thorax, 2002, Volume: 57, Issue:9

    Previous studies have indicated the benefits of adding long acting beta(2) agonists to inhaled corticosteroids in the maintenance treatment of moderate to severe asthma. The effects of adding eformoterol to corticosteroids on asthma control and exacerbations in patients with mild to moderate asthma were studied.. After a run in period of 7-14 days on existing medication, 663 symptomatic patients were randomised to receive budesonide Turbohaler 400 microg twice daily together with either eformoterol Turbohaler 9 micro g (delivered dose) or placebo twice daily. After 4 weeks patients whose asthma was well controlled (n=505) were re-randomised to receive budesonide 400 microg daily and either eformoterol 9 micro g or placebo twice daily for a further 6 months.. Patients receiving eformoterol achieved asthma control 10 days sooner than those receiving budesonide alone, and improvements in lung function, symptoms, quality of life, and relief beta(2) agonist use were significantly greater with eformoterol. During the 6 month follow up the frequency of mild exacerbations was significantly lower in the eformoterol group than in those receiving budesonide alone (7.2 versus 10.5 per patient, 95% confidence interval for ratio 0.49 to 0.96, p=0.03). The time to first day of poorly controlled asthma was 97 days in the eformoterol group compared with 42 days in the placebo group (p=0.003).. Adding eformoterol to a low or moderate dose of budesonide in mild asthma resulted in faster and more effective control than treatment with budesonide alone. Eformoterol allowed the corticosteroid dose to be reduced while also decreasing the rate of mild exacerbations compared with budesonide alone. These data suggest a therapeutic advantage of adding eformoterol to inhaled corticosteroids in patients with mild to moderate asthma.

    Topics: Administration, Inhalation; Administration, Topical; Adolescent; Adrenergic beta-Agonists; Adult; Aged; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Drug Therapy, Combination; Ethanolamines; Fluticasone; Formoterol Fumarate; Glucocorticoids; Humans; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Quality of Life; Survival Analysis; Treatment Outcome

2002
Modulite technology: pharmacodynamic and pharmacokinetic implications.
    Respiratory medicine, 2002, Volume: 96 Suppl D

    In the drive to replace chlorofluorinated hydrocarbons (CFCs) by alternative more environmentally friendly propellants in pressurized metered dose inhalers (pMDIs), Chiesi has developed new inhalers using Modulite technology. The aim was to obtain CFC-free pMDIs which are equivalent, in terms of safety and efficacy, to the previous CFC devices at the same dose. When beclometasone dipropionate (BDP) and budesonide Modulite formulations were compared to the equivalent CFC products there was no significant difference in morning serum cortisol or urinary cortisol excretion, at the maximum recommended daily dose (2000 micrograms or 1600 micrograms respectively). Single dose pharmacokinetic studies in both healthy volunteers and asthmatic patients compared systemic exposure (B17MP levels) for BDP-CFC with BDP Modulite and extrafine BDP-HFA (QVAR). B17MP levels for BDP-CFC and BDP Modulite were comparable, but substantially less than that seen with extrafine BDP-HFA. After 6 weeks of treatment in asthmatic patients, B17MP AUC after inhalation of BDP (1000 micrograms twice-daily) from BDP Modulite was comparable with that obtained after BDP-CFC (Becloforte). Plasma profile of BDP and B17MP were similar after inhalation from BDP Modulite with standard actuator or delivered via a spacer, suggesting that pulmonary delivery of BDP to the lung is similar with both actuators.

    Topics: Administration, Inhalation; Adult; Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Chemistry, Pharmaceutical; Cross-Over Studies; Double-Blind Method; Drug Delivery Systems; Female; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Male; Nebulizers and Vaporizers; Therapeutic Equivalency

2002
Airway and systemic effects of hydrofluoroalkane fluticasone and beclomethasone in patients with asthma.
    Thorax, 2002, Volume: 57, Issue:10

    With the transition to hydrofluoroalkane-134a propellants in metered dose inhalers, it is important to consider the efficacy and safety profiles of formulations containing inhaled corticosteroids. We examined the airway and systemic effects of hydrofluoroalkane-134a fluticasone propionate (FLU-HFA) and beclomethasone dipropionate (BEC-HFA) at recommended labelled doses.. Twenty mild to moderate asthmatics were randomised in crossover fashion to receive 6 weeks of 500 micro g/day followed by 1000 micro g/day FLU-HFA and BEC-HFA. Measurements were made at baseline after placebo run in and washout, and after each randomised treatment. The primary airway outcome for benefit was the dose of methacholine provoking a fall in forced expiratory volume in 1 second (FEV(1)) of 20% or more (methacholine PD(20)) and for systemic adverse effects was overnight urinary cortisol/creatinine (OUCC).. For mean responses, both doses of BEC-HFA and FLU-HFA produced significant improvements in PD(20) compared with baseline. The improvement was not significantly greater with 1000 micro g/day FLU-HFA versus BEC-HFA, a 1.69 fold difference (95% CI 0.94 to 3.04). Both doses of BEC-HFA but not FLU-HFA caused significant suppression of OUCC compared with baseline, with significantly (p<0.05) lower values at 1000 micro g/day for BEC-HFA versus FLU-HFA (1.97 fold difference (95% CI 1.28 to 3.02)).. There was no difference in the airway and systemic effects in patients with mild to moderate asthma between FLU-HFA and BEC-HFA at a dose of 500 micro g/day. At 1000 micro g/day there was increased systemic bioactivity with BEC-HFA compared with FLU-HFA, without any gain in airway efficacy.

    Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchoconstrictor Agents; Bronchodilator Agents; Creatinine; Cross-Over Studies; Dose-Response Relationship, Drug; Female; Fluticasone; Forced Expiratory Flow Rates; Forced Expiratory Volume; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Male; Methacholine Chloride

2002
Exhaled NO and assessment of anti-inflammatory effects of inhaled steroid: dose-response relationship.
    The European respiratory journal, 2002, Volume: 20, Issue:3

    Exhaled nitric oxide (eNO) is an easily measured marker of airway inflammation. This study was undertaken to evaluate the usefulness of serial eNO in investigating the dose-response relationship for inhaled beclomethasone (BDP), and to compare eNO with other markers of airway inflammation. Following withdrawal of inhaled corticosteroid (ICS) therapy, 65 patients entered a double-blind, parallel-group, placebo-controlled trial of 50, 100, 200 or 500 microg x BDP x day(-1) for eight weeks. eNO and spirometry were performed weekly and a hypertonic saline challenge with sputum induction was performed at the beginning and end of treatment. The relationship between the dose of ICS and changes in eNO and forced expiratory volume in one second (FEV1) was linear at 1 week and at the end of treatment. A linear dose-response relationship was also seen for sputum eosinophils. Changes in eNO correlated significantly with changes in sputum eosinophils. Changes in the provocative dose of saline causing a 15% fall in FEV1 saline did not differ across the treatment groups nor did they correlate with changes in other measurements. Exhaled nitric oxide may be used to assess the dose-response relationship for the anti-inflammatory effects of inhaled beclomethasone. The relationship found in this study was linear over the dose range 0-500 microg x day(-1) soon after commencing therapy and continued over time.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Breath Tests; Bronchial Hyperreactivity; Dose-Response Relationship, Drug; Double-Blind Method; Eosinophils; Female; Humans; Inflammation; Male; Middle Aged; Nitric Oxide; Peak Expiratory Flow Rate; Saline Solution, Hypertonic; Sputum

2002
Leukotriene C4 synthase gene A(-444)C polymorphism and clinical response to a CYS-LT(1) antagonist, pranlukast, in Japanese patients with moderate asthma.
    Pharmacogenetics, 2002, Volume: 12, Issue:7

    CysLT(1) antagonists are effective for a subset of patients with asthma; however, there has been no good way to predict a given patient's response. We examined the interaction between the clinical response to a cysLT(1) antagonist, pranlukast, and DNA sequence variant A(-444)C in leukotriene C(4) synthase (LTC(4) S) gene in Japanese patients with moderate asthma. The frequency of LTC(4) S C(-444) allele was 21.6% in the Japanese general population (n = 171) and 19.4% in the asthmatic subjects ( n= 349). A 4-week prospective, open trial of pranlukast (225 mg twice daily) was performed in 50 patients with moderate asthma who had been well controlled with inhaled corticosteroid (beclomethasone 400-800 microg/day or fluticasone 200-400 microg/day). The C(-444) allele carriers (n = 16) responded better to pranlukast compared to the A(-444) allele homozygotes ( n= 31) [14.3 5.3% vs. 3.1 2.4% improvement of forced expiratory volume in one second (FEV(1) ), 0.01], while LTC(4) S genotype-stratified response to inhaled beta-agonist salbutamol (200 microg) was not observed (17.5 2.1% vs. 18.7 2.2% improvement of FEV(1) ). Univariate analysis demonstrated that the better response to pranlukast (more than 10% improvement of FEV(1) ) was correlated with LTC(4) S genotype (P < 0.01) and pretreatment airway reversibility to salbutamol (P < 0.01), but not with sex, age, atopic status, urinary leukotriene E(4) excretion rate, or daily dose of inhaled corticosteroid. Furthermore, multivariate regression analysis suggested that LTC(4) S genotype and the bronchodilatory effect of salbutamol were independent variables to predict the clinical response to pranlukast (P < 0.05). We conclude that LTC(4) S genotype is predictive of the clinical response to a cysLT(1) antagonist, pranlukast, in Japanese patients with moderate asthma.

    Topics: Administration, Inhalation; Adult; Albuterol; Analysis of Variance; Androstadienes; Anti-Asthmatic Agents; Asian People; Asthma; Beclomethasone; Chromones; Female; Fluticasone; Forced Expiratory Volume; Genetic Carrier Screening; Glutathione Transferase; Humans; Japan; Leukotriene Antagonists; Male; Middle Aged; Polymorphism, Single Nucleotide; Promoter Regions, Genetic

2002
Equivalent efficacy and safety of a new HFA-134a formulation of BDP compared with the conventional CFC in adult asthmatics.
    Journal of investigational allergology & clinical immunology, 2002, Volume: 12, Issue:2

    The present study demonstrates the equivalent efficacy for BDP 500 microg bid given via MDI with the new HFA-134a propellant (Chiesi Farmaceutici S.p.A., Parma) compared to a conventional CFC propellant (Becotide, Allen & Hanburys, UK). One hundred and sixteen adult patients with stable mild to moderate asthma (FEV1 > or = 60% of predicted normal) entered a 2-week run-in period where they maintained their own inhaled corticosteroids and were then assigned to a 12-week treatment with the test drug in a randomized, multicentre, double-blind, double-dummy, parallel-group design. Ninety-one patients completed the study period. Morning and evening peak expiratory flow rate (PEFR), use of rescue salbutamol, number of daytime and nighttime asthma attacks, number of nighttime awakenings, and clinical symptoms were recorded daily by patients on a diary card. Pulmonary function tests (FEV1, FVC, PEFR, MEF50 and FEF25) were completed at study entry, at the start of treatment and every 2 weeks thereafter. Morning (08.00-10.00 AM) serum cortisol was measured at the start and at the end of treatment. Adverse events were collected for the total study period. Equivalence between groups was demonstrated for the primary end-point morning PEFR, as well as for evening PEFR and FEV1 (the 95% CI of the treatments' difference was within the 5% of the LSM of BDP CFC). The other secondary pulmonary function tests measured at the clinic visit showed a satisfactory asthma control, albeit without statistically significant differences between groups. Decreases in the use of rescue salbutamol and in clinical symptoms were also reported in both groups, with no differences between them. Adverse events were reported in 81.4% of patients in the BDP HFA group and in 82.5% in the CFC group. There were 73 and 59 adverse drug reactions in the two groups, respectively; the difference was mainly due to differences in taste. No drug-related serious adverse events were reported in either group. No difference was seen for morning serum cortisol between baseline and end of treatment, or between groups. In conclusion, the BDP-HFA 134a formulation proved to be statistically equivalent to the standard BDP CFC product over 12 weeks in adult patients with mild to moderate asthma.

    Topics: Adult; Aged; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Chemistry, Pharmaceutical; Chlorofluorocarbons; Double-Blind Method; Female; Fluticasone; Forced Expiratory Volume; Humans; Hydrocarbons, Fluorinated; Least-Squares Analysis; Male; Middle Aged; Patient Compliance; Peak Expiratory Flow Rate; Severity of Illness Index; Treatment Outcome; United Kingdom; Vital Capacity

2002
Importance of drug delivery system in steroid aerosol therapy via nebulizer.
    Pulmonary pharmacology & therapeutics, 2002, Volume: 15, Issue:5

    Aim of our study was to evaluate if the type of nebulizer can influence the effects of steroid aerosol therapy. We considered 27 asthmatics allergic to grasses with FEV1<80% of the predictive value or methacholine PD20 FEV1<750 mcg. The patients were divided into three groups in relation to the type of nebulizer they used and treated 9 weeks by aerosol therapy with beclomethasone dipropionate bid (800 mcg). Respect to the values recorded at the beginning and at the end of the therapy we found different variations of spirometric indeces and PD20 values among the three groups. We can conclude that the type of nebulizer influences steroid aerosol therapy and, particularly, jet nebulizers seem more efficient than ultrasonic nebulizers.

    Topics: Adult; Albuterol; Animals; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchoconstrictor Agents; Bronchodilator Agents; Drug Delivery Systems; Female; Forced Expiratory Flow Rates; Forced Expiratory Volume; Humans; Male; Methacholine Chloride; Mites; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Spirometry

2002
A new HFA-134a propellant in the administration of inhaled BDP via the Jet spacer: controlled clinical trial vs the conventional CFC.
    Respiratory medicine, 2002, Volume: 96, Issue:10

    This study was carried out with the aim of demonstrating the efficacy and tolerability of beclomethasone dipropionate (BDP) aerosol spray 500 microg b.i.d. via a spacer device (Jet, Chiesi Farmaceutici S.p.A.) using a new HFA-134a formulation or chlorofluorocarbon (CFC) propellant. After having completed a 2-week run-in period, 154 adult patients (77 in each group) with mild-to-moderate persistent asthma were randomised into two groups to receive the study treatment for a duration of 12 weeks in a double-blind, multinational, multicentre, parallel-group design. Morning and evening peak expiratory flow rate (PEFR), use of rescue salbutamol, number of day- and night-time asthma attacks, number of night-time awakenings due to asthma and clinical symptoms were recorded daily by patients on diary cards. Pulmonary function tests (FEV1, FVC, PEFR, FEF25-75%, MEF50 and FEF25) and vital signs were measured at the clinic at study entry, at the start of treatment and every 2 weeks thereafter. Morning serum cortisol (8.00-10.00 a.m.) was measured at the start and at the end of the treatment period. Adverse events were recorded throughout the total study period. Significant improvements over baseline were reported in both groups in terms of lung function, symptoms and use of rescue inhaled salbutamol. Equivalence between groups was demonstrated for the primary end-point morning PEFR, as well as for evening PEFR and FEV1. No statistically significant differences in the comparisons between groups, except for FEF25 (P=0.044), were observed in any of the other efficacy variables. Adverse events were reported in 31% of patients in the BDP-HFA group and in 32% in the CFC group. Adverse drug reactions were 4 and 2 in the two groups, respectively. No drug-related serious adverse events were reported in either of the groups. No signs of relevant adrenal suppression were observed in both groups: 2 patients in each group had final values below the normal range. In conclusion, the BDP-HFA-134a formulation proved to be equivalent in efficacy and comparable in safety to the standard BDP-CFC product over 12 weeks in adult patients with mild-to-moderate persistent asthma.

    Topics: Administration, Inhalation; Adolescent; Adult; Aerosol Propellants; Aerosols; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chlorofluorocarbons; Double-Blind Method; Female; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Male; Middle Aged; Peak Expiratory Flow Rate; Respiratory Mechanics; Treatment Outcome

2002
Omalizumab improves asthma-related quality of life in children with allergic asthma.
    Pediatrics, 2002, Volume: 110, Issue:5

    Omalizumab is a recombinant, humanized, monoclonal anti-immunoglobulin E (IgE) antibody, developed for the treatment of IgE-mediated diseases. In children with allergic asthma, it was shown to reduce the requirement for inhaled corticosteroids while protecting against disease exacerbation. Here we report the effects of treatment with omalizumab on asthma-related quality of life (AQoL) in children with allergic asthma.. This evaluation was part of a previously reported 28-week, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of omalizumab (at least 0.016 mg/kg/IgE [IU/mL] per 4 weeks) in children with allergic asthma who were well controlled on daily treatment with inhaled corticosteroids. Dosage of beclomethasone dipropionate was kept constant for 16 weeks (steroid-stable phase), then reduced over 8 weeks to the minimum effective dose (steroid-reduction phase). This dose was then maintained for the final 4 weeks. The Pediatric Asthma Quality of Life Questionnaire (PAQLQ) was administered at baseline, week 16, and week 28.. Baseline demographics, PAQLQ scores, and other data were comparable for the 2 treatment groups. At the end of the steroid-reduction phase, patients in the omalizumab-treated group reported significant improvements in the "activities" and "symptoms" domain scores as well as overall AQoL compared with placebo. More patients in the omalizumab group achieved clinically relevant (> or =0.5) changes in PAQLQ scores during the course of the study, and this difference was significant for activities and overall AQoL.. Omalizumab improves AQoL in children with allergic asthma.

    Topics: Anti-Asthmatic Agents; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Beclomethasone; Child; Child, Preschool; Double-Blind Method; Drug Therapy, Combination; Female; Health Status; Humans; Injections, Subcutaneous; Male; Omalizumab; Placebos; Quality of Life; Surveys and Questionnaires; Treatment Outcome

2002
The anti-IgE antibody omalizumab improves asthma-related quality of life in patients with allergic asthma.
    The European respiratory journal, 2002, Volume: 20, Issue:5

    The aim of the present study was to determine the effect of treatment with omalizumab, an anti-immunoglobulin E antibody, on asthma-related quality of life (AQoL) in patients with moderate-to-severe allergic asthma. A total of 546 patients with allergic asthma were randomised to double-blind subcutaneous treatment with either placebo or omalizumab for 52 weeks. A constant beclomethasone dipropionate dose was maintained during the first 16 weeks (steroid-stable phase). This was followed by a 12-week steroid-reduction phase. The core study was followed by a 24-week double-blind extension phase. AQoL was evaluated at baseline and at the end of the steroid-stable (week 16), steroid-reduction (week 28) and extension phases (week 52) using the Juniper Asthma Quality of Life Questionnaire (AQLQ). Baseline AQLQ scores were comparable for the two treatment groups. Relative to placebo, omalizumab-treated patients demonstrated statistically significant improvements from baseline across all four AQLQ domains, as well as overall AQoL score, at weeks 16 (except environmental exposure), 28 and 52. Patients on omalizumab were also more likely to achieve clinically significant improvements in AQoL during the course of the study. Overall, almost 70% of patients and investigators rated treatment with omalizumab as "excellent/good", compared with approximately 40% of placebo recipients. Clinical studies show that omalizumab enhances disease control whilst reducing corticosteroid consumption in patients with allergic asthma. The results of the present study show that these changes are paralleled by improvements in asthma-related quality of life that are meaningful to such patients.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Beclomethasone; Child; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Immunoglobulin E; Injections, Subcutaneous; Male; Middle Aged; Omalizumab; Peak Expiratory Flow Rate; Quality of Life

2002
Dose reduction of inhaled corticosteroids under concomitant medication with montelukast in patients with asthma.
    The European respiratory journal, 2002, Volume: 20, Issue:5

    The present study aimed at comparing the effects of a dose reduction of inhaled corticosteroids on lung function, indirect measures of airway inflammation and clinical scores during treatment with a leucotriene receptor antagonist. In 50 patients (mean forced expiratory volume in one second (FEV1) 94% predicted), steroid doses (800 microg beclomethasone dipropionate) were first reduced to 50% and then to 25%, for 6 weeks each. One group received a placebo and the other group received montelukast (10 mg). The first reduction did not cause significant effects. During the second, FEV1 and peak expiratory flow decreased in both groups (p<0.001). Daytime symptoms were not altered with placebo but were reduced by montelukast (p<0.05). Night-time symptoms were slightly elevated with placebo (p<0.05) but not montelukast, as well as the use of supplemental salbutamol. Changes in provocative concentration of methacholine causing a 20% fall in FEV1 (PC20), sputum eosinophils and exhaled nitric oxide were mostly nonsignificant for both placebo and montelukast. These data demonstrate that a 75% reduction in the dose of steroid given to patients with asthma led to a deterioration in lung function not prevented by montelukast, whereas changes in clinical state seemed to favour montelukast treatment. It therefore appears that potential effects of montelukast, in the presence of low-dose steroids, could not be attributed to single indices of lung function or airway inflammation.

    Topics: Acetates; Administration, Inhalation; Adult; Albuterol; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Breath Tests; Bronchial Provocation Tests; Bronchodilator Agents; Cyclopropanes; Drug Therapy, Combination; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Leukotriene Antagonists; Male; Nitric Oxide; Peak Expiratory Flow Rate; Quinolines; Sputum; Sulfides

2002
Effects of montelukast and beclomethasone on airway function and asthma control.
    The Journal of allergy and clinical immunology, 2002, Volume: 110, Issue:6

    Maintaining asthma control is a major objective of therapy. Traditionally, the effectiveness of asthma therapy has been judged primarily by its effect on airway function rather than on multiaspect asthma control.. An inhaled corticosteroid and a leukotriene receptor antagonist were compared to determine whether they provided equivalent effects, as judged by days of asthma control.. In a randomized, multicenter, double-blind, placebo-controlled, parallel-group study, asthmatic patients (n = 782) with FEV(1) percent predicted values of between 50% and 85% and a weekly average beta-agonist use of more than 2 puffs per day were randomized to receive montelukast (10 mg daily), beclomethasone (200 microg twice daily), or placebo treatment for 6 weeks in a double-dummy fashion. We examined the distribution of the primary end point: percentage of days of asthma control. Secondary end points included FEV(1), albuterol use, occurrence of an asthma attack, asthma flare-up, rescue corticosteroid use, sustained asthma control, and adverse experiences.. The percentage of days of asthma control was almost identical between the montelukast and beclomethasone groups (98% overlap in the distribution). Montelukast was at least equal to beclomethasone, and both were greater than placebo on the basis of frequency of asthma attacks, asthma flare-ups, and rescue corticosteroid use. Beclomethasone had a greater effect than montelukast and both treatments were better than placebo at improving FEV(1).. Montelukast was as effective as beclomethasone, as judged by indices of clinical control other than FEV(1). When evaluating the outcome of montelukast therapy, FEV(1) might underestimate clinical effectiveness.

    Topics: Acetates; Adolescent; Adult; Aged; Asthma; Beclomethasone; Cyclopropanes; Double-Blind Method; Forced Expiratory Volume; Humans; Middle Aged; Quinolines; Sulfides

2002
Possibilities of formoterol to enhance the peripheral lung deposition of the inhaled liposome corticosteroids.
    Respiratory medicine, 2002, Volume: 96, Issue:12

    The pulmonary distribution and clearance of 99m-Tc-labelled beclomethasone dipropionate (Bec)--dilauroylphosphatidylcholine (DLPC) were compared in nine asthmatic patients on inhaled steroids after a 1-week medical treatment period of long-acting beta2-agonist formoterol. The patients were given formoterol 12 microg (OxisTurbuhaler) twice daily in addition to their own regular inhaled corticosteroid therapy. Gamma lung scintigraphy and lung function tests were performed before and after formoterol treatment. The bronchodilating effect ofthe combined therapy was significant: 1-week usage of inhaled formoterol enhanced peripheral lung deposition of beclomethasone liposome and thus diminished central/peripheral deposition ratio (C/P ratio). All measured lung function values except FEV1/FVC% improved after the medication period, although statistically significant levels were not reached. A systemic positive connection was seen between enhanced lung functions and greater lung deposition measured as AUC(0-24h)/24 Beclomethasone liposome formulation maintained its long-lasting effect in connection with formoterol treatment. At the 4-h measurement, 76% of the liposome-entrapped radioactivity still remained in the lungs before and 75% after the medication period.

    Topics: Administration, Inhalation; Adult; Aged; Area Under Curve; Asthma; Beclomethasone; Bronchodilator Agents; Drug Therapy, Combination; Ethanolamines; Female; Formoterol Fumarate; Glucocorticoids; Humans; Liposomes; Lung; Male; Middle Aged; Mucociliary Clearance; Radionuclide Imaging; Respiratory Function Tests; Technetium; Time Factors

2002
Asthma exacerbations and sputum eosinophil counts: a randomised controlled trial.
    Lancet (London, England), 2002, Nov-30, Volume: 360, Issue:9347

    Treatment decisions in asthma are based on assessments of symptoms and simple measures of lung function, which do not relate closely to underlying eosinophilic airway inflammation. We aimed to assess whether a management strategy that minimises eosinophilic inflammation reduces asthma exacerbations compared with a standard management strategy.. We recruited 74 patients with moderate to severe asthma from hospital clinics and randomly allocated them to management either by standard British Thoracic Society asthma guidelines (BTS management group) or by normalisation of the induced sputum eosinophil count and reduction of symptoms (sputum management group). We assessed patients nine times over 12 months. The results were used to manage those in the sputum management group, but were not disclosed in the BTS group. The primary outcomes were the number of severe exacerbations and control of eosinophilic inflammation, measured by induced sputum eosinophil count. Analyses were by intention to treat.. The sputum eosinophil count was 63% (95% CI 24-100) lower over 12 months in the sputum management group than in the BTS management group (p=0.002). Patients in the sputum management group had significantly fewer severe asthma exacerbations than did patients in the BTS management group (35 vs 109; p=0.01) and significantly fewer patients were admitted to hospital with asthma (one vs six, p=0.047). The average daily dose of inhaled or oral corticosteroids did not differ between the two groups.. A treatment strategy directed at normalisation of the induced sputum eosinophil count reduces asthma exacerbations and admissions without the need for additional anti-inflammatory treatment.

    Topics: Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Eosinophils; Female; Humans; Leukocyte Count; Male; Middle Aged; Sputum; Treatment Outcome

2002
Effects on lung function, symptoms, and bronchial hyperreactivity of low-dose inhaled beclomethasone dipropionate given with HFA-134a or CFC propellant.
    Journal of aerosol medicine : the official journal of the International Society for Aerosols in Medicine, 2002,Winter, Volume: 15, Issue:4

    The aim of this study was to compare the efficacy of BDP 200 microg bid via metered dose inhaler, using HFA-134a (Chiesi Farmaceutici S.p.A., Parma, Italy) versus CFC (Becotide, Allen & Hanburys, U.K.) as a propellant. 172 adult patients (86 in each group) with stable mild persistent asthma who completed a 7-day run-in period were randomized to receive a 6-week treatment in a double-blind, double dummy, parallel-group design; 164 patients completed the study. Morning and evening PEFR, use of rescue salbutamol, number of day-time and night-time asthma attacks, number of night-time awakenings and clinical symptoms were recorded daily on a diary card. Pulmonary function tests (FEV(1), FVC, PEFR, and MEF(50)) were measured at the clinic before and after the 1-week run-in period, and after 3 and 6 weeks of treatment. A challenge test with inhaled methacholine was completed at baseline and at the end of the treatment period to assess potential bronchial hyper-reactivity in a subgroup of subjects (n = 65; 34 HFA, 31 CFC). In accordance with asthma of mild severity (FEV(1) predicted over 90% in both groups), a small improvement in lung function compared to baseline was seen for both treatments, significantly for FEV(1) in BDP HFA and MEF(50) in both groups. The two formulations of BDP had similar efficacy for the primary outcome variable morning PEFR (ITT population mean difference 5.8 L/min; C.I. -4.9 to +16.5) as well as for the secondary outcomes of evening PEFR and clinic FEV(1). There were small improvements in methacholine PD(20) and PC20 in both groups, with no significant difference between treatments. A total of 22 and 19 drug-related adverse events were reported in the BDP HFA and CFC groups, respectively; most events were of seasonal nature or were local effects due to the use of inhaled corticosteroids. It can be concluded that the newly developed formulation of BDP given via HFA-134a seems to provide similar asthma control, compared with the same low daily dose of the active drug delivered via CFC. Further studies are needed using higher doses in moderate to severe asthma to confirm these preliminary findings.

    Topics: Administration, Inhalation; Adult; Aerosol Propellants; Aerosols; Analysis of Variance; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Chlorofluorocarbons; Double-Blind Method; Female; Humans; Hydrocarbons, Fluorinated; Male; Middle Aged; Nebulizers and Vaporizers; Respiratory Function Tests

2002
Impact of Fluticasone Diskhaler on health-related quality of life in asthmatic patients.
    The Tokai journal of experimental and clinical medicine, 2002, Volume: 27, Issue:3

    To assess effect of a breath-actuated inhaled steroid, Fluticasone Diskhaler (Flutide) on health-related quality of life in asthmatic patients using Hyland's living with asthma questionnaire (LWAQ).. Randomly selected asthmatic patients filled out the LWAQ (the first study). Then, the eight physicians switched inhaled steroid from pressurelized metered-dose inhaler of beclomethasone (BDI) to Flutide according to their own decision. Consequently some patients were switched their prescriptions and others were not. In 12 weeks after the first study, all the patients again filled out the LWAQ (the second study).. The patients treated with Flutide were 87 and without were 159. The scale scores of the Flutide group (mean, 1.900) were significantly higher than those of the BDI-group (mean, 1.789). In the second study, there was no significant difference between the scale scores in the two groups (mean, 1.782 vs. 1.705). Among the 8 domains, only medication score significantly decreased by Flutide therapy. More than 80% of the patients favored easy handling of Flutide including no necessity of the spacer.. Flutide therapy significantly improved quality of life in asthmatic patients. The possible mechanisms are the stronger effectiveness of fluticasone propionate and improvement of adherence to inhaled steroid.

    Topics: Adult; Aged; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Female; Fluticasone; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Patient Satisfaction; Quality of Life; Surveys and Questionnaires

2002
Initial improvements in lung function and bronchial hyperresponsiveness are maintained during 5 years of treatment with inhaled beclomethasone dipropionate and terbutaline.
    Chest, 2002, Volume: 121, Issue:1

    Treatment with inhaled corticosteroids reduces bronchial hyperresponsiveness and relieves airways obstruction in patients with asthma. Up to now, it is unknown whether initial improvements are maintained over a long period of time. Therefore, we assessed whether initial improvements in FEV(1), provocative concentration of histamine causing a 20% fall in FEV(1) (PC(20)), and peak expiratory flow (PEF) persist with a constant dose of inhaled corticosteroids. Furthermore, we investigated whether FEV(1), PC(20), PEF indexes, and symptom scores improve after increasing the dose of inhaled corticosteroids in patients who did not respond sufficiently to treatment with beclomethasone dipropionate (BDP), 800 microg/d.. Sixty-eight patients with bronchial hyperresponsiveness and airways obstruction completed a previous study on 3 years of treatment with terbutaline, 500 microg qid, and BDP, 200 microg qid. Fifty-eight of these patients participated in the current extension of another 2.5 years of follow-up. Every 6 months, FEV(1) and PC(20) were measured. Five patients dropped out of the study, one for pulmonary reasons. Forty-four patients continued treatment with BDP, 800 microg/d (BDP-800 group), and 9 patients received a higher dose of BDP (500 microg tid; BDP-1,500 group) after the first 3 years because of a rapid decline in FEV(1) (> 50 mL/yr) despite BDP treatment during the previous study period.. After the initial improvement, the mean slope of individual regression lines for FEV(1), PC(20), and morning PEF were - 28 mL/yr, - 0.01 doubling concentrations per year, and 0.6 L/min/yr, respectively, in the BDP-800 group. In the BDP-1,500 group, there were no statistically significant improvements in FEV(1), PC(20), PEF indexes, and symptom scores after increasing the dose of BDP.. We conclude that initial improvements in FEV(1), PC(20), and PEF are well preserved over 5 years in patients with obstructive airways diseases who are treated with terbutaline and BDP. In the patients who responded sufficiently to 800 microg/d of BDP, there was no accelerated decline in FEV(1) compared with the general population. Increasing the dose of BDP in a small group of patients with an accelerated fall in FEV(1) (initially treated with a moderate dose of BDP) resulted in no significant improvement in FEV(1), PC(20), PEF indexes, and symptom scores.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Long-Term Care; Lung Volume Measurements; Male; Middle Aged; Terbutaline; Treatment Outcome

2002
Significant variability in response to inhaled corticosteroids for persistent asthma.
    The Journal of allergy and clinical immunology, 2002, Volume: 109, Issue:3

    A clinical model is needed to compare inhaled corticosteroids (ICSs) with respect to efficacy.. The purpose of this investigation was to compare the relative beneficial and systemic effects in a dose-response relationship for 2 ICSs.. A 24-week, parallel, open-label, multicenter trial examined the benefit-risk ratio of 2 ICSs in persistent asthma. Benefit was assessed by improvements in FEV(1) and PC(20); risk was assessed by overnight plasma cortisol suppression. Thirty subjects were randomized to either beclomethasone dipropionate (BDP) 168, 672, and 1344 microg/day (n = 15) or fluticasone propionate (FP) 88, 352, and 704 microg/day (n = 15), both administered by means of a metered dose inhaler (MDI) with chlorofluorocarbon propellant via a spacer, in 3 consecutive 6-week intervals; this was followed by 3 weeks of FP dry powder inhaler (DPI) 2000 microg/day.. Maximum FEV(1) response occurred with the low dose for FP-MDI and the medium dose for BDP-MDI and was not further increased by treatment with FP-DPI. Near-maximum methacholine PC(20) improvement occurred with the low dose for FP-MDI and the medium dose for BDP-MDI. Both BDP-MDI and FP-MDI caused dose-dependent cortisol suppression. Responsiveness to ICS treatment was found to vary markedly among subjects. Good (>15%) FEV(1) response, in contrast to poor (<5%) response, was found to be associated with high exhaled nitric oxide (median, 17.6 vs 11.1 ppb), high bronchodilator reversibility (25.2% vs 8.8%), and a low FEV(1)/forced vital capacity ratio (0.63 vs 0.73) before treatment. Excellent (>3 doubling dilutions) improvement in PC(20), in contrast to poor (<1 doubling dilution) improvement, was found to be associated with high sputum eosinophil levels (3.4% vs 0.1%) and older age at onset of asthma (age, 20-29 years vs <10 years).. Near-maximal FEV(1) and PC(20) effects occurred with low-medium dose for both ICSs in the subjects studied. High-dose ICS therapy did not significantly increase the efficacy measures that were evaluated, but it did increase the systemic effect measure, overnight cortisol secretion. Significant intersubject variability in response occurred with both ICSs. It is possible that higher doses of ICSs are necessary to manage more severe patients or to achieve goals of therapy not evaluated in this study, such as prevention of asthma exacerbations.

    Topics: Administration, Inhalation; Adolescent; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chronic Disease; Female; Fluticasone; Forced Expiratory Volume; Humans; Hydrocortisone; Male; Methacholine Chloride; Middle Aged; Prospective Studies; Treatment Outcome

2002
Ethical assessment of industry-sponsored clinical trials: a case analysis.
    Chest, 2002, Volume: 121, Issue:4

    The rapid growth of clinical trials sponsored by the pharmaceutical industry and conducted by community physicians raises concerns about the scientific quality of this research and the adequacy of protections for research participants. In this article, we present an in-depth ethical analysis of a recent industry-sponsored placebo-controlled study for treatment of asthma. The ethical analysis uses a proposed ethical framework for evaluating clinical research focusing on seven ethical requirements: (1) scientific value, (2) scientific validity, (3) fair subject selection, (4) favorable risk/benefit ratio, (5) independent review, (6) informed consent, and (7) respect for enrolled subjects.

    Topics: Administration, Inhalation; Adolescent; Adult; Asthma; Beclomethasone; Conflict of Interest; Controlled Clinical Trials as Topic; Double-Blind Method; Drug Industry; Ethics Committees, Research; Ethics, Medical; Female; Forced Expiratory Volume; Humans; Informed Consent; Male; Mometasone Furoate; Patient Selection; Pregnadienediols; Research Support as Topic; Treatment Outcome

2002
[Efficacy and safety of high doses of beclomethasone dipropionate in patients with bronchial asthma].
    Terapevticheskii arkhiv, 2002, Volume: 74, Issue:3

    To assess efficiency and safety of high-dose beklometasone dipropionate in patients with bronchial asthma (BA).. The trial included 14 female and 3 male patients with moderate or severe BA (mean age 43.6 years) in declining exacerbation. The patients inhaled beklometasone dipropionate as a dose-adjusted aerosol with built-up spacer (beklojet) in a daily dose 1000-2000 mcg for 8 weeks. Changes in clinical symptoms, life quality (AQLQ) and bronchial permeability (peak flowmetry, FEV1) were registered. Concentration of H2O2 in expired air condensate was measured spectrophotometrically to evaluate activity of airway inflammation. Oral smears were studied mycologically, hydrocortisone in blood plasma was measured with enzyme immunoassay.. The treatment produced positive trend in clinical symptoms and quality of life. Bronchial permeability improved since the 7th treatment day. H2O2 significantly fell, hydrocortisone levels and fungal flora did not change significantly.. Beklometasone dipropionate in high doses for 8 weeks is effective and safe against BA.

    Topics: Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Female; Humans; Hydrocortisone; Hydrogen Peroxide; Male; Middle Aged; Quality of Life

2002
Systemic effect comparisons of six inhaled corticosteroid preparations.
    American journal of respiratory and critical care medicine, 2002, May-15, Volume: 165, Issue:10

    The goal of this study was to establish a reliable method to evaluate systemic bioavailability and to determine equisystemic effects (microgram dose producing equal systemic cortisol suppression) of inhaled corticosteroids (ICS). Steroid naive asthma subjects (n = 156) were enrolled at six centers. A 1-week doubling dose design was used for each of six ICS and matched placebos for a total of four doses. Systemic effect was evaluated by hourly plasma cortisol concentrations (8 P.M. to 8 A.M.), 12- and 24-hour urine cortisol concentrations, and a morning blood osteocalcin. The area under the concentration-time curve for hourly cortisol concentrations was the best outcome variable to assess systemic effect. For the six ICS and matching placebos (beclomethasone-chlorofluorocarbon [CFC], budesonide dry powder inhaler [DPI], fluticasone DPI, fluticasone-CFC metered dose inhaler [MDI], flunisolide-CFC, and triamcinolone-CFC), only the placebo group and fluticasone DPI did not demonstrate a significant dose-response effect. Thus microgram comparison of all ICS could only be performed at a 10% cortisol suppression: flunisolide-CFC - 936; triamcinolone-CFC - 787; beclomethasone-CFC - 548; fluticasone DPI - 445; budesonide DPI - 268; fluticasone-CFC MDI - 111. This study represents the first step in evaluation of ICS efficacy based on equisystemic (cortisol suppression) effects of a given ICS, rather than doses judged arbitrarily to be comparable on a microgram basis.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Aged; Androstadienes; Asthma; Beclomethasone; Budesonide; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Fluocinolone Acetonide; Fluticasone; Follow-Up Studies; Humans; Hydrocortisone; Male; Middle Aged; Probability; Reference Values; Single-Blind Method; Treatment Outcome; Triamcinolone

2002
Growth, systemic safety, and efficacy during 1 year of asthma treatment with different beclomethasone dipropionate formulations: an open-label, randomized comparison of extrafine and conventional aerosols in children.
    Pediatrics, 2002, Volume: 109, Issue:6

    To assess the long-term safety of hydrofluoroalkane 134a (HFA)-beclomethasone dipropionate (BDP) extrafine aerosol administered by the Autohaler compared with chlorofluorocarbon (CFC)-BDP administered by a press-and-breathe metered-dose inhaler (pMDI) and spacer (+S) in the treatment of children with asthma.. This 12-month, open-label, randomized, multicenter study enrolled 300 children who were aged 5 to 11 years and had well-controlled asthma on inhaled CFC-BDP or budesonide; 256 patients were using doses within the recommended range (200-400 microg) and were analyzed separately. Patients were randomized in a 1:3 ratio to continue on CFC-BDP+S at approximately the same dose as they were using before study entry or switch to HFA-BDP at half the daily dose.. Asthma control was well maintained in the HFA-BDP group as evidenced by lung function tests and asthma symptoms compared with CFC-BDP+S at approximately twice the dose. There were no significant differences between the HFA-BDP 100 to 200 microg and CFC-BDP+S 200 to 400 microg treatment groups in mean change from baseline in height (5.23 cm vs 5.66 cm at month 12, respectively) or mean growth velocity from day 1 to month 12 (5.27 cm/y vs 5.71 cm/y, respectively). There were no significant differences between groups in adrenal function tests or markers of bone metabolism.. In this long-term study in children with asthma, extrafine HFA-BDP provided long-term maintenance of asthma control at approximately half the dose compared with CFC-BDP+S. There were no clinically meaningful differences between HFA-BDP extrafine aerosol and conventional CFC-BDP+S with regard to growth or other systemic effects.

    Topics: Administration, Inhalation; Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Chemistry, Pharmaceutical; Child; Child Development; Child, Preschool; Chlorofluorocarbons; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Growth; Humans; Hydrocarbons, Fluorinated; Male; Respiratory Function Tests; Treatment Outcome

2002
Step-down therapy with low-dose fluticasone-salmeterol combination or medium-dose hydrofluoroalkane 134a-beclomethasone alone.
    The Journal of allergy and clinical immunology, 2002, Volume: 109, Issue:6

    Options for step-down therapy include use of inhaled corticosteroids alone or in combination with a long-acting beta2-agonist.. We sought to evaluate step-down therapy with a fluticasone propionate-salmeterol (FP-SM) combination administered through a dry powder inhaler (DPI; Advair Diskus) versus a medium dose of hydrofluoroalkane 143a-beclomethasone dipropionate (HFA-BDP) administered through a breath-actuated pressurized metered-dose inhaler (QVAR Autohaler).. Thirty-nine patients with uncontrolled moderate-to-severe asthma were treated with 1000 microg of DPI-administered BDP twice daily (DPI-BDP) for 4 weeks and then randomized to 200 microg of HFA-BDP twice daily (n = 20) or 100 microg of FP and 50 microg of SM twice daily (FM-SM; n = 19) for 8 weeks in a double-blind, double-dummy, parallel-group design. We measured the provocative dose of methacholine producing a 20% fall in FEV1 (methacholine PD20) as the primary outcome, with secondary outcomes being lung function, surrogate inflammatory markers, diary card responses, quality of life, and safety.. There was a 0.9 (95% confidence interval, 0.5-1.2) doubling dose improvement in methacholine PD20 comparing asthma before versus after DPI-BDP. HFA-BDP maintained this improvement, whereas FP-SM produced a further significant improvement, amounting to a 1.1 (95% confidence interval, 0.2-2.1) doubling dose difference at 8 weeks for FP-SM versus HFA-BDP. Effects on FEV1, peak expiratory flow, and quality of life (symptoms and emotions) were similar to those on methacholine PD20, with a significant difference between FP-SM and HFA-BDP. Suppression of plasma and urinary cortisol and serum osteocalcin levels occurred with DPI-BDP, but values returned to baseline levels within 1 month of HFA-BDP or FP-SM administration.. After high-dose inhaled corticosteroid, stepping down with the combination inhaler conferred further improvements in bronchoprotection, bronchodilatation, and clinical control, but not inflammatory markers, compared with that seen with a medium dose of inhaled corticosteroid.

    Topics: Administration, Inhalation; Adolescent; Adult; Aerosol Propellants; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchodilator Agents; Drug Administration Schedule; Drug Therapy, Combination; Fluticasone; Humans; Hydrocarbons, Fluorinated; Middle Aged; Outcome Assessment, Health Care; Quality of Life; Respiratory Function Tests; Salmeterol Xinafoate

2002
Clinically important improvements in asthma-specific quality of life, but no difference in conventional clinical indexes in patients changed from conventional beclomethasone dipropionate to approximately half the dose of extrafine beclomethasone dipropion
    Chest, 2002, Volume: 121, Issue:6

    Clinical trials of asthma treatments usually use measures of asthma control to assess efficacy. However, it is also important to determine whether patients themselves benefit from interventions. The aim of this study was to evaluate health-related quality of life in patients with asthma switched from conventional chlorofluorocarbon (CFC) beclomethasone dipropionate (BDP) to hydrofluroalkane-134a (HFA) BDP extrafine aerosol at half the daily dose.. Open-label, 12-month, parallel-group, randomized trial.. Fifty-seven centers in four countries (United States, Belgium, the Netherlands, and United Kingdom).. Four hundred seventy-three patients with a > or = 6-month history of asthma, stable symptoms, and maintained on CFC-BDP, 400 to 1,600 microg/d.. HFA-BDP, 200 to 800 microg/d (n = 354), or CFC-BDP, 400 to 1,600 microg/d (n = 119).. The Asthma Quality of Life Questionnaire (AQLQ) and pulmonary function tests were completed at months 0, 2, 4, 8, and 12. For 1 month before each visit, patients made daily recordings of symptoms, peak expiratory flow, and beta(2)-agonist use. Two hundred ninety-six patients completed the study (HFA-BDP, 83.6%; CFC-BDP, 83.2%). At month 12, improvements in overall AQLQ scores were greater in the HFA-BDP group than in the CFC-BDP group (p = 0.0024). The number of patients who need to be treated with HFA-BDP for one to have a clinically important improvement in overall asthma-specific quality of life compared with CFC-BDP was 7.3. There was no evidence of differences (p > 0.05) between treatment groups for airway caliber, symptoms, or beta(2)-agonist use.. Clinically important improvements in the AQLQ score were observed at month 12 for HFA-BDP vs CFC-BDP, while conventional clinical indexes of pulmonary function and asthma control were similar in the two groups.

    Topics: Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Male; Particle Size; Quality of Life; Severity of Illness Index

2002
One-year trial on safety and normal linear growth with flunisolide HFA in children with asthma.
    Clinical pediatrics, 2002, Volume: 41, Issue:5

    Flunisolide hydrofluoroalkane (HFA) has efficacy equivalent to that of flunisolide chlorofluorocarbon (CFC) at one third the dose of the CFC formulation, a reduction from 250 microg/puff for flunisolide CFC to 85 microg/puff for flunisolide HFA. Flunisolide HFA delivers a smaller particle size (1.2 microm) in solution, resulting in improved lung deposition as compared with flunisolide CFC (3.8 microm), which is delivered in suspension. An added built-in spacer has reduced oropharyngeal deposition that may result in fewer adverse events and make it easier to use. The objective of this study was to compare the year-long safety of flunisolide HFA (daily dosage 340 microg) with that of CFC beclomethasone dipropionate (BDP) (daily dosage 336 microg) and cromolyn sodium (daily dosage 6,400 microg) in children 4-11 years old with mild-to-moderate asthma. The effects of these drugs on linear growth and growth velocity were also compared. The study was a 1-year open-label, parallel-group trial. Changes in physical examinations (including growth), adverse events, vital signs, electrocardiograms, cosyntropin stimulation tests, mouth and throat cultures for Candida albicans, and laboratory findings were analyzed. Patients 4-5 years old received flunisolide HFA only. In total, 235 children were evaluated (152 receiving flunisolide HFA, 39 BDP, and 44 cromolyn). The incidence of adverse events was comparable among treatment groups; most were mild or moderate and considered unrelated to treatment. Among patients 6-11 years old, mean changes from baseline height at week 52 were 6.2 cm for the flunisolide HFA and cromolyn groups and 5.1 cm for the BDP group. Thus growth in children receiving flunisolide HFA was unaffected by 1 year of treatment. Changes from baseline in other parameters, including response to cosyntropin stimulation, were insignificant and similar among the 3 treatment groups. At the dosages studied, and following 1 year of treatment, flunisolide HFA with its small particle size and built-in spacer is safe and well tolerated in children 4-11 years old. There are no adverse effects associated with hypothalamic pituitary axis (HPA) function of flunisolide HFA, including linear growth in children 6-11 years old when compared with BDP and cromolyn sodium.

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child Development; Child, Preschool; Cromolyn Sodium; Female; Fluocinolone Acetonide; Growth Disorders; Humans; Hypothalamus; Male; Pituitary Gland; Severity of Illness Index; Time Factors

2002
Pharmacokinetics of beclomethasone 17-monopropionate from a beclomethasone dipropionate extrafine aerosol in adults with asthma.
    European journal of clinical pharmacology, 2002, Volume: 58, Issue:3

    The objectives of this study were to test the dose and strength proportionalities of beclomethasone dipropionate (BDP) delivered from two strengths of a pressurized extrafine solution formulation.. Thirty adults with mild, stable asthma, aged between 18 years and 70 years, completed the study; written informed consent was obtained from all patients. Each patient received, according to a randomized four-period crossover design, 100 microg BDP as two inhalations from 50-microg/actuation strength, 100 microg BDP as one inhalation from 100-microg/actuation strength, 400 microg BDP as eight inhalations from the 50-microg/actuation strength, and 400 microg BDP as four inhalations from the 100-microg/actuation strength. Patients self-administered all inhalations at the same time of day during the study. Blood samples were collected for 12 h during each period to assay for the presence of BDP and metabolites. The log-transformed pharmacokinetic data were compared for proportionality equivalence using a confidence-interval approach.. Almost all the BDP-derived material in the plasma was the active metabolite beclomethasone 17-monopropionate (17-BMP). Due to low levels, neither elimination half-life ( t(1/2)) nor the area under the plasma concentration-time curve (AUC) for 17-BMP could be calculated for the 100-microg BDP doses. Dose proportionality of the 100-microg and 400-microg BDP doses, using 17-BMP maximum plasma concentration (C(max)) was demonstrated for each strength. Strength proportionality of the 50-microg and 100-microg/actuation strengths was observed for C(max) at both dose levels and for AUC at the higher dose level. The t(1/2) of 17-BMP was found to be approximately 2.8 h.. This study demonstrated both the strength and dose proportionalities of the BDP extrafine aerosol. This important information will allow physicians maximum flexibility in prescribing this aerosol product.

    Topics: Adult; Aerosols; Aged; Anti-Asthmatic Agents; Area Under Curve; Asthma; Beclomethasone; Cross-Over Studies; Dose-Response Relationship, Drug; Female; Half-Life; Humans; Male; Middle Aged

2002
Effects of inhaled corticosteroids on cough threshold in patients with bronchial asthma.
    Pulmonary pharmacology & therapeutics, 2001, Volume: 14, Issue:1

    In asthmatic subjects cough can be related to the degree of airway inflammation. The aim of this study was to evaluate the effect of treatment with high dose inhaled beclomethasone dipropionate (BDP) on cough threshold in asthmatic subjects. Cough threshold to inhaled capsaicin (one breath of 10(-8)-10(-4)M solution) and to citric acid (one breath of 10(-4)-1 M), expressed as provocative concentration of two (PC2) and four coughs (PC4), was measured in 16 normal and 36 asthmatic subjects. After baseline evaluation, asthmatic subjects were randomized in two groups: (a) Group A, n=20: treated with salbutamol (200 microg t.i.d.) plus BDP (500 microg t.i.d.); (b) Group B, n=16: treated with salbutamol plus placebo in the same doses. After 1 month, cough threshold and clinical and functional evaluation were repeated. After treatment, asthmatics of group A showed a significant improvement in PC4 citric acid, in total symptom and cough scores, and in PD20FEV1 methacholine. In asthmatics of group B, treatment caused no improvement in symptoms, PD20FEV1 methacoline and cough threshold. In addition, cough threshold was not different between normal and asthmatic subjects and, in asthmatics, cough threshold did not correlate with PD20FEV1 methacholine. These data confirm that cough in asthma can be partially related to airway inflammation.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Capsaicin; Citric Acid; Cough; Female; Humans; Male; Treatment Outcome

2001
Therapeutic equivalence study of two formulations (innovator v. generic) of beclomethasone dipropionate in adult asthmatic patients.
    South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 2001, Volume: 91, Issue:1

    To study the therapeutic equivalence of two formulations (innovator v. generic) of beclomethasone dipropionate (BDP) 400 micrograms twice daily administered per metered dose inhaler (MDI), in adults with moderate to severe asthma.. A double-blind randomised parallel-group trial was performed with a 2-week run-in and an 8-week treatment period. Thirty-six symptomatic adult asthmatics on a mean daily dose of 750 micrograms inhaled corticosteroids during run-in, a mean forced expiratory volume in 1 second (FEV1) of 70% predicted normal and a mean histamine concentration provoking a 20% reduction in FEV1 (histamine PC20) of 0.11 mg/l were randomised to one of the two treatment groups. Primary variables were morning peak expiratory flow (mPEF), FEV1 and histamine PC20. Secondary variables were beta 2-agonist use, symptom score and nocturnal awakening. The Schuirmann two one-sided tests procedure was used for the statistical analysis. Ninety-five per cent confidence intervals (CIs) were calculated for the differences in means.. The mean differences end of treatment to baseline for the two formulations (Becotide and Beclate) respectively were: mPEF 5.6 l/min (CI - 16.4-27.6) and -22.3 l/min (CI -35.6(-)-9); FEV1 -2.9% (CI -11-5.2) and 0.2% (CI -4.8-5.2); Histamine PC20 -0.04 mg/ml (CI -0.15-0.06) and 0.02 mg/ml (CI -0.37-0.4). Changes in clinical variables were not conclusive. The mean differences with CIs for primary variables were contained within the limits set for equivalence. The sample size was sufficient to differentiate the groups for mPEF, but this was not of clinical significance.. After 8 weeks of treatment the two formulations of BDP, delivered by MDI through a large-volume spacer, were therapeutically equivalent in moderate-to-severe asthmatic adults.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chemistry, Pharmaceutical; Double-Blind Method; Drugs, Generic; Female; Forced Expiratory Volume; Humans; Male; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Severity of Illness Index; Therapeutic Equivalency; Treatment Outcome

2001
Bone mineral density in subjects with mild asthma randomised to treatment with inhaled corticosteroids or non-corticosteroid treatment for two years.
    Thorax, 2001, Volume: 56, Issue:4

    Inhaled corticosteroids are clearly beneficial for patients with asthma of moderate severity, but the risks and benefits of using them in patients with milder asthma are less clear. We have compared the change in bone mineral density over 2 years in adults with mild asthma randomised to receive an inhaled corticosteroid or non-corticosteroid treatment.. Subjects with mild asthma (mean forced expiratory volume in one second (FEV(1)) 86% predicted, mean age 35 years, taking beta agonists only) were randomised to receive inhaled budesonide, inhaled beclomethasone dipropionate, or non-corticosteroid treatment for 2 years in a prospective randomised open study in 19 centres in France, New Zealand, Spain, and the UK. The corticosteroid dose was adjusted according to a written self-management plan. The main outcome measure-change in bone mineral density after 6, 12, and 24 months-was measured "blind". Secondary outcomes included lung function, the relation between change in bone density and inhaled steroid dose and change in biochemical markers of bone metabolism.. Of 374 subjects randomised, 239 (64%) completed the study and were included in the analysis. The median daily doses of inhaled budesonide (n=87) and beclomethasone (n=74) were 389 microg and 499 microg, respectively. Subjects treated with an inhaled corticosteroid had better asthma control than those in the reference group (n=78). Change in bone mineral density did not differ between the three groups over the 2 years, nor did it correlate with changes in markers of bone metabolism. The mean change in bone mineral density over 2 years in the budesonide, beclomethasone dipropionate, and reference groups was 0.1%, -0.4%, and 0.4% for the lumbar spine and -0.9%, -0.9%, and -0.4% for neck of the femur. Mean daily dose of inhaled steroid was related to reduction in bone mineral density at the lumbar spine but not at the femoral neck.. In subjects with mild asthma an inhaled corticosteroid provided better asthma control than alternative non-corticosteroid treatment with no difference in change in bone mineral density over 2 years. The relation between dose of inhaled corticosteroid and change in bone density at the lumbar spine may be due to a direct effect of inhaled corticosteroids on bone. Since inhaled steroid dose is also related inversely to lung function, an effect of asthma severity on bone density was also possible.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bone Density; Bronchodilator Agents; Budesonide; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Osteocalcin; Peak Expiratory Flow Rate; Prospective Studies; Regression Analysis; Treatment Outcome

2001
Mometasone furoate: efficacy and safety in moderate asthma compared with beclomethasone dipropionate.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2001, Volume: 86, Issue:2

    Mometasone furoate (MF) is a new inhaled glucocorticoid administered by dry powder inhaler (DPI).. MF-DPI was evaluated for safety and efficacy and compared with placebo DPI and beclomethasone dipropionate (BDP) administered by metered dose inhaler (MDI) in the treatment of patients with moderate persistent asthma.. Eligible patients (n = 227), 13 to 75 years of age, maintained on inhaled glucocorticoids before entering the trial, were randomized to receive: MF-DPI, 100 microg, twice daily, MF-DPI, 200 microg, twice daily, BDP MDI, 168 microg, twice daily, or placebo in a 12-week, multicenter, double-blind study.. At endpoint, FEV1 (primary efficacy variable) significantly improved for all three active treatments compared with placebo (P < .01, all comparisons). The response to MF-DPI, 200 microg, twice daily treatment was approximately twice as large as the response to MF-DPI, 100 microg, twice daily or BDP MDI treatment, although the differences between these groups did not reach statistical significance. Secondary efficacy variables including PEFR, asthma symptoms, nocturnal awakenings, and albuterol use showed similar trends. The MF-DPI, 100 microg, twice daily and BDP MDI, 168 microg, twice daily treatment groups produced comparable results for all efficacy variables.. MF-DPI, 100 microg and 200 microg, twice daily were well-tolerated and significantly improved lung function and symptom control in the treatment of patients with moderate persistent asthma. In this study, MF-DPI, 200 microg, twice daily seemed to be the most effective dosage.

    Topics: Administration, Inhalation; Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Double-Blind Method; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Mometasone Furoate; Peak Expiratory Flow Rate; Powders; Pregnadienediols; Therapeutic Equivalency

2001
Efficacy of budesonide Turbuhaler compared with that of beclomethasone dipropionate pMDI in Japanese patients with moderately persistent asthma.
    Respirology (Carlton, Vic.), 2001, Volume: 6, Issue:1

    The aim of the study was to compare the efficacy and safety of budesonide Turbuhaler with that of beclomethasone dipropionate (BDP) pMDI.. Three hundred and fifty adult asthma patients (mean age 52.7 years, mean baseline morning peak expiratory flow (PEF) 294 L/min (< 80% predicted normal)), taking BDP via pressurized metered-dose inhaler (pMDI), 400 microg daily for at least 2 months, were randomized in an open 6 week study to receive daily doses of either budesonide 100 microg or 400 microg twice daily via Turbuhaler or continued treatment with BDP, 100 microg four times daily. The primary efficacy variable was the mean change in morning PEF from baseline to the end of treatment. Outcome was also assessed using symptom scores and investigators' assessments employed in Japanese clinical trials.. At the end of the 6 week treatment period, mean morning PEF improved significantly from baseline in both budesonide groups, 16 L/min and 33 L/min in the 200 microg and 800 microg groups, respectively, but not in the BDP group, 5 L/min. There was no significant difference between 200 microg budesonide and 400 microg BDP treatment in the effect on PEF (P = 0.29), but 800 microg budesonide was significantly superior to BDP (P < 0.001). Final assessment of improvement and usefulness ratings showed that both budesonide treatments were significantly superior to BDP (P < 0.001). All treatments were well tolerated.. Budesonide Turbuhaler (200 microg) was as effective as 400 microg BDP pMDI. The efficacy of budesonide was improved significantly by increasing the dosage to 800 microg daily. The study design shows the importance of including a higher dose treatment group when comparing two formulations of inhaled corticosteroids in order to determine whether the treatments to be compared are on the steep part of the dose-response curve. Without that information, comparative studies are usually inconclusive.

    Topics: Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Consumer Product Safety; Dose-Response Relationship, Drug; Female; Forced Expiratory Volume; Humans; Japan; Male; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Statistics, Nonparametric

2001
Efficacy of HFA-beclomethasone dipropionate extra-fine aerosol (800 microg day(-1)) versus HFA-fluticasone propionate (1000 microg day(-1)) in patients with asthma.
    Respiratory medicine, 2001, Volume: 95, Issue:3

    Hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) extra-fine aerosol and HFA-fluticasone propionate (HFA-FP) are chlorofluorocarbon-free inhalers. We conducted an 8-week, open study to demonstrate the equivalence of HFA-BDP (800 microg day(-1)) and HFA-FP (1000 microg day(-1)) in moderate to severe asthma. Symptomatic patients on 500-1000 microg day(-1) CFC-BDP (or equivalent) and short-acting beta-agonist, were randomized to HFA-BDP (n = 101) or HFA-FP (n = 97) after 7-14 (+/-2) day run-in. In the intent-to-treat (ITT) population (n = 198), both treatments provided clinically and statistically significant improvements in asthma control, with increases in peak expiratory flow in the morning (AM PEF) and asthma symptoms (within treatment analysis P<0.05). Mean (SE) change in AM PEF from baseline at week 8 was equivalent (defined as 90% CI for the mean difference between treatments within +/-25 l min(-1)) in the two groups: 29.59 (5.19) l min(-1) for HFA-BDP vs. 17.3 (5.45) l min(-1) for HFA-FP (90% CI-0.02, 24.91). For the perprotocol population (n = 121), the mean (SE) change in AM PEF from baseline was not equivalent; AM PEF improved to a significantly greater extent in the HFA-BDP group than HFA-FP group [34.84 (7.08) vs. 20.63 (7.32) l min(-1) P<0.01; 90% CI; 2.66, 31.10]. At week 8 in the ITT population, there were no statistically significant differences in FEV1, beta-agonist use, asthma symptom/sleep disturbance scores, or percentage of days without asthma symptoms/sleep disturbance. There was a significantly greater reduction from baseline in mean eosinophil count for HFA-BDP compared with HFA-FP at weeks 3 and 8 (P<0.01), and eosinophil cationic protein value at week 8 (P<0.01). Both treatments were well tolerated and there were no statistically significant differences in urinary cortisol creatinine parameters. In conclusion, this study showed that, in patients with moderate-to-severe symptomatic asthma, HFA-BDP extra-fine aerosol 800 microg(-1) was at least as effective and equally well tolerated as 1000 microg day(-1) HFA-FP.

    Topics: Adolescent; Adult; Aerosol Propellants; Aged; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Eosinophils; Equipment Design; Female; Fluticasone; Humans; Hydrocarbons, Fluorinated; Leukocyte Count; Male; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Treatment Outcome

2001
Extrafine beclomethasone dipropionate breath-actuated inhaler (400 micrograms/day) versus budesonide dry powder inhaler (800 micrograms/day) in asthma.
    International journal of clinical practice, 2001, Volume: 55, Issue:2

    Hydrofluoroalkane-134a beclomethasone dipropionate extrafine aerosol breath-actuated inhaler (Qvar Autohaler; BDP-AH) provides an alternative to chlorofluorocarbon metered dose inhalers or dry powder inhalers (DPIs). The aim of this six-week, open-label study was to determine whether BDP-AH demonstrates equivalent asthma control to twice the dose of budesonide (BUD)-DPI (Pulmicort Turbuhaler). Adults with symptomatic asthma inadequately controlled on BUD-DPI 400 micrograms/day and beta-agonist were enrolled. Patients (n = 193) were randomised to receive 400 micrograms/day BDP-AH (n = 98) (two puffs of 100 micrograms/actuation inhaler twice daily) or 800 micrograms/day BUD-DPI (n = 95) (two puffs of 200 micrograms/actuation inhaler twice daily). Both groups showed a statistically significant change from baseline in morning (a.m.) peak expiratory flow (PEF) at weeks 5-6 (p < 0.01), indicating study treatment improved a.m. PEF over prestudy 400 micrograms/day BUD. Changes from baseline in a.m. PEF at weeks 5-6 were 15.9 l/min for BDP-AH and 14.2 l/min for BUD-DPI; the groups were statistically equivalent (90% CI -7.02-10.44; p < -0.001 [equivalence = within +/- 25 l/min]). Other efficacy assessments (evening PEF, FEV1, asthma symptoms, beta-agonist use) confirmed the treatments were clinically equivalent. Thirty-nine (40%) patients on BDP-AH and 35 (37%) on BUD-DPI experienced at least one adverse event (p = 0.767). Four (4%) patients on BDP-AH and 3 (3%) on BUD-DPI reported increased asthma symptoms. BDP-AH at half the daily dose provided equivalent asthma control to BUD-DPI; both treatments were well tolerated.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Analysis of Variance; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Particle Size; Peak Expiratory Flow Rate; Sleep; Vital Capacity

2001
Dose-response relationship and reproducibility of the fall in exhaled nitric oxide after inhaled beclomethasone dipropionate therapy in asthma patients.
    Chest, 2001, Volume: 119, Issue:5

    The fractional concentration of exhaled nitric oxide (FENO) is a marker of asthmatic airway inflammation. We determined the dose response and the reproducibility of the FENO fall following inhaled beclomethasone dipropionate (iBDP) therapy in nonsteroid-treated asthmatic patients.. Study A: For four 1-week periods (period 1 to period 4), the following regimens were administered in sequential order to 15 nonsteroid-treated asthmatic patients: period 1, placebo; period 2, 100 microg/d of iBDP; period 3, 400 microg/D of iBDP; and period 4, 800 microg/d of iBDP. Spirometry, FENO, and provocative concentration of methacholine resulting in a 20% fall in FEV(1) (PC(20)) were measured at each of five visits (visit 1 to visit 5). Study B: During four periods, 12 nonsteroid-treated asthmatic patients received placebo treatment for 7 days (period 1), 200 microg/d of iBDP for 14 days (period 2), washout on placebo treatment until the FENO was within 15% of baseline (period 3), and 200 microg/d of iBDP for 14 days (period 4).. Study A: Mean FEV(1) rose progressively from 3.10 L (visit 1) to 3.41 L (visit 5; p = 0.001). All iBDP doses caused a significant FEV(1) rise compared to placebo treatment, but with no significant separation of doses using FEV(1). FENO geometric mean (95% confidence limits) fell progressively from 103.5 parts per billion (ppb) (78.5 to 136.7) to 37.4 ppb (29.1 to 48.0) from visit 1 to visit 5 (p = 0.001). All doses of iBDP resulted in a significant change in FENO from placebo treatment, but with significant separation of only the 100-microg and 800-microg doses by FENO. Geometric mean (95% confidence limits) PC(20) rose progressively from 0.01 mg/mL (0.00 to 0.19) to 0.48 mg/mL (0.01 to 8.1) from visit 1 to visit 5 (p = 0.002). All doses of iBDP resulted in a significant change in PC(20) from baseline or placebo treatment, but with no significant separation of active iBDP doses using PC(20). Study B: FENO fell from 111.56 ppb (80.3 to 155.1) to 66.3 ppb (49.2 to 89.5; p < 0.001) from period 1 to period 2, and from 110.2 ppb (79.3 to 153.1) to 61.7 ppb (42.9 to 88.8; p < 0.001) from period 3 to period 4. There were no significant differences between FENO in period 1 and period 3 (p = 0.83) or between period 2 and period 4 (p = 0.220).. FENO was superior to FEV(1) and PC(20) in separating doses of iBDP. The fall in FENO after two identical administrations of iBDP separated by placebo washout was highly reproducible.

    Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Female; Forced Expiratory Volume; Humans; Male; Nitric Oxide; Prospective Studies; Reproducibility of Results

2001
A randomized, double-blind comparison of beclomethasone dipropionate extrafine aerosol and fluticasone propionate.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2001, Volume: 86, Issue:5

    Inhaled corticosteroids provide first-line treatment for asthma. An advance to improve potency was to produce new molecules with increased glucocorticoid receptor affinity (eg, fluticasone propionate [FP]). An alternative is to deliver more medication to both the large and small airway inflammation of asthma by using an extrafine aerosol (eg, beclomethasone dipropionate extrafine aerosol [BDP-extrafinel).. To demonstrate clinical equivalence of BDP-extrafine (400 microg daily) and FP (400 microg daily) in symptomatic asthmatic patients over the course of 6 weeks.. This was a double-blind, double-dummy, parallel-group, multicenter, 6-week study in adults with asthma taking conventional FP 100 to 250 microg daily or equivalent, and displaying signs/symptoms of active disease requiring additional therapy.. Eighty-eight patients were randomized to BDP-extrafine (and FP-placebo) and 84 to FP (and BDP-placebo). There were no significant differences between treatments with respect to symptom control, as evidenced by mean change from baseline in percentage days without asthma symptoms/nights without sleep disturbance observed at weeks 1 to 2, 3 to 4, or 5 to 6. Mean changes from baseline in AM PEFR at weeks 5 to 6 for BDP-extrafine (19.0) and FP (30.5) were equivalent (P = 0.022 for equivalence). There were significant (P < 0.001) within-treatment-group differences in mean change from baseline in AM PEFR at weeks 1 to 2 for both treatments. There was no difference in the incidence of patients reporting at least one adverse event during the study (BDP-extrafine 41%; FP 37%). Mean percentage change from baseline for AM plasma cortisol at week 6 was + 17.7% for BDP-extrafine and +4.2% for FP (P = 0.066 for difference).. BDP-extrafine and FP at doses of 400 microg daily provided equivalent asthma control in patients with symptomatic asthma and exhibited similar safety profiles.

    Topics: Adolescent; Adult; Aerosols; Aged; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Female; Fluticasone; Forced Expiratory Volume; Humans; Hydrocortisone; Male; Middle Aged; Particle Size; Peak Expiratory Flow Rate; Safety; Treatment Outcome

2001
A comparison of the efficacy and safety of a half dose of fluticasone propionate with beclamethasone dipropionate and budesonide in childhood asthma.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2001, Volume: 38, Issue:3

    This study was carried out in an attempt to compare the efficacy and safety of fluticasone propionate (FP) at the half dose of budesonide (BUD) and beclamethasone dipropionate (BD) in childhood asthma. Ninety-six children with moderate to severe asthma (9.6 +/- 2.17 years) whose asthma was already controlled on BUD (n = 52) or BD (n = 44) were recruited into the study. In the first part of the study (the first 12 weeks) each group was followed with three weekly lung function measurements, daily diary records, and peak expiratory flow (PEF) measurements on the initial medication. At the end of 6 weeks, drugs were switched to a half dose of FP, and the subjects were followed for another 6 weeks. Blood samples were obtained for osteocalcin and plasma cortisol levels after each treatment period. In the second part of the study, 50 patients continued to take FP at the half dose of BUD or BD for another 30 weeks. Clinic visits, including lung function and PEF measurements, were conducted every 10 weeks. After 6 weeks of FP treatment, there was a small but statistically significant decrease in FEV1 and FEF(25-75) in both groups (BUD and BD) without any significant obstruction. These mild changes in lung function measurements continued during long-term follow-up. However, there was no statistically significant further decrease in any lung function parameters while receiving FP (visits 3-8) (coefficient = -0.00751 L/day, p = 0.39 for FEF(25-75) and coefficient = -0.00910 L/sec/day, p = 0.055 for FEV1). There were no significant changes in the morning and evening PEF measurements and diurnal PEF variations after 6 weeks of treatment with FP compared with BUD and BD treatments. There were no significant changes in basal cortisol and osteocalcin levels before or after 6 weeks of FP treatment (p > 0.05). The present study concluded that, although FP at the half dose of BUD or BD seems to maintain reasonable control of the disease symptoms, a mild but significant and persistent decrease in lung function parameters may indicate that FP may not be twice as potent as BUD or BD in childhood asthma by evaluation of lung functions. This conclusion must be further verified with long-term studies.

    Topics: Administration, Inhalation; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Child; Female; Fluticasone; Follow-Up Studies; Humans; Male; Respiratory Function Tests; Time Factors

2001
[Therapy participation in ambulatory asthma patients: empirical comparison of compliance rates using different operationalization methods for drug compliance].
    Pneumologie (Stuttgart, Germany), 2001, Volume: 55, Issue:4

    Topics: Adolescent; Adult; Aged; Ambulatory Care; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Monitoring; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Nebulizers and Vaporizers; Patient Compliance; Patient Participation

2001
Inhaled corticosteroids decrease vascularity of the bronchial mucosa in patients with asthma.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2001, Volume: 31, Issue:5

    Increased vascularity in airway mucosa is a distinctive feature of airway remodelling in asthma. While corticosteroids have proved most effective in modifying airway inflammation, the effect of inhaled corticosteroids on increased airway mucosal vascularity in asthmatics has been little studied.. We examined the effect of inhaled corticosteroid on airway vascularity in bronchial biopsy specimens taken from asthmatic patients.. We studied bronchial biopsies from 28 asthmatic patients before and after treatment with inhaled beclomethasone dipropionate (BDP) 800 microg/daily, or placebo, for 6 months in a double-blind manner. Biopsy specimens were evaluated for number of vessels and percentage of area occupied by vessels, using computerized image analysis after staining for type IV collagen in vessel walls. Specimens were also examined for extent of collagen III in the subepithelial basement membrane. In addition, we compared asthmatic specimens with biopsy specimens taken from non-asthmatic control subjects.. There was a significant increase in number of vessels (P < 0.01) and percent vascularity (P < 0.001) in the submucosa of asthmatic patients compared with control subjects. After 6 months of treatment, we observed significant improvements in forced expiratory volume in 1 s (FEV1), FEV1% and airway responsiveness (P < 0.05, each) in the BDP treatment group compared with the placebo group. This was accompanied by significant decreases in both vessel number and percent vascularity in the airways of BDP-treated patients (P < 0.05, each). We also observed a significant correlation between change in percent vascularity and change in collagen III thickness in the BDP-treated patients (rs = 0.90, P < 0.001). Furthermore, the change in percent vascularity was inversely correlated with both FEV1 (rs = -0.49, P < 0.05) and airway responsiveness (rs = -0.36, P < 0.05).. These findings suggest that inhaled corticosteroid treatment of asthma reduced airway wall vascularity during airway remodelling.

    Topics: Adolescent; Adrenal Cortex Hormones; Adult; Asthma; Beclomethasone; Biopsy; Bronchi; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Mucous Membrane; Staining and Labeling; Treatment Outcome

2001
Long-term asthma control with oral montelukast and inhaled beclomethasone for adults and children 6 years and older.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2001, Volume: 31, Issue:6

    Leukotriene receptor antagonists have demonstrated clinical benefits in chronic asthma studies of up to 3 months in duration. The effects of these agents over extended periods of time have not been reported.. To describe the long-term effect of oral montelukast, a potent and specific cysteinyl leukotriene receptor antagonist, compared with inhaled corticosteroids in both adult and paediatric patients with chronic asthma.. Male and female patients with chronic, stable asthma (adults aged 15-85 years, children aged 6-14 years), who had completed double-blind, placebo-controlled clinical studies, participated in three extension studies with oral montelukast taken once daily (10 mg tablet for adults, 5 mg chewable tablet for paediatric patients) or inhaled corticosteroids (beclomethasone 200 microg twice daily for adults, beclomethasone 100 microg or equivalent three times daily for children). A double-blind adult extension study was 37 weeks in duration; open-label adult extension studies were 156 (adults) and 112 (paediatric) weeks in duration. A total of 436, 374, and 245 patients entered these extension studies, respectively.. Treatment with both montelukast and inhaled corticosteroids resulted in improvement in multiple parameters of asthma control. Improvements in daytime symptom scores were generally comparable among treatment groups. No tachyphylaxis to the effects of montelukast was evident. In the adult open-label study, however, the effect of beclomethasone on mean forced expiratory volume in 1 second (FEV1) gradually decreased from start of the study to the end of the follow-up treatment period.. Both montelukast and inhaled corticosteroids were effective in controlling mild to moderate chronic asthma; the relative effectiveness of montelukast and beclomethasone were similar in open-label conditions. The hypothesis, that clinical practice conditions (e.g., adherence) may have a significant impact on the effectiveness of these therapies, should be tested in future clinical trials.

    Topics: Acetates; Administration, Inhalation; Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Chronic Disease; Cyclopropanes; Double-Blind Method; Eosinophils; Female; Follow-Up Studies; Forced Expiratory Volume; Humans; Leukocyte Count; Leukotriene Antagonists; Male; Middle Aged; Predictive Value of Tests; Quinolines; Sulfides; Time

2001
Effect of the long-term use of inhaled corticosteroids on bone mineral density in asthmatic women.
    Respirology (Carlton, Vic.), 2001, Volume: 6, Issue:2

    Inhaled corticosteroids have become a key element in the maintenance treatment of bronchial asthma. Recent studies have shown that administration of inhaled corticosteroids is associated with evidence of derangement in bone turnover. Therefore, we studied the bone mineral density (BMD) of asthmatic women receiving long-term inhaled corticosteroids and compared them with healthy individuals matched for age, sex, menopausal status and body mass index.. Thirty-two female patients with bronchial asthma, who had been using inhaled corticosteroids (beclomethasone dipropionate 750-1500 microg/day) regularly for at least 3 months, were included in the study. Bone mineral density measurements were done with dual X-ray absorptiometry in the lumbar area of the spine and the hip. Detailed laboratory examination was also done for the patients and 26 controls.. There was a significant decrease in BMD of the patient group at the lumbar region and femur as compared with normal controls. In the patients there was a significant negative correlation between the duration of therapy, daily and cumulative doses, and BMD at the lumbar region but not BMD at the femur.. These results indicate that long-term use of inhaled corticosteroids is associated with significant bone loss in asthmatic women and is especially related to the duration of therapy. Therefore, it is necessary to appropriately screen and give prophylactic treatment to those who are likely to develop osteoporosis from inhaled corticosteroid treatment.

    Topics: Absorptiometry, Photon; Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Mass Index; Bone Density; Calcium, Dietary; Cross-Sectional Studies; Female; Glucocorticoids; Humans; Middle Aged; Pneumonia; Time Factors; Women

2001
Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab).
    Pediatrics, 2001, Volume: 108, Issue:2

    There seems to be a strong causal relationship between allergy and the origins of asthma. Susceptibility to both is determined by a combination of genetics and environment acting through a complex network of cytokines. Nearly 90% of affected children have positive skin tests indicating the presence of specific immunoglobulin E (IgE), with sensitivity to house dust mite, Alternaria, cockroach, cat, and dog most closely linked to the disease. Greater exposure to house dust mite during infancy leads to earlier onset of wheezing, and elevated serum IgE levels correlate with the appearance of asthma symptoms. Specific IgE binds to high-affinity (FcepsilonRI) receptors on mast cells and basophils. The IgE-mediated reactions that follow exposure of sensitized mast cells to an allergen are designated early- and late-phase asthmatic responses (EAR and LAR). EAR is characterized by release of histamine and other preformed mediators within 1 hour of allergen exposure. It is often followed by LAR, an infiltration of the airways by inflammatory cells associated with an episode of more prolonged, and usually more severe airflow obstruction, 4 to 8 hours after antigen exposure. Chronic airway symptoms result from persistent LAR caused by continuous allergen exposure. IgE antibodies are capable of passive transfer of both EAR and LAR sensitivity. IgE-mediated mast cell activation contributes to chronic tissue eosinophilia and airway remodeling, with permanent loss in pulmonary function. Omalizumab (rhuMAb-E25) is a recombinant, humanized, monoclonal anti-IgE antibody of mouse origin developed for the treatment of IgE-mediated diseases. Omalizumab binds to free IgE at the same site as the high-affinity receptor. Although it attaches to free IgE, it does not bind to IgA, IgG, or cell-bound IgE. It therefore does not induce cross-linking of cell-bound IgE, which would lead to the release of allergic mediators. It has been reported to decrease serum IgE levels in a dose-dependent manner, inhibit EAR and LAR, and cause a down-regulation of FcepsilonRI receptors on basophils. Omalizumab has been reported to be safe and effective in improving asthma control and reducing the requirement for oral and inhaled corticosteroids. This double-blind, randomized, placebo-controlled study evaluated the safety, steroid-sparing effects, and impact on disease exacerbations of omalizumab in the treatment of childhood asthma. Methods. Participants were 334 males and premenarchal females aged 6. More participants in the omalizumab group decreased their BDP dose, and their reduction was greater than that of the placebo group (median reduction 100% vs 66.7%). BDP was withdrawn completely in 55% of the omalizumab group versus 39% of the placebo group. The incidence and the frequency of asthma exacerbations requiring treatment with doubling of BDP dose or systemic corticosteroids were lower in the omalizumab group. The treatment differences were statistically significant during the steroid-reduction phase, during which fewer participants in the omalizumab group had asthma exacerbation episodes (18.2% vs 38.5%), and the mean number of episodes per patient was smaller than with placebo (0.42 vs 2.72). Five asthma exacerbations requiring hospitalization all occurred in the placebo group. Participants' and investigators' global evaluations of treatment effectiveness were more favorable for omalizumab than placebo. Investigators rated effectiveness excellent for 31.5% of the omalizumab group versus 16.3% of the placebo group and good for 44.7% of the omalizumab group versus 32.7% of the placebo group. There was little change in asthma symptom scores or spirometry measurements during either the stable-steroid or steroid dose-reduction phase, with minimal differences between the treatment groups. The requirement for rescue medication in the omalizumab group during both the stable-steroid and steroid dose-reduction phases was consistently lower than at baseline. At week 28, the median number of puffs of rescue medication taken daily was 0 in the omalizumab group and 0.46 in the placebo group. The change from baseline was significant in favor of omalizumab. (ABSTRACT TRUNCATED)

    Topics: Acute Disease; Anti-Allergic Agents; Anti-Asthmatic Agents; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Beclomethasone; Child; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Injections, Subcutaneous; Male; Omalizumab; Placebos; Treatment Outcome

2001
Effects of pranlukast, a cysteinyl leukotriene receptor 1 antagonist, combined with inhaled beclomethasone in patients with moderate or severe asthma.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2001, Volume: 87, Issue:2

    Although inhaled steroids are used as the first line of therapy in asthmatic patients, symptoms of asthma do not improve completely in some patients.. To investigate the effects of pranlukast, a cysteinyl leukotriene receptor 1 antagonist, in patients with moderate/severe asthma, when combined with beclomethasone dipropionate (BDP).. Protocol 1: After a 2-week observation period, 41 patients with moderate asthma were divided into those receiving BDP at 1,600 microg/day or 800 microg/day + pranlukast (450 mg/day). The effect of treatment was evaluated by measuring AM peak expiratory flow rate, symptom score, frequency of beta2-agonists, and daily variability of peak expiratory flow rate. Protocol 2: 39 patients participated in this study including those with moderate asthma on 800 microg/day BDP (group I), severe asthma on BDP at 1,600 microg/day (group II), and severe asthma on 1,600 microg/day BDP + 5 to 20 mg prednisolone (group III). Patients of all groups were additionally treated with pranlukast.. Protocol 1: Both treatment regimens resulted in improvement in each clinical parameter. There were no significant differences in the effects of two treatment regimens. Protocol 2: Pranlukast was effective in group I and II, but not in group III. In groups I and II, pranlukast tended to be more effective when BDP was introduced within the first year of onset of asthma.. Pranlukast is effective for patients with moderate asthma and those patients with severe asthma who are not treated with oral steroids. Pranlukast is more effective in patients treated with BDP early after onset.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chromones; Drug Therapy, Combination; Humans; Leukotriene Antagonists; Membrane Proteins; Peak Expiratory Flow Rate; Receptors, Leukotriene; Treatment Outcome

2001
The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics.
    The European respiratory journal, 2001, Volume: 18, Issue:2

    The clinical benefit and steroid-sparing effect of treatment with the anti-immunoglobulin-E (IgE) antibody, omalizumab, was assessed in patients with moderate-to-severe allergic asthma. After a run-in period, 546 allergic asthmatics (aged 12-76 yrs), symptomatic despite inhaled corticosteroids (500-1,200 microg daily of beclomethasone dipropionate), were randomized to receive double-blind either placebo or omalizumab every 2 or 4 weeks (depending on body weight and serum total IgE) subcutaneously for 7 months. A constant beclomethasone dose was maintained during a 16-week stable-steroid phase and progressively reduced to the lowest dose required for asthma control over the following 8 weeks. The latter dose was maintained for the next 4 weeks. Asthma exacerbations represented the primary variable. Compared to the placebo group, the omalizumab group showed 58% fewer exacerbations per patient during the stable-steroid phase (p<0.001). During the steroid-reduction phase, there were 52% fewer exacerbations in the omalizumab group versus the placebo group (p<0.001) despite the greater reduction of the beclomethasone dosage on omalizumab (p<0.001). Treatment with omalizumab was well tolerated. The incidence of adverse events was similar in both groups. These results indicate that omalizumab therapy safely improves asthma control in allergic asthmatics who remain symptomatic despite regular use of inhaled corticosteroids and simultaneous reduction in corticosteroid requirement.

    Topics: Acute Disease; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Beclomethasone; Child; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Immunoglobulin E; Male; Middle Aged; Omalizumab; Peak Expiratory Flow Rate; Recurrence; Severity of Illness Index; Time Factors; Treatment Outcome

2001
[Effect of FP inhalation and airway inflammation assessed by ECP in asthma].
    Nihon Kokyuki Gakkai zasshi = the journal of the Japanese Respiratory Society, 2001, Volume: 39, Issue:6

    We studied the effects of fluticasone propionate (FP) inhalation and the airway inflammation in beclomethasone dipropionate (BDP)-resistant bronchial asthma. Twenty-five patients who had used BDP and whose mean PEF was less then 80% were enrolled in this study. After 2 weeks of BDP inhalation. FP inhalation was administered. The total eosinophil count in the peripheral blood (/microliter), their percentage of the total WBC count (% Eos), the count in induced sputum, the serum ECP content and the induced sputum ECP content were measured before and after 6 weeks of FP treatment. There was a significant increase of morning and evening PEF, from 63.1% to 76.1% and from 63.6% to 76.2%, respectively. There was a significant positive correlation between the peripheral blood % Eos and the % increase of PEF (p < 0.01). There was also a significant positive correlation between the induced sputum % Eos and the % increase of PEF (p < 0.05). The induced sputum ECP content was still as high as 180 micrograms/l after FP treatment. The mean % PEF did not reach 80% after FP treatment. This study suggests that airway inflammation persists in some severe asthma patients despite inhalation of FP 800 micrograms.

    Topics: Administration, Inhalation; Aged; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biomarkers; Blood Proteins; Drug Resistance; Eosinophil Granule Proteins; Female; Fluticasone; Humans; Inflammation Mediators; Male; Middle Aged; Peak Expiratory Flow Rate; Ribonucleases; Sputum; Treatment Outcome

2001
Improved safety with equivalent asthma control in adults with chronic severe asthma on high-dose fluticasone propionate.
    Respirology (Carlton, Vic.), 2001, Volume: 6, Issue:3

    High-dose inhaled corticosteroids (ICS) have been associated with the same side-effects as oral corticosteroids. Beclomethasone dipropionate (BDP) and budesonide (BUD) in doses greater than 2000 microg/day are used regularly in severe asthma, despite the fact that safety and efficacy data at such high doses are limited. Fluticasone propionate (FP) has been promoted as being twice as potent clinically as BDP or BUD at doses of 2000 microg/day or less with a similar safety profile. The aim of this study was to compare the efficacy and safety of FP with BDP and BUD in 133 symptomatic adult asthmatics requiring at least 1750 microg/day of BDP or BUD.. Patients fulfilling the entry criteria were randomized to receive either their regular ICS medication or FP at approximately half the microgram dose for 6 months in an open, parallel group study. The primary efficacy measure was based on morning peak expiratory flow measurements recorded by patients on daily record cards, while determination of safety was based on a number of endpoints including changes in bone turnover indices, the incidence of topical side-effects and assessments of quality of life.. It was shown that patients who were switched to FP, but not those continuing with BDP or BUD, had significant increases in levels of morning serum cortisol and the urine cortisol:creatinine ratio while maintaining asthma control. Serum osteocalcin and the pyridinoline:creatinine ratio, as well as the deoxypyridinoline:creatinine ratio, were also shown to increase only in the FP group. Subjective assessments such as quality of life score, the incidence and ease of bruising, and reports of hoarseness also favoured the FP group.. It is concluded that, at the doses studied and with the delivery devices used clinically, FP is at least as effective as BDP/BUD in the management of severe asthma and may offer clinical advantages with respect to steroid-related adverse effects.

    Topics: Adult; Androstadienes; Asthma; Beclomethasone; Biomarkers; Budesonide; Chronic Disease; Contusions; Creatinine; Female; Fluticasone; Glucocorticoids; Hoarseness; Humans; Hydrocortisone; Male; Middle Aged; Osteocalcin; Quality of Life

2001
A comparison of clinical use of fluticasone propionate and beclomethasone dipropionate in pediatric asthma.
    The Kaohsiung journal of medical sciences, 2001, Volume: 17, Issue:6

    Inhaled steroids play a very important role in the prevention and treatment of asthma. Previous studies indicated that fluticasone propionate (FP) had low bioavailability and high local potency. However, the laboratory data in these studies were not obtained among Taiwan population. It is very important that native data should be established. Thus a 12-week research program was designed, involving 77 patients, 51 for FP group and 26 for beclomethasone dipropionate (BD) group. The objects were victims of moderate to severe asthma and their age ranged from 4 to 14 years old. An open, comparative and randomized method was adopted. Except for the 4-week-later daytime symptom score(P = 0.033, BD group was better), no other significant differences were found between the two groups in the symptom score improvement(P > 0.05). All the P-values for the daytime & night-time scores were lower than 0.001, which means obvious improvement after treatment in both groups. P-value for PEF improvement was 0.003 after 4 weeks (BD group was better) and 0.943 after 8 weeks; for FEV1 improvement, it was 0.005 after 4 weeks(BD group was better) and 0.252 after 8 weeks; and for FEV1/FVC improvements, it was 0.067 after 4 weeks and 0.097 after 8 weeks. There was no statistic significance in total eosinophil count (TEC), IgE, eosinophil cationic protein (ECP) serum level changes after 4 or 8 weeks. Adverse effects were all anticipated and no statistic significance showed up, either, between the two groups or in the cortisol levels (P > 0.05). In conclusion, native data indicated that the potency of 100 micrograms of FP was equal to that of 200 micrograms of BD and that few side effects were noted in FP group. It is recommended that this drug be introduced for clinical use.

    Topics: Adolescent; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Blood Proteins; Child; Child, Preschool; Eosinophil Granule Proteins; Eosinophils; Female; Fluticasone; Humans; Immunoglobulin E; Male; Ribonucleases

2001
Asthma stability after oral prednisone: a clinical model for comparing inhaled steroid potency.
    American journal of respiratory and critical care medicine, 2001, Oct-01, Volume: 164, Issue:7

    Clinical studies comparing the potency of inhaled corticosteroids require steep dose-response slopes (b) and minimal response variability (s), as statistical power is inversely related to the s/b ratio. To evaluate a new study model, we performed a randomized, crossover study of 12 adult asthmatics who required 800 to 2,000 microg of inhaled corticosteroids daily, and calculated s/b for 21 raw clinical outcomes and 36 mathematically derived variables based on these raw outcomes. Each of two 21-d treatment periods was preceded by 4 to 7 d of oral prednisone to maximize asthma control and minimize carry-over of previous inhaled treatment. Treatments were 100 and 800 micron/d of an HFA-134a beclomethasone dipropionate formulation. Assessments included daily home spirometry, histamine challenge, inhaled albuterol use, and asthma symptom scores. Efficacy variables with the greatest power (lowest s/b values) were A.M.FEF25-75, A.M.FEV1, and A.M.PEF, (s/b = 0.46, 0.48, and 0.59). Carry-over between treatment periods was not significant. Crossover study sample size calculations using these ratios yielded samples of 23, 25, and 37 patients, respectively. Otherwise identical parallel studies would require sample sizes of 657, 1,438, and 2,261 patients. These results support the use of a crossover asthma stability model after a short course of oral prednisone as a clinical study model for comparing topical potency of inhaled corticosteroids.

    Topics: Administration, Inhalation; Administration, Oral; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cross-Over Studies; Dose-Response Relationship, Drug; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Male; Peak Expiratory Flow Rate; Prednisone

2001
Comparison of hydrofluoroalkane-beclomethasone dipropionate Autohaler with budesonide Turbuhaler in asthma control.
    Respiration; international review of thoracic diseases, 2001, Volume: 68, Issue:5

    Hydrofluoroalkane-beclomethasone dipropionate Autohaler (HFA-BDP AH) is a breath-actuated chlorofluorocarbon (CFC)-free metered dose inhaler in which BDP is in a solution of HFA propellant. Budesonide Turbuhaler (BUD TH) is a breath-dependent dry powder inhaler.. To test the hypothesis that half the daily dose of HFA-BDP AH would provide an equivalent control of asthma symptoms to the BUD TH.. This was an 8-week open study in patients with symptomatic moderate-to-severe asthma, previously on BUD 500-1,000 microg x day(-1), or an equivalent. After 5-14 days' run-in, patients were randomized to HFA-BDP AH 800 microg x day(-1) or BUD TH 1,600 microg x day(-1). The intent-to-treat population consisted of 111 patients on HFA-BDP AH and 98 patients on BUD TH.. Mean change from baseline in PEF in the morning (AM PEF) at week 8 was 23.95 liters x min(-1) for HFA-BDP AH and 24.46 liters x min(-1) for BUD TH. A two-sided equivalence test using the 0.51 liter x min(-1) difference gave 95% confidence intervals within a defined equivalence interval of (-infinity, 25 liters x min(-1)) indicating that the mean change in AM PEF was equivalent for the two groups. There were no significant differences in the mean change from baseline in FEV1 or beta-agonist use. Patients using HFA-BDP AH had a significantly greater mean change from baseline in the percentage of days free from shortness of breath (p = 0.05), chest tightness (p = 0.02) and nights without sleep disturbance (p = 0.04) at week 3, and wheeze (p = 0.01), shortness of breath (p = 0.02), chest tightness (p < 0.01) and daily asthma symptoms (p = 0.03) at week 8. The incidence, type and severity of adverse events were similar in each group. At week 8, the mean change from baseline in corrected urine cortisol/creatinine ratio in a subgroup of patients was -0.36 for HFA-BDP and -4.88 for BUD TH (p < 0.01).. HFA-BDP 800 microg x day(-1) provided control of moderate-to-severe asthma with efficacy and safety at least similar to BUD TH 1,600 microg x day(-1).

    Topics: Administration, Inhalation; Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Blood Proteins; Budesonide; Cohort Studies; Creatinine; Eosinophil Granule Proteins; Eosinophils; Female; Follow-Up Studies; Forced Expiratory Volume; France; Germany; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Leukocyte Count; Male; Middle Aged; Netherlands; Peak Expiratory Flow Rate; Respiratory Function Tests; Ribonucleases; Treatment Outcome

2001
Effects of 2 inhaled corticosteroids on growth: results of a randomized controlled trial.
    Archives of pediatrics & adolescent medicine, 2001, Volume: 155, Issue:11

    To compare the long-term effect of treatment with fluticasone propionate or beclomethasone dipropionate on growth in asthmatic children.. Prospective, multicenter, randomized, double-blind, parallel-group study.. Children requiring regular treatment with inhaled corticosteroids and with a sexual maturity rating of Tanner stage 1 (prepubertal).. Three hundred forty-three children aged 4 to 11 years with asthma. The growth population (excluding patients with protocol violations likely to affect growth measurements) included 277 patients.. Fluticasone propionate or beclomethasone dipropionate, both at a dosage of 200 microg administered twice daily via a dry powder inhaler (Diskhaler) for 12 months.. Growth velocity, lung function, and serum and urinary cortisol levels.. The adjusted mean growth velocity in the fluticasone group was significantly greater than that in the beclomethasone group (5.01 [SE, 0.14] vs 4.10 [SE, 0.15] cm/y; difference, 0.91 cm; 95% confidence interval, 0.63-1.20 cm; P<.001). Both treatments improved lung function, with significant differences in favor of fluticasone. Adverse events were similar in both groups, and there were no significant differences in effect on serum and urinary cortisol levels.. The more favorable risk-benefit ratio of fluticasone indicates that this agent is preferable to beclomethasone for the long-term treatment of children with asthma, especially if moderate doses are required.

    Topics: Androstadienes; Asthma; Beclomethasone; Body Height; Child; Child, Preschool; Double-Blind Method; Female; Fluticasone; Glucocorticoids; Humans; Hydrocortisone; Male; Prospective Studies

2001
Effect of salmeterol and salmeterol plus beclomethasone on saliva flow and IgA in patients with moderate-persistent chronic asthma.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2001, Volume: 87, Issue:5

    The use of short-acting beta2-agonists is associated with oral mucosa injuries that are probably provoked by decreased saliva flow and decreased concentrations of immunoglobulin (Ig)A in saliva.. To explore the effect of salmeterol, alone or combined with beclomethasone, on the health of oral mucosa, as well as its effect on saliva flow and IgA concentration in saliva.. Patients ranging in age from 6 to 15 years with moderate-persistent chronic asthma were enrolled. Patients received two 6-week treatments, one with salmeterol plus beclomethasone and the other with only salmeterol, with a 1-week washout period between treatments. Patients had oral cavity examinations and assessments of saliva flow, IgA in saliva, and total protein in saliva before the beginning and at the end of each treatment. The results of the baseline oral examinations were normal in all patients. The postsalmetrol (PS) examinations detected 13 patients with gingivitis and the postbeclomethasone-salmeterol (PBS) examinations disclosed 10 patients with gingivitis and 1 with lower-lip ulceration. Baseline saliva flow was 16.25 +/- 7.04 mm/minute (confidence interval [CI] 95% 13.67; 18.89), PS was 13.53 +/- 5.93 mm/minute (CI 95% 11.33; 15.73), and PBS was 16.57 +/- 5.54 mm/minute (CI 95% 14.51; 18.62). No statistical differences between the different assessments were found. Mean saliva IgA at baseline was 4.99 +/- 1.96 mg/dL (CI 95% 4.26; 5.71), PS IgA was 6.53 +/- 3.02 mg/dL (CI 95% 5.41; 7.65), and PBS IgA was 4.82 +/- 1.98 mg/dL (CI 95% 4.08; 5.56). PS IgA was significantly higher than the other two determinations (P < 0.05 by Bonferroni and Tukey tests). Baseline saliva IgA-to-protein ratio was 0.72 +/- 0.24 (95% CI 0.64; 0.80), PS IgA:protein ratio was 1.02 +/- 0.38 (95% CI 0.88; 1.16), and PBS IgA:protein ratio was 0.72 +/- 0.25 (95% CI 0.62; 0.82). PS IgA:protein ratio was significantly higher than the other two determinations (P < 0.05 by Bonferroni and Tukey tests).. In the present study it was demonstrated that salmeterol alone or in combination with beclomethasone induced injuries in the oral mucosa, but only salmeterol alone induced increases in the total and protein-adjusted IgA in saliva.

    Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Albuterol; Asthma; Beclomethasone; Child; Chronic Disease; Cross-Over Studies; Drug Interactions; Female; Humans; Immunoglobulin A; Longitudinal Studies; Male; Mouth Diseases; Saliva; Salivary Glands; Salivary Proteins and Peptides; Salivation; Salmeterol Xinafoate; Single-Blind Method

2001
Inhaled beclomethasone dipropionate improves acoustic measures of voice in patients with asthma.
    Chest, 2001, Volume: 120, Issue:6

    Inhaled corticosteroids have the potential to produce upper-airway side effects such as hoarseness. As new compounds and delivery devices are developed and compared, it is difficult to quantify their adverse upper-airway effects.. We undertook the following study to test the ability of an acoustic analysis technique to quantify changes in vocal function in steroid-naive patients with asthma who receive inhaled beclomethasone dipropionate (BDP), 1,000 microg/d for 4 months.. Patients self-administered one of four regimens of inhaled BDP. Group 1 patients received one 250-microg puff qid via metered-dose inhaler (MDI); group 2 patients received one 250-microg puff qid via MDI with a holding chamber; group 3 patients received two 250-microg puffs bid via MDI; and group 4 patients received two 250-microg puffs bid via MDI with a holding chamber. A smaller cohort of nonsmoking asthmatic patients was managed without steroid intervention for 4 months. At baseline and again at 8 weeks and 16 weeks after the initiation of BDP treatment, patients underwent spirometry and methacholine challenge. At baseline and again at 2, 4, 8, 12, and 16 weeks, patients underwent voice recording for analysis of voice parameters. The recorded vowels were low-pass filtered (10 KHz), digitized (22 KHz), and analyzed by software to obtain two acoustic measures: (1) jitter, the cycle-to-cycle variation in the time period of the voice signal; and (2) shimmer, the cycle-to-cycle variation in voice signal amplitude.. We recruited 77 patients for randomization to inhaled steroid therapy and 10 patients who continued to receive only occasional inhaled bronchodilator therapy. In all active treatment groups, FEV(1), FVC, and provocative concentration of methacholine causing a 20% fall in FEV(1) improved significantly after BDP treatment. Mean jitter scores, a measurement of variation in voice pitch, were not significantly influenced by BDP treatment. However, mean shimmer scores, a reflection of perturbation in vocal amplitude, fell significantly (p < 0.05) in the active treatment groups. These reductions in shimmer scores were not significantly different in the active treatment groups. Shimmer scores in the bronchodilator-treated group were unchanged during the 16 weeks of follow-up.. Our data show that a simple and noninvasive acoustic analysis of voice is sensitive to subclinical changes associated with inhaled corticosteroid therapy. We have shown that 1,000 microg/d of inhaled BDP actually improves specific acoustic measures of voice in patients with inadequately controlled asthma. These improvements were uninfluenced by dosing schedule and whether a spacing chamber was used.

    Topics: Administration, Inhalation; Adolescent; Adult; Asthma; Beclomethasone; Cohort Studies; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Signal Processing, Computer-Assisted; Sound Spectrography; Speech Acoustics; Vital Capacity; Voice Quality

2001
Oral montelukast versus inhaled beclomethasone in 6- to 11-year-old children with asthma: results of an open-label extension study evaluating long-term safety, satisfaction, and adherence with therapy.
    Current medical research and opinion, 2001, Volume: 17, Issue:2

    This 6-month, open-label extension study of a previously described base study compared oral montelukast with inhaled beclomethasone in terms of safety, forced expiratory volume in one second (FEV1) measurements, parent and patient satisfaction with treatment, asthma-related medical resource utilization, school absenteeism, and parental work loss in children with asthma. A total of 124 of 266 asthmatic children, 6 to 11 years of age, who enrolled in the base study entered a 6-month open-label extension study (74 boys, 50 girls) and were re-randomized (2:1 ratio) to receive once-daily oral montelukast (n = 83) or inhaled beclomethasone 100 mcg three times daily (n = 41). Children were evaluated in the clinic prior to re-randomization (Month 0) and at regular visits at 1, 3, and 6 months. Children and their parents showed a significantly higher overall satisfaction for montelukast at 6 months than for inhaled beclomethasone (p = 0.001 and p < 0.05, respectively). According to parents, montelukast was more convenient (p < 0.001), less difficult to use (p = 0.005), and was used as instructed more of the time (p = 0.006) compared with beclomethasone. Oral corticosteroid use was similar in the montelukast (13% of patients) and beclomethasone (17%) treatment groups. The montelukast treatment group was more adherent with their regimen than the inhaled beclomethasone treatment group; almost twice as many children on montelukast compared with inhaled beclomethasone were highly compliant (82% versus 45%). The two study groups were similar with respect to overall safety, change in FEV1, asthma-related medical resource utilization, school absenteeism, and parental work loss. Montelukast represents a safe and effective asthma treatment regimen to which children with asthma are more likely to adhere.

    Topics: Acetates; Administration, Inhalation; Administration, Oral; Adolescent; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Cross-Over Studies; Cyclopropanes; Female; Forced Expiratory Volume; Health Resources; Humans; Male; Patient Compliance; Patient Satisfaction; Quinolines; Sulfides; Time Factors; Treatment Outcome

2001
[Systemic side effects of long-term treatment with low dose inhaled corticosteroids in children with asthma].
    Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases, 2001, Volume: 24, Issue:12

    To observe the systemic side effects of low dose inhaled Beclomethasone dipropionate (BDP) in children with mild asthma.. 30 children with mild asthma were randomly divided into 3 groups to receive treatment with inhaled placebo (group A), BDP 200 micrograms/d (group B) and BDP 400 micrograms/d (group C) respectively. Bronchial hyperresponsiveness (BHR), height growth, bone mineral density (BMD), calcium and phosphate metabolism and hypothalamic-pituitary-adrenal axis (HPAA) function were measured.. Inhaled BDP of 200 micrograms/d and 400 micrograms/d reduced BHR in mild asthmatic children and there was no significant difference between two groups [log(PD20-FEV1)]:(2.04 +/- 0.47) micrograms to (2.70 +/- 0.13) micrograms in group A and (1.94 +/- 0.46) micrograms to (3.15 +/- 0.18) micrograms in group B (P < 0.01). Serum osteocalcin, calcium, phosphate, alkaline phosphatase, basic cortisol and BMD didn't change significantly after BDP treatment in three groups (all P > 0.05) [In group A, B and C, concentrations serum osteocalcin were (29 +/- 12) micrograms/L, (22 +/- 6) micrograms/L, (31 +/- 11) micrograms/L, serum calcium: (2.49 +/- 0.11) mmol/L, (2.39 +/- 0.28) mmol/L, (2.20 +/- 0.35) mmol/L, serum phosphate: (1.8 +/- 0.6) mmol/L, (1.7 +/- 0.7) mmol/L, (1.5 +/- 0.4) mmol/L, radius BMD: (0.44 +/- 0.02) g/cm2, (0.42 +/- 0.05) g/cm2, (0.40 +/- 0.10) g/cm2, ulna BMD:(0.35 +/- 0.04) g/cm2, (0.36 +/- 0.08) g/cm2, (0.32 +/- 0.07) g/cm2, serum alkaline phosphatase: (410 +/- 113) U/L, (337 +/- 99) U/L, (351 +/- 122) U/L, serum basic cortisol: (350 +/- 86) nmol/L, (407 +/- 199) nmol/L, (365 +/- 71) nmol/L, lumbar spine (L4-5) BMD: (0.64 +/- 0.06) g/cm2, (0.59 +/- 0.08) g/cm2, (0.62 +/- 0.09) g/cm2 respectively]. Height growth had a trend of reducing after BDP treatment though not reaching statistical difference. Height standard deviation score (SDS): 1.1 +/- 0.7 to 1.2 +/- 0.9 in group A, 1.3 +/- 0.7 to 1.3 +/- 0.9 in group B and 1.1 +/- 0.7 to 1.0 +/- 0.7 in group C. Serum cortisol after ACTH stimulation reduced significantly in group C [(621 +/- 199) nmol/L to (482 +/- 97) nmol/L, P < 0.01].. The results of this study suggest that 200 micrograms/d BDP can reduce BHR significantly and has no detected systemic side effects in mild asthmatic children, and 400 micrograms/d BDP can reduce serum cortisol after ACTH stimulation. The long-term dose of BDP should be controlled to be less than 400 micrograms/d in children with mild asthma.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Child; Dose-Response Relationship, Drug; Female; Glucocorticoids; Humans; Male; Single-Blind Method

2001
Therapeutic equivalence and acceptability of two multidose powder inhalers in the treatment of asthma.
    Respiration; international review of thoracic diseases, 2000, Volume: 67, Issue:1

    Problems in using conventional inhalation aerosols, in addition to environmental reasons, have driven development of the dry powder inhalers.. To compare therapeutic equivalence and acceptability of two dry powder inhalers, Easyhaler (EH) and Diskhaler (DH), in the delivery of beclomethasone dipropionate (BDP) in the treatment of asthma.. Adult asthmatics (n = 185), previously treated with inhaled steroids, were recruited in this open parallel-group study. After a run-in period of 2 weeks during which the patients inhaled 800 microg/day of BDP via DH, the patients were randomly allocated into three groups: EH 200 group (62 patients) using EH 200 microg/dose inhaler (1 inhalation q.i.d.), EH 400 group (62 patients) using EH 400 microg/dose inhaler (1 inhalation b.i.d.), and DH group (61 patients) using DH 200 microg/dose inhaler (1 inhalation q.i.d.) for 12 weeks. The primary outcome variables were PEF and FEV(1).. The 95% CI for treatment difference in morning PEF between the EH 200 and DH groups was -16 to 23 litres/min and between the EH 400 and DH groups -18 to 21 litres/min. There was an increase in the morning PEF of 13 litres/min (p < 0.05) in the EH 200 group, and 9 and 11 litres/min in the DH and EH 400 groups. No differences between the groups were seen in the lung function parameters, in the symptom scores, in the use of rescue medication or in the incidence of adverse events. The treatments had no effects on morning cortisol levels. The patients in the EH groups compared the inhalers by using an 11-item questionnaire. In 8 questions the majority of the patients rated EH superior to DH.. The tested inhalers were therapeutically equal. However, based on the acceptability data, the EH was better accepted by the patients than DH.

    Topics: Adult; Asthma; Beclomethasone; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Therapeutic Equivalency

2000
Serological evidence of infection with Chlamydia pneumoniae is related to the severity of asthma.
    The European respiratory journal, 2000, Volume: 15, Issue:2

    There is evidence that infection with Chlamydia pneumoniae is associated with asthma of recent onset and that it can influence the severity of asthma. This has led to the suggestion that macrolide antibiotics may be useful in the treatment of asthma in subjects infected with C. pneumoniae. This study examined the association between immunoglobulin (Ig)G and IgA titres to C. pneumoniae and the severity of asthma. IgG and IgA antibodies to C. pneumoniae were measured in 619 subjects with asthma (18-60 yrs), using the microimmunofluoresence method. Subjects were asked about their use of asthma medicines, symptoms, previous hospitalization for asthma, smoking status and age of onset of asthma. In subjects with IgG titres of > or =1:64 and/or IgA titres > or =1:16 (n=212), spirometry was performed and peak expiratory flow rate (PEFR) and symptoms were recorded twice daily for 4 weeks on a diary card. The use of high dose inhaled steroids was associated with an increase of 74.1% in the titre of IgG antibodies (p=0.04) and an increase of 70.6% in the titre of IgA antibodies (p=0.0001) when compared with the use of low dose inhaled steroids. There was an inverse association between IgG antibodies and forced expiratory volume in one second (FEV1) as a percentage of predicted in those subjects with elevated IgG and/or IgA (p=0.04). In this group IgA antibodies were also associated with a higher daytime symptom score (p=0.04). Higher titres of antibodies to Chlamydia pneumoniae appears to be associated with markers of asthma severity. This raises the possibility that chronic infection with Chlamydia pneumoniae leads to an increase in the severity of asthma. Studies aimed at eradicating chronic infection with Chlamydia pneumoniae are necessary to determine whether or not this is the case.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Chlamydia Infections; Chlamydophila pneumoniae; Double-Blind Method; Female; Glucocorticoids; Humans; Immunoglobulin A; Immunoglobulin G; Logistic Models; Male; Severity of Illness Index

2000
Therapeutic equivalence of inhaled beclomethasone dipropionate with CFC and non-CFC (HFA 134a) propellants both delivered via the Easibreathe inhaler for the treatment of paediatric asthma.
    Respiratory medicine, 2000, Volume: 94, Issue:1

    Chlorofluorocarbon (CFC)-containing inhalers for use in the treatment of asthma are to be phased out under the terms of the Montreal Protocol (1). In this multi-centre, randomized, double-blind study, the therapeutic equivalence of two formulations of beclomethasone dipropionate (BDP) containing CFC or non-CFC (HFA134a) propellant, both delivered via the Easibreathe (Norton Healthcare Ltd, London, U.K.) inhaler, was determined in 229 asthmatic children. Each child received 100 microg doses of BDP (containing either CFC or HFA propellant) twice daily for 12 weeks. Both CFC and HFA formulations produced statistically and clinically significant improvements in patient's lung function and symptom scores when administered via the Easibreathe inhaler. The improvements in mean morning peak expiratory flow (PEF) were 41 l min(-1) and 34 l min(-1) for the BDP-HFA and BDP-CFC products respectively (P<0.001) and for mean evening PEF the improvements were 38 l min(-1) and 38 l min(-1), respectively (P<0.001). Similar findings were demonstrated for the other efficacy parameters. The two formulations were statistically equivalent with respect to efficacy. For mean morning PEF the estimated treatment difference (BDP-CFC/BDP-HFA ratio) was 102.6% (95% CI 99.1, 106.2). Similar equivalence was shown for the other efficacy parameters. Both products were well tolerated, with no difference in the adverse event profiles, effects on 24 h urinary cortisol or Candida colonisation. This study demonstrates that the new formulation of BDP with HFA-134a propellant is equivalent to and directly substitutable for BDP with the older CFC propellant in a dose for dose manner. This should enable a seamless transition from one product to the other when CFC containing products are eventually phased out. In addition this study has also shown that the Easibreathe inhaler is an effective delivery system for use with inhaled products for the treatment of asthma in children.

    Topics: Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Chlorofluorocarbons; Double-Blind Method; Female; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Male; Nebulizers and Vaporizers; Therapeutic Equivalency; Treatment Outcome

2000
[Control of inhaled triggering factors decreases prolonged drug therapy requirements in patients with asthma].
    Investigacion clinica, 2000, Volume: 41, Issue:1

    The past decade of research has led to a greater understanding of the pathogenesis of asthma and, in particular, the pivotal role of the underlying inflammatory process. Along with inheritance in atopic patients, the presence of inhaled triggering allergens are considered the predominant predisposing factors in the development of the disease. We have conducted a longitudinal clinical therapeutic study, which included 45 pediatrics patients with asthma, in order to evaluate whether the removal of any potential inhaled triggering factor, could decrease the requirement of drug based anti-inflammatory therapy. Patients admitted in this study presented at least, two monthly asthma attacks during the last four months. A single treatment with theophylline (group A), beclomethasone (group B) or salbutamol (group C), was prescribed during the first 2 weeks, along with specific instructions to avoid inhaled allergens. Regardless of the drug used, patients showed impressive and prolonged clinical improvement during 6 months, reduction of total IgE serum levels in the three groups (p < 0.02; 0.005 and 0.02 respectively) and favorable modification of force expiratory volume at the first second, forced vital capacity and flow expiratory peak. During the observation period a constant monitoring of mites allergens concentrations was performed, showing a decrease of these antigens, associated with clinical improvement, and only in those patients who remained symptomatic (group A 31%, group B 29% and group C 9%), failures performing the measures designed to reduce their exposure to environmental allergens, was demonstrated. These results suggest that reduction of inhaled triggering factors may decrease the requirement of anti-inflammatory drug therapy to control the symptoms in patients with asthma.

    Topics: Adolescent; Albuterol; Allergens; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child; Child, Preschool; Data Interpretation, Statistical; Dust; Female; Humans; Immunoglobulin E; Inhalation Exposure; Longitudinal Studies; Male; Respiratory Function Tests; Theophylline; Time Factors

2000
Treatment preferences of adolescent patients with asthma.
    Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2000, Volume: 11, Issue:1

    The study objective was to assess whether asthmatic adolescents who were regular users of inhaled corticosteroids preferred treatment with zafirlukast tablets or inhaled beclomethasone dipropionate (BDP), and, secondarily, to assess adolescents' inhaler technique and their opinions about treatment. An open-label, randomized, two-period, crossover study was conducted in 18 centres (primary care to specialist asthma centres) in South Africa, the UK, Finland and the Czech Republic. One hundred and thirty-two adolescents aged 12-17 years with asthma for at least 1 year and FEV1 > or = 75% of predicted, treated with short-acting bronchodilators and inhaled corticosteroids, entered the study. Patients received oral zafirlukast tablets (Accolate) 20 mg b.i.d. or inhaled BDP 100 or 200 microg b.i.d., provided by a standard pressurized metered-dose inhaler, for 4 weeks each. One questionnaire was used to determine preference (the primary outcome measure) and a second questionnaire was used to determine patients' likes and dislikes of treatment. Investigators also scored inhaler technique. Of 113 adolescents, 79 (70%) preferred zafirlukast compared with 31 (27%) who preferred the BDP inhaler (p < 0.001); three had no preference. Only 35 (29%) of 122 adolescents could use their inhaler correctly at study entry. Seventy-six patients (65%) rated zafirlukast tablets as 'very easy' to use, compared with 35 (30%) for the BDP inhaler. Both treatments were well-tolerated. This study shows that asthmatic adolescents prefer zafirlukast tablets by a ratio of 2.6:1 over inhaled BDP, and these results may have implications for improving adolescent patient compliance with asthma therapy.

    Topics: Administration, Oral; Adolescent; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Cross-Over Studies; Female; Humans; Indoles; Male; Nebulizers and Vaporizers; Patient Compliance; Patient Satisfaction; Phenylcarbamates; Sulfonamides; Surveys and Questionnaires; Tablets; Tosyl Compounds

2000
Effect of one year treatment with inhaled fluticasone propionate or beclomethasone dipropionate on bone density and bone metabolism: a randomised parallel group study in adult asthmatic subjects.
    Thorax, 2000, Volume: 55, Issue:5

    There is some concern that prolonged treatment with high doses of inhaled corticosteroids may have a detrimental effect on bone mass. The aim of this one year study was to investigate the effects of low and high doses of fluticasone propionate (FP) (400 microg/day and 750 microg/day) and beclomethasone dipropionate (BDP) (800 microg/day and 1500 microg/day) on bone mass and metabolism.. This was a multicentre, double blind, parallel group study involving 69 mild to moderate asthmatic subjects who were randomised to treatment as follows: 22 to FP400, 21 to BDP800, 13 to FP750, and 13 to BDP1500. Their mean age was 39 years, 67% were men, and all the women were premenopausal.. The results of peripheral quantitative computed tomographic (pQCT) measurements (primary variable) showed that, compared with baseline values, there was no loss of trabecular or integral (cortical and trabecular) bone in the distal radius or tibia in any of the patients over the 12 month study period. No consistent pattern emerged from the analysis of changes from baseline in markers of bone formation and resorption after six and 12 months of treatment.. The results of this study provide reassuring prospective one year data showing that inhaled corticosteroids, in the range of doses used, had no adverse effects on bone mass and metabolism in this group of asthmatic patients.

    Topics: Administration, Inhalation; Administration, Topical; Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biomarkers; Bone and Bones; Bone Density; Double-Blind Method; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Prospective Studies

2000
Equivalence of two steroid-containing inhalers: easyhaler multidose powder inhaler compared with conventional aerosol with large-volume spacer.
    Respiration; international review of thoracic diseases, 2000, Volume: 67, Issue:2

    An equivalence study was conducted in which the efficacy and safety of a daily dose of 800 microgram of beclomethasone diproprionate administered via a multidose powder inhaler, Easyhaler, and via a metered-dose inhaler (MDI) with a large-volume spacer were compared in adult, newly diagnosed, steroid-naive asthmatic patients. Acceptability of the medications was also compared.. One hundred and forty-four patients were recruited into the double-blind, double-dummy, randomised, parallel-group multicentre study. The study treatment period was 8 weeks. It was preceded by a 2-week run-in period. Morning and evening peak expiratory flow (PEF), numbers of inhalations of a sympathomimetic and asthma symptoms were recorded daily. Spirometry and histamine challenge were performed, and health-related quality of life and morning serum cortisol levels measured during control visits.. Criteria indicating treatment equivalence were met. The mean of the primary outcome variable, morning PEF, increased significantly, from 426 to 461 litres/min in the Easyhaler group and from 436 to 467 litres/min in the MDI+spacer group. Similar improvements between groups were also seen in relation to all secondary variables. Changes in serum cortisol levels were minor. In 6 out of 10 questions about device acceptability, the majority of patients rated Easyhaler as better than the MDI+spacer combination.. It was concluded that the devices tested were equivalent in terms of efficacy and safety.

    Topics: Administration, Inhalation; Adult; Aerosols; Asthma; Beclomethasone; Dosage Forms; Double-Blind Method; Equipment Safety; Evaluation Studies as Topic; Female; Humans; Hydrocortisone; Male; Middle Aged; Nebulizers and Vaporizers; Patient Compliance; Powders; Quality of Life; Therapeutic Equivalency; Treatment Outcome

2000
Efficacy and safety of a novel beclomethasone dipropionate dry powder inhaler (Clickhaler) for the treatment of adult asthma. Amsterdam Clinical Study Group.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2000, Volume: 37, Issue:2

    A randomized, double-blind, double-dummy protocol was used to compare the safety and efficacy of beclomethasone dipropionate (BDP) delivered by a novel dry powder inhaler (DPI, Clickhaler) or by a pressurized metered-dose inhaler (MDI) plus spacer. There was a four-week run-in period, completed by 240 adult patients, who received BDP via an MDI. Patients with stable asthma were then randomized into a 12-week treatment period and received BDP (< or =2 mg/day via DPI or MDI). There were no significant differences in morning peak expiratory flow (PEF) (primary endpoint), evening PEF, overall daytime or nighttime symptom scores, or lung function parameters (forced expiratory volume in 1 sec, forced vital capacity) between DPI and MDI. The safety profiles were similar and patient acceptability for Clickhaler was high. In conclusion, BDP administered via Clickhaler was found to be clinically equivalent to an optimally used MDI. Patients with stable asthma currently receiving BDP via MDI may be effectively switched to treatment via Clickhaler DPI.

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Female; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Powders

2000
[Effects of inhaled corticosteroid in elderly patients with chronic obstructive pulmonary disease].
    Nihon Kokyuki Gakkai zasshi = the journal of the Japanese Respiratory Society, 2000, Volume: 38, Issue:3

    We examined the efficacy of inhaled corticosteroid (beclomethazone dipropionate: BDP) in elderly patients with chronic obstructive pulmonary disease (COPD). Eighty-six patients with COPD were divided into 3 groups: COPD treated without BDP (group 1, n = 26), COPD treated with BDP (group 2, n = 25), and BDP-treated COPD with asthmatic symptoms (group 3, n = 35). Pulmonary function test findings, symptoms, and prognosis for the 3 groups were retrospectively compared. No significant differences in yearly decline of FEV1.0 were observed. Of the patients treated with inhaled corticosteroid (groups 2 and 3), 30% exhibited improved FEV1.0. Of these patients, monthly decline of FEV1.0 correlated negatively with bronchial reversibility in FEV1.0 before and after inhalation of salbutamol (delta FEV1.0) (r = -0.28, p = 0.03). Cough and sputum scores were significantly improved in groups 2 and 3 (p < 0.01). Fewer admissions and episodes of acute exacerbation were noted in groups 2 and 3 than in group 1. From these results, we concluded that inhaled corticosteroid was effective in elderly COPD patients with bronchial reversibility and airway symptoms.

    Topics: Administration, Inhalation; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Female; Humans; Lung Diseases, Obstructive; Male; Maximal Expiratory Flow Rate; Prognosis; Retrospective Studies

2000
[Long-term prognosis of asthmatic patients treated with low-dose beclomethasone dipropionate].
    Arerugi = [Allergy], 2000, Volume: 49, Issue:5

    To clarify the prognosis of asthmatics treated with low-dose of inhaled beclomethasone dipropionate (BDP), we retrospectively assessed 43 patients treated with initial dose of 200 or 400 micrograms/day for 5 years, and obtained the following results. 1) 15 patients achieved step-down therapy (group A), 17 patients maintained initial dose of BDP (group B), and 11 patients required step-up therapy of BDP or daily use of oral prednisolone (group C). 2) There was no significant difference in age, sex, duration of disease, severity of disease, peripheral eosinophil counts, %FEV1 and histamine PC20 before BDP treatment among three groups. The percentage of atopic asthmatics was significantly higher in group C than in group A. 3) There was no significant difference in symptom and histamine PC20 between after 1 year state and after 5 years state in three groups. 4) After 1 year from the start of BDP treatment, only 18% patients got symptom free and neither patients exceeded 20,000 micrograms/ml of histamine PC20 in group C. Long-term treatment of low-dose BDP inhalation was effective on mild/moderate asthmatics. Patients requiring step-up therapy had not got sufficient improvement in bronchial hyperresponsiveness after one-year treatment.

    Topics: Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Male; Middle Aged; Prognosis; Retrospective Studies

2000
Effect of inhaled indomethacin in asthmatic patients taking high doses of inhaled corticosteroids.
    The Journal of allergy and clinical immunology, 2000, Volume: 105, Issue:6 Pt 1

    Cyclooxygenase products of arachidonic acid may play a part in bronchoconstriction and airway inflammation in asthma.. We sought to determine the effect of inhaled indomethacin on asthma control and asthma exacerbations during reduction of inhaled corticosteroids in patients with moderate-to-severe steroid-dependent asthma.. We conducted a double-blind, randomized, parallel-group, multicenter study in 38 patients with asthma taking high doses (> or =1500 microg/d) of beclomethasone dipropionate (BDP). After a run-in period, patients were assigned inhaled indomethacin (50 mg/d) or placebo for 6 weeks, during which the daily doses of BDP were reduced to half at week 2 and then to one third of the baseline dose at week 4.. Data were available from 34 patients. After the reduction of BDP doses, FEV(1), peak expiratory flow, asthma symptoms, and exhaled nitric oxide concentrations deteriorated in both treatment groups, but these effects were less pronounced in the indomethacin group compared with the placebo group. During the 6-week treatment period, 89% of the patients receiving placebo had relapse of asthma, whereas only 38% of those receiving inhaled indomethacin did so (P =.003).. Inhalation of indomethacin can reduce asthma exacerbations induced by reduction of high-dose inhaled corticosteroid in steroid-dependent asthma.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Asthma; Beclomethasone; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Indomethacin; Male; Middle Aged; Nitric Oxide; Placebos; Respiratory Function Tests

2000
Comparison of the effect on bronchial hyperresponsiveness of beclomethasone dipropionate administered via a novel multidose dry-powder inhaler or a conventional pressurised metered dose inhaler.
    Respiration; international review of thoracic diseases, 2000, Volume: 67, Issue:3

    Treatment with inhaled corticosteroids improves symptoms and reduces bronchial hyperresponsiveness (BHR) associated with asthma. Delivery of drugs into the lung is dependent on the inhaler device. Furthermore, environmental concerns regarding the use of chlorofluorocarbon propellants in pressurised inhalers and patient acceptability of inhaler devices both influence the extent of use of different delivery systems.. To compare the efficacy of beclomethasone dipropionate (BDP) administered via a novel multidose dry-powder inhaler (DPI) and a conventional pressurised metered-dose inhaler (pMDI) with spacer in patients with BHR.. A randomised, double-blind, crossover study was carried out in a group of 27 patients (aged 19-55 years) with a clinical diagnosis of reversible airway disease, who demonstrated BHR to methacholine (PD(20) < or =6.4 mg). Each patient received BDP (< or =2 mg/day) via the DPI or pMDI, for periods of 4 weeks. The randomised treatment periods were preceded by 3-week washout periods when no corticosteroid was used. Five clinic visits marked the start and end of each study phase. The primary efficacy endpoint was BHR as defined by the pharmacodynamic parameter, PD(20), which was determined at the start and end of each treatment period. Clinical endpoints including lung function, symptoms and adverse events were also evaluated.. Both treatments caused a significant decrease in BHR (p<0.05 vs. pre-treatment values). Mean +/- SD changes in log PD(20) were: DPI 0.59+/-1.29; pMDI 0.59+/-0.94 mg. There was no statistically significant difference between treatments and no evidence of a carry-over effect between treatments on BHR. Clinical efficacy and safety parameters also demonstrated no statistically significant treatment differences, and patients found the DPI easier to use.. Efficacy of BDP in reducing BHR is comparable via the DPI and pMDI plus spacer.

    Topics: Administration, Inhalation; Adult; Analysis of Variance; Asthma; Beclomethasone; Bronchial Hyperreactivity; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Equipment Design; Female; Follow-Up Studies; Humans; Male; Methacholine Chloride; Nebulizers and Vaporizers; Respiratory Function Tests; Statistics, Nonparametric

2000
Inhaled glucocorticosteroids decrease hydrogen peroxide level in expired air condensate in asthmatic patients.
    Respiratory medicine, 2000, Volume: 94, Issue:5

    H2O2 is elevated in the exhaled air condensate in several inflammatory disorders of the lung, including bronchial asthma, and thus may reflect inflammatory processes in the airways. Exhaled H2O2 may be used to guide the anti-inflammatory treatment of patients with asthma. Therefore in this study we analysed the effect of inhaled glucocorticosteroid beclomethasone for 4 weeks on H2O2 level in the exhaled air condensate. Seventeen asthmatics and 10 healthy subjects were included to the study. Eleven patients were given inhaled beclomethasone and six were given placebo (3M Health Care). In all patients pulmonary function tests were performed. H2O2 in the expired air condensate was measured spectrofluorimetically (homovanillic acid method). Inhaled beclomethasone significantly decreased H2O2 in the expired air condensate in the active-treatment group, with a fall from baseline on day 1 which remained on day 43 (follow-up) (P<0.05). Exhaled H2O2 in the active-treatment group was significantly lower than that in placebo group (P<0.05). A negative correlation between H2O2 and forced expiratory volume in 1 sec (FEV1) on day 29 was observed. The decrease in exhaled H2O2 in the active-treatment group was accompanied by an improvement in pulmonary function tests results. Inhaled glucocorticoids reduce the level of H2O2 in the expired air condensate of asthmatic patients over a 4-week period and this may reflect their anti-inflammatory activity in lung diseases.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Hydrogen Peroxide; Male

2000
Post-inhalation bronchoconstriction by beclomethasone dipropionate: a comparison of two different CFC propellant formulations in asthmatics.
    Respirology (Carlton, Vic.), 2000, Volume: 5, Issue:2

    To assess the change in bronchial response to cumulative doses from two beclomethasone dipropionate metered-dose inhalers (MDI), each using chlorofluorocarbon (CFC) propellants, in asthma patients previously showing falls in forced expiratory volume in 1 s (FEV1) shortly after exposure to beclomethasone MDI.. A total of 18 patients were randomized to a single-blind, three-period cross-over treatment regimen, whereby each was administered increasing doses of control mixture (containing surfactant and CFC propellants) or beclomethasone, formulated as either Becloforte or Respocort (250-1000 microg per dose; cumulative dose 2000 microg). Bronchial response was measured by comparison of FEV1 values pre- and post-inhalation.. Respocort formulation produced the least post-dose mean maximum reduction in FEV1 (0.36 +/- 0.17 L; 14.3 +/- 7.2% of baseline FEV1), while the reduction caused by the control was similar (0.40 +/- 0.18 L; 16.2 +/- 9.9% of baseline FEV1). Becloforte produced a significantly greater maximum reduction in FEV1 than Respocort (0.55 +/- 0.32 L, P = 0.003; 22.0 +/- 15.3% of baseline FEV1, P = 0.005). No serious adverse events were reported, but four patients experienced falls in FEV1 of greater than 15% (three on Becloforte, one using the control).. The incidence of falls in FEV1 following use of beclomethasone MDI was low and generally not serious even in a selected population. The Becloforte preparation produced significantly more post-dose bronchoconstriction than the Respocort formulation, perhaps because of differences in the composition of the surfactant and/or CFC propellant mixtures used to formulate each of the aerosols.

    Topics: Administration, Inhalation; Administration, Topical; Adult; Aged; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchoconstriction; Chlorofluorocarbons, Methane; Cross-Over Studies; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Single-Blind Method; Surface-Active Agents

2000
Equivalent asthma control after dose reduction with HFA-134a beclomethasone solution aerosol. Comparative Inhaled Steroid Investigation Group (CISIG).
    Respiratory medicine, 2000, Volume: 94, Issue:6

    The replacement of chlorofluorocarbon (CFC) by hydrofluoroalkane has the potential to improve airway deposition of BDP. We investigated whether HFA-BDP extra-fine solution aerosol 400 microg day(-1) is as effective as CFC-BDP 1000 micro day(-1) in patients with stable, moderate asthma, having persistent bronchial hyperresponsiveness.. One hundred and fifty patients with moderate asthma from 20 centres, on inhaled steroids for < or = 3 months, entered a 4-week run-in period with 1000 microg day(-1) CFC-BDP. Patients were then allocated to a 10-week study phase, receiving CFC-BDP 1000 microg day(-1) or HFA-BDP 400 microg day(-1). Symptom score and PEF were measured daily and recorded as biweekly means. Spirometry, PC20FEV1, blood eosinophils and serum ECP were determined on days 15, 29, 43 and 71, and compared to the last visit of the run-in period. All group members were trained in a quality control centre.. Treating the population of the HFA-BDP group (n = 72) and the CFC-BDP group (n = 78) did not show significant differences in terms of symptoms, lung function, airway hyperresponsiveness and serum markers of inflammation at the end of the run-in period and the end of the study phase.. Using HFA instead of a CFC metered dose inhaler, containing less than half the daily dose of BDP, allows control of symptoms and lung function parameters, without changes in bronchial hyperresponsiveness.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chlorofluorocarbons; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Hydrocarbons, Fluorinated; Male; Middle Aged; Patient Compliance; Peak Expiratory Flow Rate; Reproducibility of Results

2000
Zafirlukast improves asthma control in patients receiving high-dose inhaled corticosteroids.
    American journal of respiratory and critical care medicine, 2000, Volume: 162, Issue:2 Pt 1

    Not all asthma can be adequately controlled, despite the use of high-dose inhaled corticosteroids. Because cysteinyl-leukotrienes (Cys-LT) have been implicated in the pathogenesis of asthma, we hypothesized that the leukotriene receptor antagonist zafirlukast, in combination with high-doses of inhaled corticosteroids, might be efficacious in severe asthma. In a double-blind, parallel group study, 368 chronic adult asthmatic patients treated with inhaled corticosteroids (1,000 to 4,000 microgram/d), who had a predefined level of asthma symptoms during the run in period of the study, were randomly assigned to receive additional treatment with a high dose of zafirlukast (80 mg twice daily) (n = 180) or placebo (n = 188) for 6 wk. Compared with placebo, zafirlukast produced a significant improvement over baseline in the primary study endpoint of mean morning peak expiratory flow rate (PEFR) (18.7 L/min versus 1.5 L/min, p < 0.001), as well as in evening PEFR (p < 0.01), FEV(1) (p < 0.05), daytime symptom score (p < 0.001), and beta(2)-agonist use (p < 0.001). Furthermore, zafirlukast significantly reduced the risk of an exacerbation of asthma (odds ratio [OR]: 0.61; 95% confidence interval [CI]: 0.38 to 0.99) and the risk of patients requiring a further increase in asthma controller therapy (OR: 0.4; 95% CI: 0.2 to 0.8). In conclusion, in patients taking high-dose inhaled corticosteroids, zafirlukast improves pulmonary function and asthma symptoms, and reduces the risk of an asthma exacerbation, suggesting that the contribution of leukotrienes to asthma symptoms and exacerbations is not adequately controlled by high-dose inhaled corticosteroids.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Indoles; Leukotriene Antagonists; Male; Middle Aged; Patient Compliance; Peak Expiratory Flow Rate; Phenylcarbamates; Safety; Sulfonamides; Tosyl Compounds; Treatment Outcome

2000
Treating asthma in children with beclomethasone dipropionate: Pulvinal versus Diskhaler.
    Journal of aerosol medicine : the official journal of the International Society for Aerosols in Medicine, 2000,Spring, Volume: 13, Issue:1

    Seventy-two children (mean age, 10.1 years) with stable moderate asthma who completed a 7-day run-in period were randomized to receive a 4-week treatment with beclomethasone dipropionate (200 micrograms twice daily) administered through two different powder inhalers (Pulvinal; Chiesi Farmaceutici S.p.A, Parma, Italy and Diskhaler; Glaxo-Wellcome, Evreux, France) in a parallel group design. Sixty-nine patients completed the study. Morning and evening peak expiratory flow values, the use of rescue salbutamol, and the severity of clinical symptoms were recorded daily on a diary card. Pulmonary function tests were performed at baseline and then after 2 and 4 weeks of treatment. Pulmonary function values, daily morning and evening peak expiratory flow, and most of the clinical symptoms significantly improved, although the use of rescue salbutamol significantly decreased from the second week of treatment until the end of the study in both groups. Equivalence of efficacy between groups was demonstrated for both pulmonary function and clinical parameters. We conclude that the Pulvinal inhaler is as efficacious as the Diskhaler in beclomethasone-based therapy of asthmatic children.

    Topics: Administration, Inhalation; Adolescent; Aerosols; Analysis of Variance; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Female; Humans; Male; Nebulizers and Vaporizers; Patient Compliance; Respiratory Function Tests; Statistics, Nonparametric; Treatment Outcome

2000
Effects of adding a leukotriene antagonist or a long-acting beta(2)-agonist in asthmatic patients with the glycine-16 beta(2)-adrenoceptor genotype.
    The American journal of medicine, 2000, Aug-01, Volume: 109, Issue:2

    In the United Kingdom, about 40% of patients with asthma are homozygous for the glycine-16 beta(2)-adrenoceptor polymorphism, which predisposes them to agonist-induced down-regulation and desensitization of the beta(2)-adrenoceptor. We assessed the effects of adding treatment with either a long-acting beta(2)-agonist (inhaled formoterol, 12 microg twice daily) or a leukotriene receptor antagonist (oral zafirlukast, 20 mg twice daily) to inhaled corticosteroid therapy in patients with this genotype.. We enrolled 24 patients with mild to moderate asthma who were being treated with inhaled corticosteroids. Patients were randomly assigned to receive one of three treatments (placebo, zafirlukast, or formoterol in addition to inhaled corticosteroids) for 1 week each in a crossover fashion, separated by a 1-week placebo run-in and washout period. Measurements of bronchoprotection (measured as the provocative dose of methacholine that produced a 20% decline in forced expiratory volume in 1 second [FEV(1)]), exhaled nitric oxide (a surrogate marker of airway inflammation), and symptoms were made before each treatment and 12 hours after the last dose of each treatment.. Both formoterol and zafirlukast were equally effective in maintaining asthma control compared with placebo: the geometric mean-fold difference in the methacholine provocative dose was 1.5-fold (95% confidence interval [CI]: 1.1- to 2.2-fold) for zafirlukast and 1.9-fold (95% CI: 1.2- to 2.9-fold) for formoterol. As compared with placebo, zafirlukast caused a significant suppression in exhaled nitric oxide (1.7-fold difference in geometric mean values, 95% CI: 1.1- to 2.6-fold) but formoterol did not (1.2-fold difference, 95% CI: 0.8- to 1.9-fold). Diary cards showed significant (P <0.05) improvements in the peak flow with formoterol (morning and evening) and zafirlukast (evening) as compared with placebo.. Formoterol and zafirlukast maintained asthma control in patients who might be genetically predisposed to fare worse with long-acting beta(2)-agonists. The reduction in exhaled nitric oxide with zafirlukast suggests that it may have anti-inflammatory effects in addition to those seen with inhaled corticosteroids.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchodilator Agents; Confidence Intervals; Cross-Over Studies; Ethanolamines; Female; Forced Expiratory Volume; Formoterol Fumarate; Genotype; Glucocorticoids; Glycine; Homozygote; Humans; Indoles; Leukotriene Antagonists; Male; Middle Aged; Nitric Oxide; Phenylcarbamates; Placebos; Polymorphism, Genetic; Receptors, Adrenergic, beta-2; Sulfonamides; Tosyl Compounds

2000
Effectiveness of low doses (50 and 100 microg b.i.d) of beclomethasone dipropionate delivered as a CFC-free extrafine aerosol in adults with mild to moderate asthma. Study Group.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2000, Volume: 37, Issue:5

    The objective of this study was to evaluate the efficacy and safety of low doses (50 and 100 microg b.i.d.) of hydrofluoroalkane-134a (HFA) beclomethasone dipropionate (BDP) extrafine aerosol in improving asthma control. Reformulation of BDP in a new chlorofluorocarbon (CFC)-free propellant (HFA) has produced an extrafine aerosol with increased delivery of the drug to the airways of the lung. The study population comprised 270 steroid-naive patients with mild to moderate asthma (mean baseline forced expiratory volume in 1 sec [FEV1] as a percentage of predicted normal of 65%-85%). This was a 6-week, blinded, placebo-controlled, multicenter study. Patients were randomized to receive 50 or 100 microg b.i.d. HFA-BDP or HFA-placebo. Treatment with either 50 or 100 microg b.i.d. HFA-BDP resulted in a significantly greater improvement compared with placebo in FEV1 (mean change from baseline as percentage of predicted normal of 6.7%, 8.6%, and 0.4%, respectively; p < or = 0.01 active treatment groups vs. placebo), with a significant trend toward increasing improvement with increasing doses (p < or = 0.0001). Treatment also resulted in significantly greater mean changes from baseline in morning peak expiratory flow compared with placebo (29.5, 33.8, and 5.0 L/min, respectively; p < or = 0.01 active treatment groups vs. placebo). All other pulmonary function and asthma symptom measures supported these data. The study treatments were well tolerated. These results show that low doses of HFA-BDP extrafine aerosol effectively improve asthma control in adult patients with mild to moderate asthma. However, it is important that inhaled corticosteroid therapy is still given at a dose high enough to control airway inflammation as well as asthma symptoms.

    Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Safety

2000
Serum eosinophil cationic protein for predicting the prognosis of a step-down in inhaled corticosteroid therapy in adult chronic asthmatics.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2000, Volume: 37, Issue:5

    We investigated whether the serum concentration of eosinophil cationic protein (s-ECP) can be used to determine when a step-down in inhaled corticosteroid therapy is indicated for patients with chronic asthma. A total of 24 adult patients, whose symptoms were well controlled with inhaled beclomethasone dipropionate (iBDP), were studied. The dosage of iBDP was reduced by half once a month until the dose reached one-quarter of the original level. s-ECP and blood eosinophil counts were determined once a month before and during the 6-month period after the step-down. In 12 patients, moderate and frequent exacerbation occurred, thus requiring a return to the initial or twice the initial dose of iBDP. Thus, the step-down here was defined as unsuccessful. In the remaining 12 patients, the symptoms were stable over the course of the 6 months, and the step-down was defined as successful. s-ECP correlated with eosinophil counts in peripheral blood (EOS) in both the successful and the unsuccessful groups. Although EOS before the step-down did not differ significantly between the two groups, s-ECP was significantly higher in the unsuccessful group (mean 35.7 microg/L) than in the successful group (mean 17.0 microg/L, p < 0.03). Thus, s-ECP appears to be a useful marker for determining when a step-down in iBDP therapy is indicated, and thus may contribute to successful long-term management of chronic asthma.

    Topics: Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biomarkers; Blood Proteins; Eosinophil Granule Proteins; Eosinophils; Female; Glucocorticoids; Humans; Inflammation Mediators; Leukocyte Count; Male; Middle Aged; Prognosis; Ribonucleases

2000
Influence of intranasal steroids during the grass pollen season on bronchial responsiveness in children and young adults with asthma and hay fever.
    Thorax, 2000, Volume: 55, Issue:10

    It has been reported that intranasal corticosteroids can influence bronchial hyperresponsiveness (BHR) in asthmatic subjects with seasonal rhinitis. The purpose of the present study was to evaluate the effect of intranasal fluticasone propionate and beclomethasone dipropionate on BHR and bronchial calibre (forced expiratory volume in one second, FEV(1)) in children and young adults with seasonal rhinitis and mild asthma during two consecutive grass pollen seasons.. In the first pollen season 25 patients aged 8-28 years were included in a double blind, placebo controlled study. The active treatment group used fluticasone aqueous spray 200 microgram once daily. In the second pollen season 72 patients aged 8-28 years participated in a double blind, placebo controlled study of a similar design to that of the previous year except that an additional treatment group of patients using beclomethasone 200 microg twice daily was included. FEV(1) was measured before and after three and six weeks of treatment; BHR to methacholine (PD(20)) was measured before and after six weeks of treatment.. In the first season the mean (SD) logPD(20) of the patients decreased significantly both in the fluticasone group (from 2.43 (0.8) microgram to 1.86 (0.85) microgram) and in the placebo group (from 2.41 (0.42) microgram to 1.87 (0.78) microgram) without any intergroup difference in the change in logPD(20). In the second pollen season the mean logPD(20) in the fluticasone, beclomethasone, and placebo groups did not change significantly.. Intranasal steroids did not influence BHR during two grass pollen seasons in children and young adults with seasonal rhinitis and mild asthma.

    Topics: Administration, Intranasal; Adolescent; Adult; Allergens; Androstadienes; Anti-Allergic Agents; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Child; Double-Blind Method; Female; Fluticasone; Forced Expiratory Volume; Humans; Male; Patient Compliance; Pollen; Rhinitis, Allergic, Seasonal; Treatment Outcome

2000
Comparison of high dose inhaled steroids, low dose inhaled steroids plus low dose theophylline, and low dose inhaled steroids alone in chronic asthma in general practice.
    Thorax, 2000, Volume: 55, Issue:10

    Theophylline is widely used in the treatment of asthma, and there is evidence that theophylline has anti-inflammatory or immunomodulatory effects. A study was undertaken to determine whether theophylline added to low dose inhaled steroids would be as efficacious as high dose inhaled steroids in asthma.. In a study in general practice of 155 recruited asthmatic patients with continuing symptomatic asthma while on 400 microgram beclomethasone dipropionate (BDP) daily and inhaled beta(2) agonist as required, the effect of (1) continuing low dose inhaled steroids alone (LDS, 200 microgram BDP twice daily), (2) low dose inhaled steroids plus low dose theophylline (LDT, 400 mg daily), or (3) high dose inhaled steroids (HDS, 500 microgram BDP) over a six month period was examined.. One hundred and thirty patients completed the study. Between group comparison using analysis of variance showed no overall differences in peak flow measurements, diurnal variation, and symptom scores. Changes in evening peak flows approached significance at the 5% level (p=0.077). The mean improvement in evening peak flow in the LDT compared with the LDS group was 20.6 l/min (95% confidence interval (CI) -2.5 to 38.8). In the LDT group there was an increase in evening peak flows at the end of the study compared with entry values (22.5 l/min), while in the LDS and HDS groups evening peak flows increased by 1.9 and 8.3 l/min, respectively. There was no significant difference in exacerbations or in side effects.. There were no overall significant differences between the low dose steroid, low dose steroid with theophylline, and the high dose steroid groups. The greatest within-group improvement in evening peak flows was found after theophylline. A larger study may be necessary to show significant effects.

    Topics: Adolescent; Adult; Aged; Asthma; Beclomethasone; Bronchodilator Agents; Chronic Disease; Double-Blind Method; Family Practice; Female; Glucocorticoids; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Theophylline; Treatment Outcome

2000
Effect of suplatast tosilate, a Th2 cytokine inhibitor, on steroid-dependent asthma: a double-blind randomised study. Tokyo Joshi-Idai Asthma Research Group.
    Lancet (London, England), 2000, Jul-22, Volume: 356, Issue:9226

    Th2 cytokines play an important part in the pathogenesis of asthma. Our aim was to study the effect of suplatast tosilate, a selective Th2 cytokine inhibitor, on asthma control and asthma exacerbations during reduction of inhaled corticosteroid dose in patients with steroid-dependent asthma.. 85 patients with moderate to severe asthma taking high doses (> or = 1500 microg per day) of inhaled beclometasone dipropionate, were assigned suplatast tosilate (100 mg three times daily) or placebo for 8 weeks in a double-blind, randomised, parallel-group, multicentre trial. During the first 4 weeks, other medications remained unchanged (add-on phase); during the next 4 weeks, the doses of beclometasone were halved (steroid-reduction phase). Main outcome measures were pulmonary function, asthma symptoms, and use of beta2-agonists.. Data were available from 77 patients. During the add-on phase, suplatast tosilate treatment, compared with placebo, was associated with higher forced expiratory volume in 1 s (mean difference between groups for changes from baseline at week 4, 0.20 L [95% CI 0.16-0.24], p=0.043), morning peak expiratory flow (18.6 L/min [14.1-23.1], p=0.037), and less diurnal variation in peak expiratory flow rate, asthma symptom scores (7.1 [6.6-7.6], p=0.029), and serum concentrations of eosinophil cationic protein and IgE. In the steroid-reduction phase, pulmonary function, asthma symptoms, and use of beta2-agonist deteriorated significantly more in the placebo group than in the suplatast group.. Treatment with a Th2 cytokine inhibitor in steroid-dependent asthma improves pulmonary function and symptom control, and allows a decrease in dose of inhaled corticosteroid without significant side-effects. Some improvements in pharmacokinetics are, however, needed.

    Topics: Administration, Inhalation; Administration, Oral; Anti-Allergic Agents; Anti-Asthmatic Agents; Arylsulfonates; Asthma; Beclomethasone; Circadian Rhythm; Cytokines; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Sulfonium Compounds; Th2 Cells

2000
Analysis of induced sputum before and after withdrawal of treatment with inhaled corticosteroids in asthmatic patients.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2000, Volume: 30, Issue:12

    To assess whether sputum eosinophilia predicts the recurrence of asthma symptoms after withdrawal of therapy in moderate stable asthmatics on low-dose inhaled corticosteroids. Randomized, double-blind, placebo-controlled study involving 30 subjects with stable asthma, asymptomatic, with low PEF variability measured over two run-in weeks, on treatment with low-dose inhaled beclomethasone dipropionate (BDP, 250 microgram b.i.d. in the last 3 months). At the end of the run-in, all patients underwent a methacholine challenge test and sputum induction (T1). They then stopped therapy and received either placebo (20 subjects, study group) or BDP at the same dose as in the previous 3 months (10 subjects, control group). They continued to monitor PEF and symptom score for 3 months, or until asthma symptoms recurred (diurnal and nocturnal symptom score >/=2 on two consecutive days). At the end of the study (T2), i.e., either within 5 days from the beginning of asthma symptoms or after 3 months in subjects without recurrence of asthma symptoms, all subjects repeated the methacholine challenge test and sputum induction. In the placebo-treated group, sputum eosinophils at T1 were significantly higher in subjects who subsequently developed recurrence of asthma symptoms (n = 7) after cessation of treatment than in subjects who remained asymptomatic for 3 months (8.2% [0-56.6] vs 0.9% [0-11], P < 0.05). At the time of recurrence of asthma symptoms, sputum eosinophil percentages significantly increased (from 8.2% [0-56.6] to 16.6% [5.8-73.6], P < 0.05). The positive predictive value of sputum eosinophils for the recurrence of asthma symptoms was 71%, while the negative predicting value was 84%. In the BDP-treated control group, none of the subjects experienced recurrence of asthma symptoms, and sputum eosinophil percentages measured at the beginning (T1) and at the end (T2) of the study were similar. Sputum eosinophil percentages may vary over a wide range in asthmatic subjects, although regularly treated and apparently well controlled. However, high sputum eosinophil percentages are related to early recurrence of asthma symptoms after cessation of inhaled corticosteroids.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Double-Blind Method; Eosinophils; Female; Glucocorticoids; Humans; Leukocyte Count; Male; Predictive Value of Tests; Recurrence; Sputum

2000
Airway inflammation in patients with symptoms suggesting asthma but with normal lung function.
    The European respiratory journal, 2000, Volume: 16, Issue:5

    The hypothesis that eosinophilic airway inflammation is present in many patients presenting with respiratory symptoms suggestive of asthma but with normal lung function was tested. Thirty-six consecutive patients presenting with these features were studied. Twenty-five asthmatics and 43 healthy volunteers served as control groups. Signs of eosinophilic inflammation in blood and induced sputum were studied. Patients with respiratory symptoms were single-blindly treated with inhaled beclomethasone dipropionate (BDP), 800 microg daily, or placebo for 3 months, and re-examined at 3 months and 1 yr. Patients with respiratory symptoms had higher numbers of blood and sputum eosinophils than healthy persons (p<0.0001), but the degree of eosinophilic inflammation was less pronounced than in asthmatics (p<0.01). Three-month's treatment with BDP significantly reduced total symptom score (p<0.001), cough score (p<0.0001), and the number of blood eosinophils (p<0.01). For cough alone, the improvement was significant compared with placebo (p<0.05). The patients were followed-up for 1 yr, and 17 (55%) still had symptoms but retained normal lung function. Four (13%) patients had developed asthma and another 10 (32%) had become free of symptoms. Using lung function measurements and induced sputum analyses, a group of patients with symptoms suggestive of asthma and signs of eosinophilic airway inflammation but without enough airflow variability to be diagnosed as asthmatics were detected. They seemed to respond favourably to inhaled beclomethasone dipropionate treatment.

    Topics: Administration, Inhalation; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Blood Cells; Eosinophilia; Female; Follow-Up Studies; Humans; Inflammation; Lung; Male; Middle Aged; Reference Values; Respiratory Tract Diseases; Single-Blind Method; Sputum

2000
Efficacy of nebulized fluticasone propionate compared with oral prednisolone in children with an acute exacerbation of asthma.
    Respiratory medicine, 2000, Volume: 94, Issue:12

    The aim of the present study was to investigate the efficacy and safety of nebulized fluticasone propionate (FP Nebules) compared with oral soluble prednisolone in children with an acute exacerbation of asthma. The study used an international, multi-centre, randomized, double-blind, parallel group design. Three hundred and twenty-one patients, aged 4-16 years old, who presented with an acute exacerbation of asthma, were randomly allocated to either nebulized FP (1 mg b.d.) or oral prednisolone (2 mg kg(-1) day(-1) for 4 days then 1 mg kg(-1) day(-1) for 3 days) for 7 days. Patients in the FP group showed a significantly greater increase in diary card morning peak expiratory flow (PEF) over 7 days compared with patients in the prednisolone group (difference = 9.51 min(-1), CI = 2.1, 16.8, P = 0.034). Similar increases for both treatments were shown for evening PEF. Clinic PEF improved with both treatments, but was significantly greater in patients taking FP after 7 days (difference = 11.41 min(-1), CI = 2.8, 20.0, P = 0.029). Both treatments reduced symptom scores to a similar extent. The two treatments were well tolerated, and there was no difference in the incidence of adverse events. The present study demonstrated that nebulized FP is at least as effective as oral prednisolone in the treatment of children presenting with an acute exacerbation of asthma.

    Topics: Acute Disease; Administration, Inhalation; Administration, Oral; Adolescent; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Child, Preschool; Double-Blind Method; Female; Fluticasone; Humans; Male; Peak Expiratory Flow Rate; Prednisolone; Treatment Outcome

2000
Prevention with clodronate of osteoporosis secondary to inhaled corticosteroid treatment in patients with chronic asthmatic bronchitis.
    International journal of clinical pharmacology research, 2000, Volume: 20, Issue:3-4

    Steroid therapy is the third most common cause of osteoporosis, after loss of gonad function and senescence. The aim of the present study was to evaluate the protective action of clodronate on bone mass loss induced by steroid therapy. Sixty patients with bronchial asthma receiving either fluticasone (250 mg x 4/day) or beclomethasone (250 mg x 4/day) inhaled corticosteroid treatment were enrolled. Half the patients received combination treatment with clodronate (100 mg i.m./14 days), for a total period of 12 months. All patients were evaluated at baseline and at the end of treatment for bone mineral density (BMD) and calcium/phosphor metabolism parameters (kalemia, kaluria, phosphoremia, phosphaturia, alkaline phosphatase and hydroxyprolinuria over a 24-h period). The results of this preliminary study confirm the protective influence of clodronate on bone mass loss, as documented by the increment in mean values in BMD reported at the end of treatment compared with baseline values.

    Topics: Administration, Inhalation; Aged; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bone Density; Chronic Disease; Clodronic Acid; Fluticasone; Humans; Infusion Pumps; Male; Middle Aged; Osteoporosis

2000
[Effect of low dose of inhaled corticosteroid combined with small dose of oral theophylline on treatment of bronchial asthma].
    Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases, 2000, Volume: 23, Issue:6

    To investigate the effect of small dose of oral theophyllin combined with low dose of inhaled beclomethasone dipropionate (BDP) on clinical symptoms, bronchial responsiveness and hypothalamic-pituitary-adrenal axis (HPAA).. 43 patients with mild-moderate bronchial asthma were randomly divided into A and B groups. 21 subjects in group A were treated with oral substained release theophyllin (Protheo) (200 mg/night) and inhaled BDP (300 micrograms/day); 22 cases in group B received inhaled BDP (600 micrograms/day) and oral placebo.. Before and 13 weeks after the treatment, symptom scores, peak flow(PEF), and peak flow rate (PEFR) for group A were (1.8 +/- 0.9) and (0.10 +/- 0.30), (295 +/- 98) L/min and (444 +/- 150) L/min, (22 +/- 8)% and (9 +/- 3)% respectively, and those for group B were (1.90 +/- 0.70) and (0.10 +/- 0.30), (328 +/- 129) L/min and (441 +/- 146) L/min, (24 +/- 7)% and (9 +/- 3)% respectively, which were remarkably improved in both groups (P < 0.01), and bronchial provocation responsiveness to histamine tests (BHR) in both groups were also improved significantly (P < 0.01). There were no differences between two groups (P < 0.05). Frequency of using inhaled beta 2 agonist to relieve nocturnal asthmatic attacks in group B (3.9 +/- 1.7) was significantly greater than that in group A (1.3 +/- 1.0, P < 0.05). Plasma ACTH concentrations, basic cortisol levels and cortisol responses to ACTH before and 13 weeks after the treatment in group B were (31 +/- 13) ng/L and (20 +/- 8) ng/L, (95 +/- 50) micrograms/L and (86 +/- 48) micrograms/L, (156 +/- 98)% and (74 +/- 46)% respectively, which were decreased significantly after the treatment (P < 0.05). There were no such changes in group A.. It was suggested that small dose of oral theophylline combined with low dose of inhaled BDP might have the same effect on relief of clinical symptoms and bronchial responsiveness, without suppression on HPAA function, comparing with relatively higher dose of inhaled BDP.

    Topics: Administration, Inhalation; Administration, Oral; Adrenocorticotropic Hormone; Adult; Aged; Asthma; Beclomethasone; Bronchi; Bronchial Provocation Tests; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Pituitary-Adrenal System; Theophylline; Time Factors; Treatment Outcome

2000
Hydrofluoroalkane-134a beclomethasone dipropionate, 400 microg, is as effective as chlorofluorocarbon beclomethasone dipropionate, 800 microg, for the treatment of moderate asthma.
    Chest, 1999, Volume: 115, Issue:2

    The improved lung deposition of hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) extrafine aerosol compared with chlorofluorocarbon beclomethasone dipropionate (CFC-BDP) suggests that lower doses of HFA-BDP may be required to provide equivalent asthma control. The present study was undertaken to test this hypothesis.. A 10- to 12-day run-in period confirmed that patients met established criteria of at least moderate asthma and the asthma was inadequately controlled by current therapy (inhaled beta-agonist and CFC-BDP [< or = 400 microg/d]). A short course of oral prednisone, 30 mg/d for 7 to 12 days, was followed to establish the patients were steroid responsive and to provide an "in-study" baseline of "optimal" asthma control.. A total of 347 patients were then randomized to HFA-BDP 400 microg/d, CFC-BDP 800 microg/d, or HFA-placebo for 12 weeks.. Morning peak expiratory flow (AM PEF) measurements showed that HFA-BDP 400 microg/d achieved equivalent control of asthma to CFC-BDP 800 microg/d at all time intervals after oral steroid treatment. All other efficacy variables supported the AM PEF results and both active treatments were more effective than placebo. The safety profile of HFA-BDP compared favorably with that of CFC-BDP with no unexpected adverse events reported.. These findings demonstrate that HFA-BDP provides equivalent control of moderate or moderately severe asthma as CFC-BDP in the population studied, but at half the total daily dose.

    Topics: Adult; Aerosols; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chlorofluorocarbons; Double-Blind Method; Drug Combinations; Female; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Male; Peak Expiratory Flow Rate; Treatment Outcome

1999
Efficacy of inhaled steroids (beclomethasone dipropionate) for treatment of mild to moderately severe asthma in the emergency department: a randomized clinical trial.
    Annals of emergency medicine, 1999, Volume: 33, Issue:3

    To examine the efficacy of an inhaled steroid, when added to a standard regimen of beta-agonist therapy, in the treatment of patients with mild to moderately severe asthma in the emergency department.. A convenience sample of adult patients with asthma (FEV1 % predicted 40% to 69%) presenting to the ED was randomly assigned in a double-blind fashion into 2 treatment groups. The first group received 2.5 mg nebulized salbutamol plus 1 mg (4 puffs) of beclomethasone dipropionate (BDP) at baseline, 30 minutes, and at 1, 2, and 4 hours, delivered by a metered-dose inhaler (MDI) attached to a spacer device (Vent-AH-aler, Glaxo). The second group was given the same salbutamol regimen plus MDI placebo through the Vent-AH-aler. The primary endpoint was improvement in FEV1 %predicted at 6 hours.. Of 54 patients enrolled, 28 were assigned to the BDP group and 26 to the placebo group. Spirometry improved significantly in both groups over the 6 hours compared with baseline (ANOVA, P <.001). At 6 hours, the mean absolute improvement in FEV1 % predicted for BDP was 18% versus 17% for placebo (95% confidence interval for the absolute difference of 1% [-8% to 10%]). The proportion of patients in the BDP group who were hospitalized was 7% compared with 19% for patients in the placebo group (95% confidence interval for the difference of 12% [-6%, 30%]).. In this group of patients with mild to moderately severe asthma, 5 mg BDP delivered by MDI during the initial 4 hours of an emergency visit was of no added benefit over standard therapy, as measured by improvement in FEV1 % predicted at 6 hours. However, a trend toward a difference in admission favoring BDP was observed. [Afilalo M, Guttman A, Colacone A, Dankoff J, Tselios C, Stern E, Wolkove N, Kreisman H: Efficacy of inhaled steroids (beclomethasone dipropionate) for treatment of mild to moderately severe asthma in the emergency department: A randomized clinical trial.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Albuterol; Analysis of Variance; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Double-Blind Method; Drug Therapy, Combination; Emergency Service, Hospital; Female; Forced Expiratory Volume; Humans; Male; Spirometry

1999
Comparison of oral bambuterol and inhaled salmeterol in patients with symptomatic asthma and using inhaled corticosteroids.
    American journal of respiratory and critical care medicine, 1999, Volume: 159, Issue:3

    Salmeterol inhaled twice-daily is now being used more frequently as additional treatment in asthma insufficiently controlled by inhaled corticosteroids. We compared oral bambuterol in a dose of 20 mg taken once daily in the evening with inhaled salmeterol at 50 microgram taken twice daily in 126 asthmatic patients (60 bambuterol, 66 salmeterol) aged 18 to 74 yr who were treated for at least 4 wk with inhaled corticosteroids at a constant dose of 400 to 2,000 microgram/d or with oral corticosteroids at /= 15% overnight decrease in peak expiratory flow (PEF) on 3 of the preceding 7 d, in order to be randomized into this double-blind, double dummy, multicenter parallel group study (2-wk run-in period and 6 wk of treatment). There was no significant difference between bambuterol and salmeterol in morning change from baseline in PEF (p = 0.53). The median increases in morning PEF were 50 L/min for bambuterol and 55 L/min for salmeterol. Other variables (evening PEF, percent of overnight decrease in PEF, number of awakenings, percent of nights with an awakening, number of puffs of rescue medication, asthma symptoms during the day and night, and mean tremor score) also showed no significant difference between bambuterol and salmeterol. Both treatments, at the doses given, were well tolerated. Once-daily oral bambuterol is a convenient, effective, and less expensive alternative to twice-daily inhaled salmeterol for treating nocturnal asthma.

    Topics: Administration, Inhalation; Administration, Oral; Adolescent; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Salmeterol Xinafoate; Terbutaline

1999
Oral montelukast, inhaled beclomethasone, and placebo for chronic asthma. A randomized, controlled trial. Montelukast/Beclomethasone Study Group.
    Annals of internal medicine, 1999, Mar-16, Volume: 130, Issue:6

    Oral leukotriene receptor antagonists have been shown to have efficacy in chronic asthma.. To compare the clinical benefit of montelukast, a once-daily oral leukotriene receptor antagonist; placebo; and inhaled beclomethasone.. Randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study.. 36 sites worldwide.. 895 patients 15 to 85 years of age with chronic asthma and an FEV1 50% to 85% of predicted.. Montelukast, 10 mg once daily at bedtime; inhaled beclomethasone, 200 microg twice daily, administered with a spacer device; or placebo.. Primary end points were daytime asthma symptom score and FEV1. Secondary end points were peak expiratory flow rates in the morning and evening, as-needed beta-agonist use, nocturnal awakenings, asthma-specific quality of life, and worsening asthma episodes.. Over the 12-week treatment period, the average percentage change from baseline in FEV1 was 13.1% with beclomethasone, 7.4% with montelukast, and 0.7% with placebo (P < 0.001 for each active treatment compared with placebo; P < 0.01 for beclomethasone compared with montelukast). The average change from baseline in daytime symptom score was -0.62 for beclomethasone, -0.41 for montelukast, and -0.17 for placebo (P < 0.001 for each active treatment compared with placebo; P < 0.01 for beclomethasone compared with montelukast). Each agent improved peak expiratory flow rates and quality of life, reduced nocturnal awakenings and asthma attacks, increased the number of asthma-control days, and decreased the number of days with asthma exacerbations (P < 0.001 for each active treatment compared with placebo for each end point; P < 0.01 for beclomethasone compared with montelukast for each end point). Although beclomethasone had a greater mean clinical benefit than montelukast, montelukast had a faster onset of action and a greater initial effect. The two agents caused similar decreases in peripheral blood eosinophil counts (P < 0.05 for each agent compared with placebo). Both agents had tolerability profiles similar to that of placebo over the 12-week study.. Although beclomethasone had a larger mean effect than montelukast, both drugs provided clinical benefit to patients with chronic asthma. This finding is consistent with the use of these agents as controller medications for chronic asthma.

    Topics: Acetates; Administration, Inhalation; Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Analysis of Variance; Anti-Asthmatic Agents; Asthma; Beclomethasone; Blood Cell Count; Cyclopropanes; Double-Blind Method; Drug Administration Schedule; Eosinophils; Female; Humans; Leukotriene Antagonists; Male; Middle Aged; Peak Expiratory Flow Rate; Placebos; Quality of Life; Quinolines; Sulfides

1999
Comparison of salmeterol with beclomethasone in adult patients with mild persistent asthma who are already on low-dose inhaled steroids.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1999, Volume: 36, Issue:1

    Current guidelines on asthma management recommend the early use of inhaled corticosteroids. Recent studies of patients with moderate to severe asthma show that the addition of salmeterol is superior to a further increase of the steroids. In this study with adult, mild persistent asthma patients, we compared the effects of adding salmeterol 50 microg b.i.d. versus beclomethasone dipropionate (BDP) 200 microg b.i.d. (both via Diskhaler dry powder inhaler) to the low-dose inhaled steroids. A double-blind, randomized, parallel-group study was conducted with a run-in period of 2 weeks and a treatment period of 12 weeks. Patients (n = 233) were randomized with a peak expiratory flow (PEF) reversibility of 22 +/- 10% (mean +/- SD) in the run-in period. The morning PEF was 84 +/- 17% predicted and the age was 42 +/- 14 years (45% males). The average prestudy inhaled steroid dose was 361 microg daily. Within a week of salmeterol treatment the daily PEF recordings reached maximal levels. At the end of the treatment period the evening PEF remained significantly better in the salmeterol group than in the BDP group (p = 0.036). The PEFs, measured at the general practitioners' (GPs') office, were at least 95% of the predicted values and the post-salbutamol values at the end of both treatments. However, the salmeterol group had already obtained this level after 2 weeks and differed significantly from the beclomethasone group (p = 0.003 for percent predicted and p = 0.0007 for post-salbutamol PEF values). The symptom scores and the use of rescue medication showed a similar profile. Quality of life improved with both treatments, but without significant statistical differences between the groups. The frequency of adverse events, typical for beta2-agonists, was low and showed no differences between the groups. These results showed that the addition of salmeterol is at least as effective as adding beclomethasone in normalizing peak flows and improving asthma control in mild persistent asthma patients. Furthermore, salmeterol has a much faster onset of action.

    Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Salmeterol Xinafoate; Steroids; Treatment Outcome

1999
Inhaled beclomethasone dipropionate reverts tolerance to the protective effect of salmeterol on allergen challenge.
    Chest, 1999, Volume: 115, Issue:3

    One week of regular treatment with salmeterol can induce tolerance to the protective effect of a beta2-agonist on early airway response to allergen (EAR). The objective was to assess whether inhaled corticosteroids revert tolerance to salmeterol.. The study had a randomized, double-blind, placebo-controlled design.. Twelve subjects with mild allergic asthma and positive result of specific bronchial provocation test (sBPT) to allergen underwent three sBPTs, separated by 1 week. sBPT was done in all subjects after a single dose (T1) and after 1 week of regular treatment with inhaled salmeterol (50 microg bid) (T2) in order to induce tolerance. Subjects were then randomized to receive either the same dose of salmeterol + beclomethasone dipropionate (BDP, 500 microg bid) (group 1, n = 6) or placebo + BDP (group 2, n = 6) for 1 week before sBPT (T3).. After a single dose of salmeterol (T1), all subjects were protected against EAR, whereas after 1 week of regular treatment, the protective effect of salmeterol was totally or partially lost (T2). Maximum FEV1 percent fall (MaxdeltaFEV1%) after allergen inhalation was significantly higher at T2 than at T1. All subjects except one of group 1 were protected against EAR after salmeterol + BDP (T3), and MaxdeltaFEV1% at T3 (median, 12%; range, 4 to 6%) was significantly lower than T2 (median, 22%; range, 12 to 43%; p < 0.05 by Wilcoxon test). Subjects of group 2 did not show any significant protection against EAR after placebo + BDP treatment (T3) MaxdeltaFEV1% at T2 (median, 31%; range, 9 to 40%) and T3 (median, 31%; range, 3 to 42%; not significant).. In conclusion, the addition of inhaled BDP partially restored the bronchoprotective effect of salmeterol on allergen challenge that was lost after 1 week of regular treatment with salmeterol alone. This ability of BDP in reverting tolerance cannot be ascribed to a direct effect of corticosteroids per se on allergen challenge in this group of asthmatics.

    Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Adult; Albuterol; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchodilator Agents; Double-Blind Method; Drug Therapy, Combination; Drug Tolerance; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Salmeterol Xinafoate

1999
Effects of inhaled beclomethasone dipropionate on serum IgE levels and clinical symptoms in atopic asthma.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 1999, Volume: 29, Issue:3

    A high serum immunoglobulin (Ig)E level is considered a potent predictor for the development of asthma and IgE is targeted for treatment of asthma. Although inhaled corticosteroids are well established in the treatment of asthma, the effects of inhaled corticosteroids on serum IgE levels in asthma remain uncertain.. We therefore examined asthma symptoms, concentrations of total serum IgE and specific IgE antibodies to selected allergens, blood eosinophil counts and lung functions before and 3 months after treatment with either inhaled beclomethasone dipropionate (BDP; 800 microg/day) (n = 7) or inhaled beta2-agonists alone (n = 7) in patients with atopic asthma in a randomized, double-blind, parallel-group controlled trial.. Inhaled BDP significantly improved asthma symptom scores and forced expiratory volume in 1 s, and decreased blood eosinophil counts, total serum IgE levels and specific IgE antibodies to house dust mite and cedar. Decreases in total serum IgE significantly correlated with an improvement in asthma symptom scores. In contrast, none of parameters altered in patients with atopic asthma treated with inhaled beta2-agonists alone.. Inhaled corticosteroids may improve the subsequent clinical course of atopic asthma in association with a reduction of serum IgE levels.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Double-Blind Method; Eosinophils; Female; Humans; Immunoglobulin E; Male

1999
A comparison of multiple doses of fluticasone propionate and beclomethasone dipropionate in subjects with persistent asthma.
    The Journal of allergy and clinical immunology, 1999, Volume: 103, Issue:5 Pt 1

    Inhaled corticosteroids are recommended for the treatment of persistent asthma. Comparative clinical studies evaluating 2 or more doses of these agents are few.. We sought to compare the efficacy and safety of 2 doses of fluticasone propionate (88 micrograms twice daily and 220 micrograms twice daily) with 2 doses of beclomethasone dipropionate (168 micrograms twice daily and 336 micrograms twice daily) in subjects with persistent asthma.. Three hundred ninety-nine subjects participated in this randomized, double-blind, parallel-group clinical trial. Eligible subjects were using daily inhaled corticosteroids and had an FEV1 of 45% to 80% of predicted value. Clinic visits, including spirometry, were conducted every 1 to 2 weeks. Subjects recorded symptoms, use of albuterol, and peak expiratory flows on daily diary cards.. Fluticasone propionate treatment resulted in significantly (P

    Topics: Adolescent; Adult; Aged; Albuterol; Androstadienes; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fluticasone; Forced Expiratory Volume; Humans; Male; Middle Aged; Respiratory Function Tests; Severity of Illness Index; Tachycardia

1999
Effects of inhaled corticosteroid on bone turnover in children with bronchial asthma.
    Respirology (Carlton, Vic.), 1999, Volume: 4, Issue:1

    Long-term usage of systemic steroids is associated with multiple side effects. One of the major morbidities is due to its effect on bone metabolism leading to bone loss and resulting in skeletal fractures. This study was conducted to determine the effects of inhaled steroids on bone mineral density (BMD) and biochemical bone markers. Twenty-four children with frequent episodic or mild persistent asthma who satisfied the clinical criteria for starting on inhaled corticosteroids (ICS) were enrolled into the study. The BMD scan was done using dual energy X-ray absorptiometry, prior to starting ICS therapy and 6 months later. Biochemical markers of bone metabolism, (i) serum osteocalcin as a bone formation marker, and (ii) urinary deoxypyridinoline (Upd) as a bone resorption marker, were taken prior to ICS treatment and at 2 monthly intervals. The biochemical markers were all taken in the morning. Twenty-four, age- and sex-matched children with mild episodic asthma, not requiring ICS, were used as controls for the BMD measurements. The BMD scan was done upon enrollment into the study and 6 months later. Twenty-four children on ICS and 24 controls completed the study. The subjects were on a mean dose of beclomethasone dipropionate (BDP) 0.4 mg/day. One subject needed a short course of Prednisolone in the early treatment period. None of the controls needed oral steroid therapy. One child in the control group sustained a greenstick fracture after an accidental fall. The mean rate of change of BMD was 1.8% +/- 12.3 in the subjects on BDP. This was lower than the 6.1% +/- 10.6 among the control subjects. However, this difference did not reach statistical significance (P = 0.16). There was a significant increase in serum osteocalcin level after 6 months of BDP treatment from 66.83 +/- 22.71 ng/mL to 81.61 +/- 24.66 ng/mL (P < 0.005). There was a decline in Upd from 36.2 +/- 47.1 nmol/mmol creatinine to 21.4 +/- 6.92 nmol/mmol creatinine. However, this did not reach statistical significance. There was no difference in the statural gain between the subjects on ICS and their controls. This study showed that 6 months of ICS therapy (mean dose 0.4 mg/day) had no significant adverse effect on bone metabolism in asthmatic children.

    Topics: Amino Acids; Asthma; Beclomethasone; Biomarkers; Bone Density; Bone Remodeling; Child; Child, Preschool; Female; Glucocorticoids; Humans; Male; Osteocalcin

1999
Adrenal effects and pharmacokinetics of CFC-free beclomethasone dipropionate: a 14-day dose-response study.
    The Journal of pharmacy and pharmacology, 1999, Volume: 51, Issue:3

    Since equivalent efficacy is achieved with lower doses of the reformulated beclomethasone dipropionate in the chlorofluorocarbon (CFC)-free propellant HFA-134a (HFA) than with the original CFC-beclomethasone dipropionate formulation, it is possible the HFA-beclomethasone dipropionate may have less safety concerns than the CFC formulation. Despite its chronic use, the steady-state pharmacokinetics of beclomethasone dipropionate has never been studied before. This double-blind study examined adrenal effects and pharmacokinetics after 14 days of dosing with HFA-beclomethasone dipropionate. Forty-three steroid-naïve asthmatic patients were randomised into 5 parallel groups and dosed every 12 h for 14 days with: HFA-placebo; 200, 400 or 800 microg day(-1) HFA-beclomethasone dipropionate; or 800 microg day(-1) CFC-beclomethasone dipropionate. After two weeks of dosing, the 24-h urinary free cortisol of all but one patient remained within the normal range, showing that all doses were well tolerated from a systemic safety perspective. The active HFA-beclomethasone dipropionate treatment groups showed a dose-related fall in 24-h urinary free cortisol. Total-beclomethasone (beclomethasone dipropionate and metabolites) pharmacokinetics after either the first dose of HFA-beclomethasone dipropionate or CFC-beclomethasone dipropionate were not substantially affected by subsequent doses. The extent of drug absorption from 800 microg day(-1) HFA-beclomethasone dipropionate and CFC-beclomethasone dipropionate was in the ratio of 1.7 : 1. A non-linear correlation between 24-h urinary free cortisol and the pharmacokinetic parameters was observed, reflecting smaller changes in 24-h urinary free cortisol than in pharmacokinetics as the dose was increased. No clinically meaningful change in the pharmacokinetics of beclomethasone dipropionate plus metabolites was seen on multiple dosing. The greater systemic availability of HFA-beclomethasone dipropionate was still associated with adrenal effects comparable with that of the CFC formulation at the same dose.

    Topics: Administration, Inhalation; Adrenal Glands; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biological Availability; Chlorofluorocarbons; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Male; Nebulizers and Vaporizers; Particle Size; Placebos; Smoking

1999
[Pranlukast allows reduction of inhaled steroid dose without deterioration in lung function in adult asthmatics].
    Arerugi = [Allergy], 1999, Volume: 48, Issue:4

    We undertook a community based case-control study to measure the effect of pranlukast on the reduction of inhaled steroid in adult asthmatics. Forty-one adults completed a run-in period of 4 weeks on 800 microgram of beclomethasone dipropionate (BDP) documenting twice daily peak expiratory flow (PEF) and symptom score and therapeutic score on a standard diary. Forced expiratory volume in one second (FEV1.0), V50, V25 was measured once during the run-in period. Patients were then randomized to receive either pranlukast with 400 microgram of BDP or 400 microgram alone for 8 weeks. There was no difference in the symptom score and therapeutic between the two groups at any time point. However, morning and evening % PEF run-in expressed as a % of the PEF average during the run-in period was significantly lower at 8 weeks in the groups without pranlukast. There were subjects in the group without pranlukast (35.3%) compared to those with (20.8%) who had a 10% or more reduction in % PEF from the run-in period. The patients with an FEV1.0 < 80% predicted who were randomized to the control group were more likely (5 of 7) to have a fall in % PEF run-in and those randomized to received pranlukast were less likely to have a fall in % PEF run-in though this was not significant (2 of 6). In this study, pranlukast has demonstrated steroid sparing effect. Severe asthmatics (FEV1.0 < 80%) who deteriorate after reduction of inhaled steroid may benefit most from pranlukast. Larger studies are now required to explore this important effect.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Case-Control Studies; Chromones; Drug Therapy, Combination; Female; Humans; Leukotriene Antagonists; Male; Middle Aged; Respiratory Function Tests

1999
House dust mite avoidance for children with asthma in homes of low-income families.
    The Journal of allergy and clinical immunology, 1999, Volume: 103, Issue:6

    Home exposure to high levels of house dust mite allergen has been shown to aggravate airways reactivity and asthma.. The purpose of this study was to determine whether specific house dust mite control measures could reduce exposure levels and asthma severity.. This double-blinded, randomized trial compared asthma progression over 1 year in children whose homes received standard environmental control intervention with those whose homes received aggressive intervention for dust mite elimination. The primary end point was doubling in PD20 methacholine.. Symptom scores and quality-of-life scores were similar for the standard and aggressive intervention groups. PD20 methacholine doubling occurred in 9 members of the aggressive intervention group vs 4 control patients (P <.05). Dust mite levels decreased in the aggressive intervention homes compared with the standard intervention homes (P <.05).. Aggressive dust mite intervention decreased dust mite levels and improved bronchial hyperresponsiveness.

    Topics: Adolescent; Air Pollution, Indoor; Allergens; Animals; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Antigens; Asthma; Beclomethasone; Bronchial Hyperreactivity; Child; Cromolyn Sodium; Dust; Environmental Pollutants; Glycoproteins; Humans; Methacholine Chloride; Mites; Respiratory Function Tests; Socioeconomic Factors; Triamcinolone

1999
[Budesonide (Turbuhaler) at a dosage of 400 micrograms per day is at least as effective as a double dose of beclomethasone (MDI) in patients with mild to moderately severe bronchial asthma].
    Casopis lekaru ceskych, 1999, Jan-25, Volume: 138, Issue:3

    Recent investigations revealed that in patients with bronchial asthma the same anti-inflammatory effect is achieved by inhalation of half the dose of budesonide by a Turbuhaler (i.e. by using corticosteroid in powder form) as by a full dose of beclomethasone driven into the lungs by compressed chlorofluorocarbons (i.e. MDI = pressure dosage inhalator). The objective was to assess whether there is a difference between 12-week treatment with budesonide Turbuhaler in a smaller dose of 400 micrograms/day and treatment with beclomethasone dipropionate MDI 800 micrograms/day.. After an initial two-week period of the 227 patients with mild or medium severe asthma who had not taken corticosteroids for three months, into the budesonide Turbuhaler group 94 patients were included and into the beclomethasone MDI group 99 patients. Characteristics: group treated with budesonide (46 men, 48 women, mean age 38 years, FEV1 78% of appropriate values). Group treated with beclomethasone (51 men, 48 women, mean age 39 years, FEV1 81.5% of appropriate values). Morning and evening values of the peak expiration rate (PEF) increased significantly after budesonide treatment 2 x 200 micrograms/day) as compared with beclomethasone treatment (2 x 400 micrograms/day). Differences of morning PEF between budesonide and beclomethasone: 47:28 l/min, p < 0.05, differences of evening PEF: 32:10 l/min., p < 0.027. The number of dyspnoic attacks declined after both types of treatment, as well as the amount of inhaled bronchodilatating substances (terbutalin Turbuhaler). The differences between drugs were however not statistically significant.. Budesonide Turbuhaler, 400 micrograms/day when administered to patients with bronchial asthma was at least as effective as beclomethasone MDI, 800 micrograms/day. The increase of morning and evening PEF values was after budesonide significantly higher than after beclomethasone.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Female; Humans; Male; Middle Aged

1999
Early effects of inhaled steroids on airway hyperreactivity and pulmonary function in asthma.
    Pediatric pulmonology, 1999, Volume: 27, Issue:6

    While inhaled steroids (IS) are increasingly recognized as having a more rapid onset of action than was once thought, little is known about the early changes in objective measures of respiratory function that follow the inhalation of repeated doses. These early effects were examined in a randomized, double-blind, placebo-controlled, crossover study of 20 children aged 10-16 years with stable mild asthma. Beclomethasone dipropionate (BDP) 2,000 mcg, fluticasone propionate (FP) 400 mcg, and placebo were given twice daily for three doses. Airway hyperreactivity (AHR) to methacholine (PC20), pulmonary function tests (PFT: FVC, FEV1, FEF25-75%), and the rate of recovery from methacholine-induced bronchospasm following administration of salbutamol were determined at 8 h (after 1 dose) and at 32 h (after three doses). At 8 h, minor improvements in AHR were demonstrated, averaging 0.32 doubling doses in PC20. At 32 h, significant improvements in AHR and PFTs were present, averaging 0.92 doubling doses in PC20, 3.96% of predicted values in FEV1, and 7.74% of predicted values in FEF25-75%. No significant changes occurred in FVC. There were no significant differences between the effects of BDP and FP. Inhaled steroids were associated with a slower response to salbutamol following methacholine challenge testing at 32 h. We conclude that IS, given in repeated high doses, result in significant improvements within 32 h in both AHR and PFTs, along with changes in response to beta2 agonists. These effects are likely to be the result of the topical activity of IS.

    Topics: Administration, Inhalation; Adolescent; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Child; Cross-Over Studies; Double-Blind Method; Female; Fluticasone; Glucocorticoids; Humans; Male; Respiratory Function Tests; Respiratory Mechanics; Treatment Outcome

1999
A six-month, placebo-controlled comparison of the safety and efficacy of salmeterol or beclomethasone for persistent asthma.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 1999, Volume: 82, Issue:6

    There is a paucity of data comparing the long-term safety and efficacy of long-acting inhaled beta2-agonists versus low-dose inhaled corticosteroids in the treatment of asthma.. To compare the safety and efficacy of salmeterol xinafoate, beclomethasone dipropionate (BDP), and placebo over a 6-month treatment period in patients with persistent asthma.. Salmeterol (42 microg twice daily), BDP (84 microg four times daily), or placebo was administered via metered-dose inhaler to 386 adolescent and adult inhaled corticosteroid-naive patients in a randomized, double-blind, double-dummy, parallel-group study. Eligible patients demonstrated a forced expiratory volume in 1 second (FEV1) from 65% to 90% of predicted values. Pulmonary function, symptom control, frequency of asthma exacerbations, bronchial hyperresponsiveness (BHR) to methacholine challenge, and adverse events were assessed.. There were few statistically significant differences between the two active treatments over 6 months of therapy. Asthma symptoms and lung function were significantly improved with both salmeterol and BDP compared with placebo (changes from baseline in FEV1 of 0.28 L (SE = 0.04) and 0.23 L (SE = 0.04), respectively, compared with 0.08 L (SE = 0.04); P < or = .014). There were no significant differences among the treatment groups with respect to the distribution of asthma exacerbations over time. Both salmeterol and BDP significantly reduced BHR compared with placebo (P < or = .033; changes from baseline of 1.29 (SE = 0.26) and 1.42 (SE = 0.24) doubling doses at 6 months, respectively, compared with 0.24 (SE = 0.29) doubling dose for placebo). No rebound effect in BHR was seen upon cessation of any of the three treatment regimens. There were no clinically important differences in the safety profiles among the three treatments.. Both salmeterol and BDP are effective and well-tolerated when administered for 6 months to inhaled corticosteroid-naive patients with persistent asthma.

    Topics: Adolescent; Adult; Albuterol; Asthma; Beclomethasone; Bronchial Provocation Tests; Child; Double-Blind Method; Forced Expiratory Volume; Humans; Male; Peak Expiratory Flow Rate; Placebos; Salmeterol Xinafoate; Therapeutic Equivalency

1999
Analysing repeated measurements data: a practical comparison of methods.
    Statistics in medicine, 1999, Jul-15, Volume: 18, Issue:13

    A variety of methods are available for analysing repeated measurements data where the outcome is continuous. However, there is little information on how established methods, such as summary statistics and repeated measures analysis of variance (RMAOV), compare in practice with methods that have become available to applied statisticians more recently, such as marginal models (based on generalized estimating equation methodology) and multilevel models (that is, hierarchical random effects models). The aim of this paper is to exemplify the use of these methods, and directly compare their results by application to a clinical trial data set. The focus is on practical aspects rather than technical issues. The data considered were taken from a clinical trial of treatments for asthma in 240 children, in which a baseline and four post-randomization measurements of outcomes were taken. The simplicity of the method of summary statistics using the post-randomization mean of observations provided a useful initial analysis. However, fixed time effects or treatment-time interactions cannot be included in such an analysis, and choice of appropriate weighting when there is substantial missing data is problematic. RMAOV, marginal models and multilevel models generally provided similar estimates and standard errors for the treatment effects, although in one example with a relatively complex variance structure the marginal model produced less efficient estimates. Two advantages of multilevel models are that they provide direct estimates of variance components which are often of interest in their own right, and that they can be naturally extended to handle multivariate outcomes.

    Topics: Adolescent; Analysis of Variance; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Data Interpretation, Statistical; Glucocorticoids; Humans; Models, Statistical; Multicenter Studies as Topic; Multivariate Analysis; Peak Expiratory Flow Rate; Randomized Controlled Trials as Topic

1999
Skin bruising, adrenal function and markers of bone metabolism in asthmatics using inhaled beclomethasone and fluticasone.
    The European respiratory journal, 1999, Volume: 13, Issue:5

    Fluticasone propionate (FP) is generally considered to have twice the efficacy of beclomethasone dipropionate (BDP) on a weight-to-weight basis for the control of asthma, and may have lesser effects on adrenal function. However, the effects of FP and BDP on skin integrity and bone metabolism markers require further examination. Sixty-nine asthmatic subjects were enrolled in a double-blind crossover study in which, after a baseline period, they received BDP or FP (at half the dose of BDP) for two 4-month periods each. A questionnaire on skin bruising, a skin examination, tests of adrenal function and of markers of bone metabolism were performed after 2 months of each period. The number of asthma exacerbations was not significantly different for the two treatment periods (eight for BDP and nine for FP), nor were various indices of asthma control. Whereas the frequency of bruising reported by the questionnaire was not different, there were more bruises on examination for BDP (1.6+/-2.5) than for FP (1.2+/-2.3) (p=0.04). Although baseline serum cortisol was not significantly different for the two drugs, the increase in cortisol after cortrosyn was lower for BDP (357+/-158 micromol x dL(-1)) than for FP (422+/-144 micromol x dL(-1)) (p<0.01). Serum osteocalcin levels were significantly lower in subject on BDP (2.8+/-1.7 microg x mL(-1)) than on FP (3.5+/-1.9 ng x mL(-1)) (p=0.003). Other markers of bone metabolism were not significantly altered. The three major side-effects were loosely, but significantly correlated with the periods on BDP and FP. However, skin bruises, increase in cortisol after Cortrosyn and osteocalcin were not significantly correlated for the period on either BDP or FP. In conclusion, whereas fluticasone propionate used at half the dose of beclomethasone dipropionate has a comparable effect on the control of asthma, fluticasone propionate demonstrated fewer side-effects in terms of skin bruising, adrenal suppression and bone metabolism.

    Topics: Administration, Inhalation; Administration, Topical; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Contusions; Cross-Over Studies; Double-Blind Method; Female; Fluticasone; Humans; Hydrocortisone; Male; Middle Aged; Osteocalcin; Prospective Studies; Skin Diseases

1999
[Inhaled corticosteroid therapy in mild and moderate persistent asthma. Acceptability of a new inhalation system: the jet].
    Revue de pneumologie clinique, 1999, Volume: 55, Issue:2

    The objectives of this study were to assess the acceptability and efficacy of Jet (a metered dose inhaler with a 100 ml chamber giving 250 micrograms beclomethasone dipropionate per puff) in patients with mild to moderate asthma using a dose-for-dose schedule in substitution for their standard metered dose inhaler with or without an inhalation chamber. An open trial was conducted over 5 weeks in 356 asthma patients treated with inhaled corticosteroids at a mean 914 +/- 198 micrograms/24 h dose. beta 2-agonists were used by all patients, either systematically (prescription) or as needed. Prior to the study, 27% of the patients used a standard metered dose inhaler with a large-volume inhalation chamber and 73% used a standard metered dose inhaler alone. The rate of nocturnal, early morning, and diurnal symptoms and cough decreased by 31.4, 33.4, 46.9, and 37.0% respectively and the variability of peak expiratory flow rate fell from 2 +/- 0.08% to 0.9 +/- 0.02% in the group using the metered dose inhaler with the chamber and from 1.3 +/- 0.04 to 0.5 +/- 0.01% in the group using the standard metered dose inhaler. The investigators determined that treatment efficacy was good or excellent in 94.8%. These findings should be confirmed by studies comparing Jet directly with other inhalation chamber systems or with standard metered dose inhalers. For 97.5% of the patients, it was easy to learn to use Jet and 88.2% of the patients felt no discomfort when using Jet; 64.8% of the patients stated they experienced clinical improvement. At the end of the trial, 77.9% of the patients (76.3% of those who used the inhalation chamber during the study and 78.4% of those who used the metered dose inhaler alone) stated they preferred Jet over their prior system.

    Topics: Adolescent; Adult; Aged; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Data Interpretation, Statistical; Female; Humans; Male; Middle Aged; Respiratory Therapy; Time Factors

1999
Changes in levels of catalase and glutathione in erythrocytes of patients with stable asthma, treated with beclomethasone dipropionate.
    The European respiratory journal, 1999, Volume: 13, Issue:6

    In asthmatic patients, antioxidant defence is decreased. Although inhaled corticosteroids decrease asthmatic inflammation and modulate reactive oxygen species (ROS) generation, little is known of their effect on cellular antioxidant levels. The aim of this study was to evaluate the effect of inhaled beclomethasone dipropionate (BDP; 1,000 microg x day(-1)) on erythrocyte antioxidant levels in stable asthmatic patients. Forty patients with stable, mild asthma were treated in a double-blind, placebo-controlled, parallel-group study with BDP 250 microg, two puffs b.i.d. for 6 weeks. At entry and every 2 weeks during treatment, erythrocyte antioxidant levels, haematological parameters, pulmonary function tests and asthma symptoms were determined. The results show that during treatment with BDP, erythrocyte catalase levels increased (at entry (mean +/-SEM) 41+/-4, after 6 weeks 54+/-4 micromol H2O2 x min(-1) x g haemoglobin (Hb)(-1), p = 0.05 in comparison with placebo). Erythrocyte total glutathione levels significantly decreased after 6 weeks treatment with BDP (from 7.0+/-0.4 to 6.6+/-0.3 micromol x g Hb(-1) (p = 0.04)). In the BDP-treated patients, blood eosinophil counts were higher in patients who responded with an increase in erythrocyte catalase levels during BDP treatment, as compared to those not responding ((mean +/-SEM) 340+/-39 and 153+/-52x10(6) cells x L(-1), respectively, p = 0.05). The present study shows that treatment with inhaled bedomethasone dipropionate results in changes in antioxidant levels in erythrocytes of patients with stable, mild asthma.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Antioxidants; Asthma; Beclomethasone; Catalase; Double-Blind Method; Erythrocytes; Female; Glucocorticoids; Glutathione; Glutathione Peroxidase; Glutathione Transferase; Humans; Male

1999
A randomized, double-blind study comparing the effects of beclomethasone and fluticasone on bone density over two years.
    The European respiratory journal, 1999, Volume: 13, Issue:6

    Cross-sectional studies have suggested that asthmatic patients receiving high dose inhaled corticosteroids and intermittent courses of oral corticosteroids have reduced bone mass. This prospective 2-yr study was undertaken to evaluate changes in bone density of patients receiving high doses of inhaled corticosteroids. Patients (n = 33) (males aged 18-50 yrs, females aged 18-40 yrs) on inhaled corticosteroids 1,000-2,000 microg x day(-1), were randomized in a double-blind fashion to either fluticasone propionate (FP) 1,000 microg x day(-1) or beclomethasone dipropionate (BDP) 2,000 microg x day(-1). In parallel, three open control groups of the same age range were studied: asthmatics (n = 8) receiving low dose inhaled corticosteroids (< or =400 microg x day(-1)) (group A); chronic, severe asthmatics (n = 8) receiving oral corticosteroids (> or =10 mg x day(-1) (group B); and healthy untreated volunteers (n = 7) (group C). Bone densitometry scans (quantitative computed tomography (QCT) of spine; dual X-ray absorptiometry of spine, femoral neck, and single photon absorptiometry of forearm) were performed at baseline and after 6, 12 and 24 months of treatment. Biochemical bone marker measurements (serum osteocalcin, bone alkaline phosphatase, pro-collagen type 1 carboxy terminal propeptide, deoxypyridinoline and C-telopeptide of type 1 collagen) were collected every 3 months. Fifteen FP (mean age 36 yrs, six male) and 9 BDP patients (mean age 33 yrs, five male); completed the study. At 0 months, mean bone mineral density (BMD) was lower in patients receiving inhaled corticosteroids (both low dose and high dose) than in normal volunteers. In the FP-treated group, mean vertebral trabecular BMD quantitative computed tomography remained stable with no evidence of decline, whereas there was some decline in the BDP-treated group. The treatment difference between FP and BDP was statistically significant in favour of FP for quantitative computed tomography measurements after 12 months (p = 0.006) and 24 months (p = 0.004). This study suggests that over 24 months, changes in bone density are minimal in patients on high-dose inhaled corticosteroids.

    Topics: Absorptiometry, Photon; Administration, Inhalation; Adolescent; Adult; Alkaline Phosphatase; Androstadienes; Asthma; Beclomethasone; Bone and Bones; Bone Density; Double-Blind Method; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Osteocalcin; Peptide Fragments; Procollagen; Tomography, X-Ray Computed

1999
Inhaled corticosteroids decrease subepithelial collagen deposition by modulation of the balance between matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 expression in asthma.
    The Journal of allergy and clinical immunology, 1999, Volume: 104, Issue:2 Pt 1

    Bronchial asthma is characterized by airway wall remodeling. Matrix metalloproteinases (MMPs) are members of a family of proteolytic enzymes that degrade the extracellular matrix and that restrain the effects of their tissue inhibitors (TIMPs). Treatment with inhaled corticosteroids may prevent airway remodeling in asthma. However, the effects of corticosteroid treatment on MMPs and TIMPs in asthma are unknown.. We examined the effects of inhaled beclomethasone dipropionate (BDP) on the expression of MMP-9 and TIMP-1 and subepithelial collagen deposition in bronchial biopsy specimens from 30 subjects with asthma.. Inhaled BDP, 800 microg daily, or placebo was administered for 6 months in a double-blind, parallel-group study, and bronchial biopsies were performed before and after treatment. Biopsy specimens were examined for extent of collagen type III in the subepithelial basement membrane by means of immunohistochemistry, and expression of both epithelial and submucosal MMP-9 and TIMP-1 was quantitated. Numbers of inflammatory cells were also determined.. We observed significant decreases in collagen type III deposition (P <.01) and the expression of submucosal MMP-9 (P <.01) and a significant increase in the expression of submucosal TIMP-1 (P <.05) in the BDP group. Significant correlations were found between the subepithelial collagen type III deposition and epithelial (r (s ) = 0.37, P <.05) and submucosal expression of MMP-9 (r (s ) = 0.47, P <.01). Additionally, the number of many inflammatory cells and myofibroblasts in airway mucosa were significantly decreased in the BDP group.. Our findings suggest that corticosteroid treatment of asthma can reduce subepithelial collagen deposition by downregulation of MMP-9 expression and upregulation of TIMP-1 expression.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Asthma; Beclomethasone; Biopsy; Bronchi; Collagen; Collagenases; Female; Humans; Inflammation; Male; Matrix Metalloproteinase 9; Middle Aged; Mucous Membrane; Placebos; Tissue Inhibitor of Metalloproteinase-1

1999
Improved targeting of beclomethasone diproprionate (250 micrograms metered dose inhaler) to the lungs of asthmatics with the Spacehaler.
    Respiratory medicine, 1999, Volume: 93, Issue:6

    The Spacehaler (Evans Medical Ltd, Leatherhead, U.K.) is a new, compact, inhaler device containing the same aerosol canister as a conventional metered dose inhaler (MDI). However, the design of the Spacehaler has been shown to reduce the velocity of the aerosol, thus reducing the proportion of non-respirable particles delivered to the patient. This study compared radioaerosol deposition patterns following inhalation of 250 micrograms of beclomethasone dipropionate from the Spacehaler and a conventional MDI (Beclazone, Norton Health Care, Harlow, U.K.). After rigorous in vitro validation of the radiolabelling technique, 12 asthmatic subjects (seven men aged 20-69 years, mean baseline FEV1 2.59 1 (SD 0.55 1) received one dose of 99mTc-labelled beclomethasone dipropionate 250 micrograms via either a Spacehaler or MDI on each of two study days in a randomized cross-over manner. All subjects had been taught the required inhalation technique before the dose was administered. Inhalation details were recorded using a spirometer connected in series with the device. Lung and oropharyngeal depositions were measured by gamma scintigraphy. The mean percentage of the metered dose deposited in the lungs was 23.0% (SD 8.3%) for the Spacehaler and 12.8% (SD 6.8%) for the MDI (P < 0.01). However, there was no significant difference in the distribution patterns within the lungs between the two devices. Oropharyngeal deposition was significantly lower (P < 0.01) for the Spacehaler than for the MDI [mean (SD) 27.9% (16.4%) and 73.6% (8.7%), respectively] whilst the percentage of the metered dose remaining on the Spacehaler actuator was significantly greater than that on the MDI actuator [mean (SD) 48.0% (11.8%) and 12.4% (8.5%) respectively, P < 0.01]. There was evidence from the inhalation recordings that some patients experienced the 'cold Freon effect' whilst using the metered dose inhaler which may have contributed to the lower lung deposition seen with this device. This study demonstrates that the proportion of a 250 micrograms dose of beclomethasone dipropionate that is delivered to the lungs is significantly greater with the Spacehaler than the MDI. The Spacehaler also reduces the proportion of the does that is deposited in the oropharynx to less than half that observed with the MDI, and reduces the total dose of drug received by the patient.

    Topics: Administration, Inhalation; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cross-Over Studies; Female; Humans; Male; Middle Aged; Nebulizers and Vaporizers

1999
Acute safety of beclomethasone dipropionate in a new CFC-free propellant system in asthmatic patients.
    Respiratory medicine, 1999, Volume: 93, Issue:1

    Hydrofluoroalkane-134a (HFA-134a) is a new chlorofluorocarbon (CFC)-free propellant for use in metered dose inhalers. It provides a more environmentally friendly alternative to CFC propellants because it does not contain chlorine which is responsible for ozone depletion by CFCs. Beclomethasone dipropionate (BDP) is widely used for inhalation asthma therapy and is most commonly delivered by a CFC propellant system. The present study evaluated the acute safety of BDP formulated with the new propellant (HFA-134a BDP) compared with BDP in a CFC-11/12 formulation by measuring the acute bronchial response in asthmatic patients. The study was conducted as a randomized, single-blind, placebo-controlled, four-period cross-over trial. Asthmatic patients received eight inhalations of four treatment regimens (HFA-134a BDP, 1600 mg total dose; CFC-11/12 BDP, 2000 mg total dose; HFA-134a placebo and CFC-11/12 placebo) in random order over four study days. Forced expired volume in 1 s (FEV1) was measured before and 2, 10, 20, 40 and 60 min after inhalation of the study treatments. The number of coughs was counted from the start of the first inhalation to 60 s after the last inhalation. There were no statistically significant differences between the treatment groups for changes in FEV1, for the number of coughs or for the occurrence or severity of bronchoconstriction. In asthmatic patients withholding bronchodilators, the new HFA-134a BDP propellant system proved as safe and was as well tolerated as the current CFC-11/12 BDP system. The two propellant systems without active drug were also equally well tolerated.

    Topics: Administration, Topical; Adult; Aerosol Propellants; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchi; Cross-Over Studies; Drug Evaluation; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Male; Middle Aged; Single-Blind Method

1999
Inhaled beclomethasone (BDP) with non-CFC propellant (HFA 134a) is equivalent to BDP-CFC for the treatment of asthma.
    Respiratory medicine, 1999, Volume: 93, Issue:4

    As part of a development programme for a range of new CFC-free beclomethasone dipropionate (BDP) inhalers, two multicentre double-blind studies have been conducted to compare the therapeutic equivalence of a new HFA-134a propellant-formulated BDP metered-dose inhaler (Norton Healthcare Ltd, London, U.K.) with a CFC counterpart for the management of adult patients with all grades of asthma. Doses of 100 micrograms qds for 6 weeks were administered in a low dose study and in a high dose study 500 micrograms qds doses were given for 12 weeks. Efficacy assessments included lung function (FEV1) in the clinic and asthma symptoms, peak flow rates and bronchodilator use by patients on diary cards. Safety parameters measured included routine haematology and biochemistry (including serum cortisols), clinical adverse events and throat swabs for Candida spp. Both CFC and HFA-formulations of inhaled BDP produced similar and significant improvements in lung function and asthma symptoms. In the low dose study, baseline to endpoint FEV1 increased from 2.2 +/- 0.51 to 2.5 +/- 0.81 (P = 0.0001) with BDP-CFC and from 2.2 +/- 0.51 to 2.6 +/- 0.81 with BDP-HFA (P = 0.0001), with no significant difference between treatments. In the high dose study, corresponding increases were 2.1 +/- 0.71 to 2.4 +/- 0.91 (P = 0.0002) for BDP-CFC and 2.1 +/- 0.71 to 2.3 +/- 0.71 (P = 0.017) for BDP-HFA. PEF also improved similarly on both treatments in both studies. Both formulations were well tolerated with no difference in the pattern of adverse events, effect on serum cortisol or Candida colonization. These studies showed that, in the management of asthma, the new HFA-formulated BDP metered dose inhaler is equivalent to, and directly substitutable for, the older CFC-formulated product at the same dose, making change-over for patients straightforward.

    Topics: Adolescent; Adult; Aerosol Propellants; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chlorofluorocarbons; Double-Blind Method; Female; Humans; Hydrocarbons, Fluorinated; Male; Middle Aged; Nebulizers and Vaporizers; Treatment Outcome

1999
Effects of high-dose inhaled corticosteroids on plasma cortisol concentrations in healthy adults.
    Archives of internal medicine, 1999, Sep-13, Volume: 159, Issue:16

    Recent studies suggest that inhaled corticosteroids may differ significantly in their systemic effects.. To compare the systemic effects, as measured by plasma cortisol suppression, of inhaled beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate, and triamcinolone acetonide at doses of approximately 1000 microg twice daily.. Sixty healthy adult male volunteers participated in this randomized, open-label, parallel-design study. Twenty-four-hour plasma cortisol determinations (cortisol-AUC24) were measured after a single dose of placebo medication and after a single dose and 7 consecutive doses of active medication.. After a single dose, all inhaled corticosteroid preparations caused statistically significant mean reductions in cortisol-AUC24 compared with placebo as follows: flunisolide, 7% (P= .02); budesonide, 16% (P= .001); beclomethasone, 18% (P= .003); triamcinolone, 19% (P=.001); and fluticasone, 35% (P<.001). After multiple doses, flunisolide was not significantly different from placebo (5%; P = .24), while budesonide (18%; P = .002), triamcinolone (25%; P<.001), beclomethasone (28%; P<.001), and fluticasone (79%; P<.001) all resulted in statistically significant suppression of cortisol-AUC24. After both single and multiple doses, beclomethasone, budesonide, flunisolide, and triamcinolone were not statistically different from each other, while fluticasone was significantly (P<.001) more suppressive than the other 4 medications.. These results indicate that there are differences in the systemic effects of inhaled corticosteroids when used in high doses and emphasize the importance of using the minimum dose of inhaled corticosteroids required to maintain control of asthma symptoms.

    Topics: Administration, Inhalation; Administration, Topical; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Fluocinolone Acetonide; Fluticasone; Glucocorticoids; Humans; Hydrocortisone; Male; Reference Values; Triamcinolone Acetonide; Volunteers

1999
Formoterol and beclomethasone versus higher dose beclomethasone as maintenance therapy in adult asthma.
    The European respiratory journal, 1999, Volume: 14, Issue:3

    A total of 132 adult asthmatics who were symptomatic on 500 microg x day(-1) inhaled beclomethasone dipropionate (BDP) were studied in an open-label randomized, parallel group, 12 week, clinical trial. The addition of 12 microg formoterol fumarate solution aerosol (pressurized metered dose inhaler) b.i.d. to BDP at a dose of 500 microg x day(-1) was compared with a higher dose of 1,000 microg x day(-1) BDP. Mean morning premedication peak expiratory flow rate (PEF) during the final week of treatment (primary end-point) increased in both groups compared to baseline. The estimated treatment difference of 20.4 L x min(-1) (95% confidence interval 3.2-37.6) after 12 weeks of treatment was statistically significant (p<0.05) in favour of the formoterol/BDP group. The overall mean morning premedication PEF for the entire treatment period was higher in the formotero/BDP group (p=0.002). The overall number of puffs of rescue medication and asthma symptom scores were less in the formotero/BDP group (p<0.01). Safety and tolerability evaluations were satisfactory in both groups. In conclusion, the results suggest that the addition of formoterol fumarate to the existing dose of an inhaled corticosteroid should be considered as an alternative to increasing the dose of inhaled corticosteroid in the inadequately controlled asthmatic.

    Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Adult; Aerosols; Aged; Albuterol; Asthma; Beclomethasone; Drug Therapy, Combination; Ethanolamines; Female; Formoterol Fumarate; Glucocorticoids; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Retrospective Studies; Safety; Treatment Outcome

1999
Health-related quality of life in moderate asthma: 400 microg hydrofluoroalkane beclomethasone dipropionate vs 800 microg chlorofluorocarbon beclomethasone dipropionate. The Study Group.
    Chest, 1999, Volume: 116, Issue:5

    To compare the effect of hydrofluoroalkane-134a (HFA) beclomethasone dipropionate (BDP; 400 microg/d) with that of chlorofluorocarbon (CFC) BDP (800 microg/d) on asthma health-related quality of life in a 12-week, parallel-group, multicenter study.. HFA-BDP is a new CFC-free preparation of BDP, which was developed as a result of CFCs being phased out from metered dose inhalers.. Following 7 to 12 days of prednisone, 30 mg/d, 347 adults with moderate asthma were randomized to receive either 400 microg/d HFA-BDP, 800 microg/d CFC-BDP, or HFA placebo for 12 weeks (all other oral and inhaled steroids were withdrawn). Patients completed the Asthma Quality of Life Questionnaire (AQLQ), and clinical asthma status was measured at the end of a run-in period, at randomization (after oral steroid treatment), and at the end of the study treatment.. Sixty-one patients withdrew, 43 due to worsening asthma (33 placebo; 5 HFA-BDP; 5 CFC-BDP). There was a deterioration in the AQLQ score (- 0.81) in the placebo group, and the difference between this and the stability observed in both the HFA-BDP group (+ 0.13) and the CFC-BDP group (- 0.03) was statistically significant (p

    Topics: Administration, Inhalation; Adolescent; Adult; Aerosol Propellants; Aged; Asthma; Beclomethasone; Chlorofluorocarbons; Drug Combinations; Female; Forced Expiratory Volume; Health Status; Humans; Hydrocarbons, Fluorinated; Male; Middle Aged; Patient Compliance; Peak Expiratory Flow Rate; Quality of Life; Safety; Surveys and Questionnaires; Treatment Outcome

1999
Asthma therapy modulates priming-associated blood eosinophil responsiveness in allergic asthmatics.
    The European respiratory journal, 1999, Volume: 14, Issue:4

    Eosinophils play an important role in the pathogenesis of asthma. Several pro-inflammatory responses of eosinophils are primed in vivo in this disease. The aim of the present study was to investigate whether regular antiasthma treatment could modulate priming-sensitive cytotoxic mechanisms of human eosinophils. In a randomized, two-centre, double-blind parallel group study, the effect of 8 weeks of treatment with salmeterol xinafoate 50 microg b.i.d., beclomethasone dipropionate 400 microg b.i.d. or both on pulmonary function and the activation of priming-sensitive cytotoxic mechanisms of eosinophils, i.e. degranulation of eosinophil cationic protein (ECP) in serum, and activation of isolated eosinophils in the context of induction of the respiratory burst and release of platelet-activating factor (PAF) were tested. These effects were evaluated in 40 allergic asthmatics before and 24 h after allergen inhalation challenge. Whereas baseline forced expiratory volume in one second (FEV1) improved in all treatment groups, only treatment with a combination of salmeterol and beclomethasone significantly inhibited the allergen-induced increase in serum ECP, and (primed/unprimed) PAF-release, suggesting inhibition of eosinophil priming after allergen challenge. In contrast to the combination therapy, monotherapy with beclomethasone had no influence on allergen-induced PAF-release, suggesting an additional anti-inflammatory effect of salmeterol during combination therapy. Monotherapy with beclomethasone inhibited the prechallenge serum-treated zymosan (STZ) (0.1 mg mL(-1))-induced respiratory burst and the allergen-induced increase in serum ECP levels, reflecting pre- and postchallenge anti-inflammatory effects. During monotherapy with salmeterol, an allergen-induced increase in serum ECP concentration and STZ (0.1 mg x mL(-1))-induced respiratory burst was observed, suggesting that treatment with salmeterol alone had no effect on priming-sensitive eosinophil cytotoxic mechanisms. In conclusion, this study shows that standard asthma therapy leads to inhibition of eosinophil priming of cytotoxic mechanisms in vivo.

    Topics: Adrenergic beta-Agonists; Adult; Albuterol; Allergens; Asthma; Beclomethasone; Blood Proteins; Bronchial Provocation Tests; Double-Blind Method; Drug Therapy, Combination; Eosinophil Granule Proteins; Eosinophils; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Platelet Activating Factor; Reactive Oxygen Species; Respiratory Burst; Ribonucleases; Salmeterol Xinafoate; Treatment Outcome; Zymosan

1999
Montelukast added to inhaled beclomethasone in treatment of asthma. Montelukast/Beclomethasone Additivity Group.
    American journal of respiratory and critical care medicine, 1999, Volume: 160, Issue:6

    The primary objective of this study was to determine whether montelukast, an oral leukotriene receptor antagonist, provides additional clinical benefit to the effect of inhaled corticosteroids. A total of 642 patients with chronic asthma (FEV(1) 50 to 85% of predicted value and at least a predefined level of asthma symptoms) incompletely controlled with inhaled beclomethasone, 200 microg twice daily using a spacer device, during the 4-wk run-in period were randomly allocated, in a double-blind, double-dummy manner to one of four treatment groups: (1) montelukast 10 mg plus continuing inhaled beclomethasone; (2) placebo tablet plus continuing inhaled beclomethasone; (3) montelukast 10 mg and inhaled placebo (after blind beclomethasone removal); and (4) placebo tablet and inhaled placebo (after blind beclomethasone removal). The primary endpoints were FEV(1) and daytime asthma symptoms score. Montelukast provided significant (p < 0.05) clinical benefit in addition to inhaled beclomethasone by improving FEV(1), daytime asthma symptom scores, and nocturnal awakenings. Blind removal of beclomethasone in the presence of placebo tablets caused worsening of asthma control, demonstrating that patients received clinical benefit from inhaled corticosteroids. Blind removal of beclomethasone in the presence of montelukast resulted in less asthma control but not to the level of the placebo group. All treatments were well tolerated; clinical and laboratory adverse experiences were generally similar to placebo treatment in this study. In conclusion, montelukast provided additional asthma control to patients benefitting from, but incompletely controlled on, inhaled beclomethasone.

    Topics: Acetates; Administration, Inhalation; Administration, Oral; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chronic Disease; Cyclopropanes; Double-Blind Method; Drug Therapy, Combination; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Leukotriene Antagonists; Male; Middle Aged; Quinolines; Single-Blind Method; Sulfides

1999
Allergen-induced synthesis of F(2)-isoprostanes in atopic asthmatics. Evidence for oxidant stress.
    American journal of respiratory and critical care medicine, 1999, Volume: 160, Issue:6

    It is thought that reactive oxygen species (ROS) participate in the inflammation which characterizes asthma, but the evidence supporting this contention is incomplete. F(2)-isoprostanes (F(2)-IsoPs) are arachidonate products formed on membrane phospholipids by the action of ROS and thereby represent a quantitative measure of oxidant stress in vivo. Using a mass spectrometric assay we measured urinary release of F(2)-IsoPs in 11 patients with mild atopic asthma after inhaled allergen challenge. The excretion of F(2)-IsoPs increased at 2 h after allergen (1.5 +/- 0.2 versus 2.6 +/- 0.3 ng/mg creatinine) and remained significantly elevated in all urine collections for the 8-h period of the study (analysis of variance [ANOVA]). The measured compounds were of noncyclooxygenase origin because neither aspirin nor indomethacin given before challenge suppressed them. Urinary F(2)-IsoPs remained unchanged after inhaled methacholine challenge. In nine atopic asthmatics, F(2)-IsoPs were quantified in bronchoalveolar lavage fluid (BALF) at baseline values and in a separate segment 24 h after allergen instillation. F(2)-IsoPs were elevated late in the BALF (0.9 +/- 0.2 versus 11.4 +/- 3.0 pg /ml, baseline versus allergen, respectively, p = 0.007). The increase was inhibited by pretreatment of the subjects with inhaled corticosteroids. These findings provide a new evidence for a role for ROS and lipid peroxidation in allergen-induced airway inflammation.

    Topics: Administration, Inhalation; Adult; Allergens; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchoalveolar Lavage Fluid; Cross-Over Studies; Cyclooxygenase Inhibitors; Double-Blind Method; Forced Expiratory Volume; Glucocorticoids; Humans; Hypersensitivity, Immediate; Mass Spectrometry; Methacholine Chloride; Middle Aged; Oxidative Stress; Prostaglandins F; Reactive Oxygen Species; Skin Tests

1999
Comparative effects of hydrofluoroalkane and chlorofluorocarbon beclomethasone dipropionate inhalation on small airways: assessment with functional helical thin-section computed tomography.
    The Journal of allergy and clinical immunology, 1999, Volume: 104, Issue:6

    A double-blind, randomized, parallel-group pilot study compared the relative efficacy of hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP [QVAR]; mass median aerodynamic diameter, 0. 8-1.2 m) versus cholorofluorocarbon-11/12 BDP (CFC-BDP [Beclovent]; mass median aerodynamic diameter, 3.5-4.0 m) in 31 steroid naive patients with mild to moderate asthma (PC(20,) 4 mg/mL). Functional high-resolution computed tomography was used to assess the relative efficacy of HFA-BDP and CFC-BDP on regional air trapping, as an indirect measure of small airways function and on regional hyperreactivity. Pretreatment functional computed tomography was performed at residual volume before and after methacholine challenge. After 4 weeks of treatment, functional imaging was repeated before and after the same concentration of methacholine that was administered before the treatment (n = 19 patients). Quantitative assessment of changes in distribution of lung attenuation was performed. After 4 weeks of treatment, the HFA-BDP group showed significantly more improvement in air trapping overall (a shift in the lung attenuation curve at residual volume toward more attenuation) on the posttreatment computed tomography scan (P <.05; Fisher's Exact Test). After an equal constrictor stimulus (methacholine concentration), subjects treated with HFA-BDP (n = 10 patients) showed less increase in air trapping overall than subjects treated with CFC-BDP (n = 9 patients) on the posttreatment scans compared with the pretreatment scans (P <.001; Fisher's Exact Test). No significant difference was demonstrated between the 2 treatment groups with respect to improvement in symptoms, spirometry, or methacholine responsiveness assessed by FEV(1), except for a greater reduction in breathlessness in the HFA-BDP group (P <.05). We conclude that HFA-BDP may have greater efficacy in the peripheral airways and that this effect is better assessed with functional imaging computed tomography techniques than with conventional physiologic tests.

    Topics: Administration, Inhalation; Adult; Aerosol Propellants; Asthma; Beclomethasone; Bronchial Provocation Tests; Chlorofluorocarbons; Double-Blind Method; Female; Humans; Hydrocarbons, Fluorinated; Image Processing, Computer-Assisted; Lung; Male; Middle Aged; Peak Expiratory Flow Rate; Pilot Projects; Respiratory Function Tests; Spirometry; Tomography Scanners, X-Ray Computed

1999
Montelukast, a leukotriene receptor antagonist, reduces the concentration of leukotrienes in the respiratory tract of children with persistent asthma.
    The Journal of allergy and clinical immunology, 1999, Volume: 104, Issue:6

    Leukotrienes are bronchoactive mediators secreted by inflammatory cells in the respiratory mucosa on exposure to asthma triggers.. We investigated the effect of montelukast, a leukotriene receptor antagonist, on the release of leukotrienes in the respiratory mucosa of children with persistent asthma.. Twenty-three children aged 6 to 11 years with moderately severe asthma were treated in a cross-over design starting, after a 2-week run in period, with either montelukast (n = 12) or cromolyn (n = 11) for 4 weeks with a 2-week washout period between treatments. Twelve of them were then treated with either montelukast or beclomethasone for 6 months. The use of beta(2)-agonists was recorded on a diary card. The concentration of leukotriene C(4) (LTC(4)) was measured by HPLC in nasal washes obtained before and at the end of each treatment period. Eosinophilic cationic protein (ECP) was measured in the nasal washes by RIA.. The LTC(4) concentration significantly decreased in the children treated for the first 4 weeks with montelukast, from 5.03 +/- 1.17 to 1.42 +/- 0.33 ng/mL (P <.005), and a nonsignificant increase was noted in children treated with cromolyn, from 3.37 +/- 1.11 to 5.88 +/- 2.17 ng/mL (P =.17). ECP concentration also decreased in the children receiving montelukast (P =.12). The concentration of LTC(4) remained low after 3 and 6 months of treatment with montelukast (0.8 +/- 0.7 and 1.0 +/- 0.3 microg/mL) and was lower than with beclomethasone. Children treated with montelukast required significantly fewer beta(2)-agonists (P <.04),. Montelukast reduces the concentration of leukotrienes in the respiratory tract of children with persistent asthma parallel to reduction in ECP and clinical improvement. This effect was not observed when the same children were treated with cromolyn.

    Topics: Acetates; Asthma; Beclomethasone; Blood Proteins; Child; Cromolyn Sodium; Cross-Over Studies; Cyclopropanes; Eosinophil Granule Proteins; Female; Humans; Inflammation Mediators; Leukotriene Antagonists; Leukotrienes; Male; Quinolines; Respiratory System; Ribonucleases; Sulfides

1999
Efficacy response of inhaled beclomethasone dipropionate in asthma is proportional to dose and is improved by formulation with a new propellant.
    The Journal of allergy and clinical immunology, 1999, Volume: 104, Issue:6

    This study tested the hypothesis that there would be improved asthma control with increasing doses of beclomethasone dipropionate (BDP) formulated in hydrofluoroalkane-134a (HFA-BDP) and the standard chlorofluorocarbon propellants (CFC-BDP). Because HFA-BDP has improved lung deposition compared with CFC-BDP, this study also tested the hypothesis that HFA-BDP would provide more effective control of asthma than CFC-BDP.. In this multicenter, randomized, parallel-group blinded study, asthmatic subjects who had deterioration in asthma control after discontinuation of inhaled corticosteroids were randomized to receive one of 6 possible treatments: 100 microg/d, 400 microg/d, or 800 microg/d of HFA-BDP or 100 microg/d, 400 microg/d, or 800 microg/d of CFC-BDP for 6 weeks. Changes in spirometry, daytime asthma symptom and nighttime asthma-related sleep disturbance scores, morning and evening peak expiratory flows, and daily use of inhaled beta-agonist for symptom control on diary cards were assessed over 6 weeks of treatment.. Three hundred twenty-three patients were randomized to the 6 treatment groups, which had similar demographics and baseline lung function. There were significantly larger changes from baseline at week 6 in FEV(1) percent predicted with increasing doses of both HFA-BDP and CFC-BDP. The FEV(1) percent predicted dose-response curve for HFA-BDP was shifted to the left compared with the dose-response curve for CFC-BDP. By using the Finney bioassay method, it was calculated that 2.6 times as much CFC-BDP would be required to achieve the same improvement in FEV(1) percent predicted as HFA-BDP (95% confidence interval, 1.1-11.6). All treatment groups except the 100 microg/d CFC-BDP group tolerated study drug well. Ten (17%) of 59 patients in this group reported an acute asthma episode, increased asthma symptoms (6 of the 8 reports of increased asthma symptoms were classified as severe), or both, and 8 patients withdrew from the study (3 for adverse events related to asthma).. Increasing doses of inhaled corticosteroids lead to improved lung function and asthma control. Moreover, the reformulation of BDP in HFA enables effective asthma control at much lower doses than CFC-BDP.

    Topics: Administration, Inhalation; Adult; Aerosol Propellants; Asthma; Beclomethasone; Chemistry, Pharmaceutical; Dose-Response Relationship, Drug; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Hydrocarbons, Fluorinated; Male; Safety

1999
Salmeterol added to inhaled corticosteroid therapy is superior to doubling the dose of inhaled corticosteroids: a randomized clinical trial.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1999, Volume: 36, Issue:8

    This randomized, double-blind, double-dummy, parallel group clinical trial compared the efficacy and safety of adding salmeterol xinafoate to concurrent inhaled beclomethasone dipropionate therapy with doubling the dose of beclomethasone dipropionate in patients experiencing symptoms on low-dose beclomethasone. Salmeterol added to low-dose beclomethasone was superior (p < or = 0.05) to doubling the dose of beclomethasone in improving peak expiratory flow (PEF) and forced expiratory volume in 1 sec (FEV1), and in reducing symptoms of asthma, sleep loss, nighttime awakenings, and use of albuterol. Both treatment regimens had comparable safety profiles. In asthma patients inadequately controlled despite the use of low-dose inhaled corticosteroids (i.e., less than 400 microg per day), the addition of salmeterol may be a more effective treatment option than doubling the dose of inhaled corticosteroids.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Dose-Response Relationship, Drug; Double-Blind Method; Drug Combinations; Female; Forced Expiratory Volume; Humans; Male; Medical Records; Middle Aged; Peak Expiratory Flow Rate; Salmeterol Xinafoate

1999
Pharmacokinetic differences between chlorofluorocarbon and chlorofluorocarbon-free metered dose inhalers of beclomethasone dipropionate in adult asthmatics.
    The Journal of pharmacy and pharmacology, 1999, Volume: 51, Issue:11

    We have compared the serum pharmacokinetics of the metabolites of beclomethasone dipropionate after inhalation from chlorofluorocarbon (CFC) and hydrofluoroalkane HFA-134a (HFA) formulations in asthmatic patients. Twenty-three patients completed this open-label, randomized, single-dose, three-period crossover study. Each patient received in separate periods 200 microg or 400 microg HFA-beclomethasone dipropionate, or 400 microg CFC-beclomethasone dipropionate. Venous blood samples were collected over 24 h for the determination of beclomethasone esters and beclomethasone in the serum. Significant differences in pharmacokinetics following HFA- and CFC-beclomethasone dipropionate were observed. Following a 400 microg beclomethasone dipropionate dose, the HFA formulation gave mean maximum concentrations (Cmax) and area under the curve (AUC) values of beclomethasone esters of 1153 pg mL(-1) and 4328 pg h mL(-1), respectively, and beclomethasone Cmax and AUC values of 69 pg mL(-1) and 682 pg h mL(-1), respectively. These values were approximately 2-3-fold those seen with the CFC formulation (beclomethasone esters Cmax and AUC of 380 pg mL(-1) and 1764 pg h mL(-1), respectively; beclomethasone Cmax and AUC of 41 pg ml(-1) and 366 pg h mL(-1), respectively). Beclomethasone esters, the major component of beclomethasone dipropionate in the serum, peaked significantly earlier for the HFA formulation (0.8 h) than for the CFC formulation (2 h). Tests for dose proportionality of beclomethasone esters pharmacokinetics following HFA-beclomethasone dipropionate showed that the two hydrofluoroalkane strengths were proportional. The more rapid and greater efficiency of systemic drug delivery of the HFA formulation compared with the CFC formulation can be explained if most of each inhalation from CFC-beclomethasone dipropionate is swallowed and absorbed orally, whereas most of each inhalation from HFA-beclomethasone dipropionate is absorbed through the lungs. There is a need for comprehensive dose-response efficacy trials, with the use of the steep portion of the dose-response relationship, to evaluate the significance of these pharmacokinetic differences.

    Topics: Adult; Anti-Asthmatic Agents; Area Under Curve; Asthma; Beclomethasone; Chlorofluorocarbons; Female; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Single-Blind Method

1999
Salmeterol reduces the need for inhaled corticosteroid in steroid-dependent asthmatics.
    Respiratory medicine, 1999, Volume: 93, Issue:12

    Previous results have demonstrated addition of long-acting beta2-adrenergic agonists to be beneficial in asthma patients already receiving inhaled corticosteroid. The purpose of this study was to determine, qualitatively as well as quantitatively, the steroid-sparing properties of salmeterol in stable asthma patients receiving maintenance inhaled corticosteroids (800-1600 microg day(-1)). In these patients, the daily dose of beclomethasone dipropionate was reduced by 200 microg each week until asthma deteriorated, with the minimal acceptable dose (MAD) being defined as the dose one step above deterioration (sensitivity period). Following this, patients received three times the MAD for 2 weeks. Patients were randomized to receive either salmeterol 50 microg twice daily or placebo and the MAD was again determined (treatment period). Forced expiratory volume in 1 sec (FEV1) was measured each week. Morning and evening peak expiratory flow (PEF), symptom score and use of bronchodilator were recorded each day. Fifteen patients received salmeterol and 19 placebo. The MAD was significantly lower in the salmeterol group compared with placebo during the treatment period (P<0.01). A 50% reduction of the MAD was achieved by more patients treated with salmeterol than placebo (P = 0.001). Salmeterol caused a significantly greater reduction in daytime symptom score and use of as-needed beta2-agoinist therapy between sensitivity and treatment periods compared with placebo (P<0.05 for both). The results demonstrate, that the addition of salmeterol to corticosteroid treatment offers a clinically relevant potential for reduction of inhaled corticosteroid dose in steroid sensitive asthmatics.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Salmeterol Xinafoate

1999
Comparison of different long-term asthma treatments in subjects with mild-to-moderate asthma.
    Monaldi archives for chest disease = Archivio Monaldi per le malattie del torace, 1999, Volume: 54, Issue:5

    In order to compare the efficacy of different asthma treatment in subjects with mild-to-moderate asthma, three groups of 11 patients were treated with nedocromil sodium (NS), beclomethasone dipropionate (BDP) and beclomethasone dipropionate plus salmeterol (BDP + S) in an open, randomized study. Symptom score, peak expiratory flow (PEF) maximal amplitude, forced expiratory volume in one second (FEV1), and methacholine reactivity were measured at the baseline and at intervals of 3 months up to 12 months. After 3 months, symptoms reduced significantly in all treatment groups, while PEF variability improved in BDP and BDP + S groups; FEV1 and bronchial responsiveness to methacholine were significantly improved in comparison with baseline value in the BDP + S group only. No significant difference was observed after 6 and 12 months of treatment in PEF variability, FEV1 or bronchial hyperreactivity in the NS group compared with baseline values, while a significant difference was observed in symptom score. BDP group showed a significant improvement in FEV1 and bronchial reactivity to methacholine after 6 and 12 months of treatment. In the BDP + S group, the improvement in symptoms and pulmonary function persisted until the end of the study. In conclusion, the combination of beclomethasone dipropionate and salmeterol improved pulmonary function and bronchial reactivity earlier than beclomethasone dipropionate alone, while nedocromil sodium improved symptoms but not pulmonary function. Assuming that bronchial reactivity could be an indirect measurement of airway inflammation, overtreatment of asthma in relationship with the classification of asthma severity of the International Guidelines could improve both airway inflammation and the prognosis of airway obstruction.

    Topics: Adolescent; Adult; Aged; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchodilator Agents; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Nedocromil; Peak Expiratory Flow Rate; Salmeterol Xinafoate; Time Factors

1999
Systemic effects of inhaled corticosteroids on growth and bone turnover in childhood asthma: a comparison of fluticasone with beclomethasone.
    The European respiratory journal, 1999, Volume: 13, Issue:1

    Inhaled steroids are frequently used in childhood asthma, but concerns based on limited objective evidence remain, regarding long-term side-effects. In this study the systemic effects of standard doses of inhaled steroids in childhood asthma were assessed, comparing beclomethasone dipropionate (BDP) with fluticasone propionate (FP). The study was prospective, randomized and double-blind. Twenty-three steroid-naive children with moderately severe asthma, aged 5-10 yrs, were allocated either BDP (400 microg x day(-1) or FP (200 microg x day(-1)) using a metered-dose inhaler with a spacer. Asthma control was assessed at regular intervals over 20 months. Fasting morning blood and overnight urine samples were collected for estimation of serum cortisol, serum 1-carboxyterminal telopeptide (ICTP), serum osteocalcin and urine deoxypyridinoline (DPD). Bone mineral density (BMD) was measured at each visit. None of the markers of bone turnover showed any change during the study period. BMD increased at normal rates with age. Serum cortisol significantly decreased on BDP, but not on FP. A significant difference in growth rates was found between the groups, with a slower rate of growth towards the end of the observation period in the BDP group. In conclusion when taken in a relatively modest dose over a period of time, beclomethasone dipropionate had significant effects on the hypothalamic-pituitary-adrenal axis and statural growth in childhood asthma. These systemic effects were not seen with an equipotent dose of fluticasone propionate.

    Topics: Administration, Inhalation; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bone Remodeling; Child; Double-Blind Method; Female; Fluticasone; Glucocorticoids; Growth; Humans; Male; Prospective Studies

1999
Aerosol beclomethasone dipropionate spray compared with theophylline as primary treatment for chronic mild-to-moderate asthma. The American Academy of Allergy, Asthma and Immunology Beclomethasone Dipropionate-Theophylline Study Group.
    The Journal of allergy and clinical immunology, 1998, Volume: 101, Issue:1 Pt 1

    Inhaled corticosteroids and oral theophylline are effective treatments for moderate asthma.. We sought to compare the benefits and adverse reactions of theophylline and aerosol beclomethasone spray.. A multicenter, double-blind, double-placebo, randomized, controlled trial of 1-year duration was performed. Seven hundred forty-seven patients with asthma received either beclomethasone dipropionate aerosol spray (84 microg four times per day) or sustained-release theophylline twice per day in doses adjusted for optimum control of the disease. The main outcome measures were daily diary of symptoms and peak flow rates (recorded on a mark-sense computer-readable form); supplemental bronchodilator use; doctor's office or hospital visits and absence from work or school; spirometry; methacholine testing; adverse experiences; and cortisol blood measurements.. Both treatment strategies reduced symptoms promptly and achieved low absenteeism from work or school and low rates of emergency treatment for asthma. Both maintained nearly normal pulmonary function. Beclomethasone was statistically significantly more effective in reducing symptoms, supplemental bronchodilator and systemic glucocorticoid doses, bronchial hyperresponsiveness, and eosinophilia. However, the magnitude of these differences was small. Theophylline caused more headache, nervousness, insomnia, and gastrointestinal distress, and more patients discontinued treatment because of side effects. Beclomethasone caused more oropharyngeal candidiases and hoarseness and reduced morning plasma cortisol levels before and after cosyntropin. It reduced the rate of growth in children. No new cataracts or glaucoma developed.. Theophylline effectively controlled symptoms at lower than the customarily recommended blood level. The risk/ benefit profiles of these agents suggest that inhaled corticosteroids may be the preferred agent for most adult patients and for some children.

    Topics: Adolescent; Adult; Aerosols; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child; Delayed-Action Preparations; Double-Blind Method; Female; Humans; Hydrocortisone; Male; Middle Aged; Spirometry; Theophylline

1998
A systemic bioactivity comparison of double-strength and regular-strength beclomethasone dipropionate MDI formulations.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 1998, Volume: 80, Issue:1

    The efficacy and safety of regular-strength beclomethasone dipropionate MDI prescribed within its recommended dosing range of 2 to 5 puffs three to four times daily has been well established in more than 25 years of worldwide use. A more concentrated formulation delivering 84 microg per puff was developed to provide for a more convenient twice-daily dosing regimen.. This randomized, single-blinded, positive and placebo-controlled, parallel-group, multiple-dose bioactivity study was conducted to assess the potential of a new beclomethasone dipropionate 84 microg double-strength metered-dose inhaler (Vanceril 84 microg Double Strength Inhalation Aerosol/Key) to cause hypothalamic-pituitary-adrenocortical axis suppression.. Beclomethasone dipropionate double-strength 84 microg was compared with beclomethasone dipropionate regular-strength 42 microg, orally administered prednisone, and placebo inhaler after 36 consecutive days of administration in adults with moderate asthma. Beclomethasone dipropionate double-strength was administered as 5 puffs BID and beclomethasone dipropionate regular-strength was administered as 10 puffs BID for the same total daily dose of 840 microg of beclomethasone dipropionate. Oral prednisone was administered by mouth at 10 mg once a day. The potential for hypothalamic-pituitary-adrenocortical axis suppression was evaluated by an adrenocorticotropic hormone (ACTH) stimulation test using cosyntropin 250 microg in 500 mL normal saline infused over six hours on the 36th day of treatment. Sixty-four patients completed this study.. No clinically significant post-study findings were observed from physical examination, electrocardiogram, or clinical laboratory evaluation for any treatment group. No serious or unexpected adverse events were reported. On the 36th day of treatment, there was a significant (P < .01) difference in the plasma cortisol concentration response to cosyntropin stimulation between the prednisone and placebo treatment groups at the sixth hour of infusion. There was no significant difference in the plasma cortisol concentration response to cosyntropin stimulation between the beclomethasone dipropionate double-strength and beclomethasone dipropionate regular-strength treatment groups and the placebo group. In addition, comparison of the response between the beclomethasone dipropionate double-strength and beclomethasone dipropionate regular-strength groups showed no significant difference.. Beclomethasone dipropionate, administered either via a double-strength (84 microg/puff) or regular-strength (42 microg/puff) inhaler dosed at 840 microg/day showed no evidence of hypothalamic-pituitary-adrenocortical axis suppression in adults with moderate asthma.

    Topics: Administration, Inhalation; Adolescent; Adrenocorticotropic Hormone; Adult; Asthma; Beclomethasone; Cosyntropin; Drug Evaluation; Female; Glucocorticoids; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Nebulizers and Vaporizers; Pituitary-Adrenal System; Prednisone; Safety; Single-Blind Method

1998
Neuropsychological and behavioral changes in asthmatic children treated with beclomethasone dipropionate versus theophylline.
    Pediatrics, 1998, Volume: 101, Issue:3 Pt 1

    Results from previous investigations that examined the psychological side effects of theophylline have been inconsistent, and none have reported about inhaled corticosteroids. The objective of this study was to assess the relative psychological side effects of theophylline and beclomethasone in asthmatic children.. This was a multicenter, randomized, double-blind, parallel-groups study in which 102 asthmatic patients were assigned to one of two treatments: beclomethasone three times daily or theophylline twice daily. At baseline, 1 month, and 1 year, parents completed standardized behavioral questionnaires while the children received psychometric testing of attention and concentration, memory and learning, and problem-solving.. Although power was sufficient to detect meaningful mean score changes, no consistent differential treatment effects were observed. Two significant treatment-by-period interactions were discordant, with one suggesting slightly better attention in the theophylline group, whereas the other indicated a small advantage in attention scores in the beclomethasone group. Numerous significant period effects revealed that behavior and cognitive test performance improved over the 1-year period, regardless of treatment, and confirmed a well established practice effect resulting from repeated administrations of such tests.. Neither theophylline nor beclomethasone should be avoided out of concern for significant psychological side effects. The possibility remains that a subset of asthmatic children may be susceptible to such medication-induced changes; investigators have suggested that preschool children may be at particular risk, although no controlled studies with this age group have been conducted. Parental perceptions of medication side effects can be influenced by temporary effects present at initiation of treatment or by erroneous attribution of the psychological effects of the chronic illness. Reports of psychological changes in response to asthma medications must be addressed respectfully but objectively, with due consideration of available evidence and an awareness of other potential explanations.

    Topics: Administration, Inhalation; Adolescent; Adolescent Behavior; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child Behavior Disorders; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Psychology, Adolescent; Psychology, Child; Psychometrics; Theophylline

1998
Effect of pranlukast, a leukotriene receptor antagonist, in patients with severe asthma refractory to corticosteroids.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1998, Volume: 35, Issue:1

    We investigated the effect of pranlukast (ONO-1078), a cysteinyl leukotriene receptor antagonist, in 11 patients with severe bronchial asthma. The patients had been treated with 1600 micrograms/day of beclomethasone or 800-1600 micrograms/day of beclomethasone plus 2.5-20 mg/day of prednisolone, but remained symptomatic. After a 2-week baseline period, the patients received 225 mg of pranlukast twice daily for 8 weeks. Morning and evening peak expiratory flow rate (PEF) and symptom scores (cough, dyspnea, sleep) were recorded in an asthma diary. Ten patients completed the study. Symptom scores, especially dyspnea and sleep scores, and the number of rescue beta 2-agonist inhalations were significantly decreased. The morning PEF significantly improved from a mean baseline value of 311 to 341 L/min by the end of the study period. The evening PEF also improved, from 328 to 348 L/min, although the difference was not significant. These results suggest that pranlukast may be effective in treating patients with severe asthma who are refractory to corticosteroid therapy.

    Topics: Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chromones; Female; Glucocorticoids; Humans; Leukotriene Antagonists; Male; Middle Aged; Prednisolone

1998
Safety and efficacy of fluticasone and beclomethasone in moderate to severe asthma. Belgian Multicenter Study Group.
    American journal of respiratory and critical care medicine, 1998, Volume: 157, Issue:3 Pt 1

    There are still some concerns about the safety of high doses of inhaled glucocorticosteroids (ICS). We compared the safety and efficacy of fluticasone propionate (FP) and beclomethasone dipropionate (BDP) in 306 patients with moderate to severe asthma in a double-blind, multicenter, cross-over study of 12 mo duration. During the 1-mo run-in period, bronchodilators were replaced by salmeterol 50 microg twice daily, increasing morning peak expiratory flow rate (PEFR) by 28 L/min (p < 0.001) and FEV1 by 6.2% predicted (p < 0.001). At randomization the current ICS was replaced by 500 microg BDP or 250 microg FP in accordance with previously taken 500 microg BDP or 400 microg budesonide (BUD). No significant differences between the two treatments regarding morning plasma cortisol, urinary excretion of calcium and hydroxyproline, FEV1, and PEFR were observed at any time point during the study. Osteocalcin and bone mineral density (BMD) were improved over baseline in the FP group, resulting in higher serum osteocalcin levels (mean difference 0.28 ng/ml; p < 0.001) and higher BMD in the spine (1.0%; p = 0.05), femoral neck (1.6; p < 0.01), and Ward's triangle (3.6%; p = 0.01) as compared with BDP. We conclude that chronic treatment with FP, at half the dose of BDP, results in a similar antiasthma effect but a more favorable safety profile with respect to bone metabolism and mineral density.

    Topics: Administration, Topical; Adolescent; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Belgium; Bone Density; Bronchodilator Agents; Budesonide; Calcium; Cross-Over Studies; Double-Blind Method; Female; Femur Neck; Fluticasone; Forced Expiratory Volume; Humans; Hydrocortisone; Hydroxyproline; Male; Middle Aged; Osteocalcin; Peak Expiratory Flow Rate; Safety; Salmeterol Xinafoate; Spine

1998
Collagen metabolism and growth in prepubertal children with asthma treated with inhaled steroids.
    The Journal of pediatrics, 1998, Volume: 132, Issue:3 Pt 1

    To investigate growth and markers of collagen and bone metabolism in prepubertal children with asthma.. We measured growth velocity over 12 months and markers of collagen types I and III synthesis (PINP, PICP, PIIINP), collagen type I degradation (ICTP), and bone metabolism (bone-specific alkaline phosphatase and osteocalcin) on one occasion in 56 prepubertal children with stable asthma, 39 of whom were treated with inhaled budesonide or beclomethasone. Collagen data were compared with normal control values.. Children treated with inhaled steroids had reduced collagen synthesis (PINP, PIIINP) compared with control subjects (p = 0.038, p = 0.045), although PICP was increased (p = 0.05). Carboxyterminal telopeptide of type I collagen was reduced in patients treated with inhaled steroids (p < 0.0005) compared with nonsteroid-treated patients. Serum osteocalcin but not bone-specific alkaline phosphatase was significantly reduced in children treated with inhaled steroids (p < 0.02). Significant correlation was observed between PIIINP and ICTP and growth velocity.. Collagen turnover is reduced in children with asthma receiving long-term inhaled steroid treatment. Markers of collagen synthesis provide a more accurate reflection of growth disturbance than osteocalcin and bone-specific alkaline phosphatase.

    Topics: Administration, Inhalation; Alkaline Phosphatase; Asthma; Beclomethasone; Bone and Bones; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Collagen; Female; Glucocorticoids; Growth; Humans; Male; Osteocalcin

1998
Comparative clinical study of inhaled beclomethasone dipropionate and triamcinolone acetonide in persistent asthma.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 1998, Volume: 80, Issue:4

    At this time, no placebo-controlled studies in the clinical literature compare the efficacy and safety of the most widely prescribed oral inhaled corticosteroids when dosed at their recommended daily doses. This study compared the efficacy and safety of beclomethasone dipropionate (BDP) 336 microg/day administered by metered dose inhaler (MDI) alone, and triamcinolone acetonide (TA) 800 microg/day by MDI with a built-in tube extender in adults with persistent asthma.. This 56-day, randomized, double-blind, double-dummy, placebo-controlled, multicenter trial was conducted in 328 adults with mild to moderately severe asthma (FEV1 50% to 90% of predicted while maintained on inhaled corticosteroids). Patients were seen at a baseline visit and on study days 28 and 56. Efficacy variables included pulmonary function tests, physician and patient assessments of asthma condition, and use of rescue medication.. Statistically significant improvements from baseline in most efficacy measures were demonstrated for both active treatments versus placebo, and with the following exception were the same between active treatments: mean increase in FEV1 in the beclomethasone dipropionate group was statistically significantly greater than in the triamcinolone acetonide group on day 28. Throughout the study, BDP was statistically superior to TA with respect to mean change from baseline in total asthma symptom scores and for 3 of 8 weeks in reducing the mean average weekly use of rescue albuterol (the two active treatments were comparable for this variable at all other time points). Beclomethasone dipropionate and TA were comparable in safety.. In adult patients with mild to moderately severe persistent asthma, treatment with BDP consistently conferred greater improvement from baseline in mean FEV1 than TA. This difference achieved statistical significance after 28 days of therapy but was not maintained to endpoint. Decreases in overall asthma symptom scores and in the use of rescue albuterol were statistically significantly greater for the BDP group compared with the TA group. Based on these findings, we conclude that BDP is at least as effective as TA in the treatment of persistent asthma in adults, and judged by some measures, may be superior.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Triamcinolone Acetonide

1998
Effects of inhaled corticosteroids on bone.
    The Netherlands journal of medicine, 1998, Volume: 52, Issue:1

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Bone Density; Budesonide; Female; Glucocorticoids; Humans; Lung Diseases, Obstructive; Male; Pilot Projects

1998
Duration of growth suppressive effects of regular inhaled corticosteroids.
    Archives of disease in childhood, 1998, Volume: 78, Issue:2

    The growth of 50 children receiving regular inhaled corticosteroids was segregated into divisions of six weeks from the start of treatment and compared with their growth when not receiving regular corticosteroids using a random effects regression model. Growth suppression was most marked during the initial six weeks after starting treatment, with most suppression occurring during the initial 18 weeks. Thereafter the children's growth was similar to their growth when not receiving treatment. These findings have important consequences for patterns of treatment of asthma in children.

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Double-Blind Method; Drug Administration Schedule; Growth; Humans; Longitudinal Studies; Regression Analysis; Time Factors

1998
Oral glucocorticosteroid-sparing effect of budesonide administered by Turbuhaler: a double-blind, placebo-controlled study in adults with moderate-to-severe chronic asthma. Pulmicort Turbuhaler Study Group.
    Chest, 1998, Volume: 113, Issue:5

    To determine the ability of budesonide via an inhaler (Pulmicort Turbuhaler; Astra Draco AB) to replace oral glucocorticosteroids (GCSs) in adult subjects with moderate-to-severe asthma.. Double-blind, randomized, and placebo-controlled study, with parallel groups.. Multicenter study in outpatient setting.. Eighty men and 79 women, aged 20 to 69 years, with moderate-to-severe asthma and a mean FEV1 of 58.3% predicted normal. All subjects were receiving oral GCS treatment and 79% of subjects were also receiving inhaled beclomethasone dipropionate (BDP). The mean daily doses of prednisone at baseline, including converted dose of BDP, for the placebo, budesonide 400 microg, and budesonide 800 microg, respectively, were 19.7 mg, 19.5 mg, and 18.7 mg.. After a 2-week baseline period, subjects entered a 20-week treatment period, during which the oral dose of prednisone was reduced by forced down-titration at 2-weekly intervals.. Subjects receiving 400 microg or 800 microg bid of budesonide achieved a significantly greater reduction (82.9% and 79.0% respectively) in oral GCS dose compared with placebo-treated subjects (27%; p<0.001). Two thirds of the subjects receiving budesonide were able to achieve sustained oral corticosteroid cessation, compared with 8% in the placebo group. Additionally, both doses of budesonide resulted in significant improvement in results of pulmonary function tests and asthma symptoms scores, and a significant decrease in the use of bronchodilator therapy. The mean plasma cortisol levels before and after adrenocorticotropic hormone stimulation increased most toward the normal range in the budesonide-treated groups compared with placebo-treated subjects.. Budesonide administered via Turbuhaler has a significant oral GCS-sparing capacity with maintained or improved asthma control in adult subjects with moderate-to-severe asthma.

    Topics: Administration, Inhalation; Administration, Oral; Administration, Topical; Adult; Aged; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Glucocorticoids; Humans; Hydrocortisone; Male; Middle Aged; Nebulizers and Vaporizers; Prednisone; Respiratory Function Tests

1998
Clodronate is effective in preventing corticosteroid-induced bone loss among asthmatic patients.
    Bone, 1998, Volume: 22, Issue:5

    Clodronate is a novel drug used for inhibiting osteoclastic activity. The aim of the present double-blind study was to evaluate the efficacy and tolerability of clodronate (Leiras, Finland) in corticosteroid-induced bone loss among asthmatic patients. Seventy-four adult patients (41 women and 33 men, mean age 57.3 years) having a long history (mean 8.1 years) of oral and inhaled corticosteroid therapy were randomized to four parallel treatment groups: clodronate 800, 1600, or 2400 mg/day, or an identical placebo. The bone mineral density (BMD) of the lumbar spine (L2-4), femoral neck, and trochanter were assessed using dual-energy X-ray absortiometry at entry, 6 months, and 12 months. The baseline BMDs did not differ significantly between the study groups. In the lumbar spine, the mean BMD increased significantly between the baseline and 12-month visit in the clodronate groups of 1600 and 2400 mg/day, 2.6% (0.02 g/cm2, p < 0.02) and 3.0% (0.03 g/cm2, p < 0.01), respectively, but not in the placebo and clodronate 800 mg/day groups. The test for a linear trend (BMD percent change for L2-4) at 12 months was significant (p < 0.02), indicating a dose response to clodronate. The mean BMD values of the femoral neck increased significantly in the 2400 mg/day group, 4.3% (0.03 g/cm2, p < 0.0001), as well as in the trochanter region 2.8% (0.02 g/cm2, p < 0.02). Gastric irritation was the most common adverse effect noted on a clodronate dose of 2400 mg/day. We conclude that oral clodronate is effective in preventing bone loss or increasing bone mass in asthmatic patients having a long history of continuous peroral and inhaled corticosteroid administration.

    Topics: Absorptiometry, Photon; Administration, Inhalation; Administration, Oral; Analgesics, Non-Narcotic; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bone Density; Clodronic Acid; Dose-Response Relationship, Drug; Double-Blind Method; Female; Femur; Femur Neck; Glucocorticoids; Humans; Lumbar Vertebrae; Male; Osteoporosis; Prednisolone

1998
Inhaled corticosteroid reduced lamina reticularis of the basement membrane by modulation of insulin-like growth factor (IGF)-I expression in bronchial asthma.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 1998, Volume: 28, Issue:5

    Pathological studies of bronchial biopsy specimens have confirmed the apparent thickening of lamina reticularis of the epithelial basement membrane. Corticosteroids have proven to be most effective in modifying airway inflammation. However, there is not much data on the effects of corticosteroid-treatment on the basement membrane.. To investigate the effects of inhaled beclomethasone dipropionate (BDP) on the thickness of basement membrane and cellular infiltration into the bronchial mucosa, and the expression of growth factors in patients with asthma.. We studied bronchial biopsies from 24 asthmatic patients before and after treatment with inhaled BDP, 400 microg twice a day or placebo, for 6 months in a double-blind manner. Each subject recorded daily asthma symptoms and peak expiratory flow (PEF). Lung function and bronchial responsiveness to methacholine were measured before and after treatment. The thickness of the basement membrane was determined by electron microscopy. Inflammatory cells and the expression of growth factors were examined by immunohistochemistry in endobronchial biopsy specimens.. After 6 months of treatment, we observed a significant improvement of asthma symptoms (P<0.01), PEF (P<0.01), diurnal variation of PEF (P<0.05), and airway responsiveness (P< 0.05) in the BDP group compared with the placebo group. This was accompanied by a significant decrease in the thickness of the lamina reticularis (P < 0.001), and in the number of activated eosinophils (P<0.01), T-lymphocytes (P<0.01), and fibroblasts (P < 0.05) in BDP-treated patients. There was also a reduction in the expression of insulin-like growth factor (IGF)-I (P < 0.01). Significant correlation was found between the IGF-I expression and collagen thickening (rs = 0.34, P<0.01), and the number of fibroblasts (rs = 0.45, P < 0.01).. These results suggest that corticosteroid treatment in asthma can reduce the lamina reticular thickness by modulation of IGF-I expression with consequent inhibition of the airway infiltration by inflammatory cells, and therefore may help to prevent remodelling of the airways.

    Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Basement Membrane; Beclomethasone; Bronchi; Bronchoscopy; Double-Blind Method; Forced Expiratory Volume; Humans; Inflammation; Insulin-Like Growth Factor I; Microscopy, Electron; Middle Aged; Mucous Membrane; Peak Expiratory Flow Rate

1998
Aerosol beclomethasone dipropionate compared with theophylline as primary treatment of chronic, mild to moderately severe asthma in children, by David G. Tinkelman, MD, et al, Pediatrics, 1993;92:64-77.
    Pediatrics, 1998, Volume: 102, Issue:1 Pt 2

    Topics: Aerosols; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child; History, 20th Century; Humans; Theophylline

1998
Addition of salmeterol versus doubling the dose of beclomethasone in children with asthma. The Dutch Asthma Study Group.
    American journal of respiratory and critical care medicine, 1998, Volume: 158, Issue:1

    Studies in adults revealed that addition of salmeterol to a moderate dose of inhaled corticosteroid resulted in better symptom control and higher PEF compared with doubling the dose of inhaled corticosteroid. The aim of this three group study was to compare the effects of a moderate dose of beclomethasone, the same dose of beclomethasone with salmeterol, and a doubling dose of beclomethasone on lung function and symptoms in children with moderate asthma. A total of 177 children already treated with inhaled corticosteroids, were randomized in a double-blind parallel study either to salmeterol 50 microg twice daily (BDP400+salm), beclomethasone 200 microg twice daily (BDP800), or placebo (BDP400) in addition to beclomethasone 200 microg twice daily. No significant differences between groups were found in FEV1, PD20 methacholine, symptom scores, and exacerbation rates after 1 yr. Salmeterol resulted in slightly better PEF in the first months of treatment. FEV1, and PD20 methacholine significantly improved in all groups. After 1 yr mean changes in FEV1, percent predicted were 4.3% (95% CI 1.3; 7.2), 5.8% (95% CI 2.9; 8.7), and 4.3% (95% CI 2.1; 6.5) for BDP400+salm, BDP800, and BDP400, respectively. Changes in airway responsiveness were 0.60 (95% CI 0.05; 1.14), 1.30 (95% CI 0.73; 1. 87), and 0.80 (95% CI 0.33; 1.27) doubling doses. Growth was significantly slower in the BDP800 group. We conclude that no additional benefit was found of adding either salmeterol or more beclomethasone to a daily dose of 400 microg beclomethasone in this group of children with excellent compliance of medication.

    Topics: Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child; Double-Blind Method; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Respiratory Function Tests; Salmeterol Xinafoate; Statistics, Nonparametric; Treatment Outcome

1998
Effect of low-dose beclomethasone dipropionate on asthma control and airway inflammation.
    The European respiratory journal, 1998, Volume: 11, Issue:6

    The effects of usual or low doses of inhaled corticosteroids on airway mucosal inflammation have not yet been examined. We therefore, compared the effects of inhaled beclomethasone dipropionate (BDP) 336 microg x day(-1) on asthma control outcomes and markers of airway inflammation. Twenty-four adult subjects with mild and moderate asthma were randomized to receive either BDP or placebo for four weeks; then subjects entered a single blind four week placebo run-in period. We found that the BDP group had significantly greater improvements in forced expiratory volume in one second (FEV1), morning peak flow, and rescue salbutamol use than the placebo-treated group. The improvement in FEV1 largely reversed one week after treatment was stopped. The decrease in the median percentage of eosinophils in induced sputum in the BDP group from 3.8% to 3.4% was not significant, but because eosinophils increased from 8.4% to 12.7% in the placebo group, there was a significant difference between treatment groups (p=0.03). There was no significant difference between groups during treatment in the levels of eosinophil cationic protein (ECP), tryptase mucin-like glycoprotein, or fibrinogen in induced sputum. The change in FEV1 in the BDP group did not correlate significantly with the change in eosinophil percentage or ECP levels. We concluded that four weeks of treatment with inhaled beclomethasone dipropionate 336 microg x day(-1) was associated with significant improvements in peak flow, forced expiratory volume in one second, and rescue salbutamol use in asthmatic subjects but was not associated with large reductions in markers of eosinophilic inflammation, bronchovascular permeability, or mucus hypersecretion.

    Topics: Administration, Inhalation; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Blood Proteins; Bronchial Provocation Tests; Bronchodilator Agents; Cell Count; Chymases; Double-Blind Method; Eosinophil Granule Proteins; Female; Fibrinogen; Forced Expiratory Volume; Glucocorticoids; Humans; Inflammation Mediators; Male; Maximal Midexpiratory Flow Rate; Mucins; Ribonucleases; Serine Endopeptidases; Single-Blind Method; Spirometry; Sputum; Tryptases

1998
Effects of fluticasone propionate and beclomethasone dipropionate on parameters of inflammation in peripheral blood of patients with asthma.
    Allergy, 1998, Volume: 53, Issue:7

    Bronchial inflammation plays a central role in asthma. We investigated whether parameters of inflammation were increased in peripheral blood. Furthermore, we tested whether fluticasone propionate (FP), a new inhaled corticosteroid (ICS), and beclomethasone dipropionate (BDP) affected these parameters. FP 750 microg/day and BDP 1500 microg/day were compared in a randomized, crossover study consisting of two 6-week treatment periods, each preceded by a 3-week placebo period. Twenty-one patients with symptomatic asthma completed the study. The results were compared with those of six normal subjects (controls). Immunophenotyping of inflammatory cells was performed in whole blood, and serum eosinophil cationic protein (ECP) was measured. With regard to clinical efficacy, ICS increased PC20 histamine by more than 1.9 doubling doses and FEV1 by more than 0.34 l. The number of CD3/HLA-DR+ lymphocytes was significantly increased in asthmatics compared to the normal subjects, both after placebo (P<0.01) and after therapy (P<0.05). The CD3/HLA-DR+ lymphocytes decreased significantly after treatment with FP (P<0.05). Serum ECP was elevated in patients without ICS and decreased after treatment with BDP (P<0.001). In conclusion, the number of CD3/HLA-DR+ lymphocytes and serum ECP levels were raised in the peripheral blood of symptomatic asthmatics, and decreased by clinically effective doses of ICS. In this respect, FP 750 microg/day was at least as effective as BDP 1500 microg/day.

    Topics: Administration, Inhalation; Adolescent; Adult; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; CD3 Complex; Cross-Over Studies; Double-Blind Method; Eosinophils; Female; Flow Cytometry; Fluticasone; HLA-DR Antigens; Humans; Leukocyte Common Antigens; Male; Middle Aged; Phenotype; Receptors, Interleukin-2; T-Lymphocytes

1998
Bone mineral density and bone turnover in asthmatics treated with long-term inhaled or oral glucocorticoids.
    Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 1998, Volume: 13, Issue:8

    Inhaled glucocorticoids are pivotal in maintenance therapy of chronic bronchial asthma; however, conflict exists over their effects on bone and mineral metabolism. We measured bone mineral density (BMD), bone turnover markers, and adrenal steroid hormones in 53 patients (34 female, 19 male) with chronic bronchial asthma who had taken either inhaled beclomethasone or budesonide in doses of > or = 1500 microg/day for at least 12 months to determine pathogenetic mechanisms of bone loss. To account for the effect of prior oral glucocorticoid exposure we divided patients into two groups: one with (OG) and the other without (IG) a past history of maintenance (> 1 month) oral glucocorticoid therapy. Lumbar spine (LS) and proximal femur BMDs were approximately 1 SD lower in men and women taking OG or high-dose IG for chronic bronchial asthma, potentially equivalent to a doubling of the risk of fracture at these sites. Prior exposure to OG in women was also associated with lower LS and proximal femur BMDs, while men were more sensitive to the adverse effects of IG on LS and Ward's triangle BMDs. Bone formation markers were decreased; however, bone resorption marker concentrations were normal. All patients had evidence of suppression of both endogenous glucocorticoid and adrenal androgen production. Both total duration of OG and biochemical bone turnover marker concentrations were negatively related to proximal femur and rib BMDs and total body bone mineral content, but not to LS BMD. These were stronger for bone resorption markers. Uncoupling of ongoing normal bone resorption from suppressed bone formation may therefore contribute to glucocorticoid-associated bone loss in asthma. Adrenal androgen suppression may also increase the susceptibility of postmenopausal women in particular to bone loss with OG. Although the effects of high-dose IG on BMD are associated with lower LS BMD in men, this observation should now be investigated further in prospective studies.

    Topics: Absorptiometry, Photon; Administration, Inhalation; Adolescent; Adult; Aged; Asthma; Beclomethasone; Biomarkers; Bone Density; Budesonide; Dehydroepiandrosterone Sulfate; Female; Femur; Glucocorticoids; Humans; Hydrocortisone; Lumbar Vertebrae; Male; Middle Aged; Osteoporosis; Ribs

1998
Influence of beclomethasone and salmeterol on the perception of methacholine-induced bronchoconstriction.
    Chest, 1998, Volume: 114, Issue:2

    Patient evaluation of asthma severity and medication needs is mostly based on respiratory symptoms and may be influenced by changes in perception of bronchoconstriction-induced sensations. However, the influence of asthma medication on the ability to perceive symptoms is still to be documented. This study evaluated the effects of short-term and regular use of salmeterol on the perception of methacholine-induced bronchoconstriction (MIB) in subjects with mild asthma, using inhaled salbutamol on an "as required" basis (n=15), and in subjects with moderate asthma, using daily inhaled beclomethasone (mean daily dose, 640 microg; n=15) in addition to salbutamol to control their asthma.. Methacholine challenges (MC) were performed at entry into the study, and then before, 1, and 12 h following inhalation of 50 microg of salmeterol or a placebo, after a 15-day baseline period; and after 4 weeks of twice daily use of those treatments. The measurements were then repeated with the alternate treatment after a 15-day washout period. Finally, a last MC was performed after another 15-day washout period. For each MC, the perception score of bronchoconstriction-associated breathlessness at 20% fall in FEV1 (PS20) was evaluated on a modified Borg scale from 0 to 10.. Subjects using regular beclomethasone had a higher baseline PS20 than those using only salbutamol (means: 3.06 0.06 and 2.01+/-0.07, p=0.0001). Short- and long-term use of salmeterol did not change significantly the PS20 compared with placebo (p>0.05) in either group (with or without corticosteroid). Although there were some intraindividual variations, mean PS20 did not vary significantly throughout the study.. These observations show that the perception of bronchoconstriction-associated breathlessness is not influenced by regular use of salmeterol. Patients using inhaled corticosteroids show a greater perception of MIB.

    Topics: Administration, Inhalation; Adolescent; Adult; Albuterol; Asthma; Beclomethasone; Bronchoconstriction; Bronchoconstrictor Agents; Bronchodilator Agents; Cross-Over Studies; Double-Blind Method; Female; Follow-Up Studies; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Methacholine Chloride; Middle Aged; Perception; Salmeterol Xinafoate; Severity of Illness Index; Treatment Outcome

1998
A new beclomethasone dipropionate multidose powder inhaler in the treatment of bronchial asthma.
    Respiration; international review of thoracic diseases, 1998, Volume: 65, Issue:4

    The clinical efficacy, tolerability and acceptability of a new multidose powder inhaler (MDPI) containing beclomethasone dipropionate (BDP) were compared with those of a BDP aerosol administered with a large volume spacer (MDI-spacer) among adult asthmatics currently receiving from 500 to 1,000 microgram/day of an inhaled corticosteroid. During the study, the dosage of BDP from both devices was 400 microgram twice daily. Ninety-one patients were randomized to the MDPI group and 42 to the MDI-spacer group. The trial was performed as an open, randomized, parallel group multicenter study. The duration of the treatment period was 12 weeks, and the study was preceded by a 2-week run-in period. During the run-in period, the mean morning peak expiratory flow (PEF) was 487 and 466 1/min in the MDPI and MDI-spacer groups, respectively. After the 12-week treatment, the morning PEF was 491 1/min in the MDPI group and 463 1/min in the MDI-spacer group. The evening values were 500 and 479 1/min during the run-in period and 496 and 476 1/min after the 12-week treatment, respectively. Asthma symptom scores and the use of rescue medication were low in both groups, indicating good efficacy of the preparations tested. The median dose of histamine required to decrease forced expiratory volume in 1 s by 15% increased during the study from 800 to 1,098 microgram in the MDPI group and from 795 to 960 microgram in the MDI-spacer group. The most frequent adverse events in both groups were hoarseness and sore throat. There were no statistically significant differences between the treatment groups in serum cortisol values or in the number of patients with thrush. Seventy-two percent of the patients regarded the MDPI easier to use while 95% considered it more portable. Over 80% of the patients felt that the MDPI was also easier to clean and as easy or easier to learn to use than the MDI-spacer. To conclude, the novel powder inhaler is well tolerated and at least equally effective as the conventional MDI-spacer combination in the treatment of asthma with BDP. However, in everyday use, patients clearly favored the powder inhaler.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Confidence Intervals; Dose-Response Relationship, Drug; Female; Finland; Humans; Hydrocortisone; Male; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Statistics, Nonparametric; Treatment Outcome

1998
Potential masking effects of salmeterol on airway inflammation in asthma.
    American journal of respiratory and critical care medicine, 1998, Volume: 158, Issue:3

    We hypothesized that regular use of long-acting beta-agonists could delay recognition of ("mask") increasing airway inflammation. We studied steroid-sparing and "masking" effects of salmeterol versus placebo in 13 asthmatic individuals requiring >= 1,500 microgram inhaled corticosteroid daily. Corticosteroid doses were reduced weekly until criteria were met for an exacerbation or the corticosteroid was fully withdrawn. Subjects were restabilized on their original dose of inhaled corticosteroid for 4 wk before crossover to the alternative treatment. Subjects maintained symptom and peak expiratory flow (PEF) diaries, and underwent weekly spirometric, methacholine challenge, sputum eosinophil, and serum eosinophil cationic protein (ECP) measurements. Mean corticosteroid dose was reduced by 87% during salmeterol treatment, versus 69% with placebo (p = 0.04). Sputum eosinophils increased before exacerbation despite stable symptoms, FEV1, and PEF. In the week before clinical exacerbation, sputum eosinophil counts were higher in the salmeterol-treatment arm (19.9 +/- 29.8% [mean +/- SD], versus placebo 9.3 +/- 17.6%; p = 0.006). Five subjects showed > 10% sputum eosinophilia before exacerbation during salmeterol treatment, as compared with two receiving placebo. In this model, salmeterol controlled symptoms and lung function until inflammation became significantly more advanced. We conclude that the bronchodilating and symptom-relieving effects of salmeterol can mask increasing inflammation and delay awareness of worsening asthma.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Blood Proteins; Bronchial Provocation Tests; Bronchitis; Bronchoconstrictor Agents; Bronchodilator Agents; Budesonide; Cross-Over Studies; Disease Progression; Eosinophil Granule Proteins; Eosinophils; Female; Glucocorticoids; Humans; Inflammation Mediators; Leukocyte Count; Male; Methacholine Chloride; Middle Aged; Peak Expiratory Flow Rate; Placebos; Ribonucleases; Salmeterol Xinafoate; Spirometry; Sputum

1998
[Comparison of addition of theophylline to inhaled steroid with doubling of the dose of inhaled steroid in asthma].
    Pneumologie (Stuttgart, Germany), 1998, Volume: 52, Issue:7

    The anti-asthmatic effect of theophylline may supplement those of inhaled steroids in asthma. The aim of the present trial was to study how the addition of theophylline compares to doubling the dose of inhaled steroid in asthmatics who remain symptomatic on beclomethasone dipropionate (BDP) 400 micrograms/day. The trial was designed as a randomized, double-blind, parallel-group study in several European countries. 69 patients were treated for 6 weeks with theophylline plus BDP 400 micrograms/day, compared to 64 patients treated with BDP 800 micrograms/day. The mean +/- SD serum theophylline concentration was 10.1 +/- 4.2 mg/l. Lung function measurements were made throughout the study and patients kept daily records of peak expiratory flow rate (PEF), symptoms and salbutamol usage. Forced expiratory volume in one second and PEF at week 6 were significantly increased by both treatments (p < 0.01). PEF variability was reduced by about 30% in both groups. There were significant improvements in asthma symptoms and rescue medication use (p < 0.001). There were no significant differences between the treatment groups. The study demonstrated clinical equivalence of theophylline plus beclomethasone dipropionate 400 micrograms/day and beclomethasone dipropionate 800 micrograms/day in patients whose asthma is not controlled on beclomethasone dipropionate 400 micrograms/d. The results support the use of theophylline as steroid-sparing agent. The combination of low-dose inhaled steroid plus theophylline is a suitable treatment for moderate asthma.

    Topics: Adolescent; Adult; Aged; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Europe; Forced Expiratory Volume; Humans; Middle Aged; Theophylline

1998
A comparison of triamcinolone acetonide MDI with a built-in tube extender and beclomethasone dipropionate MDI in adult asthmatics.
    Chest, 1998, Volume: 114, Issue:3

    In this study, the efficacy and safety of triamcinolone acetonide (TA) metered-dose inhaler with a built-in tube extender and beclomethasone dipropionate (BDP) metered-dose inhaler without a spacer device were compared. Both treatments were dosed at their most commonly used daily doses (within labeling).. A 56-day, randomized, double-blind, double-dummy, placebo-controlled trial.. Seventeen asthma/allergy centers.. We enrolled 339 patients 18 to 65 years of age, with a documented history of bronchial asthma (FEV1, 50 to 90% of predicted value) for > or = 2 years who required inhaled corticosteroid therapy.. Patients were randomized to receive BDP 336 microg/d (4 puffs bid) plus TA placebo (4 puffs bid), TA 800 microg/d (4 puffs bid) plus BDP placebo (4 puffs bid), or TA and BDP placebos (4 puffs of each bid). The only other asthma medication permitted was inhaled albuterol that was used as a rescue medication. All medications were administered via the closed-mouth inhalation technique.. At 8 weeks and at study end point, both active treatment groups had statistically significant and comparable improvements in FEV1 relative to baseline, and statistically significant increases relative to placebo. At study end point, improvements in forced expiratory flow (FEF25.75%), clinic peak expiratory flow (PEFR), and FVC were statistically significant for the active treatment groups compared with placebo. At end point, the mean difference between BDP and TA for mean change in FEV1 from baseline in the efficacy population was 0.02 and the 95% confidence interval was -0.11, 0.15. Asthma symptoms recorded at clinic visits showed statistically significant improvements for the BDP and TA groups compared with the placebo group. Treatment-related adverse events occurred with similar frequency in all patient groups-25.5% of placebo-treated patients, 22.3% of BDP patients, and 20.4% of TA patients. The incidence of oropharyngeal adverse events, including cough, thrush, and dysphonia, was not statistically different between the two active treatment groups.. In this randomized, double-blind, placebo-controlled study of adult asthmatics treated with either BDP without a spacer or TA with its built-in tube extender, BDP and TA were comparable in efficacy as measured by FEV1 and other pulmonary function tests, and by improvement in asthma symptoms. Both active treatments were significantly more effective than placebo. All treatment groups were comparable in safety as measured by the incidence of adverse events.

    Topics: Administration, Inhalation; Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Maximal Midexpiratory Flow Rate; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Triamcinolone Acetonide; Vital Capacity

1998
Exhaled nitric oxide and bronchial reactivity during and after inhaled beclomethasone in mild asthma.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1998, Volume: 35, Issue:6

    The measurement of exhaled nitric oxide (ENO) is recognized as a marker of airway inflammation. ENO was measured in 10 nonsteroid-treated asthmatics at recruitment, during 3 weeks of inhaled beclomethasone (1000 microg/day) and for 3 weeks after withdrawal. Baseline ENO was increased in asthma compared with nonasthmatics (85.0+/-54.5 vs. 24.5+/-14.8 ppb, p < 0.0001). After inhaled steroid, there was no significant change in forced expiratory volume in 1 sec (FEV1) and forced vital capacity (FVC), but methacholine PC20 rose significantly (p = 0.0345). ENO (mean+/-SD; % baseline) fell after 1 week on steroid to 60.6+/-31.1 and rose to 95.3+/-46.1 at 1 week after withdrawal. ENO did not correlate with PC20 or FEV1. The changes in ENO and PC20 were inversely correlated (r2 = 0.325). ENO may be an index of airway inflammation and therapeutic response in bronchial asthma.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Breath Tests; Bronchial Hyperreactivity; Bronchial Provocation Tests; Cross-Over Studies; Female; Forced Expiratory Volume; Humans; Inflammation; Male; Methacholine Chloride; Nitric Oxide; Vital Capacity

1998
Clinical efficacy and safety of beclomethasone dipropionate inhalation capsules inhaled by Cyclohaler compared with Becotide Rotacaps inhaled by Rotahaler.
    International journal of clinical pharmacology and therapeutics, 1998, Volume: 36, Issue:9

    The study was undertaken to compare the efficacy and safety of beclomethasone dipropionate inhalation powder inhaled by Rotahaler (Becotide Rotacaps, Glaxo Wellcome) and by Cyclohaler (Beclomethasone Cyclocaps, Pharmachemie). Both the Cyclohaler and the Rotahaler are single-dose dry powder inhalation devices for inhalation capsules. 182 asthma patients stabilized on inhaled beclomethasone dipropionate 800 micrograms daily, were randomly assigned to treatment with 800 micrograms beclomethasone dipropionate inhaled by Rotahaler (91 patients) or Cyclohaler (91 patients) in a double-blind manner, using the double-dummy method. It was shown that the asthma remained stable during the 16-week study period with both preparations. There were no statistically significant differences in the pulmonary parameters (morning PEF, evening PEF, FEV1). The test/reference ratio of the morning PEF (99.5%, CI 93.0% - 106.5%) was well within the equivalence interval, which had been set a priori from 85% to 117.6%. There were no marked differences between the Cyclocaps and Rotacaps group in symptom scores and adverse events. A total of 12 patients had an asthma exacerbation: 8 exacerbations occurred in the Rotahaler group and 4 in the Cyclohaler group. The difference was not statistically significant. The use of rescue medication was somewhat higher in the Rotahaler group, but the difference did not reach statistical significance. Significantly more patients (17 patients) withdrew from the study in the Rotahaler group than in the Cyclohaler group (5 patients). In conclusion, there was no difference in asthma control of patients treated with Beclomethasone Cyclocaps inhaled by Cyclohaler and Becotide Rotacaps inhaled by Rotahaler. Both preparations are therapeutically equivalent.

    Topics: Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Double-Blind Method; Female; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Respiratory Function Tests

1998
Treatment of acute asthmatic exacerbations with an increased dose of inhaled steroid.
    Archives of disease in childhood, 1998, Volume: 79, Issue:1

    To investigate the efficacy of an increased dose of inhaled steroid used within the context of an asthma self management plan for treating exacerbations of asthma.. Randomised, double blind, placebo controlled, crossover trial.. Twenty eight children aged 6-14 years with asthma of mild to moderate severity were studied for six months. Eighteen pairs of exacerbations were available for analysis, during which subjects took an increased dose of inhaled steroids or continued on the same dose.. There was no significant difference between increasing inhaled steroids or placebo on morning or evening peak expiratory flow rates (PEFRs), diurnal peak flow variability, or symptom scores in the two weeks following an asthma exacerbation. Difference (95% confidence intervals) in baseline PEFR on days 1-3 were 3.4% (-3.5% to 10.4%) and -0.9% (-4.7% to 2.9%) for inhaled steroid and placebo, respectively. Spirometric function and the parents' opinion of the effectiveness of asthma medications at each exacerbation were also not significantly different between inhaled steroid or placebo.. This study suggests that increasing the dose of inhaled steroids at the onset of an exacerbation of asthma is ineffective and should not be included in asthma self management plans.

    Topics: Acute Disease; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Child; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Drug Delivery Systems; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Lung; Male; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Treatment Failure

1998
Risk of overtreatment with current peak flow criteria in self-management plans. Dutch CNSLD Study Group. Chronic Non-Specific Lung Disease.
    The European respiratory journal, 1998, Volume: 12, Issue:4

    Home peak expiratory flow (PEF) measurements have become the cornerstone of asthma self-management plans. However, the cut-off values for changing treatment have not been formally tested. This study focusses on the possible overtreatment brought about by the different cut-off values and denominators currently employed. Data from 133 clinically stable asthmatic patients from a 2.5 yr follow-up study were analysed. The results showed that strict adherence to current criteria would lead to severe overtreatment, with up to 30% of clinically stable patients crossing into the lowest (red) zone at least once a year when personal best is the denominator and when it has not been limited to a defined time of day or to defined prior bronchodilator use. As expected, the passage of clinically stable patients into the lower zones became less frequent when cut-off values were sharpened and when time- and treatment-specific PEFs were used as the denominators. Strict adherence to commonly used peak expiratory flow cut-off values would lead to considerable overtreatment. In order to avoid overtreatment, the morning peak expiratory flow before any (bronchodilator) treatment should be related to the personal best peak expiratory flow measured under the same conditions. The choice of the right cut-off value will also depend on studies being performed to test the amount of undertreatment with a given value.

    Topics: Administration, Inhalation; Adolescent; Adult; Asthma; Beclomethasone; Bronchodilator Agents; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Follow-Up Studies; Glucocorticoids; Health Services Misuse; Humans; Ipratropium; Male; Middle Aged; Peak Expiratory Flow Rate; Prevalence; Prognosis; Risk Assessment; Self Administration; Terbutaline; Treatment Outcome

1998
Treatment adherence among low-income children with asthma.
    Journal of pediatric psychology, 1998, Volume: 23, Issue:6

    To investigate the adherence behaviors (MDI use, MDI/spacer technique, appointment attendance, smoking in the home) of low-income, urban, primarily African American children with asthma.. Participants were 55 children ages 6 to 17 with moderate to severe asthma. Adherence to MDI anti-inflammatory agents was estimated primarily from canister weight at the follow-up appointment.. The mean use of MDI medication was 44% of prescribed use, with 27% of subjects demonstrating MDI/spacer technique likely to prevent drug delivery. Almost half reported that household members smoked cigarettes, and 21% missed scheduled follow-up appointments.. These findings have implications for how clinicians should assess and improve adherence.

    Topics: Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Black or African American; Black People; Child; Cromolyn Sodium; Female; Follow-Up Studies; Health Knowledge, Attitudes, Practice; Humans; Incidence; Male; Middle Aged; Nebulizers and Vaporizers; Nedocromil; Parent-Child Relations; Patient Compliance; Patient Education as Topic; Smoking; Social Class; Socioeconomic Factors; Triamcinolone Acetonide; United States

1998
Fluticasone propionate 750 micrograms/day versus beclomethasone dipropionate 1500 micrograms/day: comparison of efficacy and adrenal function in paediatric asthma.
    Thorax, 1998, Volume: 53, Issue:8

    Previous studies have suggested a 2:1 efficacy advantage of fluticasone propionate (FP) over beclomethasone dipropionate (BDP) in adults on high dose inhaled steroids and children on low dose inhaled steroids. The lower doses of FP required to provide equivalent efficacy to BDP also appear to have fewer systemic effects as measured by adrenal function.. The efficacy and safety of FP 750 micrograms/day and BDP 1500 micrograms/day were compared in 30 children with persistent asthma (requiring 1000-2000 micrograms/day of inhaled corticosteroids) in a 12 week randomised double blind crossover study. Medication was delivered by a spacer device in two divided doses. Primary efficacy variables were peak expiratory flows (PEF). Adrenal function was assessed by 24 hour urinary free cortisol levels at eight and 12 weeks and ACTH and low dose synacthen tests (LDST) at 12 weeks. The results were adjusted for sequence and period differences.. There was no difference in the primary efficacy variables over the two 12 week treatment periods (difference in adjusted means for morning PEF 1.3 l/min (95% CI -6.1 to 8.8), p = 0.112) and symptom scores (cough, tachypnoea, wheeze, shortness of breath; difference in adjusted means of night time scores: -0.06 (95% CI -0.14 to 0.03); p = 0.136). Similar degrees of mild adrenal dysfunction were found during BDP and FP treatment phases. Identical height gain velocities were shown during the corresponding periods.. FP 750 micrograms/day is as effective as BDP 1500 micrograms/day in children with persistent asthma. At these very high doses we were unable to demonstrate a safety advantage of FP over BDP as assessed by adrenal function. However, measures of adrenal function may have been influenced by concurrent and previous systemic steroid usage, and possibly by effects of disease activity.

    Topics: Administration, Inhalation; Adolescent; Adrenal Glands; Adrenocorticotropic Hormone; Analysis of Variance; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Child, Preschool; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Female; Fluticasone; Humans; Hydrocortisone; Male

1998
Effect of inhaled corticosteroids on bone mineral density in childhood asthma: comparison of fluticasone propionate with beclomethasone dipropionate.
    Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 1998, Volume: 8, Issue:5

    There is a dearth of data on long-term effects of inhaled corticosteroids (ICS) on bone architecture in childhood asthma. This study was designed to assess the possible effects of two different inhaled steroids on bone mineral density (BMD) in steroid-naïve, prepubertal children. Twenty-three children were randomized to receive equipotent doses of either fluticasone propionate (100 micrograms twice daily) or beclomethasone dipropionate (200 micrograms twice daily). They were followed up over a period of 20 months with regular dual-energy X-ray absorptiometry scans for BMD. Densitometry of lumbar spine and total body showed a significant increase over time, which followed the normal patterns for growth. No difference was observed between the two subgroups. There was no change in fat distribution over time and no increase in percentage total body fat. As expected, girls had significantly higher total body fat. This absence of deleterious effects suggests that in the standard doses used neither beclomethasone nor fluticasone has any significant effect on bone density over a moderate period of time. Further studies should continue monitoring BMD through the critical years of bone mass accumulation during adolescence.

    Topics: Absorptiometry, Photon; Adipose Tissue; Administration, Topical; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bone Density; Child; Child, Preschool; Double-Blind Method; Female; Fluticasone; Follow-Up Studies; Glucocorticoids; Humans; Lumbar Vertebrae; Male

1998
Hydrofluoroalkane-134a beclomethasone dipropionate extrafine aerosol provides equivalent asthma control to chlorofluorocarbon beclomethasone dipropionate at approximately half the total daily dose.
    Respiratory medicine, 1998, Volume: 92 Suppl A

    The mandatory requirement to eliminate chlorofluorocarbons (CFCs) as propellants in pharmaceutical aerosols has provided the opportunity to enhance significantly the delivery of aerosol drugs to the respiratory tract. This randomized, parallel-group, double-blind, double-dummy, multicentre study was undertaken to assess whether beclomethasone dipropionate (BDP) in hydrofluoroalkane-134a (HFA) provided equivalent control of moderately severe asthma to BDP in CFC but at approximately half the total daily dose, as might be expected from the improved lung deposition of the HFA-BDP extrafine aerosol. The novel study design included a 10-12 day run-in period to confirm that patients met established criteria of moderately severe asthma and were symptomatic on current therapy (inhaled beta-agonist plus CFC-BDP 400-800 micrograms day-1). This run-in period was followed by a short course of oral steroid therapy (prednisolone 30 mg day-1 for 7-13 days) to demonstrate steroid responsiveness [> or = 15% improvement in morning peak expiratory flow (PEF)] and to provide a within-study baseline of improved asthma control. A total of 233 patients were randomized to treatment for 12 weeks with HFA-BDP 800 micrograms day-1 (116 patients) or CFC-BDP 1500 micrograms day-1 (117 patients). The mean change from oral steroid treatment in morning PEF with HFA-BDP was equivalent to that seen with CFC-BDP at all time intervals. Changes in other measures of pulmonary function, asthma symptom scores and beta-agonist use were equivalent in the two treatment groups throughout the 12 week treatment period. The safety profile of HFA-BDP compared favourably with that of CFC-BDP with no unexpected adverse events reported. Fewer patients on HFA-BDP than on CFC-BDP had plasma cortisol levels below the normal reference range after 12 weeks of therapy (5.1% vs. 17.3%, respectively). In conclusion, HFA-BDP extrafine aerosol was found to provide equivalent control of moderately severe asthma to CFC-BDP at approximately half the daily dose with a favourable safety profile, suggesting an improved therapeutic ratio.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Aerosol Propellants; Aerosols; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chlorofluorocarbons; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Middle Aged

1998
Safety of hydrofluoroalkane-134a beclomethasone dipropionate extrafine aerosol.
    Respiratory medicine, 1998, Volume: 92 Suppl A

    Herein we assess the safety of an inhaled formulation of beclomethasone dipropionate (BDP) which uses the propellant hydrofluoroalkane-134a (HFA) for the treatment of asthma. Acute local tolerability (as assessed by the incidence of cough and mean forced expiratory volume after 1 s inhalation) was similar for both BDP and placebo formulated in either chlorofluorocarbon (CFC) or HFA propellants. A total of 43 patients were treated with HFA-BDP (0, 200, 400 or 800 micrograms day-1) or CFC-BDP (800 micrograms day-1) for 14 days and their 24 h urinary free cortisol (UFC) excretion and response to cosyntropin stimulation were measured. There was no difference in UFC between any of the doses of HFA-BDP and CFC-BDP. Adrenal responsiveness to cosyntropin stimulation was normal in all but one patient. Two large 12 week phase III trials compared HFA-placebo, HFA-BDP 400 micrograms day-1 and CFC-BDP 800 micrograms day-1 (n = 347), and HFA-BDP 800 micrograms day-1 and CFC-BDP 1500 micrograms day-1 (n = 233). For HFA-BDP at either dose, CFC-BDP 800 micrograms day-1 and HFA-placebo, the number of patients with morning plasma cortisol concentrations below normal was less than 4.4% but was 14.6% for CFC-BDP 1500 micrograms day-1. The incidence of adverse events was lower in the HFA-BDP groups than in the CFC-BDP groups (P = 0.012). The data indicate that, at doses of up to 800 micrograms day-1, HFA-BDP is at least as well tolerated as CFC-BDP. Other studies have found that equivalent efficacy is reached at lower doses of HFA-BDP than CFC-BDP. Equivalent efficacy at a lower dose and equivalent safety at the same dose imply that HFA-BDP may have a more favourable risk: benefit ratio than CFC-BDP when used at the recommended lower doses.

    Topics: Administration, Inhalation; Adolescent; Adult; Aerosol Propellants; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chlorofluorocarbons; Cosyntropin; Cough; Cross-Over Studies; Drug Administration Schedule; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Hypothalamo-Hypophyseal System; Middle Aged; Pituitary-Adrenal System

1998
A comparative study of the effects of ketotifen, disodium cromoglycate, and beclomethasone dipropionate on bronchial mucosa and asthma symptoms in patients with atopic asthma.
    Respiratory medicine, 1998, Volume: 92, Issue:7

    Asthma is a chronic inflammatory disorder of the airways that is characterized by infiltration of many inflammatory cells into the bronchial mucosa. We compared the effects of ketotifen, disodium cromoglycate (DSCG), and beclomethasone dipropionate (BDP) on inflammatory cells in the bronchial mucosa and on the asthma symptoms of patients with atopic asthma. In this 12-week parallel study, 32 patients were randomly allocated to either the ketotifen group (2 mg day-1, n = 13), DSCG group (8 mg day-1, n = 9) or BDP (400 micrograms day-1, n = 10). Each subject recorded daily asthma symptoms and peak expiratory flow (PEF). Before and after treatment, pulmonary function and bronchial responsiveness to methacholine were evaluated, and fibreoptic bronchoscopy and biopsy were performed before and after treatment. Biopsy specimens were obtained by bronchoscopy. We performed immunohistochemistry using specific monoclonal antibodies for activated eosinophils (EG2), mast cells (AA1), and T cells (CD3, CD4, and CD8). Our clinical findings showed significant improvement in symptom score and bronchial responsiveness (P < 0.01) each) in all groups. Both the DSCG and the BDP groups had significantly better symptom scores than the ketotifen group (P < 0.05, both groups). PEF significantly increased in the DSCG group in comparison to the ketotifen (P < 0.01) and BDP (P < 0.05) groups, FEV1% increased significantly in the DSCG (P < 0.01) and BDP (P < 0.05) groups in comparison to the ketotifen group. Compared with their baseline values, treatment significantly decreased EG2+ activated eosinophils, and CD3+ and CD4+ T cells, in each group (P < 0.01). Both the DSCG (P < 0.05) and the BDP groups (P < 0.01) exhibited significant decreases in AA1+ mast cell count, but this was not observed in the ketotifen group. Comparing before- and after-treatment values, only the DSCG group exhibited a significant decrease in the number of CD8+ T cells (P < 0.01). Ketotifen, DSCG, and BDP all showed anti-inflammatory activity as determined by examination of the bronchial mucosa of asthmatic patients; and both the DSCG and BDP groups had better clinical responses than the ketotifen group.

    Topics: Adolescent; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchi; CD4-Positive T-Lymphocytes; CD8-Positive T-Lymphocytes; Cromolyn Sodium; Female; Forced Expiratory Volume; Humans; Immunohistochemistry; Ketotifen; Male; Middle Aged; Mucous Membrane; Peak Expiratory Flow Rate

1998
Systemic activity of inhaled and swallowed beclomethasone dipropionate and the effect of different inhaler devices.
    Postgraduate medical journal, 1998, Volume: 74, Issue:877

    Inhaled glucocorticoids such as beclomethasone dipropionate, which are used in the treatment of asthma, may be associated with systemic adverse effects. To determine whether any systemic absorption following the inhalation of beclomethasone was a result of drug being absorbed from the lung (inhaled fraction) or the gastrointestinal tract (swallowed fraction), we studied normal subjects after the inhalation or swallowing of 2 mg beclomethasone dipropionate. Systemic activity was assessed using early morning cortisol suppression. Both inhaled and swallowed fractions produced significant systemic activity, the degree of which depended on the inhaler device used. Systemic activity was greater using a dry powder inhaler (52%) than using a metered dose inhaler with a large volume spacer (28%). These findings suggest that to limit potential adverse effects from high-dose beclomethasone dipropionate it is better to use a metered dose aerosol with large volume spacer than a dry powder.

    Topics: Administration, Inhalation; Administration, Oral; Anti-Asthmatic Agents; Asthma; Beclomethasone; Glucocorticoids; Humans; Hydrocortisone; Nebulizers and Vaporizers

1998
[Inhaled corticosteroids and asthma education].
    Medicina, 1998, Volume: 58, Issue:6

    Thirty asthmatic patients were evaluated to assess the association of therapy with inhalatory corticosteroids and an educational program, EDUCASMA. Spirometric evaluation with Flow-Volume loop (MEDICAL GRAPHIC CPF-S), ambulatory FEP (mini WRIGHT meters) was performed. In regard of initial symptoms patients were qualified as moderate or severe. After two weeks of a screening period, they were randomized into 2 groups: a) beclomethasone; b) budesonide; respective doses in according to the initial status. During the study period (8 wks) they visited the medical Staff six or more times. In each visit the patients received clinical evaluation (i.e. clinical scoring), spirometry (i.e. FEV1), and FEP ambulatory revision. FEP x (mean), FEP delta, FEV1, and clinical scores values were matched at the start and at the end of the follow-up period. Non-parametric statistics were applied (Wilcoxon test) and significative changes were defined (p < 0.05).. 1) inhalatory corticosteroids therapy associated with a previous educational program could achieve early improvements of clinical scores; 2) in moderate asthma ambulatory FEP showed objective changes both in beclomethasone and budesonide treatments. It appears to indicate increasing changes very close to the clinical improvement; 3) the short period of our observation and the inflammatory condition of airways in severe asthma, could be explained as probable factors for the minor differences in the FEV1 evaluation; 4) no differences between budesonide and beclomethasone treatment were found.

    Topics: Administration, Inhalation; Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Female; Follow-Up Studies; Glucocorticoids; Health Education; Humans; Male; Middle Aged; Patient Education as Topic; Severity of Illness Index; Spirometry

1998
Benefits of induced sputum for the evaluation of therapeutic efficacy in patients with bronchial asthma.
    The Kobe journal of medical sciences, 1998, Volume: 44, Issue:4

    Airway inflammation is a major factor in the pathogenesis of asthma. Inducing sputum by hypertonic saline is a noninvasive method of assessment of the airway inflammation in asthmatic patients. To investigate sputum induction as a method for assessing airway inflammation and to evaluate the effect of inhaled beclomethasone dipropionate (BDP) in asthmatic patients, we examined the bronchial hyperresponsibility (BHR), pulmonary function and differential cell counts in induced sputum of the patients before and after BDP therapy. In asthmatic patients, the percentage of eosinophils in induced sputum was significantly higher than that in non-asthmatic subjects. Ten patients with atopic asthma (four men and six women; mean [+/- SD] age, 30.5 +/- 12.4 years) participated. Their mean percentage of eosinophils (% eosinophils) in induced sputum fell from 22.9 +/- 7.2% to 13.9 +/- 8.3% (p < 0.05) by 3 months of BDP treatment. The percentage of eosinophils in induced sputum before BDP treatment was significantly correlated with the ratio of the forced expiratory volume in one second to the forced vital capacity (FEV1%) at baseline (r = -0.75, p < 0.05), but not with log Dmin at baseline (p = 0.18). The change in FEV1% between at baseline and post-treatment correlated significantly with the change in the sputum eosinophil percentage (r = -0.79, p < 0.01). In addition, there was a significant correlation between the change of log Dmin and the change of the sputum eosinophil percentage (r = -0.64, p < 0.05). In conclusion, analysis of induced sputum is a safe, noninvasive, repeatable and useful method to assess the clinical condition of bronchial inflammation in patients with bronchial asthma.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Eosinophils; Female; Humans; Lymphocyte Count; Male; Middle Aged; Regression Analysis; Sensitivity and Specificity; Sputum; Treatment Outcome

1998
[Prophylactic and therapeutic effects of beclomethasone inhalation on bronchial hyperresponsiveness and asthma: a randomized, double-blind, parallel-group controlled trial].
    Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases, 1998, Volume: 21, Issue:1

    To better understand the effects of corticosteroid inhalation on asthma and asymptomatic bronchial hyperresponsiveness (BHR).. A double blind, randomized study was conducted to compare the effects of beclomethasone dry powder (BDP, 600 micrograms/day) inhalation with placebo on BHR and asthmatic symptoms in 59 students (12-18 yrs) for one year.. After one year of treatment, lgPD20-FEV1 increased significantly in asthmatics in the BDP group (0.385 +/- 0.424 vs 1.187 +/- 0.603 mumol histamine). Thirty percent of asthmatics in BDP group and 86% in the control group developed symptoms in this year (P = 0.076). There was no significant difference in lgPD20-FEV1 between the BDP and the control group in asymptomatic BHR students. However, none in the BDP group of asymptomatic BHR students developed asthmatic symptoms compared with 3 cases (15%) in control group. The accumulative symptom score showed significant difference between the BDP group and the control group in asymptomatic BHR students (1.50 +/- 2.54 vs 5.58 +/- 6.22, P < 0.01).. The results suggested that BDP could significantly relieve the severity of BHR and symptoms in asthmatics, and could have some prophylactic effects on the development of asthma in those with asymptomatic BHR.

    Topics: Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Child; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male

1998
Does ketotifen have a steroid-sparing effect in childhood asthma?
    The European respiratory journal, 1997, Volume: 10, Issue:1

    In view of the possible systemic side-effects of inhaled corticosteroids (ICS), a study was performed to determine whether ketotifen (versus placebo) can replace or allow a reduction in the dose of ICS required for the maintenance treatment of childhood asthma. Sixty six children (aged 6-13 yrs) with asthma (confirmed by methacholine challenge), who were maintained on ICS, at a dose of < or = 1 mg.day-1, were selected, and 52 subjects completed the trial. Children on long-term oral steroids or cromoglycate were excluded. After a 4 week baseline period, the children were randomized to receive ketotifen, 2 mg.day-1, or placebo for 32 Weeks. Between weeks 13-20 of the study, the daily dose of steroid was tapered by 25% every second week to the minimum dose tolerated by the patients. For the remainder of the study (Weeks 21-32) the patients continued on this dose (if tolerated). Beta 2-agonists were allowed, as necessary, for symptom relief. During the baseline period, the mean daily ICS dosage was 432 micrograms in the ketotifen group versus 408 micrograms in the placebo group (NS). Among the-patients who completed the study, the average ICS dosage during the final phase of the study (Weeks 21-32) was only 18% of baseline in the ketotifen group versus 35% in the placebo group (NS). Lung function, diurnal variability in peak flow rates and methacholine sensitivity (provocative concentration producing a 20% fall in forced expiratory volume in one second (PC20)) remained unchanged in both groups throughout the study. During the last 12 weeks of the study, the ketotifen-treated patients were symptomatically better controlled. In the present study, ketotifen did not have a greater steroid-sparing effect than placebo.

    Topics: Administration, Inhalation; Administration, Topical; Adolescent; Adrenergic beta-Agonists; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchoconstrictor Agents; Bronchodilator Agents; Budesonide; Child; Circadian Rhythm; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Histamine H1 Antagonists; Humans; Ketotifen; Lung; Male; Methacholine Chloride; Peak Expiratory Flow Rate; Placebos; Pregnenediones

1997
Short-term regular beta 2-adrenergic agonists treatment is safe in mild asthmatics taking low doses of inhaled steroids.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1997, Volume: 34, Issue:1

    Regular treatment with beta 2-adrenergic agonists is controversial in bronchial asthma. To investigate whether beta 2-adrenergic agonists can be used safely if associated with low doses of inhaled steroids, for a short period, without a deterioration of asthma control, we have examined 24 mild asthmatics. In a parallel, double-blind, placebo-controlled study, 1 week of run-in and run-out period framed 3 weeks of treatment. All patients received inhaled beclomethasone dipropionate (BDP 250 micrograms t.i.d.); after 1 week, 12 patients inhaled 400 micrograms of broxaterol and 12 patients received placebo t.i.d. FVC, FEV1, PD20-FEV1 methacholine, morning and evening PEF, and PEF amplitude % mean were measured before, during, and after treatment. No significant changes were noted in patients receiving inhaled broxaterol. There were no differences in symptoms and the use of rescue medication (salbutamol spray). We conclude that short-term regular treatment with beta 2-adrenergic agonists is not associated with a deterioration in asthma control in mild asthmatics inhaling low doses of steroids.

    Topics: Administration, Inhalation; Adrenergic beta-Antagonists; Adult; Asthma; Beclomethasone; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Isoxazoles; Male; Middle Aged; Respiratory Mechanics; Vital Capacity

1997
Retention of asthmatic patients in a longitudinal clinical trial.
    The Journal of allergy and clinical immunology, 1997, Volume: 99, Issue:2

    Prevention of study patient attrition and assessment of its impact on outcome data are problems that receive little attention despite their obvious importance in asthma research.. The medical, demographic, and psychologic characteristics of asthmatic children and adults who dropped out of a yearlong medication trial were assessed to determine whether this group differed from those who completed the study, potentially introducing bias into the data set and interfering with completion of the study's objectives.. Profiles of 362 adult and pediatric asthmatic patient dropouts from the multicenter trial were contrasted with profiles of those who completed the study. Despite a 1-month prerandomization screening, 24% of patients failed to complete the trial for varied reasons, which largely included noncompliance and treatment dissatisfaction.. Although attrition rates were equal among adults and children, dropout-completer differentiation was not. Adult completers did not differ from dropouts in any variables. However, pediatric dropouts were more likely than completers to be female (67% and 36%, p = 0.008) and to have more reactive airways (PD20, 2.29 +/- 1.32 and 5.2 +/- 1.23, p = 0.05), to have reduced scores on tests of intelligence (Full Scale IQ, 102.2 +/- 2.6 and 112.5 +/- 1.6, p = 0.002) and problem solving (Wisconsin Card Sorting Test Error Scores, 39.8 +/- 4.1 and 29.1 +/- 2.0, p = 0.01), and to have increased behavioral problems (Child Behavior Checklist Total Problem Score, 60.7 +/- 2.5 and 53.6 +/- 1.1, p = 0.003).. These findings demonstrate the potential of patient attrition to bias outcome in clinical trials and underscore the necessity of: (1) preventing its occurrence, (2) correctly assessing its causes, and (3) determining its ultimate impact on study results. Strategies for each of these three tasks should be implemented at the study's initial planning stages.

    Topics: Adolescent; Adult; Age Factors; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Behavior; Bias; Bronchodilator Agents; Child; Female; Humans; Intelligence Tests; Longitudinal Studies; Male; Middle Aged; Patient Dropouts; Problem Solving; Sex Factors; Theophylline; Treatment Refusal

1997
The effects of combined intravenous and inhaled steroids (beclomethasone dipropionate) for the emergency treatment of acute asthma. The Asthma ED Study Group.
    Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 1997, Volume: 4, Issue:2

    To compare the efficacy of high-dose inhaled steroids in conjunction with IV steroids with that of IV steroids alone in the emergency treatment for acute asthma.. A double-blind, placebo-controlled, randomized trial was conducted on 60 ED patients presenting with acute asthma. All patients received nebulized salbutamol, and IV methylprednisolone, 80 mg at baseline and 40 mg at 6 hours. In addition to the above therapy, the experimental group received beclomethasone dipropionate (BDP) 7 mg over 8 hours via a metered-dose inhaler (MDI) attached to a holding chamber, while the control group received a placebo administered in the same fashion. Patients were treated on the protocol for 12 hours with the primary outcome measure being the change in % predicted FEV1.. Of 60 patients, 30 were randomized to BDP (age: 42 +/- 16 years; FEV1: 0.97 +/- 0.42 L) and 30 were randomized to placebo (age: 37 +/- 18 years; FEV1: 0.98 +/- 0.35 L). Spirometry and dyspnea measured by the Borg Scale improved significantly in both groups compared with baseline (p < 0.001). Changes in spirometry measures, dyspnea, and vital signs did not differ between treatment groups over the 12 hours of study (p > 0.05).. Inhaled BDP added to the standard regimen of IV methylprednisolone, and beta-agonist did not further improve flow rates or dyspnea scores measured for up to 12 hours after presentation to the ED.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Methylprednisolone; Middle Aged; Prospective Studies; Respiratory Function Tests

1997
Effect of inhaled beclomethasone dipropionate on isocapnic hyperventilation with cold air in asthmatics, measured with forced oscillation technique.
    The European respiratory journal, 1997, Volume: 10, Issue:3

    Isocapnic hyperventilation with cold air (IHCA) is a reliable technique for assessing indirect bronchial hyperresponsiveness in patients with asthma. Impedance measurement of the respiratory system by the forced pseudorandom noise oscillation technique is a sensitive technique to assess changes in bronchial tone after IHCA. The aim of this study was to evaluate the effect of 6 weeks of treatment with beclomethasone dipropionate, 1,000 microg x day-1, on IHCA in asthmatic patients, measured with both forced oscillation technique and flow-volume recordings. Forty patients with mild asthma were included in this double-blind, placebo-controlled parallel-group study. Stratification on the basis of sex was performed to overcome differences in airway diameter. At entry and every 2 weeks during the treatment period, IHCA was performed and patient diaries were evaluated. Characteristic changes in forced oscillation parameters after IHCA were observed in all patients. After 6 weeks of treatment, BDP-treated patients showed statistically significant differences in impedance measurements after IHCA, manifested by significant attenuation of resistance at 8 Hz (p<0.01), slope of the frequency-resistance curve (p<0.01), reactance at 8 Hz (p=0.01), and resonant frequency (f0) (p<0.02). Flow-volume recordings showed only a statistically significant change in the decrease of inspiratory vital capacity (IVC) (p=0.01). Furthermore, a significant correlation was observed between serum immunoglobulin E (IgE) levels and the effect of BDP on IHCA, measured with forced oscillation technique. In this study, beclomethasone dipropionate, 1,000 microg x day(-1) for 6 weeks, decreased indirect bronchial hyperresponsiveness as assessed by cold air bronchoprovocation in asthmatic patients. The forced oscillation technique proved a more sensitive method of detecting changes in bronchial tone than flow-volume recordings.

    Topics: Adult; Airway Resistance; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Cold Temperature; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Peak Expiratory Flow Rate

1997
Leukotriene antagonist prevents exacerbation of asthma during reduction of high-dose inhaled corticosteroid. The Tokyo Joshi-Idai Asthma Research Group.
    American journal of respiratory and critical care medicine, 1997, Volume: 155, Issue:4

    To test whether the leukotriene antagonist ONO-1078 (pranlukast) prevents asthma exacerbations during reduction of high-dose inhaled corticosteroid, we conducted a randomized, double-blind, placebo-controlled study in 79 asthma patients requiring high doses (1,500 microg/d or more) of inhaled beclomethasone dipropionate (BDI) for clinical control (duration of asthma, 11.0 +/- 3.1 yr; duration of BDI treatment, 0.5 +/- 0.3 yr; FEV1 percentage of predicted, 80.7 +/- 2.0%). After a 2-wk run-in period, the doses of BDI were halved, while the patients were assigned to receive orally ONO-1078, 450 mg twice daily, or placebo. In the placebo group FEV1 decreased by 0.33 +/- 0.20 L after 6 wk (p < 0.001). Likewise, morning and evening PEF decreased by 46 +/- 7 L/min and 18 +/- 6 L/min, respectively. By contrast these variables were sustained above baseline in the ONO-1078 group. The number of daytime and nighttime asthma symptoms and the use of beta2-agonist increased in the placebo group, whereas they remained unchanged in the ONO-1078 group. In the placebo group concentrations of serum eosinophil cationic protein and exhaled nitric oxide increased (p = 0.007 and p = 0.025, respectively), compared with no change in the ONO-1078 group. Therefore, the leukotriene antagonist ONO-1078 prevents the asthma deterioration provoked by a 6-wk reduction of the dose of inhaled BDI into half.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chromones; Double-Blind Method; Female; Glucocorticoids; Humans; Leukotriene Antagonists; Male; Middle Aged; Procaterol; Substance Withdrawal Syndrome

1997
An assessment of steroid hypersensitivity in asthma.
    Respiratory medicine, 1997, Volume: 91, Issue:4

    In dermatological practice, allergy to topical corticosteroids used to treat eczema is a recognized and common event. The typical presentation is of an eczema which fails to improve or deteriorates with treatment. Topical corticosteroids are also used to treat mucosal disease. This study assesses allergy to inhaled corticosteroids in asthmatics. In the patient group selected, there was no evidence of relevant corticosteroid allergy.

    Topics: Administration, Inhalation; Administration, Topical; Adult; Aged; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Drug Hypersensitivity; Female; Glucocorticoids; Humans; Immunoglobulin G; Intradermal Tests; Male; Methylprednisolone; Middle Aged; Pregnenediones

1997
Adrenal function and high dose inhaled corticosteroids for asthma.
    Archives of disease in childhood, 1997, Volume: 76, Issue:5

    To investigate effects on adrenal function of fluticasone, a recently released inhaled steroid preparation with lower systemic bioavailability than beclomethasone dipropionate.. 34 children on high doses (400-909 micrograms/m2/d) of inhaled beclomethasone dipropionate or budesonide were recruited into a double blind, crossover study investigating the effects on adrenal function of beclomethasone and fluticasone propionate, given using a standard spacer (Volumatic). The 24 hour excretion rates of total cortisol and cortisol metabolites were determined at baseline (after a two week run in), after six weeks treatment with an equal dose of beclomethasone, and after six weeks of treatment with half the dose of fluticasone, both given through a spacer device.. The comparison of effects between fluticasone and beclomethasone during treatment periods, although favouring fluticasone in all measured variables, reached significance only after correction for urinary creatinine excretion (tetrahydrocortisol and 5 alpha-tetrahydrocortisol geometric means: 424 v 341 micrograms/m2/d). The baseline data showed adrenal suppression in the children taking beclomethasone (total cortisol geometric means: 975 v 1542 micrograms/d) and a dose related suppression in the children taking budesonide. Suppressed adrenal function in the children who were taking beclomethasone at baseline subsequently improved with fluticasone and beclomethasone during treatment periods.. Fluticasone is less likely to suppress adrenal function than beclomethasone at therapeutically equivalent doses. The baseline data also support the claim that spacer devices should be used for the administration of high doses of inhaled topical steroids.

    Topics: Administration, Topical; Adolescent; Adrenal Glands; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Child, Preschool; Cross-Over Studies; Double-Blind Method; Female; Fluticasone; Humans; Hydrocortisone; Male; Nebulizers and Vaporizers; Peak Expiratory Flow Rate

1997
Inhaled beclomethasone dipropionate (BDP) prevents seasonal changes in atopic asthmatics.
    Monaldi archives for chest disease = Archivio Monaldi per le malattie del torace, 1997, Volume: 52, Issue:2

    Inhaled corticosteroids are most effective drugs currently available for the treatment of bronchial asthma. They have been shown to reduce airway inflammation and hyperresponsiveness. The aim of this study was to assess the preventive effect of inhaled steroid therapy in seasonal asthma. In a double-blind study, two groups of 10 allergic asthmatics were randomly assigned to receive inhaled beclomethasone dipropionate (BDP), 500 micrograms b.i.d., or a matched placebo, two puffs b.i.d. The patients used inhaled salbutamol as needed. At the beginning of the study, and every month between February and June, the following parameters were assessed: lung function (forced expiratory volume in one second (FEV1); airway responsiveness (provocative dose of methacholine producing a 20% fall in forced expiratory volume in one second (PD20)), serum eosinophil cationic protein (ECP); and blood eosinophil count. All subjects recorded daily asthma symptoms, beta 2-agonist consumption and peak expiratory flow (PEF) values. In the placebo group, all parameters except FEV1 worsened significantly during the pollen season compared with preseasonal values (p < 0.001). BDP produced complete protection, although a slight change from baseline was found for symptom score (p < 0.01), beta 2-agonist consumption (p < 0.01), and eosinophil number (p < 0.05) in May, when the pollen load was highest. These data provide evidence that beclomethasone dipropionate treatment is able to inhibit the seasonal changes occurring during natural exposure in asthmatics. This preventive effect is probably due to the anti-inflammatory action of beclamethasone dipropionate, as documented by its effect on serum markers of airway inflammation.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Blood Proteins; Double-Blind Method; Eosinophil Granule Proteins; Eosinophils; Female; Humans; Inflammation Mediators; Leukocyte Count; Male; Middle Aged; Pollen; Respiratory Function Tests; Ribonucleases; Seasons

1997
A comparison of double-strength beclomethasone dipropionate (84 microg) MDI with beclomethasone dipropionate (42 microg) MDI in the treatment of asthma.
    Chest, 1997, Volume: 112, Issue:1

    To compare the efficacy and safety of a double-strength formulation of beclomethasone dipropionate (BDP 84) metered-dose inhaler (MDI) with that of beclomethasone dipropionate (BDP 42) MDI in the treatment of chronic asthma.. A 28-day, randomized, double-blind, double-dummy, placebo-controlled, multicenter study.. Outpatient.. A total of 423 patients aged 12 to 65 years (mean range, 34 to 36 years) with moderate asthma (FEV1, 50 to 80% of predicted) who required long-term inhaled corticosteroids were enrolled.. Patients were randomized to receive BDP 84, two oral inhalations bid (336 microg/d), BDP 42, four oral inhalations bid (336 microg/d), or placebo. A fourth treatment arm administering BDP 84, eight oral inhalations bid (HD BDP 84; 1,344 microg/d) was also included to determine whether a dose-response relationship could be demonstrated.. Spirometry, clinical observations.. The three active treatments were significantly more effective (p < or = 0.01) than placebo at all time points in improving FEV1, the primary efficacy parameter; BDP 42 and BDP 84 were comparable to each other at every time point. Secondary pulmonary function tests (FVC, forced expiratory flow at 25 to 75% of FVC, and peak expiratory flow rate) showed similar results. All three active treatments were well tolerated. A dose response between 336 microg/d and 1,344 microg/d was demonstrated.. In this well-controlled 28-day study, BDP 42 and BDP 84 were shown to be comparable in efficacy and safety on a microgram-for-microgram basis.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Nebulizers and Vaporizers; Time Factors

1997
Systemic corticosteriod rapidly reverses bronchodilator subsensitivity induced by formoterol in asthmatic patients.
    American journal of respiratory and critical care medicine, 1997, Volume: 156, Issue:1

    There is evidence that downregulation and desensitization of airway beta 2-adrenoceptors (beta 2-AR) develops after continuous exposure to long-acting beta 2-agonists such as formoterol and salmeterol. To investigate the facilitatory effects of acute administration of systemic corticosteroid on bronchodilator subsensitivity, as might occur in the setting of acute asthma, 12 subjects with moderately severe asthma, with a mean FEV1 of 66% predicted, of whom were all receiving inhaled corticosteriod, were randomized to receive either inhaled placebo (PL) or inhaled formoterol (FM) 24 micrograms twice daily for 4 wk in a double-blind crossover study. Subjects were also genotyped in terms of beta 2-Ar polymorphism at loci 16 and 27. A dose-response curve (DRC) and duration-time profile for FM (12 to 108 micrograms) was produced 1 h after administration of placebo tablets and after injection at 3 wk, and 1 h after administration of oral prednisolone, 50 mg, and intravenous hydrocortisone, 200 mg, at 4 wk. Comparisons between treatments were made with area-under-curve (AUC) measurements as the change from baseline. There was a significant rightward shift in the DRC after FM as opposed to placebo for delta FEV1 (as AUC, L.h): 2.51 versus 4.22 (95% CI: 0.54 to 2.89; p = 0.01) and delta FEF25-75 (as AUC, L x 10(3)): 11.30 versus 19.94 (95% CI: 2.12 to 15.12; p = 0.01). This was significantly reversed by steroid (S) for FEV1 (FM versus FM+5): 2.51 versus 3.57 (95% CI: 0.11 to 2.27; p = 0.03) and for FEF25-75: 11.30 versus 18.47 (95% CI: 2.52 to 11.70; p = 0.005). Lymphocyte beta 2-AR density (log Bmax; fmol/10(6) cells) showed significant upregulation 3 h after steroid (FM+5 versus FM): 0.34 versus 0.24 (95% CI: 0.02 to 0.18; p = 0.01). For heart-rate response (as AUC, beats), there was subsensitivity with FM versus PL: 2,700 versus 5,200 (95% CI: 40 to 5,000; p < 0.001), and this was reversed by steroid (FM+5 versus FM): 9,600 versus 2,700 (95% CI: 4,900 to 8,800; p < 0.001). This reversal by systemic corticosteroid appears to be generally independent of beta 2-AR polymorphism at loci 16 and 27. In conclusion, we have demonstrated that bronchodilator subsensitivity occurs after regular inhaled FM in asthmatic patients, and is rapidly reversed by systemic corticosteroid. Thus, in acute asthma, systemic corticosteroid should be administered a soon as possible, in order to restore normal airway beta 2-AR sensitivity, particularly in patients who are receiving regular

    Topics: Adrenergic beta-Agonists; Adult; Area Under Curve; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Drug Interactions; Drug Tolerance; Ethanolamines; Female; Formoterol Fumarate; Glucocorticoids; Humans; Male; Middle Aged; Pregnenediones; Pulmonary Ventilation

1997
Therapeutic effect of pranlukast, a selective cysteinyl leukotriene receptor antagonist, on bronchial asthma.
    International archives of allergy and immunology, 1997, Volume: 114, Issue:1

    This study was undertaken to evaluate whether the therapeutic effect of pranlukast, a selective cysteinyl leukotriene (LT) C4/D4/E4 receptor antagonist, can be observed in patients with the non-atopic or atopic type of asthma, or in asthmatics taking oral steroids. Twenty-two patients with moderate to severe bronchial asthma receiving an inhaled corticosteroid (beclomethasone dipropionate) were treated with pranlukast (225 mg b.i.d.) for 4 weeks, and their peak expiratory flow (PEF) and asthmatic symptoms were monitored during the treatment period. In the patients with the non-atopic type of asthma (n = 13), an increase in their PEF was observed both in the morning and evening following a 4-week administration ofpranlukast, but the degree was slightly inferior to that in patients (n = 9) with the atopic type of asthma. On the other hand, no significant increase was observed in the patients (n = 6) taking oral prednisolone (PSL, 5-15 mg/day). Changes in the symptom score at the end of the 4-week treatment period were closely associated with those in the PEF values; namely, a significant improvement in symptom score was observed for patients with the atopic and non-atopic type of asthma, but no improvement for the patients taking oral PSL. Pranlukast, a selective LT receptor antagonist, will be a valuable asset in the treatment of bronchial asthma, especially asthma requiring no oral steroids.

    Topics: Administration, Inhalation; Administration, Oral; Adult; Aged; Asthma; Beclomethasone; Chromones; Female; Glucocorticoids; Humans; Hypersensitivity, Immediate; Leukotriene Antagonists; Male; Middle Aged; Peak Expiratory Flow Rate; Prednisolone

1997
One year treatment with salmeterol compared with beclomethasone in children with asthma. The Dutch Paediatric Asthma Study Group.
    American journal of respiratory and critical care medicine, 1997, Volume: 156, Issue:3 Pt 1

    The aim of this study was to compare the effects of salmeterol and beclomethasone on lung function and symptoms in children with mild to moderate asthma. Sixty-seven children not treated with inhaled corticosteroids were randomized in a double-blind parallel study either to salmeterol 50 micrograms b.i.d. or beclomethasone 200 micrograms b.i.d. After one year, FEV1 significantly increased in the beclomethasone group, whereas in the salmeterol group there was a small reduction. Differences between groups were 14.2% predicted (p < 0.0001) and 7.0% predicted (p = 0.007) for pre- and postbronchodilator FEV1 values, respectively. PD20 methacholine decreased by 0.73 DD (p = 0.05) in the salmeterol group and increased by 2.02 DD (p < 0.0001) in the beclomethasone group. Morning and evening PEF and symptom scores improved in both groups, although more in the beclomethasone group. Asthma exacerbations, for which prednisolone was needed, were more frequent in the salmeterol group (17 versus two), as were the number of withdrawals due to exacerbations (six versus one). However, growth was significantly slower in the beclomethasone group (-0.28 SDS) compared with that in the salmeterol group (-0.03 SDS) (p = 0.001). We conclude that treatment with a moderate dose of beclomethasone is superior to salmeterol in children with mild to moderate asthma and recommend that salmeterol should not be used as monotherapy.

    Topics: Adolescent; Adrenergic beta-Agonists; Albuterol; Asthma; Beclomethasone; Body Height; Bronchial Provocation Tests; Bronchodilator Agents; Child; Double-Blind Method; Female; Follow-Up Studies; Forced Expiratory Volume; Humans; Male; Peak Expiratory Flow Rate; Salmeterol Xinafoate; Severity of Illness Index; Vital Capacity

1997
Clinical and physiological improvement after inhalation of low-dose beclomethasone dipropionate and salbutamol in wheezy infants.
    Respiration; international review of thoracic diseases, 1997, Volume: 64, Issue:5

    Twenty-nine of initially 42 infants with recurrent wheeze (20 male and 9 female) with an age range of 2.1-25.2 months were randomly assigned to receive either 100 micrograms beclomethasone dipropionate (BDP) combined with 200 micrograms salbutamol (group BDP-S, n = 9), 200 micrograms salbutamol (group S, n = 8), or placebo (group P, n = 6) 3 times daily for a 6 weeks' treatment period. Six infants had to be treated openly with BDP-S (group O, n = 6) because of deterioration in the disease state. Ten babies were excluded because of incomplete data and poor drug compliance and further 3 because of needed rescue medication. The drugs were inhaled from a metered dose inhaler through a baby-adapted spacer device, the Babyhaler. Control was assessed by symptom diaries, and infant whole-body plethysmography. Values of thoracic gas volume (TGV), airway conductance (Gaw) and specific airway conductance (sGaw) were calculated numerically independent of age and body length in percent predicted and in standard deviation scores using regression equations taken from healthy infants previously evaluated. Functional improvement was considered to have occurred when either TGV, and/or Gaw improved more than 2 SD from baseline. There was a significant improvement in the symptom score (p < 0.05), particularly concerning cough, in addition to a significant decrease in pulmonary hyperinflation (TGV: p < 0.05) and improvement of Gaw (p < 0.01) and sGaw (p < 0.01) in the BDP-S group when compared to the P group. No significant differences were found between the BDP-S and S group and/or between the S and P groups.. In wheezy infants BDP improves clinical status and lung function, when given in combination with salbutamol by a baby-adapted spacer device.

    Topics: Administration, Inhalation; Albuterol; Analysis of Variance; Asthma; Beclomethasone; Bronchodilator Agents; Chi-Square Distribution; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Infant; Male; Respiratory Function Tests; Respiratory Sounds; Treatment Outcome

1997
Inhaled beclomethasone dipropionate downregulates CD4 and CD8 T-lymphocyte activation in peripheral blood of patients with asthma.
    The Journal of allergy and clinical immunology, 1997, Volume: 100, Issue:3

    Previous studies demonstrated a downregulation of T-lymphocyte (CD3+ cells) activation in peripheral blood after treatment with inhaled corticosteroids in patients with asthma.. This study was carried out to evaluate the effect of inhaled corticosteroids on CD4 and CD8 T-lymphocyte activation, respectively.. We examined the expression of three surface activation markers (CD25, HLA-DR, and very late activation antigen 1) on circulating CD4+ and CD8+ T-cell subsets in subjects with asthma (n = 23) before and 8 weeks after treatment with inhaled beclomethasone dipropionate dry powder (daily dose, 800 microg).. Beclomethasone dipropionate treatment had a marked effect in reducing the expression of the activation marker CD25 (p < 0.01) in both CD4+ and CD8+ T-cell subsets in peripheral blood of patients with asthma. However, no correlation was found between the downregulation of CD4 and CD8 T-lymphocyte activation and the improvement in physiologic indices of disease activity.. These data add to the view that CD4+ and CD8+ T lymphocytes in peripheral blood of patients with asthma are in an activated state that is downregulated by inhaled corticosteroids.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; CD4-Positive T-Lymphocytes; CD8-Positive T-Lymphocytes; Down-Regulation; HLA-DR Antigens; Humans; Integrin alpha1beta1; Integrins; Lymphocyte Activation; Receptors, Interleukin-2; T-Lymphocyte Subsets

1997
Pharmacokinetics and dose proportionality of beclomethasone from three strengths of a CFC-free beclomethasone dipropionate metered-dose inhaler.
    Biopharmaceutics & drug disposition, 1997, Volume: 18, Issue:7

    As part of a development program to offer alternatives to chlorofluorocarbon (CFC) containing metered-dose inhalers, beclomethasone dipropionate has been formulated in a CFC-free system at three strengths: 50, 100, and 200 micrograms/actuation ex valve. To measure serum levels and dose proportionality of the beclomethasone derived from beclomethasone dipropionate, 13 mild to moderate asthmatic patients received a single dose of eight inhalations from each strength according to a double-blind crossover design. Seven patients were studied over 4 h and six patients over 12 h. For the total doses of 400, 800, and 1600 micrograms studied over 12 h, Cmax and AUC increased in a ratio of 1:1.8:3.1. A good correlation was seen between the fine-particle mass delivered and the in vivo performance of the three strengths. From a clinical point of view, the predictable increases in serum levels with an increase in dose will permit the clinician to effectively titrate a patient with this product.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Area Under Curve; Asthma; Beclomethasone; Chlorofluorocarbons; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Female; Half-Life; Humans; Male; Middle Aged; Nebulizers and Vaporizers

1997
A comparison of beclomethasone, salmeterol, and placebo in children with asthma. Canadian Beclomethasone Dipropionate-Salmeterol Xinafoate Study Group.
    The New England journal of medicine, 1997, Dec-04, Volume: 337, Issue:23

    An inhaled glucocorticoid is currently the medication of choice for long-term control of persistent asthma in children. The role of long-acting beta2-adrenergic-receptor agonists, such as salmeterol, needs to be defined.. We conducted a randomized, double-blind, placebo-controlled, parallel-group, one-year study of 241 children (mean [+/-SD] age, 9.3+/-2.4 years) with clinically stable asthma and less than one month of prior glucocorticoid use. We compared inhaled beclomethasone dipropionate (200 microg twice daily) with salmeterol xinafoate (50 microg twice daily) and placebo (lactose). The primary outcome measure, airway responsiveness (as assessed with a methacholine challenge) was evaluated before treatment; after 3, 6, 9, and 12 months of treatment (12 and 36 hours after study medications had been withheld); and 2 weeks after the end of treatment. Spirometry, symptoms, use of rescue medication (200 microg of albuterol inhaled as needed), and adverse effects were also assessed.. During months 1 through 12 overall, beclomethasone was associated with significantly less airway hyperresponsiveness than salmeterol (P= 0.003) or placebo (P<0.001). This effect was lost two weeks after treatment had been stopped. As compared with placebo, beclomethasone was associated with less variability between morning and evening in the peak expiratory flow (P=0.002), as was salmeterol (P=0.02). Beclomethasone was also associated with a reduced need for albuterol as rescue therapy (P<0.001) and fewer withdrawals because of asthma exacerbations (P=0.03), but salmeterol was not (P=0.09 and 0.55, respectively). During months 1 through 12, linear growth was 3.96 cm in the children receiving beclomethasone, as compared with 5.40 cm in the salmeterol group (P=0.004) and 5.04 cm in the placebo group (P=0.018). Height was not measured after treatment ended.. Beclomethasone was effective in reducing airway hyperresponsiveness and in controlling symptoms of asthma, but it was associated with decreased linear growth. Salmeterol was not as effective as beclomethasone in reducing airway hyperresponsiveness or in controlling symptoms; however, it was an effective bronchodilator and was not associated with rebound airway hyperresponsiveness, masking of symptoms, or adverse effects.

    Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Albuterol; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchodilator Agents; Child; Double-Blind Method; Female; Glucocorticoids; Growth; Humans; Male; Placebos; Pulmonary Ventilation; Salmeterol Xinafoate

1997
[The effect of nedocromil sodium on the clinical course, ventilatory parameters and nonspecific bronchial hyperreactivity in patients with nonatopic bronchial asthma treated with beclomethasone dipropionate].
    Pneumonologia i alergologia polska, 1997, Volume: 65, Issue:9-10

    The efficacy of nedocromil sodium (NED) (8mg twice daily) in controlling the clinical symptoms of asthma (score symptoms), the pulmonary parameters (FEV1, FVC) and bronchial hyperreactivity to histamine was assessed. The study was performed in double-blind, cross-over and placebo-controlled way in 16 patients suffering from nonatopic, stable, moderate asthma treated with beclomethasone dipropionate (from 400 micrograms to 800 micrograms). NED and placebo were administered in a randomized way with 8-week wash-out period. Bronchial reactivity to histamine, was measured as the amount of histamine causing a 20% fall in FEV1 (PC20H in mg/ml). Treatment with NED did not change asthma symptom scores, FVC and FEV1. Decreased usage of beta 2-agonist was observed. NED did not influence bronchial hyperreactivity to histamine (xg PC20H was respectively 0.09 and 0.11 mg/ml after placebo and 0.06 and 0.08 after NED). The authors conclude that studies with NED in nonatopic asthmatics should be continued, but the dosage of the drug ought to be bigger and the time of treatment ought to be longer.

    Topics: Adult; Aged; Asthma; Beclomethasone; Bronchial Hyperreactivity; Double-Blind Method; Drug Administration Schedule; Drug Interactions; Female; Histamine; Humans; Male; Middle Aged; Nedocromil; Respiratory Function Tests; Treatment Outcome

1997
Comparison of addition of theophylline to inhaled steroid with doubling of the dose of inhaled steroid in asthma.
    The European respiratory journal, 1997, Volume: 10, Issue:12

    The anti-asthmatic effects of theophylline may supplement those of inhaled steroids in asthma. The aim of the present trial was to study how the addition of theophylline compares to doubling the dose of inhaled steroid in asthmatics who remain symptomatic on beclomethasone dipropionate (BDP) 400 microg x day(-1). The trial was designed as a randomized, double-blind, parallel-group study in several European countries. Sixty nine patients were treated for 6 weeks with theophylline plus BDP 400 microg x day(-1), compared to 64 patients treated with BDP 800 micro x day(-1). The mean+/-SD serum theophylline concentration was 10.1+/-4.2 mg x L(-1). Lung function measurements were made throughout the study and patients kept daily records of peak expiratory flow (PEF), symptoms and salbutamol usage. Forced expiratory volume in one second and PEF at week 6 were significantly increased by both treatments (p<0.01). PEF variability was reduced by about 30% in both groups. There were significant improvements in asthma symptoms and rescue medication use (p<0.001). There were no significant differences between the treatment groups. The study demonstrated clinical equivalence of theophylline plus beclomethasone dipropionate 400 microg x day(-1) and beclomethasone dipropionate 800 microg x day(-1) in patients whose asthma is not controlled on beclomethasone dipropionate 400 microg x day(-1). The results support the use of theophylline as a steroid-sparing agent. The combination of low-dose inhaled steroid plus theophylline is a suitable treatment for moderate asthma.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Prognosis; Respiratory Function Tests; Statistics, Nonparametric; Theophylline; Treatment Outcome

1997
[Prevention and treatment of seasonal asthmatic patients by combined invigorating kidney for preventing asthma tablets and beclomethasone dipropinate].
    Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine, 1997, Volume: 17, Issue:12

    To evaluate the efficacy of combined Invigorating Kidney for Preventing Asthma (IKPA) tablets and beclomethasone dipropinate (BDP).. Fifty seven seasonal asthmatic patients were studied. They were randomly assigned to either of the two groups: the treated group (n = 32) treated with the IKPA tablets and inhalated BDP, the control group (n = 25) inhalated BDP singly. Measurements of serum eosinophil cationic protein (ECP), soluble IL-2 receptor (SIL-2), total eosinophil counts, spirometry and methacholine challenge were performed before and after treatment.. After 3 months' treatment and 6 months' observation the authors observed a significant improvement in both groups. The treated group had better clinical efficacy and the ECP level had reduced significantly, FEV1 increased greatly than the control group.. The two drugs influenced the function of eosinophils and and T lymphocytes and this might contribute to the efficacy.

    Topics: Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Blood Proteins; Drug Therapy, Combination; Drugs, Chinese Herbal; Eosinophil Granule Proteins; Female; Forced Expiratory Volume; Humans; Inflammation Mediators; Male; Middle Aged; Receptors, Interleukin-2; Ribonucleases; Seasons; Tablets

1997
Expression of RANTES by human bronchial epithelial cells in vitro and in vivo and the effect of corticosteroids.
    American journal of respiratory cell and molecular biology, 1996, Volume: 14, Issue:1

    Recent studies have demonstrated that RANTES, a member of the CC chemokine family affecting monocytes, T cells, basophils, and eosinophils, is expressed by several cell types. To investigate whether human bronchial epithelial cells can also express this chemokine, we investigated human bronchial epithelial cells for their ability to synthesize RANTES, both in vitro and in vivo. Additionally, we investigated the effect of treatment for 4 mo with inhaled corticosteroids on the expression of RANTES in these cells in vivo. Human bronchial epithelial cells cultured from surgical tissue expressed the mRNA for RANTES and synthesized RANTES, as demonstrated by polymerase chain reaction and immunocytochemical staining and enzyme-linked immunosorbent assay, respectively. Incubation of the cultures with 50 ng/ml of tumor necrosis factor-alpha (TNF-alpha) significantly increased the release of RANTES into culture medium after 18 to 48 h of incubation, an effect that was abolished by treatment of the cultures with anti-TNF-alpha antibody. RANTES was also expressed in the bronchial epithelium in vivo, as indicated by positive immunocytochemical staining of bronchial biopsy tissues obtained from mild asthmatic patients before and after treatment with 500 micrograms of inhaled beclomethasone dipropionate (BDP) twice daily or matched placebo for 4 mo. Quantitation, by color image analysis, of the percentage of epithelium staining for RANTES showed that treatment with BDP decreased the expression of RANTES in the bronchial epithelium from 17.12% to 4.22% (P < 0.05). The numbers of EG2-staining cells in the epithelium were also reduced, from 790.1/mm2 to 203.3/mm2 (geometric mean; P < 0.01), after BDP treatment. These results suggest that human bronchial epithelial cells are capable of synthesizing RANTES and may therefore play an important role in the development of inflammation in allergic airways disease. Furthermore, corticosteroids may prevent airway inflammation by downregulating the expression of proinflammatory cytokines in the bronchial epithelium.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Aged; Asthma; Base Sequence; Beclomethasone; Bronchi; Cells, Cultured; Chemokine CCL5; Epithelium; Humans; Immunohistochemistry; Middle Aged; Molecular Sequence Data; Polymerase Chain Reaction; RNA, Messenger; Tumor Necrosis Factor-alpha

1996
Corticosteroid-sparing effect of azelastine in the management of bronchial asthma.
    American journal of respiratory and critical care medicine, 1996, Volume: 153, Issue:1

    The objective of this double-blind trial was to evaluate the corticosteroid-sparing effect of azelastine in patients with chronic bronchial asthma. A total of 193 subjects received either 6 mg of azelastine twice per day or placebo (in a 2:1 ratio) in combination with beclomethasone dipropionate (6 to 16 inhalations per day). The number of daily inhalations of the corticosteroid was reduced until maximum reduction or elimination was achieved. Patients then entered a 12-wk maintenance period, during which patients were maintained on their lowest possible dose of inhaled corticosteroid. Compared with placebo, the azelastine group had a statistically significantly greater overall median reduction in inhaled corticosteroids (4.9 puffs/day for azelastine versus 3.1 puffs/day for placebo; p < or = 0.010) during the maintenance period. The azelastine group also had a statistically significantly higher percentage of patients with reductions of > or = 50% and > or = 75% from the baseline level (53 and 31%, respectively, for azelastine versus 34 and 14%, respectively, for placebo; p < or = 0.028). The results demonstrated that azelastine, 6 mg twice per day, can reduce the need for inhaled corticosteroids in patients with chronic bronchial asthma and not lead to a deterioration in pulmonary function.

    Topics: Administration, Inhalation; Administration, Topical; Adolescent; Adrenal Cortex Hormones; Adult; Aged; Analysis of Variance; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child; Data Interpretation, Statistical; Double-Blind Method; Female; Glucocorticoids; Histamine H1 Antagonists; Humans; Male; Middle Aged; Phthalazines; Placebos; Time Factors

1996
Randomised comparison of guided self management and traditional treatment of asthma over one year.
    BMJ (Clinical research ed.), 1996, Mar-23, Volume: 312, Issue:7033

    To compare the efficacy of self management of asthma with traditional treatment.. 12 month prospective randomised trial.. Outpatient clinics in Finland.. 115 patients with mild to moderately severe asthma.. Patient education and adjustment of anti-inflammatory therapy guided by peak flow measurements.. Unscheduled admissions to hospital and outpatient visits, days off work, courses of antibiotics and prednisolone, lung function, and quality of life.. The mean number of unscheduled visits to ambulatory care facilities (0.5 v 1.0), days off work (2.8 v 4.8), and courses of antibiotics (0.4 v 0.9) and prednisolone (0.4 v 1.0) per patient were lower and the quality of life score (16.6 v 8.4 at 12 months) higher in the self management group than in the traditionally treated group. In both groups admissions for asthma were rare.. Self management reduces incidents caused by asthma and improves quality of life.

    Topics: Adult; Aged; Ambulatory Care; Anti-Asthmatic Agents; Anti-Bacterial Agents; Asthma; Beclomethasone; Budesonide; Female; Finland; Glucocorticoids; Hospitalization; Humans; Male; Middle Aged; Patient Acceptance of Health Care; Patient Education as Topic; Peak Expiratory Flow Rate; Pregnenediones; Prospective Studies; Quality of Life; Risk Factors; Self Care; Single-Blind Method; Treatment Outcome

1996
Fluticasone propionate does not influence bone metabolism in contrast to beclomethasone dipropionate.
    American journal of respiratory and critical care medicine, 1996, Volume: 153, Issue:3

    Inhaled corticosteroids (ICS) in dosages above 1,000 micrograms/d may influence parameters of bone metabolism. Fluticasone propionate (FP) is a new ICS with a higher clinical potency than beclomethasone dipropionate (BDP) combined with negligible oral bioavailability. The aim of this study was to evaluate the effects of FP and BDP in clinically equipotent dosages on indices of bone metabolism and morning cortisol. FP 750 micrograms/d and BDP 1,500 micrograms/d were compared in a randomized, double-blind, crossover study consisting of two 6-wk treatment periods, each preceded by a 3-wk single-blind placebo period. Twenty-one nonsmoking asthmatic completed the study. FP had the same effect on FEV1 and peak expiratory flow as the double dose of BDP. Both treatments did not change morning cortisol. BDP decreased both osteocalcin and procollagen type 1 carboxyterminal propeptide, indices of bone formation, significantly by 18.5 and 21.9%, respectively. In contrast, FP did not change any variable of bone formation. FP and BDP did not increase type 1 collagen carboxyterminal telopeptide and deoxypyridinoline crosslinks, both markers of bone resorption. In changes in parameters of bone metabolism indicate adverse effects on bone quality in the long term, FP may offer an advantage over BDP.

    Topics: Administration, Topical; Adolescent; Adult; Amino Acids; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bone and Bones; Bone Resorption; Circadian Rhythm; Cross-Over Studies; Double-Blind Method; Female; Fluticasone; Forced Expiratory Volume; Humans; Hydrocortisone; Male; Middle Aged; Osteocalcin; Osteogenesis; Peak Expiratory Flow Rate; Peptide Fragments; Procollagen; Single-Blind Method

1996
Influence of inhaled steroids on recovery from occupational asthma after cessation of exposure: an 18-month double-blind crossover study.
    American journal of respiratory and critical care medicine, 1996, Volume: 153, Issue:3

    Occupational asthma (OA) is a useful model for the study of asthma in humans. The possibility that inhaled corticosteroids, in addition to withdrawal from the workplace, could improve clinical and functional recovery from OA can be hypothesized. We assessed clinical, functional, and behavioral characteristics of 32 subjects (22 male, 10 female), in all but one of whom OA was confirmed by specific inhalation challenges induced by either high- (n=13) or low-molecular-weight (n=19) agents within 3 mo after cessation of exposure. In this randomized, crossover, double-blind study, subjects (paired for baseline PC20 and duration of symptoms after exposure) received either placebo or 1,000 micrograms of inhaled beclomethasone daily for 1 yr, followed by the alternate medication for 6 mo. Various clinical, functional, and behavioral parameters were examined at each 3-mo visit. Significant improvement in clinical (nocturnal symptoms, cough), functional (morning and evening peak expiratory flow rates), and behavioral (quality of life) parameters were detected in the active-treatment period, although the magnitude of the improvement was relatively small. Side effects (oropharyngeal, reduced cortisol) were similar in the placebo and treatment groups. Distinguishing subjects who started with the active preparation from those who were given placebo first showed that most clinical and behavioral parameters improved in the former instance, whereas there was no significant difference in the latter. We conclude that inhaled corticosteroids induce a small but significant overall improvement of the asthmatic condition in subjects with occupational asthma caused by high- and low-molecular-weight agents after withdrawal from exposure. The beneficial effect is, however, more pronounced if inhaled steroids are given early after diagnosis.

    Topics: Administration, Inhalation; Adult; Allergens; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Candida albicans; Cough; Cross-Over Studies; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Hydrocortisone; Male; Middle Aged; Molecular Weight; Occupational Diseases; Occupational Exposure; Oropharynx; Peak Expiratory Flow Rate; Quality of Life; Vital Capacity

1996
Comparison of addition of salmeterol to inhaled steroids with doubling of the dose of inhaled steroids.
    American journal of respiratory and critical care medicine, 1996, Volume: 153, Issue:5

    A study was done to compare the efficacy and safety of the coprescription of salmeterol 50 microgram twice daily or 100 microgram twice daily with beclomethasone dipropionate (BDP) 500 micrograms twice daily (SALM 50 and SALM 100) with BDP 1,000 microgram twice daily (BDP 1,000) in patients with asthma not controlled by BDP 500 microgram twice daily (or the equivalent). Following a run-in period, 738 patients at 72 centers were randomized to treatment for 24 wk in a double-blind, parallel-group study during which they maintained a daily record of peak expiratory flow rates (PEFRs) and symptom scores. At about 40 of the centers, bronchial hyperresponsiveness (BHR) to histamine was measured during and at 3 and 14 d after stopping treatment. Both groups taking salmeterol showed an improvement of more than 45 L/min in their morning PEFR and 30 L/min in their evening PEFR, compared with respective improvements of 16 L/min and 6 L/min in the group taking BDP 1,000. Both the SALM 50 and SALM 100 groups had a significantly increased percentage of symptom-free and rescue-free days and nights compared with the BDP 1,000 group, and there was no difference between the two salmeterol groups. None of the treatments altered BHR. Exacerbation rates did not differ among the three groups. We conclude that in this selected group of symptomatic patients taking BDP 500 micrograms twice daily, the addition of salmeterol provides better improvement in lung function and symptom control, without altering BHR or increasing exacerbation rates, than does doubling the dose of BDP.

    Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Female; Forced Expiratory Volume; Histamine; Humans; Lung; Male; Middle Aged; Peak Expiratory Flow Rate; Salmeterol Xinafoate

1996
Inhaled corticosteroids do not prevent the development of tolerance to the bronchoprotective effect of salmeterol.
    Chest, 1996, Volume: 109, Issue:4

    Twice-daily inhaled salmeterol produces rapid reduction in its acute bronchoprotective effect against methacholine in patients with mild asthma. This investigation examined this effect in patients with moderate asthma who were using inhaled corticosteroids.. Eight asthmatic volunteers who required inhaled corticosteroids for control of their symptoms and who were able to withhold treatment with beta 2-agonists for 4 weeks before and during the study participated in a double-blind, crossover, placebo-controlled study with two random-order treatment periods: inhaled salmeterol, 50 microg twice a day for seven doses, and placebo in similar fashion, with a 7-day or greater washout between these periods. Methacholine inhalation tests were done 1 h after doses 1, 3, 5, and 7, and then 24 h after the last dose of the study inhaler, 10 min post-200 microg salbutamol.. Baseline FEV1 measurements before doses 3, 5, and 7 of salmeterol, ie, 12 h after salmeterol, were significantly higher than all other baseline values. Twenty-four hours after the last dose of salmeterol, the FEV1 was no different from that during the placebo period. The geometric mean methacholine concentration causing a 20% fall in FEV1 (PC20) following the third dose of salmeterol (6.8 mg/mL) was significantly lower than after the first dose of salmeterol (12.0 mg/mL; p=0.031), and this reduction of bronchoprotection persisted following doses 5 and 7. The methacholine PC20 10 min postsalbutamol measured after the salmeterol period was significantly lower than after placebo (5.6 vs 13.3 mg/mL; p<0.001).. Tolerance to the acute bronchoprotective effect of salmeterol was significant after the first two doses and persisted after the seventh dose. Tolerance to the acute bronchoprotective effect of salbutamol was also significant after regular use of salmeterol for seven doses. These effects, in subjects using inhaled corticosteroids regularly, were similar to the those previously seen in patients with mild asthma using as-required beta 2-agonists only, indicating that tolerance is not prevented by use of inhaled corticosteroids.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchoconstriction; Bronchoconstrictor Agents; Bronchodilator Agents; Budesonide; Cross-Over Studies; Double-Blind Method; Drug Tolerance; Female; Forced Expiratory Volume; Humans; Male; Methacholine Chloride; Middle Aged; Placebos; Pregnenediones; Salmeterol Xinafoate; Tachyphylaxis

1996
Comprehensive long-term management program for asthma: effect on outcomes in adult African-Americans.
    The American journal of the medical sciences, 1996, Volume: 311, Issue:6

    To determine if a comprehensive long-term management program, emphasizing inhaled corticosteroids and patient education, would improve outcomes in adult African-American asthmatics a nonrandomized control trial with a 2-year intervention was performed in a university-based clinic. Inclusion criteria consisted of (> or = 5) emergency department (ED) visits or hospitalizations (> or = 2) during the previous 2 years. Intervention patients were volunteers; a comparable control group was identified via chart review at hospitals within the same area and time period as the intervention patients. Individualized doses of beclomethasone with a spacer, inhaled albuterol "as needed," and crisis prednisone were the primary therapies. Environmental control, peak flow monitoring, and a partnership with the patient were emphasized. Detailed patient education was an integral part of management. Control patients received usual care from local physicians. ED visits and hospitalizations for 2 years before and 2 years during the intervention period were compared. Quality of life (QOL) measurements were made at baseline and every 6 months in the intervention group. Study group (n = 21) had a significant reduction in ED visits (2.3 +/- 0.2 pre-intervention versus 0.6 +/- 0.2 post-intervention; P = 0.0001). Control group (n = 18) did not have a significant change in ED visits during the 2-year post-intervention period (2.6 +/- 0.2 pre-intervention versus 2.0 +/- 0.2 post-intervention; P = 0.11). Both groups had significant reductions in hospitalizations, but the study group had a greater reduction. Sixty-two percent of study patients had complete elimination of ED visits and hospitalizations, whereas no control patients had total elimination of the need for institutional acute care. QOL in the study patients revealed significant improvements for most parameters. A comprehensive long-term management program emphasizing inhaled corticosteroids combined with other state-of-the-art management, including intensive patient education, improves outcomes in adult African-American asthmatics.

    Topics: Adrenal Cortex Hormones; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Black or African American; Drug Therapy, Combination; Emergencies; Hospitalization; Humans; Patient Education as Topic; Prednisone; Program Evaluation; Quality of Life; Treatment Outcome

1996
Is delayed introduction of inhaled corticosteroids harmful in patients with obstructive airways disease (asthma and COPD)? The Dutch CNSLD Study Group. The Dutch Chronic Nonspecific Lung Disease Study Groups.
    Chest, 1996, Volume: 110, Issue:1

    The institution of inhaled corticosteroids is generally advocated for effective treatment of patients with asthma. It is yet unknown what is the best time to start inhaled corticosteroid therapy and especially whether delayed introduction is harmful. PHASE 1: In a previous study in patients with asthma and COPD, we found that 2.5 years of treatment with a beta 2-agonist plus inhaled corticosteroid (BA + CS) was more effective in improving the FEV1 and the provocative concentration of histamine causing a 20% reduction in FEV1 (PC20) than treatment with a beta 2-agonist plus anticholinergic (BA + AC) or placebo (BA + PL). PHASE 2: We extended this study with 6 months to investigate whether delayed introduction of inhaled CS therapy (800 micrograms beclomethasone dipropionate) in the groups previously not treated with inhaled CS (BA +/- AC) could also improve FEV1 and PC20 to the same degree. A distinction was made between patients with predominantly asthma (high baseline reversibility, delta FEV1 > or = 9% of predicted), and predominantly COPD (low baseline reversibility, delta FEV1 < 9% of predicted).. Improvement of FEV1 percent predicted by inhaled CS was comparable both in the asthmatics between phase 1 (13.8% predicted) and phase 2 (8.5% predicted; p = 0.31) as well as in the patients with COPD (2.5% and 1.5% predicted, respectively). PC20, however, increased significantly more in the asthmatics in phase 1 (1.77 doubling concentration [DC]) than in phase 2 (0.79 DC; p = 0.03). Improvement of PC20 in the patients with COPD was not significantly higher in phase 1 (0.74 DC) than in phase 2 (0.00 DC; p = 0.19).. Our study indicates that although delayed introduction of inhaled CS in asthmatics leads to similar improvements in FEV1, improvements in PC20 are significantly less. These findings in patients with longer-existing asthma concur with other findings in newly detected asthma. We suggest that institution of inhaled CS therapy should not be postponed in asthmatics with documented airways obstruction and reversibility.

    Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Adult; Asthma; Beclomethasone; Bronchial Provocation Tests; Double-Blind Method; Drug Therapy, Combination; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Residual Volume; Terbutaline; Time Factors; Total Lung Capacity

1996
Asthma treatment in pregnancy: a randomized controlled study.
    American journal of obstetrics and gynecology, 1996, Volume: 175, Issue:1

    Our purpose was to study the effect of inhaled corticosteroids on asthma exacerbations in pregnancy.. We prospectively studied 84 pregnant women with 105 asthma exacerbations. Women were hospitalized if the forced expiratory volume in 1 second was < 70% after sequential bronchodilator therapy. They were randomly assigned to receive either intravenous aminophylline and inhaled beta 2-adrenergic receptor agonist or intravenous methylprednisolone and a beta 2-adrenergic receptor agonist. At discharge women were randomly assigned to receive either inhaled beclomethasone, beta 2-adrenergic receptor agonist, and an oral corticosteroid taper or a beta 2-adrenergic receptor agonist and a corticosteroid taper.. Sixty-five (62%) of 105 women with exacerbation required hospitalization. Aminophylline did not shorten response time or decrease hospital stay. Readmission rate was decreased by 55% in women given inhaled beclomethasone (33% vs 12%, p < 0.05, odds ratio 3.63, 95% confidence interval 1.01 to 13.08). Pregnancy-induced hypertension and cesarean delivery were increased over those of the general population.. Intravenous aminophylline offers no therapeutic advantages. Continuous inhaled corticosteroids reduced the need for subsequent admissions.

    Topics: Acute Disease; Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Albuterol; Aminophylline; Asthma; Beclomethasone; Bronchodilator Agents; Drug Therapy, Combination; Female; Humans; Infusions, Intravenous; Methylprednisolone; Obstetric Labor Complications; Pregnancy; Pregnancy Complications; Prospective Studies; Treatment Outcome

1996
Anti-inflammatory effects of inhaled beclomethasone dipropionate in nonatopic asthmatics.
    The European respiratory journal, 1996, Volume: 9, Issue:4

    The effects of inhaled beclomethasone dipropionate (BDP) on asthma symptoms and infiltration of the bronchial mucosa by inflammatory cells were investigated in an open study of 10 patients with mild-to-moderate nonatopic bronchial asthma. Asthma scores were recorded in an asthma diary. Peak expiratory flow (PEF), PEF diurnal variation (PEF%), forced expiratory volume in one second (FEV1%), methacholine airway hypersensitivity (minimum dose of methacholine) (Dmin) were measured. Biopsy of the bronchial mucosa was performed before and after 8 weeks of treatment with BDP (400 micrograms.day-1). The following inflammatory cells were immunostained: eosinophils with anti-EG2; mast cells with AA1; neutrophils with NP57; T-lymphocytes with anti-CD3, CD4, and CD8; and activated T-lymphocytes with anti-CD25. There was a significant improvement in the asthma symptom score, PEF%, FEV1%, and Dmin after BDP therapy and the number of EG2-, AA1-, CD3-, CD4-, and CD25-positive cells decreased significantly. We conclude that inhaled beclomethasone dipropionate inhibited inflammatory cell infiltration of airway tissue and that associated with this there was an improvement of symptoms in this open study of inhaled beclomethasone dipropionate in a group of nonatopic asthmatic subjects.

    Topics: Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biopsy; Bronchi; Bronchial Provocation Tests; Cell Count; Eosinophils; Female; Humans; Lymphocyte Count; Male; Mast Cells; Middle Aged; Mucous Membrane; Nebulizers and Vaporizers; Neutrophils; T-Lymphocyte Subsets

1996
Effect of salmeterol compared with beclomethasone on allergen-induced asthmatic and inflammatory responses.
    The European respiratory journal, 1996, Volume: 9, Issue:3

    Salmeterol is a selective long-acting beta 2-agonist bronchodilator considered to have added anti-inflammatory effects, but this is controversial. We investigated the effects of a single dose of salmeterol, 100 micrograms, on the physiological and inflammatory responses to inhaled allergen and compared these with the effects of a single dose of beclomethasone, 500 micrograms, and of placebo. Eight atopic adults with mild stable asthma, treated only with inhaled short-acting beta 2-agonist when needed, attended the laboratory sequentially for screening tests, two single-blind control inhalation tests preceded 30 min by placebo or salmeterol and three allergen inhalation tests preceded by placebo, salmeterol or beclomethasone double-blind in random order. Airway responsiveness to methacholine (assessed as the provocative concentration of methacholine producing 20% fall in forced expiratory volume in one second (PC20)), induced sputum eosinophils, blood eosinophils and serum eosinophil cationic protein (ECP) were examined before and 7-48 h after treatment. The statistical power to detect twofold changes in blood and sputum parameters was > or = 90%. Salmeterol inhaled before allergen challenge completely prevented the early asthmatic response, late asthmatic response and fall in methacholine PC20 at 24 h, and produced additional bronchodilatation. These effects were similar to those obtained by the inhalation of a single dose of salmeterol before the control inhalation test, and significantly better than those observed after a single dose of beclomethasone inhaled before the allergen test. Beclomethasone had no effect on the early asthmatic response or on the fall in methacholine PC20 at 24 h but partially inhibited the late asthmatic response. Neither salmeterol nor beclomethasone had any significant effect on sputum or blood inflammatory changes 7-48 h after allergen inhalation. In conclusion, whilst salmeterol had no demonstrable anti-inflammatory action in sputum after allergen challenge in asthma, neither did a single dose of the positive anti-inflammatory control, beclomethasone. The latter result excludes a more positive judgement on the possible anti-inflammatory action of salmeterol. However, the results do indicate that potent functional effects of a single dose of salmeterol can mask the airway inflammatory cell influx caused by inhaled allergen.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Albuterol; Allergens; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchoconstriction; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Eosinophils; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Salmeterol Xinafoate; Spirometry; Sputum; Treatment Outcome

1996
[High-dose inhaled beclomethasone in long-term management of chronic severe asthma--usefulness and dose-dependence].
    Nihon Kyobu Shikkan Gakkai zasshi, 1996, Volume: 34, Issue:5

    We studied the usefulness of 18 weeks of therapy with two high doses of inhaled beclomethasone dipropionate (BDP) in the management of severe asthma in adults. The patients had asthma symptoms that had not been controlled by combination therapy with BDP (800 micrograms/day) and bronchodilators. They were divided into two groups. Patients in group A (n = 16) were treated with 1800 micrograms/day of BDP and bronchodilators. Patients in group B (n = 10) were treated with 1400 micrograms/day of BDP and bronchodilators. BDP was inhaled via a large spacer (Volumatic). Eleven patients in group A and 6 patients in group B had been given an oral steroid regularly before the study. Asthma symptom scores, peak expiratory flow (PEF), pulmonary function, bronchial reactivity to methacholine, the total amount of oral steroid, and adrenocortical function were recorded. Results. 1) Clinical characteristics before the start of the study did not differ between groups. 2) Asthma symptom scores decreased to a greater extent in patients who received the higher dose of BDP than in those who received the lower dose. 3) Only the higher dose of BDP significantly increased evening and morning % PEF, as measured 6 weeks and 8 weeks after the start of the treatment. 4) Only the higher dose of BDP significantly increased the FEV1 and the PC20 for methacholine. FVC did not increase. 5) Only the higher dose of BDP significantly decreased the total amount of oral steroid needed to control asthma. 6) Results of the rapid ACTH test indicated that neither dose of BDP suppressed adrenocoritical function. Furthermore, the serum cortisol level measured early in the morning increased to within the normal range in the three patients in whom oral steroid therapy could be reduced or stopped after treatment. These data indicate that 1800 micrograms of BDP per day is more effective than 1400 micrograms/day at the beginning of long-term management of severe chronic asthma in adults whose symptoms are not controlled with the combination of 800 micrograms/day BDP and bronchodilators. Therapy with a higher dose (at least 1600 micrograms/day) of an inhaled steroid is more useful and should be promptly begun to treat severe asthma.

    Topics: Administration, Inhalation; Adult; Age of Onset; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chronic Disease; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged

1996
Reversion and antihistamines.
    The Journal of the Association of Physicians of India, 1996, Volume: 44, Issue:1

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Cetirizine; Cromolyn Sodium; Glucocorticoids; Histamine H1 Antagonists; Humans; Nasal Decongestants; Recurrence; Rhinitis, Allergic, Perennial; Terfenadine

1996
Influence of treatment with beclomethasone, cromoglycate and theophylline on perception of bronchoconstriction in patients with bronchial asthma.
    Clinical science (London, England : 1979), 1996, Volume: 90, Issue:3

    1. Perception of asthma by patients can be assessed from the relationship between symptom scores and peak expiratory flows. This study was designed to investigate the possibility that medication can affect perception of the sensation of asthma independently of changes in lung function. 2. Twelve subjects whose asthma was inadequately controlled by inhaled bronchodilator alone were studied during four different drug treatments over 3 months. Subjective self-assessment of asthma was scored on a 10 cm visual analogue scale and followed by three consecutive measurements of peak expiratory flow, using a coded electronic peak flow meter. This was recorded not less than three times daily on diary cards. Observations were recorded during the second week of each of four treatments: (i) a run-in period using only inhaled salbutamol as required, (ii) inhaled beclomethasone, (iii) inhaled cromoglycate and (iv) oral theophylline at a dose adjusted to achieve blood levels of 10-20 mg/l. Inhaled salbutamol was permitted during the other treatments as required. Changes in the slope and position of the regression lines of asthma scores on PEF were used to measure changes in perception of asthma on each treatment. Dynamic lung volumes were measured in the clinic before the study and after each treatment period. 3. In the group as a whole, theophylline improved lung function (mean peak flow and dynamic lung volumes) without affecting mean visual analogue scores, beclomethasone improved mean visual analogue scores with much less effect on lung function, while cromoglycate had a small though consistent effect on both. 4. Perception of asthma, measured by the relationship between peak flow rate and visual analogue scores, was unaffected by cromoglycate. On theophylline, perception of asthma was heightened in five subjects despite a definite improvement in their peak flow. On beclomethasone, perception of asthma was reduced in most subjects, often with no discernible improvement in mean peak flow or dynamic spirometry. 5. Perception of bronchoconstriction in asthma can be affected by drugs independently of control of the condition. Theophylline may produce a paradoxical increase in awareness of asthma in some individuals. With beclomethasone therapy a reduction in symptoms of asthma may occur without any improvement in tests of air flow.

    Topics: Adult; Albuterol; Asthma; Beclomethasone; Bronchoconstriction; Bronchodilator Agents; Cromolyn Sodium; Female; Humans; Lung; Lung Volume Measurements; Male; Middle Aged; Peak Expiratory Flow Rate; Perception; Theophylline

1996
A methodological assessment of diurnal variability of peak flow as a basis for comparing different inhaled steroid formulations.
    The Journal of allergy and clinical immunology, 1996, Volume: 98, Issue:3

    A "survival" model offers certain ethical and practical advantages over alternative experimental designs if used to compare antiasthmatic inhaled steroid formulations. The model requires an objective daily measure of therapeutic effect (e.g., peak expiratory flow rate, which may be expressed as the lower of two daily measurements (LPF) or as diurnal variability (DVPF). The relative efficiency of these two measures is unknown.. This study was conducted to determine the relative efficiency of LPF and DVPF.. We analyzed data from a placebo-controlled comparison of an active inhaled formulation of budesonide versus an inactive oral formulation. The primary outcome measure in this design is the number of days from the time the test treatments start until a statistically significant deterioration occurs from an optimal asthma control value established at baseline.. DVPF proved less sensitive than LPF; that is, fewer patients relapsed during the 8-week trial period: 32 versus 41, respectively. Also, the median interval until relapse was longer: 24 versus 9 days. With LPF, inhaled budesonide proved more effective than placebo or oral budesonide (p = 0.03), whereas DVPF failed to discriminate among the test treatments (p = 0.38). LPF correlated with all three symptom indices (p > or = 0.003) and two of three spirometric indices measured concomitantly (p < or = 0.04). DVPF did not correlate with any index (p > or = 0.10).. In this experimental model, LPF proved more sensitive and valid than DVPF as an indicator of differences in antiasthmatic potency between two inhaled steroid formulations.

    Topics: Administration, Inhalation; Administration, Oral; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Circadian Rhythm; Double-Blind Method; Female; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Pregnenediones; Retrospective Studies

1996
Controlled trial of methotrexate in patients with severe chronic asthma.
    European journal of clinical pharmacology, 1996, Volume: 49, Issue:5

    The aim of this study was to investigate the efficacy and adverse effects of methotrexate (MTX) in the treatment of severe chronic asthma in 12 patients with severe asthma requiring continuous treatment with oral steroids at the Outpatient Department of Helsinki University Central Hospital. The study was a randomised, double-blind placebo-controlled trial of methotrexate treatment 15 mg weekly on a crossover basis over 24 weeks. During the 2 weeks baseline phase the mean dose of oral steroids administered was 10.9 (3.2-28) mg.day-1, and the mean dose of inhaled steroids administered was 2.3 (1.6-3.2) mg budesonide or beclomethasone. The average dose of oral steroids administered was 12.8 mg.day-1 during the last 2 placebo weeks but only 7.9 mg.day-1 during the last 2 weeks with MTX treatment. The reduction in daily dose of oral steroids was 38%, while daily bronchodilator use was reduced by 22%. During MTX treatment the patients experienced significantly less wheezing, dyspnoea and coughing. Nine out of 12 patients reported better asthma control during MTX treatment. The peak expiratory flow rate (PEF) 1-s forced expiratory volume (FEV1) values did not differ between MTX and placebo treatments. There was no statistical correlation between serum MTX concentration and clinical improvement. No serious adverse effects of MTX were found during the study. It was concluded that low-dose MTX may be beneficial for severe chronic asthma and that this therapy is well tolerated by patients.

    Topics: Administration, Inhalation; Administration, Oral; Adult; Aerosols; Analysis of Variance; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Cross-Over Studies; Double-Blind Method; Female; Folic Acid Antagonists; Forced Expiratory Volume; Humans; Male; Methotrexate; Middle Aged; Peak Expiratory Flow Rate; Pregnenediones

1996
Eicosanoids and lipocortin-1 in BAL fluid in asthma: effects of smoking and inhaled glucocorticoids.
    Journal of applied physiology (Bethesda, Md. : 1985), 1996, Volume: 81, Issue:2

    Both smoking and asthma are associated with inflammatory changes in the lung, which may be suppressed with the help of exogenous anti-inflammatory drugs or by the endogenous defense system. Lipocortin-1 (LC-1; annexin-1) is an anti-inflammatory protein present in respiratory tract secretions. We report an inverse correlation between extracellular LC-1 concentration and the bronchoconstrictor prostaglandin (PG) D2 [n = 15, Spearman rank correlation coefficient (rS) = -0.597, P < 0.05] in bronchoalveolar lavage fluid (BALF) from allergic asthmatic patients, together with positive correlations between extracellular LC-1 per milliliter BALF and the prostacyclin (PGI2) metabolite 6-keto-PGF1 alpha (n = 15, rS = 0.480, P < 0.05) and between LC-1 per milliliter BALF and concentration of histamine causing a 20% decrease in forced expired volume in 1 s (n = 15, rS = 0.720, P < 0.01) in these subjects. We found no significant difference between the LC-1 concentration in BALF from nonsmoking asthmatic patients who were receiving inhaled glucocorticoid therapy (2 x 100 micrograms beclomethasone 4 times/day for 2.5 yr; median 186 ng LC-1/mg albumin; n = 6) and those who were not (median 126 ng LC-1/mg albumin; n = 12), perhaps because inhaled drugs deposit predominantly in central airways, which are poorly represented in bronchoalveolar lavage. Both asthmatic and healthy volunteers who smoked had higher levels of LC-1 in their BALF than did their nonsmoking counterparts (e.g., asthmatic smokers, median 317 ng LC-1/mg albumin, n = 10; asthmatic nonsmokers, median 162 ng LC-1/mg albumin, n = 18; P < 0.05), perhaps because smokers' lungs contain more alveolar macrophages, cells that release LC-1. We observed a positive correlation between BALF LC-1 and bronchoalveolar lavage cell number (n = 16, rS = 0.821, P < 0.001). Increased extracellular LC-1 may be part of a protective response of the lung to inflammatory insult. Regulation of prostanoid levels might be one mechanism by which LC-1 suppresses inflammation.

    Topics: 6-Ketoprostaglandin F1 alpha; Administration, Inhalation; Adult; Annexin A1; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchoalveolar Lavage Fluid; Eicosanoids; Female; Glucocorticoids; Histamine; Humans; Male; Middle Aged; Pulmonary Alveoli; Respiratory Function Tests; Smoking

1996
Serum eosinophil cationic protein (ECP) as a marker of disease activity and treatment efficacy in seasonal asthma.
    Allergy, 1996, Volume: 51, Issue:8

    This study was carried out to determine whether serum eosinophil cationic protein (ECP) represents a sensitive marker for disease activity in atopic asthmatic patients during the pollen season. The study, in double-blind fashion, was performed between February and June 1994. Two groups of 10 seasonal asthmatic patients randomly received two different treatments. The first group was treated with inhaled beclomethasone dipropionate (BDP) 500 micrograms bid; the second received a matched placebo (P). At the beginning and every month, blood samples for determination of ECP and eosinophil count were collected and lung function (FEV1) and methacholine responsiveness (PD20) were performed. Subjects recorded daily symptoms of asthma, salbutamol consumption, and peak expiratory flow (PEF) values. In the P group, all indices, except FEV1, showed significant changes during the pollen season (P < 0.001). In the BDP group, significant changes were detected for symptom score (P < 0.01), salbutamol consumption (P < 0.01), and eosinophil number (P < 0.05). Between the two groups, significant differences for symptom score (P < 0.001), salbutamol consumption (P < 0.001), ECP levels (P < 0.05), eosinophil count (P < 0.02), PD20 methacholine (P < 0.02), and PEF values (P < 0.01) were detected. Changes in serum ECP significantly correlated with changes in other parameters (P < 0.001), except FEV1. Our results provide evidence that serum ECP is a sensitive marker for monitoring of the disease activity in seasonal asthma. Furthermore, it may offer a useful tool for estimating treatment efficacy.

    Topics: Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biomarkers; Blood Proteins; Bronchial Provocation Tests; Bronchodilator Agents; Double-Blind Method; Eosinophil Granule Proteins; Eosinophils; Female; Forced Expiratory Volume; Humans; Leukocyte Count; Male; Methacholine Chloride; Middle Aged; Peak Expiratory Flow Rate; Pollen; Ribonucleases; Seasons; Skin Tests

1996
A comparison of the effects of oral cetirizine and inhaled beclomethasone on early and late asthmatic responses to allergen and the associated increase in airways hyperresponsiveness.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 1996, Volume: 26, Issue:8

    Cetirizine is a non-sedating H1 antihistamine which is effective in the treatment of allergic rhinitis and urticaria. It inhibits eosinophil and basophil chemotaxis in late cutaneous allergic reactions in skin windows. Its effect on early (EAR) and late asthmatic reactions (LAR) is less certain.. We examined the effect on EAR and LAR of 3 days treatment with oral cetirizine (15 mg twice daily) compared with a single dose of inhaled beclomethasone 10 min prior to allergen challenge in a placebo-controlled (oral and inhaled) double-blind cross-over design with three treatment arms separated by 14 days.. Cetirizine did not significantly inhibit either the EAR or LAR documented by maximum percentage fall in FEV1 (0-3 and 6-9 h) or as area under the curve (AUC between 0 and 3 and 6-9 h). Beclomethasone inhibited the LAR compared with placebo (P = 0.02) when expressed as AUC (6-9 h). This did not quite reach statistical significance (P = 0.06) when expressed as maximal percentage late fall in FEV1 between 6 and 9 h. A greater than twofold increase in airways responsiveness to methacholine was observed 3 h after challenge which was significantly reduced by beclomethasone compared with placebo (P < 0.02) and cetirizine (P < 0.05). The data suggest that oral cetirizine does not significantly inhibit either the EAR or LAR. Beclomethasone inhibited both the early increase in airways responsiveness and the subsequent LAR. Our study also confirms the view that early increases in airway responsiveness precede the late response and suggests that these associated events are not dissociable by the pharmacological treatments employed in this study.

    Topics: Administration, Inhalation; Administration, Oral; Adult; Allergens; Antigens, Dermatophagoides; Asthma; Beclomethasone; Bronchial Hyperreactivity; Cetirizine; Cross-Over Studies; Double-Blind Method; Female; Forced Expiratory Volume; Glycoproteins; Humans; Hypersensitivity, Immediate; Male; Middle Aged; Poaceae; Time Factors

1996
Effect of addition of inhaled salmeterol to the treatment of moderate-to-severe asthmatics uncontrolled on high-dose inhaled steroids. European Respiratory Study Group.
    The European respiratory journal, 1996, Volume: 9, Issue:9

    The aim of this study was to assess the efficacy and safety of inhaled salmeterol 100 micrograms b.d. (SM) versus inhaled salbutamol 400 micrograms q.d.s. (SB), both via the Diskhaler, when added to concurrent treatment, in asthmatic patients who were not controlled on high doses of inhaled steroids (> or = 1,500 micrograms beclomethasone dipropionate (BDP) or equivalent daily). This was a multicentre, parallel group, double-blind study in which 190 patients with a forced expiratory volume in one second (FEV1) or peak expiratory flow rate (PEFR) of 30-75% predicted and 15% reversibility to inhaled bronchodilator were randomized to treatment for 6 weeks. In the SM group, morning PEFR increased from 281 to 315 L-min-1 during treatment and in the SB group from 311 to 315 L.min-1 (p < 0.001). The SM group showed significantly better reduction in diurnal variation, from 39 to 22 L.min-1 during treatment, than the SB group (34 to 37 L.min-1) (p < 0.001). There was a significantly greater improvement in FEV1 in the SM group (from 1.63 to 1.85 L) than in the SB group (from 1.79 to 1.84 L). The SM group had significantly more symptom-free nights than the SB group (p < 0.001), and also more "rescue-free" nights (p = 0.04). The adverse event profile was similar in both groups. This study indicates that in asthmatic patients, not controlled on high-dose inhaled steroids, inhaled salmeterol 100 micrograms b.d. significantly improves lung function and reduces asthma symptoms.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Aged, 80 and over; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Circadian Rhythm; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Lung; Male; Middle Aged; Peak Expiratory Flow Rate; Placebos; Pregnenediones; Salmeterol Xinafoate

1996
Fluticasone propionate 1 mg daily and beclomethasone dipropionate 2 mg daily: a comparison over 1 yr.
    Respiratory medicine, 1996, Volume: 90, Issue:10

    This study was designed primarily to assess the safety and tolerability of fluticasone propionate (FP) 1 mg day-1 by comparison with beclomethasone dipropionate (BDP) 2 mg day-1 over a 12-month study period. Lung function data were also recorded and used to determine whether the potency ratio between the two inhaled corticosteroids observed in previous studies was maintained in the long-term. Two hundred and thirteen patients with an established clinical history of severe chronic asthma and who were currently receiving between 1000 micrograms and 2000 micrograms day-1 of inhaled steroids were randomized to treatment in a ratio of 3:1 for FP:BDP (159 patients FP; 54 patients BDP), both via metered dose inhalers. Both treatments were well tolerated with a similar adverse event profile. No unexpected adverse events were recorded. Most adverse events were related to the patients' asthma, an intercurrent infection or underlying atopy. The incidence of pharmacologically predictable adverse events was equally low in both treatment groups as was the incidence of events suggestive of systemic steroid effect. Mean serum cortisol levels remained within the normal range at all visits for both treatments. At 12 months, however, the mean cortisol levels for the FP group had risen 4% above the baseline value but had dropped 15% below for the BDP group, giving a ratio of FP:BDP of 1.22; P = 0.01; 95% confidence limits (CL) 1.05-1.43. Fluticasone propionate 1 mg day-1 was at least as effective as BDP 2 mg day-1 in improving lung function (PEF, FEV1 and FVC) over this period. Moreover, the difference in FEV1 values at 6 months was significantly greater for the FP group than for the BDP group (P = 0.04; difference = 0.12 1; 95% CL = 0.01, 0.24 1). The difference between treatments in the amount of FEV1 reversibility was also significantly greater for FP at 12 months (difference in treatments = -3%; 95% CL = - 7-0%; P = 0.044). This study supports previous studies and suggests that FP is likely to be of benefit in the long-term treatment of chronic severe asthma.

    Topics: Adolescent; Adult; Aged; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Double-Blind Method; Drug Administration Schedule; Drug Delivery Systems; Female; Fluticasone; Forced Expiratory Volume; Humans; Hydrocortisone; Lung; Male; Middle Aged; Nebulizers and Vaporizers

1996
A comparison of the effects of oral prednisone and inhaled beclomethasone dipropionate on circulating leukocytes.
    Australian and New Zealand journal of medicine, 1996, Volume: 26, Issue:6

    While the side effects of oral glucocorticoids are well recognised there is debate about the systemic effects of high doses of inhaled glucocorticoids such as beclomethasone dipropionate and how these compare with the effects of oral prednisone.. To compare the effects of different doses of oral prednisone and inhaled beclomethasone dipropionate (BDP) on changes in circulating leukocytes.. Changes in different subsets of circulating leukocytes were measured as an index of the systemic effects of inhaled BDP and oral prednisone. We compared the effects of inhaled placebo and 500 and 1000 micrograms of inhaled BDP with oral placebo and 2.5, 5 and 10 mg of prednisone in eight healthy volunteers. Leukocyte numbers were measured before and four hours after each dose of medicine.. Compared with inhaled placebo, 1000 micrograms of inhaled BDP led to a significant increase in neutrophils as a percentage of the total white count (p < 0.05) and a significant decrease in the total lymphocyte number (p < 0.05) and in the number of CD4 lymphocytes (p < 0.05). For 1000 micrograms BDP the increase in the % neutrophil count was 8.55% (95% CI 5.17 to 11.93) and the fall in lymphocyte numbers was -0.14 x 10(9)/L (95% CI 0.06 to -0.34) while 2.5 mg prednisone led to an increase in the % neutrophil count of 9.31% (95% CI 5.82 to 12.80) and a fall in lymphocyte numbers of -0.07 x 10(9)/L (95% CI 0.05 to -0.19).. The systemic effects of 1000 micrograms inhaled BDP and 2.5 mg of prednisone are similar.

    Topics: Administration, Inhalation; Administration, Oral; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Confidence Intervals; Double-Blind Method; Humans; Leukocyte Count; Leukocytes; Multivariate Analysis; Prednisone

1996
[Clinical study on treating asthma of cold type with wenyang tongluo mixture].
    Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine, 1996, Volume: 16, Issue:9

    Sixty-eight asthma patients of Cold type were randomly divided into two groups, 34 for each group. The treated group was treated with Chinese herbal medicine Wenyang Tongluo Mixture (WYTLM), the control group was treated with Salbutamol orally and beclomethasone dipropionate aerosol. After 8 weeks of treatment, the results showed that there was no significant difference between the short-term total effective rate of the two groups (P > 0.05). Results of followup 1 year after withdrawal of treatment, showed that 9 patients (26.47%) in the treated group and 2 (5.88%) in the control group were cured clinically, it indicated that the long-term curative rate of the former group was higher than that of the latter group significantly (P < 0.05). And the effect of treated group on eliminating Asthenia-Cold symptoms, improving pulmonary ventilation function, regulating adrenergic beta-receptors of peripheral blood lymphocyte and decreasing the serum level of 5-hydroxytryptamine was more superior to that of control group (P < 0.05-0.01). This study provided some objective basis for using WYTLM in preventing and treating asthma of Cold type.

    Topics: Adolescent; Adrenergic beta-Agonists; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drugs, Chinese Herbal; Follow-Up Studies; Humans; Male; Middle Aged; Receptors, Adrenergic, beta; Respiratory Function Tests

1996
Comparison of fluticasone propionate and beclomethasone dipropionate on direct and indirect measurements of bronchial hyperresponsiveness in patients with stable asthma.
    Thorax, 1995, Volume: 50, Issue:10

    Fluticasone propionate is a new inhaled corticosteroid with a 2:1 efficacy ratio compared with beclomethasone dipropionate with regard to lung function and symptom scores, without increased systemic activity. The aim of this study was to investigate whether this was also the case for bronchial hyperresponsiveness, assessed by both a direct (histamine) and an indirect (ultrasonically nebulised distilled water (UNDW)) provocation test.. Fluticasone propionate, 750 micrograms/day, and beclomethasone dipropionate, 1500 micrograms/day, were compared in a randomised, double blind, crossover study consisting of two six week treatment periods, each preceded by a three week single blind placebo period. Twenty one non-smoking asthmatics (mean forced expiratory volume in one second (FEV1) 74.7% predicted, mean PC20histamine 0.36 mg/ml) completed the study.. Fluticasone propionate and beclomethasone dipropionate improved FEV1, peak flow rates, asthma symptoms, and bronchial hyperresponsiveness to the same extent. Both fluticasone propionate and beclomethasone dipropionate caused an increase in PC20histamine (mean 2.29 [95% confidence interval 1.45 to 3.13] and 1.95 [1.07 to 2.84] doubling doses, respectively) and in PD20UNDW (1.12 [0.55 to 1.70] and 1.28 [0.88 to 1.70] doubling doses, respectively). Neither treatment changed morning serum cortisol levels, but fluticasone propionate decreased the number of peripheral blood eosinophils less than beclomethasone dipropionate, indicating smaller systemic effects of fluticasone propionate.. These findings show that fluticasone propionate is as effective as twice the dose of beclomethasone dipropionate on bronchial hyperresponsiveness, assessed by provocation with both histamine and UNDW, without increased systemic activity.

    Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Double-Blind Method; Female; Fluticasone; Forced Expiratory Volume; Humans; Hydrocortisone; Male; Peak Expiratory Flow Rate

1995
Validation of an asthma quality of life diary in a clinical trial.
    Thorax, 1995, Volume: 50, Issue:7

    Quality of life (QOL) is commonly measured in asthma clinical trials by a questionnaire given before and after treatment. A structured asthma QOL daily diary provides more restricted information but on a daily basis. The validity and use of such a QOL diary was examined in a clinical trial in which two asthma treatments were compared.. The effects of low dose inhaled steroid (400 micrograms beclomethasone dipropionate, BDP) combined with the long acting beta 2 agonist salmeterol (100 micrograms) (n = 220) was compared with high dose inhaled steroid (1000 micrograms BDP) (n = 206) in asthmatic outpatients in a double blind, parallel group study. Outcome measures consisted of a combined diary for peak expiratory flow (PEF) rate, symptoms, and problems, and an asthma-specific QOL questionnaire, the Living with Asthma Questionnaire.. The QOL diary correlated with the QOL questionnaire for both cross sectional and longitudinal assessments. Cross sectional correlations with PEF were higher for the QOL questionnaire than the QOL diary, but longitudinal correlations with PEF were higher for the diary than the questionnaire. Treatment with low dose steroid/salmeterol compared with high dose steroid produced better lung function, better QOL as measured by diary, and reduced night time wakenings, but treatment differences were not obtained with the QOL questionnaire nor for daytime symptoms. Diary assessed QOL was a better predictor of low PEF than diary assessed symptoms. Compliance with diary completion was good but there were floor or ceiling effects in the QOL diary records of about 25% of patients.. Structured QOL diaries are valid instruments that appear to be more responsive to longitudinal change in clinical trials than a QOL questionnaire, but QOL questionnaires provide a more sensitive cross sectional measure of disease severity. Floor and ceiling effects are found in some patients' QOL diaries which limit their usefulness. QOL diary problem events occur during the troughs of a peak flow graph, while symptoms are more widely distributed with respect to peak flow.

    Topics: Adolescent; Adult; Aged; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Cross-Sectional Studies; Double-Blind Method; Drug Combinations; Female; Humans; Longitudinal Studies; Male; Medical Records; Middle Aged; Quality of Life; Respiratory Function Tests; Salmeterol Xinafoate; Surveys and Questionnaires; Treatment Outcome

1995
[Effect of dosing schedule on efficacy of corticosteroid inhalation in chronic asthma].
    Arerugi = [Allergy], 1995, Volume: 44, Issue:7

    A randomized study was conducted for 4 weeks to evaluate the effect of twice daily inhalation of beclomethasone dipropionate (BDP) inhalation (group A) as compared to four times a day inhalation (group B) in chronic asthma. Patients were randomly allocated to receive BDP at a dosage of eight puffs twice daily (800 micrograms/day, group A) or four puffs four times daily (800 micrograms/day, group B). Forty four patients entered the study but eleven were excluded because of their insufficient records or unfitness to eligibility criteria. There was no significant difference in patients' characteristics such as types, and severity of diseases between the two groups. Daily keeping of symptom scores, twice daily measurement of morning and night peak expiratory flow (PEF) and checking of the drug consumption were performed throughout the study. There was no significant difference in the mean %PEF either at 2 and 4 weeks at the study between the two groups. Symptom scores, asthmatic scores, bronchial hyperresponsiveness, pulmonary function tests (FVC, FEV1, FEV1%) and serum cortisol levels also showed no significant difference between the two groups. These results indicate that twice daily inhalation of BDP (800 micrograms/day) for four weeks caused the same effects on the patients with chronic bronchial asthma as 4 times daily inhalation did. Therefore, twice daily inhalation therapy with BDP is recommended for chronic bronchial asthma patients.

    Topics: Administration, Inhalation; Adult; Analysis of Variance; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chi-Square Distribution; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Middle Aged

1995
Withdrawal of corticosteroid therapy after acute asthma attacks.
    CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 1995, Nov-15, Volume: 153, Issue:10

    Topics: Acute Disease; Administration, Oral; Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Double-Blind Method; Glucocorticoids; Humans; Middle Aged; Placebos; Prednisolone; Pregnenediones; Respiratory Function Tests; Respiratory Therapy; Time Factors

1995
Periodic treatment regimens with inhaled steroids in asthma or chronic obstructive pulmonary disease. Is it possible?
    JAMA, 1995, Jul-12, Volume: 274, Issue:2

    To determine whether inhaled corticosteroids can be discontinued in the stable phase of asthma or chronic obstructive pulmonary disease (COPD) or if this therapy should be continued.. Nonrandomized open uncontrolled 5-year trial.. Prospective study in general practice.. Forty-eight patients with steroid-dependent asthma or COPD who had shown a decline in forced expiratory volume in 1 second (FEV1) of at least 80 mL per year and at least one exacerbation per year during the first 2 years of bronchodilator treatment. Subjects were treated additionally with inhaled steroids for another 2 years and were finally given the option to stop using steroids. Sixteen patients were willing to stop using beclomethasone and were studied for another year. No recruitment bias took place in this consecutive sample in the fifth year of follow-up. Two of 16 patients developed carcinomas and dropped out.. Two years of bronchodilator treatment alone (400 micrograms of salbutamol or 40 micrograms of ipratropium bromide four times daily), followed by 2 years of additional inhaled corticosteroid treatment (400 micrograms of beclomethasone two times daily), and finally 1 year of bronchodilator treatment alone.. Decline in lung function (FEV1), change in bronchial hyperresponsiveness, indicated by a provocative concentration of histamine causing a 20% fall in FEV1 (PC20), morning peak expiratory flow rate (PEFR), diurnal PEFR, week-to-week variation of PEFR, bronchial symptoms, and exacerbations.. The course of FEV1 during the year in which beclomethasone was discontinued was not significantly different when compared with the 2-year period of beclomethasone treatment. Neither did the course of PC20, morning PEFR, diurnal PEFR, symptom score, and exacerbation rate change. Only the week-to-week variation of the PEFR increased after discontinuing steroids.. Discontinuing inhaled steroids is possible in some patients with asthma or COPD after 2 years of regular treatment. This might indicate that for certain groups of patients with mild asthma or COPD, periodic treatment schedules with inhaled steroids is the treatment policy for the future.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Bronchodilator Agents; Drug Administration Schedule; Drug Therapy, Combination; Female; Follow-Up Studies; Glucocorticoids; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Prospective Studies; Respiratory Function Tests; Time Factors

1995
[Effect of one year of treatment with inhaled beclomethasone dipropionate on airway hyperresponsiveness in stable chronic asthma].
    Nihon Kyobu Shikkan Gakkai zasshi, 1995, Volume: 33, Issue:5

    To study the effects of an inhaled steroid on airway hyperresponsiveness (AHR) in chronic stable asthma, AHR was measured every month for 1 year in seven patients after their asthma had stabilized, i.e., when they had no wheezing or dyspnea, and their peak expiratory flow rates (PEFR) were at least 80 percent of the highest value. During the study period, no patient wheezed or had dyspnea, and daily variation in PEFR was less than 20 percent. In six patients, FEV1 was stable, and PEFR was always at least 80 percent of the highest value. AHR became less severe, by a factor of at least 2, in five of these six patients, but one patient's condition did not improve. The one patient whose PEFR fell below 80 percent of the highest value had more than a 4-fold increase in the severity of AHR. In conclusion, the severity of AHR can be reduced, even in patients with chronic stable asthma, if daily PEFR can be maintained in an optimal range by long-term use of inhaled corticosteroids.

    Topics: Administration, Inhalation; Aged; Asthma; Beclomethasone; Bronchial Hyperreactivity; Chronic Disease; Female; Humans; Male; Middle Aged; Peak Expiratory Flow Rate

1995
[Effects and limitations of inhaled high dose beclomethasone dipropionate (2400 micrograms/day) in steroid-dependent asthmatics].
    Arerugi = [Allergy], 1995, Volume: 44, Issue:5

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Female; Humans; Male; Middle Aged; Prednisolone

1995
Budesonide inhaled via Turbuhaler: a more effective treatment for asthma than beclomethasone dipropionate via Rotahaler.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 1995, Volume: 75, Issue:2

    Chlorofluorocarbon-propelled metered dose inhalers are facing a worldwide ban. Dry powder inhalers have been developed for the agents used in treatment of asthma.. Our objective was to compare the effects of two inhaled glucocorticosteroids in dry power inhalers: budesonide (delivered via Turbuhaler) and beclomethasone dipropionate (delivered via Rotahaler).. A randomized, crossover study with two steroid-treatment periods of 8 weeks. At the end of the study, the treatment with the inhaled steroid was stopped for 4 weeks. Sixteen adult patients with moderately severe asthma participated. Before the study all patients were treated with an inhaled steroid in a median dose of 0.60 mg/day (range 0.15-0.80); during the study they received 0.20 mg twice daily. Peak expiratory flow rate was measured twice daily at home throughout the study, lung function was assessed every fourth week and airway responsiveness was measured before and after each period. Preference concerning efficacy and inhaler type was assessed at the end of the study.. Twelve patients completed the study. Lung function, airway responsiveness, and symptoms deteriorated significantly in the steroid-free washout period; this period had to be shortened in 5/12 patients. Mean morning peak expiratory flow was significantly higher during budesonide treatment than during beclomethasone dipropionate treatment, the difference being 17 L/min (95% C.I.: 2-32 L/min, P = .026). Airway responsiveness improved 1.1 doubling concentrations after budesonide treatment, but decreased 0.3 doubling concentrations after beclomethasone dipropionate treatment. The difference between the values after budesonide and beclomethasone dipropionate treatment was 1.4 doubling concentrations (95% C.I.: 0.4-2.4 doubling concentrations, P = .033). Forced expiratory flow in one second improved slightly more during budesonide than during beclomethasone treatment. The difference was 4.3% predicted (95% C.I.: -0.7-9.3%). Most patients reported budesonide Turbuhaler to be more effective (10 versus 0) and easier to use (11 versus 1) than beclomethasone dipropionate Rotahaler.. As a consequence of the difference in local potency of the steroids and the fact that Turbuhaler deposits more drug particles in the lung than Rotahaler, budesonide inhaled via Turbuhaler appeared to be a more effective steroid formulation than beclomethasone dipropionate inhaled via Rotahaler.

    Topics: Asthma; Beclomethasone; Budesonide; Cross-Over Studies; Female; Humans; Male; Nebulizers and Vaporizers; Pregnenediones

1995
Costs and effects of inhaled corticosteroids and bronchodilators in asthma and chronic obstructive pulmonary disease.
    American journal of respiratory and critical care medicine, 1995, Volume: 151, Issue:4

    The objective of this study was to determine the costs and effects of combined bronchodilator and anti-inflammatory therapy. In a 2.5-yr randomized controlled study, combined beta 2-agonist/corticosteroid therapy (BA + CS) and combined beta 2-agonist/anticholinergic therapy (BA + AC) were compared with beta 2-agonist/placebo therapy (BA + PL). Included in the study were 274 patients 18 to 60 yr of age with moderately severe obstructive airways disease. The main clinical endpoints were lung function, hyperresponsiveness, restricted activity days, and symptom-free days. The economic endpoints were the costs of health care utilization. Compared with BA + PL, BA + CS led to significant improvements in FEV1, PC20, and symptom-free days. BA + AC did not differ from BA + PL in this respect. The respective annual acquisition costs of BA + CS, BA + AC, and BA + PL were 532 US$, 277 US$, and 156 US$. Thus, BA + CS costs 376 US$ more than BA + PL. However, compared with BA + PL therapy, BA + CS led to statistically significant savings in other health care costs of about 175 US$ (95% CI from 46 to 303 US$). Thus, more than half of the additional costs of adding the inhaled corticosteroid are compensated for by a reduction in the costs of other health care services. Overall, inhaled corticosteroids lead to a small but net increase in health care costs of 201 US$ per patient per year.(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Adult; Asthma; Beclomethasone; Cost-Benefit Analysis; Double-Blind Method; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Ipratropium; Lung Diseases, Obstructive; Male; Middle Aged; Prospective Studies; Terbutaline

1995
A bioassay for topical and systemic effect of three inhaled corticosteroids.
    Clinical pharmacology and therapeutics, 1995, Volume: 57, Issue:4

    Comparisons of relative potency for the three inhaled corticosteroids in the United States are limited to assessment of skin blanching.. Development of a method for comparing relative potencies of inhaled corticosteroids for topical effect on human airway and systemic effect.. With use of partial suppression of immediate response to inhaled allergen and 24-hour urinary free cortisol output, three-point dose-response curves were constructed for beclomethasone dipropionate (50 micrograms/puff), triamcinolone acetonide (100 micrograms/puff), and flunisolide (250 micrograms/puff). A randomized, parallel, single-blind study design was used. Dosing began with one puff four times a day for flunisolide and two puffs four times a day for the others. Doses were doubled after 1 week and again after a second week.. Twenty-five patients completed the study. Dose-response relationships were shown for each inhaled corticosteroid for both topical and systemic effect. Dose-response curves for the three preparations were similar when response was plotted against delivered dose in micrograms.. Within the limits of the assays, relative potencies of the three preparations appeared to be approximately equivalent for both topical and systemic effect when dose was expressed in micrograms. Relative potency per puff is therefore approximately proportional to the dose delivered. This method has potential for evaluation of relative potency of newer inhaled corticosteroids and the relative advantage of alternative delivery systems.

    Topics: Administration, Inhalation; Administration, Topical; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biological Assay; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Fluocinolone Acetonide; Humans; Male; Single-Blind Method; Triamcinolone Acetonide

1995
Long-term follow-up of patients with a history of near fatal episodes; can inhaled corticosteroids reduce the risk of death from asthma?
    Internal medicine (Tokyo, Japan), 1995, Volume: 34, Issue:2

    We retrospectively studied the use of inhaled corticosteroids in patients who experienced near fatal episodes (NFE) to determine whether such therapy reduces the risk of death. Forty-eight patients who had near fatal episodes of asthma between January 1981 and December 1989 were divided into two groups. Group A comprised 19 patients who received beclomethasone dipropionate (BDP) daily (mean dose of BDP:687 micrograms/day: 200-2,000) following NFE, and Group B, 28 patients who did not take BDP or who took less than 6 mg BDP/month. During the follow-up period (Group A:82.9 months, Group B:66.2 months), no patients in Group A died, but eight deaths occurred in Group B (mean period between near fatal episode and death was 31.5 months: 12-66). These results suggest that the regular use of inhaled corticosteroids, even at low doses, may reduce the risk of death in patients who experience NFE.

    Topics: Acute Disease; Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Female; Follow-Up Studies; Humans; Male; Middle Aged; Retrospective Studies; Survival Analysis; Treatment Outcome

1995
The influence of an inhaled steroid on quality of life in patients with asthma or COPD.
    Chest, 1995, Volume: 107, Issue:5

    Relatively little is known about the influence of inhaled corticosteroids on general well-being (quality of life) in patients with asthma or COPD. In a 4-year prospective controlled study, we examined the influence of beclomethasone dipropionate (BDP), 400 micrograms, two times daily, on quality of life in 56 patients with asthma or COPD in comparison with the effects of BDP on symptoms and lung function. During the first 2 years, patients received only bronchodilator therapy with salbutamol or ipratropium bromide. During the third and fourth years, additional treatment with BDP was given. Fifty-six patients (28 with asthma, 28 with COPD) with an annual decline in the forced expiratory volume in 1 s (FEV1) of at least 80 mL/yr in combination with at least two exacerbations per year during bronchodilator therapy alone participated. Quality of life was assessed at the start and after 2 and 4 years by means of the Inventory of Subjective Health (ISH) and the Nottingham Health Profile (NHP). Although BDP significantly improved the course of lung function (FEV1)(p < 0.0001), it did not improve the ISH score or the six dimensions of the NHP neither in asthma nor in COPD. Beclomethasone dipropionate temporarily decreased respiratory symptoms during months 4 to 6 of BDP treatment in patients with asthma (p < 0.01) and during months 7 to 12 in patients with COPD (p < 0.05). A weak correlation was found both cross-sectionally and longitudinally between (change in) symptoms and quality of life on the one hand, and the (change in) FEV1 on the other. It was concluded that BDP did not improve the general well-being of patients with asthma or COPD as measured by these generic health instruments. However, BDP significantly improved the course of lung function and temporarily decreased the severity of symptoms. It seems probable that changes in quality of life would have been better detected by use of a disease-specific health instrument. Such an instrument was not available at the start of the study. Another possible explanation for these observations is that patients soon get used to different levels of lung function and learn to live with their disease. It is advised that disease-specific health instruments are used in future intervention studies and that quality of life is measured frequently during the early phase of the intervention, eg, once every month.

    Topics: Administration, Inhalation; Albuterol; Asthma; Beclomethasone; Female; Forced Expiratory Volume; Health Status; Humans; Ipratropium; Lung Diseases, Obstructive; Male; Middle Aged; Prospective Studies; Quality of Life

1995
Steroid-sparing effect of inhaled lysine acetylsalicylate and furosemide in high-dose beclomethasone-dependent asthma.
    The Journal of allergy and clinical immunology, 1995, Volume: 95, Issue:5 Pt 1

    Inhaled lysine acetylsalicylate and furosemide exert a mutually potentiating protective activity on experimentally induced bronchoconstriction in asthma.. Our purpose was to investigate the clinical effectiveness of combined treatment of asthma with inhaled lysine acetylsalicylate and furosemide.. We performed a randomized, double-blind, crossover study in nine patients with chronic asthma requiring a high dose (2 mg/day) of inhaled beclomethasone for clinical control. Patients were treated with a combination of 720 mg inhaled lysine acetylsalicylate and 40 mg furosemide twice daily, or with matched placebo in addition to inhaled steroids. The dose of inhaled steroids was reduced by half every 15 days and eventually suspended unless a patient's respiratory condition worsened.. During treatment with placebo, all patients had worsening of asthma at dosages of 1 or 0.5 mg/day beclomethasone (mean +/- SE, 833 +/- 83 micrograms/day). During combined treatment complete suspension of inhaled steroids in two patients and reduction to 0.5 to 0.25 mg in the remaining seven patients (mean, 250 +/- 72 micrograms/day) was achieved, with a mean reduction of 71% +/- 7%. Forced expiratory volume in 1 second, weekly peak expiratory flow rate, symptom score, and bronchodilator intake remained significantly better with combined treatment than with placebo.. Treatment with inhaled lysine acetylsalicylate and furosemide allows a considerable sparing of inhaled steroids without significant side effects in patients with severe asthma.

    Topics: Administration, Inhalation; Adolescent; Aged; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Asthma; Beclomethasone; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Drug Interactions; Drug Therapy, Combination; Female; Furosemide; Humans; Lysine; Male; Middle Aged

1995
Efficacy and cost effectiveness of inhaled steroids in asthma in a developing country.
    Archives of disease in childhood, 1995, Volume: 72, Issue:4

    Eighty six children with troublesome wheezing were studied, in a semiprospective clinical trial with the patients acting as their own controls, to assess the efficacy and cost effectiveness of inhaled steroids. Improvement in school attendance, hospitalisations, breakthrough wheezing, and acute severe attacks were used to assess clinical efficacy. Expenditure for the family, on a cost of illness framework, before and after treatment, was used to estimate cost effectiveness. Highly significant numbers of patients showed improvement in clinical parameters, confirming efficacy. Mean monthly cost before inhaled steroid treatment was Rs 2652.33 (36.33 pounds) and Rs 449.42 (6.16 pounds) after starting treatment. The mean cost per unit satisfaction (cost utility value) which was Rs 255.54 (3.50 pounds) before starting prophylaxis came down to Rs 5.42 (0.07 pound) after starting treatment. There are no previous reports of cost-benefit assessment of inhaled steroids in childhood asthma. It is concluded that, even for developing countries with financial constraints, inhaled steroid treatment for prophylaxis of asthma is a cost effective and rational form of treatment.

    Topics: Administration, Topical; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Cost-Benefit Analysis; Developing Countries; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Pregnenediones; Prospective Studies; Sri Lanka

1995
Bloodspot cortisol in mild asthma: the effect of inhaled corticosteroids.
    Archives of disease in childhood, 1995, Volume: 72, Issue:4

    Bloodspot cortisol, where finger pricked blood is applied to blotting paper, is suitable for repeated measurements in the home environment. The use of bloodspot cortisol measurements in children with asthma and the effect of inhaled corticosteroids on daytime cortisol concentrations were assessed. Twenty children with mild asthma were randomised to receive double blind either placebo or beclomethasone dipropionate 200 micrograms twice daily. Blood was taken by finger prick at home on waking, and treatment administered. Blood was then taken one hour after treatment, at lunchtime, and in the evening. The area under the curve (AUC) for the four time points was calculated as a composite index of daytime cortisol. Mean (SEM) bloodspot cortisols fell progressively over the day from 199.2 (15.6) nmol/l to 58.4 (8.9) nmol/l. Cortisol in the group treated with beclomethasone dipropionate was lower at all time points, but was significant only after treatment (mean (SEM) 120.9 (14.3) v 177.5 (21.0) nmol/l) and at lunchtime (mean (SEM) 82.7 (12.4) v 128.9 (12.6) nmol/l). AUC for the beclomethasone dipropionate treated group was also significantly decreased (mean (SEM) 317 (31.4) v 446 (29.7)). Beclomethasone dipropionate at a dose of 400 micrograms/day significantly suppresses the daytime cortisol profile.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Blood Specimen Collection; Child; Double-Blind Method; Female; Humans; Hydrocortisone; Male; Patient Acceptance of Health Care; Pituitary-Adrenal System

1995
Growth of prepubertal children with mild asthma treated with inhaled beclomethasone dipropionate.
    American journal of respiratory and critical care medicine, 1995, Volume: 151, Issue:6

    Poorly controlled severe asthma can lead to growth impairment in childhood. In children with mild asthma, it is less clear whether treatment influences growth or adrenal function. We determined in a randomized, double-blind, placebo-controlled, community-based study, the effect of inhaled beclomethasone dipropionate (BDP) 400 micrograms/day for 7 mo on the linear growth and adrenal function of 94 children 7 to 9 yr of age. Height was measured at least monthly during treatment, and adrenal function assessed by overnight urinary cortisol at baseline and after 3 and 6 mo of treatment. Mean regressed daily growth was significantly decreased during the treatment period in the BDP-treated group, 0.79 versus 1.14 mm/wk (difference 0.35 mm/wk; 95% CI -0.46 to -0.25; p < 0.0001). At the end of the 7 mo, the BDP-treated children had grown significantly less than the children on placebo: mean of 2.66 versus 3.66 cm (difference 1.0 cm; 95% CI -1.36 to -0.64 cm; p < 0.0001). Growth was significantly decreased in both males and females. During a washout period of 4 mo, there was no significant catch-up growth. BDP had no effect on overnight urinary cortisol production. BDP at a dose taken by many children significantly decreases statural growth in children with mild asthma, and this effect is unlikely to be mediated through the hypothalamo-pituitary-adrenal axis.

    Topics: Administration, Inhalation; Adrenal Glands; Asthma; Beclomethasone; Body Height; Child; Double-Blind Method; Female; Growth Disorders; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Pituitary-Adrenal System

1995
[Duration of the effect of inhaled corticosteroids on lung function and sensitivity of the respiratory tract in patients with bronchial asthma].
    Medizinische Klinik (Munich, Germany : 1983), 1995, Apr-15, Volume: 90, Issue:4

    The effects of cessation of therapy with inhaled steroids on symptoms, lung function, and airway responsiveness in stable bronchial asthma should be examined.. During a 4-week run-in period 24 patients inhaled beclomethasone dipropionate (BDP) 2000 micrograms/d and salbutamol 800 micrograms/d. This was followed by a 6-week treatment period during which the patients obtained either placebo plus 800 micrograms salbutamol or 2000 micrograms BDP plus 800 micrograms salbutamol in a randomized double-blind design. Symptoms, lung function, and airway responsiveness to histamine were measured before and after the run-in period and at the end of each week during the treatment period.. Airway responsiveness was assessed as the concentration of inhaled histamine which caused a 20% fall in FEV1 compared to baseline (PC20). During the run-in period, 21 of the 24 patients showed an increase of PC20 (p = 0.0005). In the placebo group, 5 patients had to cease the protocol after 1 to 4 weeks of the treatment period because of intolerable symptoms and severe worsening of lung function; PC20 on entry was significantly smaller in these patients compared to those who completed the protocol (p = 0.01). After 6 weeks, FEV1 had decreased by 8.5% (p = 0.005) and PC20 by 1.71 doubling concentrations (p = 0.0003). In the BDP group, all patients completed the study and PC20 after the treatment period was significantly higher (p = 0.04) in the BDP than in the placebo group.. Our data suggest that patients on long-term inhaled steroid therapy with a high degree of bronchial hyperresponsiveness are more likely to show early deterioration of their clinical state after cessation of inhaled steroids.

    Topics: Administration, Inhalation; Adult; Airway Resistance; Albuterol; Asthma; Beclomethasone; Bronchial Provocation Tests; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Long-Term Care; Male; Middle Aged; Substance Withdrawal Syndrome

1995
[Asthma is asthma, is asthma...].
    Medizinische Klinik (Munich, Germany : 1983), 1995, Apr-15, Volume: 90, Issue:4

    Topics: Administration, Inhalation; Airway Resistance; Albuterol; Asthma; Beclomethasone; Bronchial Provocation Tests; Double-Blind Method; Drug Therapy, Combination; Humans; Long-Term Care; Substance Withdrawal Syndrome

1995
Efficacy of Uniphyl, salbutamol, and their combination in asthmatic patients on high-dose inhaled steroids.
    American journal of respiratory and critical care medicine, 1995, Volume: 151, Issue:2 Pt 1

    A group of 32 patients with moderately severe, chronic asthma (mean FEV1 55% of predicted), maintained on moderately high doses of inhaled corticosteroids (mean dose 1,100 micrograms/d), participated in this double-blind, placebo-controlled crossover study. The effect on pulmonary function of adding theophylline (U, once daily Uniphyl), inhaled salbutamol (S, 200 micrograms four times per day), and their combination (C) or placebo (P) was assessed on Day 14 of each treatment phase. Patients recorded peak expiratory flow, asthma symptom severity (morning and evening), and use of rescue salbutamol inhaler in daily diaries. Mean FEV1 between 0730 and 1800 h and maximum FEV1 between 0730 and 1300 h were significantly higher on U, S, and C compared with P (p < 0.006). Morning peak flow and FEV1 (0730 h) were significantly higher on U and C compared with S and P (p < 0.01). Evening peak flow was higher on U than P (p < 0.001), and C was higher than S and P (p < 0.01). Rescue salbutamol inhaler use was significantly higher on P than on U, C, or S (p = 0.0001). Patient rating of asthma symptoms during C was significantly better than on S or P (p < 0.05). Patient rating of asthma control and study phase preference was significantly higher on combination and Uniphyl alone than on placebo, the combination also being superior to salbutamol alone. Addition of Uniphyl or a combination of Uniphyl and salbutamol significantly improves pulmonary function and asthma symptoms in patients treated with high doses of inhaled corticosteroids and as-needed beta agonists.(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Adult; Aged; Aged, 80 and over; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Cross-Over Studies; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Pregnenediones; Pulmonary Ventilation; Theophylline

1995
Oral and inhaled corticosteroids reduce bone formation as shown by plasma osteocalcin levels.
    American journal of respiratory and critical care medicine, 1995, Volume: 151, Issue:2 Pt 1

    Osteoporosis is a well-known, serious complication of long-term high-dose corticosteroid therapy. This study was performed to determine the effects of commonly used doses of oral and inhaled steroids on biochemical indices of bone formation. Initially we examined the long-term effects of oral steroids. Thirty-four outpatients with symptomatic asthma or chronic obstructive airways disease (COAD) receiving long-term oral prednisolone (mean 10.1 mg daily) were compared with 34 control subjects with asthma or COAD matched individually for age, sex, and menopausal status who were not taking oral steroids. Plasma osteocalcin concentrations were significantly lower (patients 6.3 +/- 0.1 ng/ml; control subjects 8.6 +/- 0.5 ng/ml, mean +/- SEM; p < 0.01) in patients on steroids with no difference in alkaline phosphatase. To examine the short-term effects of oral and inhaled corticosteroids, healthy male volunteers were given a 7-d course of either 15 mg oral prednisolone daily (n = 10) or 500 micrograms inhaled beclomethasone twice daily (n = 20). After 1 wk of oral prednisolone, mean plasma osteocalcin decreased from 11.8 +/- 1.1 ng/ml to 6.9 +/- 0.8 ng/ml (p < 0.001). With inhaled beclomethasone mean plasma osteocalcin decreased from 11.6 +/- 0.6 ng/ml to 9.6 +/- 0.6 ng/ml (p < 0.001) with no change in alkaline phosphatase. In doses routinely prescribed for the prophylaxis and treatment of asthma, oral and inhaled steroids suppress osteocalcin levels and may therefore inhibit bone formation. This effect is seen with short courses of steroids and also with chronic administration.(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Administration, Inhalation; Administration, Oral; Adult; Age Factors; Asthma; Beclomethasone; Bone Development; Cross-Sectional Studies; Female; Humans; Lung Diseases, Obstructive; Male; Matched-Pair Analysis; Middle Aged; Osteocalcin; Prednisolone; Prospective Studies; Sex Factors

1995
A double-blind, cross-over study using salbutamol, beclomethasone, and a combination of both in bronchial asthma.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1995, Volume: 32, Issue:1

    A double-blind, cross-over protocol was applied to 22 asthmatic patients who were previously subjected to provocation tests with methacholine. The baseline FEV1 for mild asthma was 89.6 +/- 13.6% while for moderate asthma it was 73 +/- 6%. The initial provocation tests with methacholine revealed that the mild asthma group needed a greater accumulated dose of methacholine than that required by the moderate asthma group to lower the FEV1 by 20%, stressing the enhanced bronchial hyperreactivity present in the latter group. Significant differences in the PD20 values were obtained in both groups of patients using the combination of salbutamol plus beclomethasone. Salbutamol alone was ineffective to change the PD20 values in mild asthma while beclomethasone alone was able to change significantly the PD20 values in these patients, stressing the importance of the inflammatory component in the pathogenesis of stable asthma. Furthermore, the combination of both drugs was also more effective in the moderate asthma group than either medication alone, confirming the pharmacological control of the obstructive and inflammatory changes that are already established in patients with moderate asthma.

    Topics: Adolescent; Adult; Albuterol; Asthma; Beclomethasone; Bronchial Provocation Tests; Child; Cross-Over Studies; Double-Blind Method; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Spirometry

1995
Long-term circadian effects of salmeterol in asthmatic children treated with inhaled corticosteroids.
    American journal of respiratory and critical care medicine, 1995, Volume: 152, Issue:6 Pt 1

    The present study was set up to investigate whether salmeterol in children with asthma already treated with inhaled corticosteroids (ICS) leads to a sustained bronchodilator effect and decreased bronchial responsiveness, both during the day and night. Furthermore, we investigated whether cessation of salmeterol leads to a rebound increase in bronchial responsiveness. Forty children with asthma (aged 7-15 yrs) using ICS participated in a randomized, double-blind, parallel study. They received either twice daily 50 micrograms salmeterol or placebo. FEV1 and provocative concentration of methacholine that caused a 20% fall in FEV1 (PC20) were measured at 4:00 P.M. and 4:00 A.M. at baseline and after 16 wk. The same measurements were performed at 4:00 P.M. at 8 h after the first dose, and after 1 and 8 wk. After cessation of the study drug, FEV1 and PC20 were measured at 12 and 20 h and after 1 wk. Overall mean FEV1 from 1 to 16 wk of treatment was significantly higher in the salmeterol group than in the placebo group (difference, 4.9 +/- 2.0%, p = 0.01). Evolution in time of FEV1 did not differ significantly between the two groups (p = 0.09). Overall mean PC20 from 1 to 16 wk of treatment was not significantly higher with salmeterol than with placebo (difference, 0.7 +/- 0.4 doubling dose [DD] p = 0.07); evolution in time of PC20 did not differ significantly between the two groups (p = 0.58).(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Administration, Inhalation; Adolescent; Albuterol; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchoconstrictor Agents; Bronchodilator Agents; Child; Circadian Rhythm; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Methacholine Chloride; Salmeterol Xinafoate

1995
[Inhaled beclomethasone in long-term management of asthma: optimal dose and optimal duration of treatment].
    Nihon Kyobu Shikkan Gakkai zasshi, 1995, Volume: 33, Issue:9

    We studied the usefulness of 24 weeks of therapy with inhaled beclomethasone dipropionate (BDP) in the management of mild and moderately severe asthma in adults. To determine the optimal dose and treatment duration, the patients were divided into three groups. Patients in group I (n = 10) were treated with bronchodilators but no BDP. Patients in group II (n = 12) received bronchodilators and 450 micrograms/day of BDP. Patients in group III (n = 17) received bronchodilators and 900 micrograms/day of BDP. BDP was inhaled via a large spacer (Volumatic). Asthma scores were measured before treatment began, and again every 2 weeks for the duration of the study (26 weeks). Peak expiratory flows (PEF) were measured before treatment began, 2 weeks after treatment had begun, and again every four weeks until the end of the study. Vital capacity, FEV1, and bronchial reactivity to methacholine were measured before treatment began, and again 12 weeks and 24 weeks after it had begun. Adrenocortical function in patients in group III was measured with a rapid ACTH test, at the same time as the pulmonary functions were measured. The results were: 1) Asthma scores decreased more in patients who received the higher dose of BDP than in those who received the lower dose, especially during the second 12 weeks. 2) After two weeks of treatment, %PEF had increased significantly in both groups that received BDP, but after six weeks of treatment there was no further improvement. %PEF did not improve in the group given bronchodilators only. 3) In the patients whose baseline %PEF was less than 80%, only the higher dose of BDP significantly increased %PEF. 4) Only the higher dose of BDP increased the %VC, the FEV1%, and the PD20 for methacholine. 5) Asthma type and severity were not related to the usefulness of BDP therapy. 6) Results of the rapid ACTH test indicated that the higher dose of BDP did not suppress adrenocortical function. These data indicate that 900 micrograms of BDP per day is more effective than 450 micrograms/day as initial therapy for long-term management of mild or moderate asthma in adults, and that the dose of BDP should be reviewed after 3 months of treatment. Patients in whom asthma is well-controlled may tolerate a reduction in dose, and those in whom asthma is not well-controlled may require a higher dose.

    Topics: Administration, Inhalation; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chronic Disease; Female; Humans; Male; Middle Aged; Time Factors

1995
Bone and collagen turnover during treatment with inhaled dry powder budesonide and beclomethasone dipropionate.
    Archives of disease in childhood, 1995, Volume: 73, Issue:6

    To assess bone and collagen turnover in asthmatic children treated with dry powder budesonide from the Turbuhaler and dry powder beclomethasone dipropionate from the Diskhaler in a dose of 800 micrograms/day.. Thirteen prepubertal children with asthma.. Open crossover study with two treatment periods and treatment free run-in and wash-out periods. All periods were of two weeks' duration. At day 14 in each period blood samples were taken for assessment of serum osteocalcin, the carboxyterminal propeptide of type I collagen (PICP), and the aminoterminal propeptide of type III collagen (PIIINP). At the same time urine was collected for assessment of creatinine corrected pyridinoline (uPYR/cr) and deoxypyridinoline (udPYR/cr) crosslinks.. Osteocalcin concentrations were not influenced by any of the treatments. During budesonide treatment mean (SEM) PICP was reduced by 18% (8%) (p = 0.03), PIIINP by 24% (3%) (p = 0.0002), uPYR/cr by 16% (6%) (p = 0.03), and udPYR/cr by 21% (13%) (p = 0.12). During treatment with beclomethasone dipropionate mean (SEM) PICP was reduced by 20% (6%) (p = 0.01), PIIINP by 36% (3%) (p = 0.0002), uPYR/cr by 18% (4%) (p = 0.004), and udPYR by 13% (5%) (p = 0.02). The suppressive effect of beclomethasone dipropionate on PIIINP was more marked than that of budesonide (p = 0.001).. Treatment with dry powder budesonide and beclomethasone dipropionate 800 micrograms/day is associated with suppression of bone and collagen turnover. The suppression seems to be more marked during treatment with beclomethasone dipropionate. Long term effects and effects of lower doses of budesonide and beclomethasone dipropionate on bone and collagen markers needs further study.

    Topics: Administration, Inhalation; Administration, Topical; Amino Acids; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bone and Bones; Budesonide; Child; Collagen; Cross-Over Studies; Female; Glucocorticoids; Humans; Male; Osteocalcin; Peptide Fragments; Powders; Pregnenediones; Procollagen

1995
Effect of regular inhaled beclomethasone on exercise and methacholine airway responses in school children with recurrent wheeze.
    The European respiratory journal, 1995, Volume: 8, Issue:9

    The role of airway inflammation in the pathogenesis of asthma in childhood is uncertain. In the present study, 27 atopic and nonatopic children aged 7-9 yrs who had > or = 5 episodes of wheeze and symptoms of exercise-induced asthma (EIA) in the previous 12 months, performed a methacholine challenge and exercise test on separate days at monthly intervals. The subjects had not received oral or inhaled corticosteroids for 12 months prior to the study. The dose-response relationship to inhaled methacholine was expressed as the cumulative dose provoking a 20% decrease in forced expiratory volume in one second (PD20). Forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF) were measured prior to the exercise test and at 0, 3, 5, 10, 15 and 20 min following maximal exercise. Following the first methacholine challenge and exercise test, the children were randomized in a double-blind manner to receive inhaled beclomethasone dipropionate (BDP) 200 micrograms b.i.d. or a placebo b.i.d. from a Diskhaler for 3 months. All children were asymptomatic at the time of testing, and there was no significant change in the baseline FEV1 of any subject prior to either challenge throughout the study period. When compared to placebo, the bronchial responsiveness to exercise and methacholine was significantly attenuated in the children who had received inhaled BDP for at least 1 month. There was no relationship between the bronchial responsiveness to methacholine and exercise. There was no significant difference in the bronchial responsiveness to either stimulus in the atopic and nonatopic children. The results of this study suggest that immunoglobulin E (IgE)- and non-IgE-mediated airway inflammation are important in exercise- and methacholine-induced bronchoconstriction in children with recurrent wheeze, although it is probable that different mechanisms are responsible.

    Topics: Administration, Inhalation; Administration, Topical; Analysis of Variance; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Asthma, Exercise-Induced; Beclomethasone; Bronchial Provocation Tests; Bronchoconstrictor Agents; Child; Double-Blind Method; Exercise; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Methacholine Chloride; Prospective Studies; Recurrence; Respiratory Mechanics; Respiratory Sounds

1995
Comparison between sodium cromoglycate (MDI: metered-dose inhaler) and beclomethasone dipropionate (MDI) in treatment of adult patients with mild to moderate bronchial asthma. A double-blind, double-dummy randomized, parallel-group study.
    Allergy, 1994, Volume: 49, Issue:8

    This study compared the efficacy and tolerability of sodium cromoglycate (SC) and beclomethasone dipropionate (BDP) in adult patients with bronchial asthma inadequately treated with bronchodilators alone. The study was a double-blind, randomized, double-dummy, parallel-group study. Patients with mild to moderate symptomatic asthma, inadequately treated with bronchodilators only, were, after a 2-week run-in (base-line) period, randomized to 8 weeks of treatment with either SC 10 mg four times daily or BDP 100 micrograms four times daily. Salbutamol metered-dose inhaler was given as relief medication. A total of 37 patients were randomized for treatment, 19 patients in the SC group and 18 patients in the BD group. Efficacy and safety were determined by daily record card data: morning and evening peak-expiratory-flow rates (PEFR), daytime and nighttime asthma symptom scores, and rescue salbutamol use. At clinic visits, FEV1 and FVC were measured, as were the physician's and the patient's assessment of the medication at the end of the study. The safety and tolerability of the trial medication were assessed by monitoring adverse events throughout the study. A clinically and statistically significant improvement of the asthma in FEV1, symptom scores, rescue medication, and global opinion of efficacy was observed, and both groups provided equivalent efficacy. The morning PEFR as well as the evening PEFR for both groups improved, but was statistically significant only for the BDP group (M-PEFR). Both drugs were well tolerated with only a few minor adverse events. This trial shows that SC and BDP are equally effective anti-inflammatory treatments for mild to moderate bronchial asthma in adults.

    Topics: Adult; Asthma; Beclomethasone; Cromolyn Sodium; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate

1994
Clinical efficacy of budesonide Turbuhaler compared with that of beclomethasone dipropionate pMDI with volumatic spacer. A 2-year randomized study in 102 asthma patients.
    Allergy, 1994, Volume: 49, Issue:10

    A total of 102 patients had their asthma treatment with beclomethasone dipropionate (BDP) optimized in order to achieve the best possible control of symptoms. Thereafter, the BDP doses were gradually reduced over a 2-year period (1988-90) to the lowest possible without deterioration of their asthmatic condition. In the beginning of 1990, treatment was changed in 76 patients (group A) to the nearest possible dose of budesonide delivered via Turbuhaler. Twenty-six randomly selected patients (25% of the study population; group B) continued treatment with BDP. In both groups, dose reductions were tried during 1990-2 every third month as long as the patients remained symptom-free and without significant decreases in FEV1 or PEF. In group A, the maintenance dose could be reduced from 1003.9 +/- 325.4 micrograms BDP (mean +/- SD) to 602.9 +/- 454.4 micrograms budesonide Turbuhaler (P < 0.001). In group B, no significant dose reduction was possible; the mean dose was +/- SD 1067.3 +/- 36.6 micrograms in 1990, and 1019.2 +/- 324.7 micrograms in 1992. The results indicate that, in efficacy, 0.6 mg budesonide Turbuhaler corresponds to approximately 1.0 mg BDP with volumatic spacer. This difference is probably due to an improved pulmonary delivery of budesonide with Turbuhaler.

    Topics: Adrenergic beta-Agonists; Adult; Aged; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Female; Humans; Lung; Male; Middle Aged; Nebulizers and Vaporizers; Pregnenediones; Spirometry

1994
High-dose inhaled steroids in asthmatics: moderate efficacy gain and suppression of the hypothalamic-pituitary-adrenal (HPA) axis. Research Council of the Norwegian Thoracic Society.
    The European respiratory journal, 1994, Volume: 7, Issue:12

    We wanted to evaluate the improvement in efficacy when increasing the daily dose of inhaled steroids and to compare the efficacy, safety, and tolerance of 1.6 mg beclomethasone dipropionate (BDP) with that of 2.0 mg fluticasone propionate (FP). The study was a randomized, double-blind, 3 month, multicentre study. One hundred and thirty four asthmatics currently using inhaled steroids (0.4-1.6 mg BDP or budesonide (BUD)) were stratified according to pretrial daily steroid use. Within each stratum they were randomized to either 1.6 mg BDP or 2.0 mg FP. A significant increase in the primary efficacy variables, i.e. mean morning and evening peak expiratory flow (PEF) (approximately 20 l.min-1) during the treatment period, was found for both treatments. No significant differences between the drugs were revealed for these primary or any other secondary efficacy variables (use of beta 2-agonists, symptom scores, and PEF, forced vital capacity (FVC), forced expiratory volume in one second (FEV1) recorded at the clinical visits). However, significant differences between treatments occurred regarding decrease of serum cortisol and adrenocorticotropic hormone. We conclude that, although both treatments gave statistically significant increases in efficacy parameters when compared with baseline, the increases were so small that they can be regarded as being clinically unimportant. Daily doses of BDP, 1.6 mg, and FP, 2.0 mg, had comparable effects on lung function. A suppression of the hypothalamic pituitary adrenal (HPA) axis was only found with a daily dose of 2 mg FP.

    Topics: Administration, Inhalation; Administration, Topical; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Depression, Chemical; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fluticasone; Forced Expiratory Volume; Glucocorticoids; Humans; Hypothalamo-Hypophyseal System; Male; Middle Aged; Peak Expiratory Flow Rate; Pituitary-Adrenal System; Vital Capacity

1994
Effect of inhaled beclomethasone dipropionate on expression of proinflammatory cytokines and activated eosinophils in the bronchial epithelium of patients with mild asthma.
    The Journal of allergy and clinical immunology, 1994, Volume: 94, Issue:6 Pt 1

    Increasing evidence suggests that cytokines play a role in airway inflammation by attracting and activating inflammatory cells. This may lead to epithelial cell damage and airway hyperresponsiveness. Bronchial provocative concentration of histamine causing a 20% fall in forced expiratory volume in 1 second was measured in patients with mild asthma, and bronchial biopsy specimens were stained for granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin (IL)-8, and activated eosinophils (EG2) in the bronchial epithelium. The effect of inhaled beclomethasone dipropionate was also assessed in a placebo-controlled double-blind manner. There was a correlation between GM-CSF expression and EG2-staining cells (r = 0.484 p < 0.05) in the epithelium. Provocative concentration of histamine causing a 20% fall in forced expiratory volume in 1 second was correlated with GM-CSF expression (r = -0.462, p < 0.05). Treatment with inhaled beclomethasone dipropionate 500 micrograms twice a day led to a significant decrease in both the expression of GM-CSF (p < 0.01) and IL-8 (p < 0.02) and the number of EG2-staining cells (p < 0.01) in the epithelium. The changes in GM-CSF (r = 0.798, p < 0.01) and IL-8 (r = 0.653, p < 0.02) expression were correlated with the changes in EG2-staining cells after treatment. These results suggest that GM-CSF may influence eosinophil activation in the epithelium in vivo and participate in the etiology of bronchial hyperresponsiveness in mild asthma. Also, beclomethasone dipropionate may inhibit eosinophil activation partly by downregulating the expression of GM-CSF and IL-8 in the bronchial epithelium.

    Topics: Administration, Inhalation; Adolescent; Adult; Asthma; Beclomethasone; Bronchi; Double-Blind Method; Eosinophils; Epithelium; Female; Granulocyte-Macrophage Colony-Stimulating Factor; Humans; Interleukin-8; Male; Middle Aged

1994
[Usefulness of inhaled steroids in steroid-dependent intractable asthma--equivalent dose of oral steroid to inhaled steroid].
    Arerugi = [Allergy], 1994, Volume: 43, Issue:9

    Twenty-four steroid-dependent intractable asthmatics were treated with oral prednisolone (PSL) (basic dose) + additional PSL and oral PSL (basic dose) + inhaled beclomethasone (BDP) alternately, to assess the clinical symptoms in each administration period. Equivalent doses of PSL to BDP were calculated. 1. Peak expiratory flow rate (PEF) during additional administration of BDP was markedly higher both in the morning and at night compared with that during additional administration of BDP was markedly higher both in the morning and at night compared with that during additional administration of PSL (p < 0.01 and p < 0.05 respectively). 2. The relation between additional doses of either PSL or BDP and attack scores was analysed in regression to obtain a dose equivalence line. 3. BDP 400 micrograms was equivalent to PSL 7.04 mg on average. 4. The equivalent dose of PSL to BDP tended to be lower in cases where the period of dependency on oral steroids was longer, the basic dose was larger, or the asthma was more severe. These data indicate that the application of inhaled steroids may be useful in the therapeutic management of steroid-dependent intractable asthmatics.

    Topics: Administration, Inhalation; Administration, Oral; Adult; Aged; Asthma; Beclomethasone; Drug Therapy, Combination; Female; Humans; Japan; Male; Middle Aged; Prednisolone

1994
[Different responses of morning dipping and nocturnal dipping to inhaled and/or oral steroids in chronic asthmatics].
    Nihon Kyobu Shikkan Gakkai zasshi, 1994, Volume: 32, Issue:8

    Clinical experiences have suggested distinct differences in responses to anti-asthmatic drugs between patients suffering early morning asthmatic attacks and those experiencing nocturnal ones. However, there has been no report on any difference in the improvement of asthmatic flow dipping after inhaled and/or oral steroid treatment. In this retrospective study, the peak expiratory flow rates (PEF), which had been monitored four times a day, were reviewed in 40 chronic asthmatics. The group consisted of 19 patients with very low PEF (geometrical mean PEF/week [mPEF] < 60% of the personal best PEF), 15 patients with moderately low PEF (mPEF 60% to 70% of personal best PEF), 2 patients with mildly low PEF (mPEF 70% to 80% of personal best PEF) and 4 patients with occasionally low PEF (mPEF > 80% of personal best PEF). Of 40 chronic asthmatics, 22 patients had morning dipping alone and 10 patients had both morning dipping and nocturnal dipping. After inhaled and/or oral steroid treatment at sufficient level, mPEF was improved in all patients. All the dipping disappeared except for morning dipping in five cases. We concluded that there was a difference in responses to inhaled and/or oral steroids during early morning dipping and during nocturnal dipping in chronic asthmatics. There should be further investigation to discriminate between pathophysiological events that may be related to morning dipping and to nocturnal dipping.

    Topics: Administration, Inhalation; Administration, Oral; Adolescent; Adult; Aged; Asthma; Beclomethasone; Chronic Disease; Circadian Rhythm; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Prednisolone; Retrospective Studies

1994
[Treatment modalities and hypothalamo-pituitary-adrenal (HPA) axis suppression in Japanese patients with asthma].
    Nihon Kyobu Shikkan Gakkai zasshi, 1994, Volume: 32, Issue:8

    We examined HPA axis function using a short tetracosactrin test in 94 asthmatics treated with three different modalities. The first group, (B + S), consisted of 41 patients taking BDP (910 +/- 320 micrograms, daily) plus a short term burst of oral steroids (20-40 mg daily, 3-7 days/course, 1-18 courses/year). The second group, (B + R), consisted of 19 patients taking BDP (1076 +/- 410 micrograms, daily) plus continuous oral steroids (2.5-20 mg/day for 1.8-24 years). The third group, (B alone), consisted of 34 patients taking BDP only (615 +/- 258 micrograms, daily). All patients had been inhaling BDP for more than 1 year. The rise in cortisol in response to tetracosactrin in B + S, B + R, and B alone was 12 +/- 4.3 micrograms/dl, 7.0 +/- 5.0 micrograms/dl and 14 +/- 4.5 micrograms/dl, respectively, and achieved cortisol was 21 +/- 4.5 micrograms/dl, 12 +/- 7.2 micrograms/dl and 23 +/- 4.2 micrograms/dl;, respectively. Both values were significantly lower in the B + R group than in either B + S or B alone. However, there was no difference between B + S and B alone, although the BDP dose was significantly larger in the B + S group. Significant HPA axis suppression (rise in cortisol < 7 micrograms/dl and achieved cortisol < 18 micrograms/dl) was seen in 7 patients. Although HPA axis suppression was more frequently seen in B + R (10/19), no significant difference was seen between B + S and B alone (4/41 and 1/34, respectively).(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Administration, Inhalation; Administration, Oral; Adrenal Cortex Function Tests; Adrenocorticotropic Hormone; Adult; Aged; Asthma; Beclomethasone; Drug Therapy, Combination; Female; Humans; Hypothalamo-Hypophyseal System; Male; Middle Aged; Pituitary-Adrenal System; Prednisolone

1994
[Inhaled corticotherapy sparing effect by sodium nedocromil in moderate to severe asthma].
    Revue des maladies respiratoires, 1994, Volume: 11, Issue:5

    The increased use of high dose inhaled steroid in the treatment of asthma has revealed the risk of dose-dependent side effects. Nedocromil sodium is a non steroidal agent with anti-inflammatory properties.. To demonstrate whether nedocromil sodium may have some therapeutic benefit in asthmatic patients treated with high dose inhaled steroids and whether it has an inhaled steroid sparing effect.. 134 adults with moderate to severe asthma not adequately controlled with high dose inhaled steroids (750 to 1,500 micrograms/day).. After a two week baseline period, patients were randomized to receive either nedocromil sodium (4 mg qid) or placebo for 24 weeks in a double blind fashion. During the first 12 weeks of treatment, the dose of inhaled steroid was maintained constant whereas it was altered during the last 12 weeks according to asthma scores.. Among 108 patients reaching the reduction phase, a decrease of 250 micrograms of inhaled steroid or more was possible in 79% of patients on nedocromil sodium and in 60% of patients on placebo (p < 0.03). Symptoms scores were improved on both treatments during the 12 first weeks, more on nedocromil sodium than on placebo, treatment difference reaching significance for daytime asthma (p < 0.02). FEV1 improved during the trial for patients on nedocromil (from 69 +/- 18% to 74 +/- 21%; p < 0.005) whereas it did not for those on placebo.. Nedocromil sodium is effective in improving moderate to severe asthma in addition to inhaled steroid and has some steroid sparing effect in patients treated with high dose inhaled steroid.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Double-Blind Method; Drug Synergism; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Nedocromil; Severity of Illness Index

1994
Methotrexate in steroid-dependent asthma: long-term results.
    Allergy, 1994, Volume: 49, Issue:7

    Treatment of 21 steroid-dependent asthmatic patients with methotrexate (MTX) 15 mg/week was prospectively evaluated for a mean of 14.7 (SD 3.7) months. Before MTX, therapy consisted of a mean prednisone dose of 16.6 (SD 9.2) mg, in addition to inhaled beclomethasone/budesonide (mean daily dose 1157 (SD 330) micrograms) and bronchodilators. Thirteen patients were weaned from all regular systemic steroid therapy, a 50% or more reduction was achieved in four patients, and a less than 50% reduction in four patients. Abnormal liver function tests were noted in six of the 21 patients; this resolved despite continuation of MTX in five. In one patient, MTX was stopped because of symptoms as well as a fivefold rise in serum transaminases, and a speedy resolution was noted. Gastrointestinal side-effects were reported in six patients but were resolved in five with intramuscular MTX. There were no hematologic or pulmonary complications. We conclude that MTX appears to be both safe and efficacious as a steroid-sparing agent in most steroid-dependent asthmatic patients when taken over a long period.

    Topics: Adult; Aged; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Liver; Liver Function Tests; Male; Methotrexate; Middle Aged; Prednisone; Pregnenediones; Prospective Studies; Time Factors; Treatment Outcome

1994
Influence of treatment on peak expiratory flow and its relation to airway hyperresponsiveness and symptoms. The Dutch CNSLD Study Group.
    Thorax, 1994, Volume: 49, Issue:11

    Despite effective treatments, the morbidity and mortality of obstructive airways disease (asthma and COPD) remains high. Home monitoring of peak expiratory flow (PEF) is increasingly being advocated as an aid to better management of obstructive airways disease. The few available studies describing effects of treatment on the level and variation of PEF have involved relatively small numbers of subjects and did not use control groups.. Patients aged 18-60 years were selected with PC20 < or = 8 mg/ml and FEV1 < 95% confidence interval of predicted normal. They were randomised to receive, in addition to a beta 2 agonist, either an inhaled corticosteroid (BA+CS), an anticholinergic (BA+AC), or a placebo (BA+PL). One hundred and forty one of these subjects with moderately severe obstructive airways disease completed seven periods of two weeks of morning and afternoon PEF measurements at home during 18 months of blind follow up.. Improvements in PEF occurred within the first three months of treatment with BA+CS and was subsequently maintained: the mean (SE) increase in morning PEF was 51 (8) l/min in the BA+CS group compared with no change in the other two groups. Similarly, afternoon PEF increased by 22 (7) l/min. Diurnal variation in PEF (amplitude %mean) decreased from 18.0% to 10.2% in the first three months of treatment with BA+CS. Within-subject relations between changes in diurnal variation in PEF and changes in PC20 were found to be predominantly negative (median rho-0.40) but with a large scatter. Relations between diurnal variation in PEF and changes in symptom scores, FEV1, and bronchodilator response were even weaker.. In patients with moderately severe obstructive airways disease, PEF rates and variation are greatly improved by inhaled corticosteroids. Since the relation of diurnal PEF variation with PC20, symptoms, FEV1, and bronchodilator response were all weak, these markers of disease severity may all provide different information on the actual disease state. PEF measurements should be used in addition to the other markers but not instead of them.

    Topics: Adolescent; Adult; Asthma; Beclomethasone; Circadian Rhythm; Double-Blind Method; Drug Therapy, Combination; Female; Follow-Up Studies; Forced Expiratory Volume; Humans; Ipratropium; Lung Diseases, Obstructive; Male; Middle Aged; Peak Expiratory Flow Rate; Terbutaline

1994
[Effects on bone metabolism of asthma treatment with beclomethasone dipropionate (BDP) inhalation and short term burst of oral steroids].
    Nihon Kyobu Shikkan Gakkai zasshi, 1994, Volume: 32, Issue:10

    Inhaled steroids are currently the first-line treatment of chronic asthma. Because each metered dose of beclomethasone dipropionate (BDP) is small (50 micrograms), short term burst or continuous use of oral steroids are combined in moderately to severely asthmatic patients. The effect of these treatments on bone metabolism remains unclear. Bone mineral density (BMD), osteoclacin (OC), PTH, Ca, and ALP were assessed in 130 asthmatic patients. There were 3 groups: the first group [B+R] consisted of 17 patients taking BDP (1190 +/- 536 micrograms/day) and also taking oral steroids (8.0 +/- 3.8 mg/day, 8.11 +/- 5.52 years), the second group [B+S] had 35 patients taking BDP (885 +/- 320 +/- g/day) and short-term bursts of oral steroids (PSL 20-40 mg/day, 3-7 days/course, 7.51 +/- 4.54 courses/year) and the third group [B alone] consisted of patients who were taking BDP (480 +/- 260 micrograms/day) alone. BMD was measured by dual energy X-ray absorptiometry (DEXA). In the [B+R], [B+S], and [B alone] groups, the BMD of vertebra (L1-4) was 0.75, 0.86, and 0.90 g/cm2, respectively. The percentages of predicted values based on age and sex were 92.0, 102.7, and 106.9% respectively. BMD and percent decrease were significantly lower in the [B+R] group than in the [B+S] or [B alone] group. It is likely that this phenomenon is caused by long-term use of oral steroids rather than by BDP inhalation but there is no significant difference between the [B+S] and the [B alone] groups. Daily BDP dose did not correlate with BMD by multiple regression analysis.(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Administration, Inhalation; Administration, Oral; Adult; Aged; Asthma; Beclomethasone; Bone and Bones; Bone Density; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Osteocalcin; Prednisolone

1994
Added salmeterol versus higher-dose corticosteroid in asthma patients with symptoms on existing inhaled corticosteroid. Allen & Hanburys Limited UK Study Group.
    Lancet (London, England), 1994, Jul-23, Volume: 344, Issue:8917

    Guidelines on asthma management recommend that in patients who still have symptoms on treatment with low-dose inhaled corticosteroids the first step should be an increase in inhaled corticosteroid dose. The addition of long-acting inhaled beta 2-adrenoceptor agonists is another option. We have compared these two strategies in a randomised, double-blind, parallel-group trial. We studied 429 adult asthmatic patients who still had symptoms despite maintenance treatment with 200 micrograms twice daily inhaled beclomethasone dipropionate (BDP). 3 did not provide verifiable data. Of the others, 220 were assigned salmeterol xinafoate (50 micrograms twice daily) plus BDP and 206 were assigned higher-dose BDP (500 micrograms twice daily) for 6 months. The mean morning peak expiratory flow increased from baseline in both groups, but the increase was greater in the salmeterol/BDP group than in the higher-dose BDP group at all time points (differences 16-21 L/min, p < 0.05). Mean evening PEF also increased with salmeterol/BDP but not with higher-dose BDP. There were significant differences in favour of salmeterol/BDP in diurnal variation of PEF (all time points) and in use of rescue bronchodilator (salbutamol) and daytime and night-time symptoms (some time points). There was no significant difference between the groups in adverse effects or exacerbations of asthma, indicating that in this group of patients regular beta 2-agonist therapy was not associated with any risk of deteriorating asthma control over 6 months. This study suggests a need for a flexible approach to asthma management.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Albuterol; Asthma; Beclomethasone; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Respiratory Mechanics; Salmeterol Xinafoate

1994
Comparison of two beclomethasone dipropionate inhalation aerosol spacer combinations in the treatment of asthma.
    International journal of clinical pharmacology and therapeutics, 1994, Volume: 32, Issue:6

    Fifty-five asthmatics, previously treated with inhaled steroids (mean age 48 years, range 16-68 years, mean duration of the disease 10 years, range 1-35 years) participated in this multicentric 2-phase trial. The patients were in good clinical condition (basal FEV1 3.02 litres (1.38-6.29), 90% (48-131%) of predicted values; mean (range)). In the first phase (randomized, double-blind crossover study) 2 beclomethasone dipropionate (BDP) inhalation aerosol preparations (MDI) were administered through collapsible spacer. In the second phase (open, randomized, parallel group comparison), 1 of the preparations was administered via collapsible and the other via traditional large volume spacer. The total daily dose of inhaled beclomethasone was 1,000 micrograms. The evaluation of efficacy was based on peak flow monitoring (PEFR) carried out at home twice daily and on FEV1 measured in spirometry at control visits after the run-in period and after each 4-weeks treatment period. Side-effects and asthma symptoms were recorded on patient diaries. The patients were asked to evaluate the treatment efficacy and the use and handling of the MDI-spacer combinations with Visual Analog Scale (VAS) at the end of each treatment period. No statistically significant differences were found in PEFR or FEV1 between the treatments during whole study. The asthma symptom scores were low as well as the use of concomitant inhaled sympathomimetics which indicates good and equal efficacy of the preparations. The MDI-spacer combinations were equally well tolerated. According to the VAS scores, the collapsible spacer was easier to use and statistically significantly easier to handle than traditional large volume spacer.

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Double-Blind Method; Excipients; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Peak Expiratory Flow Rate

1994
[Bronchial hyperreactivity in patients with bronchial asthma treated with salbutamol and salbutamol combined with beclocort or nedocromil].
    Pneumonologia i alergologia polska, 1994, Volume: 62, Issue:7-8

    Salbutamol alone (400 micrograms per day) or salbutamol together with beclocort (1 mg per day) was used in 20 patients with mild asthma. 12 patients received during a month salbutamol combined with nedocromil (Tilade 8 mg per day). Prior starting treatment and after concluding a histamine provocation challenge was performed allowing to assess the bronchodilating properties of salbutamol. We conclude that: salbutamol alone produced a statistically nonsignificant increase of bronchial hyperactivity; a combination of salbutamol with beclocort or nedocromil did not increase the bronchial hyperactivity; during the three month trial with salbutamol alone or in a combination with a antiinflammatory agent the bronchodilatatory effect of salbutamol remained the same.

    Topics: Adult; Albuterol; Asthma; Beclomethasone; Bronchial Hyperreactivity; Drug Therapy, Combination; Female; Humans; Male; Nedocromil; Treatment Outcome

1994
Effects of long-term use of high-dose inhaled steroids on bone density and calcium metabolism.
    The Journal of allergy and clinical immunology, 1994, Volume: 94, Issue:5

    Inhaled steroids are the mainstay in the antiinflammatory treatment of asthma. In the last few years, these agents have been used in increasing doses. Because high doses of inhaled steroids can reduce serum osteocalcin levels, there are concerns regarding their long-term effects on bone metabolism.. We examined the effects of doses of 800 micrograms/day or greater of beclomethasone or budesonide for more than 18 months in 37 asthmatic subjects (group A), matched to a control group of 37 asthmatic subjects using little or no inhaled steroids (< 500 micrograms, group B). All had a clinical evaluation, measurements of expiratory flows, and determination of serum creatinine, calcium, phosphate, gamma-glutamyl transpeptidase, alkaline phosphatase, cortisol, and osteocalcin levels. A 2-hour urinary sample was obtained for creatinine, calcium, phosphate, hydroxyproline, and cortisol measurements. Bone density was assessed at the lumbar spine level and at the hip with a Hologic-QDR-2000 osteodensitometer (Hologic, Boston, Mass.).. The mean (+/- SD) daily dose of inhaled steroids over the last 2 years was 1140 +/- 353 micrograms in group A (mean duration of use of > 800 micrograms/day, 34.2 +/- 13.0 months) and 89 +/- 98 micrograms for group B (mean duration of use of < 500 micrograms/day, 15.7 +/- 18.8 months). The number of oral steroid treatments (< 15 days) during the last 2 years was small in the two groups, 0.92 +/- 1.27 in group A and 0.05 +/- 0.23 in group B (p > 0.05). The only differences between our two groups in terms of serum or urinary parameters were for mean osteocalcin level, which was lower in group A (2.16 +/- 1.09 ng/ml) than in group B (2.70 +/- 0.98 ng/ml) (p = 0.029), and in mean urinary phosphorous level, which was higher in group A (1.44 +/- 0.76 mmol/2 hr) than in group B (1.26 +/- 0.89 mmol/2 hr (p = 0.034). Mean urinary hydroxyproline levels were 15.51 +/- 6.98 mumol/2 hr in group A and 13.53 +/- 7.13 mumol/2 hr in group B (p > 0.05). Mean mineral bone densities of the lumbar spine and hip were similar in the two groups with values of 0.923 +/- 0.136 gm/cm2 and 0.719 +/- 0.147 gm/cm2 in group A and 0.933 +/- 0.154 gm/cm2 and 0.694 +/- 0.095 gm/cm2 in group B (p > 0.05). The T and Z scores for lumbar spine were -1.32 +/- 1.22 and -0.85 +/- 1.02 in group A and -1.19 +/- 1.33 and -0.72 +/- 1.08 in group B (p > 0.05). There was no correlation between the duration or dose of steroid use and bone density or osteocalcin. Although the serum osteocalcin level was lower in the group of subjects using high-dose inhaled steroids, suggesting an osteoblastic depression, bone density was not significantly different compared with the control group.. This study shows that although the serum osteocalcin level was lower and the urinary phosphorus level was higher in subjects using high-dose inhaled steroids for a mean of 34 months, compared with a control group, no significant difference in bone density or other markers of bone metabolism was found between the two groups.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Bone Density; Bronchodilator Agents; Budesonide; Calcium; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Pregnenediones; Time Factors; Vital Capacity

1994
Placebo-controlled immunopathologic study of four months of inhaled corticosteroids in asthma.
    American journal of respiratory and critical care medicine, 1994, Volume: 150, Issue:1

    The effect of prolonged inhaled corticosteroid treatment on bronchial immunopathology was assessed in 25 nonsmoking mildly asthmatic subjects previously receiving intermittent inhaled beta 2-agonist alone. Inhaled beclomethasone dipropionate (BDP), 500 micrograms twice per day or placebo was administered for 4 mo in a double-blind parallel group study. Histamine bronchial provocation, fiberoptic bronchoscopic biopsy, and bronchoalveolar lavage (BAL) were performed before and after treatment. There was no difference in bronchial responsiveness or lung function between groups. In patients treated with BDP compared with placebo, there was a significant reduction in toluidine blue-staining mast cells (p = 0.028) and total (p = 0.005) and activated eosinophils (p = 0.05) in biopsies but no difference in eosinophils or eosinophil cationic protein in BAL. Granulocyte-macrophage colony-stimulating factor expression was significantly reduced in the bronchial epithelium, and the thickness of Type III collagen deposition in the bronchial lamina reticularis reduced from 29.7 +/- 4.4 to 19.8 +/- 3.4 microns (mean +/- 95% confidence interval) (p = 0.04). No change in helper or activated helper T cells occurred. Prolonged BDP treatment reduces inflammatory infiltration, proinflammatory cytokine expression, and subepithelial collagen deposition, a recognized abnormality in asthma.

    Topics: Administration, Inhalation; Adolescent; Adult; Asthma; Basement Membrane; Beclomethasone; Biopsy, Needle; Bronchi; Bronchoalveolar Lavage Fluid; Cell Count; Collagen; Double-Blind Method; Eosinophils; Female; Granulocyte-Macrophage Colony-Stimulating Factor; Humans; Male; Mast Cells; Middle Aged; T-Lymphocyte Subsets

1994
Effects of inhaled steroids on blood eosinophils in moderate asthma.
    Annals of the New York Academy of Sciences, 1994, May-28, Volume: 725

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Double-Blind Method; Eosinophils; Female; Humans; Leukocyte Count; Leukotriene C4; Male; Methacholine Chloride

1994
Effects of short-term and long-term treatment with inhaled corticosteroids on bone metabolism in patients with airways obstruction. Dutch CNSLD Study Group.
    Thorax, 1994, Volume: 49, Issue:7

    Recent reports have suggested short-term changes in serum parameters of bone metabolism with inhaled corticosteroids. The relevance of these findings to the balance between bone formation and resorption during years of corticosteroid treatment remains uncertain.. Two novel markers of bone turnover were first compared with conventional markers in a pilot study and subsequently measured in a long-term double blind study of inhaled corticosteroids. In study I 15 patients were newly started on at least 800 micrograms inhaled corticosteroids daily. At entry and after four weeks serum levels of alkaline phosphatase, osteocalcin, and PICP (procollagen type I carboxy terminal propeptide; a procollagen splice product) were measured as markers of bone formation, as well as the urinary hydroxyproline/creatinine ratio and serum levels of ICTP (type I collagen carboxy terminal telopeptide; a collagen degradation product) as markers of bone resorption. In study II 70 patients with airways obstruction received 800 micrograms beclomethasone daily in addition to terbutaline and 85 received bronchodilators only in a double blind fashion. Serum levels of PICP and ICTP were measured before and after 2.5 years of treatment.. In study I a decrease in osteocalcin levels was accompanied by an increase in levels of PICP and a small and non-significant rise in alkaline phosphatase. There were no changes in hydroxyproline or ICTP. In study II no differences were found in serum levels of PICP between the treatment groups; an increase in serum ICTP was found in the group treated without inhaled corticosteroids compared with the group treated with inhaled corticosteroids.. No detrimental long-term effect of inhaled corticosteroids was found with three conventional and two novel parameters of bone metabolism. The results indicate that long-term changes in bone turnover during treatment with inhaled corticosteroids should not be deduced from short-term studies with single serum parameters of bone metabolism, but well designed long-term studies of, for example, bone densitometry should be awaited before quoting detrimental effects of inhaled corticosteroids on bone metabolism.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Bone and Bones; Budesonide; Double-Blind Method; Female; Glucocorticoids; Humans; Lung Diseases, Obstructive; Male; Osteocalcin; Peptide Fragments; Pregnenediones; Procollagen

1994
A comparison of fluticasone propionate 200 micrograms/day with beclomethasone dipropionate 400 micrograms/day in adult asthma.
    Allergy, 1994, Volume: 49, Issue:5

    A total of 261 patients with symptomatic, mild to moderate asthma were randomized to treatment in this 4-week, double-blind, parallel-group comparison of fluticasone propionate 200 micrograms/d with beclomethasone dipropionate 400 micrograms/d. Improvements from both treatments were seen in diary card data. Morning peak expiratory flow rate (PEFR) improved from 375 to 390 and 371 to 382 l/min with fluticasone propionate and beclomethasone dipropionate, respectively. Symptom scores, percentage of symptom-free days and nights, and use of rescue beta 2-agonist medication also improved, as did clinical lung function. With the exception of percentage of rescue-free days, which was greater for beclomethasone dipropionate, none of the differences between the groups were statistically significant. There was a significant difference between treatments in the number of rescue-free days over days 1-28; however, there was no difference between treatments in the number of rescue-free days over days 1-14, nor was there any difference in the number of inhalations of rescue medication used throughout the study. Very few adverse effects were reported. Although all mean plasma cortisol values were within the normal range, they were significantly different between treatments, rising from 402 to 429 nmol/l with fluticasone propionate, and falling from 435 to 394 nmol/l with beclomethasone dipropionate (P = 0.006). Mean stimulated cortisol levels 30 min after tetracosactin injection were also significantly greater with fluticasone propionate (P = 0.024). In conclusion, fluticasone propionate 200 micrograms/d is as effective as beclomethasone dipropionate 400 micrograms/d with less effect on plasma cortisol levels.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Aged, 80 and over; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Cosyntropin; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fluticasone; Humans; Hydrocortisone; Injections; Male; Middle Aged; Peak Expiratory Flow Rate; Time Factors; Treatment Outcome

1994
Comparison of inhaled beclomethasone dipropionate 1000 micrograms twice daily and oral prednisone 10 mg once daily in asthmatic patients.
    Thorax, 1994, Volume: 49, Issue:1

    Glucocorticosteroids are widely used as drugs of first choice in the treatment of moderate to severe asthma. The effects of inhaled steroids in high doses have been compared with oral prednisone in asthmatic patients in a double blind crossover study.. The trial consisted of a two week run in period followed by two four week treatment periods separated by a four week washout. During the treatment period patients took either 1000 micrograms beclomethasone dipropionate twice daily and placebo tablets once daily, or 10 mg prednisone daily in one morning dose and placebo inhaler twice daily. The effects of treatment on the provocative dose of histamine producing a 20% fall in FEV1 (PC20 histamine), peak flow measurements at home, and spirometric measurements in the clinic, as well as on the basal and stimulated plasma cortisol levels were measured.. Seventeen patients with asthma completed the study. After four weeks of treatment beclomethasone dipropionate showed a significantly better effect on morning peak expiratory flow rate than prednisone. There was a trend to a greater improvement in the PC20 histamine in patients receiving beclomethasone dipropionate than in those receiving prednisone. There were no significant differences in spirometric values, symptom scores, or basal and stimulated cortisol levels between the treatments. The within treatment analysis showed a significant effect of prednisone on stimulated cortisol levels but not of beclomethasone dipropionate.. Beclomethasone dipropionate 1000 micrograms twice daily has a slightly greater therapeutic effect in this population of asthmatic patients than 10 mg of prednisone once a day with less effect on adrenocortical function.

    Topics: Administration, Inhalation; Administration, Oral; Adolescent; Adult; Aged; Asthma; Beclomethasone; Double-Blind Method; Drug Administration Schedule; Female; Forced Expiratory Volume; Humans; Hydrocortisone; Male; Middle Aged; Peak Expiratory Flow Rate; Prednisone

1994
The effect of the orally active platelet-activating factor antagonist WEB 2086 in the treatment of asthma.
    American journal of respiratory and critical care medicine, 1994, Volume: 149, Issue:5

    Platelet-activating factor (PAF) may be a major mediator of asthma and bronchial hyperreactivity through its many proinflammatory actions. Specific antagonism of PAF might offer an alternative anti-inflammatory treatment to inhaled corticosteroids. To test this, we have studied the effect of an orally active PAF antagonist, WEB 2086, on the inhaled steroid requirements of symptomatic atopic asthmatics in a double-blind randomized placebo-controlled parallel group study. The inhaled corticosteroid dose required for symptomatic control of asthma was established and further steroid reduction was attempted after treatment with WEB 2086 40 mg three times daily for 12 wk. Of 106 patients recruited, 68 entered the treatment phase and 65 completed 6 wk of treatment. The mean daily corticosteroid dose (SE) at study entry was 1,257 (75) micrograms which was reduced by 323 (66) micrograms during the run-in period without loss of symptomatic control. A further 416 (57) micrograms reduction in inhaled corticosteroid dosage was possible during the treatment phase but this was almost identical in the WEB 2086 and placebo-treated groups, amounting to 353 (92) and 481 (65) micrograms/day respectively (not significant [NS]). Rate of relapse following corticosteroid reduction was a continuous variable and relapse occurred at different times depending on the variable used to define it. Time to relapse measured by an increase in symptoms correlated with disease duration (r = 0.41, p < 0.01) and with the dose of inhaled corticosteroid at study entry (r = 0.36, p < 0.01) but no other measured variable predicted the time to relapse.(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Administration, Inhalation; Administration, Oral; Adolescent; Adult; Aged; Albuterol; Asthma; Azepines; Beclomethasone; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Platelet Activating Factor; Triazoles

1994
Comparative safety and efficacy of single or twice daily administration of inhaled beclomethasone in moderate asthma.
    Chest, 1994, Volume: 105, Issue:6

    In the treatment of stable mild to moderate asthma, twice-daily administration of inhaled steroids may allow adequate control of the asthma; however, comparisons of the efficacy of once- or twice-daily administration brought contradictory results. This study is a randomized, double-blind crossover trial, set to determine if inhaled beclomethasone dipropionate given once daily in the late afternoon or at bedtime can be as effective as a twice-daily regimen in the treatment of moderate asthma.. Subjects were randomly assigned to 3 different dosing regimens of inhaled beclomethasone: (1) regimen A, a twice-daily dose of 500 micrograms in the morning and at bedtime; (2) regimen B, a single dose of 1,000 micrograms in the late afternoon; and (3) regimen C, a single dose of 1,000 micrograms at bedtime.. Enrolled in the study were 42 subjects who required 500 micrograms of inhaled beclomethasone dipropionate twice daily to control symptoms of asthma and to minimize use of beta 2-adrenergic agonists, according to criteria suggested in a recent international consensus on asthma therapy. Prior to receiving therapy with inhaled steroids, all of these patients either had chronic symptoms of asthma that required administration of a short-acting beta 2-agonist at least twice per day, or had nocturnal asthma symptoms at least once per week.. After a 2-week baseline evaluation, each subject was given the 3 treatment regimens in randomized order, each for a period of 4 weeks. Subjects were asked to record daily symptoms of asthma and peak expiratory flows in the morning and evening. At the end of each treatment period, spirometric data and airway responsiveness to methacholine were measured.. Thirty-seven subjects completed the study. No significant difference was found among the 3 treatment regimens for asthma symptoms, FEV1, the provocative concentration of methacholine causing a 20 percent decrease in the FEV1 (PC20) (geometric means, 1.41, 1.09, and 1.09 mg/ml), and mean morning and evening peak expiratory flow rates (PEFR). The plasma cortisol level and the adrenocorticotropic hormone (ACTH) response were not significantly different among treatments, nor were side effects, which were minimal.. In moderate asthma controlled with a twice-daily dose of inhaled beclomethasone, a single total daily dose administered in the late afternoon or in the evening provides as good control of asthma for 2 months.

    Topics: Administration, Inhalation; Adrenocorticotropic Hormone; Adult; Aerosols; Asthma; Beclomethasone; Double-Blind Method; Drug Administration Schedule; Female; Forced Expiratory Volume; Humans; Hydrocortisone; Male; Peak Expiratory Flow Rate; Time Factors

1994
Airway inflammation in nonasthmatic subjects with chronic cough.
    American journal of respiratory and critical care medicine, 1994, Volume: 149, Issue:2 Pt 1

    The physiopathology of chronic cough remains obscure. We evaluated the possibility that chronic cough in nonasthmatic subjects is associated with airway inflammation, and if this is so, what the relationship between this inflammation and the possible etiology of cough might be, as well as its response to inhaled steroids. Nineteen nonsmoking, nonasthmatic subjects referred for a persistent cough (mean: 3.8 yr) were evaluated and compared with 10 normal subjects. The evaluation included a respiratory questionnaire, a physical examination, allergy skin-prick tests, chest and sinus radiographs, esophageal pH monitoring, measurements of expiratory flows, methacholine and citric acid challenges, and flexible bronchoscopy for bronchoalveolar lavage (BAL) and bronchial biopsies. Fourteen subjects further accepted participation in a randomized, double-blind crossover trial of inhaled beclomethasone (500 micrograms four times daily) and a placebo for 1 mo each. Four groups of subjects were identified according to the presence of postnasal discharge (n = 4), gastroesophageal reflux (n = 6), both conditions (n = 5), or neither (n = 4). Subjects with chronic cough had an increased number of inflammatory cells in their bronchoalveolar lavage fluid (BALF), but there was no significant difference between the four subgroups of coughers. As compared with control subjects, the bronchial biopsies of subjects with chronic cough showed increased epithelial desquamation (p = 0.004) and inflammatory cells (p = 0.005), particularly mononuclear cells (p < 0.01), in addition to submucosal fibrosis, squamous-cell metaplasia, and loss of cilia. These findings were not significantly different between the different etiologic groups. In subjects with chronic cough, basement-membrane thickness was normal and not different from that of control subjects.(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Adult; Asthma; Beclomethasone; Bronchi; Bronchitis; Bronchoalveolar Lavage Fluid; Chronic Disease; Cough; Double-Blind Method; Female; Humans; Male

1994
Absence of posterior subcapsular cataracts in young patients treated with inhaled glucocorticoids.
    Lancet (London, England), 1993, Sep-25, Volume: 342, Issue:8874

    The prevalence of posterior subcapsular cataracts in young patients receiving inhaled glucocorticoids for treatment of chronic asthma is unknown. In a cross-sectional study, slit-lamp examinations were done on 95 consecutive young patients who were taking inhaled beclomethasone or budesonide. No posterior subcapsular cataracts were found. The median age of the patients was 13.8 (range 5.8-24.8). The median dose of inhaled beclomethasone or budesonide was 750 micrograms/day (range 300-2000), or 12.9 micrograms/kg per day (range 7.5-34.2). The median duration of treatment was 5 years (range 1-15). 77% of the patients had not used oral glucocorticoids in the year preceding the examination. This study suggests that routine screening for posterior subcapsular cataracts in this patient population is not warranted.

    Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Cataract; Child; Child, Preschool; Chronic Disease; Cross-Sectional Studies; Female; Humans; Male; Manitoba; Patient Compliance; Pregnenediones

1993
Variability of bronchodilator response and effects of inhaled corticosteroid treatment in obstructive airways disease. Dutch CNSLD Study Group.
    Thorax, 1993, Volume: 48, Issue:7

    In the day to day care of obstructive airways diseases (asthma and chronic obstructive pulmonary disease) important decisions such as disease classification and choice of therapy are based on assessment of the bronchodilator response. However, surprisingly little is known of the long term course of the bronchodilator response in patients with obstructive airways disease.. Data from a multicentre trial were used in which 274 patients aged 18-60 years with airways obstruction were selected with PC20 < 8 mg/ml and FEV1 < 95% CI of predicted. FEV1 was measured before and 20 minutes after 1000 micrograms terbutaline and 40 minutes after an additional 80 micrograms ipratropium bromide. Data were analysed from 185 patients who were followed up for 21 months (five measurements). Four different expressions of bronchodilator response (BDR) were examined for change under long term therapy, long term variability, and prognostic value in predicting response to inhaled corticosteroids.. There was a significant reduction in BDR of 117 ml after three months of treatment with a beta 2 agonist plus a corticosteroid (BA + CS), but not after bronchodilators only. Significant reductions with BA + CS were also found in BDR as a percentage of initial FEV1, and in BDR as a percentage of predicted FEV1. Bronchodilator tests were quite variable (SD 186 ml or 11% of initial value) and less than half of the patients could consistently be classified as "irreversible" with recommended cutoff levels. The bronchodilator response at the start of the study proved to be a poor predictor of improvement in FEV1 under BA + CS treatment (correct prediction 60%).. Bronchodilator responses decrease substantially with inhaled corticosteroid therapy, and within subject variability is considerable both in asthma and chronic obstructive pulmonary disease. Dichotomous decisions on whether patients are "irreversible" according to any single bronchodilator measurement should therefore be made with great caution. The bronchodilator response cannot be used accurately as a predictor of response to inhaled corticosteroids in obstructive airways disease.

    Topics: Administration, Inhalation; Adolescent; Adult; Albuterol; Asthma; Beclomethasone; Bronchi; Bronchial Provocation Tests; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Ipratropium; Lung Diseases, Obstructive; Male; Middle Aged; Prognosis; Terbutaline

1993
Comparison of fluticasone propionate with beclomethasone dipropionate in moderate to severe asthma treated for one year. International Study Group.
    Thorax, 1993, Volume: 48, Issue:8

    High dose inhaled glucocorticosteroids are increasingly used in the management of patients with moderate to severe asthma. Although effective, they may cause systemic side effects. Fluticasone propionate is a topically active inhaled glucocorticosteroid which has few systemic effects at high doses.. Fluticasone propionate, 1.5 mg per day, was compared with beclomethasone dipropionate at the same dose for one year in patients with symptomatic moderate to severe asthma; 142 patients received fluticasone propionate and 132 received beclomethasone dipropionate. The study was multicentre, double blind and of a parallel design. For the first three months patients attended the clinic every four weeks and completed daily diary cards. For the next nine months they were only seen at three monthly intervals in the clinic.. During the first three months diary card peak expiratory flow (PEF) rate and lung function measurements in the clinic showed significantly greater improvement in patients receiving fluticasone propionate (difference in morning PEF 15 l/min (95% CI 6 to 25)), and these differences were apparent at the end of the first week. The improved lung function was maintained throughout the 12 month period and the number of severe exacerbations in patients receiving fluticasone propionate was reduced by 8% compared with those receiving beclomethasone dipropionate. No significant differences between the two groups were observed in morning plasma cortisol levels, urinary free cortisol levels, or response to synthetic ACTH stimulation. In addition, both the rates of withdrawal and of adverse events were low, and there were fewer exacerbations of asthma with fluticasone propionate than beclomethasone dipropionate.. This study shows that fluticasone propionate in a daily dose of 1.5 mg results in a significantly greater increase in PEF and asthma control than the same dose of beclomethasone dipropionate, with no increase in systemic or other side effects.

    Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Double-Blind Method; Female; Fluticasone; Humans; Hydrocortisone; Lung; Male; Middle Aged; Peak Expiratory Flow Rate

1993
Comparison of the efficacy and safety of inhaled fluticasone propionate 200 micrograms/day with inhaled beclomethasone dipropionate 400 micrograms/day in mild and moderate asthma.
    Archives of disease in childhood, 1993, Volume: 69, Issue:2

    This study was designed to compare the efficacy and safety of a new inhaled corticosteroid, fluticasone propionate at a total daily dose of 200 micrograms, with beclomethasone dipropionate 400 micrograms/day in childhood asthma. A total of 398 asthmatic children (aged 4-19 years) were randomised to receive either fluticasone propionate 200 micrograms daily or beclomethasone dipropionate 400 micrograms daily for six weeks inhaled via a spacer device from a metered dose inhaler. During the study the patients recorded morning and evening peak expiratory flow rate (PEFR), symptom scores, and use of beta 2 agonist rescue medication. In addition, clinic visit PEFR and forced expiratory volume in one second were measured. Safety was assessed by recording all adverse events and by performing routine biochemistry and haematology screens including plasma cortisol concentration before and after treatment. For the purposes of analysis the diary card data were grouped into three periods: week 3 (days 15-21), week 6 (days 36-42), and weeks 1-6 (days 1-42). The results showed no significant difference between treatments on most efficacy parameters. However, there were significant differences in changes from baseline in favour of fluticasone propionate for % predicted morning PEFR both at week 3 (fluticasone propionate 6.1%, beclomethasone dipropionate 3.9%) and at week 6 (fluticasone propionate 8.3%, beclomethasone dipropionate 5. 9%) and % predicted evening PEFR at week 6 (fluticasone propionate 7.3%, beclomethasone dipropionate 4.9% and over weeks 1-6 (fluticasone propionate 5.5%, beclomethasone dipropionate 3.6%. Comparison between groups showed that the group receiving fluticasone propionate had a lower % of days with symptom-free exercise at week 6 (fluticasone propionate 87%, beclomethasone dipropionate 81%) and % days without rescue medication at week 6 (fluticasone propionate 87%, beclomethasone dipropionate 80%) and over weeks 1-6 (fluticasone propionate 80%, beclomethasone dipropionate 73%). Except for a higher incidence of sore throat in the fluticasone propionate group, the two treatments did not differ with regard to safety. There was no evidence of adrenal suppression with either treatment. In conclusion, fluticasone propionate 200 microgram daily ws at least as effective and as well tolerated as beclomethasone dipropionate 400 microgram daily in childhood asthma.

    Topics: Administration, Inhalation; Adolescent; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Child, Preschool; Double-Blind Method; Drug Administration Schedule; Drug Delivery Systems; Female; Fluticasone; Humans; Lung; Male; Nebulizers and Vaporizers; Peak Expiratory Flow Rate

1993
A dose-ranging study of fluticasone propionate in adult patients with moderate asthma. International Study Group.
    Chest, 1993, Volume: 104, Issue:5

    In this 4-week, multicenter, double-blind, randomized, parallel group study, the dose-effect relationship of four doses of inhaled fluticasone propionate (50, 100, 200, and 400 micrograms twice daily) was investigated and compared with beclomethasone dipropionate, 200 micrograms twice daily. A total of 672 patients with moderate asthma currently receiving 1,000 micrograms/d or less of an inhaled steroid were recruited. The study demonstrated a significant dose-related improvement in lung function with fluticasone propionate. Linear dose-related increases were observed in morning (increase per doubling dose was 4.3 L/min; 95 percent confidence interval [CI], 1.8, 6.8 L/min; p = 0.001) and evening peak expiratory flow rate (PEFR) (increase per doubling dose was 3.0 L/min; 95 percent CI, 0.5, 5.5 L/min; p = 0.017), clinic lung function (at 4 weeks, increase in percent predicted PEFR per doubling dose = 1.1 percent; 95 percent CI, 0.2, 2.1 percent; p = 0.022; increase in percent predicted FEV1 per doubling dose = 1.1 percent; 95 percent CI, 0.3, 1.9 percent; p = 0.10:increase in percent predicted FVC per doubling dose = 1.3 percent, 95 percent CI, 0.5, 2.1 percent; p = 0.001), and the percentage of symptom-free days over days 1 to 14 of treatment (increase per doubling dose = 1.9, 95 percent CI, 0.0, 3.9; p = 0.048). There was also a dose-related reduction in extra bronchodilator usage (days 1 to 14 p = 0.002; days 15 to 28 p = 0.01). In addition, there was a significant decrease in diurnal variation with increasing doses of fluticasone propionate (decrease per doubling dose = 2.0 L/min, 95 percent CI, 0.4; p = 0.024). The number of asthma exacerbations was also reduced as the dose of fluticasone propionate increased. Fluticasone propionate was well tolerated, adverse events were few, and there was a similar incidence in all groups. Furthermore, there was no evidence of any hypothalamic pituitary adrenal axis suppression. The data from the study were consistent with other clinical studies that have shown fluticasone propionate to be more potent than beclomethasone dipropionate in terms of improvement in lung function. In conclusion, this study provided evidence of a dose-related improvement in asthma control for fluticasone propionate in the dose range 100 to 800 micrograms daily, in patients with moderate asthma.

    Topics: Administration, Topical; Adolescent; Adult; Aged; Analysis of Variance; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Respiratory Function Tests

1993
Effect of eight months of inhaled beclomethasone dipropionate and budesonide on carbohydrate metabolism in adults with asthma.
    Thorax, 1993, Volume: 48, Issue:10

    The safety of high dose inhaled steroids has been a subject of debate. The efficacy and safety of beclomethasone dipropionate and budesonide inhalations were evaluated by measuring their effects on pulmonary function, on the hypothalamic-pituitary-adrenocortical axis, and on carbohydrate metabolism in adults with unstable asthma.. Fifteen adults with unstable asthma and 15 healthy controls were studied. Eight patients were treated with beclomethasone dipropionate in initially high (2 mg/day for five months) and subsequently lower (1 mg/day for three months) doses. Seven patients were treated with budesonide at doses of 1.6 mg/day for five months followed by 0.8 mg/day for three months. Blood glucose and serum insulin were measured in an oral glucose tolerance test and plasma cortisol in an adrenocorticotrophic hormone test. The antiasthmatic effect of treatment was evaluated by measuring peak morning expiratory flow rates and forced expiratory volume in one second (FEV1).. The FEV1 increased significantly after one month of treatment (medians 88% v 96%, p < 0.01), and nocturnal symptoms disappeared within two weeks of treatment in both groups. At one month, the high dose significantly decreased serum insulin concentrations as calculated from the areas under the incremental two hours curves in the glucose tolerance test. The decrease was 59% for beclomethasone dipropionate (medians 76 v 31 mU/l/h, p < 0.005) and 42% for budesonide (medians 79 v 46 mU/l/h, p < 0.01). The median areas at five and eight months were intermediate for both drugs. No significant differences were found when the five and eight month values were compared either with the baseline or with one month values. The difference between the baseline values of both groups and the respective values in healthy controls was significant (medians 79 v 49 mU/l/h, p < 0.01). The one month values for the patients and control subjects were similar. Paralleling the changes for insulin, the area under the incremental two hour blood glucose curve decreased significantly (medians 1.4 v 0.4 mmol/l/h, p < 0.05) during the first month of treatment. The five and eight month values were intermediate (medians 0.8 and 0.7 mmol/l/h, respectively). These changes were not significant compared with the baseline or the one month areas. Similar changes were seen in both treatment groups. Neither treatment had any significant effect on plasma cortisol in the one hour adrenocorticotrophic hormone test.. In patients stressed by uncontrolled asthma, the antiasthmatic effect of high dose beclomethasone dipropionate and budesonide was accompanied by a significant initial decrease in insulin resistance with a parallel improvement in glucose tolerance. During prolonged treatment a small increase in insulin sensitivity was found. The overall effect of beclomethasone dipropionate and budesonide inhalations on carbohydrate metabolism may be beneficial in patients with uncontrolled asthma.

    Topics: Administration, Inhalation; Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Blood Glucose; Bronchodilator Agents; Budesonide; Carbohydrates; Female; Glucocorticoids; Humans; Insulin; Male; Middle Aged; Pregnenediones

1993
Evaluation of fluticasone propionate (500 micrograms day-1) administered either as dry powder via a Diskhaler inhaler or pressurized inhaler and compared with beclomethasone dipropionate (1000 micrograms day-1) administered by pressurized inhaler.
    Respiratory medicine, 1993, Volume: 87, Issue:8

    Five hundred and eighty-five patients with moderate asthma, currently receiving 400-1000 micrograms day-1 of an inhaled corticosteroid, were treated for 6 weeks in a double-blind, randomized, parallel group study with either 500 micrograms day-1 fluticasone propionate as a dry powder via a Diskhaler inhaler, 500 micrograms day-1 fluticasone propionate via a pressurized inhaler or 1000 micrograms day-1 beclomethasone dipropionate via a pressurized inhaler. For all three treatment groups, mean morning and evening peak expiratory flow rates (PEFRs) increased within 1 week of the start of treatment. There were also improvements in clinic lung function, daytime and night-time asthma symptoms and a reduction in daytime and night-time rescue bronchodilator medication in all three groups. There were no statistically significant differences between the two formulations of fluticasone propionate in any of the efficacy parameters. Fluticasone propionate via the Diskhaler was significantly more effective than beclomethasone dipropionate over the 6 week study period in reducing diurnal variation (mean difference--4 l min-1, 95% CI--8 to 0 l min-1: P = 0.03). Fluticasone propionate via the Diskhaler produced a statistically significant improvement in night-time symptoms when compared to beclomethasone dipropionate whereas, beclomethasone dipropionate 1000 micrograms day-1 was statistically significantly more effective than both formulations of fluticasone propionate in improving daytime symptoms (P < 0.05). However, these statistical differences must be viewed together with the fact that very few patients recorded a score of 2 or more for both daytime or night-time symptoms. There was a similarly low incidence of adverse events with all three treatments with no evidence of hypothalamic pituitary adrenal (HPA)-axis suppression. The results of the 6-week comparative study showed that 500 micrograms day-1 fluticasone propionate whether administered via pressurized inhaler or Diskhaler is as effective and as safe as 1000 micrograms day-1 beclomethasone dipropionate administered via a pressurized inhaler in the treatment of moderate asthma. Over 12 months fluticasone propionate 500 micrograms day-1 via a pressurized inhaler was at least as effective and as well tolerated as beclomethasone dipropionate 1000 micrograms day-1.

    Topics: Adolescent; Adult; Aerosols; Aged; Aged, 80 and over; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Double-Blind Method; Drug Administration Schedule; Female; Fluticasone; Humans; Lung; Male; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Powders

1993
Anti-inflammatory action of steroid inhalers.
    The Journal of the Association of Physicians of India, 1993, Volume: 41, Issue:5

    With mucosal inflammation contributing to the pathogenesis of asthma, it is increasingly accepted that long term steroid inhalers may induce remission in chronic long standing asthmatics. The present study involved 44 stable asthmatics who were randomly given either beclomethasone dipropionate inhaler (50 ug) 2 puffs qds or salbutamol inhaler (100 mcg) 2 puffs tds in addition to their oral bronchodilators. Pulmonary function testing, bronchoalveolar lavage and complete blood count were done at basal and weekly intervals and at the end of the study. The absolute eosinophil count showed a significant drop in the beclomethasone group as compared to the salbutamol group. Serial lung functions showed a significant improvement in the pre-bronchodilator PEFR and the pre-bronchodilator FVC in the beclomethasone group as compared to the salbutamol group. There was no significant change in the lavage eosinophil count pre and post-bronchodilator in both groups. Steroid inhalers are thus useful in long term management of bronchial asthma especially with respect to reducing bronchodilator requirement.

    Topics: Administration, Inhalation; Adult; Albuterol; Asthma; Beclomethasone; Chronic Disease; Female; Humans; Male; Middle Aged

1993
Short-term growth during treatment with inhaled fluticasone propionate and beclomethasone dipropionate.
    Archives of disease in childhood, 1993, Volume: 68, Issue:5

    Short-term lower leg growth was investigated with twice weekly knemometry measurements in 19 schoolchildren with mild asthma during treatment with daily doses of 200 micrograms fluticasone propionate, 400 micrograms, and 800 micrograms beclomethasone dipropionate from a dry powder inhaler. The design was a randomised, double blind, crossover trial. After a run in period of four days (period 1) the children were allocated to a sequence of active treatments in periods 2, 4, and 6. In periods 3 and 5 (wash out) placebo was given. All periods except the run in were two weeks long. The mean lower leg growth velocities during the wash out periods were 0.61 and 0.80 mm/week. Mean growth velocities during treatment with fluticasone propionate and low and high doses of beclomethasone dipropionate were 0.34, 0.09, and 0.06 mm/week respectively. Compared with fluticasone propionate, treatment with beclomethasone dipropionate 400 and 800 micrograms/day was associated with a statistically significant reduction in growth velocity.

    Topics: Administration, Inhalation; Administration, Topical; Adolescent; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fluticasone; Glucocorticoids; Growth; Humans; Leg; Male; Risk Factors; Time Factors

1993
[Effects of high doses of beclomethasone dipropionate in bronchial asthma].
    Arerugi = [Allergy], 1993, Volume: 42, Issue:4

    To evaluate the clinical efficacy of high dose inhaled steroids, we examined the effects of standard doses (400 micrograms/day) and high doses (800 micrograms/day) of inhaled beclomethasone dipropionate (BDP, Becotide Inhaler), and the dose for regular use (800 micrograms/day) of salbutamol (Salb. Asmidon Air) on pulmonary function, bronchial hyperresponsiveness and asthma attack score. The subjects were 17 out-patients with mild or moderate bronchial asthma who were not receiving any anti-allergics or steroids. The patients were randomly allocated into three groups i.e., Group I: BDP 400 micrograms/day, Group II: BDP 800 micrograms/day and Group III: Salb. 800 micrograms/day. The administration period was 8 weeks. Pulmonary function test were performed and bronchial hyperresponsiveness was examined before and after the 8 weeks of treatment and attack scores were recorded during this period. It was found that inhalations of 400 micrograms/day and 800 micrograms/day BDP improved FEV1.0% value, peak flow, F-V curve, Dmin. and SGrs/Grs cont. Particularly, inhalation of 800 micrograms/day of BDP significantly improved these values and reduced attack scores in the early stages of the 8 week treatment. In contrast, there was a trend for inhalation of Salbutamol to enhance bronchial hyperresponsiveness and not to improve pulmonary function and asthma attack score. In conclusion, 800 micrograms/day of inhaled BDP is considered to be useful in the treatment of mild or moderate bronchial asthma.

    Topics: Adult; Asthma; Beclomethasone; Female; Humans; Male; Middle Aged

1993
A comparative study of the efficacy of beclomethasone dipropionate delivered from a breath activated and conventional metered dose inhaler in asthmatic patients.
    Current medical research and opinion, 1993, Volume: 13, Issue:2

    In order to overcome the problem of poor co-ordination with the use of the conventional press and breathe metered dose inhaler, a breath-activated inhaler ('Autohaler' inhalation device) has been developed. The clinical response to equal doses of beclomethasone dipropionate administered from the 'Autohaler' device and the conventional metered dose inhaler was compared in 36 stable asthmatic patients receiving regular inhaled beclomethasone dipropionate. The study was performed using a double-blind, double-dummy crossover design. Each treatment was given for 4 weeks. Objective and subjective measures of asthma severity were compared in the second 14 days of each treatment period, with clinical equivalence defined as a difference of 20% or less in the adjusted mean values for the 30 patients with data from both treatment periods. Equivalence at the +/- 5% level was found in the objective measures of pre-bronchodilator FEV1 (p < or = 0.001); post-bronchodilator FEV1 (p < 0.001); morning and evening peak expiratory flow rate (both p < or = 0.001). Patient diary cards established there was equivalent usage of inhaled bronchodilator, and equivalent symptom scores for daytime disability and daytime and night-time breathlessness. The results show that, in stable asthmatics, treatment with beclomethasone dipropionate is clinically equivalent when delivered by the 'Autohaler' device or the conventional metered dose inhaler used efficiently.

    Topics: Adult; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate

1993
[High dose inhaled steroids in the treatment of bronchial asthma. A comparison of the effects of budesonide and beclomethasone dipropionate on pulmonary function, symptoms, bronchial reactivity and adrenocortical function].
    Ugeskrift for laeger, 1993, Jul-12, Volume: 155, Issue:28

    The effects of high-dose inhaled budesonide (800 micrograms twice daily) and those of inhaled beclomethasone dipropionate (750 micrograms twice daily) were compared with respect to lung function, symptoms, bronchial reactivity and adrenocortical function in a doubleblind, double-dummy cross-over study. The subjects were 40 adult patients suffering from either allergic or non-allergic asthma. The asthma was categorized as moderate to severe, and the asthma was insufficiently controlled on inhalational steroids given in doses of 300 to 500 micrograms daily. After a two week "run-in" period the patients were randomized to six weeks treatment with either budesonide or beclomethasone dipropionate, followed by six weeks treatment with the opposite drug. Both inhaled budesonide and inhaled beclomethasone dipropionate were able to improve objective measures of lung function and bronchial sensitivity to histamine. Neither drug affected adrenocortical function, and no serious side-effects were noted during the trial. It is concluded that budesonide and beclomethasone dipropionate are safe and effective drugs for the treatment of asthma in adults. The substances are equally effective taken microgram for microgram.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex; Adult; Asthma; Beclomethasone; Bronchi; Bronchodilator Agents; Budesonide; Double-Blind Method; Drug Evaluation; Female; Forced Expiratory Volume; Humans; Lung; Male; Middle Aged; Peak Expiratory Flow Rate; Pregnenediones

1993
Airways hyperresponsiveness, bronchodilator response, allergy and smoking predict improvement in FEV1 during long-term inhaled corticosteroid treatment. Dutch CNSLD Study Group.
    The European respiratory journal, 1993, Volume: 6, Issue:6

    Although most patients with obstructive airways disease show some amelioration with long-term inhaled corticosteroid therapy, the extent of improvement may vary considerably between patients. Patients with mild to moderately severe obstructive airways disease (asthma and COPD) were selected if provocative concentration producing a 20% fall in forced expiratory volume in one second (PC20) < or = 8 mg.ml-1, and forced expiratory volume in one second (FEV1) < 95% confidence intervals (CI) of predicted normal. The independent influences of baseline PC20FEV1, inspiratory vital capacity (IVC), bronchodilator response, smoking habits, and allergy both on the "immediate" (within 3 months) response in FEV1 and the change in long-term (from 3 months onwards) slope of FEV1 with inhaled corticosteroids were analysed. Patients had a larger "immediate" improvement in their FEV1 with inhaled corticosteroids with each doubling doses lower PC20, with each ten-fold higher immunoglobulin E (IgE), and if they did not smoke. Total IgE proved a better independent predictor of "immediate" response than specific IgE for house dust mite, skin tests, or blood eosinophils. A more favourable long-term slope of FEV1 was predicted by a larger baseline bronchodilator response, but not by smoking. In conclusion, PC20, total IgE, and smoking habits are independent predictors of immediate treatment response to inhaled corticosteroids. Bronchodilator response is the single independent predictor of changes in long-term slope of FEV1 with corticosteroid treatment.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Bronchi; Bronchial Hyperreactivity; Double-Blind Method; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Ipratropium; Lung Diseases, Obstructive; Male; Middle Aged; Prognosis; Smoking; Terbutaline

1993
A comparison of fluticasone propionate, 1 mg daily, with beclomethasone dipropionate, 2 mg daily, in the treatment of severe asthma. International Study Group.
    The European respiratory journal, 1993, Volume: 6, Issue:6

    We wanted to compare the efficacy and safety of fluticasone propionate, a new topically active inhaled corticosteroid, to that of high dose beclomethasone dipropionate, in severe adult asthma. Patients currently receiving between 1.5-2.0 mg.day-1 of an inhaled corticosteroid were treated for six weeks in a double-blind, randomized, parallel group study with 1 mg.day-1 fluticasone propionate (n = 82), or 2 mg.day-1 beclomethasone dipropionate (n = 72). Mean morning peak expiratory flow rates (PEFR) increased from 303 to 321 l.min-1 with fluticasone propionate, and from 294 to 319 l.min-1 with beclomethasone dipropionate. There was an increase in evening PEFR, asthma symptoms improved, and rescue beta 2-agonist use decreased for both treatment groups. None of these differences between treatments were statistically significant. However, diurnal variation was significantly reduced with fluticasone propionate, when compared with beclomethasone dipropionate (difference = 7 l.min-1; p = 0.038). Clinic lung function also improved with both treatments and, apart from % predicted PEFR, which showed no difference after beclomethasone dipropionate but increased from 73 to 78% with fluticasone propionate, there were no differences between treatments. Forced expiratory volume in one second (FEV1) increased with both treatments. The geometric mean plasma cortisol concentration rose after treatment with fluticasone propionate (from 293 to 309 nmol.l-1) and fell after beclomethasone dipropionate (from 256 to 224 nmol.l-1); the difference between treatments was significant. The incidence of adverse events was low in both treatment groups. In conclusion, 1 mg.day-1 fluticasone propionate was as effective as 2 mg.day-1 beclomethasone dipropionate in the control of severe asthma.(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Administration, Topical; Adolescent; Adult; Aged; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chronic Disease; Double-Blind Method; Female; Fluticasone; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Vital Capacity

1993
Steroid sparing effect of nedocromil sodium in asthmatic patients on high doses of inhaled steroids.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 1993, Volume: 23, Issue:5

    Nedocromil sodium is a non-steroidal prophylactic agent developed for the management of asthma. We have assessed the steroid sparing potential of inhaled nedocromil sodium 4 mg four times daily in a randomized, double blind, placebo controlled study in 69 asthmatic subjects controlled on inhaled beclomethasone dipropionate in the dose range 1000-2000 micrograms daily. Following a 4 week run-in period subjects added nedocromil sodium or placebo by metered dose inhaler to their usual medication for a further 4 weeks. The dose of inhaled steroid was then reduced at fortnightly intervals according to a predetermined schedule, with monitoring of asthma severity, symptom scores, bronchodilator use and peak flow recordings. Sixty subjects entered the steroid reduction phase and achieved median (range) % decreases in steroid dose of 80 (17-100)% with nedocromil sodium compared to 65 (0-100)% with placebo (P = 0.34) with 14 patients in the nedocromil sodium group and 10 in the placebo group being withdrawn completely from inhaled steroids. Subjective global assessment scores were significantly better with nedocromil sodium (mean 2.14) than with placebo (2.93; P < 0.02) though there was no difference between individual daily symptom scores. In this study therefore in asthmatic patients controlled on high doses of inhaled steroids, nedocromil sodium was well tolerated but the small differences in steroid sparing effect between nedocromil and placebo were not statistically significant.

    Topics: Administration, Inhalation; Adult; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Nedocromil; Quinolones; Respiratory Function Tests

1993
Effects of therapeutic doses of salbutamol alone and combined with beclomethasone dipropionate on airway responsiveness and cyclic AMP plasma levels in asthmatic patients.
    Respiration; international review of thoracic diseases, 1993, Volume: 60, Issue:2

    Twelve asthmatic patients received by inhalation for 2 weeks, in a double-blind, cross-over design, beclomethasone dipropionate (BDP; 600 micrograms/day) plus salbutamol (S; 900 micrograms/day), or S (900 micrograms/day) alone. Before and after each treatment course the subjects received intravenous cumulative doses of S up to 200 micrograms. In basal conditions and immediately before the next dose forced expiratory volume in 1 s (FEV1) and plasma cyclic AMP (cAMP) were measured. BDP+S treatment increased FEV1 basal values (p < 0.05) whereas inhaled S resulted in unsignificant improvement of ventilatory parameters. The slopes of the dose-response curves of FEV1 and plasma cAMP to intravenous S were unaffected by the two treatment courses. Our results suggest that DBP+S, differently from S alone, improves ventilatory function in asthmatic patients and that neither S nor S+BDP seem to affect adrenergic function.

    Topics: Administration, Inhalation; Adult; Albuterol; Asthma; Beclomethasone; Cyclic AMP; Double-Blind Method; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Male; Middle Aged

1993
Effects of inhaled beclomethasone on airway responsiveness in occupational asthma. Placebo-controlled study of subjects sensitized to toluene diisocyanate.
    The American review of respiratory disease, 1993, Volume: 148, Issue:2

    We investigated the effect of 5 months of treatment with inhaled beclomethasone dipropionate (BDP) on the airway responsiveness to methacholine (PD20 FEV1) and to toluene diisocyanate (TDI) in 15 sensitized asthmatic subjects who had been removed from occupational exposure to TDI. After the diagnosis was established by a positive inhalation challenge with TDI, each subject was removed from occupational exposure to isocyanates and treated with either BDP (1 mg twice per day, n = 7) or placebo (n = 8) for 5 months. The study was double blind for parallel groups. P20 FEV1 methacholine was measured before and three times during treatment and then at 6 months, that is, 4 wk after cessation of treatment. Airway sensitivity to TDI was assessed with specific inhalation challenge before treatment and at 6 months. Beclomethasone reduced the airway hyperresponsiveness to methacholine but did not affect the response to TDI. In fact, in the subjects on BDP, P20 FEV1 increased from 0.145 to 0.485 mg (p < 0.05) after 2 months of treatment. A further increase was observed at 4 and 5 months (0.548 and 0.629 mg, respectively, p < 0.01), and the improvement in nonspecific airway responsiveness was maintained after a 1-month washout period (0.637 mg, p < 0.01). In contrast, in the subjects on placebo, P20 FEV1 did not change significantly. At the end of the study, the severity of asthmatic reactions induced by bronchial challenge with TDI was significantly reduced in both groups, but no differences were observed between placebo and BDP.(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Adolescent; Adult; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Hydrocortisone; Hypoglycemia; Insulin; Male; Methacholine Chloride; Middle Aged; Occupational Diseases; Placebos; Toluene 2,4-Diisocyanate

1993
Preventive effects of beclomethasone on histamine-induced changes in breathing pattern in asthma.
    Chest, 1993, Volume: 103, Issue:1

    Bronchial mucosa inflammation is a hallmark of asthma. Epithelial damage due to inflammatory process may contribute to induce a pattern of rapid and shallow breathing (RSB). Probably due to its effects on inflammatory process, beclomethasone dipropionate (BDP) decreases bronchial hypersensitivity (BH), as assessed in terms of histamine concentration causing a 20 percent FEV1 decrease from saline solution (PC20FEV1); however, no data are available on the effect of BDP on RSB. We studied 32 asymptomatic asthmatic subjects with a severe to moderate levels of BH (PC20FEV1 0.01 to 1.7 mg/ml). After they were randomly assigned to one month of either BDP (2 mg daily, 17 patients) or placebo (15 patients), they inhaled progressively doubling concentrations of histamine phosphate by tidal breathing method. With histamine in seven BDP-treated and in five placebo-treated patients, decrease in FEV1 > or = 20 percent from saline solution was paralleled by a significant decrease in tidal volume (VT), inspiratory time (Ti), and expiratory time (Te), and increase in respiratory frequency (RF). In the remaining patients, histamine failed to change the breathing pattern. In the seven RSB patients, BDP resulted in a smaller VT decrease (p < 0.02) and a smaller RF increase (p < 0.02) with histamine. The five RSB placebo-treated patients were then given one month BDP (2 mg daily): inhaled BDP, but not placebo, resulted both in a significant increase in PC20FEV1 and modulation in histamine-induced changes in breathing pattern. We conclude that high doses of BDP seem to be able to modulate histamine-induced RSB, an effect that might be linked to reversal of airway inflammation.

    Topics: Adolescent; Adult; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Female; Forced Expiratory Volume; Histamine; Humans; Male; Middle Aged; Placebos; Respiration; Single-Blind Method; Tidal Volume; Time Factors; Vital Capacity

1993
Treatment of allergic rhinitis with intranasal corticosteroids in patients with mild asthma: effect on lower airway responsiveness.
    The Journal of allergy and clinical immunology, 1993, Volume: 91, Issue:1 Pt 1

    The effect of treatment of allergic rhinitis with intranasal corticosteroids on lower airway responsiveness was assessed in a randomized, double-blind, placebo-controlled, crossover study. Twenty-one young patients with perennial allergic rhinitis and asthma, with documented lower airway hyperresponsiveness (PC20 methacholine < 8 mg/ml), were treated with intranasal aqueous beclomethasone dipropionate and placebo, each given for 4 weeks. Patients recorded rhinitis and asthma symptom scores and monitored peak expiratory flow rates every morning and evening. Patients recorded global assessment of rhinitis and global asthma symptom scores at the beginning and end of each treatment. PC20 methacholine was performed at baseline and at the end of each treatment period. Intranasal beclomethasone dipropionate significantly reduced global rhinitis symptom scores (p = 0.05) after 4 weeks of treatment. Global asthma scores did not change significantly (p = 0.2). Geometric mean PC20 methacholine improved significantly after 4 weeks of intranasal beclomethasone, but not after placebo (p = 0.04). Daily morning and evening rhinitis symptom scores were lower in patients treated with intranasal corticosteroids over the first 4 weeks of treatment, but carryover effect of steroids precluded comparative analysis of the second 4-week block (morning p = 0.06, evening p = 0.03). Morning asthma scores tended to decrease (p = 0.07). Evening asthma scores were significantly decreased at weeks 2 and 3 (p = 0.001, p = 0.02, respectively). No change in peak expiratory flow rate was seen. This study confirms that treatment of inflammation in the upper airways indirectly improves asthma symptoms and decreases bronchial hyperreactivity. Ignoring inflammation in the upper airway may lead to suboptimal results in asthma treatment.

    Topics: Administration, Intranasal; Adolescent; Analysis of Variance; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Child; Circadian Rhythm; Double-Blind Method; Humans; Methacholine Chloride; Rhinitis, Allergic, Seasonal; Time Factors

1993
Effect of inhaled beclomethasone dipropionate on bronchial responsiveness in patients with asthma.
    Annals of allergy, 1993, Volume: 70, Issue:2

    We investigated the effect of 300 micrograms of inhaled beclomethasone dipropionate (BDP) daily on bronchial responsiveness to methacholine and pulmonary function of 22 subjects with asthma in a single-blind, crossover study. The severity of bronchial hyperresponsiveness lessened significantly during treatment with BDP (P < .01). No significant changes occurred in FEV1 or in the control value of airway conductance. We conclude that a 300-micrograms total daily dose of BDP is an efficacious treatment for patients with asthma. Because suppression of adrenal function and systemic adverse effects can occur in asthmatic patients treated with inhaled corticosteroids, especially children, long-term treatment with inhaled steroids should employ minimal daily doses necessary.

    Topics: Administration, Inhalation; Adolescent; Adult; Asthma; Beclomethasone; Bronchi; Child; Dose-Response Relationship, Drug; Female; Forced Expiratory Volume; Humans; Male; Single-Blind Method; Theophylline

1993
Slowing the deterioration of asthma and chronic obstructive pulmonary disease observed during bronchodilator therapy by adding inhaled corticosteroids. A 4-year prospective study.
    Annals of internal medicine, 1993, May-15, Volume: 118, Issue:10

    To determine if deterioration in patients with asthma or chronic obstructive pulmonary disease (COPD) during bronchodilator therapy could be slowed by additional treatment with an inhaled corticosteroid.. A 4-year prospective study.. Twenty-nine general practices in the catchment area of the University of Nijmegen, Nijmegen, the Netherlands.. The study included 56 patients (28 with asthma and 28 with COPD) who showed an annual decrease in the forced expiratory volume in 1 second (FEV1) of at least 80 mL in combination with at least two exacerbations per year during bronchodilator therapy alone. Forty-eight patients completed the study.. During the first 2 years of treatment, patients received only bronchodilator therapy (salbutamol, 400 micrograms, or ipratropium bromide, 40 micrograms). During years 3 and 4, they received additional treatment with beclomethasone dipropionate, 400 micrograms two times daily.. Prebronchodilator FEV1 increased 458 mL/y (95% CI, 233 to 683 mL/y) during the first 6 months of beclomethasone treatment; FEV1 then decreased 102 mL/y (CI, 57 to 147 mL/y) during months 7 to 24. The annual decline in FEV1 during beclomethasone treatment was less than the decline of 160 mL/y seen before beclomethasone therapy (difference, 58 mL/y; 95% CI, 2 to 87 mL/y). Only in patients with asthma did beclomethasone treatment improve bronchial hyperresponsiveness (assessed by determining the concentration of histamine that provoked a 20% decrease in FEV1 [PC20]) by 3.0 doubling doses per year (95% CI, 0.8 to 5.2 doses per year). Beclomethasone treatment was associated with improvement in peak expiratory flow rate, alleviation of symptoms, and a decrease in the number of exacerbations in both patient groups.. Adding beclomethasone, 800 micrograms daily, slowed the unfavorable course of asthma or COPD seen with bronchodilator therapy alone. This effect was most evident in asthmatic patients.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Bronchodilator Agents; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Peak Expiratory Flow Rate; Prospective Studies; Respiratory Function Tests; Smoking; Treatment Outcome

1993
Comparison of different inhalation schedules to control childhood asthma.
    Agents and actions. Supplements, 1993, Volume: 40

    In a double-blind, placebo-controlled study control of asthma was assessed by diary symptom cards, peak-flow measurements and lung function within 3 treatment groups over a 6 months period. 36 children (25 boys, 11 girls 5.5 to 13.2 years of age) with exogen allergic, perennial asthma inhaled either beclomethasone dipropionate (BDP) with salbutamol (S) or disodium cromoglycate (DNCG) with S or a placebo preparation with S from metered dose inhalers (MDI) through a large-spaced auxiliary device (Volumatic). At entry, after 2 and 4 months lung function tests were performed evaluating changes in the degree of pulmonary hyperinflation, bronchial obstruction, and bronchial hyperreactivity (BHR). Daily PF measurements showing wide variations (up to 10-12%) were insensitive to indicate any significant changes. In contrast evaluation of symptom diaries presented dramatic improvement during the first 3 months of the study. In addition, the DNCG group showed significant improvement of BHR (p = 0.02). Moreover, the majority of patients on regular therapy with salbutamol and placebo showed an increase of airway resistance. It is concluded that even in mild childhood asthma, for optimal control a combination of a beta 2-stimulant as bronchodilator and DNCG or BDP as protector should be applied.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Child; Cromolyn Sodium; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male

1993
Large volume spacer devices and the influence of high dose beclomethasone dipropionate on hypothalamo-pituitary-adrenal axis function.
    Thorax, 1993, Volume: 48, Issue:3

    The systemic effects of the inhaled corticosteroid beclomethasone dipropionate are reduced if the drug is inhaled through a large volume spacer. Use of spacers may therefore permit higher doses to be given without causing hypothalamo-pituitary-adrenal suppression.. Randomised, double blind, double dummy, parallel group study was carried out in adults with chronic asthma to determine the dose of beclomethasone dipropionate causing hypothalamo-pituitary-adrenal suppression when the drug was administered by metered dose aerosol with and without a large volume spacer. After a four week run in taking 1.5 mg beclomethasone daily 50 patients underwent tests of hypothalamo-pituitary-adrenal function (measurement of 0900 h serum cortisol concentration and 24 hour urinary free cortisol excretion and the short tetracosactrin test). Six patients had hypothalamo-pituitary-adrenal suppression (results of at least two tests subnormal) and asthma was well controlled in six others. Thirty eight patients received increasing doses of beclomethasone with (group S) or without (group MDI) a 750 ml spacer. The daily dose was increased by 0.5 mg at monthly intervals until hypothalamo-pituitary-adrenal suppression developed or a dose of 5 mg/day was achieved. Asthma symptoms and peak expiratory flow were recorded daily.. Twenty three patients completed the study, one (group S) reaching a dose of 5 mg beclomethasone dipropionate daily without hypothalamo-pituitary-adrenal suppression. Reasons for withdrawal were poor compliance (n = 10), the patient's decision (n = 3), and asthma that was too unstable (n = 2). "Intention to treat" analysis showed that the median dose of beclomethasone causing hypothalamo-pituitary-adrenal suppression was similar in the two groups (3.25 mg in S v 3.0 mg in MDI; 95% confidence interval (CI) for difference -1.0 to 1.0 mg). At 2 mg/day of beclomethasone most patients in both groups had well controlled asthma and there were no differences in symptoms or peak flow between the groups. Good control at this dose did not permit conclusions to be drawn about the efficacy of higher doses.. There is wide interindividual variation in the dose of beclomethasone dipropionate causing hypothalamo-pituitary-adrenal suppression. Whether or not a spacer is used, doses higher than the currently accepted maximum of 2 mg/day can be taken by many adults with asthma without causing subnormal function of the hypothalamo-pituitary-adrenal axis. Whether these higher doses are more effective in controlling asthma remains to be established.

    Topics: Asthma; Beclomethasone; Double-Blind Method; Drug Administration Schedule; Drug Delivery Systems; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Nebulizers and Vaporizers; Pituitary-Adrenal System; Prednisolone

1993
Detection of GM-CSF in asthmatic bronchial epithelium and decrease by inhaled corticosteroids.
    The American review of respiratory disease, 1993, Volume: 147, Issue:6 Pt 1

    The presence of granulocyte-macrophage colony-stimulating factor (GM-CSF) in airway epithelial cells in vivo was assessed in 15 asthmatic and 9 normal subjects. GM-CSF was analyzed using immunohistochemistry with a polyclonal and a monoclonal antibody. Hue saturation intensity color image analysis was used to quantify staining. Asthmatic airway epithelial cells stained significantly more with anti-GM-CSF than those from normal subjects (p = 0.0013 and p = 0.0003 for the polyclonal and monoclonal antibodies, respectively). Additionally, 8 asthmatic individuals inhaled 1,000 micrograms beclomethasone diproprionate per day for 8 wk and 6 asthmatic patients inhaled matching placebo. There was a significant reduction of GM-CSF in the epithelium in the patients who were given corticosteroids (p = 0.014), whereas the group of subjects who were given placebo showed no significant change in GM-CSF staining. There was a correlation between the percentage suppression of GM-CSF staining by inhaled corticosteroids and the percentage increase in FEV1 (r = 0.61, p < 0.05) and percentage decrease in carbachol responsiveness (r = 0.80, p < 0.01). These findings suggest that GM-CSF may play a role in the inflammatory processes of bronchial asthma and that the epithelial cell may be a target cell for drug action.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Biopsy; Bronchi; Bronchoscopy; Carbachol; Double-Blind Method; Epithelium; Female; Forced Expiratory Volume; Granulocyte-Macrophage Colony-Stimulating Factor; Humans; Immunohistochemistry; Male

1993
Beclomethasone given after the early asthmatic response inhibits the late response and the increased methacholine responsiveness and cromolyn does not.
    The Journal of allergy and clinical immunology, 1993, Volume: 91, Issue:6

    Single doses of inhaled beclomethasone or inhaled cromolyn, given before allergen inhalation, inhibit allergen-induced late asthmatic responses (LARs) and increased airway responsiveness (delta log methacholine PC20). We hypothesized that when given 2 hours after allergen, beclomethasone might work better than cromolyn.. In 10 patients with mild, stable, atopic asthma with LARs or delta log PC20 or both, we performed a double-blind, double-dummy, random-order trial comparing a single dose of inhaled beclomethasone (500 micrograms), cromolyn (20 mg), and placebo, administered 2 hours after allergen challenge on LAR and delta log PC20.. The treatment effect on LAR was significant (p < 0.001). The LAR after beclomethasone (7.3% +/- 6.1%) was significantly less than after cromolyn (20.4% +/- 15.2%) or placebo (26.4% +/- 8.2%); cromolyn was not different from placebo. There was a borderline treatment effect on delta log PC20 (p = 0.056) with beclomethasone (0.12 +/- 0.31) less than placebo (0.37 +/- 0.39) but not less than cromolyn (0.34 +/- 0.18).. Beclomethasone (500 micrograms) administered 2 hours after allergen challenge markedly inhibited the LAR and had a small effect on allergen-induced airway responsiveness. Cromolyn (20 mg) was not effective on maximal LAR; a small effect on the early part of the LAR was suggested.

    Topics: Adolescent; Adult; Asthma; Beclomethasone; Bronchial Provocation Tests; Cromolyn Sodium; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Methacholine Chloride

1993
Aerosol beclomethasone dipropionate compared with theophylline as primary treatment of chronic, mild to moderately severe asthma in children.
    Pediatrics, 1993, Volume: 92, Issue:1

    To compare the benefits and adverse reactions of theophylline and beclomethasone (BDP) in the long-term control of mild to moderate chronic asthma in children.. Multicentered, double-blind, double-placebo, randomized, controlled trial.. One hundred ninety-five children between the ages of 6 and 16 years with mild to moderate asthma.. Treatment with either BDP, 84 micrograms four times a day, or sustained-release theophylline administered twice daily in doses adjusted for optimum control of symptoms.. Daily diary record of symptoms, peak flow rates, supplemental bronchodilator and glucocorticoid treatment, doctor and hospital visits, absence from work and school, and side effects.. Aerosol BDP and sustained-release theophylline were effective primary treatments for mild to moderate chronic asthma. Beclomethasone resulted in comparable symptom control with less bronchodilator use and fewer courses of systemic steroids than did theophylline. Side effects were observed significantly more frequently with theophylline than with BDP. Growth velocity suppression was noted with BDP and was more pronounced in boys. Suppression was not associated with alterations in cortisol measurements either at baseline or following stimulation.. Both theophylline and BDP are effective therapy for mild to moderate asthma. Caution must be used with the administration of BDP in children because of possible growth velocity suppression.

    Topics: Adolescent; Aerosols; Asthma; Beclomethasone; Child; Chronic Disease; Double-Blind Method; Female; Forced Expiratory Volume; Growth; Humans; Male; Peak Expiratory Flow Rate; Theophylline; Treatment Outcome

1993
Long-term treatment with sodium cromoglycate, nedocromil sodium and beclomethasone dipropionate reduces bronchial hyperresponsiveness in asthmatic subjects.
    Respiration; international review of thoracic diseases, 1992, Volume: 59, Issue:2

    165 patients (106 males, 59 females) entered an open group comparative study of a 12-week test treatment on bronchial hyperresponsiveness (BHR) determined by methacholine challenge. Patients were randomly allocated to receive nedocromil sodium (4 mg q.i.d.), sodium cromoglycate (10 micrograms q.i.d.) and beclomethasone dipropionate (500 micrograms t.i.d.). At the end of the study, an 2.25-fold increase of the PD20FEV1 was noted in all the treated patients. No significant difference was noted among the treatments.

    Topics: Adult; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Bronchodilator Agents; Cromolyn Sodium; Female; Humans; Long-Term Care; Male; Middle Aged; Nedocromil; Quinolones

1992
Effect of inhaled beclomethasone and nedocromil sodium on bronchial hyperresponsiveness to histamine and distilled water.
    The European respiratory journal, 1992, Volume: 5, Issue:9

    In a randomized, cross-over study we compared the effects of inhaled nedocromil sodium, 4 mg q.i.d., with inhaled beclomethasone dipropionate, 200 micrograms q.i.d. in 23 atopic asthmatic patients. After a 3 week single-blind placebo period, regarded as the baseline, and after 4 and 8 weeks of active treatment, drug effects were assessed with regard to bronchial hyperresponsiveness to histamine and distilled water, lung function and beta 2-agonist use. After 4 and 8 weeks of treatment, nedocromil sodium reduced the histamine responsiveness (p < 0.005 and p < 0.0005), but not the distilled water responsiveness, and did not improve lung function and peakflow measurements compared to baseline. After 4 and 8 weeks of treatment, beclomethasone caused a significant increase in lung function (p < 0.005) and decrease in bronchial hyperresponsiveness to histamine (p < 0.0005) and distilled water (p < 0.0005) as compared to baseline. beta 2-agonist use was significantly diminished after an 8 week treatment with beclomethasone, whereas nedocromil sodium had no effect. Treatment with beclomethasone was superior to treatment with nedocromil sodium with regard to bronchial hyperresponsiveness to histamine and distilled water (p < 0.0005 and p < 0.005), lung function (p = 0.003), peakflow measurements (p < 0.05) and beta 2-agonist use (p < 0.005).

    Topics: Administration, Inhalation; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Double-Blind Method; Female; Forced Expiratory Volume; Histamine; Humans; Male; Middle Aged; Nedocromil; Quinolones; Single-Blind Method; Water

1992
Acute resistant asthma caused by excessive beta-2-adrenoceptor agonist inhalation and reversed by inhalation of beclomethasone.
    South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 1992, Volume: 82, Issue:3

    With the aim of devising an improved beta 2-agonist treatment regimen for patients presenting with acute severe resistant asthma, a double-blind, placebo-controlled randomised study of the effect of fenoterol and beclomethasone inhalations was done in 40 patients. Fenoterol inhalations had minimal effect in acute resistant asthma, but significant improvement was obtained when beclomethasone inhalations were given before fenoterol inhalations. Sequential beclomethasone and fenoterol inhalations can therefore be used as a preliminary emergency treatment for these patients.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Asthma; Beclomethasone; Double-Blind Method; Drug Resistance; Fenoterol; Humans; Respiratory Function Tests

1992
Nedocromil sodium inhibits the airway response to hyperosmolar challenge in patients with asthma.
    The American review of respiratory disease, 1992, Volume: 146, Issue:5 Pt 1

    We studied 16 asthmatic subjects sensitive to changes in airway osmolarity to determine whether nedocromil sodium has any effect on airway narrowing caused by hypertonic saline challenges. Nedocromil sodium (10 mg) or its vehicle was inhaled 10 min before a challenge with ultrasonically nebulized 4.5% NaCl. FEV1 was measured before challenge and 1 min after each challenge period of 0.5, 1, 2, 4, 8, 8 and 8 min. The challenge was stopped when there was a 20% fall in FEV1 from baseline or after the final challenge period. We measured airway sensitivity, that is, the provoking dose of 4.5% NaCl required to induce a 20% reduction in FEV1 (PD20FEV1) and calculated the fold difference in PD20FEV1 after the intervention. After inhaling nedocromil sodium there was a 3.95-fold improvement in PD20 (p < 0.001) when compared with the vehicle day. After pretreatment with nedocromil sodium two of the 16 subjects were completely protected against 4.5% NaCl challenge, and six developed a plateau in their response. We conclude that nedocromil sodium is effective in reducing airway narrowing in response to 4.5% NaCl challenge in asthmatic subjects, and it appears to be unique in its ability to produce a plateau in response to acute administration of a drug before a bronchial challenge.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; Body Height; Bronchial Provocation Tests; Confidence Intervals; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Nedocromil; Quinolones; Saline Solution, Hypertonic; Sensitivity and Specificity

1992
Inhaled beclomethasone improves the course of asthma and COPD.
    The European respiratory journal, 1992, Volume: 5, Issue:8

    The effects of inhaled beclomethasone dipropionate (BDP), 800 micrograms daily, on the long-term course of asthma and chronic obstructive pulmonary disease (COPD) were investigated in a prospective, controlled study, over three years. During the first two years, patients were treated with a bronchodilator only (salbutamol or ipratropium bromide). Fifty six patients (28 asthma, 28 COPD), with an unfavourable course of disease during bronchodilator therapy alone (an annual decline in forced expiratory volume in one second (FEV1) of > or = 80 ml.yr-1 in combination with at least one exacerbation.yr-1), were selected for additional treatment with inhaled beclomethasone dipropionate (BDP), 800 micrograms daily, during the third year. The FEV1 and provoking concentration of histamine producing a 20% fall in FEV1 (PC20-histamine) were assessed at six-monthly intervals. In asthma, the annual decline in prebronchodilator FEV1 of -158 ml.yr-1 during bronchodilator therapy alone was followed by a significant increase of 562 ml.yr-1 during months 1-6 of BDP treatment (p < 0.0005). During months 7-12 of BDP, the FEV1 declined slightly with -31 ml.yr-1, which was not statistically different from the annual decline before steroid therapy (p = 0.17). In COPD, the increase of 323 ml.yr-1 during months 1-6 of treatment with BDP was different from the annual decline of -156 ml.yr-1 before BDP (p < 0.05). The PC20-histamine improved by 308 doubling doses during 1-12 months of BDP in asthma (p < 0.05) but not in COPD.(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Bronchoconstriction; Bronchodilator Agents; Drug Evaluation; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Peak Expiratory Flow Rate; Prospective Studies; Treatment Outcome

1992
Formoterol compared with beclomethasone and placebo on allergen-induced asthmatic responses.
    The American review of respiratory disease, 1992, Volume: 146, Issue:5 Pt 1

    Formoterol is a new long-acting beta 2-agonist. We compared the protective effect of 24 micrograms formoterol with 200 micrograms beclomethasone and placebo on inhaled allergen-induced asthmatic responses in mild stable asthmatic subjects. We measured airflow rates, histamine airway responsiveness, cell counts from sputum and peripheral blood, and markers of lymphocyte and eosinophil activation. Adjustments were made for the confounding effect of bronchodilatation produced by formoterol in comparisons using a control inhalation of normal saline. Formoterol caused bronchodilation and inhibition of histamine airway responsiveness for at least 24 h. It completely inhibited the early asthmatic responses when beclomethasone had no effect. Control comparisons of the effect of formoterol and beclomethasone on the allergen-induced late asthmatic response and increase in histamine responsiveness showed each to be equally effective but not to inhibit the responses completely. Formoterol caused bronchodilation in addition to preventing bronchoconstriction. Both drugs inhibited the rise in serum eosinophil cationic protein 24 h after allergen, but neither inhibited the allergen-induced increases in sputum or blood eosinophils or CD25+ lymphocytes. These results suggest that formoterol modifies allergen-induced airway responses through functional antagonism rather than the inhibition of inflammatory cell infiltration.

    Topics: Adult; Airway Resistance; Asthma; Beclomethasone; Blood Cell Count; Blood Proteins; Bronchial Provocation Tests; Bronchoconstriction; Bronchodilator Agents; Confounding Factors, Epidemiologic; Eosinophil Granule Proteins; Eosinophils; Ethanolamines; Female; Forced Expiratory Volume; Formoterol Fumarate; Histamine; Humans; Hypersensitivity; Lymphocyte Activation; Male; Receptors, Interleukin-2; Ribonucleases; Sputum

1992
Increased inhaled bronchodilator vs increased inhaled corticosteroid in the control of moderate asthma.
    Chest, 1992, Volume: 102, Issue:6

    Undertreatment of chronic asthma may reflect uncertainty as to how it may be best controlled. We compared the effects of increased inhaled corticosteroid vs regular inhaled bronchodilator in 32 adult asthmatics. During three 16-week treatment periods, comprising baseline inhaled corticosteroid (mean 505 micrograms daily) and on-demand beta-agonist, baseline inhaled corticosteroid and increased (regularly scheduled four times daily) beta-agonist, and increased inhaled corticosteroid (mean 1478 micrograms daily) and on-demand beta-agonist, subjects recorded symptoms, morning and evening peak flow, and additional medication. Of 25 subjects whose control differed significantly between treatments with baseline vs increased corticosteroid, 22 (88 percent) favored the increased dosage (p < 0.001). Of 28 subjects whose control differed between treatments with regular beta-agonist vs increased corticosteroid, 24 (86 percent) were better controlled with increased inhaled corticosteroid and were worse with regular beta-agonist (p < 0.001). Only one quarter the number of exacerbations were experienced during treatment with increased inhaled corticosteroid. Upper airway adverse effects were minor and easily controlled. Hence, asthma with persistent symptoms was better controlled by increased inhaled corticosteroid therapy than by increased use of inhaled beta-agonist.

    Topics: Administration, Inhalation; Adult; Aerosols; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Circadian Rhythm; Double-Blind Method; Drug Administration Schedule; Fenoterol; Humans; Peak Expiratory Flow Rate; Prednisone; Pregnenediones; Terbutaline

1992
[The synonymous preparation Andion vs. the original preparation becotide in the treatment of steroid-dependent bronchial asthma. A comparative double-blind cross-over trial].
    Ugeskrift for laeger, 1992, Nov-09, Volume: 154, Issue:46

    Two different beclomethasone dipropionate inhalation aerosols (Andion and Becotide) were compared in a double-blind, cross-over study in patients with stable, steroid-dependent asthma. Fifty-two patients were included in the study, and 44 completed the two 6-week periods of treatment. The difference in therapeutic efficacy on FEV1 between Andion and Becotide was -0.018 1, and likewise no differences in therapeutic efficacy on FVC and peak expiratory flow were found. There were no significant differences between the two treatment periods regarding peak expiratory flow rates, symptoms, frequency of adverse effects, and amount of salbutamol and beclomethasone dipropionate employed. In conclusion, no significant differences could be demonstrated between Andion and Becotide with regard to pulmonary function, symptoms, and frequency of adverse effects in the treatment of patients with steroid-dependent bronchial asthma.

    Topics: Adult; Aged; Asthma; Beclomethasone; Double-Blind Method; Drug Evaluation; Drugs, Generic; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Therapeutic Equivalency

1992
Investigation of the tendency to wheeze in pollen sensitive patients.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 1992, Volume: 22, Issue:10

    We have undertaken a double blind placebo controlled study of the effect of nasal beclomethasone on the tendency to wheeze in 20 unselected hay fever sufferers, half with a history of previous seasonal wheezing. We found no difference between either bronchial hyperresponsiveness, as measured by methacholine challenge, home-monitored PEFR, nor recorded wheeze nor cough between treated and placebo groups although the numbers were small. All were allowed the antihistamine cetirizine hydrochloride 10 mg daily. Eighteen out of the 19 patients had either bronchial hyperresponsiveness (PD20 methacholine < 8 mumol or a > 2 doubling dose change in their PD20 during the pollen season). We have shown a significant positive correlation between a hay fever score (HFS) (created by taking the sum of the home scored; nasal discharge, nasal blockage, eye irritation, sneeze and antihistamine use) and peak seasonal specific IgE to mixed grass pollen (Spearman correlation coefficient 0.5 P < 0.02). There was also a positive correlation between the rise in specific IgE from pre to peak season and the HFS, correlation coefficient 0.6 P = 0.03).

    Topics: Administration, Intranasal; Adult; Asthma; Beclomethasone; Bronchial Provocation Tests; Double-Blind Method; Humans; Immunoglobulin E; Middle Aged; Respiratory Sounds; Rhinitis, Allergic, Seasonal

1992
Dissociation of symptom scores and bronchial hyperreactivity: study in asthmatic children on long-term treatment with inhaled beclomethasone dipropionate.
    Pediatric pulmonology, 1992, Volume: 13, Issue:2

    The aim of the study was to evaluate the effects of inhaled steroids (IS) on the improvement of clinical asthma symptoms and on the decrease in bronchial hyperreactivity (BHR). Twenty-four children with severe asthma were given 1,000 micrograms beclomethasone dipropionate (BDP) daily and compared with ten asthmatic control children. The study included the evaluation of daily clinical score, of exercise induced asthma, of bronchial obstruction (forced expiratory volume in 1 sec, FEV1), and of BHR at months 0, 1, 2-3, and 4-5 (M0, M1, M2-3, and M4-5). BHR was assessed by standardized inhaled carbachol provocation measuring plethysmographic specific airway resistance (SRaw). The carbachol dose causing a 40% decrease in specific conductance (SGaw) was determined (PD40 SGaw). Clinical scores decreased at M1 (P less than 0.01) and throughout the study. FEV1 increased at M1 (P less than 0.05), M2-3 (P less than 0.01), and M4-5 (P less than 0.05) compared to M0. PD40 SGaw only increased significantly at M1 and M2-3. No individual correlation was found between clinical scores and PD40 SGaw at any testing, or between the decrease of clinical scores and the decrease of BHR. We conclude that bronchoconstrictive challenge tests do not adequately assess the clinical efficacy of IS. In clinical practice non-specific BHR should be preferentially measured for diagnosing atypical forms of asthma.

    Topics: Administration, Inhalation; Adolescent; Airway Resistance; Asthma; Beclomethasone; Bronchial Hyperreactivity; Child; Child, Preschool; Exercise Test; Forced Expiratory Volume; Humans; Time Factors

1992
Nasal beclomethasone prevents the seasonal increase in bronchial responsiveness in patients with allergic rhinitis and asthma.
    The Journal of allergy and clinical immunology, 1992, Volume: 90, Issue:2

    Experimental studies have demonstrated that induction of a nasal allergic reaction can lead to an increase in bronchial responsiveness (BR). To assess the clinical relevance of these experimental changes to chronic asthma, we sought to determine the effect of nasal beclomethasone dipropionate (Bdp) on BR in patients with seasonal allergic rhinitis and asthma. Eighteen subjects with histories of seasonal allergic rhinitis and asthma during the fall pollen season with positive skin tests to short ragweed and bronchial hyperresponsiveness to inhaled methacholine were assigned to receive either nasal Bdp (336 micrograms/day) or placebo for the entire ragweed season. Patients recorded daily nasal and chest symptoms, nasal blockage index, oral peak expiratory flow rates, and supplemental medication use. BR to methacholine was measured during the baseline period and 6 weeks into the ragweed season. Although the Bdp group did have a significant improvement in nasal blockage index, there was no improvement in daily asthma symptom scores, oral peak expiratory flow, or asthma medication use. However, subjects treated with Bdp were protected from the increase in BR seen in the placebo group (geometric mean PC20 placebo group: baseline = 0.70, week 6 = 0.29; Bdp group: baseline = 0.80, week 6 = 0.93; intergroup difference, p = 0.022). We conclude that nasal corticosteroid therapy can prevent the increase in BR associated with seasonal pollen exposure in patients with allergic rhinitis and asthma.

    Topics: Administration, Intranasal; Asthma; Beclomethasone; Bronchi; Bronchial Provocation Tests; Double-Blind Method; Forced Expiratory Volume; Humans; Medical Records; Peak Expiratory Flow Rate; Pollen; Rhinitis, Allergic, Seasonal; Seasons

1992
High-dose inhaled steroids in the management of asthma. A comparison of the effects of budesonide and beclomethasone dipropionate on pulmonary function, symptoms, bronchial responsiveness and the adrenal function.
    Allergy, 1992, Volume: 47, Issue:2 Pt 2

    The efficacy of budesonide (800 micrograms b.d.) and beclomethasone dipropionate (750 micrograms b.d.) in controlling the symptoms of asthma, pulmonary function, bronchial responsiveness to histamine, and adrenal function, was assessed in a double-blind, double-dummy cross-over study of 36 adult chronic asthmatic patients. The patients, the majority of whom were assessed to be affected to a severe degree, were insufficiently controlled in their current regimen of inhaled steroids and/or inhaled and oral bronchodilators. A 2 weeks baseline period preceded 6 weeks of treatment with each of the study drugs. Both treatment groups showed improvements from baseline in clinical assessment of lung function carried out after the first 6 weeks of treatment. No significant differences were seen throughout the entire 12 weeks study, when comparing the effects of the treatments on FEV1, FVC, PEF or the histamine PC20. Asthma severity, symptom score and inhaled bronchodilator use showed the same results after both treatments. It is concluded that inhalations of budesonide and beclomethasone dipropionate in high doses are equally potent in the treatment of severe asthma. There is no significant influence on the adrenal function and no significant side effects during a period equal to that of the present study.

    Topics: Administration, Inhalation; Adolescent; Adrenal Glands; Adult; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchodilator Agents; Budesonide; Double-Blind Method; Female; Humans; Male; Middle Aged; Models, Statistical; Pregnenediones; Respiratory Mechanics

1992
Long-term multicentre trial in chronic nonspecific lung disease: methodology and baseline assessment in adult patients. Dutch CNSLD Study Group.
    The European respiratory journal, 1992, Volume: 5, Issue:1

    Airways obstruction and airways hyperresponsiveness are two dominant features in patients with chronic nonspecific lung disease (asthma and chronic obstructive pulmonary disease (COPD)). We set up a study to determine whether long-term (3 yrs) therapeutic intervention directed at airways obstruction and hyperresponsiveness is superior to one directed at airways obstruction alone. Patients were selected on functional criteria (age, baseline forced expiratory volume in one second (FEV1), and airways hyperresponsiveness) and, furthermore, extensively characterized by history, smoking habits, allergy, reversibility of airways obstruction and quality of life. The methodology and practical problems of setting up this large multicentre study are outlined, together with an analysis of baseline data. Standardization of methods and techniques and recruitment of patients required much effort, recruitment taking about twice as long as expected. A 3 month feasibility study allowed us to eliminate minor problems in the protocol. Over a 16 month period, 274 adult patients (18-60 yrs) from the out-patient clinics of six university centres entered the study; 99 met the diagnostic criteria for asthma, 51 for COPD, 88 for asthmatic bronchitis, and 36 could not be classified. Their mean (SD) FEV1% pred was 65.1 (15.2)%. Their geometric mean provoking concentration of histamine producing a 20% fall in FEV1 (PC20 histamine) was 0.28 mg.ml-1. In a multiple regression analysis, more severe airways hyperresponsiveness was associated with lower prechallenge FEV1% pred (p less than 0.0001), higher pack-years of smoking (p = 0.0099), blood eosinophil count (p = 0.0004), skin test reactivity (p = 0.0047) and with female sex (p = 0.0302). We conclude that setting up long-term multicentre trials in chronic nonspecific lung disease (CNSLD) is feasible and that these may offer valuable information on treatment and outcome of the disease.

    Topics: Adult; Asthma; Beclomethasone; Bronchial Hyperreactivity; Double-Blind Method; Follow-Up Studies; Forced Expiratory Volume; Humans; Ipratropium; Lung Diseases, Obstructive; Middle Aged; Multicenter Studies as Topic; Pilot Projects; Regression Analysis; Terbutaline; Time Factors; Total Lung Capacity

1992
Long-term comparison of three combinations of albuterol, theophylline, and beclomethasone in children with chronic asthma.
    The Journal of allergy and clinical immunology, 1992, Volume: 90, Issue:1

    Three combination regimens, (1) inhaled albuterol (ALB) with oral theophylline (THEO), (2) inhaled ALB with inhaled beclomethasone dipropionate (BDP), or (3) inhaled ALB, inhaled BDP, and oral THEO, were evaluated and compared as optimal pharmacotherapy for chronic asthma in 111 children. In this double-blind, parallel-group, multicenter study, children, aged 6 to 16 years with moderately severe asthma (unstable despite daily medications), were treated with one of the combinations for 12 weeks. Patients were evaluated every 4 weeks by spirometry and serum THEO measurement. Patients kept daily symptom diaries, measured peak flow rates twice daily, and recorded adverse events. Treatment groups did not differ in disease or demographic characteristics at study entry. All three combination treatments provided and maintained significant improvement in FVC, FEV1, and FEF25%-75% volume points, and compared with that of pretreatment, with no significant differences between treatments. Throughout the 12-week treatment period, however, patients receiving BDP had lower symptom scores, fewer had more than one asthma attack, fewer required "bursts" of prednisone (p = 0.001), and fewer required rescue medication (p = 0.009). Significantly more patients receiving BDP said that they felt better than they did at the beginning of the study compared with the number of patients not receiving BDP (p = 0.002). Adverse events were similar among treatment groups.

    Topics: Administration, Inhalation; Administration, Oral; Adolescent; Albuterol; Asthma; Beclomethasone; Chi-Square Distribution; Child; Chronic Disease; Double-Blind Method; Drug Evaluation; Drug Therapy, Combination; Humans; Theophylline

1992
[Use of beta-agonist inhalation concomitantly with regular beclomethasone dipropionate in patients with bronchial asthma--as required or on a regular basis].
    Nihon Kyobu Shikkan Gakkai zasshi, 1992, Volume: 30, Issue:5

    We investigated whether regular use of beta-agonist inhalation concomitantly with regular beclomethasone dipropionate (BDP) inhalation is necessary in chronic bronchial asthma. Twenty chronic asthmatic patients who were stable on regular BDP and beta-agonist inhalation were studied. After a 2 week observation period, the patients were randomly assigned to two groups. One group received BDP 400 micrograms/day (2 puffs 4 times) and beta-agonist inhalation as required for 4 weeks. This period was followed by 4 weeks of treatment with BDP 400 micrograms/day and regular beta-agonist inhalation. The other group received these treatments in the reverse order. No significant differences among the two groups were observed in attack score, ADL score, sleep score, and %PEFR. In addition, no differences were detected in these parameters between the periods of regular use of beta-agonist and the periods of use as required. The frequency of inhalation of beta-agonist during the use as required period correlated with the sleep score and difference in %PEFR between morning and night, and was significantly lower than the frequency of inhalation during the period of regular. From these results, we conclude that inhalation of beta-agonist on a regular basis is not necessary to achieve the same degree of relief of symptoms as treatment with beta 2-agonist and BDP inhalation on regular basis in patients with chronic asthma.

    Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Peak Expiratory Flow Rate

1992
Inhaled nedocromil sodium as additional treatment to high dose inhaled corticosteroids in the management of bronchial asthma.
    The European respiratory journal, 1991, Volume: 4, Issue:8

    Thirty five asthmatic patients were included in a randomized, double-blind, placebo-controlled, parallel group study of inhaled nedocromil sodium (4 x 4 mg daily) as an additional treatment to high dose (greater than or equal to 1,000 micrograms) inhaled corticosteroids in the management of bronchial asthma. Following a four week baseline, patients received nedocromil sodium (17) or placebo treatment (18) for eight weeks. Five patients (four in the group subsequently randomized to nedocromil sodium) used short course oral corticosteroid therapy during the baseline and four placebo treated patients used oral steroid therapy during treatment. Fifteen patients (11 nedocromil sodium) reported unusual symptoms. Two nedocromil sodium treated patients were withdrawn owing to treatment taste and vomiting. Statistically significant treatment differences in favour of nedocromil sodium were seen for daytime symptoms (p = 0.03) and morning peak expiratory flow (PEF) (p = 0.012) during weeks 5-8, and for clinician opinion (p = 0.02). Patient opinion (p = 0.053) and evening PEF (p = 0.08) failed to reach statistical significance. Eight out of fifteen and three out of seventeen patients considered nedocromil sodium and placebo, respectively, to be very or moderately effective. The results indicate that the addition of nedocromil sodium (4 mg four times daily) to moderate to severe asthmatics not fully controlled on a regimen of greater than or equal to 1,000 micrograms inhaled corticosteroids and inhaled bronchodilators can produce improvements in symptoms and pulmonary function.

    Topics: Administration, Inhalation; Adult; Aged; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Nedocromil; Peak Expiratory Flow Rate; Quinolones; Vital Capacity

1991
Inhaled formoterol during one year in asthma: a comparison with salbutamol.
    The European respiratory journal, 1991, Volume: 4, Issue:10

    Eighteen patients, who had previously taken part in a 2 wk cross-over comparison between formoterol and salbutamol, now took part in a one year double-blind study comparing salbutamol 200 micrograms b.i.d. with formoterol 12 micrograms b.i.d. Additional doses were taken when needed and were recorded. Ten patients were started on formoterol and eight on salbutamol. After one month, the patients were allowed to shift to the alternative drug. Two patients withdrew from the study. At the end of the study, 13 of 16 patients were on formoterol, thus showing a long-lasting preference for this drug. Forced expiratory volume in one second (FEV1) dose-response curves for inhaled salbutamol were repeatedly recorded during the study, and no tachyphylaxis was found. One patient stopped taking inhaled steroids but continued taking formoterol and theophylline. He deteriorated with a decreased response to salbutamol. After re-introduction of inhaled steroids his condition improved. This case indicates that effective bronchodilator therapy may mask the deterioration of asthma.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Dose-Response Relationship, Drug; Double-Blind Method; Ethanolamines; Follow-Up Studies; Forced Expiratory Volume; Formoterol Fumarate; Humans; Male; Middle Aged; Peak Expiratory Flow Rate

1991
[Treatment of asthma in the adult using a combination of salbutamol 100 micrograms--beclomethasone 50 micrograms. Results of a study on 1917 patients seen in general medicine].
    Allergie et immunologie, 1991, Volume: 23, Issue:7

    Efficacy and safety of salbutamol--beclomethasone combination were studied in a multicentre trial in general practice which included 1917 asthmatic patients. During a 7 day run-in period, the number of dyspnea episodes, the morning and evening PEFR values were recorded daily. Patients were then treated with 2 puffs of salbutamol--beclomethasone combination t.i.d. or q.i.d. Results showed a significant improvement of the daily number dyspnea episodes (from 2.7 to 1.4) and of the daily number of salbutamol puffs used as rescue medication (from 5,1 to 2,5) (p less than 0.001). Morning and evening PEFR were increased by 50 litres min-1 (p less than 0.001). Symptoms were significantly improved, particularly nocturnal dyspnea (p less than 0.001). Minor and usual adverse events were noted in only 2,7% of the population. Salbutamol--beclomethasone allows a good control of asthma, particularly a good nocturnal cover. This efficacy with a good safety profile makes salbutamol--beclomethasone combination a well-adapted maintenance treatment of asthma.

    Topics: Adolescent; Adult; Aerosols; Aged; Aged, 80 and over; Albuterol; Asthma; Beclomethasone; Drug Combinations; Drug Evaluation; Female; Humans; Male; Middle Aged

1991
Salbutamol plus beclomethasone dipropionate, but not salbutamol alone, completely prevent early and late asthmatic responses to allergen.
    Respiratory medicine, 1991, Volume: 85, Issue:5

    The effect of a week treatment with inhaled salbutamol plus placebo (S+P) vs. salbutamol combined with beclomethasone dipropionate (S+BDP) on early and late asthmatic responses to inhaled allergen was studied in ten atopic patients in a randomized, double-blind, cross-over study. All patients had previously shown a dual type response to the specific bronchial provocative test (sBPT). Each patient performed two periods of treatment for a week, with a 15 day interval between them: (a) salbutamol 0.3 mg, tid + placebo; (b) salbutamol 0.3 mg+BDP 0.2 mg, tid; at the end of each treatment period, sBPT was performed and the last treatments were given 1.5-2 h before and 3-4 h after allergen challenge. S + BDP completely prevented both early and late responses to allergen, while S + P reduced but did not completely inhibit early and late responses. The difference between the two treatments was significant for early and late asthmatic responses. Non-specific bronchial hyperresponsiveness to methacholine was performed before each treatment period, after 6 days of treatment before sBPT and the day after sBPT at the end of the treatment period; there was only a mild increase in PD15FEV1 methacholine after 6 days of treatment with S + BDP in comparison with S + P treatment. These results suggest that salbutamol plus beclomethasone may be used effectively in the prophylaxis of early and late asthmatic reactions induced by allergen in sensitized subjects.

    Topics: Adolescent; Adult; Albuterol; Asthma; Beclomethasone; Bronchial Provocation Tests; Double-Blind Method; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Lung; Male; Middle Aged; Time Factors

1991
[A clinical trial of treating asthma of moderate severity with beclomethasone dipropionate aerosol].
    Zhonghua nei ke za zhi, 1991, Volume: 30, Issue:9

    In order to investigate the efficacy of steroid inhalation in treating asthma of moderate severity, a single-blind, randomized short-term (3-4 weeks) trial was performed in 25 asthmatics uncontrolled by salbutamol inhalation, oral aminophylline and beta 2-agonist. 22 patients finished the trial. Among them, twelve received beclomethasone dipropionate 300 mcg/day and ten received placebo. There was significant improvement in asthmatic symptoms and pulmonary function (FEV1.0, V50, V25) in the group treated with steroid inhalation at the end of this trial, whereas no significant changes were observed in the placebo group. The results demonstrated that steroid inhalation could effectively control asthma of moderate severity.

    Topics: Administration, Inhalation; Adult; Aerosols; Asthma; Beclomethasone; Female; Humans; Male; Respiratory Function Tests; Single-Blind Method

1991
High-dose beclomethasone: oral steroid-sparing effect in severe asthmatic patients.
    The European respiratory journal, 1991, Volume: 4, Issue:7

    One hundred and twenty four patients with severe asthma requiring maintenance treatment with oral corticosteroids were included in a multicentre, double-blind, randomized study comparing the effects of inhaled beclomethasone dipropionate (BDP) (250 micrograms.puff-1), beginning with 1,000 micrograms daily, vs placebo (P). Pulmonary function was assessed and dosage of prednisone and BDP (or P) were adjusted every 15 days according to a clinical score. Our results showed, after 3 months: 1) A greater drop-out rate in the P group than in the BDP group (36 vs 6%, respectively, p less than 0.01); 2) A total weaning from prednisone in 76% of patients in the BDP group (mean BDP dosage = 1,270 +/- 340 micrograms.day-1, mean +/- SD), vs 34% in the P group (p less than 0.001). The mean daily dosage of prednisone was reduced from 17 +/- 7.5 mg to 3.1 +/- 7.4 mg in the BDP group vs 15.6 +/- 7.7 mg to 9.1 +/- 9.4 mg in the P group (p less than 0.001) without any relationship between the steroid-sparing effect and the initial dosage of prednisone; 3) Mean change in forced expiratory volume in one second (FEV1) was +7 +/- 21% from the initial value in the BDP group vs -6 +/- 20% in the P group; p less than 0.01. Thus, in patients with severe asthma requiring oral corticosteroids, high-dose BDP has an important oral steroid-sparing effect not related to the initial dosage of oral steroids and allows a better control of airway obstruction than oral corticosteroids alone.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Chronic Disease; Dose-Response Relationship, Drug; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Prednisone; Vital Capacity

1991
Effect of inhaled beclomethasone dipropionate on bronchial hyperreactivity in asthmatic children during maximal allergen exposure.
    Pediatric pulmonology, 1991, Volume: 10, Issue:1

    In this double blind study we evaluated the effect of a 2 months long treatment with inhaled beclomethasone dipropionate (300 micrograms/day) on methacholine responses in asthmatic children, during a period of maximal allergen exposure. Baseline values of methacholine PC20-FEV1 were 0.66 +/- 0.22 mg/mL (mean +/- SEM) in 10 children treated with the active drug and 0.78 +/- 0.21 mg/mL in 10 children treated with placebo. After 1 month of treatment PC20-FEV1 was 1.91 +/- 0.64 and 0.80 +/- 0.33 mg/mL, respectively, in the groups treated with beclomethasone versus placebo. A statistically significant reduction in bronchial hyperreactivity (PC20-FEV1, 5.49 +/- 1.86 mg/mL) but no systemic side effects were observed after 2 months of treatment with beclomethasone dipropionate. This is compared with a PC20-FEV1 of 1.38 +/- 0.52 mg/mL in the placebo group. The results confirm the effect of inhaled corticosteroids in reducing bronchial hyperreactivity, even during a period of maximal allergen exposure.

    Topics: Allergens; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchoconstriction; Child; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Methacholine Chloride; Nebulizers and Vaporizers

1991
Long-term effects of budesonide on airway responsiveness and clinical asthma severity in inhaled steroid-dependent asthmatics.
    The European respiratory journal, 1990, Volume: 3, Issue:10

    Budesonide 400 micrograms daily, in nonsteroid-dependent asthma, can produce improvements in airway responsiveness and clinical asthma severity, with some patients returning to normal responsiveness and becoming asymptomatic. This study examined whether similar improvements occur when asthmatics, who are dependent upon inhaled steroids, take either a regular maintenance dose of inhaled steroid or twice that amount for a year. Thirty two asthmatics were each stabilized on the minimum amount of inhaled steroid that would keep symptoms non-troublesome. In a double-blind, randomized manner, half were assigned to remain on a maintenance dose (MD) and the rest received twice that dose (MDx2) for one year. Before and monthly throughout the study, airway responsiveness to methacholine was measured and clinical asthma severity assessed by questionnaire, inhaled bronchodilator use and number of asthma exacerbations. There was a significant improvement in airway responsiveness and clinical asthma severity in both treatment groups. Those on MDx2 showed the greatest improvement but the difference between the two groups did not reach significance. This study provides strong evidence that prolonged use of inhaled steroids is associated with improvement in airway responsiveness and clinical asthma severity in inhaled steroid-dependent asthma with a suggestion that the improvements are dose related.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Double-Blind Method; Drug Evaluation; Female; Forced Expiratory Volume; Humans; Lung; Male; Methacholine Chloride; Middle Aged; Pregnenediones; Substance-Related Disorders; Time Factors

1990
[Bronchial tolerance to inhalation of beclomethasone. Histologic and microbiologic study in asthmatic patients].
    Presse medicale (Paris, France : 1983), 1990, Sep-29, Volume: 19, Issue:31

    The aim of the present study was to investigate the effects of a three months' treatment with beclomethasone dipropionate on the bronchial mucosa of asthmatic patients. Eleven patients suffering from a mild chronic asthma treated with inhaled salbutamol and theophylline were randomly assigned to receive either 1000 mu g of beclomethasone dipropionate (6 patients) or an aerosolized placebo (5 patients) in a double-blind manner. Bronchial biopsies and bronchial secretions were obtained through a fiberoptic procedure at the beginning and the end of the study. Repeated clinical and spirometric investigations were performed each month. Inter- and intra-group mean changes of clinical symptoms and of spirometric values were not significantly different. Pathogens were rarely found in bronchial aspirates and their occurrence did not seem to be influenced by the beclomethasone therapy. Sixty percent of the bronchial biopsies displayed pathological changes of the mucosa that observed at the beginning and at the end of the study; however, no sign of mucosal atrophy was noted.

    Topics: Adult; Asthma; Beclomethasone; Bronchi; Bronchoalveolar Lavage Fluid; Double-Blind Method; Drug Evaluation; Female; Humans; Male; Middle Aged; Placebos; Prospective Studies; Spirometry

1990
The long-term effects of nedocromil sodium and beclomethasone dipropionate on bronchial responsiveness to methacholine in nonatopic asthmatic subjects.
    The American review of respiratory disease, 1990, Volume: 141, Issue:1

    We investigated the effects of long-term treatment with two anti-inflammatory drugs, nedocromil sodium and beclomethasone dipropionate, on airway hyperresponsiveness to methacholine (PC20), on baseline FEV1 and on the bronchodilating effect of a deep breath in 25 nonsteroid-dependent nonatopic asthmatic adults. In all subjects the prestudy PC20 was less than 8 mg/ml, the postbronchodilator FEV1 was greater than 75% predicted, and skin prick tests and RAST to 13 common allergens were negative. After 2 months run-in, the subjects were randomly allocated into 3 parallel treatment groups to inhale double-blind either 4 mg nedocromil (n = 9) or 100 micrograms beclomethasone (n = 8) or placebo (n = 8) 4 times daily for 4 months. PC20 was measured using the 2-min tidal breathing method. The effect of a deep breath was measured during methacholine-induced bronchoconstriction by standardized maximal and partial expiratory flow-volume curves and was expressed as a flow ratio (M/P ratio). Pretreatment values of FEV1, PC20, and M/P ratio were not different between the 3 groups. PC20 did not change in the placebo group, but increased significantly by a factor of 3 after 8 wk of treatment with beclomethasone or nedocromil (p less than 0.001). FEV1 did not change after treatment with placebo or nedocromil (p greater than 0.2), but increased (mean change 0.2 L, SD 0.2) after 4 wk of treatment with beclomethasone (p less than 0.05). Geometric mean M/P ratio increased from 1.98 to 2.66 after 4 wk of beclomethasone (p less than 0.01), but not after nedocromil or placebo.(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; Bronchi; Bronchial Provocation Tests; Female; Forced Expiratory Volume; Humans; Male; Methacholine Chloride; Methacholine Compounds; Middle Aged; Nedocromil; Quinolones; Skin Tests

1990
A placebo-controlled blinded comparison of nedocromil sodium and beclomethasone dipropionate in bronchial asthma.
    Lung, 1990, Volume: 168 Suppl

    Two hundred and two patients aged 12-78 with chiefly moderate to severe asthma took part in a multicenter randomized blinded group comparison of nedocromil sodium (NS) 4 mg four times daily, beclomethasone dipropionate (BD) 0.1 mg four times daily, and placebo. Patients were assessed at the start and end of a two week baseline and after three and six weeks of treatment. Compared with placebo, both NS and BD significantly improved daytime dyspnoea and day and nighttime cough, as assessed by diary card scores. Lung function (FEV1) was significantly improved in the BD group. In the NS group there was also a significant reduction in concomitant use of inhaled beta 2-agonists. Overall opinions of efficacy by clinicians and patients were significantly in favor of both active treatments over placebo. There were no significant differences between the three treatments for peak expiratory flow rates, morning tightness or nighttime dyspnoea. Comparison between the two active treatments showed no significant differences in any of the variables.

    Topics: Adolescent; Adult; Aged; Airway Resistance; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Nedocromil; Peak Expiratory Flow Rate; Quinolones; Randomized Controlled Trials as Topic; Single-Blind Method

1990
A comparison of inhaled beclomethasone dipropionate and nedocromil sodium as additional therapy in asthma.
    Respiratory medicine, 1990, Volume: 84, Issue:6

    We have compared the effects of inhaled beclomethasone dipropionate (BDP) 400 micrograms day-1 with inhaled nedocromil sodium (NDS) 16 mg day-1 as additional therapy in adults with asthma not fully controlled by regular beta-2-agonist inhalers with, or without, oral theophyllines. Seventeen subjects were entered into a 2-week baseline phase, and subsequently in a double-blind crossover fashion into two 8-week phases of daily BDP or NDS. Subjects recorded daily peak expiratory flow rates, morning and evening (PEF am and pm), symptom scores and beta-2-agonist inhaler use. Thirteen subjects completed the study and the last 2 weeks of each phase were analysed. Compared to baseline, both BDP and NDS caused a significant improvement in PEF am (P less than 0.05), PEF pm (P less than 0.05) and the 'amplitude % mean' (P less than 0.001). Both drugs gave a highly significant improvement in all symptom scores. There was no significant difference between BDP and NDS for PEF am, PEF pm, amplitude % mean, cough and daytime asthma score. However, beta-2-agonist inhaler use and scores for nocturnal asthma and morning tightness were all significantly better in the BDP phase, and may have contributed to its better overall subjective performance. Thus, both NDS and BDP resulted in a significant improvement in asthma control in the subjects studied, and both drugs caused a similar improvement in PEF.

    Topics: Administration, Inhalation; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Nedocromil; Peak Expiratory Flow Rate; Quinolones; Time Factors

1990
Treatment of acute, episodic asthma in preschool children using intermittent high dose inhaled steroids at home.
    Archives of disease in childhood, 1990, Volume: 65, Issue:4

    In a double blind, controlled trial, the effect of high dose beclomethasone dipropionate (750 micrograms three times daily for five days) administered by metered dose inhaler and valved spacer, was compared with placebo, during 70 paired episodes of acute asthma in 24 preschool children. Treatment commenced at home at the first sign of an attack. Parents' blind preference for active treatment was significant. Data from 17 pairs of treatment, however, were affected by interventions such as hospital admission or oral corticosteroid treatment. These events occurred similarly in active and control periods. An intrasubject comparison was made of diary scores from the 18 pairs of episodes in which no intervention occurred in either the active or placebo treatment. Both daytime and night symptoms over the first week of the attack were significantly reduced by active treatment. Intermittent high dose inhaled beclomethasone dipropionate is beneficial in modifying the severity of acute episodic asthma in preschool children able to use a spacer device.

    Topics: Acute Disease; Administration, Inhalation; Asthma; Beclomethasone; Child, Preschool; Clinical Trials as Topic; Double-Blind Method; Home Nursing; Humans; Infant

1990
Dose-related effect of beclomethasone dipropionate on airway responsiveness in asthma.
    Respiration; international review of thoracic diseases, 1990, Volume: 57, Issue:2

    The effects of twice daily inhaled beclomethasone dipropionate (BDP) at two dose levels (500 and 1,000 micrograms daily) on the airway responsiveness to inhaled histamine was evaluated by a randomized, single-blind, cross-over study in 10 patients with stable asthma. The 12-week study began with a 3-week run-in period of baseline treatment, which was continued unchanged throughout the study, and the two treatment periods were separated by a 3-week placebo period. Patients attended the laboratory every 3 weeks for spirometry and histamine inhalation tests to determine the provocative concentration of histamine causing a 20% fall in forced expiratory volume in 1 s (PC20 of FEV1). There was a similar significant improvement (p less than 0.05) in mean FEV1 after both treatments. There was no significant change in PC20 after treatment with 500 micrograms daily, the geometric mean being 0.587 mg/ml after the placebo period and 0.860 mg/ml after BDP treatment. There was a significant improvement in PC20 (1.930 mg/ml) after treatment with 1,000 micrograms BDP daily in comparison with the placebo and treatment periods with 500 micrograms BDP daily (p less than 0.001). These results suggest that higher doses than usual of inhaled BDP must be used to control airway responsiveness in asthmatics.

    Topics: Adult; Airway Resistance; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Female; Forced Expiratory Volume; Histamine; Humans; Lung; Male; Middle Aged; Random Allocation

1990
First-time treatment with steroids in bronchial asthma: comparison of the effects of inhaled beclomethasone and of oral prednisone on airway function, bronchial reactivity and hypothalamic-pituitary-adrenal axis.
    The European respiratory journal, 1990, Volume: 3, Issue:7

    In a double-blind cross-over study of 12 asthmatic patients the effects of 1,000 micrograms.day-1 beclomethasone dipropionate (BDP) on airway function, bronchial reactivity and hypothalamic-pituitary-adrenal (HPA) axis have been compared to those of 15 mg.day-1 oral prednisone (PRD). None of the patients had ever received corticosteroids before. Fourteen days treatment with either of both steroids improved airway function, both subjectively and objectively. Both steroids slightly reduced the responsiveness to histamine. PRD suppressed the corticotrophin-releasing factor (CRF) stimulated cortisol release more than BDP did, whereas there was no significant change in adrenocorticotrophic hormone (ACTH) release. The results indicate that short-term treatment with 1,000 micrograms.day-1 BDP reduces bronchial hyperreactivity (BHR) in asthmatic patients, whilst having subtle effects on HPA axis.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Hypothalamo-Hypophyseal System; Male; Middle Aged; Peak Expiratory Flow Rate; Pituitary-Adrenal System; Prednisone

1990
Comparison of the effects of inhaled corticosteroids on the airway response to histamine, methacholine, hyperventilation, and sulfur dioxide in subjects with asthma.
    The Journal of allergy and clinical immunology, 1990, Volume: 86, Issue:6 Pt 1

    To investigate whether inhaled steroids modulate the airway response to different bronchoconstrictive stimuli, we studied 25 subjects with mild asthma with a double-blind, noncrossover design to compare the effect of a 3-week treatment with salbutamol (0.2 mg, four times a day [q.i.d.]) and placebo (N = 11) to the effect of salbutamol (0.2 mg q.i.d.) and inhaled beclomethasone dipropionate (BDP, 0.5 mg q.i.d.) (N = 14). Airway response to histamine and methacholine was assessed as the provocative concentration (in milligrams per milliliter) necessary to increase the specific airway resistance (SRaw) (in centimeters of H2O times second) by 100% (PC100 SRaw). Airway response to hyperventilation of air and to hyperventilation of 0.75 ppm of sulfur dioxide (SO2) was determined as the provocative ventilation (in liters per minute) necessary to increase SRaw by 75% (PV75 SRaw). Challenges were performed on separate days before and after treatment, and salbutamol inhalation was withheld at least 6 hours before each challenge. Salbutamol and placebo did not change perchallenge baseline SRaw nor did they have any significant effect on the airway response to the stimuli. Salbutamol and BDP decreased the mean prechallenge baseline SRaw (SEM) from 7.7 (0.37) to 5.9 (0.28) (p less than 0.01) and significantly (p less than 0.01) increased geometric mean (SEM) PC100 SRaw for histamine from 0.5 (1.42) to 0.9 (1.53) mg/ml; for methacholine, from 0.2 (1.47) to 0.5 (1.51) mg/ml; and mean (SEM) PV75 SRaw for hyperventilation of air from 51.8 (2.32) to 58.4 (1.86) L/min. In contrast, the change of PV75 SRaw during hyperventilation of SO2 from 26.2 (2.29) to 31.4 (3.30) L/min was not significant.(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Airway Resistance; Albuterol; Asthma; Beclomethasone; Bronchi; Bronchial Provocation Tests; Histamine; Humans; Hyperventilation; Methacholine Chloride; Sulfur Dioxide

1990
Can the morbidity of asthma be reduced by high dose inhaled therapy? A prospective study.
    Respiratory medicine, 1990, Volume: 84, Issue:1

    A community based, prospective study of the value of high dose inhaled therapy for the reduction of the morbidity of asthma has been undertaken. One hundred and sixty adults with airflow obstruction were treated for up to 9 months with increasing doses of salbutamol. Two thirds of the patients also received increasing doses of beclomethasone dipropionate in a 'partially double-blind' manner. The FEV1 rose by at least 10 per cent of that predicted in one third of the total patients and the overall mean domiciliary peak expiratory flow rates rose by approximately 50 l/min-1. All chronic symptoms were abolished in half of the patients and acute attacks of asthma in the majority. Asthma was controlled in a greater proportion of patients more effectively and rapidly by a combination of inhaled steroids and beta agonist than by salbutamol alone, particularly when inhaled steroids were started in relatively high dosage.

    Topics: Administration, Inhalation; Adult; Albuterol; Asthma; Beclomethasone; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Male; Peak Expiratory Flow Rate; Prospective Studies

1990
Effect of beclomethasone dipropionate on the bronchial responsiveness to propranolol in asthmatics.
    Chest, 1990, Volume: 98, Issue:2

    The effect of four weeks of treatment with beclomethasone dipropionate (BDP, 500 micrograms twice daily) on the bronchial responsiveness to propranolol was examined in 16 patients with mild asthma in a placebo-controlled, double-blind crossover study. Propranolol was inhaled in doubling concentrations and the results were expressed as the cumulative dose producing a 20 percent fall in FEV1 (PC20). After four weeks of treatment with BDP, the mean FEV1 increased from 82.0 percent predicted to 88.1 percent predicted. The difference was significant (p less than 0.001). Treatment with BDP did not significantly change the responsiveness to propranolol, the geometric mean PC20 being 3.17 mg/ml before and 3.64 mg/ml after BDP treatment. The recovery of FEV1 was faster after 60 minutes of BDP treatment in comparison with placebo treatment (beyond 90 minutes). This study suggests that BDP treatment is unable to reduce bronchial responsiveness to propranolol but can accelerate the recovery of bronchoconstriction induced by propranolol in asthmatic patients.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchial Spasm; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Propranolol; Random Allocation; Time Factors

1990
[Continuous high-dose corticosteroid pressured aerosol therapy in steroid-dependent asthma].
    Presse medicale (Paris, France : 1983), 1989, Jun-17, Volume: 18, Issue:24

    Two therapeutic trials aimed at determining whether a high-dose inhaled corticosteroid, beclomethasone dipropionate (BDP), could reduce or suppress a long term and continuous treatment with a systemic corticosteroid, triamcinolone acetonide (TA), were carried out in a homogeneous population of severe, steroid-dependent asthmatics. The first one was a controlled, double-blind versus placebo trial involving 25 patients followed up for 5 months. The second one was an open trial involving 105 patients followed up for 12 months. In both trials the mean doses of TA were reduced by 60 to 65 per cent, and TA could be totally or nearly totally suppressed in almost 60 per cent of the cases with clinical and functional results that were equal or superior to those previously obtained with systemic corticosteroid therapy. It is concluded that: (a) continuous systemic corticosteroid therapy in mean doses of more than 5 mg/day of prednisone equivalent is now rarely indicated in patients with steroid-dependent asthma, and (b) inhaled corticosteroid therapy with BDP could be extended to cases of non steroid-dependent asthma inadequately controlled by bronchodilators.

    Topics: Administration, Inhalation; Adult; Aerosols; Asthma; Beclomethasone; Clinical Trials as Topic; Female; Follow-Up Studies; Humans; Male; Middle Aged; Respiratory Function Tests; Triamcinolone Acetonide

1989
A comparison of the effects of nedocromil sodium and beclomethasone dipropionate on pulmonary function, symptoms, and bronchial responsiveness in patients with asthma.
    The Journal of allergy and clinical immunology, 1989, Volume: 84, Issue:2

    The efficacy of nedocromil sodium (NED) (4 mg twice daily) and beclomethasone dipropionate (BDP) (200 micrograms twice daily) in controlling the symptoms of asthma, the pulmonary function, and bronchial responsiveness to histamine was assessed in a double-blind, double-dummy, crossover study of 39 adult patients with chronic asthma. The patients, most of whom were assessed to be affected to a moderate degree, were insufficiently controlled in their current regimen of inhaled and/or oral bronchodilators. A 2-week baseline period preceded 6 weeks of treatment with each of the study drugs. Both treatment groups demonstrated improvements from baseline in clinical assessment of lung function performed after the first 6 weeks of treatment. No significant differences were observed when the effects of the treatments were compared on FEV1, FVC, and peak expiratory flow. Bronchial reactivity to histamine, measured as the amount of histamine causing a 20% fall in FEV1 (PC20), decreased significantly (p less than 0.05) after 6 weeks of treatment with BDP compared to the effect of NED treatment. Asthma severity, symptom score, and inhaled bronchodilator use demonstrated significantly better results with BDP. After crossover of treatment, the group transferring from NED to BDP continued to improve, whereas the group crossing from BDP to NED tended to demonstrate a major deterioration during the first 3 weeks, after which a stabilization or an increase in FEV1, FVC, and ln PC20 appeared to occur. It is concluded that NED for inhalation is a potent new drug for treatment of both atopic and nonatopic subjects with asthma. With the number of patients and dosages used, the effect on the pulmonary function was not significantly different from that of BDP after the initial 6 weeks of treatment, but BDP had a better effect on asthma severity, overall opinions, symptom score, bronchodilator use, ln PC20, and morning peak expiratory flow.

    Topics: Adult; Aerosols; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; Bronchi; Bronchial Provocation Tests; Double-Blind Method; Drug Evaluation; Female; Humans; Lung; Male; Nedocromil; Quinolones; Random Allocation; Respiratory Function Tests

1989
A placebo-controlled, blind comparison of nedocromil sodium and beclomethasone dipropionate in bronchial asthma.
    Current medical research and opinion, 1989, Volume: 11, Issue:8

    A multi-centre, randomized, blind comparative group study was carried out in 202 adult patients, who had suffered from asthma for at least 2 years, to assess the effectiveness and tolerability of maintenance treatment with either 4 mg nedocromil sodium 4-times daily, 0.1 mg beclomethasone dipropionate 4-times daily or 2 puffs of placebo 4-times daily, given by inhalation. Lung function (FEV1 and sRaw) measurements were made at the beginning and end of a 2-week baseline period and then after 3 and 6 weeks of treatment: assessment were also made of asthma severity. Patients recorded daily on diary cards details of morning and evening PEFR, usage of inhaled bronchodilators, severity of dyspnoea, cough and morning tightness. The results showed that, compared with placebo, both nedocromil sodium and beclomethasone dipropionate-treated patients showed an improvement in FEV1 and a reduction in sRaw values: PEFR increased slightly in all three groups. There was an improvement in asthma severity, diminished rate of dyspnoea and cough, and reduced usage of inhaled bronchodilators in patients receiving active treatment but not in those on placebo. Overall assessment of treatment efficacy by both investigators and patients showed that opinions were significantly in favour of active treatment over placebo. Treatment was well tolerated and no serious side-effects were reported. It was concluded that at the dosages used nedocromil sodium was comparable with and equivalent to inhaled beclomethasone dipropionate in nearly all of the parameters assessed, and both drugs were superior to placebo in the maintenance treatment of asthma in adult patients.

    Topics: Adolescent; Adult; Aged; Analysis of Variance; Asthma; Beclomethasone; Child; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Nedocromil; Placebos; Quinolones; Randomized Controlled Trials as Topic

1989
High doses of inhaled corticosteroids in unstable chronic asthma. A multicenter, double-blind, placebo-controlled study.
    The American review of respiratory disease, 1989, Volume: 140, Issue:1

    In a multicenter, randomized, double-blind study, inhaled beclomethasone dipropionate (BDP) 1,500 micrograms/day was compared to placebo in 43 chronic asthmatic patients uncontrolled by inhaled salbutamol and oral theophylline. During the prestudy period, a test of maximal steroid reversibility with oral prednisolone 0.5 mg/kg/day for 14 days was performed. The therapeutic response was measured over an 8-wk period as the ability to maintain the clinical improvement and the optimal pulmonary function induced by prednisolone. During the study, severe asthma exacerbation occurred in one (5%) of the 21 patients who received BDP and in 15 (78%) of the 22 patients who received placebo (p less than 0.001). In patients who received BDP, FEV1 and peak expiratory flow (PEF) remained above the optimal postprednisolone value, with a trend to improvement during the 8-wk study period. In patients who received placebo, FEV1 and PEF decreased and remained below the optimal value. We conclude that, in chronic asthma, inhaled BDP 1,500 micrograms/day maintains the optimal pulmonary function in addition to the clinical benefit induced by a short course of oral corticosteroids.

    Topics: Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Double-Blind Method; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Prednisolone; Random Allocation

1989
Comparison of dose-response effects of inhaled beclomethasone dipropionate and budesonide in the management of asthma.
    Allergy, 1989, Volume: 44, Issue:5

    The dose-response effects of inhaled beclomethasone dipropionate (BDP) and budesonide (BUD) administered b.i.d. with the aid of metered dose aerosols were studied in 128 patients (67 men and 61 women, mean age 53 years) suffering from asthma bronchiale. The study was designed as a multi-centre, double-blind, four-period cross-over study, followed by a single-blind double placebo period. BDP was administered in doses of 400 and 1000 micrograms, and BUD in doses of 400 and 800 micrograms. The results in terms of peak expiratory flow (PEF) in the morning and evening, daily symptoms score and use of inhaled beta 2-agonists did not reveal any clinically significant differences between the drugs or between high (800 micrograms BUD, 1000 micrograms BDP) and low (400 micrograms BUD/BDP) doses. However, statistically significant differences were recorded for the corresponding parameters when comparing the placebo with preceding steroid periods. Adverse effects consisting mainly of oropharyngeal candidiasis, hoarseness and cough occurred in 54 of 468 treatment months (12%). The carry-over effects of inhaled steroids are longer lasting than was previously assumed.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Pregnenediones

1989
[Hormonal inhalation preparations in the treatment of bronchial asthma in children].
    Wiadomosci lekarskie (Warsaw, Poland : 1960), 1989, Feb-15, Volume: 42, Issue:4

    Hormonal inhalation preparations (Becotide, Beclomet) were given to 59 children aged 3 to 18 years with severe and long-standing asthma. In most cases (70% a striking improvement of the general condition was achieved with complete regression or alleviation of dyspnoeic attacks. In 15 out of 17 children prednisone could have been withdrawn. No side effects were noted. In 4 children administration of Becotide or Beclomet was not possible.

    Topics: Administration, Inhalation; Adolescent; Asthma; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Dose-Response Relationship, Drug; Humans

1989
Changes in bronchial reactivity in asthmatic children after treatment with beclomethasone alone or in association with salbutamol.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1989, Volume: 26, Issue:6

    Airway inflammation is consistently present in patients with severe asthma. The combination of inhaled steroids and bronchodilators may be useful both for treating symptoms and improving the underlying inflammatory condition. We have compared the effect of beclomethasone dipropionate (BDP) combined with salbutamol (S), BDP alone, and placebo, on the severity of bronchial responsiveness in 30 children with allergic asthma during the period of specific allergen exposure. In children treated with BDP alone, PC20-FEV1 methacholine was 0.66 +/- 0.54 at the beginning and 1.91 +/- 2.11 at the end of the study period (p greater than 0.05). In children treated with BDP + S PC20, methacholine was 1.21 +/- 1.43 at the beginning and 4.22 +/- 3.88 at the end of the study (p less than 0.05). The group of children treated with placebo had a PC20-FEV1 methacholine of 0.79 +/- 0.61 at the beginning of the study and 0.80 +/- 0.46 at the end of the study. The results of the present study show that maintenance treatment with inhaled beclomethasone combined with salbutamol may lead to greater improvement in bronchial hyperreactivity than treatment with inhaled beclomethasone dipropionate alone.

    Topics: Adolescent; Albuterol; Asthma; Beclomethasone; Bronchi; Child; Drug Combinations; Female; Forced Expiratory Volume; Humans; Male; Methacholine Chloride

1989
The superiority of combination beclomethasone and salbutamol over standard dosing of salbutamol in the treatment of chronic asthma.
    Annals of allergy, 1989, Volume: 62, Issue:1

    We studied the clinical effect of a combination aerosol containing salbutamol and beclomethasone dipropionate in comparison to doubling the standard dose of salbutamol from an inhaler. Fifty-seven patients completed the double-blind, crossover study. They were treated with either an aerosol of 100 micrograms beclomethasone dipropionate and 200 micrograms salbutamol or 400 micrograms salbutamol alone. Both regimens were administered four times a day for 4 weeks. The patients showed significant improvement in FEV1, PEFR, and symptom scores after treatment with beclomethasone dipropionate and salbutamol compared with pre-trial values and with treatment with double the dose of salbutamol. The patients demonstrated a clear preference for treatment with the combination of beclomethasone dipropionate and salbutamol. Regular treatment with beclomethasone dipropionate in addition to salbutamol as a combination inhaler provides much better control of asthma than merely increasing the dose of salbutamol in those patients poorly controlled on standard doses of inhaled bronchodilators.

    Topics: Adolescent; Adult; Aerosols; Aged; Albuterol; Asthma; Beclomethasone; Drug Therapy, Combination; Evaluation Studies as Topic; Female; Humans; Male; Middle Aged; Peak Expiratory Flow Rate

1989
Effects of inhaled beclomethasone dipropionate on beta 2-receptor function in the airways and adrenal responsiveness in bronchial asthma.
    European journal of clinical pharmacology, 1988, Volume: 34, Issue:6

    Sixteen patients suffering from bronchial asthma, with or without chronic bronchitis, sufficiently severe to be treated with inhaled corticosteroids, were studied in a single-blind trial (blind observer) of beclomethasone dipropionate (BDP) given in three randomized dosage regimens: 500, 1000 and 2000 micrograms per day, each for 4 weeks. The beta 2-adrenergic agonist response curve showed a dose-dependent increase in FEV1 which was not affected by different doses of BDP. A small but significant reduction in basal cortisol levels was observed after BDP 500 micrograms/day. There was no significant difference between the various doses of BDP in reducing cortisol level and stimulation with tetracosactide remained unchanged. The study showed a gradual, dose-dependent improvement in lung function, statistically significant for morning peak expiratory flow rate at BDP 2000 micrograms/day. Dyspnoea score and beta 2-agonist use decreased, reflecting the anti-asthmatic effects. An increase in total leukocyte count was observed, together with a decrease in the eosinophil count. Oral candidiasis was seen in 2 out of 16 patients. It is concluded that the clinical anti-asthmatic effects of corticosteroid treatment by inhalation are not due to modulation of beta 2-receptor function in the airways.

    Topics: Adrenal Glands; Adult; Albuterol; Asthma; Beclomethasone; Blood Glucose; Bronchi; Dose-Response Relationship, Drug; Eosinophils; Female; Forced Expiratory Volume; Humans; Hydrocortisone; Leukocyte Count; Male; Middle Aged; Receptors, Adrenergic, beta

1988
Dose-dependent inhibitory effect of inhaled beclomethasone on late asthmatic reactions and increased responsiveness to methacholine induced by toluene diisocyanate in sensitised subjects.
    Pulmonary pharmacology, 1988, Volume: 1, Issue:1

    To determine whether inhaled beclomethasone, both at low and at high doses, inhibits late asthmatic reactions and the associated increase in airway responsiveness induced by toluene diisocyanate (TDI), we studied 9 sensitised subjects. Low dose beclomethasone (200 micrograms bid), high dose beclomethasone aerosol (1000 micrograms bid), and placebo were administered for 7 days before TDI inhalation challenge to each subject, according to a double-blind, crossover study design. The washout period between the treatments was at least 1 week. When the subjects were treated with placebo, forced expiratory volume in 1 sec (FEV1) markedly decreased after exposure to TDI. By contrast, high dose beclomethasone prevented the late asthmatic reaction and the low dose partially inhibited the reaction. With placebo the mean (+/- SE) value of FEV1 4 h after exposure to TDI was 2.6 +/- 0.17 L, which went to 3.3 +/- 0.12 after low dose beclomethasone, and to 3.5 +/- 0.15 L after high dose of beclomethasone (significant difference in the decrease of FEV1 in the 8 h after exposure to TDI, between treatments: F = 9.87, (P less than 0.001), After treatment with placebo or with low dose beclomethasone, airway responsiveness to methacholine increased 8 h after exposure to TDI. With placebo, the PD20 decreased from 0.66 mg (Geometric Standard Error of the Mean [GSEM], 1.38) to 0.18 mg (GSEM, 1.46); with low dose inhaled beclomethasone, the PD20 decreased from 0.93 mg (GSEM, 1.42) to 0.36 mg (GSEM, 1.63).(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Methacholine Compounds; Middle Aged; Toluene 2,4-Diisocyanate

1988
Hydroxychloroquine in steroid dependent asthma.
    Pulmonary pharmacology, 1988, Volume: 1, Issue:1

    A recent case report suggested that hydroxychloroquine had a steroid sparing effect in a patient with severe chronic asthma. We have studied the effect of hydroxychloroquine in a group of nine steroid dependent adult asthmatic patients using a randomised double blind crossover comparison of hydroxychloroquine and placebo. Each patient received hydroxychloroquine (400 mg/day) or placebo for 2 month periods. The effect of hydroxychloroquine or placebo on asthma control was assessed by change in steroid dosage, visual analogue symptom scores, response to beta 2 agonist and peak expiratory flow rate (PFR) measurement. The dose of prednisolone required during hydroxychloroquine treatment did not differ from that during placebo treatment or in pre-trial period. There was no significant change in symptom scores of PFR measurement. In this study an 8 week treatment with hydroxychloroquine was of no benefit to patients with chronic steroid dependent asthma.

    Topics: Adult; Asthma; Beclomethasone; Double-Blind Method; Female; Humans; Hydroxychloroquine; Male; Middle Aged; Steroids

1988
[Long-term therapy using beclomethasone preparations in our experience].
    Pneumonologia polska, 1988, Volume: 56, Issue:11

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Betamethasone; Bronchi; Clinical Trials as Topic; Drug Combinations; Female; Humans; Male; Middle Aged; Time Factors; Triamcinolone

1988
Urine cortisol excretion in children treated with high doses of inhaled corticosteroids: a comparison of budesonide and beclomethasone.
    The European respiratory journal, 1988, Volume: 1, Issue:5

    Thirty one children with asthma were treated with inhaled beclomethasone and budesonide in a randomized cross-over study of 2 x 6 weeks' duration. The excretion of free cortisol in two 24 hour urine samples, collected at the end of each treatment period, was significantly higher (mean = 76.3 nmol per day) during budesonide treatment than during beclomethasone treatment (mean = 53.7 nmol per day) (p less than 0.01). The difference between the two drugs was more pronounced in the eight children who received 1,000 and 1,200 micrograms per day than in the 22 children who received 800 micrograms per day. Four children had cortisol excretion below the normal range when treated with beclomethasone. This was seen in one child during budesonide treatment. The age of the child did not influence the result. The long term clinical significance of these findings has yet to be elucidated.

    Topics: Administration, Inhalation; Adolescent; Asthma; Beclomethasone; Budesonide; Child; Child, Preschool; Drug Administration Schedule; Female; Humans; Hydrocortisone; Male; Pregnenediones; Random Allocation

1988
Effect of prednisone and beclomethasone dipropionate on airway responsiveness in asthma: a comparative study.
    Thorax, 1988, Volume: 43, Issue:5

    To examine the effect of corticosteroids on bronchial hyperresponsiveness, a randomised, double dummy, single blind crossover study was performed in 18 subjects with chronic asthma, comparing the effect of three weeks' treatment with inhaled beclomethasone dipropionate, 1200 micrograms daily, and oral prednisone 12.5 mg daily. The 12 week study began with a three week run in period of baseline treatment, which was continued unchanged throughout the study, and the two treatment periods were separated by a three week washout period. Patients kept daily Airflometer readings and attended the laboratory every three weeks for spirometry and a histamine inhalation test for determining the provocative dose of histamine causing a 20% fall in FEV1 (PD20). The mean FEV1 at the start was 1.9 litres (56% predicted). There was no significant change in PD20 with prednisone treatment, the mean PD20 being 0.56 and 0.59 mumol before and after treatment. There was, however, a significant improvement in PD20 with beclomethasone dipropionate treatment, the geometric mean PD20 being 0.38 and 1.01 mumol before and after treatment (p less than 0.001). There was a small but significant improvement in mean FEV1 after beclomethasone dipropionate treatment--from 1.9 to 2.2 litres--but no change after prednisone. Both medications produced significant and similar improvements in morning and evening Airflometer readings, post-bronchodilator improvement, and diurnal variation. Thus at doses that had similar beneficial effects on lung function beclomethasone dipropionate caused a significant improvement in bronchial hyperresponsiveness whereas prednisone caused no change. The superior topical anti-inflammatory effect of beclomethasone dipropionate may account for the different effects on bronchial hyperresponsiveness.

    Topics: Administration, Inhalation; Administration, Oral; Adult; Asthma; Beclomethasone; Bronchi; Bronchial Provocation Tests; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Prednisone

1988
Evaluation of the combination inhaler of salbutamol and beclomethasone dipropionate in the management of asthma.
    Current medical research and opinion, 1988, Volume: 11, Issue:2

    An open parallel study lasting 24 weeks was performed in 39 asthmatics to evaluate patient compliance and the clinical effects of regular inhalations of beclomethasone dipropionate and salbutamol used simultaneously from a combination inhaler with regular inhalations of salbutamol and beclomethasone dipropionate used sequentially from separate inhalers. Total daily doses in the two groups were 800 micrograms salbutamol and 400 micrograms beclomethasone dipropionate. There were no differences between the two treatment groups with respect to clinic pulmonary function tests (FEV1, FVC), daily PEF measurements, symptom scores, use of symptomatic bronchodilator therapy, requirements for extra medication and patients' and physician's assessment of treatment. At 12 weeks, the physician assessed significantly more patients to have better symptom control on the combination inhaler than on separate inhalers. Patient compliance was high in both treatment groups which may have been due to the close supervision of the clinical study.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol; Asthma; Beclomethasone; Drug Combinations; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Patient Compliance; Respiratory Function Tests

1988
Six-month double-blind, controlled trial of high dose, concentrated beclomethasone dipropionate in the treatment of severe chronic asthma.
    Chest, 1988, Volume: 93, Issue:5

    A six-month double-blind controlled trial compared a 2,000 microgram per day dose of beclomethasone dipropionate aerosol (BDP), with current upper level doses of 800 micrograms per day of the standard BDP, in asthmatics requiring oral corticosteroids in addition to BDP and bronchodilators. Both groups showed a significant reduction in their oral steroid requirements during the study, with a 34 percent reduction in the lower dose group and a 57 percent reduction in the high dose BDP group while maintaining good symptomatic control of asthma; there was an associated improvement in baseline serum cortisol levels. Over the same period, the pulmonary function of the lower dose group showed significant worsening relative to that of the group receiving the high dose BDP which improved. There was no increase in dysphonia or oropharyngeal candidiasis among those using the concentrated BDP. We conclude that high dose concentrated BDP appears to be a safe medication in long-term steroid-dependent asthma, and is effective in reducing dependence on the use of oral corticosteroid with associated improvement both in pulmonary and adrenal function.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Random Allocation; Time Factors

1988
Adrenal function in children with bronchial asthma treated with beclomethasone dipropionate or budesonide.
    The Journal of allergy and clinical immunology, 1988, Volume: 81, Issue:6

    The effect of inhaled beclomethasone dipropionate and budesonide on the adrenal function was studied in 30 children (aged 7 to 15 years) with mild bronchial asthma. The trial was designed as a prospective double-blind parallel study of the effect of stepwise increase of either beclomethasone dipropionate or budesonide from 200 micrograms through 400 micrograms, to 800 micrograms daily in three consecutive periods of 4 weeks. At the end of each period, the adrenal stress response was evaluated by measurements of serum cortisol and androstenedione during a short adrenocorticotropic hormone test. The unstimulated diurnal production of glucocorticosteroids was assessed by measurements of free cortisol in 24-hour urine samples. Free cortisol in urine was found a valid measure of the total diurnal excretion of cortisol metabolites, since it exhibited a good correlation to the fractional cortisol metabolites measured by gas chromatography. The adrenal response to adrenocorticotropic hormone stimulation was unaffected by treatment or dose. The unstimulated diurnal production of glucocorticosteroids demonstrated a highly significant dose-related suppression in response to the inhaled steroids. No significant difference was found between the two topical steroids (probability value 5.3%), and yet the suppression was apparent in the group of children treated with beclomethasone dipropionate but not in the group of children treated with budesonide. Further studies are desirable in order to ascertain whether budesonide offers an improved ratio between beneficial anti-inflammatory effect and unwanted systemic activity.

    Topics: Adolescent; Adrenal Cortex Function Tests; Androstenedione; Asthma; Beclomethasone; Budesonide; Child; Circadian Rhythm; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Female; Humans; Hydrocortisone; Male; Pituitary-Adrenal Function Tests; Pregnenediones; Prospective Studies; Random Allocation

1988
Protective effect of antiasthma drugs on late asthmatic reactions and increased airway responsiveness induced by toluene diisocyanate in sensitized subjects.
    The American review of respiratory disease, 1987, Volume: 136, Issue:6

    To determine whether 4 drugs used in the treatment of asthma inhibit the late asthmatic reaction and the associated increase in airway responsiveness induced by toluene diisocyanate (TDI), we studied 24 sensitized subjects divided into 4 groups. Beclomethasone aerosol (1 mg bid), slow-release theophylline (6.5 mg/kg bid), slow-release verapamil (120 mg bid), and cromolyn (20 mg qid via spinhaler), were administered for 7 days, respectively, to 1 of the 4 groups, according to a double-blind, crossover, placebo-controlled study design. When the subjects were treated with placebo, verapamil, or cromolyn, FEV1 markedly decreased and airway responsiveness increased after exposure to TDI. By contrast, beclomethasone prevented the late asthmatic reaction and the associated increase in airway responsiveness to methacholine induced by TDI. Slow-release theophylline partially inhibited both the immediate and the late asthmatic reactions but had no effect on airway hyperresponsiveness to methacholine. These results suggest that only high-dose inhaled steroids can completely block TDI-induced late asthmatic reactions.

    Topics: Asthma; Beclomethasone; Bronchial Provocation Tests; Clinical Trials as Topic; Cromolyn Sodium; Cyanates; Delayed-Action Preparations; Double-Blind Method; Forced Expiratory Volume; Humans; Immunization; Lung; Methacholine Chloride; Methacholine Compounds; Placebos; Random Allocation; Respiratory System; Theophylline; Time Factors; Toluene 2,4-Diisocyanate; Verapamil

1987
The efficacy of nedocromil sodium (Tilade) in asthma.
    Australian and New Zealand journal of medicine, 1987, Volume: 17, Issue:6

    Nedocromil sodium is a new antiasthmatic drug with properties similar to sodium cromoglycate. We examined the efficacy of nedocromil sodium compared to placebo in 71 asthmatic patients in a three-centre double-blind parallel group study over 12 weeks. During the study the patients' maintenance inhaled corticosteroids were progressively withdrawn. Nedocromil sodium had an advantage over placebo in the number of withdrawals related to uncontrolled asthma, 14 and 24 respectively (p = 0.03). Changes in symptom scores, peak flow rates and bronchodilator use favoured nedocromil sodium occasionally during the study. The unusual taste of the active drug was reported frequently. Nedocromil sodium is more efficacious than placebo in asthma maintenance, but does not replace inhaled corticosteroids.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Asthma; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Nedocromil; Pulmonary Ventilation; Quinolines

1987
Safety and efficacy of long-term treatment with inhaled beclomethasone dipropionate in steroid-dependent asthma.
    CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 1987, Jan-15, Volume: 136, Issue:2

    An open long-term trial of inhaled beclomethasone dipropionate was carried out in 32 asthmatic patients chronically dependent on systemic corticosteroids. Our objectives were to study the efficacy and safety of beclomethasone and to determine the proportion of patients in whom systemic steroids could be replaced by the new drug. All subjects had a clear history and physical findings of asthma as well as significant improvement in respiratory function after inhalation of salbutamol. Patients were followed for 4 to 8 years. Compared with a baseline period, patients receiving beclomethasone had reduced symptoms and needed less bronchodilator therapy, but their pulmonary function was unchanged. Bronchial biopsy specimens from seven patients who had been taking beclomethasone for as long as 8 years did not differ histologically from specimens from five asthmatic patients who had never taken the drug. Nine patients were able to stop taking systemic corticosteroids within 9 months, eight required them occasionally, and in eight the requirement was substantially reduced; the requirement did not change appreciably in the remaining seven. Inhaled beclomethasone is a safe and effective drug for chronic administration to asthmatic patients, and in 78% of our subjects the need for systemic steroids was substantially reduced or eliminated.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Aged; Asthma; Beclomethasone; Biopsy; Bronchi; Clinical Trials as Topic; Female; Humans; Long-Term Care; Male; Middle Aged; Prospective Studies; Respiratory Function Tests; Safety; Substance-Related Disorders

1987
Effects of regular inhalation of beclomethasone dipropionate and sodium cromoglycate on bronchial hyperreactivity in asthmatic children.
    Acta paediatrica Scandinavica, 1987, Volume: 76, Issue:1

    The efficacy of beclomethasone dipropionate (BDP) was compared with sodium cromoglycate (SCG) and placebo in a double-blind parallel group study of 30 asthmatic children over a two-month period. All the three treatment groups received salbutamol concomitantly. Lung volumes, airway mechanics and the nonspecific bronchial hyperreactivity to carbachol were measured at the beginning and the end of the study. Two patients were excluded because of unequal clinical conditions at the entry and the end of the study and three because of lack of co-operation. Three patients (1 on SCG, 2 on placebo) dropped out because of worsening clinical symptoms. The improvement in airway mechanics shown by the group treated with BDP (n = 7) was significantly greater (p less than 0.01) than in the group treated with SCG (n = 8). Nonspecific hyperreactivity to carbachol improved significantly in the BDP group (factor 5.9) compared to the SCG group (factor 1.9). Childhood asthma seems to be better controlled by a combination of BDP and salbutamol, than by SCG and salbutamol.

    Topics: Administration, Inhalation; Adolescent; Airway Resistance; Asthma; Beclomethasone; Bronchi; Carbachol; Child; Child, Preschool; Clinical Trials as Topic; Cromolyn Sodium; Double-Blind Method; Female; Humans; Lung Volume Measurements; Male

1987
Comparative effects of inhaled salbutamol, sodium cromoglycate, and beclomethasone dipropionate on allergen-induced early asthmatic responses, late asthmatic responses, and increased bronchial responsiveness to histamine.
    The Journal of allergy and clinical immunology, 1987, Volume: 79, Issue:5

    Single-dose salbutamol (200 micrograms), beclomethasone dipropionate (200 micrograms), and sodium cromoglycate (SCG) (10 mg) administered by inhalation 10 minutes before allergen challenge were examined with regard to inhibition of allergen-induced early (EAR) and late (LAR) asthmatic responses and allergen-induced increase in bronchial responsiveness to inhaled histamine. Ten atopic subjects with asthma participated in a blinded, crossover, placebo-controlled trial. The EAR was inhibited by salbutamol and SCG but not by beclomethasone dipropionate or placebo (p less than 0.01). The LAR (p less than 0.01) and the allergen-induced increased bronchial responsiveness to histamine 7 hours (p less than 0.01) and 30 hours (p less than 0.05 and p less than 0.01 for various comparisons) were inhibited by SCG and beclomethasone diproprionate but not by salbutamol or placebo. The allergen-induced LAR and associated increased responsiveness are now believed to be more important clinically than the EAR. The clinical relevance of these results is to stress the importance of the prophylactic nonbronchodilator drugs (SCG and steroids) and the potential inadequacy of bronchodilators used alone in the treatment of both perennial and seasonal allergic asthma.

    Topics: Administration, Inhalation; Adolescent; Adult; Albuterol; Allergens; Asthma; Beclomethasone; Bronchi; Bronchial Diseases; Bronchial Provocation Tests; Clinical Trials as Topic; Cromolyn Sodium; Double-Blind Method; Female; Histamine; Humans; Male; Time Factors

1987
A comparison of the effects of sodium cromoglycate and beclomethasone dipropionate on pulmonary function and bronchial hyperreactivity in subjects with asthma.
    The Journal of allergy and clinical immunology, 1987, Volume: 80, Issue:1

    After a run-in period of 2 weeks, receiving a regimen of inhaled beta 2-agonists and/or theophyllines, 38 atopic patients with asthma with perennial symptoms were randomly allocated to receive an 8-week treatment of additional inhalation treatment with either sodium cromoglycate (SCG), 2 mg four times daily, and placebo beclomethasone dipropionate (BDP), or BDP, 200 micrograms twice daily, and placebo SCG. After crossover, each group received the opposite treatment for the final 8 weeks. FEV1, FVC, and provocation concentration of histamine causing a 20% fall in FEV1 (PC20) were determined monthly and peak expiratory flow (PEF) daily throughout the study. A significant increase in FEV1, FVC, and PEF (p less than 0.01) was observed after BDP treatment was started, and likewise, in the second period, an increase in both FEV1 and PEF (p less than 0.05) was observed. The total effect on logarithm-natural (Ln) (PC20), i.e., the mean effects of the two periods, was also significant (p less than 0.01). SCG, however, was most effective when it was used as the first drug, indicated by a significant increase in FVC in the first period (p less than 0.05). Neither in the first nor in the second period did SCG treatment influence the Ln (PC20) value positively, and the SCG treatment administered in the second period could not maintain the improvement in the pulmonary function (i.e., FEV1, FVC, and PEF) obtained initially with the BDP treatment. When the effect of BDP on FEV1, FVC, PEF, and Ln (PC20) was compared to the effect of SCG in the first 8-week treatment period, no significant difference was observed (p greater than 0.1).(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Adult; Asthma; Beclomethasone; Bronchi; Cromolyn Sodium; Female; Humans; Lung; Male; Spirometry

1987
A comparison of inhaled budesonide and beclomethasone dipropionate in childhood asthma.
    British journal of diseases of the chest, 1987, Volume: 81, Issue:2

    The objective of this study was to compare the clinical effects of beclomethasone dipropionate (BDP) and budesonide in asthmatic children using two common ways of administration. Twenty-one children, aged 4-14 years, who regularly used inhaled corticosteroids for their control of asthma were included in the study. The drugs were studied by using a double-blind randomized cross-over design trial with a single-blind placebo period at the end. Each period lasted 3 weeks. The dosage was 100 micrograms b.i.d. for both drugs. Budesonide was administered via a spacer inhaler (Inhalet), and beclomethasone dipropionate via a standard actuator. Compared with placebo, both drugs significantly improved PEFR values for morning (20% for budesonide and 14% for BDP) and evening (14% for budesonide and 9% for BDP). Both morning and/or evening peak flows were significantly higher during the budesonide treatment as compared with the BDP treatment. In comparison with the placebo period, FEV1.0 was significantly improved with budesonide but not with BDP. Plasma cortisol, WBC counts, differential and eosinophilia counts in blood were determined at the beginning and the end of each period. All of the values except for the eosinophil counts were within normal ranges. Candida was looked for but not found in any case. No other adverse effects were registered. For most of the children, a deterioration of the state of their asthma and increased need for concomitant therapy during the placebo period confirmed their steroid dependence. The number of administrations with concomitant anti-asthmatic therapy increased during placebo by 61% as compared with the budesonide therapy, and by 40% compared with the BDP therapy.

    Topics: Administration, Inhalation; Adolescent; Asthma; Beclomethasone; Budesonide; Child; Child, Preschool; Clinical Trials as Topic; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Pregnenediones; Random Allocation

1987
Cough and wheezing from beclomethasone dipropionate aerosol are absent after triamcinolone acetonide.
    Annals of internal medicine, 1987, Volume: 106, Issue:5

    To test the hypothesis that patients with asthma who develop cough and wheezing after the use of beclomethasone aerosol would have a better tolerance for triamcinolone aerosol.. Randomized, double-blinded, crossover trial.. Pulmonary function laboratory.. Volunteer sample of 24 patients attending an asthma clinic who had developed cough, with or without wheezing, after inhaling beclomethasone aerosol. All patients completed the study.. Aerosols were used in habitual manufacturers' preparations and canisters, but both were administered in three puffs through the delivery system used for triamcinolone. The preparations differed in drug (beclomethasone dipropionate or triamcinolone acetonide), propellant (trichloromonofluoromethane and dichlorodifluoromethane, or dichlorodifluoromethane alone, respectively) and dispersant (oleic acid or dehydrated alcohol, respectively). PATIENTS inhaled three puffs of one aerosol on one day and three of the other on the next.. Forced expiratory volume in one second (FEV1) was measured before and after each aerosol application. The FEV1 decreased a mean of 17.7% from baseline after inhalation of beclomethasone, and 0.8% after triamcinolone (difference, 16.9; 95% confidence limits, 12.36 to 21.34; p less than 0.001). Coughs were counted after each puff. The mean number of coughs after beclomethasone aerosol inhalation was 35.8, and after triamcinolone, 0.5 (difference, 35.3; 95% confidence limits, 22.62 to 47.98, p less than 0.001).. Asthmatic patients who are unable to inhale beclomethasone aerosol due to cough or wheezing can inhale triamcinolone aerosol without difficulty. Our investigation does not determine the exact cause of the coughing and wheezing with the beclomethasone aerosol, but we suspect the dispersant as the source.

    Topics: Adult; Aerosol Propellants; Aerosols; Aged; Asthma; Beclomethasone; Cough; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Respiratory Sounds; Triamcinolone Acetonide

1987
The effect of a structured education program on knowledge and psychomotor skills of patients using beclomethasone dipropionate aerosol for steroid dependent asthma.
    Health education quarterly, 1987,Fall, Volume: 14, Issue:3

    The purpose of the study was to evaluate the efficacy of a structured education program on knowledge and psychomotor skills of subjects using inhaled beclomethasone dipropionate. The sample was comprised of 26 male outpatients with a mean age of sixty years (range 49-69 yrs) and mean educational level of 11 years (range 7-18 yrs). Subjects were tested to assess knowledge of drug action, self-administration, and side effects. Skill in self-administration was assessed by two independent raters who were blind to group assignment. Then, patients were randomly assigned to an experimental group (n = 13), who received a structured educational program, or a control group (n = 13), who received no structured educational interventions. Patients were retested four weeks after randomization. Subjects in the experimental and control groups did not differ significantly with respect to their initial mean knowledge and performance scores. The post-test mean knowledge score was significantly higher when compared to initial score for each group. Mean knowledge score at post-test did not differ significantly between groups. However, when comparing post-test performance scores to initial scores the experimental group had a significantly greater increase in mean score than the control group. It is concluded that a structured patient education program is an effective method for improving the psychomotor skills necessary for proper use of beclomethasone dipropionate aerosol.

    Topics: Aerosols; Aged; Asthma; Beclomethasone; Educational Measurement; Evaluation Studies as Topic; Humans; Male; Middle Aged; Outcome and Process Assessment, Health Care; Patient Education as Topic; Psychomotor Performance; Self Administration; Substance-Related Disorders

1987
Comparison of budesonide and beclomethasone dipropionate for treatment of asthma.
    Archives of disease in childhood, 1987, Volume: 62, Issue:8

    Beclomethasone dipropionate (BDP) and budesonide (BUD) were each given in a dose of 200 micrograms twice daily by metered dose inhaler to 10 asthmatic children already dependent on treatment with steroids. In a double blind randomised crossover study each course lasted one month. No clinically important differences were found between the two treatments when symptom scores, symptom free days, additional use of salbutamol, and results of lung function tests were considered. Metyrapone mildly reduced the plasma concentration of 11-deoxycortisol in two patients during treatment with budesonide, and in four during treatment with beclomethasone. It is concluded that although they are usually safe, both drugs may cause mild adrenal suppression when given in a dose of 200 micrograms twice daily.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; Budesonide; Child; Double-Blind Method; Humans; Pregnenediones; Random Allocation

1987
Inhaled corticosteroids reduce the severity of bronchial hyperresponsiveness in asthma but oral theophylline does not.
    The American review of respiratory disease, 1987, Volume: 136, Issue:5

    In a double-blind crossover study, we compared the relative effects of inhaled beclomethasone dipropionate (BDP) 800 micrograms per day and oral theophylline on the severity of bronchial hyperresponsiveness (BHR) to histamine. Daily doses of theophylline were sufficient to keep serum levels between 55 and 110 mumol/L. The subjects were 26 patients with severe asthma whose symptoms were inadequately controlled by regular treatment with inhaled salbutamol. The severity of BHR improved within 3 wk in the group treated with BDP, whereas no change occurred in the group treated with theophylline. There were no significant changes in FEV1 in either group during the study. When BDP was changed to theophylline there was a deterioration in BHR. Aerosol steroids, rather than theophylline, are the treatment of choice when reduction in the severity of BHR is the aim of treatment in patients with severe asthma.

    Topics: Adult; Aerosols; Airway Resistance; Asthma; Beclomethasone; Bronchi; Bronchial Provocation Tests; Delayed-Action Preparations; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Theophylline

1987
Is the combination inhaler of salbutamol and beclomethasone dipropionate as effective as the same agents from separate inhalers in the management of childhood asthma?
    Current medical research and opinion, 1987, Volume: 10, Issue:8

    A double-blind crossover study lasting 16 weeks was carried out in children with chronic extrinsic asthma to compare the clinical effects of regular inhalations of salbutamol and beclomethasone dipropionate from a combination inhaler and regular inhalations of the same two drugs used sequentially from separate inhalers. Eighteen patients entered the study and 16 completed both 8-week treatment periods. However, there was a large amount of missing data, with only 9 complete sets of paired data; efficacy analyses were performed on data from 10 patients on separate inhaler therapy and from 14 patients on combination inhaler therapy. There were no significant differences between daily peak flow rate measurements, symptom scores, additional symptomatic bronchodilator therapy, acute exacerbations of asthma or incidence of adverse events, demonstrating that both treatments were similarly effective in controlling the patient's asthmatic symptoms. There was, however, a trend for higher peak flow values and lower symptom scores on separate inhaler therapy in this small group of asthmatic children. Although the results suggest that regular therapy using a combination inhaler is as effective as sequential administration of salbutamol and beclomethasone dipropionate from separate inhalers, it is concluded that the study should be extended to a larger group of patients to determine whether there might be any statistically significant differences between the two regimens.

    Topics: Adolescent; Albuterol; Asthma; Beclomethasone; Child; Double-Blind Method; Drug Combinations; Female; Humans; Male; Nebulizers and Vaporizers

1987
Cough and wheezing from beclomethasone aerosol.
    Chest, 1987, Volume: 91, Issue:2

    Cough and wheezing are frequent side effects of inhaling beclomethasone dipropionate aerosol (BA) in patients with asthma. Twenty percent of our outpatient asthmatic subjects are unable to take BA due to these side effects. Twelve patients with history of severe cough and wheezing after inhaling BA were tested. Three puffs of either BA or placebo (Plc) were administered from a metered dose inhaler (MDI) in a double-blind crossover design. They coughed a mean of 31 times after BA and 19 times after Plc. Forced expiratory volume in one sec (FEV1) declined a mean of 22.6 percent after BA and 22.0 percent after Plc. Pretreatment with albuterol attenuated both the cough and the drop in FEV1. Follow-up study showed that regular pretreatment with bronchodilator enabled seven of 12 patients to tolerate BA therapy. The remaining five required a short course of increased dose oral steroid therapy. Cough and wheezing are frequent side effects of BA therapy that interfere with regular compliance. Pretreatment with a bronchodilator is effective in attenuating these side effects in some patients; in others, a short course of oral steroid therapy may be necessary.

    Topics: Aerosols; Albuterol; Asthma; Beclomethasone; Cough; Double-Blind Method; Forced Expiratory Volume; Humans; Respiratory Sounds

1987
Twice-daily beclomethasone dipropionate in the treatment of childhood asthma.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1986, Volume: 23, Issue:1

    Chronic nonsteroid-dependent childhood asthma was treated by adding beclomethasone dipropionate (BDP) or placebo (P) to the daily regimen of theophylline (T). Subjects (6-12 years) were selected based on daily control of asthma by T at necessary T levels in sera of 10-20 micrograms. Active BDP (200 micrograms b.i.d.) and P groups were randomly assigned. Each subject's baseline values were evaluated on a 4-week open phase followed by a 10-12 week double-blind phase. Daily diaries were kept for signs, symptoms, Wright peak flow recordings, and medication requirements. Visits were monitored for urine and serum cortisols, pulmonary function tests (PFT), objective changes, and medication compliance. Demographics between both groups were nonsignificant (NS). Baseline PFTs in P group were significantly better than the BDP group. Serum and urine cortisols and ACTH responses were NS (p less than 0.05). Drug efficacy for asthma characteristics was significantly improved in the BDP group (p less than 0.05) only. The BDP group maximized their response by 8 weeks, with improvement of their FEV1 and FEF25-75 PFT. Thus, b.i.d. BDP provided good asthma control and the twice-daily program should insure improved compliance.

    Topics: Adrenergic beta-Agonists; Asthma; Beclomethasone; Child; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Humans; Random Allocation; Respiratory Function Tests; Theophylline

1986
[Treatment of asthma with high doses of beclomethasone].
    Schweizerische Rundschau fur Medizin Praxis = Revue suisse de medecine Praxis, 1986, Jul-22, Volume: 75, Issue:30-31

    Topics: Administration, Oral; Adrenal Cortex Hormones; Adrenocorticotropic Hormone; Aerosols; Asthma; Beclomethasone; Clinical Trials as Topic; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Evaluation; Drug Therapy, Combination; Humans

1986
Twice daily beclomethasone dipropionate administered with a concentrated aerosol inhaler: efficacy and patient compliance.
    Thorax, 1986, Volume: 41, Issue:12

    The efficacy of twice daily inhaled beclomethasone dipropionate administered by a concentrated aerosol inhaler (one puff twice daily-500 micrograms/day) has been compared with that of treatment four times daily with a standard dose inhaler (two puffs four times daily-400 micrograms/day) in 21 patients with stable asthma. Double placebo inhalers were used in a randomised crossover fashion during two four week treatment periods. Mean peak expiratory flow (PEF), mean symptom scores, and number of extra salbutamol inhalations required were not significantly different between the two treatment periods. Local side effects were more common during treatment with the four times daily active preparation; overt oropharyngeal candidiasis, however, was not found in either group during the study. On completion of the crossover study patients were transferred to the twice daily regimen. At the three month follow up all patients had remained stable and the outpatient PEF was significantly higher (mean 382 (SD 26)l min-1) than at entry into the trial (mean 345 (24)l min-1) (p less than 0.05). Twice daily beclomethasone administered by a concentrated aerosol inhaler appears to be as effective as the standard four times daily regimen in controlling stable asthma.

    Topics: Adult; Aerosols; Aged; Asthma; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Random Allocation

1986
Nebulised beclomethasone dipropionate in preschool asthma.
    Archives of disease in childhood, 1986, Volume: 61, Issue:3

    Twenty nine young children with severe recurrent asthma were given nebulised beclomethasone dipropionate or normal saline in a double blind manner over a six month period. Progress was monitored using diary score cards. Those receiving beclomethasone had lower symptom scores, had more symptom free days, and required less additional treatment with bronchodilator agents. The code needed to be broken more frequently if normal saline was used. Over the study period height and weight increases in the two groups were similar, and no serious side effects were noted.

    Topics: Aerosols; Asthma; Beclomethasone; Child, Preschool; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Infant; Male; Random Allocation

1986
Inhaled corticosteroids: are higher doses better?
    Drug and therapeutics bulletin, 1986, Jan-13, Volume: 24, Issue:1

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Budesonide; Clinical Trials as Topic; Humans; Pregnenediones

1986
Evaluation of aerosolized triamcinolone acetonide as a replacement for aerosolized beclomethasone dipropionate.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1986, Volume: 23, Issue:3

    Substitution of aerosolized triamcinolone acetonide for aerosolized beclomethasone dipropionate in treatment of 30 chronic asthmatics resulted in subjective improvement in all patients. There was reduction in requirement of systemic steroids and inhaled beta adrenergics. No adrenal suppression or oropharyngeal candidiasis occurred after replacing beclomethasone dipropionate with triamcinolone acetonide.

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Female; Humans; Male; Middle Aged; Respiratory Function Tests; Triamcinolone Acetonide

1986
Twice daily versus four times daily treatment with beclomethasone dipropionate in the control of mild childhood asthma.
    Thorax, 1986, Volume: 41, Issue:8

    The effects of controlling childhood asthma of the same daily dose (400 micrograms) of beclomethasone dipropionate, given in two or four equal divided doses from a metered aerosol, were compared in a double blind crossover study. Thirty one children aged 6-14 years completed the study. They had previously been shown to need beclomethasone by showing either symptoms or reduced peak flow when the treatment was withdrawn. They recorded their daytime and night time symptoms on a visual analogue scale and their morning and evening peak expiratory flow (PEF), and recorded their symptomatic use of bronchodilator aerosols. Spirometry was performed at the end of each treatment period. Control of asthma was good on both regimens. There were small differences in both objective and subjective measurements in favour of the four times daily regimen, but none reached statistical significance, apart from patients' assessment of daytime wheeze (p less than 0.05). In particular, the differences in the results of lung function tests were very small. Compliance was better for morning and evening doses. These results suggest that beclomethasone given as 200 micrograms twice daily is effective in controlling mild childhood asthma. It may be preferable to 100 micrograms four times daily because of better compliance and because it is unnecessary to take medication to school.

    Topics: Adolescent; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male

1986
Nebulised beclomethasone dipropionate suspension.
    Archives of disease in childhood, 1986, Volume: 61, Issue:11

    We compared nebulised beclomethasone dipropionate suspension against placebo in 16 children with moderately severe asthma in double blind crossover fashion. Three children withdrew due to deterioration while on placebo. Of the remaining 13, eight were better on beclomethasone and five on placebo. These trends in favour of nebulised beclomethasone were not significant and do not suggest that the suspension is as effective as inhaled powder or aerosol topical steroid formulation.

    Topics: Asthma; Beclomethasone; Child, Preschool; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Infant; Male; Nebulizers and Vaporizers; Suspensions

1986
Twice daily administration of beclomethasone dipropionate dry-powder in the management of chronic asthma.
    Asian Pacific journal of allergy and immunology, 1986, Volume: 4, Issue:2

    In a double-blind cross-over study beclomethasone dipropionate inhaled as a dry-powder in a dose of 400 micrograms twice daily was compared with a conventional aerosol in a dose of 100 micrograms four times daily in 16 outpatients with chronic asthma. Each of the 2 treatments lasted for 4 weeks. There was no significant difference with respect to daily peak expiratory flow rates, symptom scores, bronchodilator usages and other lung function measurements between the 2 treatments. Tetracosactrin tests were within normal limits and no clinical oral candidiasis was observed throughout the study. In conclusion, beclomethasone dipropionate dry-power given twice daily was effective for the control of asthma and could be recommended for patients with poor drug compliance.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Humans; Lung Volume Measurements

1986
Comparison of two high dose corticosteroid aerosol treatments, beclomethasone dipropionate (1500 micrograms/day) and budesonide (1600 micrograms/day), for chronic asthma.
    Thorax, 1986, Volume: 41, Issue:11

    Twenty eight patients with chronic asthma took part in a double blind single crossover controlled trial of inhaled budesonide and inhaled beclomethasone dipropionate, using high doses of 1600 micrograms and 1500 micrograms daily respectively. Both drugs were administered by pressurised aerosol inhaler; the inhaler containing budesonide and its matching placebo were fitted with a collapsible spacer device. There was no significant difference in the control of asthma during the two six week treatment periods. There was no significant difference in FEV1 and forced vital capacity after four and six weeks of treatment or in mean morning and evening peak expiratory flow rates for the last 21 days of treatment. There was a small but statistically significant reduction in the daytime wheeze score while they were taking high dose budesonide but there was no difference for daytime activity, cough, and night symptoms. The mean basal cortisol concentrations were significantly lower after six weeks of high dose treatment than before treatment (budesonide p less than 0.01, beclomethasone p less than 0.05). There was no difference between mean basal cortisol values after six weeks of high dose treatment, and there was no effect on the rise of cortisol obtained after a short tetracosactrin test. High dose inhaled corticosteroids produced few side effects and were well tolerated.

    Topics: Adult; Aerosols; Aged; Asthma; Beclomethasone; Budesonide; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Pregnenediones; Prospective Studies

1986
Is twice daily prophylaxis with salbutamol and beclomethasone dipropionate effective in the management of asthma?
    Pharmatherapeutica, 1986, Volume: 4, Issue:10

    An open, crossover study lasting 8 weeks was performed to establish if a twice daily regimen of combined inhalation of salbutamol and beclomethasone dipropionate from a single inhaler was as effective in controlling asthma as the 4-times daily regimen. The results from these two treatment periods were compared with an initial 4-week baseline period when all patients received the same agents from separate inhalers on a 4-times daily dose schedule. Twenty stable asthmatics were entered into the study and 19 completed the three treatment periods. The clinic lung function data, symptomatic inhaler usage, requests for additional therapy and physician's subjective assessment of treatment showed that all three treatment regimens were similarly effective in managing the patients' asthma. There was no significant difference between the mean PEFR measurements taken 4 times each day between the two treatment regimens of the combination inhaler. However, except for PEFR in the afternoon, the mean values for both treatment schedules of the combination inhaler were significantly greater (p less than 0.05) than those during the separate inhaler baseline period. More than half the patients considered that both treatment schedules of the combination inhaler provided better control of their asthma than treatment with the separate inhalers, and the majority preferred the twice daily regimen to the 4-times daily regimen. The results, overall, showed that in stable asthmatics the combined administration of salbutamol and beclomethasone dipropionate from one inhaler provides significantly better therapy than the same agents from separate inhalers and that the twice daily dose schedule of the combination inhaler is equally as effective as a 4-times daily regimen.

    Topics: Adult; Aged; Albuterol; Asthma; Beclomethasone; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Maximal Expiratory Flow Rate; Middle Aged

1986
Clinical, rhinomanometric, and cytologic evaluation of seasonal allergic rhinitis treated with beclomethasone dipropionate as aqueous nasal spray or pressurized aerosol.
    The Journal of allergy and clinical immunology, 1986, Volume: 77, Issue:6

    The currently available beclomethasone dipropionate (BDP) metered-dose nasal aerosol spray is considered uncomfortable by some patients because of the force of delivery. It was compared for efficacy and acceptability in a double-blind study with a new aqueous suspension BDP spray for the treatment of seasonal allergic rhinitis in 44 symptomatic patients aged 12 to 43 years. After 7 days of baseline evaluation, every patient was given both an aerosol canister and an aqueous spray bottle each containing either BDP, 42 mcg per spray, or placebo (P). For 15 days the patient sprayed each nostril twice a day with one spray of suspension (BDP or P) followed 5 minutes later by one spray of aerosol (P or BDP). Patients were evaluated before the study medications were started (day 1) and on days 4, 8, and 15 for nasal and eye symptoms. Nasal cytologic specimens were examined on days 1 and 15, and rhinomanometry was performed on days 1, 8, and 15 of the study. Topical BDP by both methods of delivery was rapidly effective in decreasing mean nasal obstruction, rhinorrhea, sneezing, and itching symptoms as well as mean eye symptoms with no statistically significant differences between them. Nasal airflow increased with both treatments; rhinomanometry significantly correlated with subjective nasal obstruction scores. Of 34 patients with nasal eosinophils, 74% had fewer eosinophils after treatment. Most patients (84%) preferred the aqueous spray over the pressurized aerosol.

    Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Allergens; Asthma; Beclomethasone; Humans; Nasal Mucosa; Pollen; Rhinitis, Allergic, Seasonal

1986
Comparison of twice-daily and four-times daily administration of beclomethasone dipropionate in patients with severe chronic bronchial asthma.
    European journal of clinical pharmacology, 1986, Volume: 30, Issue:3

    Twice-daily and four-times daily treatment with beclomethasone dipropionate aerosol were compared in a double dummy crossover study in patients with severe chronic bronchial asthma. The trial consisted of two two-month treatment periods preceded by a two-week baseline period. No significant difference was found in the morning or evening PEF, in symptom scores for wheeze, cough, sputum, sleep disturbance, limitation of daily activity, rhinitis, daily usage of bronchodilator aerosol or requirement for additional oral corticosteroids. The study has confirmed that in management of severe bronchial asthma, a twice-daily regimen of beclomethasone dipropionate aerosol is as effective as four-times daily treatment, if the total daily dose of beclomethasone dipropionate is kept unchanged.

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Chronic Disease; Female; Humans; Male; Middle Aged; Random Allocation; Time Factors

1986
[Nocturnal asthma: inhalation treatment with high doses of salbutamol and beclomethasone].
    Revista clinica espanola, 1986, Volume: 178, Issue:7

    Topics: Adult; Albuterol; Asthma; Beclomethasone; Circadian Rhythm; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Prospective Studies; Respiratory Therapy

1986
Comparison of the effects of sequential or simultaneous administration of salbutamol and beclomethasone dipropionate.
    Respiration; international review of thoracic diseases, 1986, Volume: 50, Issue:2

    The effect of the simultaneous administration of salbutamol and beclomethasone dipropionate, from a combination inhaler, was compared with the same doses given with an interval of 10 min, from separate inhalers, in a group of 40 asthmatic females. The double-blind parallel-group study was well balanced and lasted 4 weeks. Both groups showed a similar improvement in thrice-weekly lung function values and daily symptoms in week 4 compared to week 1. There were no other differences and no adverse reactions. The combination inhaler is a useful alternative for maintenance treatment in patients who require an inhaled steroid.

    Topics: Adult; Aerosols; Aged; Albuterol; Asthma; Beclomethasone; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Female; Humans; Middle Aged; Respiratory Function Tests

1986
Atopic asthma: T-cell response to corticosteroids.
    Chest, 1985, Volume: 87, Issue:1

    Atopic asthma is associated with diminished cell-mediated immunity and elevated levels of IgE, both of which may be caused by imbalances of T-lymphocyte subsets. We analyzed the response of peripheral blood T-cell subsets to two commonly used corticosteroid preparations as a probe of T-cell subset regulation. We administered prednisone (P) 60 mg or 20 mg, beclomethasone dipropionate (BDP) aerosol, 336 micrograms, placebo, or BDP vehicle in a double-blind protocol to 15 atopic asthmatic patients and ten nonatopic subjects. No difference was found between the groups of the baseline number of T-cells with T4, T8, M1, and Ia antigens, nor the ratio of T4+ (helper) to T8+ (suppressor) cells. Five hours after administration of BDP aerosol, BDP vehicle, and oral placebo, there was no change of these values in either the atopic or in the nonatopic group. In contrast, P, 20 and 60 mg, caused a fall of T4/T8 ratio in the atopic, but not in the nonatopic population. Atopic asthma is not associated with baseline imbalances of peripheral blood T-cell subsets, but is associated with an abnormal response to systemic, but not inhaled corticosteroid.

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Female; Humans; Hypersensitivity, Immediate; Leukocyte Count; Male; Prednisone; T-Lymphocytes

1985
Effect of beclomethasone dipropionate on bronchial responsiveness to histamine in controlled nonsteroid-dependent asthma.
    The Journal of allergy and clinical immunology, 1985, Volume: 75, Issue:1 Pt 1

    We investigated the possibility that corticosteroids can reduce bronchial responsiveness to histamine by mechanisms other than change in airway caliber. Ten adult asthmatic subjects were selected because their symptoms were controlled by bronchodilators alone, they had no recent respiratory infection or allergen exposure that might have temporarily altered responsiveness, their spirometry was more than 70% predicted, and they had a range of histamine bronchial hyperresponsiveness. They received, in random order and double-blind manner, beclomethasone dipropionate (400 micrograms daily) or placebo for 4 wk and then, after a 2-week washout period, they crossed over to the other treatment for 4 wk. Treatment with beclomethasone induced a small but significant reduction in bronchial responsiveness to histamine (p = 0.014). Although the improvement was too small to be considered of clinical significance, its importance lies in the mechanisms by which it was produced. Part of the improvement was related to improvement in airway caliber, but, even when the data was adjusted for this, there was still a significant difference between beclomethasone and placebo treatment (p = 0.018). The results suggest that regular treatment with corticosteroids can alter bronchial responsiveness through mechanisms other than change in airway caliber.

    Topics: Adult; Analysis of Variance; Asthma; Beclomethasone; Bronchi; Clinical Trials as Topic; Female; Forced Expiratory Volume; Histamine; Humans; Male; Patient Compliance

1985
Once daily inhalation of budesonide in the treatment of chronic asthma: a clinical comparison.
    Annals of allergy, 1985, Volume: 55, Issue:1

    In a short-term, open cross-over clinical efficacy study, inhalation of budesonide 800 micrograms once daily was compared to inhalation of budesonide 400 micrograms twice daily and beclomethasone dipropionate 200 micrograms four times daily in 20 patients with stable steroid-dependent chronic asthma. Budesonide was inhaled through a spacer tube. The drugs were given in 3-week periods. Clinical symptoms, consumption of beta 2-agonists and peak flow were measured. In all but one patient, the reduced frequency of budesonide inhalations to only once daily has not given significantly different results compared with more frequent inhalations.

    Topics: Administration, Intranasal; Asthma; Beclomethasone; Budesonide; Chronic Disease; Clinical Trials as Topic; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Middle Aged; Pregnenediones; Random Allocation

1985
Comparison of budesonide and beclomethasone dipropionate in patients with severe chronic asthma: assessment of relative prednisolone-sparing effects.
    British journal of diseases of the chest, 1985, Volume: 79, Issue:3

    The relative prednisolone-sparing effects of inhaled budesonide 400 micrograms daily and beclomethasone dipropionate (BDP) 400 micrograms daily were compared in a double-blind crossover study of 26 patients with chronic asthma requiring treatment with BDP and oral prednisolone in a daily dose of 5 mg or greater. During each period of the trial budesonide and BDP were inhaled via conventional pressurized inhalers in a dose of 100 micrograms four times daily. Prednisolone was reduced by 1 mg per month from the patient's normal maintenance dose to zero or to the point at which asthmatic symptoms became unacceptable. The mean reduction in prednisolone dose during BDP treatment was 2.65 mg compared with 1.8 mg at the end of the budesonide period. The difference between the prednisolone-sparing properties of BDP and budesonide assessed in this way in this group of patients was statistically significant in favour of BDP. The mean minimum prednisolone doses at the end of the treatment periods were 3.46 mg for BDP and 4.3 mg for budesonide. Since inhaled steroids were not withdrawn the absolute prednisolone-sparing properties of the two drugs were not assessed, and thus a pharmacological potency ratio cannot be derived from the results. It is concluded that BDP is marginally more potent than budesonide in its prednisolone-sparing properties.

    Topics: Adult; Aged; Asthma; Beclomethasone; Budesonide; Clinical Trials as Topic; Double-Blind Method; Humans; Middle Aged; Prednisolone; Pregnenediones; Random Allocation

1985
Twice or four times daily beclomethasone dipropionate in mild stable asthma?
    Clinical allergy, 1985, Volume: 15, Issue:4

    A double-blind cross-over study lasting 16 weeks was conducted to establish if a twice daily regimen of beclomethasone dipropionate (BDP) was as effective in controlling asthma as a four times daily regimen. The patient's need for inhaled steroids (100 mcg BDP qds) was confirmed prior to entering the study by deterioration of peak expiratory flow rates and/or increased bronchodilator usage during a single-blind placebo period of 6 weeks. Thirty six asthmatics were eligible to enter the study and completed both treatment periods. Daily record cards of symptom scores, four times daily peak expiratory flow rate measurements and inhaled bronchodilator usage were recorded throughout the study. There was no significant difference between the mean PEFR measurements taken four times each day and the variability in PEFR, between the two treatment groups. Symptom scores for cough, wheeze, breathlessness and overall disability also showed no significant difference. Symptomatic inhaler usage for the two groups was similar. Lung function measurements of FEV1, FVC and VC were almost identical; FEV1 being 2.1 l on twice daily regimen and 2.2 l on four times daily regimen. A slight variation was observed in PEFR taken at the end of each treatment period at the clinic visits, being 361 l/min on twice daily and 380 l/min on four times daily drug dosage. In stable asthmatics, the control of asthma measured both symptomatically and by daily lung function was independent of dosing schedule, but twice daily treatment may well lead to better compliance.

    Topics: Adult; Aerosols; Aged; Asthma; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Peak Expiratory Flow Rate

1985
Inhalation therapy during acute asthma. The role of a combined steroid and beta-stimulant preparation.
    South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 1985, Sep-14, Volume: 68, Issue:6

    A compound consisting of a beta-stimulant, salbutamol (Ventolin; Allen & Hanburys) (100 micrograms/puff), and a steroid, beclomethasone dipropionate (Becotide; Allen & Hanburys) (50 micrograms/puff), was studied to test the hypothesis that the corticosteroid could enhance the bronchodilator properties of the beta-stimulant during chronic asthma and simulated acute attacks (antigen challenge). Conventional doses (200 micrograms and 100 micrograms of salbutamol and beclomethasone respectively) were compared using a schedule which included a second administration 1 hour later. The results obtained on the baseline bronchial responsiveness of chronic asthmatics and during the delayed asthmatic response (simulated acute asthma) were similar. The compound was as effective as salbutamol alone but not more so. A significantly greater bronchodilator response was recorded in all patients after the second administration of both the compound and salbutamol alone. The practical advantages of having one rather than two inhalers are evident, but the appropriate application of this compound agent, probably in a prophylactic role, must be defined.

    Topics: Acute Disease; Adolescent; Adult; Albuterol; Asthma; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Female; Humans; Lung Volume Measurements; Male; Middle Aged; Random Allocation; Time Factors

1985
A comparison of flunisolide inhaler and beclomethasone dipropionate inhaler in bronchial asthma.
    The Journal of international medical research, 1985, Volume: 13, Issue:5

    Ninety-nine patients, who had never previously taken inhaled steroids were enrolled in a randomized, single-blind, parallel study, the aim of which was to compare the efficacy and safety of flunisolide inhalation, 500 mcg twice daily, with beclomethasone dipropionate inhaler 100 mcg four times daily for the treatment of chronic asthma. The treatment period was for 6 weeks. The patients were examined clinically at entry, week 3 and week 6 and both treatment groups showed a marked improvement in almost all parameters during the course of the study. Flunisolide was statistically significantly superior to beclomethasone dipropionate for wheezing at week 6, coughing at week 6 and chest tightness at weeks 3 and 6. The number of asthma attacks per day decreased significantly more with flunisolide treatment than with beclomethasone dipropionate. The over-all evaluation of efficacy by both doctors and patients also showed flunisolide to be superior to beclomethasone dipropionate. In several other parameters there was a trend shown favouring flunisolide, and beclomethasone dipropionate did not show a superiority over flunisolide in any efficacy parameter. Both drugs were well-tolerated, with unpleasant taste being the most frequent complaint in the flunisolide group. No patient in either group withdrew from the study because of adverse events. In this study, flunisolide inhaler was more effective than beclomethasone dipropionate inhaler for the treatment of chronic asthma exhibited by patients who had never been treated with inhaled steroids.

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Clinical Trials as Topic; Drug Tolerance; Female; Fluocinolone Acetonide; Humans; Male; Middle Aged; Random Allocation

1985
Effect of dosing schedule on efficacy of beclomethasone dipropionate aerosol in chronic asthma.
    The American review of respiratory disease, 1985, Volume: 131, Issue:5

    Fifty-two children 6 to 12 yr of age and 37 young adults 13 to 38 yr of age with moderate to severe extrinsic asthma requiring daily bronchodilators and who had been taking beclomethasone dipropionate (BDP) for at least 3 months were evaluated. All patients received their regular daily medications and BDP, 2 inhalations 4 times a day (q.i.d.) (total dose, 336 micrograms/day), for 2 wk; they were then randomized to receive either BDP or placebo aerosol, 4 inhalations twice a day (b.i.d.), with the same total dose/day as well as their regular medications, for 8 wk. Placebo patients deteriorated significantly by comparison with BDP patients in respiratory symptoms and pulmonary functions. More placebo than BDP patients ended participation in the study prematurely because of increasingly severe symptoms. In the 89 study patients, there were no significant differences in respiratory symptoms or pulmonary function measurements between the b.i.d. and q.i.d. dosage regimens in either pediatric or adult age groups. There were no significant changes in mean morning cortisol levels from baseline measurements to the end of the study period; at that time, all patients had a normal ACTH stimulation test. We conclude that BDP (336 micrograms/day) is as effective and safe for control of asthma symptoms with b.i.d. as with q.i.d. dosage schedules in pediatric and young adult patients.

    Topics: Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Child; Double-Blind Method; Drug Administration Schedule; Humans; Placebos; Respiratory Function Tests

1985
Dose frequency in the treatment of asthmatics with inhaled topical steroids. Comparison between a twice daily and a once daily dosing regimen.
    European journal of respiratory diseases, 1985, Volume: 67, Issue:4

    In 23 stable asthmatic patients sensitivity to inhaled beclomethasone dipropionate (BDP) was demonstrated during single blind gradual tapering off of BDP. After a 2 week stabilization period the patients were randomly allocated to receive either 4 puffs of 50 micrograms BDP twice daily (AM/PM) or 8 puffs of 50 micrograms once daily (AM). After 4 weeks the patients were crossed over. Fifteen patients preferred the twice daily regimen, 5 preferred once daily and 3 had no preference (p less than 0.05). During the once daily dosing regimen a decrease in morning and evening peak expiratory flow (p less than 0.05) and an increase in nighttime and daytime symptom score (p less than 0.05) was found, while the number of inhaled beta 2-agonist doses did not change significantly (p = 0.05). It is concluded that a twice daily regimen controls the asthmatic symptoms significantly better than a once daily regimen.

    Topics: Administration, Topical; Asthma; Beclomethasone; Drug Administration Schedule; Humans; Peak Expiratory Flow Rate; Respiratory Therapy

1985
Aminophylline for morning dips in chronic asthma.
    Lancet (London, England), 1984, Jul-07, Volume: 2, Issue:8393

    Topics: Albuterol; Aminophylline; Asthma; Beclomethasone; Circadian Rhythm; Clinical Trials as Topic; Double-Blind Method; Humans; Prospective Studies

1984
High-dose corticosteroid inhalers for asthma.
    Lancet (London, England), 1984, Sep-08, Volume: 2, Issue:8402

    Topics: Aerosols; Asthma; Beclomethasone; Budesonide; Clinical Trials as Topic; Double-Blind Method; Humans; Male; Middle Aged; Pregnenediones

1984
Nedocromil sodium: a new drug for the management of bronchial asthma.
    Thorax, 1984, Volume: 39, Issue:11

    Nedocromil sodium (FPL 59002) is a pyranoquinoline dicarboxylic acid that has been developed for the management of bronchial asthma. We report the results of a double blind group comparative trial in which the disodium salt of nedocromil delivered by pressurised aerosol and a placebo were compared in the management of patients with a diagnosis of bronchial asthma who entered the double blind period on a minimum dose of beclomethasone dipropionate. In almost all the assessments of clinical activity nedocromil sodium was shown to be more effective than placebo. These include improvements in diary card symptom scores, reduction in concomitant use of a bronchodilator aerosol, and patients' and investigators' assessments of efficacy. Unwanted effects were few and mild. No patients were withdrawn from the trial.

    Topics: Adrenergic beta-Agonists; Adult; Aerosols; Aged; Asthma; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Nedocromil; Quinolines

1984
Assessment of a new combination inhaler containing salbutamol and beclomethasone dipropionate in the management of asthmatic patients.
    South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 1984, May-12, Volume: 65, Issue:19

    Fifteen patients with chronic asthma completed a double-blind cross-over trial during which they were treated with the same daily doses of salbutamol and beclomethasone dipropionate (BDP) from either a combination inhaler or two separate inhalers. Lung function was measured at the end of each treatment period and each patient kept a diary card throughout. Daily assessments of patients' symptoms and additional medication requirements were similar during both treatment periods. Peak expiratory flow rate (PEFR) recordings taken four times a day showed little diurnal variation during both periods. Mean PEFRs for the groups during a period of 2 weeks were similar for both treatments at all times. Overall daily mean PEFRs showed a trend in favour of the combination inhaler. There was a suggestion of greater variability in airway obstruction during the period when the separate inhalers were used, as assessed by the number of occasions that the PEFR was outside the range (overall daily mean +/- 15%). Lung function measurements at the end of each period showed a trend in favour of the combination inhaler which was clinically significant in terms of the forced expiratory volume in the 1st second and forced vital capacity. The combination inhaler provides an alternative in the management of asthma which is at least as effective as treatment with salbutamol and BDP from two separate inhalers.

    Topics: Adolescent; Adult; Albuterol; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Respiratory Therapy

1984
A clinical comparison of aerosol and powder administration of beclomethasone dipropionate in childhood asthma.
    Allergy, 1984, Volume: 39, Issue:5

    Forty children with childhood asthma were conducted through a double-blind cross-over study to compare the effect of 400 micrograms beclomethasone dipropionate administered as aerosol and powder (Rotacaps). Children with severe asthma derived more benefit from the steroid administered as aerosol judged from their peak flow performance in the morning, although neither evening peak flow nor symptom scores revealed any difference. It is concluded that the Rotacaps are an advantageous supplement to available medication for the treatment of asthmatic children, although it should be observed that, using equal amounts of BDP, powder administration seems less effective than aerosol.

    Topics: Adolescent; Aerosols; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Double-Blind Method; Humans; Powders

1984
Comparison of a new corticosteroid aerosol, budesonide, with beclomethasone dipropionate in the treatment of chronic asthma.
    Irish medical journal, 1984, Volume: 77, Issue:8

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Budesonide; Chronic Disease; Clinical Trials as Topic; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Pregnenediones

1984
Failure of once daily inhaled corticosteroid treatment to control chronic asthma.
    Thorax, 1984, Volume: 39, Issue:12

    Twelve patients with chronic asthma received either high dose beclomethasone once a day or standard doses of beclomethasone three times a day in a double blind crossover trial to determine whether inhalation once a day would be sufficient. With the once a day regimen peak expiratory flow rates fell significantly, symptoms of nocturnal asthma increased, and two patients withdrew from the study because of worsening asthma. Whether control can be achieved with steroids inhaled once a day by simply increasing the total daily dose remains to be seen.

    Topics: Adult; Aerosols; Aged; Asthma; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Humans; Middle Aged; Peak Expiratory Flow Rate

1984
Disodium cromoglycate compared with beclomethasone dipropionate in juvenile asthma.
    Clinical allergy, 1984, Volume: 14, Issue:6

    In a double-blind controlled crossover trial of inhaled disodium cromoglycate and beclomethasone dipropionate in juvenile asthma, beclomethasone produced higher therapeutic scores but significantly so in only two indices--wheeze-free days and morning peak flow rates. Combined treatment offered no advantage over beclomethasone alone. No side-effects were noted. The findings confirm other studies of cromoglycate and a steroid aerosol (betamethasone 17-valerate) but disagree with the only other comparative trial of cromoglycate and beclomethasone, in which both were found equally effective.

    Topics: Adolescent; Asthma; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Cromolyn Sodium; Double-Blind Method; Female; Humans; Male

1984
Effect of aminophylline when added to metaproterenol sulfate and beclomethasone dipropionate aerosol.
    The Journal of allergy and clinical immunology, 1984, Volume: 73, Issue:2

    Twenty-one patients with frequently recurrent severe asthma were treated for 2 wk with placebo capsules and metaproterenol sulfate aerosol therapy followed by beclomethasone dipropionate aerosol therapy sequentially inhaled every 4 to 6 hr and for 2 wk with the same aerosols and aminophylline therapy added. Treatment was double-blind, and the therapy regimens were administered in a random sequence. Patients measured their PEFR at home before and after aerosol inhalation three times a day. The mean PEFRs before inhalation of aerosol were significantly higher when patients were receiving aminophylline therapy. In 86% of the patients, the mean PEFR that was measured after inhalation of metaproterenol sulfate was 11% greater when they were also receiving aminophylline therapy, but this difference was not significant. In 14% of the patients, however, postaerosol inhalation PEFRs were significantly higher (50% to 80%) after aminophylline therapy was added to aerosol therapy. PEFRs were always lowest in the early morning, regardless of the therapy administered. Therapy regimens that contained aminophylline were associated with less dyspnea but produced more adverse side effects and were more costly. Thus in most patients the favorable effect that aminophylline therapy produced by raising baseline PEFRs and attenuating dyspnea should be balanced against the adverse effects this medication also produced, since in most patients aminophylline therapy did not significantly enhance postinhalation PEFRs.

    Topics: Aerosols; Aminophylline; Asthma; Beclomethasone; Drug Combinations; Female; Humans; Intubation, Intratracheal; Male; Metaproterenol; Middle Aged; Peak Expiratory Flow Rate

1984
[Use of bekotid in the treatment of bronchial asthma].
    Sovetskaia meditsina, 1983, Issue:2

    Topics: Aerosols; Asthma; Beclomethasone; Clinical Trials as Topic; Humans; Hydroxycorticosteroids

1983
Effect of a timed interval between inhalation of beta-agonist and corticosteroid aerosols on the control of chronic asthma.
    Thorax, 1983, Volume: 38, Issue:5

    A randomised double-blind crossover study was undertaken in 25 patients with variable airflow obstruction to assess the benefit of separating the inhalation of beta-agonist aerosols and corticosteroid aerosols by a timed interval of more than five minutes. Twenty-two patients (11 men and 11 women) completed 12 weeks of study; they inhaled 200 micrograms salbutamol followed either immediately or after a timed interval by 100 micrograms beclomethasone dipropionate two to four times daily. Morning and evening peak expiratory flow rates, symptom scores, additional beta-agonist inhaler usage, and subjective responses on a visual-analogue scale were recorded throughout. Results from the two last four-week periods, with and without the interval between drugs, were analysed. No differences were found. It is concluded that the theoretical benefit of delaying corticosteroid inhalation until optimum bronchodilatation has been achieved with a beta-agonist is not demonstrable in outpatient practice.

    Topics: Adolescent; Adult; Aerosols; Aged; Albuterol; Asthma; Beclomethasone; Chronic Disease; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Random Allocation; Time Factors

1983
Chamber assisted inhalant treatment (CAIR).
    Annals of allergy, 1983, Volume: 51, Issue:3

    An inhalation therapy device which facilitates the use of hand-held inhaler delivered medications in infants and children has been employed on a trial basis with 17 severe asthmatic children. Using patients as their own control, the dependence on medications, office hospital and emergency room facilities before and after administration of therapy with CAIR chamber was compared. An approximate 50% improvement was noted in all parameters studied. Most notably, hospitalizations were decreased by 94% over a study period which represented 104 months of cumulative observation.

    Topics: Albuterol; Asthma; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Humans; Infant; Prednisone; Respiratory Therapy

1983
[Effect of treatment with ventolin and becotide on ventilation and hemodynamics in patients with bronchial asthma].
    Klinicheskaia meditsina, 1983, Volume: 61, Issue:12

    Topics: Aerosols; Albuterol; Asthma; Beclomethasone; Clinical Trials as Topic; Drug Therapy, Combination; Hemodynamics; Humans; Respiration

1983
Deep-inspiration induced bronchoconstriction: a mechanism for beclomethasone aerosol intolerance.
    European journal of respiratory diseases, 1983, Volume: 64, Issue:7

    We studied 17 asthmatic patients complaining of coughing attacks, with or without asthma, when inhaling beclomethasone dipropionate aerosol (Becotide). Specific airway resistance (SRaw) was measured immediately after a maximal inspiration (MI) and after Becotide inhalation. The effect of a second inhalation of Becotide was measured 10 min after inhalation of salbutamol. MI and Becotide induced large, but transient, SRaw increases in all patients; in addition, the latter induced coughing reactions. After salbutamol pretreatment, Becotide inhalation did not increase SRaw but coughing usually persisted. In 6 patients only, the increase in SRaw after Becotide was larger than that observed after MI. In those patients, placebo and Aldecine (similar to Becotide except for the metering valve) aerosols induced SRaw increases similar to that observed after Becotide. These data suggest that Becotide-induced bronchoconstriction is mainly related to the deep breath required for the inhalation. Non-specific irritation of the airways was probably responsible for the additional bronchoconstriction noticed in some patients.

    Topics: Aerosols; Airway Resistance; Albuterol; Asthma; Beclomethasone; Bronchial Spasm; Cough; Humans; Premedication

1983
Asthma treatment with a new corticosteroid aerosol, budesonide, administered twice daily by spacer inhaler.
    Archives of disease in childhood, 1982, Volume: 57, Issue:11

    Topics: Administration, Topical; Adolescent; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Child; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Pregnenediones; Respiratory Function Tests

1982
Double-blind trials of inhaled beclomethasone diproprionate and fluocortin butyl ester in allergen-induced immediate and late asthmatic reactions.
    Clinical allergy, 1982, Volume: 12, Issue:6

    The blocking effects of inhaled beclomethasone dipropionate (BDP) and fluocortin butyl ester (FCB) on the immediate and late asthmatic reactions induced by inhaled allergen were studied in two trials. In the first, a double-blind cross-over trial compared BDP (800 micrograms daily as powder) with FCB 8 mg daily (1:20 by wt.-Formulation 1). The second trial was identical in design and compared FCB 8 mg daily (1:20) with FCB 8 mg daily as Formulation 2 (1:40). Known BDP, 400 micrograms daily by pressurized aerosol was studied at the end of the second trial. Allergen provocation was performed before and after 7 days treatment with each drug, with a 2-week interval between each drug. Overall, a blocking index for the immediate reaction of greater than 50% was obtained in ten of twenty patients (50%) using BDP, and five of twenty-one (25%) using FCB (P less than 0.01). The late reaction was blocked in nine of eleven (82%) instances on BDP, and four of fourteen (33%) on FCB. Contrary to earlier reports, inhaled corticosteroid agents used for several days prior to bronchial challenge, were found to block both the immediate as well as the late reaction in many individuals.

    Topics: Administration, Intranasal; Allergens; Asthma; Beclomethasone; Bronchial Provocation Tests; Clinical Trials as Topic; Double-Blind Method; Fluocortolone; Forced Expiratory Volume; Humans; Hypersensitivity, Delayed; Hypersensitivity, Immediate

1982
[Corticosteroids (drug evaluation of corticosteroids)].
    Nihon Kyobu Shikkan Gakkai zasshi, 1982, Volume: 20, Issue:11

    Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aged; Asthma; Beclomethasone; Clinical Trials as Topic; Humans; Middle Aged

1982
Evaluation of FCB, BDP, and DSCG in allergen inhalation challenge test.
    International journal of clinical pharmacology, therapy, and toxicology, 1982, Volume: 20, Issue:12

    The protective effect of a new inhaled steroid, fluocortin butyl (FCB), was compared to that of disodium cromoglycate (DSCG) and beclomethasone dipropionate (BDP) in patients with extrinsic asthma by means of the allergen-inhalation challenge test. Three different groups of 12 patients each participated in the study. One group was treated with FCB and BDP, the two others with FCB and DSCG, all in a randomized crossover study plan. After an initial allergen challenge (FEV1 fall greater than 15%), the patients were allocated to either treatment for 7-10 days. A second challenge test was then carried out, followed by a washout period of 4 days. The treatments were then crossed-over, and a third allergen challenge was carried out at the end of the second treatment period. With BDP 5 of 12 patients were protected; with FCB, 6 of 12 in two groups and 8 of 12 patients in a third group. With DSCG 3 of 12 patients were protected in the group in which the last medication was given 12 h before challenge, and 8 of 12 patients in the second group in which medication was given 1-2 h before challenge. In the same groups on FCB no such time-dependent effect was observed. No statistically significant differences were found between either FCB and BDP, or FCB and DSCG in either group.

    Topics: Allergens; Asthma; Beclomethasone; Cromolyn Sodium; Drug Evaluation; Fluocortolone; Forced Expiratory Volume; Humans; Time Factors

1982
The effect of powder aerosol compared to pressurized aerosol.
    European journal of respiratory diseases. Supplement, 1982, Volume: 119

    A comparison was performed between inhalation of salbutamol as a powder aerosol or as a pressurized aerosol. Seven intrinsic asthmatics, well-trained in inhalation technique, were studied in an open randomized crossover comparison of the two different modes of administration. Five doses were inhaled of salbutamol from the pressurized aerosol, 0.1-2.4 mg, and five doses as a powder aerosol from a Rotahaler, 0.2-4.8 mg. The FEV1 dose-response curves were almost identical indicating bronchodilating equipotency between the two modes of administration. A preliminary report is given of the effects on morning cortisol of inhalation of beclomethasone dipropionate as a powder aerosol or as a pressurized aerosol in 10 healthy volunteers trained in inhalation technique. Morning cortisol decreased to the same degree after both modes of administration and the decrease was dose-dependent when beclomethasone dipropionate was given in the doses 200 micrograms, 500 micrograms and 1000 micrograms q.i.d. Thus, in patients with a good inhalation technique the powder aerosol does not seem to be better than the pressurized aerosol. We think, however, that it could be offered as an alternative to patients with poor inhalation technique.

    Topics: Aerosols; Albuterol; Asthma; Beclomethasone; Humans; Powders; Pressure; Random Allocation; Respiratory Therapy

1982
Dose frequency in the treatment of asthmatics with inhaled topical steroid.
    European journal of respiratory diseases. Supplement, 1982, Volume: 122

    Twenty-nine patients treated with beclomethasone dipropionate (BDP) because of asthma were tapered off BDP stepwise at 3 weeks intervals in a single blind manner. Every day the patients recorded morning and evening peak expiratory flow, symptom scores for night and day and their consumption of medicine. Evening peak flow was the most sensitive variable to detect a deterioration in the asthmatic condition. In 7 patients no significant change in asthma symptoms occurred. The remaining 22 patients then participated in a randomized double-blind trial comparing their daily dose of BDP given as 4 divided doses or as 2 doses. No significant difference was found between these two regimens.

    Topics: Adult; Aged; Asthma; Beclomethasone; Female; Humans; Male; Middle Aged; Respiratory Therapy

1982
Comparison of twice daily administration of a new corticosteroid budesonide with beclomethasone dipropionate four times daily in the treatment of chronic asthma.
    British journal of diseases of the chest, 1982, Volume: 76, Issue:1

    The efficacy and side-effects of a new corticosteroid aerosol, budesonide and beclomethasone dipropionate were assessed in 30 patients with chronic asthma in a double-blind cross-over study. Budesonide was administered, 200 micrograms twice daily, from a conventional pressurized aerosol with a tube spacer extension attached and beclomethasone was given via a conventional inhaler in the recommended four times daily dose of 100 micrograms, each treatment being administered for one month. No clinically significant differences were found between the two treatments and no significant side-effects were observed.

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Budesonide; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Middle Aged; Pregnenediones

1982
Efficacy of safety of concurrent use of intranasal flunisolide and oral beclomethasone aerosols in treatment of asthmatics with rhinitis.
    Clinical allergy, 1982, Volume: 12, Issue:1

    Steroid-dependent, chronic asthmatic patients with severe rhinitis or nasal polyps are often candidates for treatment with intranasal topical corticosteroids, such as flunisolide. The possibility of additive adrenal suppression, when flunisolide, beclomethasone and prednisone are given together, has not previously been studied. The need to asses the risk is suggested by reports of additive adrenal suppression when aerosol and oral steroids are used together to treat asthma, and by the demonstrably higher systemic availability of aerosol steroid given intranasally rather than via the lung. We performed a double-blind, placebo-controlled crossover assessment of the efficacy and safety of 3 weeks of intranasal flunisolide spray treatment (300 micrograms/day) in nineteen steroid-dependent chronic asthmatic subjects, who also had nasal polyps or severe rhinitis. During the study, their doses of prednisone and beclomethasone, used for asthma, were held stable. Morning serum cortisol levels and 24-hr urinary-free cortisol excretion were essentially the same after the placebo, and the flunisolide treatments. The intranasal flunisolide improved their nasal symptoms significantly (P less than 0.05). Local complications were negligible. Given conventional steroid doses like those used in this study, there appears to be no important risk to endogenous adrenal function from combining the use of intranasal, flunisolide spray with administration of other steroids by other routes, when this is deemed clinically necessary. If higher doses are used, the possibility of some additive adrenal suppressive effect cannot be excluded.

    Topics: Administration, Intranasal; Administration, Oral; Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Drug Therapy, Combination; Female; Fluocinolone Acetonide; Humans; Hydrocortisone; Male; Middle Aged; Nasal Polyps; Prednisone; Rhinitis, Allergic, Perennial

1982
The use of cultures and immunologic procedures to predict oropharyngeal candidiasis in patients on steroid aerosols.
    Clinical allergy, 1982, Volume: 12, Issue:3

    Sixty-seven asthmatic individuals treated with either beclomethasone diproprionate or flunisolide were sequentially evaluated for up to 32 months to determine the incidence of oropharyngeal candidiasis as well as laboratory parameters which might be predictive of this complication. Throat cultures and measurements of Candida antibody by immunodiffusion and radioimmunoassay were performed and compared over time and treatment groups. Unlike other studies, pre-treatment Candida precipitins did not predict increased risk for clinical thrush nor did quantitative determinations of Candida antibody. Those patients with positive cultures pre-trial, however, had a significantly higher incidence of clinical thrush than those with negative cultures (P less than 0.01). No significant changes occurred over time or between drugs for any of the parameters. Symptomatic thrush, however, was slightly more common in those patients treated with beclomethasone.

    Topics: Adolescent; Adult; Aerosols; Aged; Antibodies, Fungal; Asthma; Beclomethasone; Binding Sites, Antibody; Candida; Candidiasis, Oral; Female; Fluocinolone Acetonide; Humans; Male; Middle Aged; Nystatin; Risk

1982
A clinical trial of combined cromolyn/beclomethasone treatment for chronic asthma.
    The Journal of allergy and clinical immunology, 1981, Volume: 67, Issue:4

    Some patients with chronic asthma treated with beclomethasone aerosol (BA) derive significant symptom benefit, yet have persisting adrenal suppression due in part to their BA therapy. The daily dose of BA required is higher in patients with atopy. We therefore assessed the usefulness of ancillary treatment with cromolyn sodium (CS), a drug known to inhibit atopic asthma, to try to improve the balance of risk vs benefit in such patients. Thirty asthmatics, well controlled on high-dose BA (mean, 1,040 micrograms +/- 97 SE) but with morning cortisol levels averaging approximately 10 micrograms/dl, were allocated randomly to placebo or CS inhalant, used in addition to their regular BA and other asthma medications. After 4 wk, their BA dose was halved. Both groups were monitored for greater than 6 mo by daily symptom diaries and peak flows, and by spirograms and morning serum cortisol tests every 4 wk. Mean cortisol levels rose 27% after BA dose reduction (p less than 0.05) but asthma worsened. Risk-benefit assessments 20 wk after reducing the BA showed a general tendency for higher cortisol values to be coupled with worsening of the asthma symptoms and FEF25%-75%. The distributions of good, fair, and poor risk-benefit responses were the same in both CS and placebo-treated groups (p = 0.20). In other asthmatics who may have less associated bronchitis or small airways obstruction than these patients, CS might prove useful, but in these adult chronic asthmatics with this particular therapeutic problem, there was no discernible BA-sparing effect or other clinical advantage from adding CS to their established BA regimen.

    Topics: Aerosols; Asthma; Beclomethasone; Chronic Disease; Clinical Trials as Topic; Cromolyn Sodium; Drug Combinations; Humans

1981
The value of maintenance theophylline in steroid-dependent asthma.
    The New England journal of medicine, 1981, Jan-08, Volume: 304, Issue:2

    We examined the value of maintenance theophylline at serum concentrations of 10 to 20 micrograms per milliliter in a placebo-controlled, randomized, double-blind trial of 33 children with steroid-dependent chronic asthma. Patients were free of all symptoms 63 +/- 6 per cent of the days (mean +/- S.E.M.) when taking theophylline as compared with 42 +/- 6 per cent when taking placebo (P < 0.01). Inhaled metaproterenol was required twice as often with placebo (P < 0.01), and additional daily corticosteroids were needed more than three times as often with placebo (P = 0.02). Daily peak flow measurements improved with theophylline (P < 0.01) as did monthly spirometric measurements and residual volume measured by plethysmography. Theophylline was associated with a 50 per cent increase in the number of patients able to complete an exercise test (P = 0.01) and with a smaller decrease in forced expiratory volume in one second among patients completing the exercise (P < 0.02). We conclude that maintenance bronchodilator therapy with theophylline can provide clinically important benefit for patients with chronic steroid-dependent asthma.

    Topics: Adolescent; Adult; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Double-Blind Method; Forced Expiratory Flow Rates; Humans; Metaproterenol; Peak Expiratory Flow Rate; Physical Exertion; Placebos; Prednisone; Random Allocation; Spirometry; Theophylline

1981
How important is the sequence of administration of inhaled beclomethasone dipropionate and salbutamol in asthma.
    British journal of diseases of the chest, 1981, Volume: 75, Issue:3

    Sixty patients with fairly stable asthma of mild or moderate severity entered a multicentre, double-blind cross-over trial, comparing the efficacy of inhaled beclomethasone dipropionate preceded 10 minutes earlier by inhalation of salbutamol with that of beclomethasone followed 10 minutes later by salbutamol during two consecutive three-month periods. Patients received beclomethasone 100 microgram and salbutamol 200 microgram four times daily. Analysis of occurrence of exacerbations, usage of additional inhaled salbutamol, peak expiratory flow rate and symptom scores showed no evidence that regular beclomethasone was more effective when preceded by salbutamol rather than when followed by it.

    Topics: Adult; Aerosols; Aged; Albuterol; Asthma; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged

1981
Concurrent administration of flunisolide nasal solution with beclomethasone dipropionate bronchial aerosol in patients with both rhinitis and asthma.
    Annals of allergy, 1981, Volume: 47, Issue:5 Pt 1

    Twenty patients with asthma controlled by oral inhalations of beclomethasone dipropionate (400 micrograms/day) were treated for concurrent rhinitis by the addition of flunisolide nasal solution (300 micrograms/day) and its placebo for three weeks each in a randomized, double-blind, crossover trial. Flunisolide produced a statistically significant benefit for each symptom parameter: sneezing (p = 0.013), runny nose (p = 0.027), stuffy nose (p = 0.005 and over-all severity (p = 0.005). More concomitant rhinitis medication was used during placebo treatment (p = 0.069). Seventy percent of the patients had "total" or "substantial" control of nasal symptoms with flunisolide vs. 45% with placebo (p less than 0.01). Eighty percent felt that flunisolide was either the only active drug or the more active (p less than 0.01). Three morning plasma cortisol determinations during the last week of each treatment period showed no drug-related effect. No nasal cultures were positive for Candida; the incidence of positive pharyngeal; cultures did not vary significantly. Adverse reactions consisted primarily of nasal burning and stinging; none was serious. In this group of twenty patients using inhalations of beclomethasone dipropionate for asthma, accompanying perennial rhinitis was substantially controlled by 300 micrograms of flunisolide nasal solution per day without significant additive effect on plasma cortisol levels or the incidence of overgrowth of Candida.

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Candida albicans; Female; Fluocinolone Acetonide; Humans; Male; Middle Aged; Pharynx; Rhinitis, Allergic, Perennial

1981
Flunisolide intranasal solution combined with intrabronchial steroids in adults with both bronchial asthma and perennial rhinitis.
    Annals of allergy, 1981, Volume: 46, Issue:5

    Because the simultaneous use of more than one form of topical corticosteroid involves higher cumulative doses and, therefore, more potential for absorption, this study was concerned primarily with effect on adrenal function. Seventeen adults whose asthma symptoms had been stable for at least three months on 100-400 microgram/day of beclomethasone dipropionate aerosol received flunisolide intranasal solution (200 microgram/day) combined with its intrabronchial form (1 mg/day) or with beclomethasone dipropionate bronchial aerosol (400 microgram/day). Utilizing a physician-blind, crossover design, each medication combination was administered for one month. Patient and physician evaluations revealed no significant differences in efficacy, adverse effects (complaints) or effect on adrenal function between the two combinations. Thus, the addition of intranasal flunisolide to intrabronchial flunisolide or beclomethasone did not appear to result in significant systemic absorption of corticosteroid above that which might have occurred as a result of the bronchial inhalation of corticosteroid medication alone during the pretrial period.

    Topics: 11-Hydroxycorticosteroids; Administration, Intranasal; Adult; Aerosols; Asthma; Beclomethasone; Female; Fluocinolone Acetonide; Forced Expiratory Volume; Humans; Male; Middle Aged; Rhinitis, Allergic, Perennial; Vital Capacity

1981
Atropine responsiveness in asthma in relation to steroid aerosol therapy.
    British journal of diseases of the chest, 1981, Volume: 75, Issue:4

    Topics: Adult; Aerosols; Asthma; Atropine; Beclomethasone; Bronchial Provocation Tests; Female; Forced Expiratory Volume; Humans; Male; Middle Aged

1981
[Treatment of seasonal asthmatic symptoms. A multicentre trial to compare the effects of ketotifen and disodium cromoglycate (author's transl)].
    MMW, Munchener medizinische Wochenschrift, 1980, Feb-29, Volume: 122, Issue:9

    A randomized multicentre trial was done to investigate the protective effects of ketotifen and disodium cromoglycate (DSCG) in the therapy of bronchial asthma. 236 patients with seasonal asthmatic symptoms were treated and controlled in the summer of 1978. Both drugs showed a significant improvement of the lung function and a marked reduction of asthmatic symptoms, cough and expectoration.

    Topics: Adrenergic beta-Agonists; Asthma; Beclomethasone; Bronchitis; Clinical Trials as Topic; Cromolyn Sodium; Histamine H1 Antagonists; Humans; Ketotifen; Piperidines; Random Allocation; Seasons; Spirometry; Theophylline; Thiophenes

1980
A comparative trial of flunisolide and beclomethasone dipropionate in the treatment of perennial allergic rhinitis.
    Clinical allergy, 1980, Volume: 10, Issue:1

    An open, parallel comparison of flunisolide and beclomethasone dipropionate nasal sprays is described. Sixty patients entered the study of whom fifty-six completed the full 4 weeks' therapy. The dosage of flunisolide was two actuations (25 micrograms/actuation) into each nostril twice a day (total 200 micrograms). The dosage of beclomethasone dipropionate was one actuation (50 micrograms) in each nostril four times a day (total 400 micrograms). Both drugs produced statistically significant improvements compared with admission values in sneezing, stuffiness, runny nose, nose blowing and post-nasal drip. Both drug significantly decreased the interference by symptoms with routine life and sleep. At the end of the trial both treatment groups showed total or good control of symptoms in the majority of patients. No statistically significant difference was shown between the effects of the two drugs. Side-effects did not cause withdrawal from the trial in any patient and were mostly confined to minor headache and nose and throat complaints. In neither treatment group was there any evidence of adrenal suppression or growths of Candida from nasal swabs.

    Topics: Adult; Asthma; Beclomethasone; Clinical Trials as Topic; Female; Fluocinolone Acetonide; Humans; Hydrocortisone; Male; Physician-Patient Relations; Rhinitis, Allergic, Perennial; Skin Tests

1980
[Clinical effects of beclomethasone dipropionate in bronchial asthma].
    Orvosi hetilap, 1980, Apr-20, Volume: 121, Issue:16

    Topics: Adult; Asthma; Beclomethasone; Clinical Trials as Topic; Drug Evaluation; Humans; Middle Aged

1980
Beclomethasone dipropionate aerosol compared with dry powder in the treatment of asthma.
    Clinical allergy, 1980, Volume: 10, Issue:3

    In a double-blind trial, beclomethasone dipropionate inhaled as a dry powder in doses of 200 micrograms three times a day was compared with the conventional aerosol of 100 micrograms three times a day, each for a period of 4 weeks. Neither the dry powder nor the aerosol showed any significant advantage over each other in terms of ventilatory function. Plasma cortisol levels were unaltered with the two medications in spite of the doubled dose of the corticosteroid powder. Choice of one or the other method of administration of medication depended on patient preference and the ease with which he could familiarize himself with either technique.

    Topics: Administration, Intranasal; Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Powders

1980
[Results and prospects of using becotid in bronchial asthma and other allergic diseases].
    Sovetskaia meditsina, 1980, Issue:8

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Bronchitis; Child; Clinical Trials as Topic; Double-Blind Method; Humans; Placebos; Respiratory Hypersensitivity; Rhinitis, Allergic, Seasonal; Time Factors

1980
Beclomethasone dipropionate in asthma: a comparison of two methods of administration.
    British journal of diseases of the chest, 1980, Volume: 74, Issue:2

    Beclomethasone dipropionate inhaled as a dry powder in doses of 200 microgram four times a day was compared with the usual dose of 100 microgram four times a day from a pressurized aerosol in 65 patients with asthma who used pressurized aerosols correctly. Each treatment was given for an eight-week period. The dry powder did not show any clinically significant advantage over the aerosol in terms of ventilatory function as measured by FEV1 and the daily peak flow measurements during both treatments did not differ. The incidence of oral candidiasis was low and no other side-effects were encountered. It was concluded that beclomethasone dipropionate in dry powder form was as effective as aerosol in the treatment of asthma.

    Topics: Administration, Oral; Adult; Aerosols; Aged; Asthma; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Powders; Respiratory Function Tests

1980
Candidiasis and dysphonia complicating beclomethasone treatment of asthma.
    The Journal of allergy and clinical immunology, 1980, Volume: 65, Issue:2

    Topics: Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Candidiasis; Candidiasis, Oral; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Nystatin; Respiratory Tract Infections; Time Factors; Voice Disorders

1980
In vivo comparison of triamcinolone and beclomethasone inhalation delivery systems.
    Annals of allergy, 1980, Volume: 45, Issue:4

    The efficiencies of two metered dose delivery systems designed for oral inhalation of glucocorticoids (triamcinolone acetonide and beclomethasone dipropionate) were compared in an open-labeled, randomized, crossover fashion in 18 asthmatic patients. Measurements were made of the mean amount of glucocorticoid released per actuation at the aerosol valve of each delivery system, the mean amount in a post-dose gargle and saliva specimen and the mean amount that remained in the oral adapter after use of each system. Retention in the oropharyngeal cavity was 7.3% and 40.3% of delivered dose for the triamcinolone acetonide and beclomethasone dipropionate systems (P < 0.001). The amount of glucocorticoid potentially available to the bronchial airways was 92.7% of the delivered dose for the triamcinolone acetonide and 59.7% for the beclomethasone dipropionate system.

    Topics: Administration, Intranasal; Adult; Aerosols; Aged; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Triamcinolone Acetonide

1980
Beclomethasone diproprionate in twice daily treatment of asthma.
    Australian family physician, 1980, Volume: 9, Issue:10

    Beclomethasone dipropionate (BDP) was used in a trial to assess the effectiveness of twice daily compared with four times daily dosage in the control of asthma. Prior to the introduction of BDP all but one of the patients were dependent on oral steroids in addition to other therapeutic regimes for adequate control of their asthma. A cross-over design was used with patients randomly allocated to either a twice daily or four times daily initial BDP regime. The trial continued for thirty-two weeks, with patients changing their dose regime at the end of each eight week period. Maintenance steroids were eliminated in all but two of the patients. According to all the criteria used in assessing control of asthma, there were no significant differences between the two regimes, indicating that both were equally effective. Compliance was better with the twice daily regime, and most patients preferred it.

    Topics: Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Child; Child Development; Eczema; Female; Humans; Male; Middle Aged; Patient Compliance; Rhinitis, Allergic, Seasonal; Statistics as Topic; Steroids

1980
Are steroid inhalers safer than tablets?
    Lancet (London, England), 1979, Apr-14, Volume: 1, Issue:8120

    Topics: Aerosols; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Drug Evaluation; Humans; Tablets

1979
Inhaled steroid aerosols and alternate-day prednisone.
    Lancet (London, England), 1979, Aug-04, Volume: 2, Issue:8136

    Topics: Adrenal Cortex; Aerosols; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Cushing Syndrome; Depression, Chemical; Drug Antagonism; Drug Therapy, Combination; Humans; Prednisone; Stimulation, Chemical

1979
[Pharmacotherapy of asthma and its prospects].
    Polski tygodnik lekarski (Warsaw, Poland : 1960), 1979, Jan-29, Volume: 34, Issue:5

    Topics: Aspirin; Asthma; Beclomethasone; Clinical Trials as Topic; Humans; Sympathomimetics

1979
A clinical comparison of beclomethasone dipropionate delivered by pressurised aerosol and as a powder from a rotahaler.
    Archives of disease in childhood, 1979, Volume: 54, Issue:3

    14 children with severe asthma were studied for 2 months in a double-blind cross-over trial to compare the efficacy of beclomethasone dipropionate delivered as an aerosol and as a powder from a rotahaler. Inhalation via the aerosol was satisfactory in 13 patients, each of whom used the rotahaler correctly. Younger children preferred to use the rotahaler. Comparison of daily symptoms, twice daily peak expiratory flow rate (PEFR), and use of salbutamol during the 2 months of the trial showed that control of asthma was equally good, irrespective of the device used to deliver active beclomethasone.

    Topics: Adolescent; Aerosols; Age Factors; Asthma; Attitude to Health; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Powders

1979
Double-blind trial comparing two dosage schedules of beclomethasone dipropionate aerosol with a placebo in chronic bronchial asthma. Second report of the Brompton Hospital/Medical Research Council Collaborative Trial.
    British journal of diseases of the chest, 1979, Volume: 73, Issue:2

    A follow-up study to 52 weeks is reported on 95 corticosteroid-dependent asthmatics who took part in a double-blind, controlled trial of beclomethasone dipropionate for 28 weeks. During the 28 weeks two dosage schedules (800 microgram and 400 microgram daily) were compared with a placebo. If the corticosteroid tablet dosage had been at least halved and the clinical condition was satisfactory, the allocated regimen was continued 'blind' for the second period (29-52 weeks); 51 patients continued for this period, 46 on beclomethasone dipropionate. If progress was unsatisfactory, known beclomethasone dipropionate 800 microgram daily was substituted, the supervision remaining unchanged, the clinical supervisors remaining unaware which schedule had been received during the first 28 weeks. Nearly all the patients who at least halved their corticosteroid tablet dosage by 28 weeks continued to do well up to 52 weeks on the allocated regimen. When the placebo patients with unsatisfactory progress at 28 weeks were changed to 800 microgram beclomethasone dipropionate they showed a substantial improvement. Patients changed from 400 to 800 microgram showed little improvement on average. Approximately 30% of the whole group of patients failed to have their dosage of corticosteroid tablets, despite receiving 800 microgram beclomethasone dipropionate daily for six or more months. The cumulative incidence of 'oral candidiasis' (as defined for this report) in placebo patients changed at 28 weeks to 800 microgram beclomethasone dipropionate daily was 30% at 36 weeks and 43% at 52 weeks. Of eight patients increased from 400 microgram to 800 microgram daily, one had 'candidiasis' by 36 weeks and three by 52 weeks. Oral candidiasis was often asymptomatic and never led to the discontinuation of the corticosteroid aerosol, although the dosage was reduced in nine of the 30 who received 800 microgram beclomethasone dipropionate during the first 28 weeks. The incidence of bacterial infections in patients on beclomethasone dipropionate was similar to that of the placebo group and systematic laboratory investigations revealed no increase in the rate of isolation of potential pathogens.

    Topics: Adolescent; Aerosols; Asthma; Beclomethasone; Candidiasis, Oral; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Humans; Placebos; Sputum

1979
A comparison of oral choline theophyllinate and beclomethasone in severe perennial asthma in children.
    British journal of diseases of the chest, 1979, Volume: 73, Issue:2

    Fourteen children with perennial asthma previously treated with beclomethasone dipropionate were studied for four months in a crossover trial to compare the efficacy of choline theophyllinate and beclomethasone dipropionate aerosol in the control of their symptoms. Assessments were made using twice daily peak flow measurements, together with daily records of symptom scores and use of extra salbutamol. Beclomethasone and oral choline theophyllinate together improved control of asthma in comparison with beclomethasone alone. Reduction of the dose of beclomethasone from 400 microgram/day caused worsening of asthma. Oral choline theophyllinate did not prevent this deterioration and therefore cannot replace beclomethasone for the long-term treatment of such asthmatic patients.

    Topics: Administration, Oral; Aerosols; Asthma; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Female; Humans; Male; Theophylline

1979
Combined therapy with salbutamol and beclomethasone inhalers in chronic asthma.
    Lancet (London, England), 1978, Jul-08, Volume: 2, Issue:8080

    A double-blind cross-over trial was carried out to compare the effect of identical placebo with that of salbutamol inhalers used 30 min before inhalation of 100 microgram of beclomethasone dipropionate (B.D.P.) in 18 chronic asthmatics over two consecutive 4-week periods. The salbutamol and B.D.P. combination resulted in a significant improvement in the peak expiratory flow-rate and F.E.V.1, significantly less use of the rescue inhaler, and better control.

    Topics: Adult; Aerosols; Aged; Albuterol; Asthma; Beclomethasone; Bronchi; Chronic Disease; Circadian Rhythm; Clinical Trials as Topic; Double-Blind Method; Drug Synergism; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Placebos

1978
Trial of beclomethasone dipropionate aerosol in the treatment of severe chronic asthma.
    The Practitioner, 1978, Volume: 220, Issue:1318

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Clinical Trials as Topic; Drug Evaluation; Humans; Hydrocortisone; Time Factors

1978
Treatment of chronic childhood asthma with beclomethasone dipropionate aerosols: II. Effect on pituitary-adrenal function after substitution for oral corticosteroids.
    Pediatrics, 1978, Volume: 62, Issue:2

    The effects of beclomethasone, dipropionate aerosol (DBA) (400 microgram/day) on clinical course, pulmonary function, and pituitary-adrenal function was studied in 34 steroid-dependent asthmatic children. Asthma severity was assessed by daily symptom and medication scores, peak flow measured three times a day, and weekly spirometry. Pituitary-adrenal function was evaluated by diurnal cortisol levels, cortisol responses to intravenous (IV) corticotropin (ACTH), and steroid responses to IV metyrapone. After 12 weeks of BDA therapy, 30 of 34 patients no longer required prednisone. Mean weekly symptom and medication scores and the number of attacks decreased significantly (P less than .01)). A significant improvement was demonstrated in the patients' peak flow (P less than .01), forced expiratory volume in one second, and maximum midexpiratory flow rates (P less than .01). Thirty of the 34 patients initially had abnormal metyrapone responses, 28 had abnormal diurnal cortisol levels, whereas only 14 had abnormal IV ACTH response tests. Although significant improvement was noted in the mean metyrapone and diurnal cortisol tests, only partial recovery of pituitary-adrenal function was observed in 20 patients, complete recovery in 5, and no change in 9. BDA was found to be therapeutically superior to oral steroids in the group of steroid-dependent asthmatic children and produced no serious adverse effects.

    Topics: Administration, Oral; Adolescent; Adrenal Glands; Adult; Aerosols; Asthma; Beclomethasone; Child; Child, Preschool; Chronic Disease; Clinical Trials as Topic; Drug Evaluation; Female; Humans; Lung; Male; Pituitary Gland; Pituitary-Adrenal Function Tests; Prednisone

1978
Beclomethasone dipropionate dry-powder inhalation compared with conventional aerosol in chronic asthma.
    British medical journal, 1978, Sep-02, Volume: 2, Issue:6138

    In a double-blind study beclomethasone dipropionate inhaled as a dry powder in doses of 100 microgram four times daily and 150 microgram four times daily was compared with the conventional aerosol dose of 100 microgram four times daily in 20 outpatients with chronic asthma. Each of the three treatments was given for four weeks. The dry powder in a dose of 150 microgram four times daily had advantages over the other two treatments in terms of FEV1 and the number of exacerbations of asthma during the study. There were no adverse reactions to inhaling dry-powder beclomethasone. It was concluded that this new way of administering the drug was effective in chronic asthma, and should allow most patients with chronic asthma who cannot use conventional pressurised aerosols efficiently to benefit from inhaled corticosteroid treatment.

    Topics: Adult; Aerosols; Aged; Asthma; Beclomethasone; Chronic Disease; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Powders; Respiratory Function Tests; Respiratory Therapy

1978
Effects of inhaled beclomethasone dipropionate and alternate-day prednisone on pituitary-adrenal function in children with chronic asthma.
    The New England journal of medicine, 1978, Dec-21, Volume: 299, Issue:25

    Two corticosteroid regimens, alternate-day prednisone and inhaled beclomethasone dipropionate, have been more acceptable than daily oral corticosteroids for treatment of chronic asthma. To compare the effect of these regimens on hypothalamic-pituitary-adrenal function, 20 children with asthma were evaluated while receiving 20 to 40 mg of prednisone on alternate mornings or 400 to 800 microgram per day of inhaled beclomethasone dipropionate in divided daily doses; seven children requiring only non-corticosteroid medication served as controls. Early-morning serum cortisol concentration, urinary free-cortisol excretion and the 11-desoxycortisol response to metyrapone were decreased to a similar degree among children receiving both corticosteroid regimens in comparison with the control patients and were lowest when alternate-day prednisone and inhaled beclomethasone dipropionate were given together. Thus, inhaled beclomethasone dipropionate appears similar to alternate-day prednisone in its effect on hypothalamic-pituitary-adrenal function when used alone; the effect is additive when the two are used together.

    Topics: Administration, Oral; Adolescent; Aerosols; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Desoxycorticosterone; Drug Administration Schedule; Drug Therapy, Combination; Humans; Hydrocortisone; Metyrapone; Pituitary-Adrenal System; Prednisone

1978
Steroid-dependent asthma treated with inhaled beclomethasone dipropionate in children.
    Annals of allergy, 1978, Volume: 41, Issue:5

    The efficacy of beclomethasone diproprionate aerosal (BDA) was studied in 27 steroid-dependent asthmatic children. In the double-blind portion of the study BDA was found to be superior to placebo. The benefits of BDA therapy were sustained through the two-year, open-label portion of the study. Adverse effects were few and minor. Transfer from oral corticosteroid therapy to BDA was carried out uneventfully and was not associated with untoward effects.

    Topics: Adolescent; Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Female; Humans; Male

1978
Long-term effects of beclomethasone dipropionate on prednisone dosage in the corticosteroid-dependent asthmatic.
    The Journal of allergy and clinical immunology, 1978, Volume: 62, Issue:2

    The average prednisone dosage of 54 corticosteroid-dependent asthmatics was computed for one year prior to initiation of beclomethasone dipropionate. This was compared to the average prednisone dosage after nine months on the beclomethasone with progressive tapering of prednisone to either dose compatible with control of asthma or discontinuation. Beclomethasone was found clinically useful in the great majority of these patients because it permitted a significant decrease in dosage of prednisone, a change from daily to alternate-day prednisone, or discontinuation of prednisone after cautious tapering. The first two advantages were most evident in those asthmatics who initially required higher doses of oral steroids while the latter was evident in those requiring lower doses. Those patients whose prednisone dosage does not appear to be beneficially affected by the use of beclomethasone should be suspect as to adherence to proper medical dosage schedule.

    Topics: Administration, Oral; Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Patient Compliance; Prednisone; Retrospective Studies; Time Factors

1978
A clinical comparison of aerosol and powder administration of beclomethasone dipropionate in asthma.
    Clinical allergy, 1978, Volume: 8, Issue:5

    A clinical comparison of conventional aerosol administration of beclomethasone dipropionate and insufflation as a powder using the "Rotahaler" device in four doses of 100 microgram each was made in thirty-seven cases. Each treatment was given for 4 weeks, the order being randomized. Symptom records, twice daily peak flow readings and records of bronchodilator and steroid dosage showed the powder to be as effective as the aerosol. In the physician's opinion the powder was preferable to the aerosol in some cases.

    Topics: Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Child; Female; Humans; Male; Peak Expiratory Flow Rate; Powders

1978
Intranasal beclomethasone.
    British medical journal, 1977, Feb-05, Volume: 1, Issue:6057

    Topics: Administration, Intranasal; Asthma; Beclomethasone; Clinical Trials as Topic; Humans; Rhinitis, Allergic, Seasonal

1977
A graded dose assessment of the efficacy of beclomethasone dipropionate aerosol for severe chronic asthma.
    The Journal of allergy and clinical immunology, 1977, Volume: 59, Issue:4

    In a 26-wk double-blind controlled study of 34 patients whose asthma had been poorly controlled despite oral steroids, valuable clinical and pulmonary function improvement was derived by adding beclomethasone aerosol to the prednisone regimen. The amount of improvement correlated linearly with beclomethasone dosage over the range 200 to 1,600 microng/day. These patients required relatively high dosage. Success in achieving asymptomatic status was only 26% with the conventional 400 microng/day and 60% at 1,600 microng/day. Oropharyngeal candidiasis was also dose-related but did not prohibit the use of high-dosage beclomethasone. Respiratory infections, physical signs, blood glucose, and electrolytes were unaffected by the drug. A dose-related suppression of cortisol secretion was demonstrated, but about 1/4 of the group had normal plasma cortisol even at 1,600 microng/day plus the oral prednisone. An individualized risk-benefit assessment seems a better basis for choosing an optimal beclomethasone regimen for each patient than adherence to a conventionalized fixed dosage of 400 microng/day. This requires definition of: (1) a specific goal of treatment in the individual patient and the beclomethasone dosage required to achieve it; (2) the adrenocortical functional response of that particular patient to the desired dose of beclomethasone; and (3) the presence and degree of any dose-limiting constraints such as preexisting complications of steroid use.

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Candidiasis, Oral; Chronic Disease; Clinical Trials as Topic; Dose-Response Relationship, Drug; Drug Therapy, Combination; Eosinophils; Female; Humans; Hydrocortisone; Leukocyte Count; Male; Middle Aged; Prednisone

1977
Steroid-dependent asthma treated with inhaled beclomethasone dipropionate. A long-term study.
    Annals of internal medicine, 1977, Volume: 86, Issue:5

    The efficacy of inhaled beclomethasone dipropionate has been examined in 44 steroid-dependent asthmatics observed for 9 months to 2 years. A 3-month double-blind trial found that subjects treated with beclomethasone had a significant diminution in symptoms, were able to reduce their use of medication, and had improved maximum expiratory flow rates. Approximately one half were able to discontinue the use of oral prednisone within 9 months after starting beclomethasone, and a further one third reduced their dose by at least 50%. No characteristics could be defined to predict responsiveness to beclomethasone. The effectiveness of beclomethasone was sustained for as long as 2 years and was not associated with any abnormal urine, blood, or serum values or chest X-ray findings. Candidiasis of the palate appeared in approximately one third of the subjects and was usually transient. The chronic use of beclomethasone did not result in endocrine suppression.

    Topics: Administration, Oral; Aerosols; Anti-Bacterial Agents; Asthma; Beclomethasone; Candidiasis; Clinical Trials as Topic; Forced Expiratory Volume; Humans; Placebos; Prednisone; Substance-Related Disorders; Vital Capacity

1977
[Four years use of beclomethasone dipropionate aerosols].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Bronchitis; Chronic Disease; Clinical Trials as Topic; Cough; Humans; Spasm

1977
[Steroid aerosols in asthma. Comparative simple blind study of beclomethasone dipropionate and dexamethasone isonicotinate].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: 17-Hydroxycorticosteroids; Adolescent; Adrenal Cortex Hormones; Adult; Aerosols; Asthma; Beclomethasone; Clinical Trials as Topic; Dexamethasone; Dexamethasone Isonicotinate; Eosinophils; Female; Humans; Leukocyte Count; Male; Middle Aged

1977
Treatment of chronic childhood asthma with beclomethasone dipropionate aerosol: I. A double-blind crossover trial in nonsteroid-dependent patients.
    Pediatrics, 1977, Volume: 60, Issue:1

    Topics: Adolescent; Aerosols; Asthma; Beclomethasone; Candida; Child; Clinical Trials as Topic; Double-Blind Method; Drug Evaluation; Female; Humans; Male; Pharynx; Pituitary-Adrenal Function Tests; Placebos

1977
Beclomethasone in steroid-dependent asthma. Effective therapy and recovery of hypothalamo-pituitary-adrenal function.
    JAMA, 1977, Oct-03, Volume: 238, Issue:14

    Beclomethasone dipropionate was administered by aerosol to 30 patients whose chronic bronchial asthma required oral corticosteroid therapy. During the initial 12 weeks of the trial, beclomethasone therapy could be discontinued in 12 of 16 patients in contrast to only one of 14 patients receiving the inert aerosol placebo. Patients receiving the placebo were then given beclomethasone, and prednisone therapy was discontinued in five more. During six months of observation, adrenal function improved and steroid toxic reactions decreased in patients in whom oral corticosteroid therapy had been discontinued. Beclomethasone aerosol was generally well-tolerated. Asymptomatic thrush developed in four patients and rhinitis developed in ten patients as prednisone therapy was discontinued.

    Topics: Administration, Oral; Adrenal Glands; Aerosols; Asthma; Beclomethasone; Chronic Disease; Clinical Trials as Topic; Humans; Hydrocortisone; Hypothalamus; Pituitary Gland; Prednisone; Substance Withdrawal Syndrome

1977
Experience with the use of a corticosteroid aerosol.
    British journal of clinical pharmacology, 1977, Volume: 4 Suppl 3

    1. In 48 patients with chronic asthma who had been receiving treatment with beclomethasone dipropionate aerosol (BDA) at a daily dose of 400 microgram for several years, observations were made on the effect of increasing the dose to 800 microgram daily for 6 months. 2. There was subjective improvement in 37 of the 48 patients, but the only objective evidence of improvement was a slight reduction in airways resistance. 3. The higher dose of BDA did not produce impairment of pituitary-adrenal function or an increase in the incidence of oropharyngeal candidiasis.

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Female; Humans; Male; Middle Aged; Time Factors

1977
Beclomethasone dipropionate aerosol in long-term treatment of perennial and seasonal asthma in children and adults: a report of five-and-half years' experience in 600 asthmatic patients.
    British journal of clinical pharmacology, 1977, Volume: 4 Suppl 3

    Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aerosols; Aged; Aspergillosis; Asthma; Beclomethasone; Candidiasis; Child; Child, Preschool; Chronic Disease; Clinical Trials as Topic; Female; Humans; Male; Middle Aged; Pregnancy; Seasons; Substance-Related Disorders; Time Factors

1977
Long-term results with beclomethasone dipropionate aerosol in children with bronchial asthma: why does it sometimes fail?
    British journal of clinical pharmacology, 1977, Volume: 4 Suppl 3

    1. Beclomethasone dipropionate aerosol has been shown to be a highly effective treatment for asthma in childhood, with virtual absence of side effects at this age. 2. When treatment is unsuccessful, this is usually due to failure to take it correctly and regularly. 3. A good response is usually associated with an improvement in ventilatory function and a marked increase in growth velocity.

    Topics: Adolescent; Adrenal Cortex Hormones; Aerosols; Asia; Asthma; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Female; Humans; Ireland; Male; Social Class; Time Factors; United Kingdom; West Indies

1977
Beclomethasone dipropionate aerosol in childhood asthma: a three- to five-year follow-up.
    British journal of clinical pharmacology, 1977, Volume: 4 Suppl 3

    Topics: Aerosols; Asthma; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Follow-Up Studies; Humans

1977
Experience of the use of beclomethasone dipropionate aerosol in general practice.
    British journal of clinical pharmacology, 1977, Volume: 4 Suppl 3

    1. The findings of an open trial of beclomethasone dipropionate aerosol (BDA), carried out in 1972 in the author's general practice, are discussed in the light of subsequent, more extensive experience of its use of BDA. 2. An important reason why BDA may be unsuccessful in controlling asthma, and may give rise to various problems, is that patients are often given an inadequate explanation of the purpose and proper use of this treatment.

    Topics: Adrenal Cortex Hormones; Adult; Aerosols; Aged; Asthma; Beclomethasone; Clinical Trials as Topic; Family Practice; Female; Humans; Male; Middle Aged; Time Factors

1977
Beclomethasone dipropionate aerosol in treatment of perennial and seasonal rhinitis: a review of five years' experience.
    British journal of clinical pharmacology, 1977, Volume: 4 Suppl 3

    1. Five years' experience in the use of beclomethasone dipropionate aerosol (BDA) in the treatment of 315 patients with upper respiratory tract allergy is reviewed. 2. A total of 223 patients with perennial rhinitis was treated. In 23, where the nasal allergy had recurred after oral corticosteroid therapy for asthma was withdrawn, BDA was effective in 69% of cases. A similar success rate (68%) was recorded in 169 patients suffering from perennial allergic rhinitis alone, but a satisfactory response was observed in only 45% of 31 patients with nasal polypi. 3. In 92 patients with seasonal allergic rhinitis freedom from symptoms was achieved in 80%. 4. A total of approximately 534 patient-years of treatment has been recorded without any evidence of side-effects either clinically or on nasal biopsy.

    Topics: Aerosols; Asthma; Beclomethasone; Chronic Disease; Clinical Trials as Topic; Humans; Rhinitis; Seasons

1977
Experience of local inhalation of beclomethasone dipropionate (becotide) in the treatment of adult steroid-dependent asthmatic patients.
    Scandinavian journal of respiratory diseases. Supplementum, 1977, Volume: 101

    Topics: Administration, Oral; Adult; Asthma; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Drug Evaluation; Female; Humans; Male; Middle Aged; Respiratory Therapy; Time Factors

1977
Bronchoscopic biopsies of bronchial mucosa before and after beclomethasone dipropionate therapy.
    Scandinavian journal of respiratory diseases. Supplementum, 1977, Volume: 101

    Topics: Asthma; Beclomethasone; Biopsy; Bronchi; Bronchoscopy; Clinical Trials as Topic; Double-Blind Method; Drug Evaluation; Follow-Up Studies; Humans; Mucous Membrane; Time Factors

1977
Bronchoscopic biopsies of bronchial mucosa before and after beclomethasone dipropionate therapy.
    British journal of clinical pharmacology, 1977, Volume: 4 Suppl 3

    Topics: Aerosols; Asthma; Beclomethasone; Bronchial Diseases; Bronchoscopy; Humans; Time Factors

1977
Beclomethasone dipropionate aerosol in perennial rhinitis.
    The Journal of allergy and clinical immunology, 1977, Volume: 59, Issue:3

    Beclomethasone dipropionate aerosol (BDA), 50 mug four times daily sprayed into each nostril, was compared with placebo in a double-blind crossover trial in 26 patients with perennial rhinitis. Patients received BDA for 3 weeks and placebo for 3 weeks; the order of administration was randomized. Response was assessed with daily symptom score cards and twice weekly measurements of nasal airway inspiratory resistance at a standard flow rate of 0.4 L/sec. Symptom score and nasal resistance during BDA treatment were significantly lower than those duirng placebo treatment (p less than 0.02 and p less than 0.05, respectively) in the third week. Eighteen of the patients expressed a preference for BDA, 6 for placebo, and 2 for neither (p less than 0.05). Acceptable symptomatic improvement (moderate or marked) was achieved by 54%. Mild side effects were noted by 5 patients; these included nasal irritation and bleeding in 2, aerosol-induced sneezing in 2, and headache in 1. These side effects occurred in 3 patients who used BDA, 1 who used placebo, and 1 who used both. After a 6-mo follow-up period, in which the dose of BDA was adjusted and concurrent initial oral prednisone was administered to patients who were treatment failures, 73% of the patients obtained moderate or marked symptomatic improvement. No further side effects were noted during this time. Results in those in whom a possible allergic component could be identified were not different from those of the whole group. We conclude that BDA is a useful addition to the therapy of perennial rhinitis.

    Topics: Administration, Intranasal; Aerosols; Airway Resistance; Asthma; Beclomethasone; Dust; Female; Humans; Immunoglobulin E; Male; Mites; Nasal Polyps; Rhinitis, Allergic, Seasonal

1977
Beclomethasone dipropionate aerosol trial.
    Irish medical journal, 1977, Oct-21, Volume: 70, Issue:15

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Child; Drug Evaluation; Female; Humans; Male; Middle Aged

1977
Clinical and physiological assessment of asthmatic children treated with beclomethasone dipropionate.
    The Journal of allergy and clinical immunology, 1976, Volume: 57, Issue:2

    Forty-two perennial asthmatic children were selected for a 12-wk study using beclomethasone dipropionate. The groups included 21 steroid-dependent children (Group I) and 21 patients (Group II) whose disease was of sufficient severity that corticosteroid therapy was contemplated. All children received the drug in a dose of 100 mug 4 times daily. During the study, oral prednisone was withdrawn from the steroid-dependent children while other therapy was essentially unchanged. Group II children underwent a double-blind trial, receiving beclomethasone for 6 wk and placebo for 6 wk. Objective assessment of adrenal and pulmonary function was obtained at regular intervals. For the latter, total lung capacity and its subdivisions, airways resistance, maximum expiratory flow volume, and oxygen tension, were measured in both groups. In Group II static elastic recoil was measured also. For most tests the results were statistically significant. In both groups, 18 of 21 patients demonstrated an excellent clinical response, no evidence of adrenal suppression, and improvement in pulmonary function. Forty of 42 patients were followed for another 12 wk, and 19 of each group did well. After 20-24 wk of therapy, 16% of patients harbored monilia in their oropharynx, and 1 patient had clinical monilial stomatitis. Within the limits of the time of the study, beclomethasone dipropionate appeared to provide adequate clinical control in many chronic, severe, steroid-dependent and nonsteroid-dependent asthmatic children.

    Topics: 17-Ketosteroids; Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Candidiasis, Oral; Child; Clinical Trials as Topic; Female; Humans; Hydrocortisone; Male; Methylprednisolone; Respiratory Function Tests

1976
Editorial: Inhaled corticosteroids in the treatment of asthma.
    The New Zealand medical journal, 1976, Feb-11, Volume: 83, Issue:557

    Topics: Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Betamethasone; Clinical Trials as Topic; Humans; Prednisone

1976
Beclomethasone dipropionate aerosol in the treatment of chronic bronchial asthma.
    The Journal of allergy and clinical immunology, 1976, Volume: 58, Issue:2

    In a double-blind, randomized study, 93 corticosteroid-independent patients with chronic bronchial asthma were treated with either beclomethasone dipropionate aerosol at 400 mug per day of its vehicle for 4 wk to determine and compare the effectiveness and safety of the preparations. Evaluations made before, at weekly intervals during, and 1 wk after treatment indicated that beclomethasone dipropionate aerosol was superior to its vehicle is improving FVC, FEV1, FEF25%--75%, and clinical signs and symptoms, and in the overall evaluations by both the investigators and the patients. Plasma cortisol levels measured at the end of the second and fourth weeks were not substantially different from those before treatment in either group. No significant side effects or abnormalities in laboratory results were noted.

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Chronic Disease; Clinical Trials as Topic; Drug Evaluation; Female; Humans; Male; Methylprednisolone; Middle Aged; Respiratory Function Tests

1976
Long-term beclomethasone dipropionate aerosol therapy in juvenile asthma.
    Thorax, 1976, Volume: 31, Issue:3

    Following a short-term clinical trial reported elsewhere, beclomethasone dipropionate aerosol has been given to 15 children with asthma for between 2 1/2 and 3 years except for a short placebo period after the first year. Month-by-month records of wheezing, peak flow rate, and other treatments used are presented for the first 17 months, adrenocortical function tests are reported for the first 2 years, and growth is recorded for 2 1/2-3 years. The short-term clinical benefits of the treatment are confirmed in the longer term, adrenocortical function appears to be unchanged, and growth proceeds along expected lines. The main disadvantage seems to be worsening of eczema and allergic rhinitis in those children who have ceased using corticotrophin or oral steroids for the control of asthma. It is concluded that in the long term beclomethasone dipropionate aerosol provides safe and effective day-to-day control of asthma in children, although occasional recourse to systemic steroid therapy cannot be avoided. Oral candidasis has not been a clinical problem.

    Topics: Adolescent; Adrenal Cortex Function Tests; Aerosols; Asthma; Beclomethasone; Body Height; Body Weight; Child; Clinical Trials as Topic; Cosyntropin; Female; Humans; Male; Methylprednisolone; Placebos; Rhinitis, Allergic, Seasonal

1976
A controlled trial of inhaled corticosteroids in patients receiving Prednisone tablets for asthma.
    British journal of diseases of the chest, 1976, Volume: 70, Issue:2

    The theraprutic efficacy of inhaled beclomethasone dipropionate and inhaled betamethasone valerate in chronic asthma has been studied in 14 treatment centres in 158 patients who had previously been taking prednisone tablets regularly. Doses of 400 mug daily of beclomethasone dipropionate and a dose of 800 mug daily of betamethasone valerate allowed approximately 80% of patients to discontinue prednisone initially and 60% to remain off daily prednisone for 24 weeks. A mean reduction in daily prednisone dose of 8 mg was achieved by patients inhaling corticosteroids whilst placebo inhaler permitted a 5 mg reduction. The three inhaled corticosteroid preparations were equally effective in facilitating prednisone reduction and provided equally good control of asthma, alone or as an ancillary to prednisone. The higher dose of beclomethasone dipropionate was superior to the lower in permitting more patients to remain off daily prednisone for the period of the trial. Although 82% of patients recovered a normal adrenal response to tetracosactrin 24 weeks after prednisone was discontinued and inhaled corticosteroids subsituted, 18% still showed some suppression of adrenal function. There was no significant difference between the treatment groups in this.

    Topics: Aerosols; Asthma; Beclomethasone; Betamethasone; Betamethasone Valerate; Clinical Trials as Topic; Female; Humans; Male; Methylprednisolone; Middle Aged; Placebos; Prednisone; Substance Withdrawal Syndrome

1976
Beclomethasone dipropionate aerosol in the treatment of steroid-dependent asthma. A 12-week double-blind study comparing beclomethasone dipropionate and a vehicle aerosol.
    Chest, 1976, Volume: 70, Issue:03

    In a randomized double-blind 12-week trial of steroid-dependent patients with chronic asthma, ten (59 percent) out of 17 patients receiving beclomethasone dipropionate aerosol in a total daily dose of 400mug were able to discontinue systemic corticosteroid therapy successfully, compared to two (13 percent) out of 15 patients in the placebo group (P=0.002). At the end of the trial, the average 8 am plasma cortisol level in the group receiving beclomethasone was more than twice the pretherapy value, whereas the level in the placebo group showed no significant change. There was no significant difference between the beclomethasone group and the placebo group in the overall incidence of side effects related to the aerosol and the effects of systemic corticosteroid withdrawal. Oral candidiasis was not found in any patient receiving beclomethasone dipropionate aerosol. Allergic nasal symptoms were disabling in many patients when the oral dosage of corticosteroids was tapered.

    Topics: Administration, Oral; Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Clinical Trials as Topic; Drug Evaluation; Female; Humans; Hydrocortisone; Lung Volume Measurements; Male; Methylprednisolone; Middle Aged; Prednisolone; Prednisone

1976
[Treatment of asthma with beclomethasone].
    Ugeskrift for laeger, 1976, Oct-25, Volume: 138, Issue:44

    Topics: Aerosols; Asthma; Beclomethasone; Clinical Trials as Topic; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Male; Methylprednisolone; Prednisolone; Prednisone

1976
Beclomethasone dipropionate in long-term treatment of asthma in children.
    The Journal of pediatrics, 1976, Volume: 89, Issue:5

    Beclomethasone dipropionate was found to be effective in reducing symptoms of asthma in children. There was no measurable influence on pulmonary function. An 18-month follow-up did not show untoward side effects on adrenal function, growth, serum electrolytes, and hepatic and renal functions with a dose of 100 mug three times daily. The treatment predisposes to the colonization with Candida albicans in the oropharynx.

    Topics: Adrenal Cortex Function Tests; Asthma; Beclomethasone; Body Height; Body Weight; Child; Clinical Trials as Topic; Drug Evaluation; Female; Humans; Male; Respiratory Function Tests

1976
Beclomethasone dipropionate aerosol for asthmatic children requiring maintenance oral steroid therapy.
    The Medical journal of Australia, 1976, Jun-19, Volume: 1, Issue:25

    A single-blind crossover trial comparing beclomethasone dipropionate by inhalation with prednisolone by mouth in the treatment of asthmatic children over a period of 10 months is reported. Fourteen children aged between nine and 16 years entered the trial. All had severe chronic asthma requiring maintenance oral prednisolone therapy in doses ranging from 2 to 7-5 mg/day. Beclomethasone dipropionate given by inhalation in a dose of 400 mug/day was found to be a satisfactory alternative to prednisolone by mouth for controlling the symptoms of asthma. During the course of this trial, three of the children died suddenly during acute exacerbations of asthma. All three had evidence of extensive inflammation of the tracheobronchial tree.

    Topics: Adolescent; Aerosols; Asthma; Autopsy; Beclomethasone; Bronchi; Child; Clinical Trials as Topic; Death, Sudden; Humans; Placebos; Prednisolone; Trachea

1976
[Long-term inhalation treatment with betamethasone dipropionate (beclomethasone) for asthmatic children].
    Nederlands tijdschrift voor geneeskunde, 1976, Oct-09, Volume: 120, Issue:41

    Topics: Aerosols; Asthma; Beclomethasone; Bronchitis; Candida albicans; Child; Female; Humans; Male; Pharynx; Respiratory Therapy

1976
[A new local corticoid, Becotide, in asthma and chronic spastic bronchitis].
    Lille medical : journal de la Faculte de medecine et de pharmacie de l'Universite de Lille, 1976, Volume: 21, Issue:7 Suppl 3

    Topics: Adult; Asthma; Beclomethasone; Bronchitis; Chronic Disease; Clinical Trials as Topic; Female; Humans; Male; Middle Aged

1976
[Beclomethasone in the treatment of infantile asthma].
    Minerva pediatrica, 1976, Mar-03, Volume: 28, Issue:7

    Topics: Adolescent; Age Factors; Asthma; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Drug Evaluation; Female; Humans; Male

1976
Double blind cross over trial of beclamethasone dipripionate aerosol and oral prednisolone in bronchial asthma.
    The Journal of the Association of Physicians of India, 1976, Volume: 24, Issue:5

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Female; Humans; Infant; Infant, Newborn; Male; Middle Aged; Prednisolone

1976
Compared assay of beclomethasone dipropionate aerosol in corticodependent asthmatic and spastic bronchitic patients.
    Current therapeutic research, clinical and experimental, 1976, Volume: 19, Issue:3

    Topics: Adrenal Cortex Hormones; Adrenal Glands; Aerosols; Asthma; Beclomethasone; Body Weight; Bronchitis; Clinical Trials as Topic; Female; Humans; Male; Methylprednisolone; Middle Aged; Substance-Related Disorders

1976
Treatment of childhood asthma with sodium cromoglycate and beclomethasone dipropionate aerosol singly and in combination.
    British medical journal, 1976, Aug-21, Volume: 2, Issue:6033

    Topics: Adolescent; Aerosols; Asthma; Beclomethasone; Child; Child, Preschool; Cromolyn Sodium; Drug Combinations; Female; Humans; Male; Methylprednisolone; Placebos

1976
Bronchial reactions to aerosol inhalant vehicle.
    British medical journal, 1976, May-29, Volume: 1, Issue:6021

    Topics: Adult; Aerosol Propellants; Aerosols; Asthma; Beclomethasone; Bronchi; Chlorofluorocarbons, Methane; Forced Expiratory Volume; Humans; Hydrocarbons, Halogenated; Middle Aged

1976
Inhaled corticosteroids compared with oral prednisone in patients starting long-term corticosteroid therapy for asthma. A controlled trial by the British Thoracic and Tuberculosis Association.
    Lancet (London, England), 1975, Sep-13, Volume: 2, Issue:7933

    Inhaled beclomethasone dipropionate and inhaled betamethasone valerate have been compared with oral prednisone in the treatment of 75 patients with asthma who were starting long-term corticosteroids for the first time. Both of the inhaled corticosteroids controlled asthma as well as did oral prednisone in those who had responded to therapy in the initial period of the trial. A daily dose of 400 mug of inhaled drug was approximately equivalent to 7-5 mg daily of prednisone. Prednisone suppressed the adrenal response to tetracosactrin, whereas the mean responses in the groups receiving inhaled corticosteroids did not change significantly from pre-trial values. The 30% incidence of other systemic unwanted effects of prednisone contrasted sharply with the low incidence (5%) of symptomatic oropharyngeal candidiasis in the patients receiving inhaled corticosteroids. In a sample of 19 patients no change in exfoliative cytology was detected over the period of the trial nor was there any evidence of fungal colonisation of the bronchial tree. There was no difference between the three treatment groups in the number of antibiotic courses prescribed. The persistent production of sputum made no difference to the response to inhaled corticosteroids. Patients not on sodium cromoglycate did as well in the trial as those receiving sodium cromoglycate. Both inhaled beclomethasone dipropionate and inhaled betamethasone valerate have advantages over oral prednisone in the maintenance treatment of patients with asthma, but in the management of exacerbations systemic corticosteroids will usually be needed as a supplement to inhaled therapy.

    Topics: Administration, Intranasal; Administration, Oral; Adolescent; Adrenal Cortex Function Tests; Adrenal Glands; Aerosols; Asthma; Beclomethasone; Betamethasone; Clinical Trials as Topic; Cosyntropin; Cromolyn Sodium; Female; Humans; Hydrocortisone; Male; Methylprednisolone; Placebos; Prednisone

1975
Bronchial asthma and its treatment with disodium cromoglycate.
    Acta allergologica, 1975, Volume: 30 suppl 12

    Topics: Adolescent; Adult; Allergens; Animals; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Cromolyn Sodium; Desensitization, Immunologic; Drug Hypersensitivity; Female; Histamine Release; Humans; Male; Middle Aged; Physical Exertion; Rats; Rhinitis, Allergic, Seasonal; Stimulation, Chemical

1975
Beclomethasone dipropionate inhaler: a review of its pharmacology, therapeutic value and adverse effects. I: Asthma.
    Drugs, 1975, Volume: 10, Issue:3

    Beclomethasone dipropionate is a topically active corticosteroid used as an adjuvant in the control of chronic asthma when given by inhalation as an aerosol. It is not intended for treatment of acute attacks. It appears that the main difference between beclomethasone dipropionate and other corticosteroids previously used by inhalation is its high topical activity together with a lower systemic activity due to metabolic inactivation of the swallowed portion of the dose. Clinical experience has shown that at doses of 200 to 600mug daily, beclomethasone dipropionate inhaler is preferable to oral corticosteroids, because of lack of side-effects, when adult patients and children who are inadequately controlled by full doses of sodium cromoglycate and bronchodilators, are first considered to need maintenance corticosteroids. Inhaled beclomethasone dipropionate can allow a worthwhile reduction in maintenance doses of systemic corticosteroids in many patients already receiving these drugs and can replace systemic steroids entirely in some patients, particularly when their initial dose of steroids is less than 10mg daily of prednisone or its equivalent. Substitution should be attempted when the patient's asthma is well controlled on their usual doses of systemic steroids and full doses of other adjuvant therapy. Withdrawal of systemic corticosteroids should be performed slowly and carefully. Because recovery from impaired adrenocortical function caused by prolonged systemic steroid therapy is usually slow, special care is necessary for 9 to 12 months after transfer to beclomethasone dipropionate aerosol until the hypothalamo-pituitary-adrenal axis has sufficiently recovered to cope with emergencies such as trauma, surgery, severe infections or an acute attack of asthma. It is essential that additional therapy including high doses of systemic corticosteroids be used immediately to control any acute exacerbation of asthma which occurs during maintenance therapy with beclomethasone dipropionate aerosol. Tests of adrenal function suggest that beclomethasone dipropionate at dosages of 400 to 800 mug daily has little or no adverse effect. The most common side-effect associated with the continuous use of beclomethasone dipropionate inhaler has been oropharyngeal candidiasis, which appears to be dose-related and more common in women than in men. Systemic steroid withdrawal effects, like being generally unwell, and exacerbation of underlying allergic diseases such as aller

    Topics: 17-Ketosteroids; Administration, Oral; Adrenal Cortex Hormones; Adrenocorticotropic Hormone; Adult; Aerosols; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Drug Evaluation; Forced Expiratory Volume; Half-Life; Humans; Hydrocortisone; Kinetics; Methylprednisolone; Middle Aged; Substance-Related Disorders

1975
Beclomethasone dipropionate aerosol in asthma--a double blind study.
    The Indian journal of medical research, 1975, Volume: 63, Issue:11

    Topics: Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Female; Humans; Male; Methylprednisolone; Middle Aged

1975
Beclomethasone dipropionate aerosol in adult steroid independent patients with perennial bronchial asthma.
    Current therapeutic research, clinical and experimental, 1975, Volume: 18, Issue:4

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Chronic Disease; Clinical Trials as Topic; Female; Forced Expiratory Volume; Humans; Male; Methylprednisolone; Middle Aged; Peak Expiratory Flow Rate; Vital Capacity

1975
The impact of beclomethasone dipropionate aerosol on patients with reversible airways obstruction attending a chest clinic.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Cromolyn Sodium; Female; Humans; Infant; Infant, Newborn; Lung Diseases, Obstructive; Male; Methylprednisolone; Middle Aged; Prednisone; Substance-Related Disorders

1975
Effects of inhaled beclomethasone dipropionate on bronchial provocation test reactions.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Aerosols; Asthma; Beclomethasone; Clinical Trials as Topic; Cromolyn Sodium; Humans; Hypersensitivity, Delayed; Hypersensitivity, Immediate; Methylprednisolone

1975
Long-term treatment of asthma with beclomethasone dipropionate.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Clinical Trials as Topic; Cromolyn Sodium; Female; Follow-Up Studies; Humans; Male; Methylprednisolone; Middle Aged; Steroids; Substance-Related Disorders

1975
Corticosteroid aerosols for the treatment of asthma.
    JAMA, 1975, Jan-27, Volume: 231, Issue:4

    Topics: Administration, Oral; Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Betamethasone; Clinical Trials as Topic; Humans; Lung Diseases, Obstructive; Particle Size; Propionates; Triamcinolone; Valerates

1975
Beclomethasone dipropionate in asthma.
    Canadian Medical Association journal, 1975, Aug-09, Volume: 113, Issue:3

    Beclomethasone dipropionate aerosol therapy can replace or diminish systemic corticosteroid therapy in the majority of asthmatics. In a clinical trial of 41 patients with perennial asthma, the 10 who had not required long-term corticosteroid therapy improved symptomatically and in pulmonary function. Of the 31 who had required prolonged systemic corticosteroid therapy 12 were able to discontinue oral prednisone therapy, 15 were able to decrease the maintenance dose of prednisone and only 4 were unable to decrease the dose; all maintained satisfactory lung function and some showed improvement. Discontinuation of systemic corticosteroid therapy was accomplished more readily in patients whose daily maintenance dose was less than 15 mg and who had been taking the drug for less than 3 years. Side effects consisted of a "dry throat" in seven patients, two of whom had throat infections with Candida albicans. Recurrence of rhinitis after discontinuation or reduction of systemic corticosteroid therapy was noted in 11 patients.

    Topics: Administration, Oral; Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Bronchodilator Agents; Child; Chronic Disease; Clinical Trials as Topic; Cough; Female; Humans; Hydrocortisone; Male; Methylprednisolone; Middle Aged; Prednisone; Respiratory Function Tests; Sputum

1975
[Treatment of asthma in children with beclomethasone dipropionate aerosols].
    Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke, 1975, Jul-10, Volume: 95, Issue:19-21

    Topics: Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Humans; Hydrocortisone; Methylprednisolone

1975
Proceedings: Inhaled corticosteroids compared with oral prednisone in asthmatic patients commencing regular corticosteroids.
    Tubercle, 1975, Volume: 56, Issue:2

    Topics: Administration, Intranasal; Administration, Oral; Asthma; Beclomethasone; Betamethasone; Betamethasone Valerate; Clinical Trials as Topic; Humans; Methylprednisolone; Prednisone

1975
Systemic side effects of beclomethasone dipropionate aerosols (becotide, aldecine, sanasthmyl) in otherwise non steroid treated asthmatic patients.
    Pneumonologie. Pneumonology, 1975, Dec-12, Volume: 153, Issue:1

    Topics: Adolescent; Adult; Aerosol Propellants; Asthma; Beclomethasone; Clinical Trials as Topic; Female; Humans; Hydrocortisone; Leukocytosis; Male; Methylprednisolone; Middle Aged

1975
Inhaled beclomethasone dipropionate in the treatment of childhood asthma.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adolescent; Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Female; Humans; Male; Methylprednisolone

1975
The effect of inhalations of beclomethasone dipropionate on plasma cortisol levels and growth hormone production.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adrenal Cortex Hormones; Adult; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Growth Hormone; Humans; Hydrocortisone; Methylprednisolone

1975
An investigation of the bronchial mucous membrane after long-term treatment with beclomethasone dipropionate.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Asthma; Beclomethasone; Bronchi; Clinical Trials as Topic; Humans; Methylprednisolone; Mucous Membrane

1975
Beclomethasone dipropionate as a substitute for oral steroid treatment in asthmatic patients.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Aerosols; Asthma; Beclomethasone; Clinical Trials as Topic; Humans; Methylprednisolone; Prednisolone

1975
Beclomethasone dipropionate aerosol: studies in chronic bronchial asthma.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adult; Aerosols; Aged; Asthma; Beclomethasone; Chronic Disease; Clinical Trials as Topic; Female; Humans; Male; Methylprednisolone; Middle Aged; Spirometry

1975
A two-stage clinical assessment of beclomethasone dipropionate aerosols.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Administration, Intranasal; Adult; Aerosols; Aged; Asthma; Beclomethasone; Bronchitis; Chronic Disease; Clinical Trials as Topic; Cough; Female; Humans; Male; Methylprednisolone; Middle Aged; Rhinitis; Rhinitis, Allergic, Seasonal

1975
Treatment of allergy of the respiratory tract with beclomethasone dipropionate steroid aerosol.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Female; Humans; Methylprednisolone; Middle Aged; Pregnancy; Rhinitis, Allergic, Seasonal; Steroids; Substance-Related Disorders

1975
The measurement of response to beclomethasone dipropionate treatment for asthma.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adolescent; Adult; Aerosols; Aged; Albuterol; Asthma; Beclomethasone; Clinical Trials as Topic; Humans; Methylprednisolone; Middle Aged; Respiratory Function Tests; Steroids

1975
A double-blind comparison of beclomethasone dipropionate aerosol and prednisolone in asthmatic patients.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Aerosols; Asthma; Beclomethasone; Clinical Trials as Topic; Humans; Hydrocortisone; Methylprednisolone; Prednisolone; Respiratory Function Tests

1975
A double-blind cross-over study of beclomethasone dipropionate in asthmatic patients with and without chronic bronchitis.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Aerosols; Asthma; Beclomethasone; Bronchitis; Chronic Disease; Clinical Trials as Topic; Humans; Methylprednisolone; Middle Aged; Prednisone

1975
Beclomethasone dipropionate: an aerosol corticosteroid for topical use in bronchial asthma.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aerosols; Aged; Asthma; Beclomethasone; Clinical Trials as Topic; Humans; Methylprednisolone; Middle Aged

1975
Beclomethasone dipropionate--adrenal function and acute bronchial asthma.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adolescent; Adrenal Glands; Adult; Aerosols; Aged; Asthma; Beclomethasone; Clinical Trials as Topic; Female; Humans; Male; Methylprednisolone; Middle Aged

1975
Beclomethasone dipropionate aerosol in bronchial asthma.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adult; Aerosols; Aged; Asthma; Beclomethasone; Clinical Trials as Topic; Humans; Methylprednisolone; Middle Aged

1975
Beclomethasone dipropionate by aerosol in the treatment in asthmatic children.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aerosols; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Humans; Methylprednisolone; Pituitary-Adrenal Function Tests; Substance-Related Disorders

1975
Beclomethasone dipropionate--its effect on airways resistance in children with severe asthma.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Airway Resistance; Asthma; Beclomethasone; Child; Humans; Methylprednisolone

1975
Therapeutic index of steroid aerosols in asthma. A single-blind comparative trial of beclomethasone dipropionate vs dexamethasone isonicotinate.
    Acta allergologica, 1975, Volume: 30, Issue:6

    1) A 4-week single-blind study is reported which compares the responses of 10 matched pairs of adult asthmatic patients to Beclomethasone Dipropionate and Dexamethasone Isonicotinate aerosols, each at 12 metered-doses per day. 2) Therapeutic efficacy was evaluated by measurement of pulmonary function (PEFR) and by a physician's "overall evaluation" scale. 3) Side-effects related to systemic absorption were evaluated by A.M. blood cortisol levels and total eosinophil counts. 4) At the doses studied, Beclomethasone Dipropionate produced both no side-effects and a significant favourable clinical response, while Dexamethasone Isonicotinate produced significant side-effects and a lesser clinical response.

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Dexamethasone; Dexamethasone Isonicotinate; Eosinophils; Female; Humans; Hydrocortisone; Leukocyte Count; Male; Methylprednisolone; Middle Aged

1975
Double-blind trial comparing two dosage schedules of beclomethasone dipropionate aerosol in the treatment of chronic bronchial asthma. Preliminary report of the Brompton Hospital-Medical Research Council Collaborative Trial.
    Lancet (London, England), 1974, Aug-10, Volume: 2, Issue:7876

    Topics: Administration, Oral; Administration, Topical; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Candidiasis; Chronic Disease; Clinical Trials as Topic; Drug Therapy, Combination; Glucocorticoids; Humans; Methylprednisolone; Mouth Diseases; Mouth Mucosa; Nystatin; Pharyngeal Diseases; Placebos; Prednisone; Propionates

1974
Local and systemic effects of beclomethasone inhalation in steroid-dependent asthmatic patients.
    Current therapeutic research, clinical and experimental, 1974, Volume: 16, Issue:10

    Topics: 17-Ketosteroids; Administration, Topical; Adult; Aerosols; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Blood Pressure; Body Weight; Clinical Trials as Topic; Female; Humans; Hydrocortisone; Hydroxysteroids; Lung; Male; Middle Aged; Spirometry; Steroids; Substance-Related Disorders

1974
Treatment of childhood asthma for 13 months and longer with beclomethasone dipropionate aerosol.
    Archives of disease in childhood, 1974, Volume: 49, Issue:8

    Topics: Administration, Topical; Adolescent; Adrenal Glands; Adrenocorticotropic Hormone; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Body Height; Child; Child, Preschool; Clinical Trials as Topic; Eczema; Female; Growth; Humans; Hydrocortisone; Male; Prednisone; Rhinitis; Rhinitis, Allergic, Seasonal; Time Factors

1974
Conference on the scientific basis of respiratory therapy. Aerosol therapy. Steroid and antibiotic aerosols.
    The American review of respiratory disease, 1974, Volume: 110, Issue:6 Pt 2

    Topics: Aerosols; Airway Obstruction; Anti-Bacterial Agents; Asthma; Bacteria; Bacterial Infections; Beclomethasone; Carbenicillin; Child; Clinical Trials as Topic; Colistin; Corticosterone; Dexamethasone; Gentamicins; Humans; Hydrocortisone; Kanamycin; Lung Diseases, Fungal; Placebos; Polymyxins; Respiratory Therapy; Triamcinolone Acetonide

1974
A comparative study of the efficacy of inhaled beclomethasone and systemic prednisolone in bronchial asthma.
    Scandinavian journal of respiratory diseases, 1974, Volume: 55, Issue:6

    Topics: Adolescent; Adult; Asthma; Beclomethasone; Betamethasone; Clinical Trials as Topic; Cyclic AMP; Female; Humans; Hydrocortisone; Male; Methylprednisolone; Middle Aged; Placebos; Prednisolone; Respiration; Respiratory Therapy; Sputum; Time Factors

1974
Plasma cortisol levels in normal subjects after inhaled corticosteroids.
    Postgraduate medical journal, 1974, Volume: 50 suppl 4

    Topics: Adrenal Glands; Asthma; Beclomethasone; Betamethasone; Betamethasone Valerate; Depression, Chemical; Dexamethasone; Dexamethasone Isonicotinate; Dose-Response Relationship, Drug; Humans; Hydrocortisone; Hypothalamus; Male; Methylprednisolone; Pituitary Gland

1974
Steroid aerosols in asthma: an assessment of betamethasone valerate and a 12-month study of patients on maintenance treatment.
    British medical journal, 1974, Feb-02, Volume: 1, Issue:5900

    Betamethasone valerate aerosol is a new compound for the treatment of asthma. Its clinical effectiveness was established in a double-blind cross-over trial in non-steroid-dependent asthmatic patients. At a dosage of 400 to 800 mug/day for three months there was no evidence of suppression of hypothalamic-pituitary-adrenal function, as assessed by tetracosactrin and insulin stress tests.A 12-month follow-up study of 120 patients using steroid aerosols (betamethasone valerate or beclomethasone dipropionate) indicated that tolerance does not develop and that a daily maintenance dose of 200 mug/day was adequate in most patients. Temporary lack of response was observed during episodes of sputum production or of heavy exposure to antigen.There were no observed side effects other than fungal infections of the respiratory tract. However, the incidence of candidiasis of the pharynx (13%) and particularly of the larynx (5%) in apparently immunologically normal patients was disturbing. These infections were not seen in patients taking 200 mug/day. Though there is yet no evidence that fungal infections associated with steroid aerosols may penetrate the trachea and bronchi the possibility of this indicates that caution should be exercised in their use, particularly in long-term high dosage.

    Topics: Adolescent; Adrenal Glands; Adult; Aerosols; Asthma; Beclomethasone; Betamethasone; Blood Glucose; Candidiasis, Oral; Clinical Trials as Topic; Drug Tolerance; Female; Follow-Up Studies; Humans; Hypersensitivity, Delayed; Hypothalamus; Insulin; Kidney Function Tests; Laryngeal Diseases; Lymphocyte Activation; Male; Middle Aged; Pharyngeal Diseases; Pituitary Gland; Placebos; Pulmonary Ventilation

1974
Response to rimiterol and salbutamol aerosols administered by intermittent positive-pressure ventilation.
    British medical journal, 1974, May-04, Volume: 2, Issue:5913

    The bronchodilator and cardiac effects produced by aerosols of 0.5% salbutamol and 0.5% and 1% rimiterol administered for three minutes in 40% oxygen by intermittent positive-pressure ventilation (I.P.P.V.) were compared in 15 asthmatic patients. Salbutamol and both the concentrations of rimiterol were equipotent in peak bronchodilator effect, but salbutamol had a significantly longer duration of bronchodilator action. There was significantly less increase in heart rate after rimiterol than after salbutamol. Aerosols of 0.5% rimiterol, 0.5% salbutamol, and saline were administered by I.P.P.V. to 10 normal volunteers. There was no difference between the mean heart rates after 0.5% rimiterol and saline but a highly significant increase in mean heart rate was observed after 0.5% salbutamol. It was concluded that 0.5% rimiterol was an effective short-acting bronchodilator drug with little or no cardiac beta(1)-adrenergic activity when administered for three minutes by I.P.P.V. in 40% oxygen.

    Topics: Adult; Aerosols; Aged; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Electrocardiography; Female; Heart Rate; Humans; Male; Middle Aged; Positive-Pressure Respiration; Prednisolone; Spirometry; Sympathomimetics; Time Factors

1974
A controlled trial of beclomethasone dipropionate in asthma.
    The New Zealand medical journal, 1974, Mar-27, Volume: 79, Issue:511

    Topics: 17-Hydroxycorticosteroids; Administration, Topical; Adolescent; Adult; Aerosols; Aged; Albuterol; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Drug Evaluation; Female; Humans; Male; Methylprednisolone; Middle Aged; Placebos; Prednisone; Spirometry

1974
A controlled trial of beclomethasone dipropionate by aerosol in chronic asthmatics.
    The New Zealand medical journal, 1974, Mar-27, Volume: 79, Issue:511

    Topics: Administration, Topical; Aerosols; Albuterol; Anti-Inflammatory Agents; Asthma; Beclomethasone; Clinical Trials as Topic; Drug Evaluation; Glucocorticoids; Humans; Methylprednisolone; Placebos; Spirometry; Vital Capacity

1974
Beclomethasone dipropionate and oropharyngeal candidiasis.
    British medical journal, 1974, Sep-28, Volume: 3, Issue:5934

    A survey of 936 patients attending a respiratory diseases unit outpatient department was performed to assess the incidence of oropharyngeal candidiasis in patients inhaling beclomethasone dipropionate in daily doses of 400 mug or less. Throat swabs from 209 (41%) patients treated with beclomethasone were positive on culture for yeasts compared with positive swabs from 77 (27.2%) patients not receiving corticosteroid therapy either orally or by inhalation. Clinical oropharyngeal thrush, confirmed by culture, was detected in 28 (5.5%) patients inhaling beclomethasone, one (0.7%) patient receiving treatment with oral prednisolone, and two (0.7%) patients not being treated with corticosteroids.

    Topics: Administration, Oral; Administration, Topical; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Candida; Candida albicans; Candidiasis; Candidiasis, Oral; Clinical Trials as Topic; Glucocorticoids; Humans; Pharyngeal Diseases; Pharynx; Prednisolone

1974
Beclomethasone dipropionate aerosol in asthma. Transfer of steroid-dependent asthmatic patients from oral prednisone to beclomethasone dipropionate aerosol.
    The American review of respiratory disease, 1974, Volume: 110, Issue:4

    Topics: Administration, Oral; Administration, Topical; Adrenal Insufficiency; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Clinical Trials as Topic; Glucocorticoids; Humans; Pharyngitis; Placebos; Prednisone; Respiratory Function Tests; Respiratory Tract Infections; Rhinitis, Allergic, Seasonal; Substance Withdrawal Syndrome; Substance-Related Disorders

1974
[Beclomethasone aerosol in asthma therapy].
    Duodecim; laaketieteellinen aikakauskirja, 1974, Volume: 90, Issue:18

    Topics: Administration, Topical; Adult; Aerosols; Aged; Albuterol; Anti-Inflammatory Agents; Asthma; Beclomethasone; Clinical Trials as Topic; Drug Therapy, Combination; Female; Humans; Hydrocortisone; Isoproterenol; Male; Middle Aged; Placebos; Prednisolone

1974
Beclomethasone dipropionate aerosol in adult steroid-dependent obstructive lung disease.
    Scandinavian journal of respiratory diseases, 1974, Volume: 55, Issue:3

    Topics: Administration, Topical; Adult; Aerosols; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Clinical Trials as Topic; Drug Evaluation; Eosinophils; Female; Humans; Hydrocortisone; Leukocyte Count; Male; Middle Aged; Placebos; Respiration; Spirometry; Time Factors

1974
A comparison of betamethasone valerate, beclomethasone dipropionate and placebo by inhalation for the treatment of chronic asthma.
    Postgraduate medical journal, 1974, Volume: 50 suppl 4

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Betamethasone Valerate; Child; Clinical Trials as Topic; Female; Humans; Male; Methylprednisolone; Middle Aged; Placebos; Substance Withdrawal Syndrome

1974
Betamethasone valerate and beclomethasone dipropionate aerosols in patients with asthma.
    Postgraduate medical journal, 1974, Volume: 50 suppl 4

    Topics: Adolescent; Aerosols; Aged; Asthma; Beclomethasone; Betamethasone; Betamethasone Valerate; Clinical Trials as Topic; Female; Humans; Male; Methylprednisolone; Middle Aged

1974
Effect of corticosteroids on exercise-induced asthma.
    The Journal of allergy and clinical immunology, 1974, Volume: 54, Issue:1

    Topics: Administration, Oral; Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Child; Child, Preschool; Exercise Test; Female; Glucocorticoids; Humans; Male; Physical Exertion; Placebos; Prednisone; Pulmonary Ventilation; Time Factors

1974
Aerosol beclomethasone dipropionate in chronic bronchial asthma.
    Lancet (London, England), 1973, Mar-31, Volume: 1, Issue:7805

    Topics: Administration, Topical; Adult; Aerosols; Aged; Airway Obstruction; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chronic Disease; Clinical Trials as Topic; Female; Humans; Hydrocortisone; Male; Methylprednisolone; Middle Aged; Placebos; Spirometry; Time Factors

1973
Beclomethasone dipropionate steriod aerosol in treatment of perennial allergic asthma in children.
    British medical journal, 1973, Jul-21, Volume: 3, Issue:5872

    Thirty-one chronic perennial asthmatics aged from 2(1/2) to 16 years were treated with beclomethasone dipropionate pressurized aerosols for up to 20 months. Of these, 16 patients dependent on oral corticosteroid or corticotrophin for up to 11 years were successfully transferred to this treatment, with one exception. Steroid withdrawal symptoms were slight. Loss of weight, disappearance of Cushingoid features, and resumption of growth indicated lack of systemic side effects. Fifteen others inadequately controlled on bronchodilators or disodium cromoglycate, were also effectively treated, and no clinical evidence of adrenal suppression was noted.

    Topics: Administration, Oral; Administration, Topical; Adolescent; Adrenal Cortex Hormones; Adrenocorticotropic Hormone; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Body Weight; Child; Child, Preschool; Clinical Trials as Topic; Cromolyn Sodium; Female; Glucocorticoids; Humans; Male; Methylprednisolone; Spirometry

1973
Beclomethasone aerosol in childhood asthma.
    Archives of disease in childhood, 1973, Volume: 48, Issue:9

    Topics: Administration, Topical; Adolescent; Adrenal Cortex Hormones; Adrenocorticotropic Hormone; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Eczema; Female; Humans; Hydrocortisone; Male; Methylprednisolone; Recurrence; Rhinitis, Allergic, Seasonal; Spirometry

1973
Beclomethasone dipropionate aerosol in childhood asthma.
    Archives of disease in childhood, 1973, Volume: 48, Issue:9

    Topics: Administration, Topical; Adolescent; Adrenal Cortex Hormones; Adrenocorticotropic Hormone; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Cromolyn Sodium; Female; Humans; Hydrocortisone; Male; Methylprednisolone; Peptides; Prednisone; Spirometry

1973
Substitution of beclomethasone aerosol for oral prednisolone in the treatment of chronic asthma.
    British medical journal, 1973, Oct-27, Volume: 4, Issue:5886

    In a double-blind study 10 patients with chronic asthma received beclomethasone dipropionate 400 mug daily in a Freon propellant from a pressurized dispenser, and 10 patients received the Freon propellant alone. At the start of the trial each patient was receiving long-term maintenance treatment with oral prednisolone in a dose of 7.5 to 15 mg daily. The daily dose of prednisolone was reduced by 1 mg every four weeks and the patient's progress followed by regular clinical assessment and studies of pituitary-adrenal function. The trial was continued until the dose of prednisolone was reduced to zero or until asthmatic symptoms increased to an unacceptable level.In the 10 patients who received beclomethasone the mean maintenance dose of oral prednisolone was reduced by 5.6 mg/day but in only two cases could this drug be withdrawn completely. In the placebo group the mean reduction in dose was only 1.3 mg, thus there was a significant difference between the two groups (P <0.01). Studies of pituitary-adrenal function showed that a normal adrenal response to tetracosactrin stimulation returned only in the two patients from whom prednisolone was withdrawn.Hence the addition of beclomethasone dipropionate by inhalation to systemic corticosteroid therapy allows useful reductions to be made in the oral maintenance doses of corticosteroid. Reductions must be made with caution since there is wide individual variation in response to beclomethasone and in only a minority of patients can oral treatment by completely withdrawn.

    Topics: Administration, Oral; Administration, Topical; Adrenocorticotropic Hormone; Aerosols; Albuterol; Anti-Inflammatory Agents; Asthma; Beclomethasone; Clinical Trials as Topic; Glucocorticoids; Humans; Methylprednisolone; Pituitary-Adrenal Function Tests; Placebos; Prednisolone

1973
Beclomethasone dipropionate used as an aerosol in the treatment of asthma.
    The Practitioner, 1973, Volume: 211, Issue:261

    Topics: Administration, Topical; Adolescent; Adrenal Insufficiency; Adult; Aerosols; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Clinical Trials as Topic; Female; Glucocorticoids; Humans; Male; Methylprednisolone; Middle Aged

1973
A controlled trial of beclomethasone dipropionate for asthma.
    British journal of diseases of the chest, 1973, Volume: 67, Issue:3

    Topics: Administration, Topical; Adrenal Cortex Hormones; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Clinical Trials as Topic; Female; Glucocorticoids; Humans; Male; Methylprednisolone; Middle Aged; Placebos; Pulmonary Ventilation; Respiratory Therapy; Spirometry

1973
A clinical trial of beclomethasone dipropionate aerosol in children and adolescents with asthma.
    Clinical allergy, 1973, Volume: 3, Issue:3

    Topics: Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Child, Preschool; Clinical Trials as Topic; Evaluation Studies as Topic; Female; Glucocorticoids; Humans; Male; Methylprednisolone; Respiratory Therapy; Time Factors

1973

Other Studies

814 other study(ies) available for (9R)-9-chloro-11-17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10-13-16-trimethyl-6-7-8-11-12-14-15-16-octahydrocyclopenta[a]phenanthren-3-one and Asthma

ArticleYear
Combined analysis of five non-interventional studies of the effectiveness, tolerability, and safety of the extrafine fixed dose beclomethasone/formoterol combination in the treatment of asthma in Austria.
    Respiratory medicine, 2023, Volume: 207

    The real-world effectiveness and tolerability of an extrafine fixed dose beclomethasone/formoterol (BDP/FF) treatment of patients with partially or non-controlled asthma was evaluated in five non-interventional studies (NISs) from Austria.. Asthma patients enrolled in these five NISs were treated with beclomethasone/formoterol (Foster® or Foster® Nexthaler®) as maintenance and reliever over 12 weeks. Asthma control, lung function and symptom scores were assessed at baseline, after 4-8 weeks and at the end of the investigations in week 12. In addition, tolerability and handling of the devices were evaluated by questionnaires.. This combined analysis of five non-interventional studies confirms the effectiveness and tolerability of the extrafine fixed-dose BDP/FF combination (Foster® and Foster® Nexthaler®) in a heterogenous patient population suffering from partially or non-controlled asthma. Therapy was associated with a high patient satisfaction and the absence of serious adverse reactions.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Austria; Beclomethasone; Drug Combinations; Female; Formoterol Fumarate; Humans; Male; Treatment Outcome

2023
Transport and deposition of beclomethasone dipropionate drug aerosols with varying ethanol concentration in severe asthmatic subjects.
    International journal of pharmaceutics, 2023, Apr-05, Volume: 636

    This study aims to assess the effects of varying an ethanol co-solvent on the deposition of drug particles in severe asthmatic subjects with distinct airway structures and lung functions using computational fluid dynamics. The subjects were selected from two quantitative computed tomography imaging-based severe asthmatic clusters, differentiated by airway constriction in the left lower lobe. Drug aerosols were assumed to be generated from a pressurized metered-dose inhaler (MDI). The aerosolized droplet sizes were varied by increasing the ethanol co-solvent concentration in the MDI solution. The MDI formulation consists of 1,1,2,2-tetrafluoroethane (HFA-134a), ethanol, and beclomethasone dipropionate (BDP) as the active pharmaceutical ingredient. Since HFA-134a and ethanol are volatile, both substances evaporate rapidly under ambient conditions and trigger condensation of water vapor, increasing the size of aerosols that are predominantly composed of water and BDP. The average deposition fraction in intra-thoracic airways for severe asthmatic subjects with (or without) airway constriction increased from 37%±12 to 53.2%±9.4 (or from 20.7%± 4.6 to 34.7%±6.6) when the ethanol concentration was increased from 1 to 10%wt/wt. However, when the ethanol concentration was further increased from 10 to 20%wt/wt, the deposition fraction decreased. This indicates the importance of selecting appropriate co-solvent amounts during drug formulation development for the treatment of patients with narrowed airway disease. For severe asthmatic subjects with airway narrowing, the inhaled aerosol may benefit from a low hygroscopic effect by reducing ethanol concentration to penetrate the peripheral region effectively. These results could potentially inform the selection of co-solvent amounts for inhalation therapies in a cluster-specific manner.

    Topics: Administration, Inhalation; Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Ethanol; Humans; Hydrocarbons, Fluorinated; Respiratory Aerosols and Droplets; Solvents

2023
Pharmacokinetics of extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide in adolescent and adult patients with asthma.
    Pharmacology research & perspectives, 2022, Volume: 10, Issue:4

    Topics: Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Drug Combinations; Formoterol Fumarate; Glycopyrrolate; Humans; Middle Aged; Young Adult

2022
Can the response to a single dose of beclomethasone dipropionate predict the outcome of long-term treatment in childhood exercise-induced bronchoconstriction?
    Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2022, Volume: 33, Issue:6

    Exercise-induced bronchoconstriction (EIB) is a frequent and highly specific symptom of childhood asthma. Inhaled corticosteroids (ICS) are the mainstay of controller therapy for EIB and asthma; however, a proportion of asthmatic children and adolescents is less responsive to ICS. We hypothesized that a single dose response to ICS could function as a predictor for individual long-term efficacy of ICS.. To assess the predictive value of the bronchoprotective effect of a single-dose beclomethasone dipropionate (BDP) against EIB for the bronchoprotective effect of 4 weeks of treatment, using an exercise challenge test (ECT).. Thirty-two steroid-naïve children and adolescents aged 6 to 18 years with EIB were included in this prospective cohort study. They performed an ECT at baseline, after a single-dose BDP (200µg) and after 4 weeks of BDP treatment (100 µg twice daily) to assess EIB severity.. The response to a single-dose BDP on exercise-induced fall in FEV1 showed a significant correlation with the response on exercise-induced fall in FEV1 after 4 weeks of BDP treatment (r = .38, p = .004). A reduction in post-exercise fall in FEV1 of more than 8% after a single-dose BDP could predict BDP efficacy against EIB after 4 weeks of treatment with a positive predictive value of 100% (CI: 86.1-100%) and a negative predictive value of 29.4% (CI: 11.7%-53.7%).. We found that the individual response to a single-dose BDP against EIB has a predictive value for the efficacy of long-term treatment with BDP. This could support clinicians in providing personalized management of EIB in childhood asthma.

    Topics: Administration, Inhalation; Adolescent; Asthma; Beclomethasone; Bronchoconstriction; Child; Exercise Test; Humans; Prospective Studies

2022
Cost-effectiveness of single-inhaler extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium in patients with uncontrolled asthma in England.
    Respiratory medicine, 2022, Volume: 201

    A Markov cohort state transition model (focusing on exacerbations) was used to investigate the cost-effectiveness of medium- or high-dose BDP/FF/G vs medium- or high-dose BDP/FF, and high-dose BDP/FF/G vs high-dose BDP/FF + tiotropium. The model analysed cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER), and was developed from the England National Health Service perspective (2020 costs). Uncertainty of the inputs was estimated using one-way and probabilistic sensitivity analyses.. Both medium- and high-dose BDP/FF/G were cost-effective vs BDP/FF, with ICERs of £12,224 and £15,587 per QALY gained. High-dose BDP/FF/G was dominant vs BDP/FF + tiotropium, as it was both cheaper and gained QALYs. Sensitivity analyses were consistent with the base model: medium- and high-dose BDP/FF/G had 94.3% and 88.3% likelihoods to be cost-effective vs BDP/FF; high-dose BDP/FF/G had 100% likelihood to be a dominant strategy vs BDP/FF + tiotropium.. Both medium- and high-dose BDP/FF/G were cost-effective vs medium- and high-dose BDP/FF in adults with asthma that was uncontrolled by ICS/LABA. In addition, high-dose BDP/FF/G was a dominating strategy to high-dose BDP/FF + tiotropium.. GOV: NCT02676076 and NCT02676089.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Asthma; Beclomethasone; Clinical Trials as Topic; Cost-Benefit Analysis; Drug Combinations; Formoterol Fumarate; Fumarates; Glycopyrrolate; Humans; Nebulizers and Vaporizers; State Medicine; Tiotropium Bromide

2022
Characterisation of patients with chronic obstructive pulmonary disease initiating single-device inhaled corticosteroids/long-acting β
    BMJ open respiratory research, 2022, Volume: 9, Issue:1

    This is a retrospective, descriptive study of linked primary and secondary healthcare data (Clinical Practice Research Datalink Aurum, Hospital Episode Statistics). Patients with COPD were indexed on first prescription of fixed-dose, single-device ICS/LABA (June 2015-December 2018). Demographics, clinical characteristics, prescribed treatments, healthcare resource use (HCRU) and direct healthcare costs were assessed over 12 months pre-index. Incident users (indexed on first ever prescription) could be non-triple users (no concomitant long-acting muscarinic antagonist at index); a subset were initial maintenance therapy (IMT) users (no history of pre-index maintenance therapy).. Overall, 13 451 incident users (non-triple users: 7448, 55.4%; IMT users: 5162, 38.4%) were indexed on beclomethasone dipropionate/formoterol (6122, 45.5%), budesonide/formoterol (2703, 20.1%) or Other ICS/LABA combinations (4626, 34.4%). Overall, 20.8% of incident users had comorbid asthma and 42.6% had ≥1 moderate-to-severe acute exacerbation of COPD pre-index. Baseline characteristics were similar across indexed therapies. At 3 months pre-index, 45.3% and 35.4% of non-triple and IMT users were receiving maintenance treatment. HCRU and direct healthcare costs were similar across indexed treatments. Prescribing patterns varied regionally.. Patient characteristics, prior treatments, prior COPD-related HCRU and direct healthcare costs were similar across single-device ICS/LABAs in primary care in England. A high proportion of patients were not receiving any respiratory medication pre-index, indicating that prescribing in primary care in England is more closely aligned with national guidelines than global treatment strategies. Comorbid asthma may have influenced prescribing decisions. Less than half of users had preindex exacerbations, suggesting that ICS/LABA is not being prescribed principally based on exacerbation history.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Asthma; Beclomethasone; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate; Humans; Muscarinic Antagonists; Primary Health Care; Pulmonary Disease, Chronic Obstructive; Retrospective Studies

2022
Efficacy and safety of Jinshuibao capsule combined with beclomethasone propionate in the treatment of bronchial asthma.
    Minerva surgery, 2022, Volume: 77, Issue:3

    Topics: Asthma; Beclomethasone; Fluticasone; Humans; Propionates

2022
Beclometasone dipropionate/formoterol maintenance and reliever therapy asthma exacerbation benefit increases with blood eosinophil level.
    The European respiratory journal, 2021, Volume: 58, Issue:1

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Drug Combinations; Eosinophils; Ethanolamines; Formoterol Fumarate; Humans

2021
Serum Inhaled Corticosteroid Detection for Monitoring Adherence in Severe Asthma.
    The journal of allergy and clinical immunology. In practice, 2021, Volume: 9, Issue:12

    Daily inhaled corticosteroids (ICSs) are fundamental to asthma management, but adherence is low.. To investigate (1) whether LC-MS/MS could be used to detect ICSs in serum and (2) whether serum levels related to markers of disease severity.. We collected blood samples over an 8-hour period from patients with severe asthma prescribed at least 1000 μg daily of beclomethasone dipropionate equivalent. Following baseline sampling, patients were observed taking their usual morning dose. Subsequent blood samples were obtained 1, 2, 4, and 8 hours postinhalation and analyzed by LC-MS/MS. Correlations between serum ICS levels and severity markers were investigated.. A total of 60 patients were recruited (41 females; 39 prescribed maintenance prednisolone; mean age, 49 ± 12 years; FEV. Commonly used ICSs can be reliably detected in the blood at least 8 hours after dosing, and could therefore be used as a measure of adherence in severe asthma. Higher exacerbation rates and poorer lung function (for fluticasone propionate) were associated with lower blood levels.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Chromatography, Liquid; Female; Fluticasone; Humans; Middle Aged; Tandem Mass Spectrometry

2021
Treatment response according to small airways disease status: The effects of high-strength extrafine pMDI beclomethasone dipropionate/formoterol fumarate in fixed dose combination in moderate uncontrolled asthmatic patients.
    Pulmonary pharmacology & therapeutics, 2020, Volume: 60

    Inflammation in small airways is particularly clinically active in severe asthma but they still continue to be ignored as considered silent. Recently, the Atlantis study reports small airways involvement in 91% of the asthma population. Therefore in the era of phenotype driven therapy, the aim of this study was to verify if high-strength extrafine ICS/LABA in fixed dose increases clinical efficacy in moderate asthmatic patients with small airways dysfunction and it could be proposed as phenotype driven therapy.. Treatment with extrafine BDP/FF(200/6 μg) in SAP group showed a more significant improvement of FEF25-75%, FVC, RV, and a reduction of alveolar inflammatory markers such as FENO350 and alveolar exhaled pH compared with NSAP patients.. Our preliminary results support the use of high-strength extrafine pMDI BDP/FF (200/6 μg) as phenotype driven treatment directed to small airways dysfunction demonstrating an increase of clinical efficacy in moderate asthmatics with SAP.

    Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Combinations; Female; Forced Expiratory Volume; Formoterol Fumarate; Humans; Lung; Male; Maximal Midexpiratory Flow Rate; Metered Dose Inhalers; Middle Aged; Nitric Oxide; Phenotype; Pilot Projects; Prospective Studies; Pulmonary Disease, Chronic Obstructive; Residual Volume; Smokers; Treatment Outcome; Vital Capacity

2020
Asthmatic children and MDI verbal inhalation technique counseling.
    Pulmonary pharmacology & therapeutics, 2020, Volume: 61

    The present work aimed to study the role of metered-dose inhalers (MDI) verbal counseling on asthmatic children patients inhalation technique and their pulmonary functions.. In this study many children younger than 18 years old with asthma were collected from University hospital outpatient clinics throughout two years period Their MDI inhalation technique was checked and the number of MDI inhalation technique mistakes were detected and corrected at the first visit and every month for two more visits (three visits). Their peak expiratory flow (PEF) and forced expiratory volume in 1 s (FEV. 81 asthmatic subjects (54 female) younger than 18 years old were collected with a mean (SD) age 14.4 (1.8) years old. Most of the patients' owned MDI contained salbutamol, however, some patients were using Beclometasone MDI or Beclometasone and salbutamol combination MDI. The mean number of correct steps performed was significantly increased (p < 0.05) as the number of visits increased. "Place the MDI mouthpiece between the teeth and seal with lips" and "To maintain slow inhalation rate until lungs are full" were the least steps correctly performed by the asthmatics children studied. There was a significant increase (p < 0.05) in the pulmonary function test scores at the third visit.. MDI's verbal counseling should be repeated and checked at every opportunity, especially with children, to improve and maintain the recommended MDI inhalation technique. That could be a tool to possibly improve patients' pulmonary functions.

    Topics: Administration, Inhalation; Adolescent; Albuterol; Asthma; Beclomethasone; Child; Counseling; Female; Humans; Male; Metered Dose Inhalers

2020
Persistence and Adherence to ICS/LABA Drugs in UK Patients with Asthma: A Retrospective New-User Cohort Study.
    Advances in therapy, 2020, Volume: 37, Issue:6

    A retrospective new-user active comparator database study was conducted in the IQVIA Medical Research Database. Propensity score (PS) matching was performed for FF/VI versus BUD/FM, and FF/VI versus BDP/FM. The primary objective was to compare patient treatment persistence (time to discontinuation), while secondary objectives included assessing adherence (mean proportion of days covered [PDC] with medication in the study period) and the proportions of patients achieving ≥ 50% and ≥ 80% PDC.. New users of FF/VI (N = 966), BUD/FM (N = 5931) and BDP/FM (N = 9607) were identified and PS-matched: FF/VI (n = 945) versus BUD/FM (n = 3272), and FF/VI (n = 902) versus BDP/FM (n = 3465). At 12 months, treatment persistence was 69% (FF/VI), 53% (BUD/FM) and 57% (BDP/FM). The likelihood of treatment discontinuation within 12 months after initiation with FF/VI was 35% lower than with BUD/FM and 31% lower than for BDP/FM (both p < 0.001). Mean PDC was higher for FF/VI compared with BUD/FM (77.7 vs 72.4; p < 0.0001) and BDP/FM (78.2 vs 71.0; p < 0.0001). The odds of achieving ≥ 50% and ≥ 80% PDC were greater for FF/VI than for BUD/FM and BDP/FM.. In this study, patients who initiated FF/VI were less likely to discontinue treatment and showed greater treatment adherence versus patients who initiated BUD/FM or BDP/FM.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Aged, 80 and over; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Benzyl Alcohols; Budesonide, Formoterol Fumarate Drug Combination; Child; Chlorobenzenes; Cohort Studies; Female; Humans; Male; Medication Adherence; Middle Aged; Retrospective Studies; United Kingdom; Young Adult

2020
Nasal gene expression changes with inhaled corticosteroid treatment in asthma.
    Allergy, 2020, Volume: 75, Issue:1

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Female; Gene Expression; Humans; Male; Middle Aged; Nasal Mucosa

2020
Effect of long term inhaled corticosteroid therapy on adrenal suppression, growth and bone health in children with asthma.
    BMC pediatrics, 2019, 11-05, Volume: 19, Issue:1

    Inhaled corticosteroids (ICS) are the most effective treatment for children with persistent asthma. However adverse effects of ICS on Hypothalamo Pituitary Adrenal (HPA) axis, growth and bone metabolism are a concern. Hence the primary objective of this study was to describe the effects of long term inhaled corticosteroid therapy (ICS) on adrenal function, growth and bone health in children with asthma in comparison to an age and sex matched group of children with asthma who were not on long term ICS. Describing the association between the dose of ICS and duration of therapy on the above parameters were secondary objectives.. Seventy children with asthma on ICS and 70 controls were studied. Diagnosis of asthma in selected patients was reviewed according to the criteria laid down by GINA 2018 guidelines. The estimated adult heights were interpreted relative to their Mid Parental Height (MPH) range. Serum calcium, alkaline phosphatase and vitamin D levels were analyzed in both groups and cortisol value at 30 min following a low dose short synacthen test was obtained from the study group. The average daily dose of ICS (Beclamethasone) was categorized as low, medium and high (100-200, 200-400, > 400 μg /day) respectively according to published literature.. Heights of all children were within the MPH range. There was no statistically significant difference in the bone profiles and vitamin D levels between the two groups (Ca: p = 0.554, vitamin D: p = 0.187) but vitamin D levels were insufficient (< 50 nmol/l) in 34% of cases and 41% of controls. Suppressed cortisol levels were seen in 24%. Doses of ICS were low, medium and high in 56, 32 and 12% of children respectively. The association between adrenal suppression with longer duration of therapy (p < 0.01) and with increasing dose of ICS (p < 0.001) were statistically significant.. ICS had no impact on the growth and bone profiles but its dose and duration were significantly associated with adrenal suppression.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenal Glands; Adrenal Insufficiency; Alkaline Phosphatase; Asthma; Beclomethasone; Body Height; Bone and Bones; Calcium; Case-Control Studies; Child; Child, Preschool; Female; Growth; Humans; Hydrocortisone; Male; Time Factors; Vitamin D

2019
Comparison of adverse events associated with different spacers used with non-extrafine beclometasone dipropionate for asthma.
    NPJ primary care respiratory medicine, 2019, 02-08, Volume: 29, Issue:1

    Co-prescription of Aerochamber

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Candidiasis, Oral; Female; Hoarseness; Humans; Inhalation Spacers; Male; Metered Dose Inhalers; Middle Aged

2019
A Chest X-Ray causing confusion.
    Acute medicine, 2019, Volume: 18, Issue:2

    A 91-year old female presented to Acute Medical Unit with a 2 week history of shortness of breath and haemoptysis. Her past medical history included osteoporosis, depression, irritable bowel syndrome, asthma, cataracts, and a colonic polypectomy. Her medications: Citalopram 10 mg, Co-codamol, Beclomethasone 200 mcg inhaler, Salbutamol MDI inhaler, Omeprazole 20 mg and Alendronic acid. She was an ex-smoker with a 20-pack year history who had stopped smoking 40-years ago. She did not drink alcohol and lived alone independently.

    Topics: Aged, 80 and over; Asthma; Beclomethasone; Female; Humans; Metered Dose Inhalers; Nebulizers and Vaporizers; Radiography, Thoracic

2019
Blood eosinophils: The forgotten man of inhaled steroid dose titration.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2018, Volume: 48, Issue:1

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Eosinophils; Female; Humans; Leukocyte Count; Male

2018
Effect of delayed pMDI actuation on the lung deposition of a fixed-dose combination aerosol drug.
    International journal of pharmaceutics, 2018, Aug-25, Volume: 547, Issue:1-2

    Lack of coordination between the beginning of the inhalation and device triggering is one of the most frequent errors reported in connection with the use of pMDI devices. Earlier results suggested a significant loss in lung deposition as a consequence of late actuation. However, most of our knowledge on the effect of poor synchronization is based on earlier works on CFC devices emitting large particles with high initial velocities. The aim of this study was to apply numerical techniques to analyse the effect of late device actuation on the lung dose of a HFA pMDI drug emitting high fraction of extrafine particles used in current asthma and COPD therapy. A computational fluid and particle dynamics model was combined with stochastic whole lung model to quantify the amount of drug depositing in the extrathoracic airways and in the lungs. High speed camera measurements were also performed to characterize the emitted spray plume. Our results have shown that for the studied pMDI drug late actuation leads to reasonable loss in terms of lung dose, unless it happens in the second half of the inhalation period. Device actuation at the middle of the inhalation caused less than 25% lung dose reduction relative to the value characterizing perfect coordination, if the inhalation time was between 2 and 5 s and inhalation flow rate between 30 and 150 L/min. This dose loss is lower than the previously known values of CFC devices and further support the practice of triggering the device shortly after the beginning of the inhalation instead of forcing a perfect synchronization and risking mishandling and poor drug deposition.

    Topics: Administration, Inhalation; Aerosols; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Drug Combinations; Formoterol Fumarate; Humans; Hydrodynamics; Lung; Metered Dose Inhalers; Models, Biological; Pulmonary Disease, Chronic Obstructive; Time Factors

2018
A Biocompatible Synthetic Lung Fluid Based on Human Respiratory Tract Lining Fluid Composition.
    Pharmaceutical research, 2017, Volume: 34, Issue:12

    To characterise a biorelevant simulated lung fluid (SLF) based on the composition of human respiratory tract lining fluid. SLF was compared to other media which have been utilized as lung fluid simulants in terms of fluid structure, biocompatibility and performance in inhalation biopharmaceutical assays.. The structure of SLF was investigated using cryo-transmission electron microscopy, photon correlation spectroscopy and Langmuir isotherms. Biocompatibility with A549 alveolar epithelial cells was determined by MTT assay, morphometric observations and transcriptomic analysis. Biopharmaceutical applicability was evaluated by measuring the solubility and dissolution of beclomethasone dipropionate (BDP) and fluticasone propionate (FP), in SLF.. SLF exhibited a colloidal structure, possessing vesicles similar in nature to those found in lung fluid extracts. No adverse effect on A549 cells was apparent after exposure to the SLF for 24 h, although some metabolic changes were identified consistent with the change of culture medium to a more lung-like composition. The solubility and dissolution of BDP and FP in SLF were enhanced compared to Gamble's solution.. The SLF reported herein constitutes a biorelevant synthetic simulant which is suitable to study biopharmaceutical properties of inhalation medicines such as those being proposed for an inhaled biopharmaceutics classification system.

    Topics: A549 Cells; Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Fluids; Fluticasone; Humans; Lung; Solubility

2017
Experimental and computational study of the effect of breath-actuated mechanism built in the NEXThaler
    International journal of pharmaceutics, 2017, Nov-25, Volume: 533, Issue:1

    The breath-actuated mechanism (BAM) is a mechanical unit included in NEXThaler

    Topics: Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Dry Powder Inhalers; Formoterol Fumarate; Humans; Lung; Models, Biological; Particle Size; Respiration

2017
Effectiveness of inhaled corticosteroids in real life on clinical outcomes, sputum cells and systemic inflammation in asthmatics: a retrospective cohort study in a secondary care centre.
    BMJ open, 2017, Nov-28, Volume: 7, Issue:11

    The impact of inhaled corticosteroids (ICS) on eosinophilic inflammation in asthma is well established, but their effect in a real-life setting has not been extensively studied. Our purpose was to investigate the effect of ICS on airway and systemic inflammation as well as on clinical outcomes in patients with asthma from clinical practice.. We conducted a retrospective analysis on asthmatics from a secondary care centre in whom ICS were initiated/increased (n=101), stopped/decreased (n=60) or remained stable (n=63, used as a control group) between two visits with available sputum and blood cell counts.. Our results confirm the effectiveness of ICS on eosinophilic inflammation in real life and demonstrate that their clinical benefit seems to be restricted to eosinophilic asthmatics. Our data also support a try for stepping-down ICS in non-eosinophilic asthmatics.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Asthma; Beclomethasone; Case-Control Studies; Dose-Response Relationship, Drug; Eosinophils; Female; Forced Expiratory Volume; Humans; Inflammation; Leukocyte Count; Male; Middle Aged; Quality of Life; Respiratory Function Tests; Retrospective Studies; Sputum

2017
A pilot study to investigate the use of serum inhaled corticosteroid concentration as a potential marker of treatment adherence in severe asthma.
    The Journal of allergy and clinical immunology, 2017, Volume: 139, Issue:3

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Male; Medication Adherence; Middle Aged; Pilot Projects; Treatment Adherence and Compliance; Young Adult

2017
Asthma control in adult patients treated with a combination of inhaled corticosteroids and long‑acting β2‑agonists: a prospective observational study.
    Polish archives of internal medicine, 2017, 01-18, Volume: 127, Issue:2

    INTRODUCTION    Asthma is a highly prevalent disease that often requires maintenance therapy. Combined inhaled corticosteroid (ICS) and long‑acting β2‑agonist (LABA) inhalers are one of the available maintenance treatment options. OBJECTIVES    This prospective observational study aimed to assess asthma control in patients treated with ICS/LABA inhalers and to identify factors related to optimal asthma control. PATIENTS AND METHODS    The study included 5789 asthmatic patients from Poland, treated with one of the following ICS/LABA inhalers at clinically appropriate doses: beclomethasone/formoterol, fluticasone/ salmeterol, or budesonide/formoterol. The follow‑up lasted 6 months (4 visits in total). The outcomes were physician-reported and patient‑reported asthma control and occurrence of adverse drug reactions. A retrospective logistic regression analysis was performed to identify a potential association between age, obesity, and smoking and the level of disease control. RESULTS    A total of 4469 patients completed the study. Throughout the study period, the rate of patient‑reported control of asthma increased from 24.8% to 67.7%, while physician‑reported control increased from 22.6% to 66.4%. The incidence of exacerbations decreased from 23.4% to 1.9%. Less than 0.1% of the patients reported adverse drug reactions. Age, obesity (body mass index ≥30 kg/m2), and smoking were confirmed as factors negatively affecting disease control, with combined ICS/LABA inhalers potentially reducing their effect. CONCLUSION    Our results confirm the efficacy and safety of combined ICS/LABA inhalers in a real‑life clinical setting. They also corroborate the finding that obesity, older age, and smoking are risk factors for poor asthma control.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Drug Therapy, Combination; Female; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Humans; Male; Middle Aged; Prospective Studies; Treatment Outcome; Young Adult

2017
Respiratory Tract Deposition of HFA-Beclomethasone and HFA-Fluticasone in Asthmatic Patients.
    Journal of aerosol medicine and pulmonary drug delivery, 2016, Volume: 29, Issue:2

    The asthmatic patient's respiratory tract deposition of HFA fluticasone (Flovent HFA(™)) has not been established. There is a known large particle size difference with another commercial inhaled HFA steroid (QVAR(™)). This study compared the 2D and 3D respiratory tract deposition of each inhaled steroid.. This study was an open label, crossover study in eight patients diagnosed with asthma. The regional respiratory and oropharyngeal deposition of the two steroids were compared and contrasted using planar and SPECT imaging following delivery of the (99m)Tc-radiolabeled drug in each product. The SPECT images were merged with computed tomography images to quantify regional deposition within the patients.. Two-dimensional (2D) planar images indicated that 24% of the Flovent HFA dose and 55% of the QVAR dose deposited in the lungs. 2D oropharyngeal deposition indicated that 75% of the Flovent HFA dose was deposited in the oropharynx, while 42% of the QVAR dose deposited in the oropharynx. Three-dimensional (3D) SPECT data indicated that 22% of the Flovent HFA dose and 53% of the QVAR dose deposited in the lungs. 3D oropharyngeal and gut deposition indicated 78% of the Flovent HFA dose was deposited in the oropharynx, while 47% of the QVAR dose deposited in the oropharynx. The increased lung deposition and decreased oropharynx deposition for both 2D and 3D image data of QVAR were statistically different from Flovent HFA.. QVAR exhibited a significant increase in lung delivery compared to Flovent HFA. Conversely, QVAR delivered a significantly lower dose to the oropharynx than Flovent HFA. The findings were presumed to be driven by the smaller particle size of QVAR (0.7 microns MMAD) compared with Flovent HFA (2.0 microns MMAD).

    Topics: Administration, Inhalation; Adult; Aerosol Propellants; Aerosols; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Cross-Over Studies; Drug Compounding; Fluticasone; Humans; Hydrocarbons, Fluorinated; Lung; Male; Metered Dose Inhalers; Middle Aged; Multimodal Imaging; Oropharynx; Particle Size; Radiographic Image Interpretation, Computer-Assisted; Tomography, Emission-Computed, Single-Photon; Tomography, X-Ray Computed; Young Adult

2016
Multivariate Analysis of Effects of Asthmatic Patient Respiratory Profiles on the In Vitro Performance of a Reservoir Multidose and a Capsule-Based Dry Powder Inhaler.
    Pharmaceutical research, 2016, Volume: 33, Issue:3

    The aim of this work was to evaluate the effect of two different dry powder inhalers, of the NGI induction port and Alberta throat and of the actual inspiratory profiles of asthmatic patients on in-vitro drug inhalation performances.. The two devices considered were a reservoir multidose and a capsule-based inhaler. The formulation used to test the inhalers was a combination of formoterol fumarate and beclomethasone dipropionate. A breath simulator was used to mimic inhalatory patterns previously determined in vivo. A multivariate approach was adopted to estimate the significance of the effect of the investigated variables in the explored domain.. Breath simulator was a useful tool to mimic in vitro the in vivo inspiratory profiles of asthmatic patients. The type of throat coupled with the impactor did not affect the aerodynamic distribution of the investigated formulation. However, the type of inhaler and inspiratory profiles affected the respirable dose of drugs.. The multivariate statistical approach demonstrated that the multidose inhaler, released efficiently a high fine particle mass independently from the inspiratory profiles adopted. Differently, the single dose capsule inhaler, showed a significant decrease of fine particle mass of both drugs when the device was activated using the minimum inspiratory volume (592 mL).

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Capsules; Chemistry, Pharmaceutical; Dry Powder Inhalers; Female; Formoterol Fumarate; Humans; Inspiratory Capacity; Male; Middle Aged; Multivariate Analysis; Particle Size; Pharynx; Powders; Respiration; Young Adult

2016
Respiratory medications.
    Nursing, 2016, Volume: 46, Issue:1

    Topics: Administration, Inhalation; Aminopyridines; Androstadienes; Asthma; Beclomethasone; Benzamides; Cyclopropanes; Humans; Indans; Maleates; Nasal Sprays; Powders; Pulmonary Disease, Chronic Obstructive; Quinolones; Respiratory Tract Diseases; Rhinitis, Allergic

2016
Voice evaluation in asthma patients using inhaled corticosteroids.
    Kulak burun bogaz ihtisas dergisi : KBB = Journal of ear, nose, and throat, 2016, Volume: 26, Issue:2

    This study aims to assess voice changes and laryngeal abnormalities in asthmatic patients using inhaled corticosteroids (ICSs).. This study included 30 patients (15 females; mean age 21.3±2.6 years; range, 17 to 26 years and 15 males; mean age 20.7±2.3 years; range, 16 to 27 years) with bronchial asthma treated with ICSs between May 2013 and December 2013. A speech sample from each patient was evaluated by two phoniatricians and the degrees of dysphonia were scored. Each patient's voice was acoustically analyzed using the multidimensional voice program software. Videolaryngoscopy was used to detect laryngeal abnormalities including the vocal folds.. A total of 53.3% of ICSs users had dysphonia; most of them had a mild degree dysphonia. Of patients, vocal folds erythema was present in 56.7%, interarytenoid thickening in 56.7%, vocal folds bowing in 5.3% and vocal fold atrophy in 5.5%. A total of 36.7% patients had manifestations of laryngopharyngeal reflux. The presence of vocal fold bowing and atrophy was significantly related to the duration of ICS use (p=0.048). Soft phonation index values were positively associated with the duration of the ICS use (p=0.013).. Inhaled corticosteroids have abnormally adverse effects both on the function and the structure of the vocal folds.

    Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Atrophy; Beclomethasone; Budesonide; Dysphonia; Erythema; Female; Glucocorticoids; Humans; Laryngeal Diseases; Laryngoscopy; Male; Nebulizers and Vaporizers; Phonation; Speech; Video Recording; Vocal Cords; Voice; Young Adult

2016
Growth velocity in prepubertal children using both inhaled and intranasal corticosteroids.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2016, Volume: 116, Issue:4

    Topics: Administration, Inhalation; Administration, Intranasal; Adrenal Cortex Hormones; Asthma; Beclomethasone; Child; Child Development; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Male; Prospective Studies; Puberty; Rhinitis, Allergic

2016
Treatment response according to small airway phenotypes: a real-life observational study.
    Therapeutic advances in respiratory disease, 2016, Volume: 10, Issue:3

    Scant clinical data are available on the effects of current treatments for asthma on different subgroups of patients with this disease. We conducted a prospective, noninterventional, multicenter real-life study in adult patients with persistent asthma, and we specifically analyzed the effects of treatment with extrafine beclometasone dipropionate/formoterol (BDP/F) in asthma patients categorized by phenotypes related to small airways (i.e. smoking habits, disease duration, and air trapping).. Patients received BDP/F as a fixed combination (100/6 μg), administered in 1-2 inhalations twice daily over a period of 12 weeks. Peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), number of asthma attacks, asthma control, and severity of asthma symptoms were evaluated in the overall population and in different subgroups at three different time points.. Overall, 213 patients were enrolled. In the overall population the treatment resulted in a significant increase in the proportion of well controlled patients (from 6.1% to 66.3%; p<0.001), and a reduction of uncontrolled subjects (70.3% versus 10.0%; p<0.001). BDP/F was also associated with a reduction in asthma attacks and an improvement of symptoms. These results were confirmed in specific subgroups of patients identified as small airway phenotypes: smokers, elderly patients, those with long duration of disease and air trapping.. This real-life observational study indicates that extrafine BDP/F in a fixed combination improves asthma control and symptoms in the overall population as well as specific subgroups of patients.

    Topics: Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Combinations; Female; Forced Expiratory Volume; Formoterol Fumarate; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Phenotype; Prospective Studies; Smoking; Time Factors; Treatment Outcome; Vital Capacity

2016
[Allergic asthma - civilization disease].
    MMW Fortschritte der Medizin, 2016, May-12, Volume: 158, Issue:9

    Topics: Adult; Asthma; Beclomethasone; Cross-Sectional Studies; Dose-Response Relationship, Drug; Drug Combinations; Formoterol Fumarate; Humans; Nebulizers and Vaporizers; Respiratory Hypersensitivity; Young Adult

2016
Effectiveness of initiating extrafine-particle versus fine-particle inhaled corticosteroids as asthma therapy in the Netherlands.
    BMC pulmonary medicine, 2016, May-17, Volume: 16, Issue:1

    Most randomised clinical trials typically exclude a significant proportion of asthma patients, including those at higher risk of adverse events, with comorbidities, obesity, poor inhaler technique and adherence, or smokers. However, these patients might differentially benefit from extrafine-particle inhaled corticosteroids (ICS). This matched cohort, database study, compared the effectiveness of extrafine-particle with fine-particle ICS in a real-life population initiating ICS therapy in the Netherlands.. Data were from the Pharmo Database Network, comprising pharmacy and hospital discharge records, representative of 20 % of the Dutch population. The study population included patients aged 12 - 60, with a General Practice-recorded diagnosis for asthma (International Classification of Primary Care code R96), when available, ≥2 prescriptions for asthma therapy at any time in their recorded history, and receiving first prescription of ICS therapy as either extrafine-particle (ciclesonide or hydrofluoroalkane beclomethasone dipropionate [BDP]) or fine-particle ICS (fluticasone propionate or non-extrafine-particle-BDP). Patients were matched (1:1) on relevant demographic and clinical characteristics over 1-year baseline. Primary outcomes were severe exacerbation rates, risk domain asthma control and overall asthma control during the year following first ICS prescription. Secondary outcomes, treatment stability and being prescribed higher versus lower category of short-acting β2 agonists (SABA) dose, were compared over a 1-year outcome period using conditional logistic regression models.. Following matching, 1399 patients were selected in each treatment cohort (median age: 43 years; males: 34 %). Median (interquartile range) initial ICS doses (fluticasone-equivalents in μg) were 160 (160 - 320) for extrafine-particle versus 500 (250 - 500) for fine-particle ICS (p < 0.001). Following adjustment for residual confounders, matched patients prescribed extrafine-particle ICS had significantly lower rates of exacerbations (adjusted rate ratio [95 % CI], 0.59 [0.47-0.73]), and significantly higher odds of achieving asthma control and treatment stability in the year following initiation than those prescribed fine-particle ICS, and this occurred at lower prescribed doses. Patients prescribed extrafine-particle ICS had lower odds of being prescribed higher doses of SABA (0.50 [0.44-0.57]).. In this historical, matched study, extrafine-particle ICS was associated with better odds of asthma control than fine-particle ICS in patients prescribed their first ICS therapy in the Netherlands. Of importance, this was reached at significantly lower prescribed dose.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cohort Studies; Databases, Factual; Female; Fluticasone; Humans; Logistic Models; Male; Middle Aged; Netherlands; Particle Size; Pregnenediones; Treatment Outcome

2016
Effect of tranilast in comparison with beclomethasone in chronic murine model of asthma.
    Experimental lung research, 2016, Volume: 42, Issue:6

    The current investigation was taken to scrutinize the action of tranilast on the airway remodeling in chronic asthma in mice.. Intraperitoneal injection of ovalbumin was applied to mice for sensitization and subsequent inhalation of 1% ovalbumin three times week for 10 weeks for challenge. Beclomethasone or tranilast were given daily for the 10 week challenge period. At the end of the study, lung weight index, total collagen content, bronchoalveolar lavage level of total and differential cell counts, interleukin-13, in addition to lung tissue nitrate/nitrite and transforming growth beta-1 were measured. Also, histological analysis was done.. Asthmatic mice demonstrated apparent fibrotic changes. Significant airway fibrosis was demonstrated by hyperplasia of goblet cells and thickening of airway epithelium, increased content of lung collagen, lung and bronchoalveolar lavage of transforming growth factor beta-1 and interleukin-13 mutually accompanied by reduction in nitrate/nitrite generation.. Beclomethasone influence on airway remodeling was mediated mainly via suppression of eosinophilic recruitment into the airways and reduction of interleukin-13 cytokine levels. Whereas, tranilast effects on airway remodeling was found to be mainly mediated via its inhibitory effect on transforming growth beta-1. Both beclomethasone and tranilast influence airway remodeling by different degrees and mechanisms.

    Topics: Airway Remodeling; Animals; Anti-Allergic Agents; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchoalveolar Lavage Fluid; Chronic Disease; Collagen; Disease Models, Animal; Drug Evaluation, Preclinical; Interleukin-13; Leukocyte Count; Lung; Male; Mice; Nitric Oxide; ortho-Aminobenzoates; Transforming Growth Factor beta1

2016
Free asthma medications reduces hospital admissions in Brazil (Free asthma drugs reduces hospitalizations in Brazil).
    Respiratory medicine, 2016, Volume: 121

    Since June 2011, the Brazilian health system started providing asthma medications (beclomethasone and salbutamol), totally free of charge to patients with asthma. The aim of this study was to evaluate the impact of the provision of free asthma medications on hospital admissions for asthma in Brazil, using a national hospitalization database (DATASUS), comparing the incidence of hospital admissions before and after the free supply of these drugs.. Admissions of patients with 1-49 years of age by the Brazilian public health system with the diagnosis of asthma were compared pre (2008-2010) and post (2012-2014) provision of free medicines (beclomethasone and salbutamol). The number of hospital admissions due to asthma and non-respiratory diseases, as well as the amount spent with asthma hospitalization, were obtained from DATASUS, the Brazilian government open-access public health database system.. Admission rates for asthma significantly decreased from 90.09/100.000 (2008-2010) to 59.85/100.000 (2012-2014), when the period pre and post provision of free medicines were compared [OR 0.67 (CI 0.48-0.92)]. Non-respiratory admission rates remained stable, when both periods were also compared.. Asthma hospitalization rates significantly decreased in the three-year period after the provision of free medicines to treat asthma. Our findings suggest that the provision of free medications for asthma may have a particular public health impact by its own in developing countries.

    Topics: Adolescent; Adult; Age Distribution; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Brazil; Child; Child, Preschool; Databases, Factual; Drug Costs; Female; Glucocorticoids; Health Care Costs; Hospitalization; Humans; Infant; Male; Middle Aged

2016
High- and low-dose allergen challenges in asthmatic patients using inhaled corticosteroids.
    British journal of clinical pharmacology, 2015, Volume: 79, Issue:3

    The inhaled allergen challenge model has been used previously to investigate the effects of novel anti-inflammatory drugs in inhaled corticosteroid (ICS)-naïve asthmatics. The aim of this study was to characterize high- and low-dose allergen challenges in asthmatic patients using ICS.. Twenty-eight asthmatic patients taking ICS (beclomethasone equivalent <1000 μg day(-1) ) were recruited for high-dose allergen challenge, of whom 10 subsequently also had a repeat low-dose challenge comprising seven allergen challenges. Induced sputum was collected for measurements of cell counts and supernatant biomarkers.. The high-dose allergen challenge caused an early and late asthmatic response in 19 of 28 patients; the mean maximal fall in the forced expiratory volume in 1 s (FEV1 ) was 29.1% (SD 6.2%) and 25.1% (SD 9.6%), respectively. There was also an increase in sputum eosinophils of 6.2% (P = 0.0004), as well as supernatant eosinophil cationic protein levels. The low-dose allergen challenge caused an acute fall in FEV1 , but had no effect on FEV1 at 24 h after challenge or sputum measurements.. The high-dose allergen challenge in asthmatics using ICS induces a late asthmatic response associated with an increase in eosinophilic airway inflammation. This may be a suitable model for studying the effects of novel anti-inflammatory drugs added to maintenance ICS treatment.

    Topics: Administration, Inhalation; Adult; Allergens; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchoconstriction; Dose-Response Relationship, Drug; Female; Forced Expiratory Volume; Humans; Male; Spirometry; Surveys and Questionnaires

2015
High blood eosinophil counts predict sputum eosinophilia in patients with severe asthma.
    The Journal of allergy and clinical immunology, 2015, Volume: 135, Issue:3

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Eosinophilia; Eosinophils; Humans; Leukocyte Count; Predictive Value of Tests; Prednisone; Severity of Illness Index; Sputum; Th2 Cells; Triamcinolone

2015
Effect of CYP3A5*3 on asthma control among children treated with inhaled beclomethasone.
    The Journal of allergy and clinical immunology, 2015, Volume: 136, Issue:2

    Topics: Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Aryl Hydrocarbon Hydroxylases; Asthma; Beclomethasone; Child; Child, Preschool; Cytochrome P-450 CYP3A; Disease Management; Female; Gene Expression; Humans; Male; Polymorphism, Single Nucleotide; Treatment Outcome

2015
Differential effects of inhaled corticosteroids in smokers/ex-smokers and nonsmokers with asthma.
    American journal of respiratory and critical care medicine, 2015, Apr-15, Volume: 191, Issue:8

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Age Distribution; Aged; Androstadienes; Asthma; Beclomethasone; Cohort Studies; Fluticasone; Humans; Middle Aged; Smoking; Smoking Cessation; Treatment Outcome; United Kingdom

2015
Prescribing of long-acting beta-2-agonists/inhaled corticosteroids after the SMART trial.
    BMC pulmonary medicine, 2015, May-06, Volume: 15

    After the SMART trial evaluating the safety of salmeterol (long-acting beta-2-agonist (LABA)) in asthma patients, regulatory actions were taken to promote a guideline-adherent prescribing of LABA only to patients receiving inhaled corticosteroids (ICS). We aim to analyse LABA- and ICS-related prescription patterns after the SMART trial in Germany.. Patients documented in the Bavarian Association of Statutory Health Insurance Physicians database (approximately 10.5 million people) were included if they had a diagnosis of asthma and at least one prescription of LABA and/or ICS between 2004 and 2008. Annual period prevalence rates (PPRs) were estimated and Cochrane Armitage tests were used for time trend analyses.. Highest annual PPRs were found for budesonide and the fixed combination of salmeterol/fluticasone. The proportion of "concomitant LABA and ICS users" increased from 52.0 to 57.6% within the study period, whereas for "LABA users without ICS" a slight decrease from 6.5 to 5.4% was found. In 2008, the proportion of patients with at least one quarter with a LABA prescription without concomitant ICS was highest in elderly, male patients (≈20%). In the majority of these patients, a concomitant diagnosis of COPD (i.e. asthma-COPD overlap syndrome [ACOS]) was present.. Between 2004 and 2008, we found a moderate increase in guideline-adherent LABA prescribing in a representative German population. Elderly men received a significant number of LABA prescriptions without concomitant ICS probably due to ACOS.

    Topics: Administration, Inhalation; Adolescent; Adrenergic beta-2 Receptor Agonists; Adult; Aged; Asthma; Beclomethasone; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Child; Drug Combinations; Drug Therapy, Combination; Drug Utilization Review; Female; Fluticasone-Salmeterol Drug Combination; Germany; Glucocorticoids; Guideline Adherence; Humans; Male; Middle Aged; Mometasone Furoate; Practice Guidelines as Topic; Practice Patterns, Physicians'; Salmeterol Xinafoate; Young Adult

2015
Impact of Age and Sex on Response to Asthma Therapy.
    American journal of respiratory and critical care medicine, 2015, Sep-01, Volume: 192, Issue:5

    Age and sex are associated with differences in asthma prevalence and morbidity.. To determine if age and sex associate with distinct phenotypes and a variable response to therapy in subjects with mild to moderate asthma.. We used Asthma Clinical Research Network data to determine the impact of age and sex on phenotypes and treatment failures among subjects participating in 10 trials from 1993 to 2003.. A total of 1,200 subjects were identified (median age, 30.4 yr; male, 520 [43.3%]; female, 680 [56.7%]) and analyzed. A higher proportion of subjects greater than or equal to 30 years old experienced treatment failures (17.3% vs. 10.3%; odds ratio [OR], 1.82; confidence interval [CI], 1.30-2.54; P < 0.001), and rates increased proportionally with increasing age older than 30 across the cohort (OR per yr, 1.02 [CI, 1.01-1.04]; OR per 5 yr, 1.13 [CI, 1.04-1.22]; P < 0.001). Lower lung function and longer duration of asthma were associated with a higher risk of treatment failures. A higher proportion of subjects greater than or equal to 30 years old receiving controller therapy experienced treatment failures. When stratified by specific therapy, treatment failures increased consistently for every year older than age 30 in subjects on inhaled corticosteroids (OR per year, 1.03; CI, 1.01-1.07). Females had a slightly higher FEV1 % predicted (84.5% vs. 81.1%; P < 0.001) but similar asthma control measures. There was not a statistically significant difference in treatment failures between females and males (15.2% vs. 11.7%; P = 0.088).. Older age is associated with an increased risk of treatment failure, particularly in subjects taking inhaled corticosteroids. There was no significant difference in treatment failures between sexes.

    Topics: Administration, Inhalation; Adult; Age Factors; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Cohort Studies; Female; Glucocorticoids; Humans; Leukotriene Antagonists; Logistic Models; Male; Odds Ratio; Phenotype; Retrospective Studies; Sex Factors; Treatment Failure; Treatment Outcome

2015
Control of asthma in adults treated with beclomethasone and formoterol in extrafine particle formulation in a real-life setting in Poland: the CASPER noninterventional, observational trial.
    Polskie Archiwum Medycyny Wewnetrznej, 2015, Volume: 125, Issue:10

    INTR​ODUCTION: Asthma is one of the most common health problems, and its poor control can seriously affect patients' lives.. We assessed the level of asthma control in a real-life setting in Poland, in outpatients treated with a beclomethasone and formoterol combination pressurized metered-dose inhaler (BDP/F-pMDI).. The study lasted for 6 months (3 visits). Patients were aged 18 years or older, were diagnosed with asthma at least 12 months before the inclusion to the study, and had been using BDP/F-pMDI hydrofluoroalkanes (HFA) for a minimum of 2 weeks before the enrollment. Asthma control was determined in accordance with the criteria of the Global Initiative for Asthma. Patients' data were collected during study visits, using unified questionnaires with close-ended questions.. During the first visit, 8.6% of the patients had controlled asthma; 27.6%, partly controlled asthma; and 63.9%, uncontrolled asthma. Poorer control of asthma was observed in men, smokers, patients with a longer history of asthma, higher body mass index, lower physical activity, shorter treatment with BDP/F-pMDI HFA, and inaccurate inhaler technique. After 6 months of therapy, asthma control improved in 74.2% of the patients; 60.1% of the patients met the criteria of controlled asthma; 31.4%, of partly controlled asthma; and 8.3%, of uncontrolled asthma.. The use of BDP/F-pMDI HFA was effective in the long-term control of asthma, and one of the important factors improving treatment outcomes is the training of patients in the correct inhaler technique.

    Topics: Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Disease Management; Female; Formoterol Fumarate; Humans; Male; Middle Aged; Poland; Surveys and Questionnaires; Treatment Outcome; Young Adult

2015
Clusterin expression level correlates with increased oxidative stress in asthmatics.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2014, Volume: 112, Issue:3

    Oxidative stress is thought to play a role in the pathogenesis of asthma. Clusterin is a sensitive cellular biosensor of oxidative stress and has antioxidant properties. The function and expression of clusterin in patients with asthma have not been fully investigated.. To investigate whether the expression of clusterin in patients with asthma is regulated by increased oxidative burden and whether clusterin expression could be used to assess the response to inhaled corticosteroids.. Clusterin levels in serum, induced sputum, and peripheral blood mononuclear cells of patients with asthma were measured by enzyme-linked immunosorbent assay and western blotting and compared with pulmonary function and levels of expression of hyperoxidized peroxiredoxins. Serum concentrations of clusterin in treatment-naive patients were compared before and after inhaled corticosteroid use.. Serum clusterin concentration was significantly elevated in patients with severe asthma and was inversely correlated with pulmonary function. The expression of hyperoxidized peroxiredoxins was greatly increased in peripheral blood mononuclear cells of patients with asthma and was strongly correlated with clusterin expression. Serum clusterin concentrations in treatment-naive patients with asthma were decreased significantly after initial treatment with inhaled corticosteroids.. Clusterin may be a biomarker of asthma severity and the burden of oxidative stress in patients with asthma. Moreover, clusterin may be useful for the prompt assessment of airway inflammation.

    Topics: Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biomarkers; Clusterin; Female; Forced Expiratory Volume; Humans; Leukocytes, Mononuclear; Male; Middle Aged; Oxidative Stress; Peroxiredoxins; Respiratory Function Tests; Sputum

2014
Between-visit variability of small airway obstruction markers in patients with asthma.
    The European respiratory journal, 2014, Volume: 44, Issue:1

    Topics: Adrenal Cortex Hormones; Aged; Airway Obstruction; Asthma; Beclomethasone; Bronchodilator Agents; Clinical Trials as Topic; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Oscillometry; Prednisolone; Reproducibility of Results; Surveys and Questionnaires

2014
[Possibility of achieving and maintaining asthma control in patients with bronchial cold hyperreactivity].
    Terapevticheskii arkhiv, 2014, Volume: 86, Issue:3

    To evaluate the clinical efficiency of tactics to widen the scope of monotherapy with inhaled glucocorticosteroids (IGCS) in asthmatic patients with bronchial cold hyperreactivity (BCHR) during winter to achieve control of the disease in real clinical practice.. An open-label longitudinal study was conducted in a cold period in 106 asthmatics divided into 2 groups: 1) those with BCHR and 2) those with unchanged bronchial reactivity to a cold stimulus. The study involved monitoring the symptoms by the asthma control test, peak expiratory flow rate (PEFR), and spirometry results before and after cold bronchoprovocation testing; assessment of the pattern of bronchial inflammation from the ratios of induced sputum (IS) cell populations; and estimation of the number of asthma exacerbations and emergency care recourses. Group 1 used a stepwise increase of the scope of basic therapy with beclomethasone dipropionate 1000 microg/day until asthma control was achieved, which was followed by the therapy with the stable dose. Group 2 received monotherapy with beclomethasone dipropionate as the stable dosage of < or = 500 microg/day.. After the first 12 weeks of a follow-up, Group 1 showed the most marked positive changes in the intensity of clinical symptoms, forced expiratory volume in one second, and PEFR that remained within the following 12 weeks during the continued therapy with the stable dose of the drug. A preponderance of the eosinophilic and neutrophilic pattern of inflammation was seen in the patients of this group. By the end of the study, there was a decline in the number of IS inflammatory cells. A discriminant model was developed as a tool to predict asthma control achievement in patients with BCHR.. A stepwise increase in the scope of IGCS monotherapy in asthmatic patients with BCHR during winter can yield the results of disease control and the incidence of exacerbations, which are similar to those seen in asthmatics with no signs of BCHR (53 and 49%, respectively).

    Topics: Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Cold Temperature; Discriminant Analysis; Disease Management; Disease Progression; Emergency Medical Services; Female; Humans; Longitudinal Studies; Male; Middle Aged; Respiratory Function Tests; Russia; Seasons

2014
Glucocorticoids.
    Chemical immunology and allergy, 2014, Volume: 100

    Glucocorticoids are the most effective anti-inflammatory treatment for allergic diseases, and inhaled glucocorticoids have now become the first-line treatment for asthma. Glucocorticoids were discovered in the 1940s as extracts of the adrenal cortex and this was followed by the isolation of adrenocorticotropic hormone (ACTH) from pituitary gland extracts. Cortisone and ACTH were found to be very beneficial in the treatment of rheumatoid arthritis and Kendall, Reichstein and Hench received the Nobel Prize in Physiology and Medicine for this work in 1950. Bordley and colleagues first showed that ACTH was very beneficial in the treatment of allergic diseases in 1949, but the use of systemic glucocorticoids was limited by side effects. Inhaled glucocorticoids were discovered from topical steroids developed for skin inflammation and beclomethasone dipropionate was introduced in 1972, initially in low doses but later in higher doses, and became the standard treatment for persistent asthma. Subsequently, inhaled glucocorticoids were combined with long-acting β2-agonists in combination inhalers for even greater therapeutic benefit. There is now a good understanding of the molecular basis for the anti-inflammatory effects of glucocorticoids in allergic diseases. The search for even safer glucocorticoids based on the dissociation of anti-inflammatory and side effect mechanisms is currently ongoing.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Anti-Inflammatory Agents; Asthma; Beclomethasone; Drug Therapy, Combination; Glucocorticoids; History, 20th Century; Humans

2014
Harry Morrow Brown (1917-2013). Derby, UK.
    Chemical immunology and allergy, 2014, Volume: 100

    Topics: Aerosols; Asthma; Beclomethasone; Eosinophils; History, 20th Century; Humans; Steroids; United Kingdom

2014
A novel therapeutic use of HFA-BDP metereddose inhaler for asthmatic patients with rhinosinusitis: Case series.
    International journal of clinical pharmacology and therapeutics, 2014, Volume: 52, Issue:10

    Most asthmatics have been found to have rhinosinusitis (RS). Patients with ethmoid sinusitis, in particular, often suffer from an impaired sense of smell; this is clinically important and necessitates concurrent treatment for both asthma and RS. As a rational therapeutic strategy, we focused on a fine particle HFA-134abeclomethasone dipropionate (HFA-BDP) metered-dose inhaler. Because of its small size, the medication is still present in the exhaled breath after inhalation.. Five mild-to-moderate asthmatics with ethomoidpredominant sinusitis characterized by an impaired sense of smell and mild peripheral blood eosinophilia received a single-agent treatment with orally-inhaled HFA-BDP which was then exhaled through the nose. In addition, the stained small particles were created by an ultrasonic nebulizer and flow image of them during oral inhalation and nasal exhalation was evaluated by using nasal endoscopy.. After treatment, the sense of smell was restored in all cases with a concomitant improvement in sinusitis as confirmed by computerized tomography. In addition, amelioration of peripheral blood eosinophilia as well as small airway obstruction as indicated by pulmonary function tests was observed. Macroscopical imaging revealed that small particles flow toward olfactory cleft during both the inhalation and exhalation phases.. We have presented 5 cases of asthmatic patients with RS treated with a concurrent single therapy, HFA-BDP exhaled through the nose (ETN). A clinical trial must be considered to establish this new therapeutic strategy based on the concept of "one airway, one disease."

    Topics: Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Metered Dose Inhalers; Middle Aged; Rhinitis; Sinusitis

2014
[Rapid effectiveness and better medication compliance].
    MMW Fortschritte der Medizin, 2014, Oct-09, Volume: 156, Issue:17

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Asthma; Beclomethasone; Delayed-Action Preparations; Disease Progression; Drug Combinations; Ethanolamines; Formoterol Fumarate; Humans; Medication Adherence; Pulmonary Disease, Chronic Obstructive

2014
Asthma outcomes and costs of therapy with extrafine beclomethasone and fluticasone.
    The Journal of allergy and clinical immunology, 2013, Volume: 132, Issue:1

    Characteristics of inhaled corticosteroids (ICSs) differ, but data comparing the real-life effectiveness of various ICSs for asthma are lacking.. We sought to compare real-life asthma outcomes and costs of extrafine hydrofluoroalkane (HFA)-beclomethasone and fluticasone administered through a pressurized metered-dose inhaler.. This retrospective matched cohort study examined database markers of asthma control from a large US longitudinal health care claims database over 1 baseline and 1 outcome year for 10,312 patients with asthma aged 12 to 80 years receiving their first ICS as HFA-beclomethasone or fluticasone and matched on baseline demographic characteristics and asthma severity.. Patients started on HFA-beclomethasone had significantly higher odds (adjusted odds ratio, 1.19; 95% CI; 1.08-1.31) of achieving overall control (risk and impairment), which was defined as no hospital attendance for asthma, oral corticosteroids, or antibiotics for lower respiratory tract infection and less than 2 puffs per day of short-acting β-agonist; they also experienced a lower rate of respiratory-related hospitalizations or referrals (adjusted rate ratio, 0.82; 95% CI, 0.73-0.93) than patients started on fluticasone. Other database outcome measures were similar in the 2 cohorts. Prescribed HFA-beclomethasone doses were lower (P < .001) than fluticasone doses (median, 320 μg/d [interquartile range, 160-320 μg/d] vs 440 μg/d [interquartile range, 176-440 μg/d]). Adjusted respiratory-related health care costs were significantly lower for HFA-beclomethasone than fluticasone (mean, $1869 [95% CI, $1727-$2032] vs $2259 [95% CI, $2111-$2404]), representing a mean annual savings of $390 (95% CI, $165-$620) per patient prescribed HFA-beclomethasone rather than fluticasone.. Asthma treatment outcomes were similar or better with HFA-beclomethasone prescribed at significantly lower doses and with lower costs than fluticasone.

    Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Cohort Studies; Female; Fluticasone; Health Care Costs; Humans; Hydrocarbons, Fluorinated; Male; Metered Dose Inhalers; Middle Aged; Retrospective Studies

2013
Novel functional imaging of changes in small airways of patients treated with extrafine beclomethasone/formoterol.
    Respiration; international review of thoracic diseases, 2013, Volume: 86, Issue:5

    Inhaled formulations using extrafine particles of long-acting β2-agonists and corticosteroids were developed to optimize asthma treatment. Findings that these combinations reach and treat smaller airways more effectively are predominantly based on general non-specific outcomes with little information on regional characteristics.. This study aims to assess long-term effects of extrafine beclomethasone/formoterol on small airways of asthmatic patients using novel functional imaging methods.. Twenty-four stable asthma patients were subdivided into three groups (steroid naive, n = 7; partially controlled, n = 6; well controlled, n = 11). Current treatment was switched to a fixed combination of extrafine beclomethasone/formoterol (Foster®; Chiesi Pharmaceuticals, Parma, Italy). Patients underwent lung function evaluation and thorax high-resolution computerized tomography (HRCT) scan. Local airway resistance was obtained from computational fluid dynamics (CFD).. After 6 months, the entire population showed improvement in pre-bronchodilation imaging parameters, including small airway volume (p = 0.0007), resistance (p = 0.011), and asthma control score (p = 0.016). Changes in small airway volume correlated with changes in asthma control score (p = 0.004). Forced expiratory volume in 1 s (p = 0.044) and exhaled nitric oxide (p = 0.040) also improved. Functional imaging provided more detail and clinical relevance compared to lung function tests, especially in the well-controlled group where only functional imaging parameters showed significant improvement, while the correlation with asthma control score remained.. Extrafine beclomethasone/formoterol results in a significant reduction of small airway obstruction, detectable by functional imaging (HRCT/CFD). Changes in imaging parameters correlated significantly with clinically relevant improvements. This indicates that functional imaging is a useful tool for sensitive assessment of changes in the respiratory system after asthma treatment.

    Topics: Adrenergic beta-2 Receptor Agonists; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchioles; Bronchography; Ethanolamines; Female; Formoterol Fumarate; Humans; Hydrodynamics; Male; Middle Aged; Respiratory Function Tests; Tomography, X-Ray Computed

2013
Real-life comparison of beclometasone dipropionate as an extrafine- or larger-particle formulation for asthma.
    Respiratory medicine, 2013, Volume: 107, Issue:7

    Beclometasone dipropionate is an inhaled corticosteroid (ICS) available in both extrafine and larger-particle hydrofluoroalkane formulations. Extrafine beclometasone has greater small airway distribution and inhalation technique tolerance than larger-particle beclometasone; therefore, its use may be associated with improved asthma outcomes at population levels. The study objective was to compare real-life effectiveness of extrafine and larger-particle beclometasone.. Retrospective matched cohort study including primary care patients with asthma (ages 12-60 and non-smokers 61-80 years) prescribed extrafine or larger-particle beclometasone by metered-dose inhaler. We studied patients receiving their first ICS (initiation population, n = 11,289) or switched from another ICS without dose change (switch population, n = 19,065). The extrafine and larger-particle beclometasone cohorts were matched in each population for demographic and database measures of asthma control during a baseline year; and endpoints assessed during 1 outcome year were adjusted for residual confounding factors.. The odds of no loss of asthma control (no asthma-related hospital attendance, consultation for lower respiratory tract infection, or oral corticosteroids) were significantly higher in the extrafine beclometasone cohorts of both initiation population (adjusted odds ratio [aOR] 1.12; 95% CI 1.02-1.23) and switch population (aOR 1.10; 95% CI 1.01-1.19). The odds of better adherence to ICS therapy were also significantly higher in both extrafine beclometasone cohorts (initiation population, aOR 1.64; 95% CI 1.52-1.75 and switch population, aOR 1.35; 95% CI 1.27-1.43).. These findings are consistent with the hypothesis that delivery of beclometasone in extrafine particle size produces real-life asthma treatment benefits. Clinical trials no. NCT01400217.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chemistry, Pharmaceutical; Child; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Medication Adherence; Metered Dose Inhalers; Middle Aged; Particle Size; Primary Health Care; Retrospective Studies; Treatment Outcome; Young Adult

2013
Asthma patients' inability to use a pressurised metered-dose inhaler (pMDI) correctly correlates with poor asthma control as defined by the global initiative for asthma (GINA) strategy: a retrospective analysis.
    Primary care respiratory journal : journal of the General Practice Airways Group, 2013, Volume: 22, Issue:4

    In practice it is logical that inhalers are prescribed only after patients have received training and demonstrated their ability to use the device. However, many patients are unable to use their pressurised metered-dose inhaler devices (pMDIs) correctly. We assessed the relationship between asthma control and patients' ability to use their prescribed pMDIs.. Evaluation of 3,981 (46% male) primary care asthma patient reviews, which included inhaler technique and asthma control, by specialist nurses in primary care in 2009. The paper focuses on people currently prescribed pMDI devices.. Accurate data on reliever and preventer inhaler prescriptions were available for 3,686 and 2,887 patients, respectively. In patients prescribed reliever inhalers, 2,375 (64%) and 525 (14%) were on pMDI alone or pMDI plus spacer, respectively. For those prescribed preventers, 1,976 (68%) and 171 (6%) were using a pMDI without and with a spacer, respectively. Asthma was controlled in 50% of patients reviewed. The majority of patients (60% of 3,686) were using reliever pMDIs, 13% with spacers. Incorrect pMDI use was associated with poor asthma control (p<0.0001) and more short burst systemic steroid prescriptions in the last year (p=0.038). Of patients using beclometasone (the most frequently prescribed preventer drug in our sample), significantly more of those using a breath-actuated pMDI device (p<0.0001) and a spacer (p<0.0001) were controlled compared with those on pMDIs alone.. Patients who are able to use pMDIs correctly have better asthma control as defined by the GINA strategy document. Beclometasone via a spacer or breath-actuated device resulted in better asthma control than via a pMDI alone. Patients prescribed pMDIs should be carefully instructed in technique and have their ability to use these devices tested; those unable to use the device should be prescribed a spacer or an alternative device such as one that is breath-actuated.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Albuterol; Androstadienes; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Drug Combinations; Ethanolamines; Female; Fluticasone; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Glucocorticoids; Humans; Inhalation Spacers; Male; Metered Dose Inhalers; Middle Aged; Mometasone Furoate; Patient Education as Topic; Pregnadienediols; Retrospective Studies; Self Administration; Treatment Outcome; Young Adult

2013
The availability, pricing and affordability of three essential asthma medicines in 52 low- and middle-income countries.
    PharmacoEconomics, 2013, Volume: 31, Issue:11

    Almost 300 million people suffer from asthma, yet many in low- and middle-income countries have difficulty accessing essential asthma medicines. Availability, price and affordability of medicines are likely to affect access. Very few studies have included asthma medicines, particularly inhaled corticosteroids, in these countries. Reflections about international reference prices (IRPs) are generally absent from pricing studies, yet some IRPs may be masking the extent of access problems.. Our objective was to determine the availability, pricing and affordability of beclometasone, budesonide and salbutamol, the three asthma medicines on the World Health Organization's Model List of Essential Medicines (EML) in selected low- and middle-income countries and to reflect on the appropriateness of using IRPs.. A cross-sectional pricing survey was conducted in 52 countries. Data were collected on country demographics including national currency, $US exchange rate and daily wage of the lowest-paid unskilled government worker. Pricing and availability data were collected for salbutamol, beclometasone and budesonide in two private retail pharmacies, the national procurement centre and a main public hospital.. Availability was particularly poor for corticosteroids, and worse in national procurement centres and main hospitals. The surveyed strength of beclometasone was only on the EML of ten countries. Considerable variability was found in pricing and affordability across countries. Procurement systems appeared largely inefficient when Asthma Drug Facility prices were applied as references. Some countries appear to be subsidising asthma medicines, making them free or less expensive for patients, while other countries are applying very high margins, which can significantly increase the price for patients unless a reimbursement system exists.. Findings raise important policy concerns. Availability of inhaled corticosteroids is poor; many EMLs are not updated; IRPs can be misleading; health systems and patients are paying more than necessary for asthma medicines, which are unaffordable for many patients in many countries.

    Topics: Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Cross-Sectional Studies; Data Collection; Developing Countries; Drug Costs; Glucocorticoids; Health Services Accessibility; Humans; Reimbursement Mechanisms

2013
Clinical and cost effectiveness of switching asthma patients from fluticasone-salmeterol to extra-fine particle beclometasone-formoterol: a retrospective matched observational study of real-world patients.
    Primary care respiratory journal : journal of the General Practice Airways Group, 2013, Volume: 22, Issue:4

    Efficacy trials suggest that extra-fine particle beclometasone dipropionate-formoterol (efBDP-FOR) is comparable to fluticasone propionate-salmeterol (FP-SAL) in preventing asthma exacerbations at a clinically equivalent dosage. However, switching from FP-SAL to efBDP-FOR has not been evaluated in real-world asthma patients.. The REACH (Real-world Effectiveness in Asthma therapy of Combination inHalers) study investigated the clinical and cost effectiveness of switching typical asthma patients from FP-SAL to efBDP-FOR.. A retrospective matched (1:3) observational study of 1,528 asthma patients aged 18-80 years from clinical practice databases was performed. Patients remaining on FP-SAL (n=1,146) were compared with those switched to efBDP-FOR at an equivalent or lower inhaled corticosteroid (ICS) dosage (n=382). Clinical and economic outcomes were compared between groups for the year before and after the switch. Non-inferiority (at least equivalence) of efBDP-FOR was tested against FP-SAL by comparing exacerbation rates during the outcome year.. efBDP-FOR was non-inferior to FP-SAL (adjusted exacerbation rate ratio 1.01 (95% CI 0.74 to 1.37)). Switching to efBDP-FOR resulted in significantly better (p<0.05) odds of achieving overall asthma control (no asthma-related hospitalisations, bronchial infections, or acute oral steroids; salbutamol ≤200μg/day) and lower daily short-acting β2-agonist usage at a lower daily ICS dosage (mean -130μg/day FP equivalents; p<0.001). It also reduced mean asthma-related healthcare costs by £93.63/patient/year (p<0.001).. Asthma patients may be switched from FP-SAL to efBDP-FOR at an equivalent or lower ICS dosage with no reduction in clinical effectiveness but a significant reduction in cost.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cost-Benefit Analysis; Drug Combinations; Drug Costs; Drug Substitution; Ethanolamines; Female; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Health Care Costs; Health Services; Humans; Male; Middle Aged; Retrospective Studies; Treatment Outcome; Young Adult

2013
Single inhaler as maintenance and reliever therapy--is it SMART?
    The Lancet. Respiratory medicine, 2013, Volume: 1, Issue:1

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Ethanolamines; Female; Formoterol Fumarate; Humans; Male

2013
Influence of inhaled beclomethasone and montelukast on airway remodeling in mice.
    Inflammopharmacology, 2013, Volume: 21, Issue:1

    This study examined the effect of montelukast and beclomethasone on airway remodeling in murine model of asthma. Mice were sensitized by i.p. injection of ovalbumin (OVA) on days 0 and 14, and then challenged by nebulization of 1% OVA 3 days/week for 6 or 10 weeks. Results of 6-week OVA-challenged group showed moderate inflammation, but the 10-week OVA-challenged group exhibited mild inflammation. The OVA challenge (6 and 10 weeks) exhibited marked airway fibrosis, illustrated by significant increase in goblet cell hyperplasia and epithelial thickness, increased lung content of collagen and transforming growth factor-β(1), together with a decrease in nitric oxide production; also, there was an increase in bronchoalveolar lavage fluid level of interleukin-13. Administration of montelukast or beclomethasone before each OVA challenge was capable of restoring most of the measured parameters to near normal levels. Inhalation of beclomethasone has a similar role in airway remodeling as montelukast, but its effects in regulating inflammatory changes is less pronounced than montelukast.

    Topics: Acetates; Administration, Inhalation; Airway Remodeling; Animals; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cyclopropanes; Disease Models, Animal; Inflammation; Male; Mice; Ovalbumin; Quinolines; Severity of Illness Index; Sulfides; Time Factors

2013
Inhaled corticosteroids increase the risk of oropharyngeal colonization by Streptococcus pneumoniae in children with asthma.
    Respirology (Carlton, Vic.), 2013, Volume: 18, Issue:2

    Recent studies have raised concerns about the link between use of inhaled corticosteroids (ICS) and risk of pneumonia in patients with chronic obstructive pulmonary disease. This cross-sectional study aimed to investigate the association between ICS and oropharyngeal colonization by Streptococcus pneumoniae (S. pneumoniae) among children (up to 18 years old) with asthma.. Two age-matched groups of patients were consecutively recruited: (i) exposed group: children who had persistent asthma and were being treated with daily ICS for at least 30 days and (ii) non-exposed group: children who had asthma and were not being treated with ICS at study entry. Oropharyngeal specimens from the tonsillar area and posterior pharyngeal wall were collected. S. pneumoniae was identified according to National Committee for Clinical Laboratory Standards recommendations.. A total of 200 consecutive patients were recruited and 192 (96 in each group) were included in the analysis. In the exposed group, the mean daily dose of ICS was 400 µg of beclomethasone or equivalent and the mean duration of treatment was 8.6 months. The prevalence of oropharyngeal colonization by S. pneumoniae was higher in the exposed group compared with the non-exposed group (27.1% vs 8.3%, P = 0.001). After adjusting for potential confounders, use of ICS was an independent risk factor for oropharyngeal carriage of S. pneumoniae, with an adjusted prevalence ratio of 3.75 (95% confidence interval: 1.72-8.18, P = 0.001).. Regular use of ICS is associated with an increased risk of having oropharyngeal colonization by S. pneumoniae in children with asthma.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Asthma; Beclomethasone; Case-Control Studies; Child; Child, Preschool; Cross-Sectional Studies; Dose-Response Relationship, Drug; Female; Humans; Male; Oropharynx; Pneumococcal Infections; Prevalence; Risk Factors; Streptococcus pneumoniae

2013
Cost-utility analysis of the inhaled steroids available in a developing country for the management of pediatric patients with persistent asthma.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2013, Volume: 50, Issue:4

    The choice among the different treatments available can have a great impact on the costs of asthma,. The objective of this study was to estimate the incremental cost-utility ratio of three inhaled corticosteroids (ICs): budesonide (BUD), fluticasone propionate (FP), and ciclesonide, compared to beclomethasone dipropionate (BDP) (the only IC included in the Compulsory Health Insurance Plan of Colombia),. A Markov-type model was developed to estimate costs and health outcomes of a simulated cohort of patients less than 18 years of age with persistent asthma treated over a 12-month period. Effectiveness parameters were obtained from a systematic review of the literature. Cost data were obtained from a hospital´s bills and from the national manual of drug prices. The study assumed the perspective of the national healthcare in Colombia. The main outcome was the variable "quality-adjusted life years" (QALY), RESULTS: While treatment with BDP was associated with the lowest cost (£106.16 average cost per patient during 12 months), treatment with FP resulted in the greatest gain in QUALYs (0.9325 QALYs). FP was associated with a greater gain in QALYs compared to BUD and ciclesonide (0.9325 vs. 0.8999 and 0.9051 QALYs, respectively) at lower costs (£231.19 vs. £309.27 and £270.15, respectively), thus leading to dominance. The incremental cost-utility ratio of FP compared to BDP was £19,835.28 per QALY, CONCLUSIONS: BDP is the most cost-effective therapy for treating pediatric patients with persistent asthma when willingness to pay (WTP) is less than £21,129.22/QALY, otherwise, FP is the most cost-effective therapy.

    Topics: Adrenal Cortex Hormones; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Cohort Studies; Colombia; Computer Simulation; Cost-Benefit Analysis; Drug Costs; Female; Fluticasone; Humans; Male; Markov Chains; Models, Economic; Pregnenediones; Quality-Adjusted Life Years; Randomized Controlled Trials as Topic

2013
Real-life prospective study on asthma control in Italy: cross-sectional phase results.
    Respiratory medicine, 2012, Volume: 106, Issue:2

    To estimate the prevalence of partly controlled and uncontrolled asthmatic patients, to evaluate quality of life and healthcare resource consumption.. Cross-sectional phase followed by a 12-month prospective phase. Asthma Control Test and the EQ-5D were used.. 2853 adult patients recruited in 56 Hospital Respiratory Units in Italy were evaluated: 64.4% had controlled asthma, 15.8% partly controlled asthma and 19.8% were uncontrolled. The mean (SD) EQ-5D score was 0.86 (0.17) in controlled, 0.75 (0.20) in partly controlled and 0.69 (0.23) in uncontrolled patients (p<0.001 between groups). The number of patients requiring hospitalization or emergency room visits was lower in controlled (1.8% and 1.6%, respectively) than in partly controlled (5.1% and 11.5%) and uncontrolled (6.4% and 18.6%). A combination of an inhaled corticosteroid and a long-acting beta-2 agonist was the reported therapy by 56.0% of patients, with the rate of controlled asthma and improved quality of life being higher in patients on extrafine beclomethasone/formoterol compared to budesonide/formoterol (p<0.05) and fluticasone/salmeterol (p<0.05 for quality of life).. Asthma control is achieved in a good proportion of Italian patients. Differences may be detected in a real-life setting in favor of extrafine beclomethasone/formoterol combination.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Cross-Sectional Studies; Drug Therapy, Combination; Emergency Service, Hospital; Ethanolamines; Female; Formoterol Fumarate; Hospitalization; Humans; Italy; Male; Middle Aged; Prospective Studies; Quality of Life; Surveys and Questionnaires; Treatment Outcome; Young Adult

2012
Extrafine aerosols and peripheral airway function in asthma.
    Pediatric pulmonology, 2012, Volume: 47, Issue:6

    Topics: Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Hydrocarbons, Fluorinated; Lung; Male

2012
Inhaled glucocorticoids during pregnancy and offspring pediatric diseases: a national cohort study.
    American journal of respiratory and critical care medicine, 2012, Mar-01, Volume: 185, Issue:5

    Glucocorticoid inhalation is the preferred asthma treatment during pregnancy. Previous studies on its safety focused on obstetric outcomes and offspring malformations.. To determine whether glucocorticoid inhalation during pregnancy is a risk factor for offspring pediatric diseases.. We studied offspring (live singletons) of pregnant women suffering from asthma during pregnancy (prevalence = 6.3%; n = 4,083 mother-child pairs) from the Danish National Birth Cohort (births, 1996-2002; prospective data). We estimated the associations between use of inhaled glucocorticoids for asthma treatment during pregnancy (n = 1231; 79.9% budesonide, 17.6% fluticasone, 5.4% beclomethasone, and 0.9% other or unspecified glucocorticoids) and offspring diseases (International Classification of Diseases-10th Revision, diagnoses) during childhood. We conducted Cox or logistic regression analyses for each International Classification of Diseases-10th Revision category, controlling for use of non-glucocorticoid-containing inhalants, and confirmed results by addressing confounding by treatment indication using propensity score.. Offspring median age at end of follow-up was 6.1 (range, 3.6-8.9) years. Glucocorticoid inhalation was not associated with offspring disease risk in most categories, except for offspring endocrine, metabolic, and nutritional disorders (hazard ratio, 1.84; 95% confidence interval, 1.13-2.99). When repeating analyses with the major subgroup that used budesonide only, association estimates were of similar magnitude.. Regarding most disease categories, data are reassuring, supporting the use of inhaled glucocorticoids during pregnancy. In line with animal data, glucocorticoid inhalation during pregnancy may be a risk factor for offspring endocrine and metabolic disturbances, which should be considered further.

    Topics: Administration, Inhalation; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Child, Preschool; Denmark; Endocrine System Diseases; Female; Fluticasone; Glucocorticoids; Humans; Logistic Models; Male; Metabolic Diseases; Morbidity; Pregnancy; Pregnancy Complications; Prenatal Exposure Delayed Effects; Proportional Hazards Models; Risk Factors

2012
Maternal asthma medication use and the risk of selected birth defects.
    Pediatrics, 2012, Volume: 129, Issue:2

    Approximately 4% to 12% of pregnant women have asthma; few studies have examined the effects of maternal asthma medication use on birth defects. We examined whether maternal asthma medication use during early pregnancy increased the risk of selected birth defects.. National Birth Defects Prevention Study data for 2853 infants with 1 or more selected birth defects (diaphragmatic hernia, esophageal atresia, small intestinal atresia, anorectal atresia, neural tube defects, omphalocele, or limb deficiencies) and 6726 unaffected control infants delivered from October 1997 through December 2005 were analyzed. Mothers of cases and controls provided telephone interviews of medication use and additional potential risk factors. Exposure was defined as maternal periconceptional (1 month prior through the third month of pregnancy) asthma medication use (bronchodilator or anti-inflammatory). Associations between maternal periconceptional asthma medication use and individual major birth defects were estimated by using adjusted odds ratios (aOR) and 95% confidence intervals (95%CI).. No statistically significant associations were observed for maternal periconceptional asthma medication use and most defects studied; however, positive associations were observed between maternal asthma medication use and isolated esophageal atresia (bronchodilator use: aOR = 2.39, 95%CI = 1.23, 4.66), isolated anorectal atresia (anti-inflammatory use: aOR = 2.12, 95%CI = 1.09, 4.12), and omphalocele (bronchodilator and anti-inflammatory use: aOR = 4.13, 95%CI = 1.43, 11.95).. Positive associations were observed for anorectal atresia, esophageal atresia, and omphalocele and maternal periconceptional asthma medication use, but not for other defects studied. It is possible that observed associations may be chance findings or may be a result of maternal asthma severity and related hypoxia rather than medication use.

    Topics: Abnormalities, Drug-Induced; Adult; Albuterol; Anal Canal; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Anus, Imperforate; Asthma; Beclomethasone; Bronchodilator Agents; Case-Control Studies; Esophagus; Female; Fluticasone; Heart Defects, Congenital; Humans; Kidney; Limb Deformities, Congenital; Male; Middle Aged; Pregnancy; Pregnancy Complications; Pregnancy Trimester, First; Radius; Risk Factors; Spine; Trachea; United States; Young Adult

2012
Cost-effectiveness and cost-utility of beclomethasone/formoterol versus fluticasone propionate/salmeterol in patients with moderate to severe asthma.
    Clinical drug investigation, 2012, Apr-01, Volume: 32, Issue:4

    Asthma is a chronic disease characterized by acute symptomatic episodes with variable severity and duration. Pharmacological asthma management aims to achieve and maintain control without side effects, thus improving quality of life and reducing the economic impact. Recently, a clinical trial showed the non-inferiority of beclomethasone/formoterol (BDP/F) versus fluticasone propionate/salmeterol (FP/S) in adults with moderate to severe persistent asthma. However, this study did not provide evidence on costs and did not quantify quality-of-life parameters.. The objective of the present study was to assess the cost effectiveness and cost utility of BDP/F versus FP/S in patients with moderate to severe asthma from the perspective of the Italian National Health Service (NHS).. A Markov model (MM) was used, with five health states for the different levels of asthma control: successful control, sub-optimal control, outpatient-managed exacerbation, inpatient-managed exacerbation, and death. Model data were derived from the ICAT SE study and from expert panels. Three outcomes were considered: time spent in successful control state, costs and quality-adjusted life-years (QALYs).. The model shows that BDP/F treatment led to a slight increase of weeks in successful control compared with FP/S, with a lower cost. The probabilistic sensitivity analysis highlights that in 64% and 68% of the Monte Carlo simulations, BDP/F outperformed FP/S in terms of weeks in successful control and QALYs. Considering the expected cost of the two strategies, in 90% of simulations BDP/F was the least expensive choice. In particular, BDP/F was cost saving as compared with FP/S in about 63% and 59% of simulations as shown by the cost-utility and cost-effectiveness analysis, respectively.. Overall, from the Italian NHS perspective, BDP/F treatment is associated with a reduction in cost and offers a slight increase of effectiveness in terms of weeks spent in successful control and QALYs.

    Topics: Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Computer Simulation; Cost-Benefit Analysis; Drug Combinations; Ethanolamines; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Humans; Italy; Markov Chains; Models, Economic; Quality-Adjusted Life Years; Severity of Illness Index

2012
Characterization of respiratory deposition of fluticasone-salmeterol hydrofluoroalkane-134a and hydrofluoroalkane-134a beclomethasone in asthmatic patients.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2012, Volume: 108, Issue:3

    Fixed combination fluticasone-salmeterol is the most used anti-inflammatory asthma treatment in North America, yet no studies report the actual respiratory tract dose or the distribution of drug within the lungs. Inflammation due to asthma affects all airways of the lungs, both large and small. Inhaled steroid delivery to airways results from a range of drug particle sizes, with emphasis on smaller drug particles capable of reaching the peripheral airways. Previous studies suggested that smaller drug particles increase pulmonary deposition and decrease oropharyngeal deposition.. To characterize the dose of fluticasone-salmeterol hydrofluoroalkane-134a (HFA) (particle size, 2.7 μm) delivered to asthmatic patients and examine the drug distribution within the lungs. The results were compared with the inhalation delivery of HFA beclomethasone (particle size, 0.7 μm).. A crossover study was conducted in asthmatic patients with commercial formulations of fluticasone-salmeterol and HFA beclomethasone radiolabeled with technetium Tc 99m. Deposition was measured using single-photon emission computed tomography/computed tomography gamma scintigraphy.. Two-dimensional planar image analysis indicated that 58% of the HFA beclomethasone and 16% of the fluticasone-salmeterol HFA were deposited in the patient's lungs. The oropharyngeal cavity and gut analyses indicated that 77% of the fluticasone-salmeterol HFA was deposited in the oropharynx compared with 35% of the HFA beclomethasone.. The decreased peripheral airway deposition and increased oropharyngeal deposition of fluticasone-salmeterol HFA was a result of its larger particle size. The smaller particle size of HFA beclomethasone allowed a greater proportion of lung deposition with a concomitant decrease in oropharyngeal deposition.

    Topics: Administration, Inhalation; Aerosol Propellants; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cross-Over Studies; Drug Combinations; Fluticasone-Salmeterol Drug Combination; Humans; Hydrocarbons, Fluorinated; Lung; Particle Size; Radionuclide Imaging

2012
Influence of dentures on residual inhaled corticosteroids in the mouths of elderly asthma patients.
    Respiratory investigation, 2012, Volume: 50, Issue:2

    The influence of dentures on residual inhaled corticosteroids (ICSs) in the mouths of elderly asthmatic patients and the appropriate time for gargling after inhaling ICSs are unclear.. Twenty elderly patients in whom moderate persistent asthma was stably controlled using fluticasone propionate Diskus (FP, n = 10) or hydrofluoroalkane-beclomethasone dipropionate (HFA-BDP, n = 10) for more than 3 months and who wore dentures daily were switched to the other type of ICS for 4 weeks in a crossover manner. The residual amount of each ICS in their mouths after inhalation was measured along with determination of peak inspiratory flow (PIF) and pharyngeal culture for detecting Candida albicans.. The total amounts of residual ICSs in gargling fluids (μg) with HFA-BDP were significantly greater than those with FP (15.6 ± 14.6 vs. 11.5 ± 13.8, p = 0.028). The residual amounts of HFA-BDP were significantly greater in the patients with complete dentures than in those with partial dentures. The residual amounts of FP were significantly correlated with the PIF values in the FP treatment (p = 0.013) but not in the HFA-BDP treatment (p = 0.202). No residual ICSs remained after the third gargling in either treatment. The occurrence of candidiasis during the HFA-BDP period was significantly higher than that during the FP treatment (p = 0.046).. The dentures of elderly asthmatics affect the oral residues of ICSs and occurrence of candidiasis in HFA-BDP treatment; meanwhile, the PIF values affected these factors in FP treatment. Three times gargling after inhaling ICSs is required.

    Topics: Administration, Inhalation; Aged; Aged, 80 and over; Androstadienes; Asthma; Beclomethasone; Bronchodilator Agents; Candidiasis, Oral; Dentures; Female; Fluticasone; Humans; Hydrocarbons, Fluorinated; Male; Mouth; Mouthwashes

2012
A case of recurrent acute haemorrhagic cystitis associated with salbutamol and beclomethasone use in a paediatric patient.
    Journal of paediatrics and child health, 2012, Volume: 48, Issue:7

    Topics: Acute Disease; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Cystitis; Hematuria; Humans; Male

2012
Are we overlooking persistent small airways dysfunction in community-managed asthma?
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2012, Volume: 109, Issue:3

    Whether small airways dysfunction persists in patients with asthma receiving standard community treatment is unknown. Impulse oscillometry (IOS) is a sensitive measure of small airways function.. To assess the degree of small airways dysfunction in a cross-section of patients with community-managed asthma.. We analyzed primary care referral data from patients with persistent asthma (n = 378) receiving standard community therapy, screened using spirometry and IOS. We compared patients by British Thoracic Society asthma treatment step (2-4).. Step 2 patients were not different from step 3 patients receiving long-acting beta-agonist (LABA). Step 4 patients differed from step 2 by: higher inhaled corticosteroid (ICS) dose (P < .0001); lower forced expiratory volume in 1 second (FEV(1)%; P = .02) and forced mid-expiratory flow (FEF(25-75%); P = .001); higher frequency of resonance (F(res); P = .02) and peripheral airway resistance (R5-R20; P = .006); whereas for steps 3 vs 4 there were differences in F(res) (P < .05) and R5-R20 (P = .006). There were high proportions of abnormality for R5-R20 (>0.03 kPa/L/s) at steps 2, 3, and 4, respectively: 64.6%, 63.5%, and 69.9%. Step 2 patients receiving extra-fine particle ICS demonstrated lower total airway resistance at 5Hz (R5) vs patients receiving standard ICS (124.1% vs 138.3%, P < .05), with no difference in FEV(1). At step 4, R5 remained elevated at 141.3% despite concomitant LABA, with only 2.4% using extra-fine ICS.. Persistent small airways dysfunction occurs despite treatment at steps 2 through 4 of current asthma guidelines. Extra-fine ICS may reduce airway resistance at step 2. Prospective studies with extra-fine ICS ± LABA at steps 2 through 4 are required to discern whether improving small airways function might result in long-term improved control.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Airway Resistance; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Drug Combinations; Female; Fluticasone-Salmeterol Drug Combination; Humans; Male; Middle Aged; Oscillometry; Respiratory Function Tests; Respiratory System; Spirometry

2012
[Characteristics of the latent period of sensorimotor reactions in middle-aged and elderly outpatients with asthma during long-term treatment with inhaled glucocorticosteroids].
    Terapevticheskii arkhiv, 2012, Volume: 84, Issue:8

    To study a relationship of the characteristics of simple and complex visual sensorimotor reactions to asthma controllability in middle-aged and elderly outpatients during disease-modifying antirheumatic drug therapy with beclomethasone, fluticasone, or budesonide in average and high daily doses.. Eighty middle-aged and elderly patients with asthma were examined. The level of asthma control, the main parameters of external respiratory function, and the characteristics of simple and complex visual sensorimotor reactions were assessed.. Uncontrolled asthma was observed in more than 50% of the asthmatic patients in the outpatient setting. Moderate linear relationships were found between the main physiological parameters and the level of the standard asthma control test.. In the patients with controlled asthma, the latent periods of simple and complex visual sensorimotor reactions were significantly shorter than in those with poorly controlled asthma.

    Topics: Administration, Inhalation; Adult; Aged; Androstadienes; Antirheumatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Female; Fluticasone; Glucocorticoids; Humans; Long-Term Care; Male; Middle Aged; Outpatients; Psychomotor Performance

2012
[Therapy of bronchial asthma: MART concept: maintenance and acute therapy with extra fine particles].
    MMW Fortschritte der Medizin, 2012, Oct-04, Volume: 154, Issue:17

    Topics: Acute Disease; Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Combinations; Ethanolamines; Formoterol Fumarate; Humans; Long-Term Care

2012
New insights into the treatment of persistent asthma.
    Lancet (London, England), 2011, Feb-19, Volume: 377, Issue:9766

    Topics: Administration, Inhalation; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Randomized Controlled Trials as Topic

2011
Treatment of mild persistent asthma in children.
    Lancet (London, England), 2011, May-21, Volume: 377, Issue:9779

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Albuterol; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child; Chronic Disease; Drug Administration Schedule; Drug Therapy, Combination; Humans; Long-Term Care; Secondary Prevention; Treatment Outcome

2011
Asthma control with extrafine-particle hydrofluoroalkane-beclometasone vs. large-particle chlorofluorocarbon-beclometasone: a real-world observational study.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2011, Volume: 41, Issue:11

    The extrafine-particle formulation of hydrofluoroalkane-beclometasone (EF HFA-BDP; Qvar®) demonstrates improved total and small airway deposition compared with large-particle chlorofluorocarbon (CFC)-BDP. In some short-term studies, EF HFA-BDP provides greater effects on lung function than CFC-BDP, and hence is recommended to be prescribed at a lower dose, but whether there are differences in asthma outcomes during long-term treatment is unknown.. To compare the effectiveness of EF HFA-BDP vs. CFC-BDP over 1 year.. This retrospective matched cohort study examined outcomes in a large primary care database for patients aged 5-60 years with asthma receiving their first inhaled corticosteroid (ICS) prescription (initiation population) or first ICS dose increase (step-up population) by a pressurized metered-dose inhaler (pMDI) as EF HFA-BDP or CFC-BDP. Patients were matched on baseline demographic and asthma severity measures in EF HFA-BDP:CFC-BDP ratios of 1:3 and 1:2 for initiation and step-up populations, respectively. Step-up patients were matched also on ICS dose during a baseline year. Co-primary endpoints were asthma control (composite measure comprising no recorded hospital attendance for asthma, oral corticosteroids, or antibiotics for lower respiratory infection) and exacerbation rate during the outcome year.. For the initiation population (EF HFA-BDP n=2882; CFC-BDP n=8646), adjusted odds of achieving asthma control with EF HFA-BDP vs. CFC-BDP was 1.15 (95% CI 1.02-1.28). For the step-up population (n=258 and 516), adjusted odds of asthma control with EF HFA-BDP was 1.72 (95% CI 1.14-2.56). EF HFA-BDP was prescribed at a median dose half that of CFC-BDP.. During 1 year after initiating or stepping up ICS therapy by pMDI, patients who received EF HFA-BDP were more likely to achieve asthma control than those receiving CFC-BDP. These findings suggest that ICS formulation, particle size, and deposition characteristics play important roles in real-life effectiveness of asthma therapy. This study shows that an EF-particle formulation of beclometasone can be used at half the dose of the large-particle formulation with at least as good clinical outcomes.

    Topics: Adolescent; Adult; Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Chlorofluorocarbons; Cohort Studies; Female; Humans; Hydrocarbons, Fluorinated; Male; Metered Dose Inhalers; Middle Aged; Particle Size; Risk Factors; Treatment Outcome; Young Adult

2011
Asthma control in patients receiving inhaled corticosteroid and long-acting beta2-agonist fixed combinations. A real-life study comparing dry powder inhalers and a pressurized metered dose inhaler extrafine formulation.
    BMC pulmonary medicine, 2011, Jul-15, Volume: 11

    Although patients have more problems using metered dose inhalers, clinical comparisons suggest they provide similar control to dry powder inhalers. Using real-life situations this study was designed to evaluate asthma control in outpatients with moderate to severe persistent asthma and to compare efficacy of fixed combinations of inhaled corticosteroids (ICS) and long acting beta-agonists (LABA).. This real-life study had a cross-sectional design. Patients using fixed combinations of ICS and LABA had their asthma control and spirometry assessed during regular visits.. 111 patients were analyzed: 53 (47.7%) received maintenance therapy of extrafine beclomethasone-formoterol (BDP/F) pressurized metered dose inhaler (pMDI), 25 (22.5%) fluticasone-salmeterol (FP/S) dry powder inhaler (DPI), and 33 (29.7%) budesonide-formoterol (BUD/F) DPI. Severity of asthma at time of diagnosis, assessed by the treating physician, was comparable among groups. Asthma control was achieved by 45.9% of patients; 38.7% were partially controlled and 15.3% were uncontrolled. In the extrafine BDF/F group, asthma control total score, daytime symptom score and rescue medication use score were significantly better than those using fixed DPI combinations (5.8±6.2 vs. 8.5±6.8; 1.4±1.8 vs. 2.3±2.1; 1.8±2.2 vs. 2.6±2.2; p=0.0160; p=0.012 and p=0.025, respectively) and the mean daily ICS dose were significantly lower.. pMDI extrafine BDP/F combination demonstrated better asthma control compared to DPIs formulated with larger particles. This could be due to the improved lung deposition of the dose or less reliance on the optimal inhalation technique or both.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Adult; Aged; Aged, 80 and over; Asthma; Beclomethasone; Budesonide; Cross-Sectional Studies; Drug Therapy, Combination; Dry Powder Inhalers; Ethanolamines; Female; Formoterol Fumarate; Humans; Male; Metered Dose Inhalers; Middle Aged; Retrospective Studies; Severity of Illness Index; Surveys and Questionnaires; Treatment Outcome; Young Adult

2011
Development of the Asthma Control Composite outcome measure to predict omalizumab response.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2011, Volume: 107, Issue:3

    Previous assessments of response to omalizumab were based on diary-based data rather than standard validated instruments. A composite instrument that translates diary-based data into standard validated asthma control measures would characterize patient response to treatment in terms of current asthma control definitions.. To develop the Asthma Control Composite (ACC) tool, using real-time diary-based data to predict treatment response in terms of asthma control.. The ACC tool was derived retrospectively using pooled data from two phase 3 studies in patients with moderate to severe allergic asthma. Patients were randomized to receive subcutaneous omalizumab or placebo for 16 weeks plus stable beclomethasone dipropionate therapy, followed by a 3-month corticosteroid reduction period and 5-month double-blind safety extension. Control was assessed as "complete," "good," or "not controlled," based on a composite score of 4 elements: rescue medication (puffs/day), total asthma symptom score, average number of awakening nights/28 days, and activity limitation.. The ACC was mapped to standard validated measures of patient-reported outcomes, with results consistent with clinical outcomes. The proportion of patients with baseline uncontrolled asthma achieving "good" or "complete" asthma control was 48% with omalizumab and 32% with placebo at approximately 4 months. The mean composite score also was improved with omalizumab (3.52) vs placebo (2.56) at approximately 4 months.. The ACC tool accurately reflects asthma control in moderate to severe asthma patients eligible for biological therapy. Unlike the ACT, which has not been validated in this patient population, the ACC shows promise as an asthma control assessment tool in patients with moderate to severe asthma.

    Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aged; Anti-Asthmatic Agents; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Beclomethasone; Child; Female; Humans; Immunoglobulin E; Male; Middle Aged; Omalizumab; Retrospective Studies; Surveys and Questionnaires; Treatment Outcome; Young Adult

2011
Achieving control of asthma in preschoolers.
    CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2010, Mar-09, Volume: 182, Issue:4

    Topics: Albuterol; Amoxicillin; Anti-Infective Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchiolitis; Bronchodilator Agents; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Male; Practice Guidelines as Topic; Respiratory Syncytial Virus Infections

2010
Children in the ACT with asthma--are they taking preventer medication according to guidelines?
    Australian family physician, 2010, Volume: 39, Issue:3

    To ascertain whether children with asthma in the Australian Capital Territory were taking preventer medications in accordance with National Asthma Council Australia guidelines.. Questionnaires were distributed to all parents who indicated in an ACT wide survey of school entry children in 2005 that their child had asthma (n=435), or experienced asthma symptoms/took asthma medication (n=501), exploring dose, frequency and mode of delivery of preventer their child was currently taking.. Data were available for 256 children (response rate 27%). Of the children with parent reported asthma (n=435) the response rate was 42%. Eighty-three (32%) children were currently taking preventers; complete medication details were provided for 60 children. A total of 32% of children on preventers were taking doses of preventers not in accordance with guidelines, while 80% of children were taking their medications at frequencies, or using delivery devices, not in accordance with guidelines.. This study suggests that home medical management of asthma with preventers for children may not be optimal.

    Topics: Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Australian Capital Territory; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Child Welfare; Female; Fluticasone; Glucocorticoids; Health Status Indicators; Health Surveys; Humans; Male; Medication Adherence; Pediatrics; Practice Guidelines as Topic; Severity of Illness Index; Surveys and Questionnaires

2010
[Bronchial thermoplasty in asthma: an updated review].
    Archivos de bronconeumologia, 2010, Volume: 46, Issue:7

    Topics: Adrenergic alpha-Agonists; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchi; Catheter Ablation; Combined Modality Therapy; Double-Blind Method; Humans; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Treatment Outcome

2010
Assessment of inhaled corticosteroid treatment response in asthma using hypertonic histamine challenge-induced cough.
    The clinical respiratory journal, 2010, Volume: 4, Issue:2

    Bronchial provocation tests may be utilised to monitor the efficacy of the corticosteroid treatment. Unfortunately, these measurements necessitate good patient cooperation during the spirometry. Coughing during such tests is related to the degree of the bronchoconstriction and occurs involuntarily, i.e. independent of patient cooperation. This study aimed to evaluate the utility of a hypertonic histamine challenge-induced cough in assessing the efficacy of inhaled corticosteroid treatment.. A total of 16 steroid-naïve asthmatics and 10 non-asthmatic, symptomatic controls received 800-microg beclomethasone (Beclomet Easyhaler(R), Orion Ltd., Orion Pharma, Helsinki, Finland) via powder inhaler per day for 8 weeks. Videoed inhalation challenge with hypertonic histamine solution was performed before and after the treatment. Symptom questionnaire was completed before both challenges. The airway responsiveness to hypertonic histamine was expressed as the cumulative number of coughs divided by the final histamine concentration administered [coughs/concentration ratio (CCR)] and as the provocative concentration of histamine to induce a 20% fall in FEV(1)(PC(20)).. CCR [geometric mean; 95% confidence interval (CI)] of the asthmatic subjects decreased from 494 (209-1168) to 73.6 (29.8-182) coughs per mg/mL (P = 0.002). Their PC(20) levels were 1.31 (1.07-1.60) and 1.91 (1.33-2.74) mg/mL over the treatment period (P = 0.01). The symptom frequency also decreased significantly in the asthmatics (P = 0.039). There were no significant changes in PC(20) level, in CCR level or in symptom frequency in non-asthmatic subjects during the treatment.. Hypertonic histamine challenge-induced cough and PC(20) are sensitive measures in assessing the treatment effect in asthma. The cough response may be especially useful in subjects who cannot perform spirometry reliably.

    Topics: Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Bronchial Provocation Tests; Case-Control Studies; Dose-Response Relationship, Drug; Female; Forced Expiratory Volume; Glucocorticoids; Histamine; Humans; Male; Middle Aged; Spirometry

2010
Prescribing practices and asthma control with hydrofluoroalkane-beclomethasone and fluticasone: a real-world observational study.
    The Journal of allergy and clinical immunology, 2010, Volume: 126, Issue:3

    Long-term randomized trials comparing asthma outcomes between inhaled corticosteroids in real-world populations are lacking. As such, rigorously conducted observational studies to complement the findings of randomized trials are needed.. We sought to compare asthma-related outcomes over 1 year as recorded in a large primary care database for patients aged 5 to 60 years receiving a first prescription (initiation population) or dose increase (step-up population) of hydrofluoroalkane (HFA)-beclomethasone or fluticasone.. We used a retrospective matched cohort study in which patients were matched on baseline demographic and disease severity measures. Coprimary outcomes were asthma control (a composite measure comprising no unplanned visit or hospitalization for asthma, oral corticosteroids, or antibiotics for lower respiratory tract infection) and exacerbation rate.. More than 80% of patients in each population achieved asthma control; 10% and 16% of patients in the initiation and step-up populations, respectively, received add-on or combination therapy during the year. Fluticasone was prescribed at significantly higher doses than HFA-beclomethasone for both populations (P

    Topics: Adolescent; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Fluticasone; Humans; Longitudinal Studies; Male; Middle Aged; Practice Guidelines as Topic; Retrospective Studies; Treatment Outcome

2010
Factors predicting inhaled corticosteroid responsiveness in African American patients with asthma.
    The Journal of allergy and clinical immunology, 2010, Volume: 126, Issue:6

    African American patients disproportionately experience uncontrolled asthma. Treatment with an inhaled corticosteroid (ICS) is considered first-line therapy for persistent asthma.. We sought to determine the degree to which African American patients respond to ICS medication and whether the level of response is influenced by other factors, including genetic ancestry.. Patients aged 12 to 56 years who received care from a large health system in southeast Michigan and who resided in Detroit were recruited to participate if they had a diagnosis of asthma. Patients were treated with 6 weeks of inhaled beclomethasone dipropionate, and pulmonary function was remeasured after treatment. Ancestry was determined by genotyping ancestry-informative markers. The main outcome measure was ICS responsiveness defined as the change in prebronchodilator FEV(1) over the 6-week course of treatment.. Among 147 participating African American patients with asthma, average improvement in FEV(1) after 6 weeks of ICS treatment was 11.6%. The mean proportion of African ancestry in this group was 78.4%. The degree of baseline bronchodilator reversibility was the only factor consistently associated with ICS responsiveness, as measured by both an improvement in FEV(1) and patient-reported asthma control (P = .001 and P = .021, respectively). The proportion of African ancestry was not significantly associated with ICS responsiveness.. Although baseline pulmonary function parameters appear to be associated with the likelihood to respond to ICS treatment, the proportion of genetic African ancestry does not. This study suggests that genetic ancestry might not contribute to differences in ICS controller response among African American patients with asthma.

    Topics: Administration, Inhalation; Adolescent; Adult; Asthma; Beclomethasone; Black or African American; Child; Female; Genetic Predisposition to Disease; Humans; Male; Middle Aged; Prognosis; Treatment Outcome; United States

2010
Products at risk.
    The New England journal of medicine, 2010, Oct-28, Volume: 363, Issue:18

    Topics: Administration, Inhalation; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Cholinergic Antagonists; Comparative Effectiveness Research; Cross-Over Studies; Drug Industry; Drug Therapy, Combination; Glucocorticoids; Humans; Placebos; Salmeterol Xinafoate; Scopolamine Derivatives; Tiotropium Bromide

2010
Anticholinergics for patients with asthma?
    The New England journal of medicine, 2010, Oct-28, Volume: 363, Issue:18

    Topics: Administration, Inhalation; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Cholinergic Antagonists; Drug Therapy, Combination; Glucocorticoids; Humans; Salmeterol Xinafoate; Scopolamine Derivatives; Tiotropium Bromide

2010
[The curative effect of inhaled vitamin A with corticosteroid on rat after asthmatic pneumonia and its influence on TSLP expression].
    Zhongguo ying yong sheng li xue za zhi = Zhongguo yingyong shenglixue zazhi = Chinese journal of applied physiology, 2010, Volume: 26, Issue:3

    To study the alteration of thymus matrix lymphocyte generator (TSLP) and change of the Th factor in the course of disease development, and to analyze the curative effect of inhalation of Vitamin A (VA) with corticosteroid for the treatment of asthmatic pneumonia.. Asthmatic pneumonia models were prepared by challenging rats with inhalation of ovalbumin for 4 weeks, and rested for 1 week. The treatment with VA and corticosteroid inhalation for 1 week was followed. The rat thymus and lung specimen were examen by histochemical and immunofluorescence staining.. After 4 - 5 weeks of stimulation, there were more TSLP-positive cells and alveolar macrophages (AM) found in thymus and lung tissue of asthmatic group, the cell proliferation in spleen and thymus was obvious, and blood Th factors elevated. The inflammation within the lung tissue aggravated gradually. In VA group, the expression of TSLP and Th2 factors were all lowered at the 4th week. The TSLP expression slightly increased at the 5th week, and the cell proliferation within T-cell zone of spleen and thymus was strong at first and weakened later. Alveolar microphages (AM) increased significantly and the inflammation in the lung subsided gradually at the 5th week. In the hormone group, TSLP and Th2 factors expression in both thymus and lung were decreased at the 5th week, while the cell proliferation in thymus and lung was gradually increased. The quantity of AM was decreased, whereas the inflammation of the lung was increased gradually at the 5th week.. During asthmatic period elevated TSLP expression was accompanied by Th2 type responses while VA and corticosteroid both suppressed TSLP and Th2 factors expression. VA alone promoted T lymphocyte proliferation as well as the antigen elimination function by AM, after ceasing the usage, the lung inflammation abated gradually. In contrast, after ceasing the use of corticosteroid, inflammation aggravated.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Animals; Asthma; Beclomethasone; Cytokines; Pneumonia; Rats; Rats, Sprague-Dawley; Thymic Stromal Lymphopoietin; Vitamin A

2010
Anti-asthmatic drug prescriptions to an Italian paedriatic population.
    Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2009, Volume: 20, Issue:6

    To estimate the prevalence and evaluate the appropriateness of anti-asthmatic drug prescriptions in an Italian paediatric population, drug prescriptions involving 24,407 children <18 years old, dispensed during 2003 by the retail pharmacies of the local health unit in Lecco, Italy, were analysed. Children > or = 6 years old receiving anti-asthmatics were categorized into three subgroups based on the number of boxes prescribed: occasional (one box), low (two and three boxes) and high (> or = four boxes) users. A logistic regression analysis was performed to estimate the relationship between the drug use patterns and formulations, antibiotic co-prescriptions, systemic steroid prescriptions and rate of hospitalization. Anti-asthmatic drugs were prescribed to 6594 (12%) children and adolescents; 58% of whom received only one box of the drug. Prevalence varied according to age, with the highest values at 1 and 4 years (24% and 21% respectively), and decreased to 6% in 17-year-old adolescents. Inhaled steroids were the most prescribed drugs (83%). The most common of these was beclomethasone. Occasional, low and high users represented 58%, 29%, and 13%, respectively, of the treated population > or = 6 years old. High users were found to be at increased risk of systemic steroid prescriptions (OR 8.6) and hospital admission for asthma (OR 6.8). This study confirms that in Italy the prevalence of anti-asthmatic prescription is much higher than prevalence of disease, indicating that anti-asthmatics are over-prescribed. Moreover, steroids, especially nebulized, are mainly prescribed only once in a year, supporting the idea that are prescribed not for asthma, which as chronic disease requires a chronic therapy. The approach to create subgroups on the basis of number of boxes prescribed seems to be effective in estimating asthma severity and appropriateness of the therapies.

    Topics: Adolescent; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Drug Prescriptions; Drug Utilization; Female; Humans; Italy; Male; Pediatrics; Young Adult

2009
Adherence rate to inhaled corticosteroids and their impact on asthma control.
    Allergy, 2009, Volume: 64, Issue:5

    Poor asthma control is associated to high morbidity. The objective of this study was to assess the association between adherence rates to beclomethasone dipropionate (BDP) and the degree of asthma control.. A cohort concurrent study was carried out for 12 months with 122 asthmatic patients, aged 3-12 years, randomly selected in a pediatric pulmonology outpatient clinic, who received BDP free of charge. Adherence rates were verified by pharmacy records. Clinical control was assessed through a scoring system comprised four variables (nocturnal and morning symptoms, limitation of physical activities and exacerbations). Total score was 16 points. Patients whose score was below or equal to two were considered controlled (group 1), and patients whose score was above or equal to three were considered uncontrolled (group 2). For patients able to perform spirometry, we considered as controlled the patients with forced expiratory volume in 1 s (FEV(1)) equal to or above 80% of the predicted value, and as uncontrolled the patients with FEV(1) below 80%.. Fewer than half (40.3% maximum) of the 122 patients maintained asthma control. Median adherence rate of groups 1 and 2 were 85.5% and 33.8%, (P < 0.001) in the 4th month, 90.0% and 48.0% (P < 0.001) in the 8th month and 84.4% and 47.0% in the 12th month (P < 0.001), respectively.. In all periods, there were statistically significant differences in adherence rates for maintaining or not maintaining the asthma control. Optimal asthma control entailed adherence rate higher than 80%. Strategies for reducing asthma morbidity should include a regular monitoring of adherence to inhaled steroids.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Female; Humans; Male; Medication Adherence; Treatment Outcome

2009
Comparative in vitro evaluation of four corticosteroid metered dose inhalers: Consistency of delivered dose and particle size distribution.
    Respiratory medicine, 2009, Volume: 103, Issue:8

    Recent developments concerning pressurized metered dose inhalers (pMDIs) with inhaled corticosteroids (ICS) are the introduction of ciclesonide and the replacement of propellants. As the results of in vivo studies depend on pMDIperformance, it is necessary to evaluate pMDIs in vitro for delivered dose and particle size distributions under different conditions.. Fluticasone 125microg, budesonide 200microg, beclomethasone HFA100microg, and ciclesonide 160microg were compared for delivered dose and particle size using laser diffraction analysis with inspiratory flow rates of 10, 20 and 30l/s.. The volume median diameter of budesonide was 3.5microm, fluticasone 2.8microm, beclomethasone and ciclesonide both 1.9microm. The mouthpiece retention was up to 30% of the nominal dose for beclomethasone and ciclesonide, 11-19% for the other pMDIs. Lifespan, flow rate, and air humidity had no significant influence on particle size distribution. The delivered dose of beclomethasone, budesonide, and ciclesonide remained constant over the lifespan. The delivered dose of fluticasone 125 decreased from 106% to 63%; fluticasone 250 also decreased whereas fluticasone 50 remained constant.. There is a significant difference in median particle size distribution between the different ICS pMDIs. Air humidity and inspiratory flow rate have no significant influence on particle size distribution. Ciclesonide 160 and beclomethasone 100 deliver the largest fine particle fractions of 1.1-3.1microm. The changes in delivered dose during the lifespan for the fluticasone 125 and 250 may have implications for patient care.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Androstadienes; Asthma; Beclomethasone; Budesonide; Drug Delivery Systems; Equipment Design; Fluticasone; Humans; Materials Testing; Metered Dose Inhalers; Particle Size; Pregnenediones

2009
[Involvement of distal airways in symptoms, control and natural history of asthma].
    Revue des maladies respiratoires, 2009, Volume: 26, Issue:2

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Humans; Inflammation; Radiography, Thoracic

2009
Monitoring adherence to beclomethasone in asthmatic children and adolescents through four different methods.
    Allergy, 2009, Volume: 64, Issue:10

    Suboptimal adherence to inhaled steroids is a known problem in children and adolescents, even when medications are administered under parental supervision. This study aimed to verify the adherence rate to beclomethasone dipropionate (BDP) by four currently available methods.. In this concurrent cohort study, 102 randomly selected asthmatic children and adolescents aged 3-14 years were followed for 12 months. Adherence rate was assessed every 2 months by self and/or parent report, pharmacy dispensing data, electronic device (Doser); Meditrack Products, Hudson, MA, USA) monitor, and canister weight.. Mean adherence rates to BDP by self and/or parent report, pharmacy records, Doser, and canister weight were 97.9% (95% CI 88.0-98.6), 70.0% (95% CI 67.6-72.4), 51.5% (95% CI 48.3-54.6), and 46.3% (95% CI 44.1-48.4), respectively. Agreement analysis between (Doser) and canister weight revealed a weighted kappa equal to 0.76 (95% CI 0.65-0.87).. Adherence was a dynamic event and rates decreased progressively for all methods over the 12-month follow-up. Canister weight and electronic monitoring measures were more accurate than self/parent reports and pharmacy records. Rates obtained by these two methods were very close and statistical analysis also showed a substantial agreement between them. As measurements by canister weight are less costly compared with currently available electronic devices, it should be considered as an alternative method to assess adherence in both clinical research and practice.

    Topics: Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Cohort Studies; Drug Administration Schedule; Female; Humans; Male; Medical Records; Medication Adherence; Monitoring, Ambulatory; Pharmacies; Self Administration; Severity of Illness Index

2009
Analysis of inhaled corticosteroid selection in patients with bronchial asthma using a questionnaire survey--effects of age, gender, and disease severity.
    Allergology international : official journal of the Japanese Society of Allergology, 2009, Volume: 58, Issue:3

    Inhaled corticosteroid (ICS) has played an important role in the management of asthma. Although several kinds of ICSs are currently available, there is no established strategy for ICS selection.. Using the data from the 2004 questionnaire surveys by the Niigata Asthma Treatment Study Group, we analyzed relationships between each patient and the ICS employed on the basis of patient background, asthma control and treatment, and indicated characteristics of ICS selection by the physician.. Of 2852 cases, 2279 (79.9%) were ICS users, and 1513 (66.4% of ICS users) were classified as being in the fluticasone propionate (FP) group, 438 (19.2%) in the budesonide (BUD) group, and 240 (10.5%) in the hydrofluoroalkane-beclomethasone (HFA-BDP) group, indicating that FP was a standard ICS in this study. The mean age was significantly lower in the BUD group (52.3+/-18.2 years) and was significantly higher in the HFA-BDP group (59.9+/-17.0 years) than that in the FP group (55.8+/-16.6 years). The proportion of female patients was significantly higher not in the HFA-BDP (46.5%) but in the BUD group (59.0%) than in the FP group (51.1%). These results indicated that BUD was frequently prescribed to young female and HFA-BDP was employed in the elderly patients irrespective of gender compared with FP.. Our study indicates that ICS selection is reasonably adapted to each patient's background at least in the surveyed area. We need to elucidate the characteristics of ICS selection further in the future as new ICS and devices are developed.

    Topics: Administration, Inhalation; Age Factors; Androstadienes; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Drug Prescriptions; Female; Fluticasone; Humans; Hydrocarbons, Fluorinated; Japan; Male; Middle Aged; Retrospective Studies; Sex Factors; Surveys and Questionnaires; Treatment Outcome

2009
Inhaled steroid/tobacco smoke particle interactions: a new light on steroid resistance.
    Respiratory research, 2009, Jun-11, Volume: 10

    Inhaled steroid resistance is an obstacle to asthma control in asthmatic smokers. The reasons of this phenomenon are not yet entirely understood. Interaction of drug particles with environmental tobacco smoke (ETS) could change the aerodynamic profile of the drug through the particle coagulation phenomenon. Aim of the present study was to examine whether steroid particles interact with smoke when delivered in the presence of ETS.. Beclomethasone-hydrofluoralkane (BDP-HFA) pMDI particle profile was studied after a single actuation delivered in ambient air or in the presence of ETS in an experimental chamber using a light scattering Optical Particle Counter capable of measuring the concentrations of particle sized 0.3-1.0, 1.1-2.0, 2.1-3.0, 3.1-4.0, 4.1-5.0, and > 5.1 microm in diameter with a sampling time of one second. The number of drug particles delivered after a single actuation was measured as the difference between total particle number after drug delivery and background particle number. Two groups of experiments were carried out at different ambient background particle concentrations. Two-tail Student's t-test was used for statistical analysis.. When delivered in ambient air, over 90% of BDP-HFA particles were found in the 0.3-1.0 microm size class, while particles sized 1.1-2.0 microm and 2.1-3.0 represented less than 6.6% and 2.8% of total particles, respectively. However, when delivered in the presence of ETS, drug particle profile was modified, with an impressive decrease of 0.3-1.0 microm particles, the most represented particles resulting those sized 1.1-2.0 microm (over 66.6% of total particles), and 2.1-3.0 microm particles accounting up to 31% of total particles.. Our data suggest that particle interaction between inhaled BDP-HFA pMDI and ETS takes place in the first few seconds after drug delivery, with a decrease in smaller particles and a concurrent increase of larger particles. The resulting changes in aerosol particle profile might modify regional drug deposition with potential detriment to drug efficacy, and represent a new element of steroid resistance in smokers. Although the present study does not provide any functional or clinical assessment, it might be useful to advise smokers and non smokers with obstructive lung disease such as asthma or COPD, to avoid to act inhaled drugs in the presence of ETS in order to obtain the best therapeutic effect.

    Topics: Administration, Inhalation; Aerosols; Asthma; Beclomethasone; Drug Resistance; Glucocorticoids; Humans; Nicotiana; Particle Size; Pulmonary Disease, Chronic Obstructive; Smoke; Smoking; Steroids

2009
Outcomes and costs of patients with persistent asthma treated with beclomethasone dipropionate hydrofluoroalkane or fluticasone propionate.
    Advances in therapy, 2009, Volume: 26, Issue:8

    Examine outcomes and costs of patients with persistent asthma who initiated treatment with beclomethasone dipropionate hydrofluoroalkane (BDP-HFA) or fluticasone propionate (FP).. MedStat's Commercial Claims and Encounters database (July 1, 2002-June 30, 2007) was utilized. Patients (n=13,968) were included if they initiated treatment with BDP-HFA or FP (first use=index date). Patients also met these criteria: (a) no receipt of other study medication in the 1-year post-period; (b) persistent asthma in the 1-year pre-period; (c) age 5-64 years; (d) no diagnosis of chronic obstructive pulmonary disease; and (e) continuous insurance coverage from 1 year pre-period to 1 year post-period. Multivariate regressions examined the probability of an ER visit or hospitalization, probability of reaching alternative adherence thresholds, and costs.. Receipt of BDP-HFA, compared with FP, was associated with a 17% reduction in the odds of an ER visit (OR=0.834, 95% CI 0.751 to 0.925), a 30% reduction in the odds of an asthma-related ER visit (OR=0.697, 95% CI 0.571 to 0.852), and an increase in the odds of obtaining a medication possession ratio (MPR) of at least 50% (OR=1.324; 95% CI 1.164 to 1.506) or 75% (OR=1.311; 95% CI 1.072 to 1.604). Total medical costs ($5063 vs. $5377, P=0.0042), prescription drug costs ($2336 vs. $2581, P<0.0001), and ER costs ($185 vs. $249, P<0.0001) were significantly lower among the BDP-HFA cohort. Asthma-related outpatient ($191 vs. $224, P<0.0001) and ER costs ($28 vs. $45, P<0.001) were significantly lower in the BDP-HFA group, while asthma-related inpatient ($101 vs. $59, P<0.0001) and drug costs ($451 vs. $540, P<0.0001) were significantly lower in the FP cohort.. Results indicate that receipt of BDP-HFA, compared with receipt of FP, is associated with a decreased probability of ER visits or asthma-related ER visits and higher odds of reaching a medical possession ratio threshold of 50% or 75%. Receipt of BDP-HFA was also associated with lower total drug costs and lower total medical costs.

    Topics: Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Cost of Illness; Drug Costs; Drug Therapy, Combination; Emergency Service, Hospital; Female; Fluticasone; Health Care Costs; Hospitalization; Humans; Insurance Claim Reporting; Male; Medication Adherence; Middle Aged; Multivariate Analysis; Outcome Assessment, Health Care; Patient Selection; Regression Analysis; Retrospective Studies; United States

2009
On the superiority of BDP/FF HFA pMDI fixed combination over the free combination of BDP CFC pMDI and FF DPI.
    Respiratory medicine, 2009, Volume: 103, Issue:12

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Bronchodilator Agents; Drug Administration Schedule; Drug Combinations; Ethanolamines; Formoterol Fumarate; Humans; Metered Dose Inhalers; Powders

2009
Evaluation of asthma control using patient based measures and peak expiratory flow rate.
    The West Indian medical journal, 2009, Volume: 58, Issue:3

    Asthma control has not been formally evaluated in the Caribbean. This study evaluated disease control on The Asthma Control Test (ACT), The Royal College of Physicians "Three questions" for Assessing Asthma Control (RCP), peak expiratory flow rate (PEFR) and patients' self-assessment of control.. Asthma control was examined in a cross-section of 205 asthmatics above 16 years of age using the ACT, RCP and on the PEFR % predicted. Scores below 20 and equal to or above 1 on the ACT and RCP respectively, and PEFR below 80% predicted indicated uncontrolled asthma. Patients stated whether they perceived their asthma was controlled or uncontrolled.. Overall there were more females (63.9%, p < 0.001) than males (36.1%). Males aged between 17-30 years predominated (60.8%, p < 0.001) with gender reversal beyond 30 years of age (33.2%, p < 0.002) years. Self-assessed control was higher (69.3%, p < 0.001) than control evaluated by the ACT and RCP tests, which were comparable (p > 0.05). Fewer patients (13.2%) achieved control on PEFR > 80% predicted than on the ACT (22.4%) and RCP (18%). The Kappa statistic indicated good reproducibility of the RCP and ACT and concordance between the PEFR and RCP (0.63) and the PEFR and ACT (0.56). Higher education was associated with control on the ACT (p < 0.0005) and RCP (p < 0.002) but not on PEFR or self-assessment (p > 0.05).. Approximately 80% of study asthmatics were uncontrolled, and patients tended to overestimate their disease control. The ACT and RCP instruments were comparable with the PEFR. Efforts to study their validity and formal evaluation of asthma control in Trinidad are recommended.

    Topics: Adolescent; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Confidence Intervals; Cross-Sectional Studies; Female; Humans; Male; Middle Aged; Patient Compliance; Patient Satisfaction; Peak Expiratory Flow Rate; Respiratory Function Tests; Surveys and Questionnaires; Treatment Outcome; Young Adult

2009
Switching to CFC-free beclometasone for asthma.
    Drug and therapeutics bulletin, 2008, Volume: 46, Issue:6

    Chlorofluorocarbon (CFC) compounds, the traditional propellants in aerosol metered-dose inhalers (MDIs), damage the ozone layer in the atmosphere. Following adoption of the Montreal Protocol on Substances that Deplete the Ozone Layer almost 20 years ago, the UK Government produced a transition strategy to enable CFC-containing MDIs to be phased out as quickly as possible.(1, 2) Hydrofluoroalkanes (HFAs) are now being used as propellants in most MDIs (i.e. CFC-free inhalers). However, there have been particular difficulties in developing CFC-free beclometasone inhalers, as this drug dissolves in the new propellant. There are now two CFC-free beclometasone inhalers available in the UK - Qvar (Teva) and black triangle [see text for formula]Clenil Modulite (Trinity-Chiesi), both licensed for asthma. CFC-containing beclometasone MDIs will become unavailable as stocks run out (within the next year). Here we discuss the issues around switching to the CFC-free beclometasone inhalers.

    Topics: Administration, Inhalation; Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chlorofluorocarbons; Humans; Randomized Controlled Trials as Topic

2008
Type III IFN-lambda mRNA expression in sputum of adult and school-aged asthmatics.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2008, Volume: 38, Issue:9

    The increased susceptibility of asthmatics to rhinovirus infection has recently been related to deficient IFN-lambda 1 (IL-29) and IFN-lambda 2/3 (IL-28) production by bronchial epithelial cells and macrophages.. Here, we studied IFN-lambda mRNA expression in the airways of stable asthmatics in comparison with healthy subjects and in relation to asthma symptoms, non-invasive parameters of airway inflammation and lung function parameters.. Airway cells were obtained by sputum induction, in 14 healthy and 35 asthmatic adults and 12 asthmatic school-aged children. IFN-lambda was studied at the mRNA level by quantitative RT-PCR.. Asthmatic adults have increased sputum IL-28 mRNA but similar IL-29 mRNA expression in comparison with healthy subjects. In asthmatics, both sputum IL-28 and IL-29 mRNA expression correlate with the sputum CD3 gamma mRNA expression (reflecting infiltrated T cells). IL-28 (but not IL-29) mRNA levels correlate with the relative and absolute number of eosinophils present in the sputum sample. Sputum IL-29 mRNA (but not IL-28) correlates negatively with asthma symptoms in steroid-naive patients and is significantly higher in steroid-treated than in steroid-naive patients. Finally, both IL-28 and IL-29 mRNA levels are higher in asthmatic children than in asthmatic adults.. Our results show that asthmatic subjects have substantial type III IFN-lambda mRNA levels in the airways. Our data furthermore suggest that IL-29 could have an immunoprotective role in the lower airways.

    Topics: Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Female; Humans; Interferons; Interleukins; Male; Middle Aged; RNA, Messenger; Sputum; Young Adult

2008
Biochemical markers as a response guide for steroid therapy in asthma.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2008, Volume: 45, Issue:5

    Exhaled breath condensate pH and hydrogen peroxide concentration is a non-invasive, simple and inexpensive assay that can be performed for monitoring in patients with asthma.. To evaluate the possibility of usefulness of expired breath condensate pH and H(2)O(2) concentration as well as serum total antioxidant capacity and malondialdehyde as markers for steroid treatment response.. A total of 153 patients were included in this study (age range 18 to 64 years). Asthmatic patients, regularly followed for at least 3 months, were randomly recruited for the study over a period of one month. All patients received inhaled beclomethasone dipropionate (1,000 microg daily in four divided doses) and salbutamol inhalers (800 microg daily in four divided doses) for 4 weeks. Expired breath condensate was collected at the end of the study to determine hydrogen peroxide concentration and pH. Venous blood samples were collected for determination of total antioxidant capacity and malondialdehyde as markers of peroxidation.. In asthmatic patients with poorly controlled asthma, expired breath condensate hydrogen peroxide concentration was higher and the pH was lower than stable asthma. Serum malondialdehyde concentration in poorly controlled asthma was higher (6.98 micromol/L), and total antioxidant capacity was lower (589 micromol/L) than in stable asthma.. Exhaled hydrogen peroxide concentration and pH can be used as predictors for monitoring of nonresponse to asthma treatment.

    Topics: Administration, Inhalation; Adolescent; Adult; Albuterol; Asthma; Beclomethasone; Biomarkers; Breath Tests; Cohort Studies; Confidence Intervals; Drug Resistance; Female; Follow-Up Studies; Glucocorticoids; Humans; Hydrogen Peroxide; Hydrogen-Ion Concentration; Male; Malondialdehyde; Middle Aged; Monitoring, Physiologic; Predictive Value of Tests; Respiratory Function Tests; Retrospective Studies; Risk Assessment; Sensitivity and Specificity; Severity of Illness Index; Treatment Outcome

2008
[Effectiveness of inhaled corticosteroids (ics) combination therapy; the addition of qvar to flutide].
    Arerugi = [Allergy], 2008, Volume: 57, Issue:6

    We recently reported treatment of asthmatic patients with a combination of FP-DPI 800 microg/day and BDP-HFA 400 microg/day. This regimen induced significant improvement in subjective symptoms and pulmonary function tests. This led us to study the additive effect of BDP-HFA 400 microg/day for seven unstable severe persistent bronchial asthma patients.. PEF improved, daily (circadian) variation was minimized and FVC and FEV1.0 testing showed slight improvement. V25/height also revealed significant improvement. The more peripheral the airways are, the greater improvement was observed. The annual emergency admission rate of 4.6 times per patient decreased to 2.1 times after the addition of BDP-HFA 400 microg/day. All the three cases dependent on oral steroid medication could be removed from the drug and 6 out of 7 cases were able to lower the dose of anti-asthmatic drugs.. The effectiveness of inhaled corticosteroids (ICS) differs based on the site reached in the bronchi and depending on the inhalation devices used. Addition of a second ICS has the potential to further alleviate symptoms of unstable asthmatics on conventional therapy with ICS and other drugs.

    Topics: Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Drug Therapy, Combination; Female; Fluticasone; Humans; Male; Middle Aged; Treatment Outcome

2008
Strategies to screen for adrenal suppression in children with asthma: there is no consensus among UK centres.
    Thorax, 2008, Volume: 63, Issue:9

    Topics: Adrenal Cortex Hormones; Adrenal Insufficiency; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Consensus; Fluticasone; Health Policy; Humans; Hydrocortisone; Prednisolone

2008
Personality influences the reporting of side effects of inhaled corticosteroids in asthma patients.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2008, Volume: 45, Issue:8

    Negative affectivity is a measure of anxiety associated with increased reporting of symptoms. Few studies have explored this association with respect to drug-induced symptoms in patients taking medication for a chronic disease in real life.. In this cross-sectional study we examined the relationship between negative affectivity and self-reported side effects of inhaled corticosteroids in patients with asthma. We also investigated differential associations due to side effect type (subjective versus observable side effects) and treatment impact (i.e., hierarchical dosing).. A total of 228 asthma patients, taking inhaled corticosteroids, completed scales measuring inhaled corticosteroid-induced side effects (Inhaled Corticosteroid Questionnaire scored: 0 = none; 100 = worst) and negative affectivity (Positive and Negative Affect Schedule scored: 10-50). Patients were grouped into low, average, and high negative affectivity groups based on published norms.. Patients high in negative affectivity reported significantly greater (p < 0.001) side effects (median score 20.5 (IQR: 11.4-33.0) than the groups of patients scoring lower on this measure (low negative affectivity: 7.1 (3.1-15.6); average: 13.3 (4.9-23.3)). The relationship between negative affectivity and side effects was stronger among patients taking low (r = 0.40-0.45) rather than mid to high inhaled corticosteroid doses (r = 0.16-0.28).. Asthma patients with higher negative affectivity using inhaled corticosteroids report increased medication-induced symptoms. Clinicians should be aware that aside from inhaled corticosteroid dosage, the personality of the patient is an important factor in the reporting of drug-related side effects.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Adverse Drug Reaction Reporting Systems; Aged; Asthma; Beclomethasone; Cross-Sectional Studies; Female; Humans; Male; Middle Aged; Personality; Surveys and Questionnaires

2008
Cost effectiveness of asthma treatment with a breath-actuated inhaler: how has the story changed?
    Journal of medical economics, 2008, Volume: 11, Issue:3

    A database analysis evaluating the comparative costs and outcomes of asthma treatment with breath-actuated inhalers (BAIs) and metered-dose inhalers (MDIs) has previously been undertaken in 2001. This analysis found that, despite the higher acquisition cost associated with BAIs, economies elsewhere meant that the overall cost associated with BAIs was lower than MDIs. Between 2001 and 2007, the comparative price of MDIs was significantly reduced thus widening the gap between the comparative acquisition cost of MDIs and BAIs. Furthermore, the introduction of specific targets for asthma review included a requirement for regular checks on inhaler technique. Such initiatives may be expected to enhance the overall effectiveness of MDIs. Given the potential impact of such changes, it appeared to be timely to update the original database analysis to assess the extent to which the original findings have been altered by changes in the clinical and economic environment over the past 5 years.. As in all chronic diseases, it is important that economic analyses evaluate cost effectiveness over as long a period as possible, and so the 2006 analysis was conducted over a 12- and a 24-month time period.. The results emphasised that the clinical benefits associated with BAIs for certain patients can still be translated into greater cost effectiveness, but that altered cost structures required a longer time period for the greater cost effectiveness of BAIs to become evident.. Since completing this study, the reimbursement costs for beclometasone MDIs have increased significantly (since October 2007) due to the discontinuation of Becotide and Becloforte. As a consequence of this higher acquisition cost for MDI inhalers, the current cost-effectiveness advantages of BAI compared to MDI can be expected to be even greater than that identified in the study.

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Cohort Studies; Cost-Benefit Analysis; Fees, Pharmaceutical; Health Expenditures; Humans; Nebulizers and Vaporizers; Retrospective Studies

2008
Influence of allergy in patients with nasal polyposis after endoscopic sinus surgery.
    Acta oto-laryngologica, 2008, Volume: 128, Issue:2

    Allergy does not modify the symptoms and steroid consumption (oral and local) of nasal polyposis (NP) patients after functional endoscopic sinus surgery (FESS).. To assess the role of allergy in the evolution after FESS of patients presenting with the diagnosis of NP.. This was a prospective study of 63 consecutive patients with NP (57% males, mean age 45.8 years), who were analyzed to detect whether the results of a surgical treatment of NP were influenced by the presence of positive allergic tests (Phadiatop). Three nasal criteria were scored: nasal obstruction, posterior rhinorrhea, and the loss of smell. The frequency of asthma was evaluated. Medical treatment of NP after FESS consisted of washing of the nasal cavities, steroid spray, and oral steroid administration. The amount of consumption of steroids (prednisolone and beclomethasone) was studied.. Decrease of all nasal symptoms was not statistically different in the two groups of patients with and without allergy. Cumulative consumption of prednisolone and beclomethasone after surgery was similar in the two groups.

    Topics: Adult; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Combined Modality Therapy; Cross-Sectional Studies; Endoscopy; Ethmoid Sinusitis; Female; Follow-Up Studies; Humans; Male; Middle Aged; Nasal Obstruction; Nasal Polyps; Olfaction Disorders; Postoperative Complications; Prednisolone; Recurrence; Respiratory Hypersensitivity

2008
Treatment of mild persistent asthma.
    Primary care respiratory journal : journal of the General Practice Airways Group, 2008, Volume: 17, Issue:4

    There are several treatment options available for patients who have mild persistent asthma. After being shown a typical case study and three possible treatment options, three respiratory specialists each selected a different option. The options were: using a combination beclometasone/albuterol inhaler on an as-needed basis; daily treatment with an oral leukotriene receptor antagonist together with asneeded use of a short-acting beta2-agonist (SABA) inhaler; and using a combination inhaled corticosteroid/long-acting beta2-agonist inhaler once-daily together with as-needed SABA. The evidence for each option is reviewed in the light of recent research.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Leukotriene Antagonists; Severity of Illness Index

2008
Seasonal allergic rhinitis: limited effectiveness of treatments.
    Prescrire international, 2008, Volume: 17, Issue:93

    (1) Seasonal allergic rhinitis, otherwise known as hayfever, is a harmless condition, although it can cause major discomfort and interfere with activities of daily living. We conducted a review of the literature, based on our in-house methodology, to determine the risk-benefits of treatments used in this setting. (2) Placebo-controlled trials show that sodium cromoglicate relieves symptoms, especially if it is used before symptoms appear. Adverse effects are rare with sodium cromoglicate nasal solutions and eye drops. (3) Nasal steroids have well-documented efficacy. Beclometasone is the best choice. Adverse effects include epistaxis, nasal irritation and, occasionally, systemic disorders. (4) Oral antihistamines are less effective than nasal steroids. They also provoke adverse effects, especially drowsiness. Nasal azelastine seems to have a similar efficacy as oral antihistamines. (5) The adverse effects of systemic steroids must not be overlooked, especially with long-term use. Oral administration is an alternative for severe symptoms that do not respond to other treatments, although this is rarely the case. Long-acting intramuscular steroids carry an increased risk of adverse effects. (6) Despite evaluation in several randomised controlled trials, there is no firm evidence that homeopathic preparations have any specific efficacy in allergic rhinitis. (7) Vasoconstrictors, ipratropium and montelukast, have negative risk-benefit balances in hay fever. (8) When a single allergen is responsible (grasses, ragweed, birch), clinical trials suggest that specific desensitisation can provide a modest improvement. However, this treatment carries a risk of local adverse effects, as well as a risk of rare but severe anaphylactic reactions, especially in patients who also have unstable severe asthma. (9) Sublingual desensitisation seems to be even less effective than subcutaneous desensitisation in adults. Follow-up is too short to know whether there is a risk of severe anaphylactic reactions. The results of paediatric studies are even less convincing. (10) In practice, when drug therapy is needed to relieve symptoms of seasonal allergic rhinitis, sodium cromoglicate is the first-line treatment. If a nasal steroid solution is chosen, it should be used for the shortest possible period.

    Topics: Acetates; Adrenal Cortex Hormones; Adult; Allergens; Asthma; Beclomethasone; Child; Cost-Benefit Analysis; Cromolyn Sodium; Desensitization, Immunologic; Female; Histamine H1 Antagonists; Homeopathy; Humans; Ipratropium; Male; Pollen; Pregnancy; Quinolines; Rhinitis, Allergic, Seasonal; Steroids; Vasoconstrictor Agents

2008
Glucocorticoids ameliorate antigen-induced bronchial smooth muscle hyperresponsiveness by inhibiting upregulation of RhoA in rats.
    Journal of pharmacological sciences, 2008, Volume: 106, Issue:4

    To determine the mechanism(s) of the inhibitory effect of glucocorticoids on airway hyperresponsiveness in allergic bronchial asthma, the effects of systemic treatment with glucocorticoids on bronchial smooth muscle hyperresponsiveness and RhoA upregulation were investigated in rats with allergic bronchial asthma. Rats were sensitized and repeatedly challenged with 2,4-dinitrophenylated Ascaris suum antigen. Animals were also treated with prednisolone or beclomethasone (each 10 mg/kg, i.p.) once a day during the antigen inhalation period. Repeated antigen inhalation caused a marked bronchial smooth muscle hyperresponsiveness to acetylcholine with an upregulation of RhoA. Augmented acetylcholine-induced activation of RhoA and phosphorylation of myosin light chain were observed in bronchial smooth muscles of the antigen-exposed animals. Systemic treatment with either glucocorticoid used inhibited the bronchial smooth muscle hypercontraction until the level of the sensitized control rats that received saline inhalation instead of antigen challenge. Interestingly, both glucocorticoids also inhibited the upregulation of RhoA and augmented acetylcholine-induced activation of RhoA and phosphorylation of myosin light chain. In conclusion, glucocorticoids ameliorated the augmented bronchial smooth muscle contraction by inhibiting upregulation of RhoA. These effects of glucocorticoids may account for, in part, their beneficial effects in the treatment of asthma.

    Topics: Acetylcholine; Animals; Anti-Asthmatic Agents; Antigens, Helminth; Ascaris suum; Asthma; Beclomethasone; Bronchi; Bronchial Hyperreactivity; Bronchoconstrictor Agents; Dose-Response Relationship, Drug; Enzyme Activation; Glucocorticoids; Humans; Muscle, Smooth; Myosin Light Chains; Phosphorylation; Prednisolone; Rats; Rats, Wistar; rhoA GTP-Binding Protein; Up-Regulation

2008
One-year evaluation of the preventative effect of hydrofluoroalkane-beclomethasone dipropionate on eosinophilic inflammation of asthmatic peripheral airways.
    Respiration; international review of thoracic diseases, 2007, Volume: 74, Issue:2

    In asthmatic patients with eosinophilic inflammation of the peripheral airways, appropriate drug delivery to the affected area is required.. It was the aim of this study to assess persistent eosinophilic inflammation of the peripheral airways in asthmatic patients, stabilized by the long-term use of dry powder type inhaled steroids, and to evaluate the clinical efficacy of hydrofluoroalkane-beclomethasone dipropionate (HFA-BDP) over 1 year.. Seventy-four outpatients with moderate stable asthma were studied for at least 6 months, 37 treated with fluticasone propionate Diskus (FP-DK) and 37 with budesonide Turbuhaler (BUD-TH). The eosinophil count, eosinophil cationic protein (ECP), eotaxin and RANTES levels in 10% hypertonic saline-induced sputum were examined before treatment, as well as 4 weeks, 8 weeks, 6 months and 1 year after switching patients to HFA-BDP.. Fifteen patients (40.5%) in the FP-DK group and 12 (32.4%) in the BUD-TH group had eosinophils in induced sputum. The sputum ECP in the eosinophil-positive and the eosinophil-negative groups was 1,510.1 +/- 2,009.3 versus 426.6 +/- 464.1 microg/l (p = 0.037) in the FP-DK group, and 3,850.0 +/- 5,486.2 versus 492.0 +/- 1,150.7 microg/l (p = 0.011) in the BUD-TH group, respectively. Four weeks after the switch to HFA-BDP, the number of eosinophil-positive patients decreased in both groups. Significant reductions in sputum ECP and eotaxin were observed at 8 weeks, and their concentrations continued decreasing for 1 year.. There is a certain proportion of asthmatic patients for whom long-term treatment with dry powder type steroids may not be suitable; however, their peripheral airway inflammation improved after switching them to HFA-BDP, suggesting its excellent delivery.

    Topics: Administration, Inhalation; Aerosol Propellants; Aged; Asthma; Beclomethasone; Bronchitis; Eosinophilia; Eosinophils; Female; Follow-Up Studies; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Leukocyte Count; Male; Middle Aged; Sputum; Time Factors; Treatment Outcome; Vital Capacity

2007
Spacer inhalation technique and deposition of extrafine aerosol in asthmatic children.
    The European respiratory journal, 2007, Volume: 29, Issue:2

    The aim of the present study was to measure airway, oropharyngeal and gastrointestinal deposition of (99m)Tc-labelled hydrofluoroalkane-beclomethasone dipropionate after inhalation via a pressurised metered-dose inhaler and spacer (Aerochamber Plus) in asthmatic children. A group of 24 children (aged 5-17 yrs) with mild asthma inhaled the labelled drug. A total of 12 children took five tidal breaths after each actuation (tidal group). The other 12 children used a slow maximal inhalation followed by a 5 - 10-s breath-hold (breath-hold group). Simultaneous anterior and posterior planar gamma-scintigraphic scans (120-s acquisition) were recorded. For the tidal group, mean+/-sd lung deposition (% ex-actuator, attenuation corrected) was 35.4+/-18.3, 47.5+/-13.0 and 54.9+/-11.2 in patients aged 5-7 (n = 4), 8-10 (n = 4) and 11-17 yrs (n = 4), respectively. Oropharyngeal and gastrointestinal deposition was 24.0+/-10.5, 10.3+/-4.4 and 10.1+/-6.2. With the breath-hold technique, lung deposition was 58.1+/-6.7, 56.6+/-5.2 and 58.4+/-9.2. Oropharyngeal and gastrointestinal deposition was 12.9+/-3.2, 20.1+/-9.5 and 20.8+/-8.8. Inhalation of the extrafine formulation with the breath-hold technique showed significantly improved lung deposition compared with tidal breathing across all ages. Oropharyngeal and gastrointestinal deposition was markedly decreased, regardless of which inhalation technique was applied, compared with a previous paediatric study using the same formulation delivered via a breath-actuated metered-dose inhaler.

    Topics: Administration, Inhalation; Adolescent; Aerosols; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Female; Gastrointestinal Tract; Humans; Lung; Male; Metered Dose Inhalers; Oropharynx; Radionuclide Imaging; Tissue Distribution

2007
Treatment and outcomes in patients with asthma and allergic rhinitis in the United kingdom.
    International archives of allergy and immunology, 2007, Volume: 142, Issue:4

    Since allergic rhinitis in asthma patients is associated with worse asthma control, the treatment of the comorbid condition may improve outcomes.. A 1-year retrospective study using the UK Mediplus database (2001-2004) included asthmatic patients aged 15-55 with allergic rhinitis. Patients starting therapy based on the Global Initiative for Asthma guidelines, defined as an increase in inhaled corticosteroids (high-dose inhaled corticosteroids, hdICS), or the addition of montelukast (ICS+MON) or long-acting beta-agonists (ICS+LABA) to ICS, were studied. Univariable and multiple logistic regressions evaluated asthma-related outcomes.. Among 2,596 asthma and allergic rhinitis patients, 83.2% initiated ICS+LABA, 12.1% hdICS and 4.7% ICS+MON. The mean age was 34 years and 60% were female. ICS+MON patients had more moderate-severe asthma (p = 0.04). Approximately 84% of the ICS+LABA patients experienced an asthma control failure compared to 50% in the other groups (p < 0.0001). The proportions of patients requiring treatment change were 73.8, 22 and 27.3% in the ICS+LABA, hdICS and ICS+MON groups, respectively (p = 0.001). Asthma-related resource use was similar among all groups. The ICS+MON group received fewer mean prescriptions for oral corticosteroids (p = 0.024) than the other groups (p = 0.026).. In asthma and allergic rhinitis, treatment with ICS+MON or hdICS was associated with lower rates of asthma control failure and fewer treatment changes than the ICS+LABA group. MON users also required fewer oral corticosteroids.

    Topics: Acetates; Adolescent; Adrenergic beta-Agonists; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Cohort Studies; Comorbidity; Cyclopropanes; Drug Therapy, Combination; Female; Fluticasone; Humans; Male; Middle Aged; Quinolines; Rhinitis; Sulfides; Treatment Outcome; United Kingdom

2007
Hypertrichosis as a side effect of inhaled steroids in children.
    Pediatric pulmonology, 2007, Volume: 42, Issue:4

    Three spontaneous reports of patients in whom a relationship between hypertrichosis and inhaled corticosteroids (ICS) was suspected, were reported to Lareb, The Netherlands Pharmacovigilance Center. We sought evidence for and against a causal relationship between hypertrichosis and ICS in children. The relationship between hypertrichosis and ICS was studied mathematically by assessing the Reporting Odds Ratio (ROR) and by determining the Naranjo Score (NS). We also studied the reports sent to the Pharmacovigilance Database of the Uppsala Monitoring Centre (UMC) of the WHO and reviewed the literature. In the Dutch children, the ROR between hypertrichosis and ICS was 14.6 (95%CI 3.6-59.5), the NS was 4. In the database of the UMC 20 more reports on hypertrichosis and ICS were found, contributing to the results of the Dutch database. Taken together, 11 boys and 12 girls were involved with a mean age of 7 years (range 1-17). The time between the start of ICS and the occurrence of hypertrichosis varied between 1 month and 3 years. Besides the hypertrichosis, growth retardation was found in 5 children and adrenal suppression in 12. In 12 children the outcome after cessation was reported: in 6 children the hypertrichosis improved, whilst in 6 it did not. We found sufficient evidence to support the suspicion that hypertrichosis might be a true adverse effect of ICS. We found no simple dose-effect relationship but obviously there is an individual susceptibility. After cessation of ICS the exaggerated hair growth will not disappear in all children. Hypertrichosis may be a useful clinical pointer to exogenous steroid excess.

    Topics: Adolescent; Androstadienes; Asthma; Beclomethasone; Budesonide; Child; Child, Preschool; Databases as Topic; Female; Fluocinolone Acetonide; Fluticasone; Glucocorticoids; Humans; Hypertrichosis; Infant; Male; Nebulizers and Vaporizers

2007
Clinical Decisions. Treatment of mild persistent asthma.
    The New England journal of medicine, 2007, May-17, Volume: 356, Issue:20

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Leukotriene Antagonists

2007
Clinical Decisions. Mild persistent asthma--polling results.
    The New England journal of medicine, 2007, Jul-12, Volume: 357, Issue:2

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Therapy, Combination; Glucocorticoids; Humans; Leukotriene Antagonists

2007
Beclomethasone and albuterol in mild asthma.
    The New England journal of medicine, 2007, Aug-02, Volume: 357, Issue:5

    Topics: Administration, Inhalation; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Combinations; Humans; Peak Expiratory Flow Rate; Sensitivity and Specificity

2007
Beclomethasone and albuterol in mild asthma.
    The New England journal of medicine, 2007, Aug-02, Volume: 357, Issue:5

    Topics: Administration, Inhalation; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Drug Combinations; Humans

2007
How much is too much? The treatment of mild asthma.
    The European respiratory journal, 2007, Volume: 30, Issue:3

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Disease Progression; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Ethanolamines; Forced Expiratory Volume; Formoterol Fumarate; Humans; Leukotriene Antagonists; Peak Expiratory Flow Rate; Practice Guidelines as Topic; Randomized Controlled Trials as Topic

2007
Long-term asthma therapy: adapt steroid therapy to severity.
    Prescrire international, 2007, Volume: 16, Issue:91

    (1) Asthma is influenced by a variety of factors and its natural history varies over time. Clinically, asthma ranges from fleeting respiratory discomfort to incapacitating dyspnoea due to frequent and severe attacks. (2) This article examines the general principles of long-term drug therapy for asthma patients, taking into account the results of the clinical drug evaluation described in part I of this review (French edition). (3) The four most recent clinical practice guidelines did not take into account the latest data on the potentially severe adverse effects of long-acting beta-2 agonists. At least two of these guidelines received financial support from drug companies. (4) There is a general consensus that intermittent asthma does not require continuous therapy. For these patients, drug treatment is based on short-acting beta-2 agonists taken solely when symptoms arise. (5) Long-term treatment of persistent asthma is based on inhaled steroids at doses adapted to severity. However, given the adverse effects of inhaled steroids, the minimal effective dose should be identified and treatment should be reduced in a stepwise manner once asthma is under control. (6) When severe asthma persists or does not improve with high-dose inhaled steroid therapy, the treatment with the best risk-benefit balance is oral steroid therapy. (7) The use of long-acting beta-2 agonists is limited to the control of nocturnal symptoms when inhaled steroid therapy is inadequate. (8) Standard drugs used for asthma have no proven foetotoxicity, whereas poorly controlled asthma carries a risk of complications for both the mother and her unborn child.

    Topics: Administration, Inhalation; Administration, Oral; Adrenergic beta-Agonists; Asthma; Beclomethasone; Bronchodilator Agents; Canada; Chronic Disease; Disease Management; Female; France; Humans; Long-Term Care; Male; Practice Guidelines as Topic; Prednisolone; Pregnancy; Pregnancy Complications; Steroids; Theophylline; United Kingdom; United States

2007
Comparison of kinin B(1) and B(2) receptor expression in neutrophils of asthmatic and non-asthmatic subjects.
    International immunopharmacology, 2007, Dec-20, Volume: 7, Issue:14

    Kinins have been implicated in the pathophysiology of asthma and activation of kinin receptors stimulates neutrophil chemotaxis. However, the expression of kinin receptors on neutrophils of asthmatic subjects has not been assessed. The aim of this study was to compare the expression of kinin B(1) and B(2) receptor mRNA and proteins in neutrophils of asthmatic and non-asthmatic subjects, and to assess whether inhaled corticosteroid treatment may influence expression of the kinin receptors. Neutrophils were isolated from peripheral blood of asthmatic (n=27) and non-asthmatic subjects (n=14). The presence of kinin B(1) and B(2) receptor protein on neutrophils was confirmed by immunolabeling with specific antibodies followed by immunoperoxidase, immunofluorescence and FACS detection. Kinin B(1) and B(2) receptor mRNA expression was assessed by RT-PCR. Quantitative image analysis of fluorescence immunolabeled neutrophils showed no differences in kinin B(1) or B(2) receptor protein expression between asthmatic and non-asthmatic subjects. Similarly, quantitative real time RT-PCR analysis demonstrated no differences in expression of mRNA for the kinin B(1) or B(2) receptors between asthmatic and non-asthmatic subjects. However, B(1) receptor mRNA expression was significantly lower in asthmatic subjects using > or =2000 microg of inhaled corticosteroid per day (p<0.05) and B(1) receptor protein levels also tended to be lower in these subjects. Corticosteroids may have a beneficial anti-inflammatory effect in asthma by down-regulating B(1) receptor expression on neutrophils, thereby decreasing the migration of these inflammatory cells into the airways.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chemotaxis; Dose-Response Relationship, Drug; Female; Gene Expression Regulation; Humans; Immunohistochemistry; Kinins; Male; Middle Aged; Neutrophils; Protein Biosynthesis; Receptor, Bradykinin B1; Receptor, Bradykinin B2; RNA, Messenger; Transcription, Genetic

2007
[Influence of changing from chlorofluorocarbon (CFC)-beclomethasone dipropionate (BDP) to hydrofluoroalkane (HFA)-BDP on pulmonary function in asthmatic children].
    Arerugi = [Allergy], 2007, Volume: 56, Issue:12

    The discontinuation of chlorofluorocarbon- beclomethasone dipropionate (CFC-BDP) products has made it necessary to switch to hydrofluoroalkane (HFA)-BDP. We studied the influence of the changing from CFC-BDP to HFA-BDP on pulmonary function in asthmatic children.. In twenty asthmatic children (mean: 10.5 years of age) who were clinically well-controlled with CFC-BDP for longer than 6 months, CFC-BDP was switched to HFA-BDP, at half the dose of CFC-BDP. We examined the changes in spirometric parameters at 3-6 months after the switch.. FEV1.0% ([FEV1.0/FVC]x100) and %V50 ([V50 measured/V50 predicted]x100) were significantly improved (FEV1.0%: pre 81.7+/-4.7-->post 84.1+/-4.1 [p<0.05], % V50: pre 66.9+/-6.9-->post74.4+/-11.3 [p<0.05]). Comparison between patients with greater than 10% improvement in %V50 and those with less than 10% improvement revealed differences in the duration of using CFC-BDP (former 2.8+/-0.9 years, latter 5.2+/-2.4 years [p<0.05]) despite lack of difference in age at initiation of treatment with CFC-BDP.. The changing from CFC-BDP to HFA-BDP showed the improvement of lung function in a part of asthmatic children. We should keep in mind that there are some differences of efficacy among the inhaled corticosteroid products. The long-term anti-inflammatory medication should be adjusted to normalize the pulmonary function on the basis of the degree of airway inflammation.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Chlorofluorocarbons; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Male

2007
Asthma control following initial inhaled corticosteroid monotherapy in mild to moderate asthma: a 4- to 8-week observational study.
    Respiration; international review of thoracic diseases, 2006, Volume: 73, Issue:5

    There is an increasing trend for the use of combination therapy of inhaled corticosteroids (ICS) and long-acting beta(2)-agonists as initial treatment for asthma.. To assess the efficacy of initial monotherapy with ICS for achieving asthma control in steroid-naive mild to moderate asthmatics.. During an observational survey, steroid-naive patients received ICS in a dosage of 400-2,000 mug/day. After 4-8 weeks' treatment, achievement of asthma control, defined according to the Global Initiative for Asthma (GINA) guidelines, was assessed and the Asthma Control Questionnaire (ACQ) was completed.. Among 537 selected patients, 21 were excluded because of severe asthma and 96 because of inadequate ICS daily dosage. Four hundred and twenty patients were analyzed, 396 (94%) of whom completed the survey. Mean ICS dosage, in equivalent beclomethasone, was 479 +/- 62 mug/day for mild asthma (group A) and 1,115 +/- 306 mug/day for moderate asthma (group B). Asthma control was achieved for 71 and 65% of the patients, mean ACQ score improved from 1.1 +/- 0.6 to 0.5 +/- 0.5 (p < 0.001) and from 2.0 +/- 0.8 to 0.8 +/- 0.7 (p < 0,001), and FEV(1) (% predicted) improved from 93 +/- 9 to 96 +/- 13 (p < 0.05) and from 85 +/- 15 to 91 +/- 15 (p < 0.001) for groups A and B, respectively.. Asthma control can be achieved by ICS monotherapy for two thirds of steroid-naive patients with mild to moderate asthma. For these patients, we suggest that ICS alone could be started as initial therapy and that additional therapy should be considered after 4-8 weeks for patients who do not achieve control.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male

2006
Bronchospasm induced by inhalant corticosteroids: the role of ethanol.
    Allergy, 2006, Volume: 61, Issue:1

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchial Spasm; Drug Interactions; Ethanol; Follow-Up Studies; Glucocorticoids; Humans; Male; Respiratory Function Tests; Risk Assessment; Severity of Illness Index

2006
Is ethanol-induced bronchospasm an inflammation-driven event?
    Allergy, 2006, Volume: 61, Issue:2

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Aerosol Propellants; Androstadienes; Anti-Allergic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchial Spasm; Ethanol; Fluticasone; Humans; Inflammation; Male; Solvents; TRPV Cation Channels

2006
Higher patient perceived side effects related to higher daily doses of inhaled corticosteroids in the community: a cross-sectional analysis.
    Respiratory medicine, 2006, Volume: 100, Issue:8

    The range and extent of inhaled corticosteroid (ICS) side effects experienced by patients in the general community are likely to be underestimated.. To identify the side effects of ICS perceived by patients in the community and, through the use of a self-report questionnaire, measure their intensity, prevalence and relationship with daily medication dose.. Focus groups and in-depth interviews were conducted to identify side effects that patients associated with their use of ICS. In an international multicentre cross-sectional survey, 395 inhaler users from community pharmacy (mean age 50, 53% female), divided into 4 daily dosage groups (beta2-agonist without ICS n=66, beclometasone dipropionate (BDP) equivalent ICS low dose 400 microg, n=109; mid dose 401-800 microg, n=151; and high dose>800 microg, n=69) reported how much they were affected by these side effects on a 7-point Likert scale.. Focus groups and interviews revealed 57 side effects that were associated with ICS use. Cross-sectional survey results showed significant differences in side effect perception between the four dosage groups for 31 items (all P0.01) and a rising intensity with increasing ICS dose for total side effect score (P<0.001). For ICS users reporting the most bothersome side effects (scoring 3 on 0-6 scale) there was a rising prevalence as ICS dose increased for 34 items. A multivariate model confirmed that mid and high ICS dosages were statistically significantly associated with side effect perception after controlling for the other factors and covariates.. Higher daily ICS doses were associated with a higher intensity and a higher prevalence of many patient perceived side effects, lending support to the call for dose titration in clinical practice. Results indicate the usefulness of patient self-report scales for understanding the burden of side effects of ICS in the community.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Aged; Asthma; Beclomethasone; Cross-Sectional Studies; Dose-Response Relationship, Drug; Female; Glucocorticoids; Humans; Male; Middle Aged; Netherlands; Pulmonary Disease, Chronic Obstructive; Qualitative Research; Scotland

2006
Contact dermatitis around a tracheostoma due to salbutamol sulfate and Aldecin.
    Contact dermatitis, 2006, Volume: 54, Issue:2

    Contact dermatitis around a tracheostoma is quite rare. So far, there have been only 2 reports about this in medical literature. We, in this study, report herewith contact dermatitis in a 61-year-old Japanese man around a tracheostoma due to salbutamol sulfate and Aldecin. The patient used inhaled Sultanol and Aldecin for the treatment for allergic asthma. On examination, it was found that there was lichenified, exudative erythema with pigmentation around the tracheostoma. Patch testing with 1% aq. Sultanol and Aldecin revealed a positive reaction. Furthermore, patch testing for salbutamol sulfate 1% pet. also showed positive reaction. Although the contact allergen of our patient has not been fully determined (beclomethasone or other ingredients), this must be the first reported case of double contact dermatitis around a tracheostoma from salbutamol and Aldecin.

    Topics: Albuterol; Allergens; Anti-Asthmatic Agents; Asthma; Beclomethasone; Dermatitis, Allergic Contact; Diagnosis, Differential; Humans; Male; Middle Aged; Patch Tests; Tracheostomy

2006
Growth impairment and adrenal suppression on low-dose inhaled beclomethasone.
    Journal of paediatrics and child health, 2006, Volume: 42, Issue:3

    Growth impairment and adrenal suppression secondary to inhaled corticosteroids (ICS) is a well-recognised phenomenon. We report a 13-year-old boy, treated long-term for asthma, who presented with short stature while on low-dose inhaled corticosteroid (beclomethasone 200 microg/d). Investigations revealed evidence of severe adrenal suppression. Weaning off the steroid treatment resulted in recovery of adrenal activity and rapid growth. While low-dose ICS are normally considered to have few side effects, this case illustrates the extreme variability of individual sensitivity and the need for careful surveillance of all children treated with long-term steroids.

    Topics: Adolescent; Adrenal Insufficiency; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Height; Child; Child Development; Chronic Disease; Developmental Disabilities; Growth Hormone; Humans; Male; Time Factors

2006
Sputum induction in asthma: a research technique or a clinical tool?
    Chest, 2006, Volume: 129, Issue:3

    Topics: Asthma; Beclomethasone; Eosinophilia; Eosinophils; Glucocorticoids; Humans; Sputum

2006
Low sputum eosinophils predict the lack of response to beclomethasone in symptomatic asthmatic patients.
    Chest, 2006, Volume: 129, Issue:3

    The prognostic role of low sputum eosinophils in steroid-naïve, symptomatic asthmatic patients is controversial.. To verify whether low sputum eosinophils predict poor response to treatment with inhaled corticosteroids.. Sixty-seven symptomatic asthmatic patients with moderate asthma were examined before and after 2 weeks and 4 weeks of treatment with beclomethasone dipropionate, 500 microg bid. None received corticosteroids in the 3 months preceding the study. At each visit, all patients underwent spirometry, methacholine challenge, and sputum induction. The patients recorded symptom scores and peak expiratory flow (PEF) throughout the study.. Seventeen patients had low sputum eosinophils despite being symptomatic. Patients with high (> 3%) sputum eosinophils at baseline showed significant improvement in symptoms, pulmonary function, and bronchial hyperresponsiveness after treatment, whereas patients with low sputum eosinophils showed no significant improvement in most clinical and functional outcomes. Among the baseline indexes examined, sputum eosinophils had the highest negative predictive value but low positive predictive value for the response to treatment. Multiple stepwise regression showed that only baseline FEV(1) and sputum eosinophil percentages significantly correlated with changes in FEV(1) after treatment.. We suggest that, among the indexes examined, low sputum eosinophils are the best predictor for poor corticosteroid effects in asthma.

    Topics: Adult; Asthma; Beclomethasone; Bronchial Provocation Tests; Eosinophil Cationic Protein; Eosinophils; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Leukocyte Count; Lymphocytes; Male; Neutrophils; Prognosis; ROC Curve; Sensitivity and Specificity; Sputum; Treatment Outcome

2006
Reported adverse drug reactions during the use of inhaled steroids in children with asthma in the Netherlands.
    European journal of clinical pharmacology, 2006, Volume: 62, Issue:5

    Inhaled corticosteroids (ICS) are widely used in the treatment of asthma. We studied the suspected adverse drug reactions (sADRs) reported during the use of ICS in the Netherlands.. In the Netherlands, health professionals and patients can report suspected ADRs to the Pharmacovigilance Centre Lareb. All reported sADRs on ICS were categorised and assessed as to whether these were likely to be associated with use of the steroid. Age and gender adjusted Reported Odds Ratios (RORs) and Naranjo Scores (NS) were computed for sADRs reported more than 3 times.. Since 1984, sADRs of ICS were reported in 89 children (mean age 6 years), 48 (54%) were boys. Suspected drugs were fluticasone in 46 children (52%), budesonide in 21 (24%), and beclomethasone in 22 cases (24%). Psychiatric symptoms were reported in 19 children (21%; ROR 3.8, NS 3.6), growth retardation in 6 children (7%; ROR 47.8, NS 3.0) and rashes in 6 cases (7%; ROR 0.7, NS 2.4). There were 7 reports (8%; ROR 2.1, NS 3.4) concerning abnormalities of the teeth, 4 reports of alopecia (4%; ROR 3.3, NS 3.5), and 3 reports of hirsutism and hypertrichosis (NS 4.0). Non-fatal adrenal insufficiency was reported once.. Alteration of behaviour was the most frequently reported sADR. There are more indications that alterations of behaviour could be a real sADR of ICS. Non-fatal adrenal insufficiency was the only reported possible life threatening sADR. The association of hypertrichosis and teeth abnormalities after ICS in children has not been reported in the literature before.

    Topics: Administration, Inhalation; Adolescent; Adverse Drug Reaction Reporting Systems; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Female; Fluticasone; Glucocorticoids; Humans; Male; Netherlands

2006
[The clinicofunctional characterization of the phenotypes of severe uncontrollable bronchial asthma].
    Klinicheskaia meditsina, 2006, Volume: 84, Issue:2

    The aim of the study was to compare the clinical characteristics and the inflammatory process activity in the airway of patients with severe therapy-sensitive and therapy-resistant bronchial asthma (TSBA; TRBA). The subjects were 171 patients with severe bronchial asthma (BA) aged 18 to 60; the diagnosis was established prior to the study according to GINA 2002 criteria. There were 50 TSBA patients, 121 TRBA, and 50 controls. According to a range of criteria, BA in TRBA was more severe than that in TSBA. TRBA patients displayed significantly higher indices of inflammatory process activity, such as absolute and relative number of eosinophiles and neutrophiles in induced sputum (IS), and IS level of IL-5. Evaluation of IS inflammatory markers in patients with severe BA allowed substantiation of the central role of persistent inflammation as a risk factor of TRBA development.

    Topics: Adolescent; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Data Interpretation, Statistical; Drug Resistance; Eosinophils; Humans; Middle Aged; Neutrophils; Phenotype; Sputum; Time Factors

2006
Potential mechanisms of improvement of airway hyperresponsiveness by inhaled corticosteroid therapy in asthmatic patients.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2006, Volume: 43, Issue:2

    Recent clinical trials with administration of IL-5 antibodies to asthmatic patients have revealed reduction of eosinophilia but unaltered airway hyperresponsiveness (AHR). In contrast, inhaled corticosteroid (ICS) therapy eliminates both eosinophilia and AHR. This study was designed to examine the mechanisms by which ICS improves airway hyperresponsiveness in asthmatic patients.. Clinical variables of asthma involving vascular permeability and IL-5 levels were examined in 23 asthmatic patients and 11 normal control subjects. After the first sputum induction, inhaled beclomethasone dipropionate (BDP 800 microg/day) was administered to asthmatic patients for 8 weeks, and sputum induction was repeated.. IL-5 levels in induced sputum and airway vascular permeability index were significantly higher in asthmatic patients. IL-5 was positively correlated with percentage of eosinophils in induced sputum, and negatively correlated with FEV1, but not correlated with PC20 methacholine. After BDP therapy, eosinophils, ECP, and IL-5 levels were significantly decreased to the same levels as in normal subjects. Conversely, PC20 methacholine and airway vascular permeability did not improve to the same levels as in normal subjects. Increase in PC20 methacholine from before to after BDP therapy was significantly correlated with decrease in airway permeability index, but not with decrease in IL-5 level.. Our results suggest a clear dissociation between IL-5 and AHR. ICS therapy improves AHR at least in part through decrease in airway vascular permeability.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Capillary Permeability; Female; Glucocorticoids; Humans; Interleukin-5; Male; Respiratory Hypersensitivity; Sputum

2006
Mometasone and beclomethasone comparison article observations.
    Chest, 2006, Volume: 129, Issue:5

    Topics: Administration, Inhalation; Anti-Allergic Agents; Anti-Asthmatic Agents; Asthma; Beclomethasone; Humans; Mometasone Furoate; Periodicals as Topic; Pregnadienediols; Treatment Outcome

2006
High-dose inhaled corticosteroids and add-on therapy use in adults with asthma in the UK in 2003: an observational study.
    Primary care respiratory journal : journal of the General Practice Airways Group, 2006, Volume: 15, Issue:3

    To quantify use of high dose inhaled corticosteroids (ICS) and add-on therapy in adults, and children aged 12 and over, in the community.. Cross-sectional observational survey of UK general practice prescribing records from July 2002 to June 2003 utilising the Doctors Independent Network clinical database.. 30,895 patients aged 12 and over were treated for asthma with inhaled corticosteroids, with a quantifiable daily dose recommendation in 22,027 cases. Twenty-seven percent (95% Confidence Intervals 26-28%) were prescribed 'high-dose' ICS (>800 mcg/day beclomethasone or equivalent). Of these, 32% (31-33%) were not currently prescribed add-on therapy (long acting B2 agonists, leukotriene antagonists, theophylines), and most of these (84%, 82-86%) had never received a prior trial of add-on therapy.. High dose ICS therapy was commonly prescribed to people with asthma, frequently without co-prescribed add-on therapy. Many adults with more severe asthma may be receiving treatment that does not accord with current evidence of best practice.

    Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cross-Sectional Studies; Drug Therapy, Combination; Guideline Adherence; Humans; Practice Guidelines as Topic; Practice Patterns, Physicians'; United Kingdom

2006
Applicability of an ultrasonic nebulization system for the airways delivery of beclomethasone dipropionate in a murine model of asthma.
    Pharmaceutical research, 2006, Volume: 23, Issue:8

    We have assessed the use of an ultrasonic nebulization system (UNS), composed of ultrasonic nebulizer and diffusion dryer filled with charcoal, for the effective delivery of beclomethasone to the airways in a murine asthma model.. Solution of beclomethasone in ethanol was aerosolized using an ultrasonic nebulizer. Passage of the aerosol through a drying column containing charcoal and deionizer produced dry beclomethasone particles. Particles were delivered to BALB/c mice placed in a whole-body exposition chamber 1 h before intranasal challenge with ovalbumine. Efficacy of beclomethasone delivery was evaluated by examining bronchoalveolar lavage fluid (BALF) cytology.. Effect of three UNS system parameters on aerosol particle size was investigated. The critical parameter affecting the size of dry particles was beclomethasone concentration in aerosolized solution and solution flow rate while power level of ultrasonic nebulizer generator had no effect. Administration of beclomethasone at calculated dose of 150 microg/kg to mice significantly decreased total cell number and relative eosinophil number in BALF.. The UNS system produces a monodisperse aerosol that can be used for inhalative delivery of poorly water soluble substances to experimental animals. The UNS system minimizes formulation requirements and allows rapid and relatively simple efficacy and toxicity testing in animals.

    Topics: Algorithms; Animals; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchoalveolar Lavage Fluid; Male; Mice; Mice, Inbred BALB C; Nebulizers and Vaporizers; Ovalbumin; Particle Size; Powders; Respiratory Hypersensitivity; Ultrasonics

2006
Influence of allergy on the symptoms and treatment of nasal polyposis.
    Acta oto-laryngologica, 2006, Volume: 126, Issue:8

    Allergy does not modify the symptoms of nasal polyposis, either initially or after a 1-year medical treatment.. To assess the role of allergy in the symptoms and treatment of patients presenting with the diagnosis of nasal polyposis.. Two simultaneous studies were carried out. In the first study, 180 consecutive patients with nasal polyposis (60% males, mean age = 48.4 years) were analyzed to detect whether the severity of their symptoms correlated with the presence of positive allergic tests. In the second study, 74 consecutive patients (57.5% males, mean age = 48.3 years) were analyzed to detect whether the results of a 1-year medical treatment of nasal polyposis were influenced by the presence of positive allergic tests (Phadiatop). Five nasal criteria were scored: nasal obstruction, anterior and posterior rhinorrhea, facial pain, and the loss of sense of smell. The frequency of asthma was evaluated. Treatment of nasal polyposis consisted of washing of the nasal cavities, steroid spray, and oral steroid administration. The amount of steroid consumption (prednisolone and beclomethasone) was studied.. In the first study, mean scores of nasal symptoms did not differ between the two groups of patients with and without allergy. The prevalence of asthma (p = 0.03) was higher in the group with than without allergy. In the second study, decrease of all nasal symptoms was not statistically different in the two groups. Cumulative consumption of prednisolone and beclomethasone between baseline and year 1 were similar in the two groups.

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Asthma; Beclomethasone; Bronchial Provocation Tests; Comorbidity; Cross-Sectional Studies; Drug Hypersensitivity; Follow-Up Studies; Forced Expiratory Volume; Humans; Immunoglobulin E; Methacholine Chloride; Nasal Obstruction; Nasal Polyps; Olfaction Disorders; Prednisolone; Prospective Studies; Rhinitis, Allergic, Perennial

2006
Beclometasone dipropionate/formoterol: in an HFA-propelled pressurised metered-dose inhaler.
    Drugs, 2006, Volume: 66, Issue:11

    A hydrofluoroalkane (HFA)-propelled pressurised metered-dose inhaler (pMDI) has been developed (using Modulite technology) for a new fixed combination of beclometasone dipropionate/formoterol fumarate (BDP/formoterol) 100 microg/6 microg. Each actuation of the BDP/formoterol HFA pMDI 100 microg/6 microg delivers 86.4 microg of BDP and 5 microg of formoterol. BDP/formoterol HFA pMDI was associated with significantly higher morning peak expiratory flow (PEF) values than BDP administered alone via a chlorofluorocarbon (CFC) pMDI (including when BDP was administered at a higher dosage) in well designed trials in adults with mild to moderate or moderate to severe asthma. In terms of morning PEF values, BDP/formoterol HFA pMDI was noninferior to BDP plus formoterol administered via separate inhalers in well designed trials in adults with moderate to severe asthma. BDP/formoterol HFA pMDI was noninferior to fixed-combination budesonide/formoterol (the daily dosage of BDP was half that of budesonide) in terms of lung function, asthma symptoms and use of rescue medications in adults with moderate to severe asthma. BDP/formoterol HFA pMDI was also noninferior to, and had a faster onset of bronchodilation than, fixed-combination fluticasone propionate/salmeterol. BDP/formoterol 200 microg/12 microg per day or 400 microg/24 microg per day administered by the HFA pMDI was generally well tolerated. Moreover, a single high dose of BDP/formoterol (1000 microg/60 microg) was generally well tolerated in patients with asthma.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Ethanolamines; Formoterol Fumarate; Humans; Metered Dose Inhalers

2006
Bronchial asthma showing reduction in FEV1 after inhalation of Qvar.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2006, Volume: 43, Issue:6

    The administration of Qvar (a hydrofluoroalkane-134a beclomethasone dipropionate; HFA-BDP) is highly useful for the treatment of patients with asthma. However, we found in a case of bronchial asthma that replacing the prior inhaled corticosteroids with Qvar resulted in temporary dyspnea and reduction in forced expiratory volume in 1 second (FEV1). Qvar contains beclomethasone dipropionate combined with absolute ethanol and an alternative to fluorocarbon. The patient had complicated alcohol-induced asthma. FEV1 decreased markedly and immediately after Qvar inhalation. The Qvar placebo is free of beclomethasone but contains other ingredients (ethanol and fluorocarbon). FEV1 did not decrease after the Qvar placebo, Aldecin inhalation, and Qvar inhalation orally treated with atropine before inhalation of Qvar. It seems unlikely that the components of Qvar (except beclomethasone) are responsible for the reduction in FEV1 observed immediately after inhalation of Qvar. These findings would be noteworthy when using Qvar for Japanese patients with asthma known to have a relatively high frequency of the complication of alcohol-induced asthma.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Forced Expiratory Volume; Humans; Male

2006
Pharmacokinetics of beclomethasone dipropionate in an hydrofluoroalkane-134a propellant system in Japanese children with bronchial asthma.
    Allergology international : official journal of the Japanese Society of Allergology, 2006, Volume: 55, Issue:3

    Hydrofluoroalkane-134a (HFA) has been shown to be a safe replacement for chlorofluorocarbons (CFCs) as a pharmaceutical propellant, with the advantage that it has no ozone-depleting potential. This is the first report of the pharmacokinetics of beclomethasone dipropionate (BDP) delivered from a pressurized solution formulation using an HFA propellant system (HFA-BDP) in Japanese children with bronchial asthma.. Plasma concentrations of beclomethasone 17-monopropionate (17-BMP),a major metabolite of BDP, following an inhaled dose of HFA-BDP (200 microg as four inhalations from 50 microg/actuation) in five Japanese children with bronchial asthma were quantified and analyzed by a non-compartmental analysis to obtain pharmacokinetic parameters.. The area under the concentration-time curve from time zero to the last quantifiable time (AUC(0-t)) was 1659 +/- 850 pg x h/mL (arithmetic mean +/- standard deviation (SD)), the maximum concentration observed (C(max)) was 825 +/- 453 pg/mL and the apparent elimination half-life (t(1/2)) was 2.1 +/- 0.7 hours. The time to reach Cmax Tmax was 0.5 hours in all patients. No special relationship was observed between these parameters and age or body weight. These parameters were compared with the previously reported parameters of American children with bronchial asthma. The Japanese/American ratio of the geometric means of each parameter was 1.36 for AUC(0-t), 1.04 for Cmax and 1.4 for t(1/2). The median of Tmax was 0.5 hours in American patients as well as Japanese patients.. The pharmacokinetics of HFA-BDP in Japanese children with bronchial asthma are reported for the first time and a similarity to those in American children is suggested.

    Topics: Adolescent; Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Female; Humans; Hydrocarbons, Fluorinated; Japan; Male; United States

2006
A new small volume holding chamber for asthmatic children: comparison with Babyhaler spacer.
    Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2006, Volume: 17, Issue:8

    When a new holding chamber for administrating inhaled medication is to be marketed, it needs to be compared with existing chambers with two questions in mind: is this chamber well accepted by patients and is there an in vitro equivalence? We compared the new small volume non-electrostatic valved holding chamber, usable with all pressurized metered-dose inhalers and equipped with a funny facemask, Vortex (Pari GmbH, Germany), to the most frequently prescribed holding chamber in France, Babyhaler (GlaxoSmithKline Laboratories). Preferences were studied for 75 families with a child no more than 4 yr old, using standard questionnaires. An in vitro study assessed the delivered dose and the particle size distribution of two HFA beclomethasone dipropionate pressurized metered dose inhalers (Becotide 250 microg per dose and Nexxair 100 microg per dose) by dose uniformity sample apparatus and cascade impactor according to the European Pharmacopoeia. Vortex was preferred by 95% of the families because of its small size, its duck facemask, and its robust appearance. Among children able to give their opinion, 86% preferred Vortex to Babyhaler. In vitro, both holding chambers reduced the delivered dose of beclomethasone dipropionate and increased the quantity of particles smaller than 5 microm in diameter with both medications. A higher proportion of fine particles was obtained with Nexxair than with Becotide (p < 0.05) and with Vortex than with Babyhaler (p < 0.05). As expected, throat deposition is dramatically reduced for both drugs with both holding chambers. The in vitro difference in the particle size distribution of beclomethasone dipropionate with both holding chambers probably has no clinical influence.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Child, Preschool; Humans; Infant; Inhalation Spacers; Metered Dose Inhalers; Particle Size; Patient Satisfaction

2006
[How to make easier the treatment of asthma].
    Revue des maladies respiratoires, 2006, Volume: 23, Issue:4 Pt 2

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Aerosols; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Cohort Studies; Developing Countries; Drug Costs; Fluticasone; Glucocorticoids; Humans; Pilot Projects; Poverty; Prevalence; Socioeconomic Factors; Terbutaline; World Health Organization

2006
Changes in prescribing of inhaled corticosteroids (1999-2002) in Scotland.
    Pharmacoepidemiology and drug safety, 2005, Volume: 14, Issue:3

    To investigate the trend in prescribing of inhaled corticosteroids and general practitioner (GP) consultations for respiratory diseases.. A longitudinal observation study of all prescriptions, from primary care, for inhaled corticosteroids dispensed in Scotland from January 1999 to May 2002 was undertaken. The main outcome measures were the trends in prescribing of inhaled corticosteroids and GP consultations for respiratory diseases.. The prescribing of all inhaled corticosteroids has risen over the study period. The rise in prescribing of the combination product containing fluticasone and salmeterol appears not to have been at the expense of the prescribing of fluticasone alone while the prescribing of the budesonide/eformoterol combination may be at the expense of budesonide (BUD) alone. GP consultations for both asthma and chronic obstructive pulmonary disease (COPD) have declined over a similar period. The increased prescribing of inhaled corticosteroids over this period is associated with the increased use of the fluticasone/salmeterol combination rather than an increase in the use of all inhaled corticosteroids. The accompanying fall in number of consultations with GPs may be due to this increased prescribing or a move to nurse led clinics.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Asthma; Beclomethasone; Budesonide; Drug Combinations; Drug Prescriptions; Drug Utilization Review; Ethanolamines; Formoterol Fumarate; Humans; Pharmacoepidemiology; Practice Patterns, Physicians'; Pulmonary Disease, Chronic Obstructive; Scotland; Time Factors

2005
Biochemical interaction between effects of beclomethasone dipropionate and salbutamol or formoterol in sputum cells from mild to moderate asthmatics.
    Allergy, 2005, Volume: 60, Issue:3

    Several in vitro studies demonstrate that corticosteroids and long-acting beta(2) agonists may have a complementary and synergistic mode of action on the inflammatory processes in asthma.. Sputum was induced in 20 mild to moderate asthmatic patients and the induced sputum cells (ISC) were cultured with beclomethasone dipropionate (BDP) 10(-7) M, salbutamol 10(-8) M and formoterol 10(-8) M either alone or in combination, BDP plus salbutamol and BDP plus formoterol, for 24 h. We measured the levels of growth macrophages-colony stimulating factor (GM-CSF), released on activation normal T cells expressed and activated (RANTES) and interleukin-8 (IL-8), in the supernatant of stimulated cells by ELISA. Furthermore, we assessed nuclear translocation of glucocorticoid receptor (GR) and the expression of beta(2) receptor in ISC by immunofluorescence and RT-PCR, respectively.. The release of GM-CSF, RANTES and IL-8 in ISC was significantly reduced by BDP plus salbutamol or formoterol as compared with either drug alone (P < 0.0001). beta(2) receptor expression was increased after 30 min of incubation with BDP and continued to increase over a time period of 4 h (P < 0.0001). Furthermore after 30 min of incubation, nuclear translocation of GR was greater with BDP plus salbutamol or formoterol than with any of the drugs alone (P < 0.0001).. The present ex vivo study demonstrates a complementary mode of action between BDP and salbutamol or formoterol leading to an enhanced anti-inflammatory activity.

    Topics: Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Cells, Cultured; Chemokine CCL5; Drug Interactions; Drug Therapy, Combination; Ethanolamines; Female; Formoterol Fumarate; Granulocyte-Macrophage Colony-Stimulating Factor; Humans; Interleukin-8; Male; Middle Aged; Receptors, Adrenergic, beta-2; Receptors, Glucocorticoid; Severity of Illness Index; Sputum; Tissue Distribution

2005
[The small airway inflammation of asthmatic patients who have used dry powder type inhaled steroid for moderate-long term evaluated by induced sputum and the efficacy of HFA-BDP (QVAR) inhalation].
    Arerugi = [Allergy], 2005, Volume: 54, Issue:1

    Although the dry powder type inhaled steroids, such as Fluticasone Propionate Diskhaler (FP-DH), FP Diskus (FP-DK), Budesonide Turbuhaler (BUD-TH), are widely distributed in daily clinical fields, we clinicians are required to evaluate whether it is effectively inhibiting inflammation of distal airway or not. We also investigated the effect of Hydrofluoroalukan-beclomethasone dipropionate (HFA-BDP), a new type of inhaled steroid which forms super micro aerosol particles, in the distal small airway.. 85 patients with moderate asthma, who daily used dry powder type inhaled steroid for at least more than 6 months with stable asthmatic condition, were the subject of this study. All subjects underwent sputum induction with the inhalation of 10% of hypertonic saline solution for 15 min and eosinophil counts and eosinophil cationic protein (ECP) in individual induced sputum were measured. Then, patients who had eosinophils detected in their induced sputum changed their previously inhaled steroid to HFA-BDP inhalation (400 i.g./day). Their eosinophil counts and the values of eosinophil cationic protein (ECP), Eotaxin, RANTES and neutrophil elastase (PMN-E) in their induced sputum were also examined before and 4weeks after changing HFA-BDP inhalation.. Increased eosinophils were found in the induced sputum of 40.5% patients of the FP-DK group, 36.3% of the FP-DH group and 32.4% of the BUD-TH group, respectively. Compared with group of patients in which no sputum eosinophil were detected, the sputum ECP values, in which sputum eosinophils were detected, were significantly high. 4 weeks after changing to HFA-BDP inhalation, eosinophil counts, ECP, Eotaxin, RANTES and PMN-E in their induced sputum were decreased in every group.. Compared with the ordinary dry powder type inhaled steroids, HFA-BDP can effectively diminish distal airway inflammation, suggesting the possibility that HFA-BDP can effectively reach to the distal small airway by forming super micro aerosol particles.

    Topics: Administration, Inhalation; Aged; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Eosinophil Cationic Protein; Eosinophils; Female; Fluticasone; Humans; Hydrocarbons, Fluorinated; Leukocyte Count; Male; Middle Aged; Powders; Sputum

2005
[Asthma: control as therapeutic goal].
    Medicina clinica, 2005, Apr-09, Volume: 124, Issue:13

    Topics: Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Fluticasone; Humans

2005
Short-acting beta 2-agonist and oral corticosteroid use in asthma patients prescribed either concurrent beclomethasone and long-acting beta 2-agonist or salmeterol/fluticasone propionate combination.
    International journal of clinical practice, 2005, Volume: 59, Issue:2

    Prescriptions for short-acting beta(2)-agonists (SABAs) and oral corticosteroids recorded in a primary care database were used as markers of asthma control. Drug use in the 6 months before and after step-up in treatment from inhaled corticosteroids [ICs; total daily dosage of < or =1000 microg beclomethasone dipropionate (BDP) or equivalent] to either salmeterol/fluticasone propionate combination (SFC) or concurrent BDP and long-acting beta(2)-agonists (LABAs) given in separate inhalers was compared. After step-up, the calculated median number of doses of SABAs prescribed fell by 100 in the SFC group (n = 211) but was unchanged with BDP + LABA (n = 377, p < 0.0001), and fewer patients in the SFC group were prescribed oral corticosteroids (13.7 vs. 20.7%, p = 0.036). Other measures of SABA use after step-up indicated lower use in the SFC group. In clinical practice, adding LABA to IC therapy by using a combination inhaler produces significantly better asthma control than administering the drugs in separate inhalers.

    Topics: Administration, Inhalation; Administration, Oral; Adrenergic beta-Agonists; Adult; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Drug Combinations; Drug Therapy, Combination; Female; Fluticasone; Glucocorticoids; Humans; Longitudinal Studies; Male; Retrospective Studies; Salmeterol Xinafoate; Treatment Outcome

2005
Glucocorticoid receptor nuclear translocation in airway cells after inhaled combination therapy.
    American journal of respiratory and critical care medicine, 2005, Sep-15, Volume: 172, Issue:6

    Clinical evidence is accumulating for the efficacy of adding inhaled long-acting beta(2)-agonists (LABAs) to corticosteroids in asthma. Corticosteroids bind to cytoplasmic glucocorticoid receptors (GRs), which then translocate to the nucleus where they regulate gene expression. This article reports the first evidence in vivo of an interaction between inhaled LABA and corticosteroid on GR nuclear translocation in human airway cells using immunocytochemistry. We initially demonstrated significant GR activation 60 minutes after inhalation of 800 microg beclomethasone dipropionate in six healthy subjects. Subsequently, we determined the effects of salmeterol and fluticasone propionate (FP) in seven steroid-naive patients with asthma. We observed dose-dependent GR activation with 100- and 500-microg doses of FP, and to a lesser extent with 50 microg salmeterol alone. However, combination therapy with 100 microg FP and salmeterol augmented the action of FP on GR nuclear localization. In vitro, salmeterol enhanced FP effects on GR nuclear translocation in epithelial and macrophage-like airway cell lines. In addition, salmeterol in combination with FP enhanced glucocorticoid response element (GRE)-luciferase reporter gene activity and mitogen-activated protein kinase phosphatase 1 (MKP-1) and secretory leuko-proteinase inhibitor (SLPI) gene induction. Together, our data confirm that GR nuclear translocation may underlie the complementary interactions between LABAs and corticosteroids, although the precise signal transduction mechanisms remain to be determined.

    Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biological Transport; Bronchodilator Agents; Case-Control Studies; Cell Cycle Proteins; Cell Line; Cell Nucleus; Cytoplasm; Drug Therapy, Combination; Dual Specificity Phosphatase 1; Female; Fluticasone; Genes, Reporter; Humans; Immediate-Early Proteins; Luciferases; Phosphoprotein Phosphatases; Protein Phosphatase 1; Protein Tyrosine Phosphatases; Proteinase Inhibitory Proteins, Secretory; Proteins; Receptors, Glucocorticoid; Response Elements; Salmeterol Xinafoate; Secretory Leukocyte Peptidase Inhibitor; Sputum; Transcription, Genetic

2005
Relationship between vascular endothelial growth factor and angiopoietin-2 in asthmatics before and after inhaled beclomethasone therapy.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2005, Volume: 42, Issue:2

    Vascular endothelial growth factor (VEGF) and Angiopoietin-2 (Ang-2) play complementary roles in the process of vascular remodeling. Therefore, this study was designed to examine an interaction between VEGF and Ang-2 in asthmatic airways. VEGF, Ang-2, and hepatocyte growth factor (HGF) levels in induced sputum obtained from 17 asthmatic patients and 10 normal control subjects were examined. Eight weeks of inhaled beclomethasone dipropionate (BDP) therapy (800 microg/day) was administered to all asthmatic patients, and sputum induction was repeated. VEGF, Ang-2, and HGF levels in induced sputum were significantly higher in asthmatic patients than in control subjects. Ang-2 levels were significantly correlated with VEGF levels but not with HGF levels. We also found that there was a significant correlation between airway vascular permeability index and VEGF levels but not HGF levels. In addition, VEGF/Ang-2 ratio in asthmatic patients was significantly higher than that in control subjects, and it was significantly correlated with airway vascular permeability index. After inhaled BDP therapy, VEGF levels were significantly decreased, but Ang-2 levels did not change. Therefore, VEGF/Ang-2 ratio after BDP therapy was markedly decreased to the same level as in the control subjects. Our findings suggest that interaction between VEGF and Ang-2 in asthmatic airways may exist and that high VEGF/Ang-2 ratio may be responsible for increased airway microvascular permeability. In addition, inhaled glucocorticoids therapy may reduce airway vascular permeability and remodeling via VEGF/Ang-2-dependent mechanism.

    Topics: Administration, Inhalation; Adult; Angiopoietin-2; Anti-Asthmatic Agents; Asthma; Beclomethasone; Capillary Permeability; Case-Control Studies; Female; Hepatocyte Growth Factor; Humans; Male; Vascular Endothelial Growth Factor A

2005
Prevalence and clinical features of cough variant asthma in a general internal medicine outpatient clinic in Japan.
    Respirology (Carlton, Vic.), 2005, Volume: 10, Issue:3

    The aims of the present study were to examine the prevalence and clinical features of cough variant asthma (CVA) among patients with chronic and persistent cough at an outpatient clinic in Japan, and the efficacy of treatment with an inhaled corticosteroid.. This prospective study was conducted at a general internal medicine outpatient clinic in Japan over a 12-month period. CVA was diagnosed as chronic cough without wheezing or any apparent cause, that had persisted for more than 8 weeks, with a normal CXR and spirometry but with bronchial hyperresponsiveness to methacholine, and relief of cough after bronchodilator treatment. We also examined the effects of inhaled beclomethasone propionate on symptoms and differences in PEF between early morning and evening.. Of 55 patients suffering from chronic cough, 23 satisfied the criteria for CVA. Their cough occurred more frequently at night and early in the morning. Early morning PEF was significantly lower than evening PEF with a mean variability of 11.5 +/- 4.1%. Treatment with beclomethasone propionate improved coughing and significantly increased early morning PEF, reducing variability to less than 10%.. These findings suggest that CVA is most common among patients with chronic cough not due to any apparent cause. The efficacy of inhaled corticosteroid suggests that early intervention is effective in the treatment of CVA.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Chronic Disease; Circadian Rhythm; Cough; Female; Follow-Up Studies; Forced Expiratory Volume; Glucocorticoids; Hospitals, General; Humans; Japan; Male; Middle Aged; Outpatient Clinics, Hospital; Prevalence; Prospective Studies; Treatment Outcome

2005
Exhaled nitric oxide and asthma.
    The New England journal of medicine, 2005, Aug-18, Volume: 353, Issue:7

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Anti-Asthmatic Agents; Asthma; Beclomethasone; Breath Tests; Drug Therapy, Combination; Glucocorticoids; Humans; Nitric Oxide

2005
Exhaled nitric oxide and asthma.
    The New England journal of medicine, 2005, Aug-18, Volume: 353, Issue:7

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Algorithms; Anti-Asthmatic Agents; Asthma; Beclomethasone; Breath Tests; Drug Therapy, Combination; Humans; Nitric Oxide

2005
[Coagulation parameters associated with inhaled glucocorticosteroid therapy in stable asthma].
    Polski merkuriusz lekarski : organ Polskiego Towarzystwa Lekarskiego, 2005, Volume: 18, Issue:107

    The aim of this study was to determine if there are changes in laboratory investigations which allow to recognize coagulation disturbances associated with inhaled glucocorticoid therapy.. The study group consist of 26 patients with stable asthma (5 male, 21 female) without risk factors of venous thrombosis, mean age 45 +/- 14 years. 15 patients were treated with 500-1000 mg beclomethasone daily, 11 patients received a daily dose of 1000-2000 microg of beclomethasone. The laboratory investigations included: hemoglobin concentration (Hb), hematocrit (Ht), platelet count (PLT), red blood cell count (E), white blood cell count (L), percentage of eosinophils (Eos%), fibrinogen (Fib), D-dimer concentration, activated partial thromboplastin time (APTT), prothrombin time (PT), prothrombin index (Quick), INR and von Willebrand factor (vWF).. An elevated concentration of D-dimers was detected in 4 patients (15%) the others investigated coagulation parameters were within normal range. We found a significant correlation between the dose of inhaled glucocorticosteroid and the PT, prothrombin index and INR.. The results revealed no evidence of increased fibrinolytic activity in subjects with stable bronchial asthma treated with inhaled glucocorticosteroids.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Blood Coagulation Factors; Female; Glucocorticoids; Humans; Male; Middle Aged

2005
Salivary IgA and oral candidiasis in asthmatic patients treated with inhaled corticosteroid.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2005, Volume: 42, Issue:7

    Inhaled corticosteroids are used for the treatment of bronchial asthma. Systemic side effects are rare, but local problems, such as oral candidiasis, can occur. Only a proportion of patients encounter this problem, and the mechanism of oral candidiasis induced by inhaled corticosteroids remains obscure. According to reports in immunodeficient patients, oral candidiasis is related to deficiencies in topical immunity, such as salivary IgA.. We evaluated differences in salivary IgA between asthmatics in whom Candida was detected or not detected from the pharynges, respectively.. Saliva was collected from 18 healthy controls and 37 asthmatic patients treated with inhaled corticosteroids. The amounts of total IgA and the Candida-specific IgA of the saliva were measured. Fungal culture of the pharyngeal wall was also performed.. There were no differences in salivary total IgA and Candida-specific IgA between healthy controls and culture-negative asthmatic patients. Salivary total IgA of Candida-positive asthmatic patients was significantly lower than that of Candida-negative patients. However, there was no difference in Candida-specific IgA levels between these two groups.. Our results suggest that inhaled corticosteroids can potentially decrease salivary total IgA but that host factors are also important in the development of oral candidiasis.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Aged; Androstadienes; Anti-Asthmatic Agents; Antibody Specificity; Asthma; Beclomethasone; Candida albicans; Candidiasis, Oral; Female; Fluticasone; Humans; Immunoglobulin A, Secretory; Male; Middle Aged; Nebulizers and Vaporizers; Opportunistic Infections; Pharynx; Risk; Saliva

2005
Annual increase in body mass index in children with asthma on higher doses of inhaled steroids.
    The Journal of pediatrics, 2005, Volume: 147, Issue:4

    There is a greater annual increase in body mass index in children with asthma receiving inhaled steroids at a dose > or =400 microg/day (0.5 kg/m2/year; n=100) compared with those receiving < or =200 microg/day (0.1 kg/m2/year; n=98) (P=.0003). This is consistent with an annual increase in body fat in children with asthma receiving > or =400 microg/day of inhaled steroids.

    Topics: Administration, Inhalation; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Body Mass Index; Budesonide; Child; Dose-Response Relationship, Drug; Female; Fluticasone; Glucocorticoids; Humans; Longitudinal Studies; Male

2005
[Treatment compliance in asthma: a Tunisian transversal study].
    La Tunisie medicale, 2005, Volume: 83, Issue:8

    As a chronic disease, asthma requires a continued treatment and poses the problem of compliance with medication. To study in a Tunisian population of asthmatics, the level of compliance and the factors affecting it, we included 190 adults with persistent asthma in a transversal study using a self-questionnaire. The mean age was 38.56 years. 2/3 of patients had medium or poor socioeconomic status. 1/3 had severe persistent asthma, progressing for 5 years in 68 % of case. All patients received inhaled corticosteroids; only 44 had high dosed corticosteroids. 29.5 % of patients were compliant with medication in our study. Omission and intentional negligence were the two main reasons for non-compliance. Level of compliance was positively related to socioeconomic status, urban way of life, hystory of hospitalization, high dosed corticosteroids and knowledge of their indication. We conclude that treatment compliance in asthma is very low. Further efforts should be made to improve compliance: by increasing the accessibility of medication and by the educational programs which should be a priority in the management of asthma.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Cross-Over Studies; Disease Progression; Female; Fluticasone; Humans; Male; Middle Aged; Patient Compliance; Patient Education as Topic; Socioeconomic Factors; Surveys and Questionnaires; Theophylline; Time Factors; Tunisia

2005
[Treatment of asthma--an analysis of clinical judgment among general practitioners].
    Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke, 2005, Nov-03, Volume: 125, Issue:21

    The asthma patient's symptoms, use of drugs, and peak expiratory flow rates dictate treatment of asthma according to the guidelines. Our aim was to examine which information influenced the decisions of general practitioners.. Out of 100 general practitioners attending a course on asthma management, 75 responded to several constructed patient cases on asthma treatment. They decided whether or not to give oral steroids in case of an acute exacerbation and judged the quality of pharmacological treatment. Age, symptoms, body temperature, peak expiratory flow measurement and the dose of beta-2 agonists and inhaled steroids varied from patient to patient. Their attitudes to the use of oral steroids and to the usefulness of measuring peak expiratory flow were evaluated.. Among the doctors, 52% evaluated only one characteristic of the patients when deciding upon treatment with oral steroids. The use of drugs was evaluated by one quarter of the doctors when they judged the quality of treatment. Respectively, 81% and 73% were influenced by objective measurements in these decisions. The majority of doctors applied oral steroids and measured peak expiratory flow in asthmatics.. This study indicates that general practitioners focus mainly on measured peak expiratory flow rate. The patient's symptoms ought to be given more consideration in the treatment of asthma. The patient's use of anti-asthmatics is emphasised in guidelines, but was of only limited importance to the doctors in this study.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Decision Making; Education, Medical, Continuing; Family Practice; Female; Glucocorticoids; Humans; Male; Middle Aged; Patient Participation; Peak Expiratory Flow Rate; Physicians, Family; Practice Guidelines as Topic; Surveys and Questionnaires

2005
Effect of beclomethasone dipropionate on basic fibroblast growth factor levels in induced sputum samples from asthmatic patients.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2005, Volume: 95, Issue:6

    Airway remodeling in asthma refers to certain structural changes and is regulated by several growth factors. One molecule of potential relevance to these pathologic changes is basic fibroblast growth factor (bFGF).. To examine the relationship between bFGF levels and type III collagen synthesis in asthmatic airways and the effect of inhaled corticosteroid therapy on bFGF levels.. We simultaneously measured bFGF, vascular endothelial growth factor (VEGF), and procollagen type III peptide (P-III-P) levels in induced sputum samples from 17 asthmatic patients and 10 controls. Sputum induction was performed before and after 1 year of inhaled beclomethasone dipropionate therapy.. Before beclomethasone dipropionate therapy, mean (SD) VEGF and bFGF levels were significantly higher in asthmatic patients (VEGF: 4270 [650] pg/mL; bFGF: 46.4 [20.0] pg/mL; P < .001 for both) than in controls (VEGF: 1730 [1140] pg/mL; bFGF: 6.0 [3.0] pg/mL). Although P-III-P was detected in none of the controls, P-III-P levels could be measured in all the asthmatic patients. No significant correlation was found between P-III-P and VEGF levels in asthmatic patients. However, a close correlation was found between bFGF and P-III-P levels in these patients (r = 0.84; P < .001). After 1 year of beclomethasone dipropionate therapy, VEGF levels were significantly decreased, whereas bFGF and P-III-P levels did not differ before vs after therapy. There remained a significant correlation between bFGF and P-III-P levels even after beclomethasone dipropionate therapy.. A close correlation between bFGF and P-III-P levels was observed in asthmatic airways. However, corticosteroid therapy might not prevent airway remodeling via the bFGF-dependent pathway.

    Topics: Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Fibroblast Growth Factor 2; Humans; Male; Peptide Fragments; Procollagen; Sputum; Treatment Outcome; Vascular Endothelial Growth Factor A

2005
[A case of severe persistent bronchial asthma who showed significant improvement by switching to hfa-bdp, with reducing the dosage of oral steroids].
    Arerugi = [Allergy], 2005, Volume: 54, Issue:11

    A case, 54-year-old female teacher, has been treated for severe persistent asthma mainly with an inhaled corticosteroid, budesonide (BUD), 600 microg/day. The higher dose was considered inappropriate due to the adverse effects including hoarseness, thus, prednisolone (PSL) was frequently given when needed. In this situation, administration of hydrofluoroalkane-beclomethasone dipropionate (HFA-BDP), 400 microg/day, was started instead of BUD, and then improvement of the clinical symptoms, PEF and pulmonary function were observed promptly, followed by reduction in the dosage of PSL and a short-acting beta-stimulant. With higher doses of HFA-BDP, her pulmonary condition improved more remarkably. The levels of ECP, Eotaxin and RANTES in induced sputum obtained by inhalation of 10%-hypertonic saline were measured prior to the medication change and after one year, and all of the levels were found to be decreased, from 19000 to 96.0 microg/L, from 410 to 319 pg/ml, and from 281 to 85.1 pg/ml, respectively, indicating improvement of the condition. The overall score of Asthma Quality of Life Questionnaire by Juniper also improved from 5.3 to 6.6 points after one year. In this case study, it was suggested that HFA-BDP may reduce eosinophilic inflammation remained in the peripheral airway, and may be effective in supplementing the activity of PSL which must be taken orally by severe asthmatic patients.

    Topics: Administration, Inhalation; Administration, Oral; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Middle Aged; Prednisolone; Sputum

2005
Do the British Guidelines for Asthma Management facilitate concordance?
    Health expectations : an international journal of public participation in health care and health policy, 2004, Volume: 7, Issue:1

    Asthma is an example of a common, chronic illness in which clinicians are encouraged to promote concordance and adhere to guidelines. Some existing research suggests that these aims may be incompatible.. To describe patient goals for life and for asthma management in order to inform concordance with people with asthma.. A cross-sectional, qualitative survey.. A purposive sample of 47 adults with asthma from Dundee, UK. The subjects were identified from general practice asthma registers and had a range of ages and asthma severity but no significant comorbidity.. Tape-recorded semi-structured interviews. The topic guide was based on the literature and had been piloted in a previous study.. The participants focussed on improving their lives, only aiming to improve their asthma as a means of improving their lives. Three aspects of asthma were reported to help or hinder improving life: the use of asthma medication, trigger avoidance and exercise. People integrated these three aspects of asthma in order to maximize life.. The study supports the more individualized goals of the recently revised British Guidelines for Asthma Management but highlights the need to develop this further in future revisions. It also provides an explanation for patients' acceptance of less than 'perfect' asthma control and it suggests that shared goals may be achieved in practice by considering the advantages and disadvantages of medication and allergen avoidance on everyday life rather than on asthma.

    Topics: Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Attitude to Health; Beclomethasone; Drug Administration Schedule; Female; Goals; Humans; Life Style; Male; Practice Guidelines as Topic; Smoking; United Kingdom

2004
HFA inhalers.
    Pediatric pulmonology. Supplement, 2004, Volume: 26

    Topics: Aerosol Propellants; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Glucocorticoids; Humans; Hydrocarbons, Fluorinated; Metered Dose Inhalers; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic

2004
Matching the device to the patient.
    Pediatric pulmonology. Supplement, 2004, Volume: 26

    Aerosol therapy is complex, especially in young children, and can only succeed when the physician has detailed knowledge about: aerosol characteristics of the various aerosol delivery systems; the pathophysiology of the lung disease; the skills of the patient in various age groups. Only when this knowledge is available the appropriate delivery device for the child can be selected and the proper instructions can be given. Most aerosol delivery devices are not primarily developed for use in children. Particle size characteristics of most delivery systems are suboptimal for children since they deliver only a low mass of extra fine aerosol particles.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Humans; Nebulizers and Vaporizers; Pulmonary Disease, Chronic Obstructive

2004
Role of microvascular permeability on physiologic differences in asthma and eosinophilic bronchitis.
    American journal of respiratory and critical care medicine, 2004, May-15, Volume: 169, Issue:10

    Asthma and eosinophilic bronchitis are characterized by a similar type of eosinophilic inflammation. However, eosinophilic bronchitis differs from asthma in that there is no variable airflow obstruction or airway hyperresponsiveness. We evaluated the roles of vascular endothelial growth factor (VEGF) and microvascular permeability in causing these differences between the two diseases. Inflammatory indexes in induced sputum, exhaled nitric oxide levels, and vascular permeability index were examined in 11 normal control subjects, 19 beclomethasone dipropionate (BDP)-treated subjects with asthma, 20 non-BDP-treated subjects with asthma, and 17 patients with eosinophilic bronchitis. The percentage of eosinophils in sputum and exhaled nitric oxide levels were significantly higher in non-BDP-treated subjects with asthma and patients with eosinophilic bronchitis than in other two groups; however, VEGF levels and vascular permeability index were significantly higher in non-BDP-treated (VEGF: mean; 4,710 [SD; 1,150] pg/ml, p < 0.0001; vascular permeability index: 0.028 [0.009], p < 0.0001) and BDP-treated (2,560 [1,070] pg/ml, p = 0.0002; 0.016 [0.006], p = 0.004) subjects with asthma than in patients with eosinophilic bronchitis (1,120 [800] pg/ml; 0.01 [0.005]) and normal control subjects (1,390 [1,280] pg/ml; 0.008 [0.003]). We found significant correlations between the VEGF level and the airway vascular permeability index in all patient groups. Thus, interaction between airway microcirculation and VEGF may be a key element in differences in airway function between asthma and eosinophilic bronchitis.

    Topics: Adult; Analysis of Variance; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchitis; Capillary Permeability; Case-Control Studies; Eosinophilia; Female; Humans; Male; Middle Aged; Nitric Oxide; Probability; Risk Assessment; Sensitivity and Specificity; Severity of Illness Index; Sputum; Vascular Endothelial Growth Factor A

2004
Non-specific bronchial hyperresponsiveness is a risk factor for steroid insensitivity in nasal polyposis.
    Acta oto-laryngologica, 2004, Volume: 124, Issue:3

    Management of nasal polyposis should be primarily medical. Resorting to intranasal ethmoidectomy should not be envisaged before a trial of dual steroid therapy. Nevertheless, no risk factor for steroid insensitivity in patients with nasal polyposis is actually defined. The aim of this study is to evaluate whether the presence of asthma and/or non-specific bronchial hyperresponsiveness (BHR) can be considered a risk factor for steroid insensitivity.. This study focused on the evaluation of a dual modality, topical and systemic, over a follow-up period of 3 years. A total of 55 subjects with and 45 subjects without BHR were treated according to a standardized therapeutic protocol combining short-term oral administration of prednisolone and a daily intranasal spray of beclomethasone.. Over the follow-up period of 3 years, this dual modality proved to be successful in 93.4% of subjects without BHR and without aspirin idiosyncrasy, in 82.2% of subjects with BHR and without aspirin idiosyncrasy and in 60% of subjects with BHR and aspirin idiosyncrasy. The percentage of patients who underwent surgery after the failure of medical treatment was significantly larger in patients with than without BHR (p < 0.05) and in patients with than without aspirin idiosyncrasy (p < 0.02).. The presence of BHR and/or aspirin idiosyncrasy can be considered a major risk factor for steroid insensitivity in patients with nasal polyposis.

    Topics: Administration, Oral; Aerosols; Anti-Asthmatic Agents; Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Agents, Hormonal; Aspirin; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Drug Hypersensitivity; Drug Resistance; Ethmoid Sinus; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Middle Aged; Nasal Polyps; Prednisolone; Risk Factors; Tablets; Therapeutic Irrigation; Tomography, X-Ray Computed; Treatment Outcome

2004
The efficacy and safety of QVAR (hydrofluoroalkane-beclometasone diproprionate extrafine aerosol) in asthma (Part 2): Clinical experience in children.
    International journal of clinical practice, 2004, Volume: 58, Issue:8

    QVAR [hydrofluoroalkane-134a beclometasone dipropionate (BDP)] produces equivalent asthma control to chlorofluorocarbon-based BDP inhalers, at approximately half the daily dose in adults, a probable consequence of the increased lung deposition of QVAR that results from its greater fine particle fraction. Recent studies have relied on the clinical experience with QVAR in adults as a basis for investigations in childhood asthma. Design considerations, such as the use of the breath-actuated Autohaler delivery device and measurement of direct health benefits, account for problems of variation in inspiratory flow, handling difficulties and low airways resistance that are associated with children. QVAR appears to be well tolerated in children with no clinically relevant adverse effects on adrenal function, bone metabolism or growth at recommended doses.

    Topics: Administration, Inhalation; Aerosol Propellants; Aerosols; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Humans; Hydrocarbons, Fluorinated; Lung; Treatment Outcome

2004
Asthma update: clinical aspects and management.
    Pediatrics in review, 2004, Volume: 25, Issue:10

    Topics: Adrenergic beta-Agonists; Albuterol; Algorithms; Anti-Asthmatic Agents; Anti-Bacterial Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child; Child, Preschool; Drug Therapy, Combination; Glucocorticoids; Humans; Respiratory Function Tests

2004
Comparison of atopic cough with cough variant asthma: is atopic cough a precursor of asthma?
    Thorax, 2003, Volume: 58, Issue:1

    We have described a group of patients who present with isolated chronic bronchodilator resistant non-productive cough with an atopic constitution, eosinophilic tracheobronchitis, and airway cough receptor hypersensitivity without bronchial hyperresponsiveness, which we have termed "atopic cough". Although cough variant asthma (in which the cough responds to bronchodilators) is recognised as a precursor of typical asthma, it is not known whether atopic cough is also a precursor of asthma.. Eighty two patients with atopic cough were retrospectively examined for onset of typical asthma and compared with 55 patients with cough variant asthma (20 untreated patients and 35 treated with long term inhaled beclomethasone dipropionate (BDP), 218-467 micro g/day). The median follow up period for patients with atopic cough and cough variant asthma was 4.8 (1-11.5) years and 3.7 (1-12.4) years, respectively.. Onset of typical asthma occurred in only one of the patients with atopic cough. In patients with cough variant asthma, typical asthma developed in two of 35 patients taking BDP and six of 20 untreated patients (difference 24.3%, 95% CI 2.8 to 45.8, p<0.02).. These findings suggest that cough variant asthma is a precursor of typical asthma but that atopic cough is not. Treatment with inhaled steroids may prevent the transformation of cough variant asthma into typical asthma.

    Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Cough; Drug Resistance; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Recurrence; Retrospective Studies; Vital Capacity

2003
Potency of inhaled corticosteroid fails to predict reduced emergency department visits.
    Archives of internal medicine, 2003, Jan-27, Volume: 163, Issue:2

    Topics: Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Emergency Medical Services; Emergency Service, Hospital; Fluticasone; Glucocorticoids; Humans; Triamcinolone Acetonide

2003
A neglected breakthrough in asthma therapy.
    Lancet (London, England), 2003, Feb-01, Volume: 361, Issue:9355

    Topics: Administration, Inhalation; Aerosol Propellants; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Drug Combinations; Eosinophils; Humans; Hydrocarbons, Fluorinated; Patient Selection; Predictive Value of Tests; Sputum; Treatment Outcome

2003
Interferon therapy induces the improvement of lung function by inhaled corticosteroid therapy in asthmatic patients with chronic hepatitis C virus infection: a preliminary study.
    Chest, 2003, Volume: 123, Issue:2

    Several reports have suggested that subsets of asthmatic patients with chronic viral infection fail to respond to corticosteroid therapy. Therefore, this study was designed to determine that asthmatic patients with chronic hepatitis C virus (HCV) infection fail to improve lung function by inhaled corticosteroid therapy, and that interferon (IFN) therapy against HCV is effective for such patients.. Prospective observational study.. University hospital.. Forty asthmatic patients with chronic HCV infection.. After a 4-week run-in period, all asthmatic patients received therapy with inhaled beclomethasone dipropionate (BDP), 400 micro g twice daily for 6 weeks. After the first study, all asthmatic patients continued to receive inhaled BDP, and 30 HCV-positive asthmatic patients received IFN-alpha therapy for 6 months.. Prebronchodilator and postbronchodilator FEV(1) values were examined after a 4-week run-in period, after 6 weeks of BDP therapy, and at 1 year from the end of IFN therapy. After a 4-week run-in period as well as after 6 weeks of BDP therapy, there were no significant differences in either prebronchodilator or postbronchodilator FEV(1) values among the three groups. However, 1 year after the end of IFN therapy, the mean prebronchodilator and postbronchodilator FEV(1) values were significantly higher in the IFN responder group (n = 11) [prebronchodilator FEV(1), 1.93 L (SD, 0.13 L); postbronchodilator FEV(1), 2.28 L (SD, 0.15 L)] than in the IFN nontreatment group (n = 10) [prebronchodilator FEV(1), 1.78 L (SD, 0.10 L); p = 0.01; postbronchodilator FEV(1), 2.07 L (0.13 L); p = 0.005] or the IFN nonresponder groups (n = 19) [prebronchodilator FEV(1), 1.79 L (SD, 0.15 L); p = 0.006; postbronchodilator FEV(1), 2.07 L (SD, 0.18 L); p = 0.002]. Moreover, prebronchodilator and postbronchodilator FEV(1) values were significantly higher only in the IFN responder group at 1 year after the end of IFN therapy than after the 4-week run-in period (prebronchodilator FEV(1), p = 0.028; postbronchodilator FEV(1); p = 0.002) or after 6 weeks of BDP therapy (p = 0.016 and p = 0.004, respectively).. Our findings suggest that chronic HCV infection in asthmatic patients is associated with impaired responses to inhaled BDP therapy and that intervention with IFN reverses such responses only in the IFN responder group.

    Topics: Administration, Inhalation; Adult; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Drug Therapy, Combination; Female; Follow-Up Studies; Forced Expiratory Volume; Hepatitis C, Chronic; Humans; Injections, Intramuscular; Interferon-alpha; Japan; Male; Middle Aged; Treatment Outcome

2003
No impairment of peripheral deposition in novel asthmatics treated with an MDI corticosteroid with spacer.
    Respiratory medicine, 2003, Volume: 97, Issue:2

    Pulmonary distribution and lung functions were evaluated during a 4-month inhaled corticosteroid treatment period in 10 steroid-naïve novel asthmatics with normal or slightly reduced lung functions. Patients were given a total daily dose of 1000 microg of beclomethasone dipropionate aerosol twice a day via a pressured metered dose inhaler with a large-volume chamber device (Volumatic, GlaxoSmith Kline, U.K.). Gamma lung scintigraphy and lung function tests were performed before and after 2 months and 4 months. Inhaled 99mTc-labelled beclomethasone dipropionate liposomes were used to assess lung deposition patterns during inhaled steroid therapy. Serum eosinophil cationic protein (ECP) concentration was used as a surrogate marker of asthmatic inflammation. Following beclomethasone treatment, all lung functions were enhanced, but only FVC values showed significant improvement. The FEV1/FVC ratio remained slightly reduced in spite of inhaled corticosteroid therapy. However, the association between changes in improved FVC values and reduced ECP levels proved to be statistically significant. In lung scintigraphy, no evidence of changes in pulmonary deposition patterns were seen during the follow-up period. We conclude that inhaled corticosteroid therapy can lead to improvements in lung functions and surrogate markers of airway inflammation in novel asthma without affecting the peripheral deposition pattern of aerosols.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Blood Proteins; Eosinophil Granule Proteins; Forced Expiratory Volume; Glucocorticoids; Humans; Lung; Metered Dose Inhalers; Middle Aged; Radionuclide Imaging; Radiopharmaceuticals; Ribonucleases; Sodium Pertechnetate Tc 99m; Vital Capacity

2003
Introduction. Nebulized beclometasone dipropionate therapy in asthma.
    Respiratory medicine, 2003, Volume: 97 Suppl B

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Humans; Nebulizers and Vaporizers

2003
Conclusion. Nebulized beclometasone dipropionate therapy in asthma.
    Respiratory medicine, 2003, Volume: 97 Suppl B

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Humans; Metered Dose Inhalers

2003
[An evaluation of the acceptance of budesonide turbuhaler by older Japanese patients with bronchial asthma when changed from fluticasone propionate (FP) or beclomethasone dipropionate (BDP)].
    Arerugi = [Allergy], 2003, Volume: 52, Issue:1

    Although the clinical reputation of the inhaled steroid budesonide(R) (BUD) has become well established in Europe and the USA, we found that in clinical practice many older Japanese patients were resistant to changing to this form of inhaled steroid from fluticasone propionate (FP) or beclomethasone dipropionate (BDP). This study was accordingly designed to evaluate the acceptability and clinical efficacy of budesonide in older Japanese patients with bronchial asthma.. Forty-five Japanese asthma patients aged over 65 (22 using FP and 23 using BDP) were changed to BUD inhalation from their existing inhaled steroid. After two weeks, patients were questioned as to their acceptance of BUD, their inhalation technique was checked, and the duration of inhalation required to dispense the drug and peak expiratory flow (PEF) was measured. The rate of pharyngeal candidiasis was also assessed, both before and after changing to BUD.. Most of the patients in both groups considered BUD inhalation to be easy and could quickly learn to use the Turbuhaler. However, as no sensation of drug inhalation was generally experienced, over 70% of patients felt anxious about whether they had successfully inhaled the medication. Furthermore, there were various misunderstandings in correct inhaler technique. Although there were no significant differences in PEF or in the rate of pharyngeal candidiasis before and after changing to BUD administration, side effects occurred in about 40% of both groups. In patients aged 65-74, 50.0% of patients who had previously been taking FP and 38.9% of those who had previously been taking BDP intended to continue BUD inhalation, while in patients over 75, only 8.3% of former users of FP and 20.0% of former users of BDP intended to continue using BUD.. In older patients, factors influencing satisfaction with inhaled medication include not only ease of use and time needed to become accustomed to a new delivery method, but also the important issue of satisfaction with the sensation of drug inhalation.

    Topics: Administration, Topical; Aged; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Female; Fluticasone; Glucocorticoids; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Patient Satisfaction

2003
[A Cochrane report compares inhaled steroids for asthma. No big differences between the most common preparations].
    Lakartidningen, 2003, Apr-10, Volume: 100, Issue:15

    Topics: Administration, Inhalation; Administration, Topical; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Fluticasone; Glucocorticoids; Humans; Meta-Analysis as Topic

2003
Longitudinal decline in pulmonary function in atopic cough and cough variant asthma.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2003, Volume: 33, Issue:5

    Cough variant asthma and atopic cough are different clinical manifestations of eosinophilic airway inflammation presenting with isolated chronic non-productive cough. The aim of this study was to examine the longitudinal change in pulmonary function in cough variant asthma and atopic cough.. Longitudinal change in FEV1 was prospectively examined in 20 patients with cough variant asthma, 14 patients with atopic cough and 271 asymptomatic healthy subjects. All were lifetime non-smokers. Of the 20 cough variant asthma patients, 13 were taking long-term inhaled corticosteroid therapy (ICS) (beclomethasone dipropionate 615 +/- 58 micro g/day) and the other seven were not. Spirometry was taken at first visit, after cough was almost completely relieved on therapy, and at least once every year for 5 or more years afterwards.. The slope of longitudinal change in FEV1 was not significantly different among cough variant asthma patients (- 0.029 +/- 0.007/year), atopic cough patients (- 0.021 +/- 0.022/year) and asymptomatic subjects (- 0.028 +/- 0.002 L/year). In patients with cough variant asthma, the slope in patients not taking inhaled corticosteroids (ICS) was 0.032 +/- 0.007 L/year, which was not significantly different from that in patients taking ICS (- 0.027 +/- 0.010 L/year).. Pulmonary function decline is not greater in cough variant asthma than atopic cough and the normal population, and long-term ICS has no effect on the decline in cough variant asthma.

    Topics: Asthma; Beclomethasone; Cough; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Hypersensitivity, Immediate; Longitudinal Studies; Lung; Male; Middle Aged; Prospective Studies; Vital Capacity

2003
Increased levels of vascular endothelial growth factor in induced sputum in asthmatic patients.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2003, Volume: 33, Issue:5

    Vascular endothelial growth factor (VEGF) is highly expressed in the airway of asthmatic patients. As VEGF increases airway vascular permeability, consequent thickening of the airway wall mucosa may lead to narrowing of the airway lumen.. We evaluated the relationship between VEGF levels in induced sputum and eosinophilic inflammatory profiles, and the degree of airway vascular permeability in asthmatic patients and we evaluated the effect of inhaled corticosteroids on VEGF levels in induced sputum.. Induced sputum specimens were obtained from 28 glucocorticosteroids free asthmatics and 11 healthy control subjects. We examined VEGF levels and airway vascular permeability index in induced sputum. After the initial sputum induction, 21 asthmatics received 8-week inhaled beclomethasone dipropionate (BDP, 800 micro g/day) therapy, then sputum induction was repeated.. The VEGF levels in asthmatics were significantly higher than in healthy control subjects (P < 0.0001). The VEGF levels were negatively correlated with forced expiratory volume of 1 s (FEV1, % predicted, r = - 0.68, P < 0.001), the percentage of eosinophils (r = 0.51, P < 0.01) and ECP levels (r = 0.39, P < 0.05). Moreover, the VEGF levels were significantly correlated with airway vascular permeability index (r = 0.61, P < 0.001). After 8-week inhaled BDP therapy, the VEGF levels were significantly decreased compared to pretreatment levels (P < 0.0001) and the VEGF levels were significantly correlated with airway vascular permeability index even in post-treatment asthmatics (r = 0.62, P < 0.01).. The VEGF levels in induced sputum were increased in asthmatics and its levels were associated with degree of airway narrowing and airway vascular permeability. These findings provide strong evidence that VEGF may play an important role in the pathogenesis of bronchial asthma.

    Topics: Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Capillary Permeability; Endothelial Growth Factors; Eosinophils; Female; Humans; Intercellular Signaling Peptides and Proteins; Leukocyte Count; Lymphokines; Male; Middle Aged; Sputum; Vascular Endothelial Growth Factor A; Vascular Endothelial Growth Factors

2003
Asthma variability.
    The European respiratory journal, 2003, Volume: 21, Issue:5

    Topics: Acetates; Anti-Asthmatic Agents; Asthma; Beclomethasone; Clinical Trials as Topic; Cyclopropanes; Humans; Quinolines; Sulfides; Treatment Outcome

2003
Effects of low dose fluticasone/salmeterol combination on surrogate inflammatory markers in moderate persistent asthma.
    Allergy, 2003, Volume: 58, Issue:7

    Noninvasive surrogate markers provide valuable information on the asthmatic inflammatory process. We wished to examine the effects of low dose fluticasone/salmeterol combination on different commonly used inflammatory markers in moderate persistent asthma.. Twenty-five moderate persistent atopic asthmatics were enrolled of whom 20 completed an open label study. Following an initial 4 week steroid washout period in which patients took salmeterol 50 microg dry powder inhaler 1 puff BD, they received the addition of fluticasone as fluticasone 100 microg/salmeterol 50 microg combination dry powder inhaler 1 puff BD for the next 2 weeks. Exhaled nitric oxide, spirometry, methacholine PD20, sputum/blood eosinophils and sputum/serum eosinophil cationic protein (ECP) were measured following the salmeterol only and fluticasone/salmeterol combination treatment periods.. Compared to salmeterol alone (i.e. after the steroid washout), the use of fluticasone/salmeterol combination conferred significant improvements (P < 0.05) in all surrogate markers of inflammation apart from serum ECP. Geometric mean fold changes were 4.3-fold/1.3-fold for sputum/blood eosinophils, 2.2-fold/1.2-fold for sputum/serum ECP, 2.3-fold for methacholine PD20 and 1.8-fold for exhaled nitric oxide.. Surrogate markers apart from serum ECP may be used as a guide to evaluate the anti-inflammatory effects of low dose inhaled corticosteroids. Sputum markers tend to be more sensitive than blood when assessing the anti-inflammatory response.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biomarkers; Blood Proteins; Bronchial Provocation Tests; Bronchoconstrictor Agents; Bronchodilator Agents; Budesonide; Chlorofluorocarbons; Dose-Response Relationship, Drug; Drug Therapy, Combination; Eosinophil Granule Proteins; Eosinophils; Fluticasone; Forced Expiratory Flow Rates; Forced Expiratory Volume; Humans; Methacholine Chloride; Middle Aged; Predictive Value of Tests; Ribonucleases; Salmeterol Xinafoate; Severity of Illness Index; Spirometry; Sputum; Treatment Outcome

2003
Relationship of airway wall thickness to airway sensitivity and airway reactivity in asthma.
    American journal of respiratory and critical care medicine, 2003, Oct-15, Volume: 168, Issue:8

    Airway wall thickening has been assumed to cause airway hyperresponsiveness, but a protective effect against airway narrowing has also been suggested. We investigated the relationship between airway wall thickness as assessed by helical computed tomography and two components of airway responsiveness, airway sensitivity and reactivity, in patients with stable asthma with (n = 23) and without (n = 22) inhaled steroid treatment. A cross-section of the apical bronchus of the right upper lobe was obtained. Airway wall area corrected by body surface area was measured as an index of wall thickness. Airway sensitivity and reactivity were measured by continuous inhalation of methacholine, on the basis of the methacholine respiratory resistance dose-response curve. The eosinophil count in sputum was determined in 16 patients [steroid (+) group] and 14 patients [steroid (-) group]. In both groups of patients, airway sensitivity was not related to airway reactivity. Airway sensitivity was related to eosinophil count [r = 0.57 in the steroid (+) group and r = 0.49 in the steroid (-) group], but not to airway wall thickness. In contrast, airway reactivity negatively correlated with airway wall thickness [r = -0.56 in the steroid (+) group and r = -0.55 in the steroid (-) group] but not with eosinophil count. Our results suggest that airway wall thickening attenuates airway reactivity in patients with asthma. These findings may have important implications in pathophysiology and in the treatment of airway remodeling.

    Topics: Adrenergic beta-Agonists; Aged; Airway Resistance; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Bronchoconstrictor Agents; Eosinophils; Female; Forced Expiratory Volume; Humans; Hyperplasia; Hypertrophy; Inflammation; Leukocyte Count; Male; Methacholine Chloride; Middle Aged; Severity of Illness Index; Sputum; Tomography, X-Ray Computed

2003
Trends in the use of inhaled corticosteroids for childhood asthma in New Zealand.
    European journal of clinical pharmacology, 2003, Volume: 59, Issue:5-6

    To compare the dispensed volumes and prescribed doses for inhaled corticosteroids (ICS) for children in New Zealand.. Longitudinal analysis of prescribing trends using the Royal New Zealand College of General Practitioners Research Unit database and the Pharm Warehouse database of the New Zealand Health Information System.. New Zealand from 1993 to 2001.. Children aged 0-5 years and 6-17 years.. The ratio of potency-adjusted mean daily dose of fluticasone propionate (FP) to beclomethasone (BDP) and dispensed volumes of FP, BDP and budesonide.. The ratio of potency-adjusted mean daily dose of FP to BDP prescribed to children aged 0-17 years ranged from 1.22 to 1.91. With the introduction of FP, the total amount of ICS dispensed to children aged 0-5 years in New Zealand nearly doubled, when adjusted for potency.. The introduction of FP into New Zealand corresponds with an increase in the total amount of ICS dispensed and an increase in the adjusted daily dose prescribed.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Child; Child, Preschool; Databases, Factual; Dose-Response Relationship, Drug; Drug Utilization Review; Fluticasone; Humans; Infant; Infant, Newborn; New Zealand; Retrospective Studies

2003
Systematic assessment of difficult-to-treat asthma.
    The European respiratory journal, 2003, Volume: 22, Issue:3

    Five per cent of asthmatics remain symptomatic despite high-dose treatment. The aim of the study was to investigate how often such difficult-to-treat asthma is due to intractable asthma, misdiagnosis, non-adherence with therapy, or psychiatric problems. Difficult asthma was defined as persistence of symptoms despite treatment at step 4 of British guidelines or requirement for long-term oral glucocorticoids (step 5). One-hundred patients with a respiratory physician diagnosis of asthma were investigated in a single tertiary respiratory unit in an open and descriptive study. Twelve of the patients studied did not have asthma and a further seven had additional diagnoses. Of the remainder, 55 had an asthma diagnosis confirmed by demonstration of reversible airflow narrowing or peak flow variability, whilst 20 did not. Non-compliance with prednisolone therapy was more frequent in the 55 with confirmed asthma (nine of 18 prescribed oral prednisolone at a dose of > or = 15 mg x day(-1)) and was not detected in the "unconfirmed asthma" group. There were no other significant differences between these groups. A major psychiatric component was detected in 10 patients. Systematic evaluation of difficult asthma is useful as it can identify alternative or additional diagnoses, psychiatric illness or nonconcordance with therapy in a substantial proportion of cases (32% in the present series).

    Topics: Administration, Oral; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Female; Glucocorticoids; Humans; Hypersensitivity, Immediate; Lung Diseases; Male; Middle Aged; Patient Compliance; Prednisolone; Pulmonary Disease, Chronic Obstructive; Respiratory Function Tests

2003
Distribution of therapeutic response in asthma control.
    The European respiratory journal, 2003, Volume: 22, Issue:3

    Topics: Acetates; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cyclopropanes; Humans; Quinolines; Statistics as Topic; Sulfides

2003
Tapering inhaled steroids effective for chronic asthma.
    The Journal of family practice, 2003, Volume: 52, Issue:10

    Topics: Administration, Inhalation; Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chronic Disease; Double-Blind Method; Fluticasone; Humans; Randomized Controlled Trials as Topic

2003
Differential prescribing of inhaled corticosteroids in New Zealand general practice.
    The New Zealand medical journal, 2003, Aug-22, Volume: 116, Issue:1180

    To determine how inhaled budesonide, beclomethasone and fluticasone are prescribed by general practitioners in New Zealand.. Retrospective study of computerised clinical records from 42 general practices in New Zealand for the period 1 July 1997 to 30 June 1998. The study population comprised 174 929 consulting patients, of whom 9878 patients were prescribed budesonide, fluticasone, or beclomethasone with full dosing instructions.. The mean daily prescribed dose was higher for patients receiving inhaled budesonide (886 microg) than beclomethasone (547 microg), a difference of 339 microg (95% CI 311 microg to 367 microg), and fluticasone (508 microg), a difference of 378 microg (95% CI 344-412). The difference between mean daily prescribed doses of beclomethasone and fluticasone was 39 microg (95% CI 15-63). The overall difference was consistent across age groups and with different types of inhalation device. Evidence of systematic prescribing of higher doses of budesonide to patients with more severe asthma was not found. Patients prescribed fluticasone were more likely to have been prescribed oral steroids in the preceding year.. Conclusions about the relative potencies of inhaled corticosteroids cannot be made with the data presented. However, data presented show that inhaled corticosteroids have not been prescribed in line with their reported relative potencies. This study provides benchmark data for the prescribing of inhaled steroids in New Zealand general practice.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Androstadienes; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Family Practice; Female; Fluticasone; Humans; Infant; Male; Middle Aged; Nebulizers and Vaporizers; New Zealand; Practice Patterns, Physicians'; Retrospective Studies

2003
Sputum peroxynitrite inhibitory activity is stimulating.
    Chest, 2003, Volume: 124, Issue:5

    Topics: Administration, Inhalation; Antioxidants; Asthma; Beclomethasone; Glucocorticoids; Humans; Inflammation; Nitrates; Nitrites; Peroxynitrous Acid; Sputum

2003
Effect of inhaled beclomethasone dipropionate on peroxynitrite inhibitory activity in induced sputum from asthmatic patients.
    Chest, 2003, Volume: 124, Issue:5

    We recently found that peroxynitrite inhibitory activity in induced sputum was significantly lower in asthmatic patients than in normal control subjects. Current guidelines recommend inhaled corticosteroids as first-line control therapy in asthma. Therefore, this study was designed to examine the effect of inhaled beclomethasone dipropionate (BDP) on peroxynitrite inhibitory activity in induced sputum from asthmatic patients.. Interventional study.. University hospital.. Twenty-one asthmatic patients and 10 age-matched, normal control subjects.. Inflammatory indexes in induced sputum were examined in all study subjects, and peroxynitrite inhibitory activity was also assayed by monitoring rhodamine formation. For 8 weeks after the first sputum induction, BDP 400 microg bid, was administered to all asthmatic patients and sputum induction was repeated.. Nitrite and nitrate levels in induced sputum were significantly higher in asthmatic patients (1,121 micro mol/L [SD, 205 micro mol/L], p < 0.0001) than in normal control subjects (642 micromol/L [SD, 137 micromol/L]). In contrast, peroxynitrite inhibitory activity in induced sputum was significantly lower in asthmatic patients (50.0% [SD, 25.7%], p < 0.0001) than in normal control subjects (93.0% [SD, 3.6%]). After 8 weeks of BDP therapy, nitrite and nitrate levels were significantly decreased (847 micromol/L [SD, 143 micromol/L], p < 0.0001) and peroxynitrite inhibitory activity was increased (73.9% [SD, 19.2%], p = 0.0005). Moreover, the increase in peroxynitrite inhibitory activity from before to after BDP therapy was significantly correlated with decrease in nitrite and nitrate levels (r = 0.79, p = 0.0004). We also found the significant relationship between increase in peroxynitrite inhibitory activity in induced sputum and increase in FEV(1) percentage of predicted after BDP therapy (r = 0.68, p = 0.0023).. Large amounts of peroxynitrite, which are exaggerated in acute asthma attacks, might overwhelm endogenous antioxidant defenses. However, inhaled corticosteroid therapy enhanced antioxidant activity against peroxynitrite, and therefore might reduce the susceptibility to peroxynitrite-induced injury in asthmatic airways.

    Topics: Administration, Inhalation; Adult; Antioxidants; Asthma; Beclomethasone; Blood Proteins; Eosinophil Granule Proteins; Eosinophils; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Nitrates; Nitrites; Peroxynitrous Acid; Rhodamines; Ribonucleases; Sputum

2003
Exhaled nitric oxide continues to reflect airway hyperresponsiveness and disease activity in inhaled corticosteroid-treated adult asthmatic patients.
    Respirology (Carlton, Vic.), 2003, Volume: 8, Issue:4

    Exhaled nitric oxide (eNO) has been used as a surrogate of airway inflammation in mild asthma. However, whether eNO levels reflect disease activity in symptomatic asthmatics receiving moderate doses of inhaled corticosteroid (ICS) is more uncertain.. To examine the relationship between eNO levels, sputum and blood eosinophils (SpE and PbE), PD(20) methacholine as a marker of airway hyperresponsiveness (AHR) and clinical status in 28 ICS-treated asthmatic subjects with persistent asthma compared to that in 25 symptomatic asthmatics managed with beta2-agonists alone.. As expected, eNO levels were normalized in ICS-treated subjects and significantly elevated in the beta2-agonist only group (P < 0.001). SpE, PbE and PD20M did not differ between asthmatic groups but FEV1 was significantly worse in ICS-treated subjects (P < 0.01). Exhaled NO levels correlated with PbE within both asthmatic groups (P < 0.005), but with SpE only in ICS-untreated subjects (r(s) = 0.6, P < 0.05). In contrast, PD20M was negatively correlated with eNO and PbE in ICS-treated subjects only (r(s) = - 0.4, r(s) = - 0.4, respectively, P < 0.05). SpE and PbE were strongly correlated in both asthmatic groups (r(s) = 0.8, r(s) = 0.7, respectively, P < 0.005). Exhaled NO levels, SpE and PbE were all positively associated with increased nocturnal awakenings ( P < 0.05) in ICS-treated subjects, but not in ICS-untreated subjects.. In ICS-treated asthma, eNO reflects clinical activity, PbE and AHR but not eosinophilic airway inflammation. Exhaled NO levels are quantitatively and relationally different in asthmatic subjects treated with ICS and continue to have potential for use as a surrogate of asthma pathophysiology in this group.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biomarkers; Bronchial Hyperreactivity; Cross-Sectional Studies; Drug Monitoring; Eosinophils; Female; Humans; Linear Models; Male; Methacholine Chloride; Middle Aged; Multivariate Analysis; Nitric Oxide; Severity of Illness Index; Sputum; Statistics, Nonparametric

2003
Clinical effects of long-term administration of pranlukast, a leukotriene receptor antagonist, on adult patients with bronchial asthma.
    Arzneimittel-Forschung, 2003, Volume: 53, Issue:10

    Eighty-one adult patients with bronchial asthma who suffered from an unstable peak expiratory flow rate (PEFR) and asthmatic attacks that developed at irregular intervals in spite of inhaling beclometasone dipropionate (CAS 5534-09-8, BDP) in excess of 400 micrograms/day were treated with pranlukast (CAS 103177-37-3, Onon) 450 mg/day for 1 to 2 years and the clinical effects of its long-term administration were studied. The patients were divided into 3 groups: Group I with drug effect seen on peak expiratory flow rate (PEFR) in a short-term; Group II showing long term PEFR improvement; and Group III with no sustained improvement in PEFR. Those in the first two groups continued oral medication for 2 years, while those of the third group withdrew from medication after one year and their clinical course was observed. The evaluation parameters were: PEFR, frequency of beta 2-stimulant inhalation, number of night time visits to health service facilities, quantity of inhalation steroids used, amount of oral steroids used at fixed intervals, peripheral eosinophil count, serum eosinophil cationic protein (ECP) concentration and FEV1.0. In Group I, the frequency of beta 2-stimulant inhalation, number of night time visits to health service facilities, quantity of inhalation steroids used, and the amount of oral steroids used at fixed intervals were reduced; and after two years, the frequency of beta 2-stimulant inhalation and quantity of inhalation steroids used were further reduced. In Group II, reductions were seen in the peripheral eosinophil count and serum ECP level. The asthmatic severity shifted from step 3 to 2 in 12 patients and from step 4 to 3 in 4 patients in Group I; and from step 3 to 2 in 3 patients in Group II. In Group III, an increase in the number of night time visits to health service facilities after the medication was interrupted and a rise in the serum ECP concentration were recognized.

    Topics: Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chromones; Eosinophils; Female; Forced Expiratory Volume; Humans; Leukocyte Count; Leukotriene Antagonists; Male; Middle Aged; Peak Expiratory Flow Rate

2003
Outcome of occupational asthma in patients with continuous exposure: a 3-year longitudinal study during pharmacologic treatment.
    Chest, 2003, Volume: 124, Issue:6

    To evaluate the effect of treatment with beclomethasone dipropionate (500 microg bid) and salmeterol (50 microg bid) on lung function and respiratory symptoms in 20 subjects with occupational asthma (OA) still exposed to the work environment cause of their disease.. At enrollment and every 6 months for 3 years, respiratory symptom score (from 0 [no symptoms] to 2 [moderate-to-severe symptoms]), spirometry, methacholine challenge, peak expiratory flow (PEF) variability, and the use of rescue salbutamol were evaluated. During the 3 years of follow-up, 10 subjects were excluded from the study because they retired or changed jobs.. Symptoms of work-related asthma started 12.6 +/- 13.1 years (mean +/- SD) before diagnosis. At baseline, mean FEV(1) was 80.2% of predicted values and provocative dose of methacholine causing a 20% fall in FEV(1) (PD(20)) was 1,001 +/- 1,275 microg; the workers received 2.1 +/- 2.4 puffs of salbutamol per day. After 3 years, no significant differences in any of the morbidity outcomes (FEV(1), PD(20), PEF variability, use of rescue salbutamol, respiratory symptom score) were found as compared with baseline or run-in values.. Regular treatment with inhaled corticosteroids and long-acting bronchodilators seems to prevent respiratory deterioration over a 3-year period in workers with mild-to-moderate persistent OA who were still exposed at work to the environmental cause of their disease.

    Topics: Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Longitudinal Studies; Male; Middle Aged; Occupational Diseases; Occupations; Respiratory Function Tests; Salmeterol Xinafoate; Severity of Illness Index; Treatment Outcome

2003
Cough after inhalation of corticosteroids delivered from spacer devices in children with asthma.
    Fundamental & clinical pharmacology, 2003, Volume: 17, Issue:5

    Children using a spacer device rather than another device for delivering inhaled corticosteroids (ICS) has been identified as a risk factor for cough immediately after inhalation. The aim of this study was to point out the different factors influencing the occurrence of such lateral side-effects. We studied this local side-effect in 402 asthmatic children (55.6 +/- 34.9 months; 65.6% boys) treated for at least 1 month with beclomethasone dipropionate (n = 331), budesonide (n = 47) or fluticasone propionate (n = 24) delivered from pressurized metered-dose inhalers and small (75.1%) or large volume (24.8%) spacer devices mainly used with face mask (90.7%). A total of 219 patients (54.5%), treated with either high doses of ICS or ICS and long-acting beta2-agonist, were considered as having severe asthma. Cough was reported after each inhalation of corticosteroids in 216 patients (53.7%). Among them, about 30% also complained of cough with beta2-agonists. Despite different propellants and dispersants, all corticosteroids induced cough similarly. Cough was not linked with asthma severity, but was significantly related to therapy duration and use of long-acting beta2-agonist. Type and volume of the spacer device, use of a face mask or mouthpiece were not influencing factors. Cough after inhalation of corticosteroids delivered from spacer devices is a frequent local side-effect in children with asthma. This side effect can greatly alter compliance. A practitioner must be sought at each visit.

    Topics: Administration, Inhalation; Adolescent; Asthma; Beclomethasone; Chi-Square Distribution; Child; Child, Preschool; Confidence Intervals; Cough; Drug Delivery Systems; Female; Humans; Infant; Male; Metered Dose Inhalers

2003
The use of inhaled and related respiratory medications in Christchurch rest homes.
    The New Zealand medical journal, 2003, Dec-12, Volume: 116, Issue:1187

    To describe the use of inhaled and related respiratory medications ('asthma medications') and associated management amongst Christchurch rest-home residents.. Fifty per cent of Christchurch rest homes were randomly selected. All residents on asthma medications, the rest-home managers, care-giving staff, and the residents' general practitioners were interviewed using specific questionnaires.. All of the rest homes, residents using asthma medications and senior staff members participated. Seventy five per cent of caregivers and 73% of general practitioners took part. Asthma medications were used by 13% of 1416 rest-home residents. Eighty four per cent of these used a preventer medication, mostly inhaled steroids. Some daily doses exceeded current treatment guidelines. One third of residents using inhalers had an inadequate technique. Some staff and residents chose the wrong inhaler to manage 'shortness of breath'. Regular bronchodilator dosing, rather than 'as required', was common. Those using a spacer device usually had a good technique. Residents appreciated non-pharmacological strategies for breathlessness. Staff identified a need for clear written management plans.. There were significant deficiencies in the staff and residents' knowledge of obstructive airways management and medications. Regular review of inhaler technique, greater use of spacers, and regular staff education may improve residents' respiratory management. Inhaled corticosteroids may be used in too high a dose. Inconsistent management of acutely deteriorating asthma/chronic obstructive pulmonary disease may be addressed by greater use of written management plans in residents' notes.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Aged; Aged, 80 and over; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Therapy, Combination; Drug Utilization; Female; Humans; Ipratropium; Male; Nebulizers and Vaporizers; New Zealand; Nursing Homes; Pulmonary Disease, Chronic Obstructive; Terbutaline

2003
Vertebral fracture and cortical bone changes in corticosteroid-induced osteoporosis.
    Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2002, Volume: 13, Issue:8

    Despite an intriguing understanding of trabecular bone dynamics, little is known about corticosteroid-induced cortical bone loss and fractures. Recently, we verified a steroid-induced decrease in cortical bone volume and density using peripheral quantitative computed tomography (pQCT) in adult asthmatic patients given oral corticosteroids. Subsequently, the pQCT parameters and presence of vertebral fractures were investigated to further clarify the role of cortical bone quality in fractures in 86 postmenopausal (>5 years after menopause) asthmatic patients on high-dose oral steroid (>10 g cumulative oral prednisolone) (steroid group) and 194 age-matched controls (control group). Cortical and trabecular bone was subjected to measurement of various parameters using pQCT (Stratec XCT960). Relative Cortical Volume (RCV) was calculated by dividing the cortical area by the total bone area. Strength Strain Index (SSI) was determined in the radius based on the density distribution around the axis. Spinal fracture was assessed on lateral radiographs. Patients treated with high doses of oral steroid (>10 g cumulative oral prednisolone) were found to have an increased risk of fracture compared with control women receiving no steroid medication (odds ratio, 8.85; 95% CI, 4.21-18.60) after adjustment was made for years since menopause, body mass index and RCV. In both groups, the diagnostic and predictive ability of the pQCT parameters for vertebral fracture was assessed by the areas under their receiver operating characteristic (ROC) curves. All parameters were found to be significant predictors ( p<0.0001) in the control group. In the steroid group, however, the cortical bone mineral density (BMD) ( p = 0.001), RCV ( p<0.0001) and SSI ( p = 0.001) were found to be significant predictors, but not trabecular BMD ( p = 0.176). For comparison between the two groups, thresholds of all parameters for vertebral fracture were also calculated by the point of coincidence of sensitivity with specificity in ROC testing and the 90th percentile value. Although a rise in fracture threshold in the steroid group was suggested, considerable difference in the values obtained by the two methods of calculation precluded any conclusion. High-dose oral steroid administration was associated with an increased risk of fracture. Cortical bone parameters obtained by pQCT could play a role as good predictors of future corticosteroid-induced vertebral fractures.

    Topics: Administration, Oral; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bone and Bones; Bone Density; Epidemiologic Studies; Female; Humans; Osteoporosis; Prednisolone; Radius; Risk Factors; Spinal Fractures; Tomography, X-Ray Computed

2002
Clinical studies in asthmatics with a new non-extra fine HFA formulation of beclometasone dipropionate (BDP Modulite).
    Respiratory medicine, 2002, Volume: 96 Suppl D

    The main objective of the clinical development programme for BDP Modulite, a new non-extra fine formulation of beclometasone dipropionate (BDP) in hydrofluoroalkane (HFA), has been to demonstrate therapeutic equivalence compared with standard BDP chlorofluorocarbon (CFC) products at the recommended posology (delivered dose and patient population). A total of 1158 asthmatic patients were included in five clinical studies and 658 patients were treated with BDP Modulite. Four studies were undertaken in mild or moderate-to-severe asthmatic adults, while one study was carried out in children. The duration of treatment was 12 weeks in three studies and 6 weeks in the other two studies. A range of doses of BDP Modulite from 200 micrograms bid up to 1500 micrograms bid was evaluated against CFC comparators. The primary efficacy variable in all studies was morning PEFR while secondary variables included other lung function parameters, symptom scores and salbutamol use. All studies demonstrated equivalence of efficacy for morning PEFR for BDP Modulite versus BDP-CFC when compared on a microgram for microgram basis. The secondary outcome variables also consistently support similar efficacy of the two products. The safety and tolerability profile for BDP Modulite was similar to BDP-CFC; the incidence of adverse events was comparable between treatments and plasma and urinary cortisol were generally unchanged in patients receiving 1000 micrograms day-1 for 6-12 weeks. In conclusion, the results of the clinical studies with BDP Modulite show that this new HFA formulation allows a seamless transition to CFC-free BDP, thus simplifying the changeover.

    Topics: Administration, Inhalation; Adult; Aerosol Propellants; Aerosols; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Chlorofluorocarbons; Double-Blind Method; Forced Expiratory Volume; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Maximal Midexpiratory Flow Rate; Multicenter Studies as Topic; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Randomized Controlled Trials as Topic; Therapeutic Equivalency; Vital Capacity

2002
[Bronchial asthma. Small bronchi are not spared].
    MMW Fortschritte der Medizin, 2002, May-02, Volume: 144, Issue:18

    Topics: Aerosol Propellants; Airway Resistance; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchi; Dose-Response Relationship, Drug; Humans; Hydrocarbons, Fluorinated; Nebulizers and Vaporizers

2002
[Contribution of salmeterol in ambulatory practice to the improvement of asthma and quality of life in childhood].
    Allergie et immunologie, 2002, Volume: 34, Issue:8

    International guidelines on asthma recommend to add inhaled long-acting b2-agonists in patients insufficiently controlled with an inhaled corticosteroid alone. A multicentre prospective study was carried out in 250 children (age 8.4 +/- 2.7 years) whose asthma remained symptomatic with impaired lung function despite a treatment with 400-1000 micrograms/day of beclomethasone or equivalent. Salmeterol 100 micrograms/day was added to the previous dose of inhaled corticosteroid for 2 months. PEFR was improved as soon as the first month of treatment (67.2 +/- 44.4 L/min, p < 0.001) and at month 2 (75.0 +/- 44.1 L/min, p < 0.001). The percentage of symptomatic patients, the number of days and nights with symptoms, the number of days with prn bronchodilator use were significantly reduced (p < 0.001). The decrease in the distress and severity scores of the Childhood Asthma Questionnaire indicated an improvement in quality of life due to better asthma control. This study showed that lung function and symptoms were significantly improved as soon as the first month of treatment, improvement maintained thereafter, with a better quality of life and a good tolerability.

    Topics: Adolescent; Adrenergic beta-2 Receptor Antagonists; Adrenergic beta-Antagonists; Albuterol; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Child, Preschool; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Male; Prospective Studies; Quality of Life; Salmeterol Xinafoate; Surveys and Questionnaires; Treatment Outcome

2002
Choice of a medication to treat asthma: is an improvement in symptoms sufficient for deciding?
    The Journal of allergy and clinical immunology, 2002, Volume: 110, Issue:6

    Topics: Acetates; Asthma; Beclomethasone; Cyclopropanes; Forced Expiratory Volume; Humans; Quinolines; Sulfides

2002
Evaluation of the combined effect of pranlukast during high-dose steroid inhalation.
    Arzneimittel-Forschung, 2002, Volume: 52, Issue:11

    In 40 patients with moderate to severe persistent adult asthma who had been requiring more than 1200 micrograms/day of beclomethasone dipropionate (CAS 5534-09-8, BDP) inhalation, the present study evaluated the combined effects of pranlukast (CAS 103177-37-3, Onon) during highdose steroid inhalation (20 in the pranlukast group and 20 in the control group). In the pranlukast group, 450 mg/day of pranlukast was administered. The course of these patients was monitored for 6 weeks during which the dose of BDP was decreased to 1/2 of the initial dose 2 weeks later and to 1/4 of the initial dose additional 4 weeks later. The dose of BDP was also decreased in the control group. The concomitant use of pranlukast significantly improved asthmatic symptoms and respiratory functions in asthmatic patients receiving high-dose steroid inhalation. Furthermore, the concomitant use of pranlukast significantly inhibited worsening of asthmatic symptoms, respiratory functions and parameters, which are frequently observed when the dose of inhalation steroids is decreased.

    Topics: Administration, Inhalation; Adrenergic beta-Antagonists; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Blood Proteins; Chromones; Eosinophil Granule Proteins; Eosinophils; Female; Humans; Leukocyte Count; Male; Middle Aged; Respiratory Function Tests; Ribonucleases; Treatment Outcome

2002
On the inappropriateness of an EM algorithm based procedure for blinded sample size re-estimation.
    Statistics in medicine, 2002, Jan-30, Volume: 21, Issue:2

    When planning a clinical trial the sample size calculation is commonly based on an a priori estimate of the variance of the outcome variable. Misspecification of the variance can have substantial impact on the power of the trial. It is therefore attractive to update the planning assumptions during the ongoing trial using an internal estimate of the variance. For this purpose, an EM algorithm based procedure for blinded variance estimation was proposed for normally distributed data. Various simulation studies suggest a number of appealing properties of this procedure. In contrast, we show that (i) the estimates provided by this procedure depend on the initialization, (ii) the stopping rule used is inadequate to guarantee that the algorithm converges against the maximum likelihood estimator, and (iii) the procedure corresponds to the special case of simple randomization which, however, in clinical trials is rarely applied. Further, we show that maximum likelihood estimation leads to no reasonable results for blinded sample size re-estimation due to bias and high variability. The problem is illustrated by a clinical trial in asthma.

    Topics: Administration, Inhalation; Algorithms; Anti-Asthmatic Agents; Asthma; Beclomethasone; Clinical Trials as Topic; Computer Simulation; Humans; Models, Statistical; Nebulizers and Vaporizers; Sample Size

2002
Duration of steroid therapy determines dose-response effect.
    Chest, 2002, Volume: 121, Issue:1

    Topics: Asthma; Beclomethasone; Breath Tests; Dose-Response Relationship, Drug; Drug Administration Schedule; Humans; Methacholine Chloride; Nasal Provocation Tests; Nitric Oxide

2002
Inhaled steroids for children's acute asthma exacerbations?
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2002, Volume: 88, Issue:1

    Topics: Administration, Inhalation; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Humans

2002
Symptomatic asthma: attendance and prescribing in general practice.
    Respiratory medicine, 2002, Volume: 96, Issue:2

    Under-prescribing and low attendance continue to be cited as reasons for ongoing asthma symptoms in primary care despite marked increases in prescribing and structured care for asthma over the past 10 years. The objective of this study was to determine the relationship between continuing asthma morbidity and the attendance of and prescribing for symptomatic asthmatic patients in primary care. A random sample of 402 subjects from 801 who reported at least one of six symptoms in the previous month on most or every day were identified from responses to a validated morbidity questionnaire. An analysis of their care over a 2-year period (1 year before and 1 year after the questionnaire) was carried out from their general practice case-notes. Data on 308 patients was available for analysis. Ninety-four per cent of these symptomatic asthma patients attended over the 2-year period, with 77% attending for an asthma related consultation. Most patients were managed exclusively in primary care. Inhaled steroids were prescribed for 78% of patients and high dose inhaled steroids (> or = 800 mcg of beclomethasone or equivalent per day) were prescribed for 38%. Patients with most symptoms were more likely to be prescribed inhaled steroids. Rescue courses of oral steroids were prescribed for 29% of patients. Changes in asthma medications were recorded for 31% during the study period. Metered dose inhalers (MDI) were prescribed for 86% with more than half prescribed MDIs combined with some other delivery device. Elements of structured care were more frequently recorded in patients who reported most symptoms. In conclusion the asthma management of the majority of patients in this study was active with high levels of steroid prescribing. There appeared to be room to increase prescribing and to improve the structure of care. While patients who were 'symptomatic on steroids' should have had their medications, delivery devices and structured care reviewed regularly many were already on maximal treatment and were therefore likely to remain symptomatic. It is unclear how practitioners could improve morbidity in many of these patients as under-treatment and low attendance seem unlikely to be the principal causes of continuing symptoms.

    Topics: Administration, Oral; Adolescent; Adrenergic beta-Agonists; Adult; Asthma; Beclomethasone; Chi-Square Distribution; Drug Administration Schedule; Family Practice; Female; Glucocorticoids; Health Surveys; Humans; Male; Middle Aged; Morbidity; Nebulizers and Vaporizers; Patient Acceptance of Health Care; Practice Patterns, Physicians'; Regression Analysis; Statistics, Nonparametric

2002
[Dose-effect relation of inhalation steroids in asthma should be paid attention to. Comment to a Cochrane report].
    Lakartidningen, 2002, Jan-24, Volume: 99, Issue:4

    The Cochrane collaboration has performed a meta-analysis of all studies found on the dose-effect relation with beclomethasone dipropionate (BDP) in the treatment of asthma. Fifteen studies were found and included, of which only two comprised children. Daily doses of 100 to 2000 micrograms were used. A two-fold increased dose was used in 9 studies but only few significant improvements were seen with the higher dose. A four- to fivefold increased dose gave significant improvement in one of two studies with an improvement of FEV1 of 16% versus 7% with the lower dose. The dose-effect of BDP seems to be very flat and a four-fold increase of the dose seems more reasonable than the two-fold commonly used today, when improved effect is desired. This increases the risk of side effects, and for long-term therapy other alternatives should be considered.

    Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Dose-Response Relationship, Drug; Glucocorticoids; Humans; Lung Volume Measurements; Meta-Analysis as Topic; Randomized Controlled Trials as Topic

2002
[Official therapy guidelines for the family physician. Your time table in asthma].
    MMW Fortschritte der Medizin, 2002, Feb-21, Volume: 144, Issue:8

    Topics: Administration, Topical; Adrenal Cortex Hormones; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Fluticasone; Forced Expiratory Volume; Glucocorticoids; Humans; Phosphodiesterase Inhibitors; Practice Guidelines as Topic; Respiratory Therapy; Sympathomimetics; Theophylline; Time Factors

2002
Clinical relevance of airway 11beta-hydroxysteroid dehydrogenase type II enzyme in asthma.
    American journal of respiratory and critical care medicine, 2002, Apr-01, Volume: 165, Issue:7

    11beta-hydroxysteroid dehydrogenases (11beta-HSD) are responsible for the conversion of bioactive glucocorticoids to and from inactive metabolites. 11beta-HSD2 is generally considered a high-affinity inactivator of natural glucocorticoids, although its activity with synthetic compounds in vivo is unknown. Inhaled corticosteroids (ICS) remain the primary antiinflammatory agents for treating asthma, but little is known about their metabolism in the lung. The aims of this study were to determine whether the 11beta-HSD2 enzyme can be localized to human airway tissue and whether differential expression of this enzyme relates to asthma severity and ICS needs. We studied airway biopsy specimens from 22 asthmatic subjects, in two groups: (1) a group not treated with ICS (n = 7); and (2) a group treated with ICS (range: 200 to 1,500 microg/d; n = 15). A control population consisted of nine nonasthmatic subjects. Immunostaining was done with an immunopurified antibody to human 11beta-HSD2. Immunoreactivity was generally localized to the endothelium of vessels in the lamina propria and to airway epithelium both in asthmatic patients and nonasthmatic controls. There was a statistically significant inverse relationship between the ICS dose required for effective treatment and the extent of epithelial 11beta-HSD2 staining (r = -0.44; p = 0.04). This is consistent with 11beta-HSD2 acting as an oxidoreductase that regenerates rather than inactivates ICS. This study suggests that glucocorticoid sensitivity in the lung is not determined by ICS breakdown, but may be related to 11beta-HSD2 sustaining the activation of synthetic glucocorticoids.

    Topics: 11-beta-Hydroxysteroid Dehydrogenase Type 2; Administration, Inhalation; Administration, Topical; Adult; Aged; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchi; Endothelium, Vascular; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Hydroxysteroid Dehydrogenases; Immunohistochemistry; Male; Middle Aged; Respiratory Mucosa

2002
Mass output and particle size distribution of glucocorticosteroids emitted from different inhalation devices depending on various inspiratory parameters.
    Journal of aerosol medicine : the official journal of the International Society for Aerosols in Medicine, 2002,Spring, Volume: 15, Issue:1

    Efficient inhalation therapy depends on successful delivery of the drug to the lung. The efficacy of drug delivery is not only influenced by the characteristics of the inhalation device, but also by the patient's handling of the device and by the inspiratory maneuver achieved through the device. We analyzed the output characteristics of three different chlorofluorocarbon (CFC)-free breath-actuated inhalers for inhaled glucocorticosteroids (BUD Turbohaler, FP Diskus/Accuhaler and HFA-BDP Autohaler, respectively). Mass output and particle size distribution of drug aerosol delivered by the inhalers were determined depending on different inhalation parameters in vitro using an Andersen cascade impactor. We found that, beside the peak inspiratory flow (PIF), other factors such as flow acceleration and inhalation volume also have significant effects on aerosol generation with respect to mass output and particle size distribution. Thus, these parameters should be taken into account when a suitable device for an individual patient is to be selected. The dependency on inspiratory parameters was most pronounced for the dry powder inhalers. The Turbohaler showed by far the highest variance in particle output (fine particle fraction ranging from 3.4% to 22.1% of label claim), whereas the Diskus was less dependent on variations in inhalation (10.6% to 18.5% of label claim). The most constant aerosol output was found for the Autohaler, which also released the highest fine particle fraction (43.1% to 56.6% of label claim).

    Topics: Administration, Inhalation; Adult; Aerosols; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Child; Fluticasone; Humans; Inhalation; Lung; Nebulizers and Vaporizers; Particle Size; Pulmonary Disease, Chronic Obstructive; Respiratory Mechanics

2002
Predictive parameters of dropout during inhaled corticosteroid tapering.
    Chest, 2002, Volume: 121, Issue:5

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Maximal Midexpiratory Flow Rate; Middle Aged; Patient Dropouts; Retrospective Studies

2002
The decline of pulmonary function among patients with chronic asthma treated with inhaled corticosteroid.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2002, Volume: 39, Issue:3

    We analyzed the rate of decline of pulmonary function annually over 2 years in 49 patients with chronic asthma, who were being treated with inhaled corticosteroid (beclomethasone). The coefficient of linear regression of pulmonary function based on dose of inhaled corticosteroid may be used to track the exact rate of the decline of pulmonary function. The declining rate of pulmonary function is faster in the early stages of the disease, in spite of the treatment with inhaled beclomethasone. In chronic asthmatics, the distal airway units appear to deteriorate, and the extent of deterioration probably changes with the progression of the disease.

    Topics: Administration, Inhalation; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chronic Disease; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Respiratory Function Tests

2002
Peripheral blood Th1 and Th2 profile in patients with moderate asthma: effect of inhaled corticosteroid.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2002, Volume: 39, Issue:3

    The peripheral blood from healthy subjects and asthma patients was stimulated with phorbol 12-myristate 13-acetate and ionomycin, and the cells were stained with anti-CD4 antibody, permeabilized, stained with anti-IFN-gamma and anti-IL-4 antibodies, and analyzed by flow cytometry. Compared with healthy subjects, asthma patients showed a greater percentage of both IL-4(+) IFN-gamma(-) CD4 cells (Th2 cells) and IFN-gamma(+) IL-4(-) CD4 cells (Th1 cells). The percentage of Th2 cells was correlated with serum IgE level. After treatment with inhaled corticosteroid, Th2 cells decreased at week 24, but not week 4. Long-term therapy with inhaled steroid may thus be required for improvement in lymphocytic inflammation.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Female; Glucocorticoids; Humans; Male; Severity of Illness Index; Th1 Cells; Th2 Cells

2002
Inhaled corticosteroids and the risk of diabetes among the elderly.
    British journal of clinical pharmacology, 2002, Volume: 54, Issue:1

    There is evidence that large doses of inhaled corticosteroids lead to an increased risk of glaucoma, cataracts and other problems associated with oral corticosteroid use. However, no formal investigation so far has been conducted into the relationship between inhaled corticosteroids and diabetes.. Our nested case-control design studied the association between current use of inhaled corticosteroids and the risk of using antidiabetic medications among a cohort of 21 645 elderly subjects. We also investigated the possibility of a dose-response relationship in users of beclomethasone. Data were obtained from the medical and pharmaceutical databases of the Regie de l'assurance maladie du Québec.. Within the cohort, we identified 1494 cases and we selected 14 931 controls using density sampling. The unadjusted rate ratio (and 95% confidence interval, CI) for developing diabetes among current users of inhaled corticosteroids was 1.4 (1.2, 1.5). After adjusting for covariates, the rate ratio (95% CI) decreased to 0.9 (0.8, 1.1). The loss of statistical significance was due in large part to adjusting for the current use of oral corticosteroids. We also did not observe a statistically significant increase in risk among users of high-dose beclomethasone compared to nonusers, after adjusting for covariates.. Our results do not indicate an increased risk of diabetes among current users of inhaled corticosteroids.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Aged; Aged, 80 and over; Anti-Asthmatic Agents; Asthma; Beclomethasone; Case-Control Studies; Cohort Studies; Diabetes Mellitus; Dose-Response Relationship, Drug; Female; Humans; Male; Risk Factors

2002
The topical glucocorticoids beclomethasone dipropionate and fluticasone propionate inhibit human T-cell allergen-induced production of IL-5, IL-3 and GM-CSF mRNA and protein.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2001, Volume: 31, Issue:1

    T-cell production of eosinophil-active cytokines (IL-5, IL-3, GM-CSF) is thought to be fundamental to asthma pathogenesis. Inhaled aeroallergens may be one important stimulus for T-cell cytokine production in asthma.. To compare the potency and efficacy of the topical anti-asthma glucocorticoids beclomethasone dipropionate (BDP) and fluticasone propionate (FP) in inhibiting allergen-driven peripheral blood T-cell proliferation and production of IL-3, IL-5 and GM-CSF mRNA and protein.. Peripheral blood mononuclear cells from six atopic asthmatics sensitized to house dust mite (HDM) were cultured in the presence of HDM and serial dilutions of BDP or FP in vitro. Cellular proliferation (7 days) and culture supernatant cytokine concentrations (6 days) were measured by uptake of tritiated thymidine and ELISA, respectively. Cytokine mRNA expression (24 h) was measured in three subjects using a quantitative PCR technique.. Both BDP and FP inhibited allergen-induced T-cell proliferation, expression of IL-3, IL-5 and GM-CSF mRNA, and secretion of the corresponding proteins in a concentration-dependent fashion. FP was considerably more potent, but not more efficacious, in exerting these actions.. Both BDP and FP have the potential markedly to inhibit allergen-induced T-cell production of asthma-relevant cytokines. This activity is effected at the level of T-cell proliferation and cytokine gene transcription. These properties may be key features of the anti-asthma activity of these drugs. The greater potency of FP in vitro may be responsible for its greater clinical potency.

    Topics: Administration, Topical; Androstadienes; Anti-Inflammatory Agents; Antigens, Dermatophagoides; Asthma; Beclomethasone; Cytokines; Dust; Fluticasone; Glucocorticoids; Glycoproteins; Granulocyte-Macrophage Colony-Stimulating Factor; Humans; Hypersensitivity, Immediate; Interleukin-3; Interleukin-5; Lymphocyte Activation; RNA, Messenger; T-Lymphocytes

2001
Non-parametric estimates of overlap.
    Statistics in medicine, 2001, Jan-30, Volume: 20, Issue:2

    Kernel densities provide accurate non-parametric estimates of the overlapping coefficient or the proportion of similar responses (PSR) in two populations. Non-parametric estimates avoid strong assumptions on the shape of the populations, such as normality or equal variance, and possess sampling variation approaching that of parametric estimates. We obtain accurate standard error estimates by bootstrap resampling. We illustrate the practical use of these methods in two examples and use simulations to explore the properties of the estimators under various sampling situations.

    Topics: Acetates; Anti-Asthmatic Agents; Asthma; Beclomethasone; Computer Simulation; Cyclopropanes; Data Interpretation, Statistical; Female; Hip; Humans; Models, Biological; Osteoporosis, Postmenopausal; Quinolines; Statistics, Nonparametric; Sulfides

2001
e-NO peak versus e-NO plateau values in evaluating e-NO production in steroid-naive and in steroid-treated asthmatic children and in detecting response to inhaled steroid treatment.
    Pediatric pulmonology, 2001, Volume: 31, Issue:1

    SUMMARY. Airway nitric oxide (NO) production can be measured by chemiluminescence analyzer in children able to perform a single low exhalation. The aim of the present study was to evaluate whether exhaled NO (e-NO) peaks (first part of the exhalation) were as useful as e-NO plateaus (last part of the exhalation) in evaluating e-NO production in asthmatic children and in detecting responses to inhaled steroid treatment. E-NO peak, plateau, and rate of production values were measured in 100 atopic asthmatic children using a chemiluminescence analyser. Thirty-seven patients (mean age, 11.1 +/- 0.7 years) were receiving inhaled steroids (flunisolide, 0.8-1 mg daily) or beclomethasone (0.2-0.4 mg daily), while the remaining 63 (mean age, 12.0 +/- 0.4 yrs) were-steroid naive and treated only with inhaled beta(2)-agonists on an as-needed basis. Fifteen out of the 63 steroid-naive patients were reevaluated after a short course (3 weeks) of inhaled corticosteroid treatment (flunisolide, 0.8-1 mg daily, or beclomethasone, 0.2-0.4 mg daily). Regardless of the type of data analysis (peak, plateau, or rate of production), the e-NO values of the steroid-naive patients were significantly higher than those of inhaled steroid-treated patients (P < 0.01, each comparison). Similarly, in the subgroup of steroid-naive patients, the three methods were able to detect a decrease in e-NO levels by inhaled steroid therapy (P < 0.001, each comparison). Plotting the difference between e-NO peak and e-NO plateau values against their average, the peak e-NO concentrations were higher than e-NO plateau values. This difference was independent of the absolute e-NO concentration. The results of the two types of data analysis seems to agree more closely in steroid-naive patients than in steroid treated patients, or in the subgroup of steroid-naive patients who received a short course treatment with inhaled steroids. In steroid-treated subjects, the differences were up to five times higher for peak than plateau e-NO values. These data suggest that both e-NO plateau and e-NO peak values are useful in detecting airway NO production in atopic asthmatic children, but they cannot be used interchangeably. Because of possible nasal contamination in e-NO peak measurement, we prefer e-NO plateau levels for evaluating lower airway e-NO production.

    Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Child, Preschool; Female; Fluocinolone Acetonide; Forced Expiratory Volume; Humans; Hypersensitivity; Luminescent Measurements; Lung; Male; Maximal Midexpiratory Flow Rate; Nitric Oxide; Peak Expiratory Flow Rate; Pulmonary Ventilation; Reproducibility of Results; Statistics as Topic; Vital Capacity

2001
Asthma, corticosteroids, and growth.
    The New England journal of medicine, 2001, Feb-22, Volume: 344, Issue:8

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Forced Expiratory Volume; Glucocorticoids; Growth; Humans; Research Design

2001
The risk of cataract among users of inhaled steroids.
    Epidemiology (Cambridge, Mass.), 2001, Volume: 12, Issue:2

    Prolonged exposure to inhaled corticosteroids among adults over 49 years old has been reported to increase cataract risk. Small-scale studies of inhaled steroid users suggest that no increased risk for children and young adults exists. To describe cataract risk among people with asthma who use inhaled corticosteroids relative to patients with asthma with no history of corticosteroid use, we conducted a retrospective observational cohort study of patients identified from the United Kingdom-based General Practice Database with a nested case-control analysis. Relative to patients who do not use corticosteroids, all inhaled corticosteroid users were at a marginally increased risk of cataract (RR = 1.3). Among individuals 40 years of age or older, the risk ratio increased with use of increasing numbers of inhaled corticosteroid prescriptions after controlling for diabetes mellitus, hypertension, and smoking history. This trend was not evident in those under age 40.

    Topics: Administration, Inhalation; Adolescent; Adult; Age Distribution; Aged; Aged, 80 and over; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Cataract; Child; Child, Preschool; Cohort Studies; Drug Prescriptions; Fluticasone; Humans; Incidence; Middle Aged; Nebulizers and Vaporizers; Odds Ratio; Retrospective Studies; Risk Factors; Time Factors; United Kingdom

2001
Inhaled corticosteroids reduce bone mineral density in early postmenopausal but not premenopausal asthmatic women.
    Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2001, Volume: 16, Issue:4

    Inhaled corticosteroids are widely used in the treatment of bronchial asthma, but it is still uncertain whether long-term use of the inhaled corticosteroids affects bone metabolism in asthmatic patients. In this study, we examined the effect of inhaled beclomethasone dipropionate (BDP) on bone mineral density (BMD) and biochemical markers of bone metabolism in pre- and early postmenopausal asthmatic women. Thirty-six (17 premenopausal and 19 early postmenopausal) asthmatic women and 45 healthy control (24 premenopausal and 21 early postmenopausal) women were investigated. All the asthmatic patients were treated with BDP (542 +/- 298 microg/day; 100-1200 microg/day) without any systemic administration of corticosteroids for at least 1 year. In premenopausal women, BMD as well as the biochemical markers of bone metabolism did not differ between control subjects and BDP-treated asthmatic patients. By contrast, in early postmenopausal women, BMD was significantly lower in BDP-treated asthmatic patients than in control subjects. In these early postmenopausal women, serum intact osteocalcin concentration was lower in the BDP-treated asthmatic patients than in the control subjects whereas urinary free pyridinoline (F-PYD) and free deoxypyridinoline (F-DPD) concentrations did not differ between the groups. Thus, early postmenopausal, but not premenopausal, asthmatic patients who were treated with inhaled BDP had reduced BMD, which was associated with a decreased level of the bone formation marker. Ovarian hormones may be protective against the adverse effect of inhaled BDP on bone metabolism in the premenopausal patients.

    Topics: Absorptiometry, Photon; Administration, Inhalation; Adult; Amino Acids; Anti-Asthmatic Agents; Asthma; Beclomethasone; Biomarkers; Bone Density; Bone Resorption; Disease Susceptibility; Female; Gonadal Steroid Hormones; Humans; Lumbar Vertebrae; Middle Aged; Osteocalcin; Osteoporosis, Postmenopausal; Postmenopause; Premenopause

2001
Changes in indices of airway hyperresponsiveness during one year of treatment with inhaled corticosteroids in patients with asthma.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2001, Volume: 38, Issue:2

    We analyzed the changes in indices of airway hyperresponsiveness, including hypersensitivity and hyperreactivity, during one year of treatment with inhaled corticosteroids. We then investigated on which of them the inhaled corticosteroids had a primary effect. Fifty outpatients with asthma were recruited and treated with inhaled beclomethasone dipropionate. They underwent bronchoprovocation tests on the initial visit and at 3, 6, and 12 months. The dose of methacholine required to produce a 20% fall in the forced expiratory volume in 1 second (PD20-FEV1) was measured to evaluate airway hypersensitivity. A relatively novel index, the percent change in the forced vital capacity (deltaFVC%) at the PD20-FEV1, was assessed as a marker of airway hyperreactivity. PD20-FEV1 and deltaFVC% were assumed to indicate the horizontal shift of the dose-response curve and the vertical change in the maximal response plateau, respectively. Log(PD20-FEV1) and deltaFVC% continued to improve throughout the year (p < 0.001 and p = 0.002, respectively). Log(PD20-FEV1) improved significantly at the 3-month evaluation (p < 0.001), and deltaFVC% improved at the 6-month evaluation (p = 0.012). Log(PD20-FEV1) had no or weak relationships with deltaFVC% at all evaluation points. In conclusion, inhaled corticosteroids continued not only to reverse the leftward shift of the curve, but also to restore the plateau. Furthermore, their effect was reflected primarily by the former rather than the latter: They should be followed separately to examine how much airway inflammation is reduced.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Treatment Outcome; Vital Capacity

2001
Effects of glucocorticoids on endogenous and transcellular metabolism of eicosanoids in asthma.
    The Journal of allergy and clinical immunology, 2001, Volume: 107, Issue:5

    Human blood polymorphonuclear cells, which biosynthesize eicosanoids from the 5-lipoxygenase (5-LO) pathway, are likely to be involved in asthma, in which glucocorticoids represent the first line of therapy. Their effects on leukotriene release after a short course of treatment, which have been reported in several studies, are controversial.. We sought to investigate whether long-term oral glucocorticoids inhibit lipid mediators from the 5-LO pathway.. Twelve normal control subjects, 29 asthmatic subjects, and 50 glucocorticoid-dependent asthmatic subjects were included in the study. Polymorphonuclear cells were studied for endogenous and transcellular metabolism of eicosanoids.. Total leukotriene B(4) production was significantly lower in cells from glucocorticoid-dependent asthmatic subjects (mean +/- SD, 177 +/- 26 ng/10(7) cells) than in control subjects (406 +/- 27), untreated asthmatic subjects (421 +/- 34), and asthmatic subjects treated with inhaled glucocorticoids (290 +/- 56). When incubated with arachidonic acid, these polymorphonuclear cells released very low amounts of 5(S)- and 12(S)-hydroxy-eicosatetraenoic acid (HETE), whereas endogenous 15(S)-HETE was found in substantial amounts. The transformation of exogenous 15(S)-HETE into 5(S),15(S)-diHETE and lipoxins was significantly more important in untreated asthmatic subjects than in control subjects and glucocorticoid-dependent asthmatic subjects.. This study showed that long-term oral corticotherapy affects the 5-LO activity and leads to a decrease production of all metabolites in contrast to short-term or inhaled glucocorticoids. This study also questions the site of action of glucocorticoids in regulating the availability of arachidonic acid and potential eicosanoid regulation, as previously held in phospholipase A2 studies.

    Topics: 5-Lipoxygenase-Activating Proteins; Administration, Inhalation; Administration, Oral; Adrenergic beta-Antagonists; Adult; Albuterol; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Arachidonate 5-Lipoxygenase; Arachidonic Acids; Asthma; Beclomethasone; Calcimycin; Calcium; Carrier Proteins; Chromatography, High Pressure Liquid; Drug Therapy, Combination; Eicosanoids; Female; Humans; Ionophores; Male; Membrane Lipids; Membrane Proteins; Methylprednisolone; Neutrophils; Phospholipids; Prednisone; Salmeterol Xinafoate; Theophylline

2001
[Recent advance in pulmonary function tests--advance in pulmonary function tests for diagnosis and management of asthma].
    Rinsho byori. The Japanese journal of clinical pathology, 2001, Volume: 49, Issue:4

    Development of new machine and small-sized equipment have the advantage on both diagnosis and management of various diseases. In terms of bronchial asthma, the understanding of pathophysiology has been changed from a disease with acute episodes of bronchoconstriction to a disorder with chronic airway inflammation. To verify bronchial responsiveness induced by chronic inflammation, a direct-writing respiratory impedance method(Astograph) is more useful compared with a conventional standard method with measuring FEV1.0. Peak expiratory flow(PEF), an index of pulmonary function test with effort, can be measured with peak flow meter which is small and handy. Repeated measurements of PEF have been recommended by the International Consensus Report on diagnosis and treatment of asthma. The PEF monitoring is effective not only on the understanding of individual pathophysiology but also on the long-term management of patients with asthma. It is needed to develop noninvasive simple technique to evaluate airway inflammation although many investigators have examined hypertonic saline-induced sputum or bronchial mucosal biopsy. Repeated measurements of exhaled nitric oxide may become to a safe and valid method to access inflammatory change in the airway.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Humans; Monitoring, Physiologic; Nitric Oxide; Peak Expiratory Flow Rate; Respiration; Respiratory Function Tests

2001
Churg-Strauss syndrome after reduction of inhaled corticosteroid in a patient treated with pranlukast for asthma.
    Internal medicine (Tokyo, Japan), 2001, Volume: 40, Issue:5

    Recently, various forms of Churg-Strauss syndrome (CSS) have been reported in association with the use of leukotriene receptor antagonists. A 53-year-old woman with a 5-year history of asthma associated with chronic sinusitis presented mononeuropathy, hypereosinophilia, and positive P-ANCA in October 1999. She had been treated with pranlukast (450 mg/day) and beclomethasone dipropionate (BDP) at a dose of 1,200 microg/day which had gradually been tapered to 800 microg/day over the previous 17 months. She was found to have CSS, and 60 mg/day of prednisolone was administered instead of pranlukast, resulting in an improvement of her symptoms and eosinophilia. Later, we confirmed that serum P-ANCA had been positive before the pranlukast treatment, but CSS vasculitis had not appeared at that time. We speculated that an underlying incomplete form of CSS was being masked in this case and that the reduction of inhaled corticosteroid might have been responsible for the unmasking of CSS.

    Topics: Administration, Inhalation; Administration, Topical; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chromones; Churg-Strauss Syndrome; Female; Glucocorticoids; Humans; Leukotriene Antagonists; Middle Aged

2001
[Effect of fluticasone propionate at half dose of beclomethasone dipropionate divided twice daily and once daily in asthmatics inhaling beclomethasone dipropionate 800 micrograms daily or more].
    Arerugi = [Allergy], 2001, Volume: 50, Issue:4

    We conducted a 12 weeks' single-arm prospective study comparing beclomethasone dipropionate (BDP), 1/2 doses of fluticasone propionate (FP) twice daily and the same dose of FP once daily in 47 asthmatics who had been inhaling BDP 800 mcg daily or more. Peak expiratory flow (PEF), FEV1, a symptom score and a frequency of beta 2 agonist were all significantly better in FP twice daily phase than BDP phase (329 vs. 306 L/min, 1.87 vs. 1.76 L, 3.6 vs. 6.0/week and 2.7 vs. 4.5 puffs/day, respectively). There was no significant difference in these endpoints between FP twice daily phase and FP once daily phase. FP twice daily produced better plumonary function and symptom relief than the double doses of BDP. Furthermore, FP twice daily could, at least in a short-term basis, safely be changed into the same doses of FP once daily.

    Topics: Administration, Inhalation; Adult; Aged; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Administration Schedule; Female; Fluticasone; Humans; Male; Middle Aged

2001
[A case of sarcoidosis exacerbated during improvement of bronchial asthma].
    Arerugi = [Allergy], 2001, Volume: 50, Issue:4

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Middle Aged; Sarcoidosis, Pulmonary

2001
[Stabilization of two patients with brittle asthma by inhaled beclomethasone dipropionate with small particle size].
    Pneumologie (Stuttgart, Germany), 2001, Volume: 55, Issue:5

    Two patients with brittle asthma whose bronchial obstruction was less variable during treatment with HFA-beclomethasone (HFA-BDP) solution aerosol than with other previous treatments are presented here. In order to evaluate whether this improvement was related to the smaller particle size of the new formulation (MMAD 1.1 mu vs 4 mu with the CFC-formulation) both patients participated in a prospective case study sequence.. During a 4 week run-in both patients inhaled 200 micrograms of HFA-BDP (Ventolair) BID from the Autohaler followed by 4 weeks of treatment with 500 micrograms CFC-BDP (Aerobec) BID from the Autohaler in study phase 1 and 4 weeks of treatment with 200 mcg HFA-BDP (Ventolair) BID from the Autohaler in study phase 2. During the entire study period other concomitant medications remained unchanged. The dose of CFC-BDP was chosen to be 2.5 times higher than the HFA-BDP dose to get approximately comparable amounts of intrabronchial deposition. During the study Peak-Flow and concomitant medications were recorded daily.. Both patients showed significantly higher Peak-flow values during treatment with Ventolair (HFA-BDP) than during treatment with AeroBec (CFC-BDP). P-values were p < 0.0001 and p < 0.005 for patient 1 and 2 respectively.. At a comparable intrabronchial dose these two cases of brittle asthma showed significant improvements in control of bronchial obstruction with a BDP-formulation of smaller particle size. This is an indicator that smaller airways in the periphery of the lung participate in the inflammatory process leading to bronchial obstruction and that deposition of inhaled steroids in this region could have therapeutic advantages.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chemistry, Pharmaceutical; Humans; Male; Middle Aged; Respiratory Function Tests; Time Factors

2001
Symptomatic adrenal insufficiency during inhaled corticosteroid treatment.
    Archives of disease in childhood, 2001, Volume: 85, Issue:4

    Symptomatic adrenal insufficiency, presenting as hypoglycaemia or poor weight gain, may occur on withdrawal of corticosteroid treatment but has not previously been reported during inhaled corticosteroid treatment. This case series illustrates the occurrence of clinically significant adrenal insufficiency in asthmatic children while patients were on inhaled corticosteroid treatment and the unexpected modes of presentation. General practitioners and paediatricians need to be aware that this unusual but acute serious complication may occur in patients treated with inhaled corticosteroids.

    Topics: Administration, Inhalation; Administration, Topical; Adrenal Insufficiency; Adrenocorticotropic Hormone; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Child; Child, Preschool; Female; Fluticasone; Humans; Hydrocortisone; Male

2001
Effects of inhaled corticosteroid and short courses of oral corticosteroids on bone mineral density in asthmatic patients : a 4-year longitudinal study.
    Chest, 2001, Volume: 120, Issue:5

    It is not certain whether inhaled corticosteroid (ICS) therapy reduces bone mineral density (BMD) in asthmatic patients. In addition, the potential risk of osteoporosis associated with the rescue use of short courses of oral corticosteroids (SC-OCS) is unclear.. To evaluate the effect of inhaled beclomethasone dipropionate (BDP) and SC-OCS on BMD in asthmatic patients.. A 4-year longitudinal study.. Lumbar BMD was measured twice by dual-energy x-ray absorptiometry at a mean (+/- SD) interval of 4.2 +/- 0.1 years in 35 asthmatic adults (15 men and 20 postmenopausal women; mean age at the second evaluation, 60.6 +/- 11.5 years) who had been treated with BDP and SC-OCS.. The average period of BDP treatment was 7.7 +/- 2.2 years (range, 4.8 to 13.0 years) at the second evaluation. During the study period, the daily dose of BDP was 765 +/- 389 microg (range, 100 to 1,730 microg), and the frequency of SC-OCS was 1.9 +/- 2.7 courses per year (range, 0.0 to 8.9 courses per year). As a whole, lumbar BMD was unchanged during the course of the study, whereas the Z score (ie, the percentage of normal value predicted from age and sex) increased significantly. Changes in BMD and Z scores in patients receiving high doses of BDP (ie, > 1,000 microg/d; n = 9) were not significantly different from those of patients receiving lower doses (ie, 2.5 courses per year; n = 9) showed a significantly greater loss in BMD and Z score compared with those receiving sporadic courses (ie,

    Topics: Absorptiometry, Photon; Administration, Inhalation; Administration, Oral; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bone Density; Bone Diseases, Metabolic; Dexamethasone; Drug Administration Schedule; Female; Glucocorticoids; Humans; Longitudinal Studies; Lumbar Vertebrae; Male; Middle Aged; Osteoporosis; Prednisolone

2001
Apoptosis of airway epithelial cells induced by corticosteroids.
    American journal of respiratory and critical care medicine, 2001, Nov-15, Volume: 164, Issue:10 Pt 1

    Damage to the airway epithelium is one prominent feature of chronic asthma. Corticosteroids induce apoptosis in inflammatory cells, which in part explains their ability to suppress airway inflammation. However, corticosteroid therapy does not necessarily reverse epithelial damage. We hypothesized that corticosteroids may induce airway epithelial cell apoptosis as one potential explanation for persistent damage. We tested this hypothesis in cultured primary central airway epithelial cells and in the cell line 1HAEo(-). Treatment with dexamethasone, beclomethasone, budesonide, or triamcinolone each elicited a time-dependent and concentration-dependent cell death. This cell death was associated with cleavage of nuclear chromatin, mitochondrial depolarization, cytochrome c extrusion, activation of caspase-9, and expression of phosphatidylserine on the outer cell membrane. Inhibitors of caspase activity blocked apoptotic cell death, as did overexpression of the apoptosis regulators Bcl-2 or Bcl-x(L). We demonstrated that CD95 ligation is not essential for the corticosteroid-induced apoptosis in airway epithelial cells. These data demonstrate that corticosteroids induce apoptotic cell death of airway epithelium. This raises the possibility that at least one of the major components of chronic airway damage in asthma, epithelial shedding and denudation, may in part result from a major therapy for the disease.

    Topics: Anti-Asthmatic Agents; Anti-Inflammatory Agents; Apoptosis; Asthma; bcl-X Protein; Beclomethasone; Bronchodilator Agents; Budesonide; Caspase 9; Caspases; Cells, Cultured; Chronic Disease; Cytochrome c Group; Dexamethasone; Dose-Response Relationship, Drug; Drug Evaluation, Preclinical; fas Receptor; Genes, bcl-2; Humans; Inflammation; Proto-Oncogene Proteins c-bcl-2; Receptors, Interleukin-2; Respiratory Mucosa; Time Factors; Triamcinolone

2001
Effects of theophylline withdrawal in well-controlled asthmatics treated with inhaled corticosteroid.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 2001, Volume: 38, Issue:8

    We examined effects of theophylline withdrawal in 17 adult asthmatics whose symptoms were well controlled under a treatment of a combination of theophylline and inhaled beclomethasone dipropionate (iBDP). We measured daily symptoms, daily peak flow values, spirometry, peripheral blood eosinophil count (EOS), and serum eosinophil cationic protein (sECP) at intervals of 1-3 weeks for 3 months after theophylline withdrawal. Twelve patients experienced exacerbation of asthma (exacerbation group), whereas the remaining 5 patients exhibited no symptoms (stationary group). In the exacerbation group, forced expiratory volume in 1 sec (FEV1) and percent vital capacity (% VC) gradually decreased until exacerbation of asthma, and the extent of these decreases within the first week after the withdrawal was greater compared with that at later than the third week. V25/HT decreased in both the exacerbation and stationary groups. In particular, the extent of the velocity of expiratory flow at 25% of the vital capacity/height (V25/HT) decrease in the exacerbation group was much greater than that of FEV1 or % VC in this group. Neither EOS nor sECP changed significantly during the clinical course in any patient. The rapid decrease in FEV1 and % VC after the withdrawal suggests that under treatment with iBDP, theophylline causes direct bronchodilating effects on smooth muscle, rather than anti-inflammatory effects. These results also suggest the importance of theophylline on peripheral as well as central airways.

    Topics: Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Blood Proteins; Bronchodilator Agents; Drug Therapy, Combination; Eosinophil Granule Proteins; Eosinophils; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Ribonucleases; Spirometry; Substance Withdrawal Syndrome; Theophylline; Time Factors

2001
[Difficulties in diagnosis and treatment of asthma in the elderly].
    Nihon Ronen Igakkai zasshi. Japanese journal of geriatrics, 2001, Volume: 38, Issue:6

    The cause of the high asthma mortality in the elderly is not exactly known. We measured intrabronchial pressures in elderly asthma patients who had long-standing asthma and compared them with those in newly-diagnosed asthma and young healthy volunteers. In elderly asthmatics, at baseline conditions, both central and peripheral airway resistances were significantly higher compared with those in the other groups, which may partly explain the high asthma mortality in the elderly. We report a case of severe acute asthma associated with disturbed consciousness, in which asthma-induced cerebral swelling was considered to be accompanied by neuronal damage, after examination of cerebrospinal fluid. Inhaled steroid is essential for the treatment of moderate to severe asthma. However, approximately 40% of the elderly patients in this category did not use inhaled steroid. Physicians should strongly recommend the use of inhaled steroid to prevent asthma death in elderly asthma patients.

    Topics: Administration, Inhalation; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cognition; Humans

2001
Cost analysis of the use of inhaled corticosteroids in the treatment of asthma: a 1-year follow-up.
    Respiratory medicine, 2001, Volume: 95, Issue:12

    A retrospective cohort using pharmacy and medical claims was analysed to determine whether the differences in efficacy of various inhaled corticosteroids demonstrated in clinical trials lead to differences in costs of care observed in clinical practice. Subjects that had an ICD-9 (493.XX) code for asthma and a new pharmacy claim for inhaled fluticasone propionate 44 mcg (FP), beclomethasone dipropionate (BDP), triamcinolone acetonide (TAA), budesonide (BUD) or flunisolide (FLU) were identified and followed for 12 months. Annual asthma care charges (pharmacy and medical) over the 12-month observation period were significantly (P < 0.03) higher in patients treated with BDPTAA, BUD and FLU compared to FP, 24%, 27%, 34% and 45% respectively In addition, patients treated with BDPTAA, and FLU were associated with significantly (P < 0.005) higher total healthcare (asthma + non-asthma) charges compared to patients on FP, 53%, 46% and 39% respectively Asthma care and total healthcare charges remained lower for FP after including FP110 mcg and excluding patients who were extreme cost outliers (+/- 2 SD from the mean) in a univariate sensitivity analysis. This analysis supports recent randomized control trials that FP offers a superior efficacy profile at lower asthma care as well as total healthcare charges compared to other inhaled corticosteroids.

    Topics: Administration, Inhalation; Adolescent; Adult; Androstadienes; Asthma; Beclomethasone; Budesonide; Child; Child, Preschool; Cost-Benefit Analysis; Databases, Factual; Drug Costs; Fluocinolone Acetonide; Fluticasone; Follow-Up Studies; Glucocorticoids; Humans; Middle Aged; Retrospective Studies; Triamcinolone

2001
Hypothalamo-pituitary-adrenal axis function in asthmatics taking low dose inhaled beclomethasone dipropionate.
    The Journal of the Association of Physicians of India, 2001, Volume: 49

    Topics: Administration, Inhalation; Adrenocorticotropic Hormone; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Corticotropin-Releasing Hormone; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Pituitary-Adrenal Function Tests; Pituitary-Adrenal System; Sensitivity and Specificity

2001
[Experience in the use of flixotide in the treatment of bronchial asthma].
    Voenno-meditsinskii zhurnal, 2000, Volume: 321, Issue:7

    Topics: Adolescent; Adult; Aerosols; Aged; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Fluticasone; Humans; Middle Aged; Respiratory Therapy; Time Factors

2000
Changes in sputum eosinophils predict loss of asthma control.
    American journal of respiratory and critical care medicine, 2000, Volume: 161, Issue:1

    Exacerbations of asthma are likely to be due to an increase in airway inflammation. We have studied noninvasive markers of airway inflammation in asthma exacerbations induced by reducing the dose of inhaled corticosteroids. Following a 2-wk run-in period, mild exacerbations were induced in subjects with stable asthma controlled with medium- to high-dose inhaled corticosteroids (beclomethasone dipropionate >/= 800 microg or equivalent daily) by switching them to budesonide 200 microg daily given from a dry-powder inhaler (Turbohaler). Fifteen subjects were enrolled and were seen twice weekly for 8 wk after steroid reduction. At each visit, exhaled nitric oxide (NO), and methacholine airway responsiveness were measured and spirometry and sputum induction were performed. Mild exacerbation was defined as: (1) a decrease in morning peak expiratory flow (PEF) of >/= 20% but < 30% on at least two consecutive days as compared with the mean for the last 7 d of the run-in period; (2) awakening on two consecutive nights because of asthma; or (3) increased use of a short-acting beta(2)-agonist to eight or more puffs daily. Eight subjects did not develop exacerbations during the 8-wk study, whereas seven subjects developed mild exacerbations at Week 4 (n = 1), Week 6 (n = 1), and Week 8 (n = 5). The only significant difference between these two groups at baseline was a higher baseline sputum eosinophil count in subjects with subsequent exacerbations (p < 0.05). The increases in sputum eosinophils and exhaled NO were correlated with decreases in airway function, including decreases in morning PEF and FEV(1). However, multiple regression analysis suggested that the change in sputum eosinophils is a potentially useful marker in predicting loss of asthma control reflected by loss of airway function.

    Topics: Administration, Inhalation; Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Breath Tests; Budesonide; Eosinophils; Female; Glucocorticoids; Humans; Leukocyte Count; Male; Middle Aged; Nitric Oxide; Prognosis; Respiratory Function Tests; Single-Blind Method; Sputum

2000
Long-term follow-up of pulmonary function in patients with nasal polyposis.
    American journal of respiratory and critical care medicine, 2000, Volume: 161, Issue:2 Pt 1

    The outcome of asthma and/or nonspecific bronchial hyperresponsiveness (BHR) associated with nasal polyposis (NP) is uncertain. Over a 4-yr period, we investigated the long-term changes of pulmonary function and BHR in 46 patients with NP. Each subject was assessed for nasal symptoms and tested for allergy skin prick tests, serum total IgE, spirometry, and carbachol challenge at baseline before initiating any treatment (T0). Nasal symptoms evaluation, spirometric measurements, and carbachol challenge were repeated at T1 and at T2 (respectively, 12.7 +/- 0.9 and 47.9 +/- 2. 2 mo after T0). In addition, bronchodilator response was measured at T2. At T0, 25 patients exhibited BHR and 16 of 25 were asthmatic. All patients were treated first with topical steroids for 6 wk (beclomethasone 600 microg/d). Eighteen patients were successfully treated with topical steroids (topical steroids responders). Intranasal ethmoidectomy was performed in 28 patients who did not improve with topical steroids alone (topical steroids nonresponders). Nasal score improved at T1 and remained improved at T2 as compared with T0 in both groups (p < 0.005). Topical steroids nonresponders demonstrated a significant decrease of FEV(1), FEV(1)/FVC ratio, and FEF(25-75) at T1 (p < 0.05) and at T2 (p < 0.0005), whereas no significant change was observed in FEV(1) and FEV(1)/FVC ratio in responders. DeltaFEV(1) (%) between T2 and T0 was not related to the presence of asthma, BHR, or atopy. Bronchodilator response at T2 was similar in the two groups. BHR did not significantly change over the 4-yr follow-up period in the two groups. No change in pulmonary symptoms and/or asthma severity occurred. Our results show that nonreversible airflow obstruction appears over a 4-yr follow-up period in topical steroids nonresponders patients with NP requiring nasal surgery. The long-term contribution of these changes to the development of respiratory symptoms in patients with NP remains to be documented.

    Topics: Administration, Intranasal; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Combined Modality Therapy; Ethmoid Sinus; Female; Follow-Up Studies; Humans; Immunoglobulin E; Intradermal Tests; Lung Volume Measurements; Male; Middle Aged; Nasal Polyps; Prospective Studies; Respiratory Hypersensitivity; Spirometry

2000
Relationship between exhaled nitric oxide and mucosal eosinophilic inflammation in mild to moderately severe asthma.
    Thorax, 2000, Volume: 55, Issue:3

    Exhaled levels of nitric oxide (NO) are raised in asthma but the relationship between exhaled NO levels and a direct measure of airway inflammation has not been investigated in asthmatic patients treated with inhaled steroids.. The relationship between exhaled NO levels, clinical measures of asthma control, and direct markers of airway inflammation were studied in patients with asthma treated with and without inhaled corticosteroids. Thirty two asthmatic patients (16 not using inhaled steroids and 16 using inhaled beclomethasone dipropionate, 400-1000 microg/day) were monitored with respect to measures of asthma control including lung function, symptom scores, medication usage, and variability of peak expiratory flow (PEF) for one month. Measurements of exhaled NO and fibreoptic bronchoscopy were performed at the end of the monitoring period. Bronchial mucosal biopsy specimens were stained with an anti-MBP antibody for quantification of eosinophils.. There was no significant difference in lung function, symptom scores, or medication usage between the two groups, but there was a significant difference in PEF variability (8.7 (1.2)% in steroid naive patients versus 13.6 (1.9)% in steroid treated patients, p<0.05) and exhaled NO levels (9.9 (3.5) ppb in steroid naive patients versus 13.6 (2.0) ppb in steroid treated patients, p<0.05). There was no correlation between exhaled NO and mucosal eosinophils, or between NO and conventional measures of asthma control. There was a significant correlation between mucosal eosinophils and lung function (r = -0.43, p<0.05).. Exhaled NO levels do not reflect airway mucosal eosinophilia and these markers reflect different aspects of airway inflammation. The clinical usefulness of exhaled NO needs to be determined in prospective longitudinal studies.

    Topics: Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biopsy; Breath Tests; Cross-Sectional Studies; Eosinophils; Female; Forced Expiratory Volume; Humans; Leukocyte Count; Male; Middle Aged; Nitric Oxide; Peak Expiratory Flow Rate

2000
Effects of high-dose inhaled corticosteroids on bone metabolism in prepubertal children with asthma.
    Pediatric pulmonology, 2000, Volume: 29, Issue:3

    We studied the effect of inhaled corticosteroids on the increase in bone mineral content in prepubertal children with asthma. Forty-eight asthmatic, prepubertal children receiving either inhaled beclomethasone dipropionate or budesonide were evaluated. Nine children of similar age not receiving inhaled steroids served as controls. The average age of corticosteroid-treated children was 7.8 +/- 2.4 years, and of control children, 8.4 +/- 2.1 years (NS). The average dose of inhaled corticosteroids in the treated children was 0.67 +/- 0.48 mg/m(2)/day, and they were followed over a 9-20-month period. Total bone mineral content (TBMC) was measured at baseline and after 9-20 months. A derived value for 12 months' TBMC was calculated, assuming that changes in TBMC were linear with the passage of time. The change in TBMC over a 12-month period was 264 +/- 68 mg for the corticosteroid-treated children and 330 +/- 84 mg for control children (P < 0.025). In a multiple regression analysis in which adjustments were made for the effects of age, height, and weight, the change in TBMC in corticosteroid-treated children was inversely related to the inhaled steroid dose/m(2)/day (P = 0.016). The increase in the lumbar vertebral bone mineral density in control children was also significantly greater than in the corticosteroid-treated children (P < 0.025). We conclude that inhaled steroids, at an average dose of 0.67 mg/m(2)/day, when used in the treatment of asthma reduce the acquisition of bone mineral in prepubertal children.

    Topics: Absorptiometry, Photon; Administration, Inhalation; Administration, Topical; Adolescent; Age Factors; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Body Height; Body Mass Index; Body Weight; Bone and Bones; Bone Density; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Female; Follow-Up Studies; Glucocorticoids; Humans; Linear Models; Lumbar Vertebrae; Male; Puberty

2000
Identification of ten corticosteroids in human hair by liquid chromatography-ionspray mass spectrometry.
    Forensic science international, 2000, Jan-10, Volume: 107, Issue:1-3

    This paper describes a screening procedure based upon high-performance liquid chromatography-ionspray mass spectrometry for the identification of ten corticosteroids in human hair: triamcinolone, prednisolone, prednisone, methylprednisolone, cortisone, cortisol, beta- and dexamethasone, flumethasone and beclomethasone. Hair strands were washed in methylene chloride, pulverized in a ball mill and 50 mg of the powdered hair were incubated in 1 ml Soerensen buffer, pH 7.6 for 16 h at 40 degrees C, in presence of 50 ng cortisol-d3 used as internal standard. Purification of the incubation medium was achieved on SPE C18 Isolute extraction columns. The eluates were evaporated to dryness and resuspended in 30 microliters MeOH before analysis by HPLC-IS-MS in positive and negative modes of detection. The validation parameters were found satisfactory for a corticosteroid screening procedure. The correlation coefficient of the calibration curve ranged from 0.939 to 0.997, showing linearity between 0.1 and 10 ng/mg, excepted for beclomethasone which was between 0.2 and 10 ng/mg. Extraction recovery at 4 ng/mg ranged from 43.2 to 85.7%. Repeatability (CV values) at 4 ng/mg ranged from 6.1 to 17.5%. The limits of detection ranged from 0.03 to 0.17 ng/mg for a signal-to-noise ratio of 2. The detection of prednisone and beclomethasone in three hair specimens obtained from forensic and clinical cases have documented corticosteroids incorporation into human hair.

    Topics: Adrenal Cortex Hormones; Adult; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; Chromatography, High Pressure Liquid; Forensic Medicine; Hair; Humans; Kidney Transplantation; Male; Prednisone; Reproducibility of Results; Spectrometry, Mass, Secondary Ion

2000
Beclomethasone decreases elevations in phosphodiesterase activity in human T lymphocytes.
    International archives of allergy and immunology, 2000, Volume: 121, Issue:2

    We recently reported that CD4+ T cells that have been activated in vivo or in vitro contain elevated cyclic adenosine monophosphate (cAMP) phosphodiesterase (PDE) activity. Since both phosphodiesterase inhibitors and glucocorticoids have anti-inflammatory activity, we sought to investigate the effect of beclomethasone on PDE activity.. PDE activity was measured in CD4+ T cells after 24 h of culture with beclomethasone. Cells were obtained from the peripheral blood of nonatopic persons (nCells), pre-seasonal (pCells), seasonal (within the first 2 weeks; sCells) and mid-seasonal (mCells) allergic rhinitics and asymptomatic allergic asthmatics (aCells). In addition, the effect of beclomethasone on Th2 cell lines and cells that had been activated in vitro with PHA or interleukin (IL)-2 was determined.. PDE activity was decreased in a concentration-dependent manner by incubation of mCells, Th2 lines and PHA or IL-2-activated CD4+ T cells with beclomethasone (p < 0.05). However, beclomethasone did not modulate PDE activity in nCells, pCells, sCells, or aCells.. Beclomethasone only decreases cAMP PDE activity in CD4+ T cells when it is increased by cell activation either in vitro or in vivo.

    Topics: Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; CD4-Positive T-Lymphocytes; Cell Line; Cells, Cultured; Cyclic AMP; Female; Humans; Hypersensitivity, Immediate; Interleukin-2; Lymphocyte Activation; Male; Middle Aged; Phosphoric Diester Hydrolases; Phytohemagglutinins; Rhinitis, Allergic, Seasonal; Th2 Cells

2000
Baseline airway hyperresponsiveness and its reversible component: role of airway inflammation and airway calibre.
    The European respiratory journal, 2000, Volume: 15, Issue:2

    Airway hyperresponsiveness (AHR), in which airway inflammation has been reported to be a key factor, is an important component of asthma. However the precise role of inflammation in AHR is still unclear. In this report, airway inflammatory changes were assessed using hypertonic saline-induced sputum examination and exhaled nitric oxide analysis, and the relation between AHR to methacholine, airway calibre forced expiratory volume in one second (FEV1) and airway inflammatory indices examined. Furthermore, the changes in these variables were also examined by means of 8 weeks' open uncontrolled inhaled steroid administration (800 microg x beclomethasone x day(-1)). Asthmatic subjects had higher eosinophil counts and bradykinin concentration in induced sputum and higher exhaled NO levels, and showed AHR to methacholine. Baseline AHR significantly correlated with FEV1 but not with indices of inflammation in sputum or exhaled air. Steroid inhalation therapy was associated with a reduction in eosinophil and bradykinin concentration in sputum and NO levels in exhaled air and an improvement in FEV1 and AHR. The changes in FEV1 and AHR were significantly related to changes in markers in sputum and exhaled air (p<0.01 for each). These results suggest that baseline airway hyperresponsiveness can be predicted from the airway calibre but not from inflammatory parameters in sputum or exhaled air. In contrast, the reversible component of airway hyperresponsiveness appeared to be associated with the reduction in airway inflammation.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Female; Fenoterol; Forced Expiratory Volume; Humans; Male; Methacholine Chloride; Nitric Oxide; Sputum

2000
Equivalence of hydrofluoroalkane (HFA) and chlorofluorocarbons (CFC) formulations of inhaled beclomethasone.
    Respiratory medicine, 2000, Volume: 94, Issue:2

    Topics: Administration, Inhalation; Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Chemistry, Pharmaceutical; Chlorofluorocarbons; Humans; Hydrocarbons, Fluorinated; Therapeutic Equivalency

2000
Inhaled beclomethasone (BDP) with non-CFC propellant (HFA-134a) is equivalent to BDP-CFC for the treatment of asthma: Milanowski et al. (Respir Med 1999; 93: 245-251)
    Respiratory medicine, 2000, Volume: 94, Issue:2

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Chemistry, Pharmaceutical; Chlorofluorocarbons; Forced Expiratory Volume; Humans; Hydrocarbons, Fluorinated; Therapeutic Equivalency

2000
Affordability of inhaled corticosteroids as a potential barrier to treatment of asthma in some developing countries.
    The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2000, Volume: 4, Issue:3

    The cost and availability of the medications required for the treatment of asthma may represent potential barriers to effective management.. A survey of prices and policies for components of asthma treatment in 1998, in Algeria, Burkina Faso, Ivory Coast, Guinea, Mali, Syria, Turkey and Vietnam.. Medications were consistently available in only four of the eight countries studied. The cost of essential medications for standard case management varied by over five times for beclomethasone and by over three times for inhaled salbutamol. In all but two countries, the cost of one year of drugs for treatment of a moderate, persistent case exceeded the monthly salary of a nurse in that country. The essential drugs list included inhaled salbutamol in five of eight countries and beclomethasone in three of eight. The costs of medications were lower where generic preparations were available and, to a lesser extent, where the medications are on the essential drugs list.. The cost and availability of medications vary widely, and may represent an important barrier to effective management in some low and middle income countries.

    Topics: Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Developing Countries; Glucocorticoids; Humans

2000
Airway mast cells and eosinophils correlate with clinical severity and airway hyperresponsiveness in corticosteroid-treated asthma.
    The Journal of allergy and clinical immunology, 2000, Volume: 105, Issue:4

    The relationship between airway inflammation and asthma severity in corticosteroid-treated asthma is unclear.. Our purpose was to characterize the inflammatory cell profile of the airway lumen and epithelium in corticosteroid-treated asthma and to relate these findings to clinical and physiologic markers of asthma severity.. Adults (n = 20) with asthma received standardized high-dose inhaled corticosteroid therapy with beclomethasone 2000 microgram per day for 8 weeks. Airway responsiveness to methacholine and hypertonic (4.5%) saline solution was then assessed, followed by sputum induction and, 1 week later, bronchoscopy with bronchoalveolar lavage and bronchial brush biopsy to assess inflammatory cells.. Clinical asthma severity was associated with airway hyperresponsiveness. Metachromatic cells were the main granulocyte present in bronchial brush biopsy specimens and correlated with airway responsiveness to saline solution (r = -0.75), methacholine (r = -0.74), peak flow variability (r = 0.59), and clinical asthma severity (r = 0.57). Eosinophils were the main granulocyte present in sputum and correlated with airway responsiveness to saline solution (r = -0.63) but not with other clinical markers of asthma severity. Bronchoalveolar lavage cell counts were not related to clinical asthma severity.. In asthmatic patients treated with cortico-steroids, the dominant inflammatory effector cell in the epithelium is the metachromatic cell, and in sputum it is the eosinophil. These cells correlate with the degree of airway hyperresponsiveness. Clinical asthma severity correlates with airway responsiveness and epithelial metachromatic cells. Induced sputum eosinophils and airway responsiveness to hypertonic saline solution may be useful markers of airway inflammation for clinical practice.

    Topics: Adult; Asthma; Beclomethasone; Bronchi; Bronchial Hyperreactivity; Bronchitis; Bronchoalveolar Lavage Fluid; Dose-Response Relationship, Drug; Eosinophils; Female; Glucocorticoids; Humans; Male; Mast Cells; Peak Expiratory Flow Rate; Severity of Illness Index

2000
Airway nitric oxide diffusion in asthma: Role in pulmonary function and bronchial responsiveness.
    American journal of respiratory and critical care medicine, 2000, Volume: 161, Issue:4 Pt 1

    If the nitric oxide (NO) diffusing capacity of the airways (DNO) is the quantity of NO diffusing per unit time into exhaled gas (q) divided by the difference between the concentration of NO in the airway wall (Cw) and lumen, then DNO and C(w) can be estimated from the relationship between exhaled NO concentration and expiratory flow. In 10 normal subjects and 25 asthmatic patients before and after treatment with inhaled beclomethasone, DNO averaged 6.8 +/- 1.2, 25.5 +/- 3.8, and 22.3 +/- 2.7 nl/s/ppb x 10(-3), respectively; C(w) averaged 149 +/- 31.9, 255.3 +/- 46.4, and 108.3 +/- 14.3 ppb, respectively; and DNOC(w) (the maximal from diffusion) averaged 1,020 +/- 157.5, 6,512 +/- 866, and 2,416 +/- 208.5 nl/s x 10(-3), respectively. DNO and DNOC(w) in the asthmatic subjects before and after steroids were greater than in normal subjects (p < 0.0001), but C(w) was not different. Within asthmatic subjects, steroids caused C(w) and DNOC(w) to fall (p < 0.0001), but DNO was unchanged. DNOC(w) after steroids, presumably reflecting maximal diffusion of constitutive NO, was positively correlated with methacholine PC(20) and FEV(1)/FVC before or after steroids. The increased DNO measured in asthmatic patients may reflect upregulation of nonadrenergic, noncholinergic, NO-producing nerves in airways in compensation for decreased sensitivity of airway smooth muscle to the relaxant effects of endogenous NO.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Case-Control Studies; Female; Humans; Male; Nitric Oxide; Nitric Oxide Synthase; Nitric Oxide Synthase Type II; Pulmonary Diffusing Capacity

2000
[Immunohistochemical analysis of bronchial mucosa in severe asthmatics treated with long-term, high-dose inhaled BDP].
    Nihon Kokyuki Gakkai zasshi = the journal of the Japanese Respiratory Society, 2000, Volume: 38, Issue:2

    To analyze specific mucosal changes in asthmatic patients receiving long-term, high-dose beclomethazone dipropionate (BDP) inhalation therapy, we performed bronchial mucosal biopsies and immunohistochemical analysis of patients who had been treated with or without BDP-inhalation. Our study enrolled 6 chronic severe asthmatics who were treated with 1,800 micrograms/day or more of BDP with regular use for more than 3 years (HD-BDP group), 6 mild asthmatics who were not treated with BDP (non-BDP group), and 6 control subjects. Specimens of bronchial mucosa were stained with anti-EG 2 (eosinophils), anti-UCHLA-1 (T lymphocytes) and anti-tryptase (mast cells). Although limited eosinophil infiltration was observed in the HD-BDP and control groups, a significant increase was noted in the non-BDP group. The infiltration of both T lymphocytes and mast cells exhibited a statistically significant increase in the non-BDP group compared to the HD-BDP and control groups. In chronic severe asthmatics, airway mucosal cell infiltration was reduced by high-dose and long-term inhaled BDP therapy, and BDP also relieved their asthmatic symptoms. However, in mild asthmatics, bronchial mucosal cell infiltration remained high. For such patients, we concluded that initiating BDP therapy from an early stage may bring clinical improvement and help prevent cell infiltration.

    Topics: Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Bronchi; Eosinophils; Female; Humans; Immunohistochemistry; Male; Mast Cells; Middle Aged; Respiratory Mucosa; T-Lymphocytes

2000
[Bronchial reactivity as factor of effectiveness of new antiasthmatic drugs].
    Terapevticheskii arkhiv, 2000, Volume: 72, Issue:3

    To evaluate bekotid and bekodisk effects on bronchial reactivity and sensitivity.. Bronchial reactivity and sensitivity were studied in a comparative study of two corticosteroids for inhalation--bekotid and bekodisk--in 37 patients with bronchial asthma. Unlike bekotid, bekodisk does not contain freon which irritates mucosa of the upper respiratory tracts and bronchi. The examination included clinical and allergological tests, provocative inhalation tests, peak flowmetry, assessment of bronchial resistance and external respiration function.. Bekodisk treatment reduced the number of asphyxia episodes, sensitivity to carbacholine, the need in inhalation sympathomimetics, improved external respiration function.. Determination of reactivity and sensitivity of the bronchi is essential for comparison of drugs against bronchial asthma. Bekodisk significantly lowers reactivity to nonspecific mediatory substances, is simple and available in application, is more tolerable than bekotid.

    Topics: Administration, Inhalation; Airway Resistance; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Bronchoscopy; Carbachol; Cholinergic Agonists; Evaluation Studies as Topic; Female; Glucocorticoids; Humans; Hydroxycorticosteroids; Male; Treatment Outcome

2000
Controlling asthma. Highlights of the 1999 Canadian Asthma Consensus Report.
    Canadian family physician Medecin de famille canadien, 2000, Volume: 46

    Topics: Administration, Topical; Adrenergic beta-Agonists; Adult; Aminophylline; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child; Cromolyn Sodium; Emergencies; Glucocorticoids; Hospitalization; Humans; Leukotriene Antagonists; Prednisone; Time Factors

2000
A persistent wheeze.
    Australian family physician, 2000, Volume: 29, Issue:4

    Topics: Anti-Asthmatic Agents; Aphonia; Asthma; Beclomethasone; Female; Humans; Middle Aged; Respiratory Sounds

2000
Risk of cataract among users of intranasal corticosteroids.
    The Journal of allergy and clinical immunology, 2000, Volume: 105, Issue:5

    Oral corticosteroid users are at increased risk of cataract, but the risk among intranasal corticosteroids users is unknown.. Our purpose was to describe the risk of cataract among users of intranasal steroids.. A retrospective observational cohort study of cataract incidence was conducted among users of oral and intranasal steroids identified from the United Kingdom-based General Practice Research Database with a nested case-control analysis to control for confounding factors. The study population included 286,078 subjects aged less than 70 years old drawn from 350 general practices in England and Wales. Patients were classified as users of only intranasal corticosteroids, users of only oral corticosteroids, and nonusers of either medication. Computerized medical records were used to identify cases of cataract. Two hundred twenty-five cases were randomly selected for validation against general practitioners' held referral and hospitalization letters.. The incidence rate of cataract (1.0/1000 person-years) among users of intranasal corticosteroids was similar to the incidence rate among nonusers. However, oral corticosteroid users were at higher risk of cataract (2.2/1000 person-years). Approximately 70% of intranasal corticosteroid exposure was to beclomethasone dipropionate only; the event rate in this group was similar to that in the unexposed group. Cataract risk did not increase with the number of prior prescriptions for intranasal corticosteroids.. The use of intranasal corticosteroids was not associated with an increased risk of cataracts in this study population.

    Topics: Administration, Intranasal; Administration, Oral; Adrenal Cortex Hormones; Adult; Aged; Asthma; Beclomethasone; Cataract; Cohort Studies; Female; Humans; Male; Middle Aged; Retrospective Studies; Risk Factors

2000
[Effect of beclomethasone increment on airflow limitation in asthmatic children treated with high dose beclomethasone].
    Arerugi = [Allergy], 2000, Volume: 49, Issue:4

    In order to evaluate the effect of higher dose BDP therapy (1200-1660 micrograms/day), we studied 12 asthmatic children (mean age 9.7 years-old) with airflow limitation on respiratory function test who were asymptomatic with high-dose BDP therapy (800 micrograms/day). After 4 weeks of higher dose BDP therapy, FVC, FEV1 and V50 were significantly improved, but those improvement were insufficient compared with those after salbutamol inhalation. The personal best values after salbutamol inhalation were not different in every parameter of respiratory function test between BDP 800 micrograms/day and 1200 micrograms/day. We conclude that less than 800 micrograms of daily BDP is generally adequate for prevention in most asthmatic children, because higher dose BDP therapy is no more effective on respiratory function in those treated with 800 micrograms of daily BDP, and that the best value of respiratory function after salbutamol inhalation is not always a goal of high dose BDP therapy.

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Female; Humans; Male; Respiration; Respiratory Function Tests

2000
Timing of lowest and highest peak expiratory flow in patients with asthma: influence of anti-inflammatory treatment.
    Respiratory medicine, 2000, Volume: 94, Issue:4

    We sought to determine the optimal time for measuring peak expiratory flow rate (PEF) in patients with mild to moderate asthma, before and after treatment with inhaled beclomethasone dipropionate (BDP). After 2 weeks of observation, BDP (400 microg/d) was given to 22 patients with mild to moderate asthma. The dose of BDP (800-1200 microg/d) was increased every 2 weeks until PEF varied by no more than 20% each day. PEF was measured four times daily: on awakening, around noon, in the evening and at bedtime. Significant (P < 0.05) rhythms were detected by single cosinor analysis in all patients, both during observation and during treatment. Analysis by the population mean-cosinor method showed that the mean mesor was 378.8+/-59.1 lmin(-1), the mean amplitude was 53.9+/-13.4 lmin(-1), and the mean acrophase was at 16:26+/-0:32 before treatment. After treatment, the mean mesor was 528.0+/-61.9 l min(-1), the mean amplitude was 37.6+/-12.2 lmin(-1), and the mean acrophase was at 16:35+/-0:32. The mesor increased significantly (P<0.05), and the amplitude decreased significantly (P<0.05) after treatment. The acrophase did not change. These data indicate that PEF is lowest at 04:30 and highest at 16:30 in patients with mild to moderate asthma, both during observation and during treatment. We conclude that if one needs to assess PEF twice a day, this should ideally be done at 04:30 and 16:30, not only before but also after treatment with BDP.

    Topics: Adolescent; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Circadian Rhythm; Female; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Time Factors

2000
Effects of several glucocorticosteroids and PDE4 inhibitors on increases in total lung eosinophil peroxidase (EPO) levels following either systemic or intratracheal administration in sephadex- or ovalbumin-induced inflammatory models.
    Inflammation, 2000, Volume: 24, Issue:4

    Representative glucocorticosteroids (GCS) and phosphodiesterase IV (PDE4) inhibitors were compared in several models of pulmonary inflammation ranging in severity. Lung tissue eosinophil peroxidase (EPO) levels rather than bronchoalveolar lavage fluid (BALF) EPO or eosinophil percentages were used to indicate eosinophil recruitment after intratracheal instillation of sephadex beads in rats or nebulized ovalbumin in sensitized guinea pigs. A single oral or intratracheal administration of a GCS was effective against mild and robust sephadex-induced eosinophilia whereas the PDE4 inhibitors evaluated appeared more effective in the milder sephadex models. The GCS were also more effective against sephadex-induced than ovalbumin-induced eosinophilia. The effectiveness of the GCS and PDE4 inhibitors improved when the severity of the ovalbumin-induced eosinophilia was decreased. Multiple day dosing also improved activity. These studies indicated that activity was influenced greatly by administration protocols, the severity of the inflammatory response and possibly the method used for estimating eosinophil recruitment.

    Topics: 3',5'-Cyclic-AMP Phosphodiesterases; Androstadienes; Animals; Asthma; Beclomethasone; Benzamides; Budesonide; Cyclic Nucleotide Phosphodiesterases, Type 4; Dexamethasone; Dextrans; Disease Models, Animal; Enzyme Inhibitors; Eosinophil Peroxidase; Eosinophils; Fluticasone; Glucocorticoids; Guinea Pigs; Inflammation; Lung; Male; Ovalbumin; Peroxidases; Pyridines; Rats; Rats, Sprague-Dawley; Rolipram

2000
Montelukast added to inhaled beclomethasone in treatment of asthma.
    American journal of respiratory and critical care medicine, 2000, Volume: 162, Issue:1

    Topics: Acetates; Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cyclopropanes; Drug Therapy, Combination; Humans; Quinolines; Sulfides

2000
Low-dose inhaled corticosteroids and the prevention of death from asthma.
    The New England journal of medicine, 2000, Aug-03, Volume: 343, Issue:5

    Although inhaled corticosteroids are effective for the treatment of asthma, it is uncertain whether their use can prevent death from asthma.. We used the Saskatchewan Health data bases to form a population-based cohort of all subjects from 5 through 44 years of age who were using antiasthma drugs during the period from 1975 through 1991. We followed subjects until the end of 1997, their 55th birthday, death, emigration, or termination of health insurance coverage; whichever came first. We conducted a nested case-control study in which subjects who died of asthma were matched with controls within the cohort according to the length of follow-up at the time of death of the case patient (the index date), the date of study entry, and the severity of asthma. We calculated rate ratios after adjustment for the subject's age and sex; the number of prescriptions of theophylline, nebulized and oral beta-adrenergic agonists, and oral corticosteroids in the year before the index date; the number of canisters of inhaled beta-adrenergic agonists used in the year before the index date; and the number of hospitalizations for asthma in the two years before the index date.. The cohort consisted of 30,569 subjects. Of the 562 deaths, 77 were classified as due to asthma. We matched the 66 subjects who died of asthma for whom there were complete data with 2681 controls. Fifty-three percent of the case patients and 46 percent of the control patients had used inhaled corticosteroids in the previous year, most commonly low-dose beclomethasone. The mean number of canisters was 1.18 for the patients who died and 1.57 for the controls. On the basis of a continuous dose-response analysis, we calculated that the rate of death from asthma decreased by 21 percent with each additional canister of inhaled corticosteroids used in the previous year (adjusted rate ratio, 0.79; 95 percent confidence interval, 0.65 to 0.97). The rate of death from asthma during the first three months after discontinuation of inhaled corticosteroids was higher than the rate among patients who continued to use the drugs.. The regular use of low-dose inhaled corticosteroids is associated with a decreased risk of death from asthma.

    Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Case-Control Studies; Child; Child, Preschool; Cohort Studies; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Logistic Models; Male; Risk; Theophylline

2000
In children with asthma, do inhaled steroids reduce linear growth (height)?
    The Journal of family practice, 2000, Volume: 49, Issue:7

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Height; Child; Humans; Randomized Controlled Trials as Topic; Reproducibility of Results

2000
Differences in the potencies of inhaled steroids are not reflected in the doses prescribed in primary care in New Zealand.
    European journal of clinical pharmacology, 2000, Volume: 56, Issue:5

    To determine whether the average doses of inhaled beclomethasone, fluticasone and budesonide prescribed in primary care reflect the relative potencies of these medicines.. Retrospective analysis of 95,540 prescriptions for inhaled steroids written by 293 general practitioners in Auckland, New Zealand, between November 1995 and June 1998. In addition, 177 general practitioners were presented with two case histories describing patients with uncontrolled asthma who were not on treatment with inhaled steroids. They were asked which medicine they would prescribe and in what dose.. The average daily doses prescribed were 600 microg for fluticasone, 747 microg for beclomethasone and 1184 microg for budesonide. The average dose of fluticasone was 80% of that for beclomethasone. In May 1997, when 4.5% of the prescriptions for inhaled steroids were for fluticasone, the average doses of fluticasone and beclomethasone were 632 microg and 760 microg, respectively. By May 1998, when 23% of prescriptions were for fluticasone, the average doses of fluticasone and beclomethasone were little changed at 610 microg and 726 microg, respectively. In response to the two case histories, the average doses of fluticasone chosen were 71% and 77% of the doses of beclomethasone.. The average prescribed dose of fluticasone was 80% of that for beclomethasone, even though fluticasone is at least twice as potent as beclomethasone. Similar findings were observed when the general practitioners responded to the case histories. The high doses of fluticasone prescribed may be due to a failure to appreciate that fluticasone is twice as potent as beclomethasone and to the availability of high strength preparations of fluticasone, i.e. 250 microg per actuation.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Dose-Response Relationship, Drug; Drug Prescriptions; Female; Fluticasone; Humans; Male; New Zealand; Primary Health Care; Retrospective Studies

2000
The production of extracellular matrix proteins by human passively sensitized airway smooth-muscle cells in culture: the effect of beclomethasone.
    American journal of respiratory and critical care medicine, 2000, Volume: 162, Issue:6

    Airway remodeling is a key feature of persistent asthma. Part of the remodeling process involves the laying down of extracellular matrix (ECM) proteins within the airways. In this study we compared the production of ECM proteins by human airway smooth-muscle (ASM) cells in culture after exposure to 10% serum from an asthmatic individual or 10% serum from a nonasthmatic individual with or without beclomethasone (0.01 to 100 nM). Enzyme-linked immunosorbent assays were done with antibodies to human fibronectin; perlecan; elastin; the laminin beta(1), gamma(1), beta(2), alpha(1) chains; thrombospondin; chondroitin sulfate; collagen types I, III, IV, and V; versican; and decorin. Serum from the asthmatic individual, when compared with that from the nonasthmatic individual, caused a significant increase in the production of fibronectin, perlecan, laminin gamma(1), and chondroitin sulfate. Beclomethasone caused a significant reduction in the number of cells exposed to serum from either the asthmatic or nonasthmatic individual, but did not reverse the increase in ECM protein induced by the former. These results suggest an interaction between the ASM and the allergic process that may alter components of the airway wall in asthma, and that corticosteroids may not prevent the fibrosis induced by resident cells within the airways.

    Topics: Adult; Analysis of Variance; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchi; Cell Culture Techniques; Cells, Cultured; Enzyme-Linked Immunosorbent Assay; Extracellular Matrix Proteins; Humans; Immunoglobulin E; Middle Aged; Muscle, Smooth

2000
Problems prescribing inhaler devices.
    The British journal of general practice : the journal of the Royal College of General Practitioners, 2000, Volume: 50, Issue:459

    Topics: Anti-Inflammatory Agents; Asthma; Beclomethasone; Family Practice; Humans; Nebulizers and Vaporizers; Pharmacy

2000
Allergic contact dermatitis due to beclometasone dipropionate in an inhalant for asthma.
    Contact dermatitis, 2000, Volume: 43, Issue:6

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Dermatitis, Allergic Contact; Drug Hypersensitivity; Female; Humans; Middle Aged; Patch Tests

2000
Hypothalamo-pituitary-adrenal axis function in asthmatics taking low dose inhaled beclomethasone dipropionate.
    The Journal of the Association of Physicians of India, 2000, Volume: 48, Issue:7

    Anti-inflammatory drugs, particularly inhaled corticosteroids remain the mainstay of treatment of bronchial asthma. However, these drugs have potential side effects. This study was undertaken to evaluate the effects of inhaled beclomethasone dipropionate (400 and 800 micrograms) over a period of six months on the hypothalamo-pituitary-adrenal axis (HPA) suppression.. Assessment of the hypothalamo-pituitary-adrenal axis function was carried out by tetracosactrin test at time zero, (before start of treatment), three months, and six months. The baseline values served as the controls for each patient. Serum cortisol was estimated by radioimmuno assay. The response to short tetracosactrin test was classified as normal if serum cortisol levels rose at least 200 nmol/L to a minimum of 500 nmol/L.. There were seven patients who were inhaling beclomethasone dipropionate in a dose of 400 micrograms/day and another seven patients were taking the same drug in a dose of 800 micrograms/day. There was no side effect of the drug in any patient except in one patient who had dysphonia. The mean basal cortisol levels were normal in all the subjects at 0, 3 and 6 months of therapy. Tetracosactrin stimulation test was also normal in all patients at all the times who were receiving the dose of 400 micrograms/day. However, one patient (14%) receiving 800 micrograms/day had HPA axis suppression at six months. Two patients in this group also had low basal cortisol levels. There was no clinical evidence of such suppression/deficiency.. Beclomethasone dipropionate in a dose of 800 micrograms/day may suppress the hypothalamo-pituitary-adrenal axis if used for long periods (six months). However, this may not have any clinical significance.

    Topics: Administration, Inhalation; Adolescent; Adult; Asthma; Beclomethasone; Cosyntropin; Dose-Response Relationship, Drug; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Pituitary-Adrenal System

2000
[Chronic eosinophilic pneumonia complicated by bronchial asthma and diabetes mellitus successfully treated with suplatast tosilate and high-dose inhaled corticosteroid therapy].
    Nihon Kokyuki Gakkai zasshi = the journal of the Japanese Respiratory Society, 1999, Volume: 37, Issue:11

    A 54-year-old woman complained of dyspnea, cough, and productive sputum. Auscultation detected a wheeze in the left and right lung fields. Chest x-ray and computed tomographic films showed non-segmental infiltration in the left upper lung field. Laboratory data revealed eosinophilia in peripheral blood and sputum, elevated levels of serum interleukin-5 (IL-5), airflow limitation, hypoxemia, and heightened airway sensitivity to methacholine (D min : 0.42 units). Bronchoalveolar lavage disclosed an increase in the total number of cells, a 32% increase in eosinophils, and a decreased CD 4/CD 8 ratio of 0.7. Transbronchial lung biopsy specimens revealed infiltrations of eosinophils in the alveolar and interstitial compartments. The histologic features of bronchial biopsy specimens included increased eosinophils in the submucosa and squamous metaplasia. In addition, blood glucose and HbA 1 c levels were elevated. Chronic eosinophilic pneumonia complicated by bronchial asthma and diabetes mellitus was diagnosed. Because the patient was diabetic, she was given suplatast tosilate to reduce the production of IL-5, and high-dose inhaled corticosteroid (beclometasone dipropionate, 1,600 mcg/day) instead of oral corticosteroid therapy. Her symptoms were relieved, peak expiratory flow rates increased, serum IL-5 levels became undetectable, airway sensitivity to methacholine decreased (D min : 4.64 units), and the radiographic abnormalities disappeared. Furthermore, treatment with beclomethasone dipropionate was progressively reduced to 1,200 mcg/day over the subsequent year without relapse. It was concluded that suplatast tosilate and high-dose inhaled corticosteroid therapy may be an effective alternative therapeutic approach to chronic eosinophilic pneumonia in some cases.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Arylsulfonates; Asthma; Beclomethasone; Chronic Disease; Diabetes Complications; Diabetes Mellitus; Female; Humans; Interleukin-5; Middle Aged; Pulmonary Eosinophilia; Sulfonium Compounds

1999
Effect of inhaled glucocorticoid on the cellular profile and cytokine levels in induced sputum from asthmatic patients.
    Lung, 1999, Volume: 177, Issue:1

    Cytokines are considered to play a role in the airway inflammation of bronchial asthma. We examined the cellular profile and cytokine levels in induced sputum samples obtained before and after treatment with beclomethasone dipropionate (BDP, 800 microg/day, for 4 weeks) in 12 mild to moderate asthmatic subjects who had not previously received inhaled glucocorticosteroids. Sputum was induced with a 20-min inhalation of 3% saline by an ultrasonic nebulizer. The freshly expectorated sputum separated from the saliva was analyzed for cell counts, for the concentration of interleukin-8 (IL-8), and for the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF). The mean percentage of eosinophils in the sputum samples decreased significantly after BDP treatment, but no significant change in the percentage of neutrophils was observed. The mean IL-8 and GM-CSF levels also decreased significantly after treatment. The BDP treatment was associated with an increase in the mean peak expiratory flow (PEF) and with a decrease in the diurnal variation of PEF. These results suggest that inhaled steroids improve airway inflammation and lung function in asthmatics, presumably in part by inhibiting the synthesis of inflammatory cytokines such as IL-8 and GM-CSF.

    Topics: Administration, Inhalation; Administration, Topical; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Cell Count; Eosinophils; Female; Glucocorticoids; Granulocyte-Macrophage Colony-Stimulating Factor; Humans; Interleukin-8; Male; Middle Aged; Neutrophils; Peak Expiratory Flow Rate; Reproducibility of Results; Spirometry; Sputum

1999
Long-term influence of inhaled corticosteroids on bone metabolism and density. Are biological markers predictors of bone loss?
    American journal of respiratory and critical care medicine, 1999, Volume: 159, Issue:3

    Long-term effects of high doses of inhaled corticosteroids (ICS) on bone density and metabolism are still uncertain. Fifty-one patients (37 male, 14 female) using beclomethasone or budesonide at a daily dose > 800 microgram/d (high-dose group [Group HD] mean: 983 microgram/d [prescribed dose x estimated compliance]) or no or < 500 microgram/d (control group [Group C] mean: 309 microgram/d) for more than 5 yr were enrolled in this study. Each had, 3 yr ago and at this last evaluation, a clinical evaluation and measurements of expiratory flows and of bone density and bone metabolism markers. Lumbar spine bone density (last visit) was similar in the two groups with respective values of 0.94 +/- 0.03 (HD) and 0.96 +/- 0.03 g/cm2 (C) (p > 0.05). T and Z scores were -1.21 +/- 0.19 and -0.70 +/- 0.18 (HD), -0.95 +/- 0.25 and -0.47 +/- 0.21 (C) respectively (p > 0.05). A correlation was found between the decrease in bone density and the mean daily dose of corticosteroid in Group HD although these changes were quite small, mean bone density being unchanged over the 3-yr period. Serum and urinary parameters were similar in the two groups. Furthermore, neither initial bone density nor any of the biological parameters could predict changes in bone density over a period of 3 yr. In conclusion, bone density was similar in both study groups and not significantly different over a 3-yr period. Neither initial bone density nor biological markers of bone metabolism helped to predict changes in bone mass.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Bone and Bones; Bone Density; Bone Diseases, Metabolic; Budesonide; Calcium; Female; Glucocorticoids; Humans; Male; Middle Aged; Time Factors

1999
Comparison of exhaled nitric oxide to spirometry during emergency treatment of asthma exacerbations with glucocorticoids in children.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 1999, Volume: 82, Issue:2

    Asthma is characterized as a chronic inflammatory process; however, there is no easily measured marker for airway inflammation. Such a marker, particularly in children, would be very helpful in the management of asthma even in the acute setting.. The purposes of this study were to determine whether asthmatic children have (1) elevation of exhaled breath nitric oxide (ENO) during acute exacerbations when presenting to the emergency room, (2) reduction of ENO following glucocorticoid treatment, or (3) improvement in spirometry and clinical examination accompanying reduction of ENO levels.. Peak ENO levels were measured by chemiluminescence during exhalation into the NO analyzer. Ten asthmatic children (mean age 10 years) who presented to the Pediatric Special Care Unit at National Jewish Medical and Research Center in acute respiratory distress with an asthma exacerbation were studied. The subjects were recruited, after informed consent was obtained from the parent, on the basis of specific inclusion/exclusion criteria. Measurements of ENO in parts per billion (ppb) and spirometry, including percentiles of forced expiratory volume in one second (FEV1%) and peak expiratory flow (PEF%), were performed before and after at least 5 days of glucocorticoid therapy.. The mean ENO level in the asthmatic children prior to glucocorticoid treatment was 48 +/- 8ppb, and after glucocorticoid treatment the ENO level was 17 +/- 1ppb; (P < .002). Prior to glucocorticoid treatment, the mean FEV1% value was 68 +/- 3% compared with the postglucocorticoid treatment FEV1% value of 100 +/- 5%; (P < .0001). Prior to glucocorticoid treatment, the mean PEF% value was 81 +/- 7%, compared with the postglucocorticoid treatment PEF% value of 105 +/- 6%; (P < .02).. The mean peak ENO level after glucocorticoid therapy was significantly less than that measured before treatment in children with acute asthma exacerbations. Concomitant with the decrease in ENO levels, there was improvement in the spirometry values and physical examination in the asthmatic children; thus, ENO is a sensitive marker for response to anti-inflammatory treatment in children.

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Biomarkers; Breath Tests; Child; Cytokines; Emergencies; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Luminescent Measurements; Male; Nitric Oxide; Nitric Oxide Synthase; Nitric Oxide Synthase Type II; Spirometry; Triamcinolone Acetonide

1999
Vascularity in asthmatic airways: relation to inhaled steroid dose.
    Thorax, 1999, Volume: 54, Issue:4

    There is an increase in vascularity in the asthmatic airway. Although inhaled corticosteroids (ICS) are an effective anti-inflammatory treatment in asthma, there are few data on any effects on structural changes.. Endobronchial biopsy specimens from seven asthmatic subjects not receiving ICS and 15 receiving 200-1500 microg/day beclomethasone dipropionate (BDP) were immunohistochemically stained with an anti-collagen type IV antibody to outline the endothelial basement membrane of the vessels. These were compared with biopsy tissue from 11 non-asthmatic controls (four atopic and seven non-atopic).. There was a significant increase in the density of vessels (number of vessels/mm2 of lamina propria) in the asthmatic subjects not on ICS compared with non-asthmatic controls (mean 485 (interquartile range (IQR) 390-597) versus 329 (IQR 248-376) vessels/mm2, p<0.05; 95% CI for the difference 48 to 286). There was no significant difference between asthmatic subjects on ICS and those not on ICS or control subjects in the number of vessels/mm2 (mean 421 (IQR 281-534)). However, patients who received >/=800 microg/day BDP tended to have a reduced number of vessels/mm2 compared with patients not on ICS and those receiving

    Topics: Administration, Inhalation; Adult; Asthma; Basement Membrane; Beclomethasone; Bronchi; Bronchoconstrictor Agents; Bronchoscopy; Case-Control Studies; Collagen; Drug Administration Schedule; Female; Glucocorticoids; Humans; Hypersensitivity; Immunohistochemistry; Male; Methacholine Chloride; Middle Aged; Neovascularization, Pathologic

1999
Inhaled corticosteroid therapy in asthma: a balancing act.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 1999, Volume: 82, Issue:3

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Child; Drug Resistance; Drug Therapy, Combination; Ethanolamines; Fluticasone; Forced Expiratory Volume; Formoterol Fumarate; Humans; Leukotriene Antagonists; Salmeterol Xinafoate; Theophylline

1999
Effect of long-term treatment with inhaled beclomethasone dipropionate on growth of asthmatic children.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1999, Volume: 36, Issue:2

    The effect of long-term inhaled steroid therapy on linear growth in asthmatic children is still a point of controversy. We tried to clarify the effect of long-term treatment with inhaled beclomethasone dipropionate (BDP) on linear growth and final height of asthmatic children. Height data measured annually from 12 years (beginning at age 10 years in most patients) to 20 years of age were retrospectively collected from clinical records in 97 moderate to severe asthmatics (49 boys, 48 girls) born in 1971-1975 who were observed regularly for more than 8 years at our outpatient clinic. Data were expressed as standard deviation scores and were compared between patients treated with BDP (30 boys and 31 girls, mean daily dosages were 300-800 microg) and without BDP. Growth delay in the early period of puberty and catch-up growth in the late period of puberty was found in both patients treated with and without BDP. The age of onset of treatment with BDP inhalation had no influence on linear growth, and asthmatic children receiving optimum treatment eventually attained standard final height for their age group. Long-term treatment with inhaled BDP in conventional doses does not significantly impair linear growth in asthmatic children.

    Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Height; Child; Female; Follow-Up Studies; Growth; Humans; Male; Retrospective Studies; Time Factors

1999
[Asthma therapy with a Beclomethasone auto-inhaler. Advantages of the AeroBec 250 auto-inhaler under in medical practice].
    Fortschritte der Medizin, 1999, Apr-30, Volume: 117, Issue:12

    Topics: Aerosols; Anti-Asthmatic Agents; Asthma; Beclomethasone; Humans; Respiratory Therapy

1999
Does treatment of asthmatic children with inhaled corticosteroids affect their adult height?
    Pediatric pulmonology, 1999, Volume: 27, Issue:6

    In this retrospective study, adult height was assessed in young adult asthmatics who were treated with inhaled corticosteroids (ICs) during childhood (n = 42; 26 boys) and compared to those obtained in asthmatic patients who were never treated with ICs during childhood (n = 43; 23 boys). Standing height of all subjects and their parents was measured. Height data were analyzed using actual length and target height in centimeters, standard deviation scores (SDS), and difference between adult height of the patients and their target height (adult height minus target height). Mean adult height was the same in subjects who took ICs during childhood as compared to those who had never received ICs (boys: 179.3cm+/-6.8 vs. 180.4 cm+/-5.6; girls: 165.8 cm+/-7.5 vs. 167.7 cm+/-7.2). SDS of adult height was also not different between the two groups: in subjects who did not take ICs it was 0.89+/-1.00, while in those who took ICs it was 0.66+/-1.10 (P = 0.31). SDS of target height was also not different between the two groups: in subjects not taking ICs it was 0.95+/-0.86, while in those who took ICs it was 0.28+/-0.76 (P = 0.30). However, subjects who took ICs during childhood showed a statistically significant lower value of adult height minus target height than those who never took ICs (whole group: -0.003+/-5.9 vs. 2.54 +/-4.8, P = 0.03 ; boys: 0.004+/-5.8 vs. 3.09+/-4.5, P = 0.04 ; girls: -0.075+/-6.3 vs. 1.91+/-5.2, P = 0.31). Patients on ICs during childhood who had ever been hospitalized for asthma showed a lower value for adult height minus target height than those who took ICs but were never hospitalized (-3.08+/-7.8 vs. 1.06+/-4.8, P = 0.046). A logistic regression analysis predicting growth impairment showed that the best-fitting model was one that used only ICs as a dependent variable (crude odds ratio, 3.3; 95% CI, 1.3-8.4). Patients who were treated with ICs in combination with intranasal corticosteroids (treatment for rhinitis) tended to have a lower value of adult height minus target height than the other children, but the difference was not statistically significant (P = 0.07). We conclude that although adult height was the same in young adults who were treated with ICs during childhood compared to those who were not treated with ICs during childhood, there was a statistically significant difference between the two groups for adult height minus target height, suggesting mild growth retardation in patients who took ICs during childhood. These findings

    Topics: Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Height; Female; Glucocorticoids; Humans; Male; Retrospective Studies; Treatment Outcome

1999
Asthma management with HFA-BDP (Qvar).
    Hospital medicine (London, England : 1998), 1999, Volume: 60, Issue:4

    This report reviews the role of hydrofluoroalkane-beclomethasone dipropionate (HFA-BDP; Qvar, 3M, Laughborough) in the management of asthma, based on pharmacokinetic, efficacy and safety clinical trial data presented at a satellite symposium to the European Respiratory Society in 1998. Qvar provides equivalent efficacy and safety to chlorofluorocarbon-BDP at about half the dose.

    Topics: Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chlorofluorocarbons; Dose-Response Relationship, Drug; Humans; Respiratory Therapy

1999
[Growth and collagen synthesis disorders in asthmatic children treated with inhaled steroids].
    Revue medicale de la Suisse romande, 1999, Volume: 119, Issue:6

    We report the case of an atopic patient aged 16 with a perannual asthma. He has been treated since the age of 4 with inhaled corticosteroïds. His growth was regular until he was 14 when beclomethasone was replaced by fluticasone (both administered by pressurized inhaler) due to adrenal suppression. Growth inhibiting effects of different inhaled corticosteroids are discussed focusing mainly on their effect on collagen synthesis.

    Topics: Administration, Inhalation; Adolescent; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Collagen; Fluticasone; Growth Disorders; Humans; Male

1999
The effect of cigarette smoking on exhaled nitric oxide in mild steroid-naive asthmatics.
    Chest, 1999, Volume: 116, Issue:1

    It has been demonstrated previously that exhaled nitric oxide (eNO) is increased in steroid-naive asthmatics and that inhaled steroids reduce eNO in these patients. Cigarette smoking has also been reported to reduce the eNO in healthy volunteers. Recently a correlation has been demonstrated between eNO and airway hyperresponsiveness in steroid-naive, mild asthmatics. We hypothesized that cigarette smoking would reduce the eNO level in steroid-naive asthmatics and might, therefore, affect the correlation between eNO and airway hyperresponsiveness.. Comparison of eNO in healthy smoking and nonsmoking volunteers with the level of eNO in steroid-naive and steroid-treated asthmatics. Correlate the eNO level with the provocative concentration of histamine causing a 20% fall in FEV1 (PC20hist) in the asthmatic smoking and nonsmoking patients.. University outpatient asthma clinic.. eNO levels and PC20hist were measured in three different asthmatic patient groups (group A = 29 steroid-naive, nonsmoking asthmatics; group B = 19 steroid-treated, nonsmoking asthmatics; and group C = 13 smoking, steroid-naive asthmatics) and in two healthy volunteer groups (group D = 18 nonsmoking; and group E = 16 smoking).. eNO in group A was significantly increased compared with the values in groups B and D (21.8+/-12.7, 12.8+/-4.9, and 10.6+/-2.2 parts per billion [ppb], respectively). Cigarette smoking decreased eNO in healthy volunteers (7.4+/-1.8 ppb, group E) as well as in steroid-naive asthmatics (12.7+/-5.1 ppb, group C). There was a significant correlation between eNO and PC20hist in group A (r = -0.45, p < 0.05); this correlation was, however, lost in both groups B and C.. Cigarette smoking and inhaled steroids reduce the eNO in patients with mild asthma to a comparable extent. Because the correlation between eNO and airway hyperresponsiveness was lost in steroid-treated and smoking, steroid-naive asthmatics, we question the value of eNO as a marker of airway inflammation, at least in mild asthmatics who are already being treated with inhaled steroids or who are currently smoking.

    Topics: Administration, Inhalation; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Case-Control Studies; Female; Glucocorticoids; Humans; Male; Nitric Oxide; Smoking

1999
Leukotriene receptor antagonists versus inhaled steroids in asthma.
    The Journal of family practice, 1999, Volume: 48, Issue:7

    Topics: Acetates; Administration, Inhalation; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chronic Disease; Cyclopropanes; Double-Blind Method; Forced Expiratory Volume; Humans; Leukotriene Antagonists; Middle Aged; Quinolines; Randomized Controlled Trials as Topic; Reproducibility of Results; Sulfides; Treatment Outcome

1999
Inhaled and systemic corticosteroid therapies: Do they contribute to inspiratory muscle weakness in asthma?
    Respiration; international review of thoracic diseases, 1999, Volume: 66, Issue:4

    Patients with asthma incur the risk of steroid-induced myopathy, which is a well-known side effect of treatment with corticosteroids. However, the adverse effect of long-term steroid treatment on respiratory muscle function remains controversial.. We aimed to evaluate the effects of long-term moderate dose of systemic corticosteroids and high-dose inhaled beclomethasone on maximal inspiratory and expiratory pressures (PImax and PEmax, respectively) in two groups of asthmatic patients exhibiting comparable levels of hyperinflation.. Twelve steroid-dependent asthmatic patients requiring 10-20 mg/day of prednisone-equivalent corticosteroids for an average of 9.83 +/- (SD) 9.86 years; 14 subjects with moderate to severe asthma who have used inhaled beclomethasone for at least 1 year at a daily dose higher than 1,000 microg and 15 healthy controls were included to the study.. No significant difference in pulmonary function tests and arterial blood gases appeared between two asthmatic groups with different treatment modalities. PImax as an absolute value was significantly lower in steroid-dependent asthmatics than in patients treated with inhaled beclomethasone and controls (p < 0.01). %PImax was also lower in steroid-dependent asthmatics than in control groups (p < 0.01). A significant correlation was found between %PImax and hyperinflation assessed by %RV, %FRC, %FRC/TLC (p < 0.05) in all asthmatic patients.. We believe that hyperinflation plays a major role in inspiratory muscle dysfunction in asthma, but the finding of significantly decreased PImax values in steroid-dependent asthmatics when compared with patients on high-dose inhaled beclomethasone with a comparable level of hyperinflation points to a deleterious effect of long-term, moderate-dose systemic corticosteroid but not high-dose beclomethasone on inspiratory muscle function in asthmatics.

    Topics: Administration, Inhalation; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Case-Control Studies; Female; Humans; Male; Muscular Diseases; Prednisone; Respiratory Muscles; Risk Factors; Time Factors

1999
Inhalation technique of 166 adult asthmatics prior to and following a self-management program.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1999, Volume: 36, Issue:5

    Self-management of asthma and self-treatment of exacerbations are considered important in the treatment of asthma. For successful self-treatment, medication has to be inhaled correctly, but the percentage of patients inhaling effectively varies widely. As part of a self-management program we checked and corrected inhalation technique. This paper addresses differences among inhalers in relation to patient characteristics and the effect of instruction, 1 year after enrollment. Maneuvers that are essential for adequate inhalation were identified. When errors in inhalation technique were observed, patients were instructed in the correct use of their devices. One year later, inhalation technique was checked again. Only patients who used the same inhaler throughout the entire study period were analyzed. Of the 245 adult asthmatic patients who were enrolled in the self-management program, 166 used the same inhaler throughout the study period. One hundred twenty patients (72%) performed all key items correctly at baseline and this increased to 80% after 1 year. At follow-up, older patients were less likely to demonstrate a perfect inhalation. Patients with a Diskhaler made fewest errors. Adjustment for differences in patient characteristics did not significantly change the results. Because many patients with asthma use their inhaler ineffectively, there is a need to know which inhaler leads to fewest errors. Diskhaler was nominated by this study. When patients are not able to demonstrate adequate inhalation technique in a "tranquil" setting, it is doubtful that they can do so when they experience an exacerbation. Therefore, inhalation instruction should be considered an essential ingredient, not only of self-management programs, but also of asthma patient care in general.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Self Care

1999
Comparison of inhaled beclometasone and budesonide. Back titration of inhaled steroids is uncommon in New Zealand.
    BMJ (Clinical research ed.), 1999, Jul-10, Volume: 319, Issue:7202

    Topics: Administration, Inhalation; Administration, Topical; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Drug Administration Schedule; Glucocorticoids; Humans

1999
Comparison of inhaled beclomethasone and budesonide. Study was inadequate.
    BMJ (Clinical research ed.), 1999, Jul-10, Volume: 319, Issue:7202

    Topics: Administration, Topical; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Drug Administration Schedule; Drug Delivery Systems; Glucocorticoids; Humans

1999
Extra fine hydrofluoroalkane-134A beclomethasone aerosols: selecting an optimal inhaled steroid for an individual patient.
    Chest, 1999, Volume: 116, Issue:3

    Topics: Aerosols; Asthma; Beclomethasone; Humans; Hydrocarbons, Fluorinated; Particle Size

1999
Which inhaled corticosteroid for asthma?
    The Journal of family practice, 1999, Volume: 48, Issue:9

    Topics: Administration, Inhalation; Adolescent; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Chronic Disease; Double-Blind Method; Female; Fluticasone; Humans; Male; Randomized Controlled Trials as Topic; Reproducibility of Results; Respiratory Function Tests

1999
A case of 43-year-old fighter pilot with bronchial asthma.
    Aviation, space, and environmental medicine, 1999, Volume: 70, Issue:9

    A Japan Air Self-Defense Force (JASDF) fighter pilot with adult onset atopic bronchial asthma was successfully returned to flying status. This was against the common wisdom of most Japanese military flight surgeons. Bronchial asthma generally results in permanent disqualification from flying duties because of possible acute incapacitation during flight. This JASDF pilot was treated with inhaled medications, including beclomethasone, for 6 mo with suppression of all clinical symptoms. All medications were discontinued and the pilot was observed for another 7 mo before resumption of flying status. This aeromedical disposition was based on the thinking that his long asymptomatic period indicated bronchial inflammation was resolved, bronchial reactivity was improved, and thus the risk of exacerbation was reduced.

    Topics: Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Disability Evaluation; Humans; Japan; Military Personnel; Peak Expiratory Flow Rate

1999
[Therapeutic potential of glucocorticoids inhalation in bronchial asthma].
    Terapevticheskii arkhiv, 1999, Volume: 71, Issue:8

    To assess effectiveness and safety of inhalation glucocorticoids (budesonide, beklometasone dipropionate) in bronchial asthma (BA).. 19 BA patients (8 males and 11 females) inhaled glucocorticoids for 9 months.. The treatment reduced the need in inhalation of short-acting beta-2-adrenomimetics, episodes of asphyxia occurred less frequently. A significant improvement of bronchial permeability was achieved only after 3 months of therapy. Blood levels of hydrocortisone, concentrations of magnesium, calcium and potassium in the serum, red cells and 24-h urine, serum osteocalcin, lumbar vertebral tissue density 3, 6 and 9 months after the treatment start were almost similar to the baseline.. Glucocorticoids for inhalation are clinically effective in BA. They should be used for not less than 3 months. Topical steroids in mean therapeutic doses had no negative effects on the levels of hydrocortisone, mineral metabolism and bone tissue.

    Topics: Administration, Inhalation; Administration, Topical; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchi; Budesonide; Calcium; Female; Humans; Hydrocortisone; Magnesium; Male; Osteocalcin; Permeability; Potassium; Respiratory Function Tests; Treatment Outcome

1999
Clinical use of nebulized budesonide inhalation suspension in a child with asthma.
    The Journal of allergy and clinical immunology, 1999, Volume: 104, Issue:4 Pt 2

    Childhood asthma contributes to significant morbidity among patients and significantly impacts the quality of life and daily routines of their caregivers. The parents or caregivers assume responsibility for tasks that children are too young to perform; this often includes daily administration of controller medications and nightly administration of reliever medications. Most young children do not have the coordination or understanding to effectively use pressurized metered-dose inhalers or inhalation-driven devices; thus nebulizer therapy often is preferred for children younger than 4 years of age. Budesonide inhalation suspension will be the first inhaled corticosteroid available for children younger than 4 years of age and the first inhaled corticosteroid for delivery by nebulization in the United States. This is a case report of a 3-year-old boy who received budesonide inhalation suspension as part of several double-blind and open-label studies evaluating the drug. Before study entry, the boy was experiencing more breakthrough wheezing episodes at night than the parents were used to, resulting in an increase in nighttime awakenings that required nebulizer therapy. These nighttime awakenings had a substantial impact on the quality of life of the entire family and interfered with the parents' ability to function at work. Even though they wanted to have more children, this situation discouraged them from doing so. Budesonide inhalation suspension improved overall asthma control and was well tolerated. The boy had a decrease in nighttime symptoms and an increase in both height and weight percentiles for his age. Importantly, use of budesonide inhalation suspension in this boy eased the management of severe asthma and improved the quality of life of the entire family. The parents subsequently decided to have a second child. Budesonide inhalation suspension represents a major breakthrough for infants and young children by providing a formulation that, on approval, can be delivered reliably by nebulizer for effective maintenance treatment of persistent asthma.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child, Preschool; Humans; Male; Nebulizers and Vaporizers; Suspensions

1999
Salmeterol, inhaled corticosteroids, and tolerance to allergen bronchoprotection.
    Chest, 1999, Volume: 116, Issue:5

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Albuterol; Allergens; Asthma; Beclomethasone; Drug Hypersensitivity; Glucocorticoids; Humans; Randomized Controlled Trials as Topic; Research Design; Salmeterol Xinafoate

1999
Bone mineral density in steroid-dependent asthma assessed by peripheral quantitative computed tomography.
    The European respiratory journal, 1999, Volume: 14, Issue:4

    Chronic use of systemic glucocorticoids results in progressive bone loss and pathologic fractures. This study identified the predictive variables for bone loss and used peripheral quantitative computed tomography (pQCT) to measure changes in cortical and trabecular bone in patients receiving systemic glucocorticoid therapy of prednisone 15.4 g. Eighty-four asthmatic patients were included in the study. Vertebral fractures were diagnosed via plain spinal radiograms. pQCT was used to measure cortical and trabecular bone mineral density. Multiple regression analysis identified variables with predictive value. The cumulative dose of glucocorticoid correlated with the bone mineral density (p<0.05) and the trabecular bone density (p<0.01). Among patients > or = 65 yrs of age, the cumulative dose of glucocorticoid correlated with the occurrence of vertebral fractures (p<0.05), total bone mineral density (p<0.01) and cortical bone mineral density (p<0.01). Bone mineral density in the distal radius measured by pQCT and the vertebral bodies by axis QCT were correlated, regardless of whether systemic glucocorticoids were administered. Glucocorticoid administration not only decreases trabecular but also cortical bone mineral density. Since cortical bone provides strength and stiffness, it appears that the loss of cortical bone is responsible for the increased incidence of fracture seen in patients receiving systemic glucocorticoid therapy.

    Topics: Aged; Asthma; Beclomethasone; Bone Density; Bone Resorption; Chronic Disease; Female; Glucocorticoids; Humans; Lumbar Vertebrae; Male; Outpatients; Predictive Value of Tests; Radius; Spinal Fractures; Tomography, X-Ray Computed

1999
Multiple inhalers confuse asthma patients.
    The European respiratory journal, 1999, Volume: 14, Issue:5

    This study investigated the influence of the use of different types of inhalers on the adequacy of inhalation technique among adult asthmatics. Three hypotheses were tested: first, patients using only one type of inhaler will demonstrate adequate inhalation technique more often than those with two or more types. Secondly, patients using a combination of dry powder inhalers (DPIs) will demonstrate correct inhalation technique more often than those using the combination of a metered dose inhaler (MDI) and a DPI. Thirdly, some inhalers or combinations of inhalers are more prone to erroneous inhalation technique than others. Adult outpatients with asthma who regularly used inhaled steroid therapy (n=321) participated in the study. The inhalers investigated were MDIs on the one hand, and the DPIs Turbuhaler, Diskhaler, Cyclohaler, Inhaler Ingelheim and Rotahaler on the other. Of 208 adult asthmatics with only one inhaler, 71% made no inhalation errors versus 61% of 113 patients with two or more different inhalers. Of patients with a combination of DPIs 68% performed all essential checklist items correctly, versus 54% of patients with the combination of "regular" MDI and DPI. Patients using only the Diskhaler made fewest errors. Whenever possible, only one type of inhaler should be prescribed. If a combination is unavoidable, combinations of DPIs are preferable to MDI and DPI. The Diskhaler seems to be the most foolproof device.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Male; Nebulizers and Vaporizers

1999
Inhaled corticosteroids or antileukotrienes for asthma?
    Annals of internal medicine, 1999, Dec-07, Volume: 131, Issue:11

    Topics: Acetates; Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cyclopropanes; Glucocorticoids; Humans; Leukotriene Antagonists; Quinolines; Sulfides

1999
[Influence of steroid inhalation therapy on microorganism of respiratory infections in patients with bronchial asthma].
    Kansenshogaku zasshi. The Journal of the Japanese Association for Infectious Diseases, 1999, Volume: 73, Issue:11

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Haemophilus influenzae; Humans; Immunocompromised Host; Respiratory Tract Infections; Staphylococcus aureus; Streptococcus pneumoniae

1999
Feasibility of spirometry and reversibility testing for the identification of patients with chronic obstructive pulmonary disease on asthma registers in general practice.
    Respiratory medicine, 1999, Volume: 93, Issue:12

    There is renewed interest in the diagnosis of chronic obstructive pulmonary disease (COPD) within primary care. Primary care physicians have difficulty distinguishing asthma from COPD. We tested the feasibility of using spirometry and if appropriate, reversibility testing, to identify patients with COPD on asthma registers in primary care. We carried out a cross-sectional study in three inner-city group practices in east London. Three hundred and twenty-eight patients aged 50 years and over on practice asthma registers were invited to attend for spirometry and, if appropriate, a trial of oral corticosteroids. The main outcome measures were: feasibility of carrying out spirometry; lung function; severity of COPD; prior diagnosis of COPD; response to a corticosteroid trial; quality of life. One hundred and sixty-eight of 328 (51%) patients attended for spirometry. According to British Thoracic Society criteria, 58 (34%) patients had normal spirometry at the time of assessment; 40 (24%) had active asthma and 57 (34%) had COPD. Thirteen patients (8%) were unable to perform spirometry. Of 57 patients with COPD 30 (53%) had mild, 15 (26%) had moderate and 12 (21%) had severe disease. Twenty-three of 57 (40%) patients with COPD on spirometry had this diagnosis recorded prior to the study. New diagnoses of COPD were more likely in those with mild or moderate disease (P<0.05). Twenty-three of 57 (40%) patients with COPD completed a corticosteroid trial: one showed significant reversibility of lung function. Spirometry was feasible and helped identify patients with COPD on asthma registers in these inner-city practices. Patients aged 50 years and over on asthma registers had a wide spectrum of lung function with considerable diagnostic misclassification. Some patients with normal lung function when tested may have had well controlled asthma. New diagnoses of COPD were mainly in those with mild or moderate disease.

    Topics: Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Cross-Sectional Studies; Diagnosis, Differential; Feasibility Studies; Female; Glucocorticoids; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Prednisolone; Quality of Life; Respiratory Function Tests; Spirometry

1999
[Two cases of Kimura's disease associated with bronchial asthma].
    Nihon Kokyuki Gakkai zasshi = the journal of the Japanese Respiratory Society, 1999, Volume: 37, Issue:12

    We encountered two rare cases of Kimura's disease associated with bronchial asthma presenting eosinophilia and hyperimmunoglobulinemia E. Patient 1 was a 26-year-old man who had been admitted to our hospital with recurrent increase in left parotid mass in May 1997. He had previously undergone surgery for local excision at another hospital in September 1987; the excised specimens were re-evaluated and the diagnosis of Kimura's disease was confirmed. Because the patient was suffering from an acute asthma attack on admission, prednisolone (PSL) 30 mg/day was administered orally. PSL reduced the parotid mass and improved control of the asthma. Patient 2 was an 18 year-old man who had been given a diagnosis of Kimura's disease on the basis of histologic findings from a biopsy specimen of a subcutaneous tumor in the left cheek in 1988. Following the diagnosis, the patient was treated with methotrexate for the first several months, and then with loxioprofen for 9 years, but the size of the mass remained unchanged. Bronchial asthma developed in this patient in 1995 and had been treated with theophylline. However, because this therapy caused a deterioration of asthma control, the patient was admitted to our hospital in October 1997 for the treatment of bronchial asthma. Inhaled corticosteroids (beclometasone 0.8 mg/day) in addition to theophylline alleviated the patient's asthma symptoms and yielded improved lung function. Because few cases of Kimura's disease associated with bronchial asthma have been reported, patients with eosinophilia and hyperimmunoglobulinemia E were not necessarily considered at high risk for the onset of bronchial asthma.

    Topics: Adolescent; Adult; Angiolymphoid Hyperplasia with Eosinophilia; Asthma; Beclomethasone; Drug Therapy, Combination; Humans; Male; Prednisolone; Theophylline; Treatment Outcome

1999
Aerosol characterization of three corticosteroid metered dose inhalers with volumatic holding chambers and metered dose inhalers alone at two inspiratory flow rates.
    Journal of aerosol medicine : the official journal of the International Society for Aerosols in Medicine, 1999,Winter, Volume: 12, Issue:4

    Inhaled corticosteroids are first-choice drugs in the treatment of chronic asthma. A metered dose inhaler (MDI) equipped with a spacer device is easier to use for patients with a poor inhalatory technique; it favors a reduction in the size of the particles delivered to the patient and thus a reduction in the incidence of local and systemic side effects of these drugs. The aim of this study was to determine the particle characteristics of fluticasone propionate (FP), flunisolide (FLUN), and beclomethasone dipropionate (BDP), each administered at a rate of 250 micrograms per puff and at inspiratory flow rates of 30 and 60 L/min in vitro, to estimate the particle characteristics of these drugs aspirated via an MDI alone and via a large-volume holding chamber (Volumatic). Compared with the MDI alone, at 30 L/min, the Volumatic (Glaxo Wellcome, Ware, UK) significantly reduced the mass median aerodynamic diameter (MMAD) and increased the fine particles (< 5 microns and < 2 microns) generated by all three drugs. At 60 L/min, the MMAD increased and the generation of fine particles decreased with both devices. These data suggest that the inspiratory flow applied by means of the devices may be a determinant for the deposition of the drug in the lower airways in that by increasing the inspiratory flow, the MMAD increases and the percentage of fine particles decreases, probably because of the reaggregation favored by the higher flows.

    Topics: Aerosols; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Fluocinolone Acetonide; Fluticasone; Glucocorticoids; Humans; Nebulizers and Vaporizers; Particle Size

1999
Beta2-adrenoceptor regulation and function in female asthmatic patients receiving the oral combined contraceptive pill.
    Chest, 1998, Volume: 113, Issue:2

    Previously it has been shown that there is abnormal hormonal control of beta2-adrenoceptors in asthmatic women. Exogenous progesterone but not estradiol produces paradoxic downregulation and desensitization of beta2-adrenoceptors in asthmatic women when compared with nonasthmatic subjects. This study investigates the effect of the oral combined contraceptive pill (OCP) on beta2-adrenoceptor regulation and function in female asthmatic patients.. The study population was comprised of 11 women with stable mild to moderate asthma. The mean age was 25 years; the FEV1 was 89% of predicted, and the forced expiratory flow, mid-expiratory phase (FEF25-75%) was 69% of predicted.. Patients were evaluated while on (day 20 to 21) and off (day 5 to 7) the OCP during a 28-day calendar period.. Serum sex hormones, lymphocyte beta2-adrenoceptor parameters, and bronchodilator and systemic dose-response curves (DRCs) to albuterol (Salbutamol) (100 to 1,600 microg) were measured at both on and off periods.. Serum levels of endogenous estradiol and progesterone were both suppressed by the OCP. Baseline FEV1 were not different while patients were on (2.70 L) and off (2.72 L) the OCP. There were no significant differences in lymphocyte beta2-adrenoceptor parameters between the two phases of the cycle. Receptor density (geometric mean Bmax) was 1.78 (on OCP) vs 1.86 (off OCP) fentomole/10(6) cells, maximal cyclic adenosine monophosphate response to isoprenaline was 6.60 (on OCP) vs 7.58 (off OCP) pmol/10(6) cells, and binding affinity was 14.0 (on OCP) and 13.6 (off OCP) pmol/L. Likewise, there were no significant differences in the bronchodilator and systemic DRCs constructed at both phases of the cycle as evaluated: area-under-curve (AUC) FEV1 was 0.53 (on OCP) vs 0.56 (off OCP) L.h; and AUC FEF25-75% was 3,130 (on OCP) vs 3,640 (off OCP) L. Potassium (K) and finger tremor responses were unaltered between the two periods: AUC K was 0.50 (on OCP) vs 0.44 (off OCP) mmol . h/L and AUC tremor was 0.72 (on OCP) vs 0.89 (off OCP) log units.h.. The OCP did not alter beta2-adrenoceptor regulation and function in stable female asthmatic patients. Further studies are required in patients who have premenstrual asthma.

    Topics: Adrenergic beta-Agonists; Adult; Albuterol; Anti-Asthmatic Agents; Area Under Curve; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Contraceptives, Oral, Combined; Cyclic AMP; Dose-Response Relationship, Drug; Down-Regulation; Estradiol; Female; Fingers; Forced Expiratory Volume; Humans; Isoproterenol; Lymphocytes; Maximal Midexpiratory Flow Rate; Menstrual Cycle; Potassium; Progesterone; Receptors, Adrenergic, beta; Tremor

1998
Exhaled nitric oxide correlates with airway hyperresponsiveness in steroid-naive patients with mild asthma.
    American journal of respiratory and critical care medicine, 1998, Volume: 157, Issue:3 Pt 1

    Endogenously released nitric oxide (NO) has been detected in the exhaled air of humans. Exhaled NO (NOexh) levels have been significantly increased in patients with inflammatory airways disorders such as asthma, and NOexh has been suggested to be a usable marker of airway inflammation. In the present study, NOexh levels were measured both in steroid-treated and untreated subjects with mild asthma, and were correlated with the degree of airway hyperresponsiveness (AHR), measured as the dose of histamine that produced a 20% decrease in FEV1 (PC20histamine). NOexh levels, which were significantly increased in steroid-naive patients (Group A1: NOexh = 21 +/- 11 ppb; n = 56) in comparison with levels in control subjects (Group B: NOexh = 10 +/- 2 ppb; n = 20; p < 0.001), correlated significantly with the PC20histamine (r = -0.65; p < 0.0001). The NOexh level was significantly lower in patients with chronic cough of other causes than bronchial asthma (Group A2: NOexh = 11 +/- 3 ppb; n = 18) when compared with the level in subjects with mild asthma (Group A1: p < 0.001). Therefore, the noninvasive measurement of NOexh allowed us to discriminate, among patients with respiratory complaints, between those with and without AHR. In asthmatic subjects treated with inhaled steroids, the NOexh levels were significantly lower (Group A3: NOexh = 13 +/- 5 ppb; n = 25) than in untreated subjects (Group A1; p < 0.01), and there was no relationship with the PC20histamine (r = -0.18, p = NS). These findings confirm that NOexh reflects AHR in patients with mild asthma who have not already been treated with inhaled steroids. Patients treated with inhaled steroids had an NOexh level comparable to levels in control subjects, although AHR could still be demonstrated.

    Topics: Adrenergic beta-Agonists; Adult; Airway Obstruction; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biomarkers; Bronchial Hyperreactivity; Bronchial Provocation Tests; Chronic Disease; Cough; Dyspnea; Female; Forced Expiratory Volume; Glucocorticoids; Histamine; Humans; Male; Nitric Oxide; Respiration; Respiratory Sounds

1998
Is normal bronchial responsiveness in asthmatics a reliable index for withdrawing inhaled corticosteroid treatment?
    Chest, 1998, Volume: 113, Issue:4

    Inhaled corticosteroid (ICS) treatment is first-line maintenance therapy in bronchial asthma. However, it is not clear whether and when ICS treatment can be withdrawn. The aim of this open study was to assess whether normalization of bronchial responsiveness could be used as a reliable index to assess the opportunity of ICS treatment withdrawal.. Open study at two different points in time.. Outpatient pulmonary clinic.. Eighteen asthmatic subjects.. ICS therapy was withdrawn in subjects treated with beclomethasone dipropionate, at the maintenance dose of 889+/-246 microg/d for >3 months. Upon recruitment, all subjects were asymptomatic, had FEV1 >70% of predicted value, and were in treatment with beta2-agonists on an as-needed basis. Eight subjects (group 1) had normal bronchial responsiveness (methacholine provocative dose causing a 20% fall in FEV1 [PD20] >2,000 microg) and 10 subjects (group 2) had bronchial hyperresponsiveness (BHR) (PD20 < or = 2,000 microg). After withdrawal of ICS treatment, subjects were followed up for 3 weeks and were asked to record their asthma symptoms (cough, dyspnea, and wheezing) and their beta2-agonist use. At recruitment and at the end of follow-up, subjects underwent spirometry and a methacholine challenge test. Frequency of asthma exacerbation was similar in subjects with normal bronchial responsiveness (NBR) and in subjects with BHR (50% vs 60%), but subjects with NBR tended to remain asymptomatic for longer than those with BHR (mean+/-SD, 10.7+/-4.4 days vs 5.5+/-3.8 days) (p=0.08). None of the subjects reported any condition that could have triggered exacerbation. Asthma exacerbation was associated with a significant decrease in FEV1 (-105+/-107 mL; p<0.05) and in PD20 (-1,332+/-1,020 microg; p<0.001).. Our study shows that the likelihood of asthma exacerbation is not reduced if ICS treatment is withdrawn when the subjects have NBR, but the exacerbation could be delayed. Further studies in larger populations of asthmatics are needed to confirm these findings.

    Topics: Adolescent; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Child; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Treatment Outcome

1998
The responsiveness of disease-specific and generic health measures to changes in the severity of asthma among adults.
    Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 1998, Volume: 7, Issue:3

    The objective of the study was to compare the validity of asthma-specific and generic health outcome measures in relation to changes in the severity of asthma and to treatment. Adult patients (n = 142) participating in a randomized placebo-controlled trial at six clinics were assessed at baseline, prior to the withdrawal (placebo) or continuation of treatment with Vanceril and again after 8 weeks. The criterion measures of change in severity included pulmonary function expressed as the percent predicted FEV1, five physician-assessed asthma severity measures (cough, chest tightness, wheezing, shortness of breath and overall condition) and two patient-assessed severity measures (night-time symptoms and overall symptoms). The 8 week change scores were estimated for all generic and specific measures and the results were compared across groups of patients who did and did not change in terms of clinical criteria of disease severity and across treatment groups. The responsiveness of each generic and specific measure was estimated independently using the relative validity (RV) methodology, which compares F-ratios for the mean change scores across measures in analyses of the same comparison groups. RV coefficients estimate how much worse each measure discriminated between comparison groups, relative to the best measure (RV = 1.0). Four standardized asthma-specific measures and a total scale score (based on the Marks questionnaire), an individualized asthma-specific scale measuring limitations in activities most important to each patient (based on the Juniper method) and two newly-developed scales measuring physical and psychosocial symptoms were used as outcome measures, generic health outcome measures included eight functional health and well-being scales as well as the physical and mental health summary scales from the SF-36 health survey. A standardized asthma-specific scale was most valid in discriminating between groups of patients who did and did not change according to all of the clinical criterion variables studied and in discriminating between treated and untreated groups. Different scales performed best, depending on the clinical criterion. The asthma-specific Marks breathlessness scale was significant in all nine comparisons (RV = 0.62-1.0) and was most valid in discriminating between groups in six of nine tests. The overall scale also performed well in all comparisons (RV = 0.58-1.0). The newly-developed physical symptoms scale was significant in discr

    Topics: Activities of Daily Living; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Discriminant Analysis; Female; Forced Expiratory Volume; Health Status Indicators; Humans; Male; Psychometrics; Reproducibility of Results; Severity of Illness Index; Surveys and Questionnaires; Treatment Outcome

1998
[Effect of treatment on health-related quality of life in patients with asthma].
    Nihon Kokyuki Gakkai zasshi = the journal of the Japanese Respiratory Society, 1998, Volume: 36, Issue:1

    The aim of the study was to assess the effect of treatment on health-related quality of life (HRQoL) in patients with asthma. We used the Japanese version of the Living With Asthma Questionnaire (LWAQ) as an asthma-specific HRQoL measure. Thirty-four new patients were enrolled and treated according to Guidelines on the Management of Asthma by the British Thoracic Society. The LWAQ and spirometry were evaluated on the initial visit, and three and six months after treatment. The LWAQ score, forced expiratory volume in one second (FEV1), and forced vital capacity (FVC) were significantly improved three months after treatment. The Japanese version of the LWAQ was reliable. For the first three months, there were no correlations between changes in FEV1 or FVC and LWAQ scores (Rs = 0.11-0.25). Pulmonary functions could not predict HRQoL well. Therefore, HRQoL should be measured directly to assess HRQoL in asthmatics.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Female; Forced Expiratory Volume; Humans; Lung; Male; Quality of Life; Spirometry; Surveys and Questionnaires; Treatment Outcome; Vital Capacity

1998
[Eosinophil count in induced sputum samples as a marker of airway inflammation and adequacy of corticosteroid inhalation treatment in asthmatic patients].
    Nihon Kokyuki Gakkai zasshi = the journal of the Japanese Respiratory Society, 1998, Volume: 36, Issue:2

    We tried to use eosinophil counts in induced sputum samples as a marker of airway inflammation, and as a guide for reducing inhaled corticosteroids in patients with well-controlled persistent asthma. The eosinophil count in induced sputum smears was defined as follows: Eos%; eosinophil percentage of 200-400 leukocytes in properly cell-separated fields, TEC; total eosinophil counts in the 5 most eosinophil-dense high power view fields (x 400). First, the eosinophil count in induced sputum samples was compared between 29 asthmatic subjects treated with inhaled corticosteroid and 15 age- and sex-matched healthy controls. Second, inhaled corticosteroid was reduced by 50% in 20 patients with green-zone asthma (morning PEF > 80% of patient's best PEF). PEF measurements were followed prospectively for 12 weeks thereafter. Once PEF decreased below 70% of their best PEF, subjects were considered as treatment "failures". Both Eos% and TEC were significantly higher than in the controls, even in well-controlled (morning PEF > 80% of their best) asthmatic patients (p = 0.001, 0.03). The chance of treatment "failure" was significantly higher in those having more eosinophils (Eos% > 10%, TEC > 100) in their initial induced sputum sample (p = 0.03, 0.001). Airway inflammation still persists in many well-controlled chronic asthmatic patients, and induced sputum eosinophilia predicts an early decrease of PEF after reduction of inhaled corticosteroids.

    Topics: Administration, Inhalation; Adult; Aged; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biomarkers; Bronchitis; Eosinophils; Female; Humans; Leukocyte Count; Male; Middle Aged; Peak Expiratory Flow Rate; Sputum

1998
[Effect of pharmacist's instruction on the treatment of asthmatics with inhaled steroid].
    Arerugi = [Allergy], 1998, Volume: 47, Issue:4

    Pharmacist's instruction is provided to asthmatic patients who received an inhaled steroid in Hamamatsu University Hospital. We studied influences of pharmacist's instruction on the repeutic effects of an inhaled steroid, beclomethasone dipropionate (BDP). In 29 patients who had been treated with inhaled BDP under the physician's instruction for more than 3 months, we examined drug compliance, correctness of inhalation procedure and treatment score, symptom score, peak expiratory flow (PEF) values, and compared these before and after the instruction. The instruction was repeatedly provided at an interval of about one month. Patients who followed the indicated regimen were 55.2 and 93.1% before and after the instruction, respectively. An appropriate inhalation maneuver was respectively. An appropriate inhalation maneuver was performed in 24.1 and 93.1% of patients before and after the instruction, respectively. PEF values increased by 12.9 +/- 9.3% (mean +/- standard deviation, p < 0.01) after the instruction. In conclusion, pharmacist's repeated instruction enhanced the therapeutic effects of inhaled BDP in patients with asthma.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Female; Humans; Male; Middle Aged; Patient Compliance; Patient Education as Topic; Pharmacists

1998
Regional lung deposition and clearance of 99mTc-labeled beclomethasone-DLPC liposomes in mild and severe asthma.
    Chest, 1998, Volume: 113, Issue:6

    To compare the distribution and clearance of inhaled beclomethasone dipropionate (Bec)-dilauroylphosphatidylcholine (DLPC) liposomes in patients with mild and severe asthma.. A 99mTc-labeled Bec-DLPC suspension was delivered via a nebulizer (Aerotech II). Immediately after inhalation, anterior and posterior views of the lungs and an anterior view of the oropharynx were measured by a large field gamma camera with the patient in a supine position. To evaluate the mucociliary clearance of the inhaled liposomes, anterior and posterior lung scans were repeated 1, 2, 4, and 24 h after the aerosol delivery.. Ten patients with mild asthma (FEV1 >80% of the predicted) and 10 patients with severe asthma (FEV1 <60% of the predicted) were included in an open, parallel group study.. Clearance is more rapid among patients with severe asthma (p<0.0001). At the 4-h measurement, a mean of 82% (SD, 5.9) of the total pulmonary dose was detected in the lungs of patients with mild asthma while in those with severe asthma the figure was 69% (SD, 10.9). The ratio between central and peripheral deposition was significantly higher for patients with severe asthma than for those having a mild form of the disease; 1.07 (SD, 0.29) and 0.76 (SD, 0.07), respectively (p=0.008).. Inhaled Bec-DLPC liposomes were deposited more centrally in the lower airways of patients with severe asthma than those having a milder form of the disease. The clearance of Bec-DLPC liposomes is strikingly slow in both groups of asthmatic patients. However, due to the more peripheral penetration of inhaled liposomes in patients with mild asthma, the clearance rate in this group was slower than in those with severe asthma.

    Topics: Administration, Inhalation; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Carriers; Female; Forced Expiratory Volume; Gamma Cameras; Humans; Liposomes; Lung; Male; Middle Aged; Nebulizers and Vaporizers; Phosphatidylcholines; Radionuclide Imaging; Technetium

1998
Inhaler medicament effects on saliva and plaque pH in asthmatic children.
    The Journal of clinical pediatric dentistry, 1998,Winter, Volume: 22, Issue:2

    The purpose of the present study was to investigate the effect on saliva and plaque pH of beta 2 agonist (salbutamol 400 mcg) and inhaler corticosteroid (fluticasonepropionate 250 mcg). The interproximal plaque pH responses to these medicaments and examine the effect of chewing gum after the usage of these inhalers. Thirty children of both sexes, from six to fourteen years old, participated in the study. The pH microelectrode was used in the study. The interdental sites chosen were those between the premolars in the 4 quadrants. The pH measurements were made baseline and 1, 5, 10, 20, 30 minutes after the use of medicaments as inhaler and also saliva was stimulated by sugar free chewing gum (Vivident). Data analyses were conducted using a statistical package through the University's computing center. The resulting pH values decreased in all four plaque sites and saliva during 30 minutes after inhaler drugs. After rinsing with water, the pH values also decreased (p < 0.001). Decreasing pH increased with chewing gum (p < 0.001). The hypothesis is that a decrease in pH in medicated asthmatics could be caused by inhaler drugs. Conclusive evidence for the relative role of the disease and the drug in saliva secretion and composition seems to require a longitudinal study on asthmatics before and after the onset of drug administration. We suggest that children with bronchial asthma treated with inhaler drugs should receive special preventive attention.

    Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Albuterol; Analysis of Variance; Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Chewing Gum; Child; Dental Care for Chronically Ill; Dental Caries; Dental Plaque; Drug Combinations; Female; Fluticasone; Humans; Hydrogen-Ion Concentration; Male; Saliva; Statistics, Nonparametric; Time Factors

1998
Montelukast for persistent asthma.
    The Medical letter on drugs and therapeutics, 1998, Jul-17, Volume: 40, Issue:1031

    Topics: Acetates; Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Cyclopropanes; Double-Blind Method; Drug Interactions; Fees, Pharmaceutical; Humans; Leukotriene Antagonists; Quinolines; Sulfides

1998
Longitudinal evaluation of bone mass in asthmatic children treated with inhaled beclomethasone dipropionate or cromolyn sodium.
    Allergy, 1998, Volume: 53, Issue:7

    Inhaled corticosteroids are recommended as first-line therapy in patients with moderate to severe asthma. The use of these agents in the milder form of asthma is controversial because of their potential adverse effects, especially in growing children. We investigated 49 asthmatic children (38 treated with beclomethasone dipropionate (BDP) at a daily dose of 276+/-125 microg/day and 11 treated with cromolyn sodium (CS) at a daily dose of 30+/-10 mg/day) for 7.4 months, with bone-mass measurements at baseline and after the treatment period. Evaluation of changes in cortical and trabecular bone mass (bone mineral density [BMD]; m/cm2) was performed by absorptiometry at the proximal forearm and at the lumbar spine, respectively. Furthermore, to correct for bone size changes due to growth, we calculated volumetric BMD (VOL-BMD; mg/cm3). At the end of the treatment period, the children who had received regular inhaled BDP had grown as well as children treated with CS, from 120+/-1.4 to 123+/-1.3 cm and from 118+/-3.2 to 120.3+/-2.8 cm, respectively. No children showed deviation from their percentile level of growth. Trabecular and cortical BMD increased after 7 months of follow-up in both groups to the same extent. When BMD was adjusted for body size (VOL-BMD; mg/cm3), bone mass was found not to have changed after BDP or CS treatment course within and between the two groups.

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bone and Bones; Bone Density; Child; Cromolyn Sodium; Female; Follow-Up Studies; Humans; Longitudinal Studies; Male; Prospective Studies

1998
Comparison of beclomethasone, salmeterol, and placebo in children with asthma.
    The New England journal of medicine, 1998, Sep-03, Volume: 339, Issue:10

    Topics: Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Height; Child; Humans; Salmeterol Xinafoate

1998
Bronchial mucosal immunoreactivity of sensory neuropeptides in severe airway diseases.
    American journal of respiratory and critical care medicine, 1998, Volume: 158, Issue:3

    Neuropeptides act on most of the components of the bronchial environment. They influence bronchomotor tone and bronchial vascular caliber and permeability. To investigate the nonadrenergic, noncholinergic system within the airways in asthma and chronic bronchitis, we performed endobronchial biopsies in 16 normal human volunteers, 49 patients with asthma of varying severity, including 16 patients treated with oral corticosteroids, and 13 patients with chronic bronchitis. Frozen sections of biopsies stained with specific antibodies against the neural marker PGP 9.5, vasoactive intestinal peptide (VIP), substance P (SP), calcitonin gene-related peptide (CGRP), and neuropeptide Y (NPY) were analyzed for the presence of nerves through indirect immunofluorescence. Nerves were present in most of the biopsies and were found within and below the epithelium and adjacent to smooth muscle, glands, and blood vessels. By comparison with those in normal subjects, the numbers of VIP-immunoreactive nerves were not significantly decreased in patients with asthma and chronic bronchitis, but NPY-immunoreactive nerves were significantly decreased in the smooth muscle of these latter two groups of patients (p < 0.005). There was no correlation between disease severity and the number of nerves found in the biopsies. This study does not confirm previous findings in autopsy material of some defects in sensory and VIP-containing nerves in severe asthma.

    Topics: Administration, Oral; Adolescent; Adult; Aged; Asthma; Beclomethasone; Biomarkers; Biopsy; Bronchi; Bronchitis; Bronchoconstriction; Calcitonin Gene-Related Peptide; Capillary Permeability; Chronic Disease; Epithelium; Female; Fluorescent Antibody Technique, Direct; Glucocorticoids; Humans; Male; Middle Aged; Mucous Membrane; Muscle, Smooth; Nerve Tissue Proteins; Neuropeptide Y; Neuropeptides; Prednisone; Substance P; Thiolester Hydrolases; Ubiquitin Thiolesterase; Vasoactive Intestinal Peptide; Vasomotor System

1998
[Theophylline and inhaled n corticosteroids in asthma: a reliable combination].
    Pneumologie (Stuttgart, Germany), 1998, Volume: 52, Issue:7

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Budesonide; Dose-Response Relationship, Drug; Drug Therapy, Combination; Forced Expiratory Volume; Humans; Theophylline; Treatment Outcome

1998
Effect of sex of fetus on asthma during pregnancy: blind prospective study.
    BMJ (Clinical research ed.), 1998, Sep-26, Volume: 317, Issue:7162

    Topics: Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Female; Fetus; Humans; Male; Pregnancy; Pregnancy Complications; Sex Factors

1998
Bone mineral density and body composition in patients with airflow obstruction--the role of inhaled steroid therapy, disease and lifestyle.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 1998, Volume: 28, Issue:9

    Inhaled steroid therapy has been shown to be associated with low bone mineral density (BMD) in asthmatic patients, but its effect in men has not been specifically studied; and the relative importance of therapy, disease and lifestyle leading to low BMD has not been investigated.. The study was designed to compare BMD in women and men who had airflow obstruction (asthma or COAD with or without inhaled steroid therapy) with normal controls. The role of inhaled steroid treatment, disease severity and lifestyle was studied among patients.. One hundred and fourty-four patients (106 on inhaled steroids and 38 not on inhaled steroids) and 212 age-matched controls were studied. Body composition and BMD (at the total body, hip and spine) were measured by dual-X-ray densitometry (DEXA). Forced expiratory volume (FEV1) was measured in patients. A validated questionnaire was administered to measure lifestyle factors.. The body mass indices (BMI) (P < 0.001) and percentage of body fat (P < 0.001) were higher among female patients on inhaled steroids than controls. However, the BMD of the total body (P < 0.05) and spine (P < 0.001) were significantly lower in premenopausal and postmenopausal women than controls, respectively (P < 0.005). The BMD at the spine (P<0.01) and hip (P < 0.01) in male patients were significantly lower than the controls. By multiple regression, age and use of inhaled steroid was negatively associated with BMD at the hip (P < 0.01), but not at the spine (P>0.05). Cigarette smoking was associated with significantly lower BMD at the femoral neck (P < 0.05), and a low dietary calcium intake was associated with lower BMD at the spine (P<0.05). In women, use of inhaled steroid was not associated with significantly lower BMD.. Men who had asthma and/or COAD had lower BMD, and this was not attributable entirely to steroid use. Cigarette smoking and a low dietary calcium intake may partially account for this difference. The difference in BMD between female patients and controls, even in those taking inhaled steroid, was small.

    Topics: Absorptiometry, Photon; Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Body Composition; Bone Density; Bone Resorption; Budesonide; Calcium, Dietary; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Life Style; Male; Middle Aged; Sex Factors; Smoking; Surveys and Questionnaires

1998
Comparison of potency of inhaled beclomethasone and budesonide in New Zealand: retrospective study of computerised general practice records.
    BMJ (Clinical research ed.), 1998, Oct-10, Volume: 317, Issue:7164

    To determine whether inhaled budesonide and beclomethasone are equipotent in the treatment of asthma in primary care.. Retrospective study of computerised clinical records from 28 general practices in New Zealand.. 5930 patients who received 16 725 prescriptions for inhaled budesonide or beclomethasone from 1 July 1994 to 30 June 1995.. General practices on the database of the Royal New Zealand College of General Practitioners Research Unit. Linked information from secondary care was available for a subset of the practices.. Mean prescribed daily inhaled corticosteroid dose.. The daily prescribed dose was higher for patients receiving inhaled budesonide (mean 979 microg) than beclomethasone (mean 635 microg), a difference of 344 microg (95% confidence interval 313 to 376 microg). This difference was consistent in all age bands and with different types of inhalation device. Evidence of systematic prescribing of higher doses of budesonide to patients with more severe asthma was not found.. In primary care in New Zealand evidence suggests that budesonide is less potent than beclomethasone. Consideration of validated, established, and other possible markers of asthma severity did not support confounding by severity as a reason for the higher prescribed doses of budesonide. Pending further epidemiological evaluation, international asthma guidelines may need to be modified on the equivalence of inhaled corticosteroid doses. Furthermore, the comparative potency of newly developed inhaled steroids in clinical trials will need to be confirmed in appropriately designed epidemiological studies based in general practice.

    Topics: Administration, Inhalation; Adolescent; Adult; Age Distribution; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Child, Preschool; Drug Prescriptions; Humans; Infant; Infant, Newborn; Middle Aged; New Zealand; Retrospective Studies

1998
Targeting drug delivery and the small airways in asthma.
    Hospital medicine (London, England : 1998), 1998, Volume: 59, Issue:6

    This year will see the launch of the first chlorofluorocarbon (CFC)-free formulation of beclomethasone. Developed by 3M Health Care, its extrafine formulation gives significant benefits resulting from increased lung deposition and improved inhaler technology. Its difference from CFC-propelled inhalers is so marked that it will challenge views about about the risk-benefit profile of beclomethasone.

    Topics: Aerosol Propellants; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchi; Humans; Nebulizers and Vaporizers

1998
Inverse association between sarcoidosis and atopic asthma.
    Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG, 1998, Volume: 15, Issue:2

    Topics: Acute Disease; Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Follow-Up Studies; Humans; Male; Sarcoidosis, Pulmonary; Theophylline

1998
Clinical observations on catch-up growth in asthmatic children following withdrawal of inhaled glucocorticosteroids.
    Pediatric pulmonology, 1998, Volume: 26, Issue:4

    Topics: Administration, Inhalation; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Child; Female; Glucocorticoids; Growth; Growth Disorders; Humans; Male

1998
Contact allergy to beclomethasone dipropionate.
    Contact dermatitis, 1998, Volume: 39, Issue:5

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Dermatitis, Allergic Contact; Diagnosis, Differential; Facial Dermatoses; Foot Dermatoses; Hand Dermatoses; Humans; Male; Middle Aged; Patch Tests

1998
[Metamorphopsia of the Alice in Wonderland-syndrome].
    Nederlands tijdschrift voor geneeskunde, 1998, Dec-19, Volume: 142, Issue:51

    A boy aged 9 had had two years previously and again since a few weeks complaints of observing objects with distortion and reduction in size. He was known to suffer from asthma for which he received beclomethasone in a low dosage. Physical and supplementary examinations revealed no abnormalities. The condition was diagnosed as 'metamorphopsia'.

    Topics: Asthma; Beclomethasone; Child; Electroencephalography; Humans; Male; Medical History Taking; Migraine Disorders; Perceptual Distortion; Recurrence; Somatoform Disorders; Syndrome; Tomography, X-Ray Computed; Visual Perception

1998
Selenium, glutathione peroxidase and superoxide dismutase in maltese asthmatic patients: effect of glucocorticoid administration.
    Pulmonary pharmacology & therapeutics, 1998, Volume: 11, Issue:4

    Oxidative processes, mediated by free radical chemistry, are recognized to contribute significantly to the inflammatory pathology of bronchial asthma. This study analysed the degree of defence against reactive oxygen species in Maltese, asthmatic patients and in normal individuals, by measuring plasma selenium concentration, erythrocyte glutathione peroxidase (GSH-Px) activity and erythrocyte superoxide dismutase (SOD) activity, in order to determine their antioxidant status. The effect of glucocorticoids on the status of these antioxidants in patients was also investigated. The measurement of antioxidant status was carried out both in mild (n = 22) and severe (n = 37) asthmatics, as well as in healthy controls (n = 49). The same antioxidant profile was then investigated in a group of 16 severe asthmatics following treatment for 4 weeks with inhaled beclomethasone dipropionate (750 micrograms twice daily), and in a second group of 16 patients suffering from severe asthma, following 2-weeks treatment with oral prednisolone (15 mg daily during the first week and 10 mg daily during the second). No statistically significant difference was found in the plasma selenium concentrations and erythrocyte glutathione peroxidase activities between patients and controls. Both mild and severe asthmatics, however, exhibited a statistically significant lower erythrocyte superoxide dismutase activity than normal subjects (mild asthmatics: 62.9 (2.9) SOD 525 U/ml, severe asthmatics: 60.6 (1.9) SOD 525 U/ml, normal: 68.5 (1.1) SOD 525 U/ml, P < 0.01). Inhaled beclomethasone dipropionate exerted no effect on this antioxidant profile, while prednisolone caused a significant increase in plasma selenium concentration over pretreatment values (pretreatment: 118.3 (4.4) ng/ml, post-treatment: 138.1 (4.6 ng/ml, P < 0.01). It is thus suggested that asthmatic patients in Malta might be more susceptible to superoxide-induced damage than normal individuals. The reason for the prednisolone-induced augmentation of plasma selenium could not be determined from this study. It is postulated that the drug may decrease the excretion rate of the element, and may thus exert a positive antioxidant effect in individuals of established low selenium status.

    Topics: Administration, Inhalation; Administration, Oral; Adolescent; Adult; Asthma; Beclomethasone; Erythrocytes; Female; Glucocorticoids; Glutathione Peroxidase; Humans; Male; Malta; Middle Aged; Oxidative Stress; Prednisolone; Respiratory Function Tests; Selenium; Severity of Illness Index; Superoxide Dismutase

1998
Inhaled corticosteroids are considered by many to be the most effective therapy.
    Respiratory medicine, 1998, Volume: 92 Suppl B

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Humans

1998
[Effect of inhaled-corticosteroids on the mRNA expressions of endothelin-1 and endothelin converting enzyme in bronchial asthma].
    Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases, 1998, Volume: 21, Issue:6

    To investigate the expressions of endothelin-1(ET-1) and endothelin converting enzyme (ECE) mRNA in bronchial mucosal biopsis from asthmatics, and the effect of inhaled-corticosteroids on the expressions of ET-1 and ECE genes.. The expressions of ET-1 and ECEmRNA in bronchial mucosal tissue were evaluated by reverse transcription DNA polymerase chain reaction (RT-PCR); With fibro bronchoscopy, the naked-eye inflammatory severity and inflammatory score of bronchial mucoses were recorded.. (1) The expression level of ET-1 mRNA was 0.86 +/- 0.06 in non-steroids-treated group and 0.14 +/- 0.06 in control non-asthmatic group. The expression of ECE mRNA in non-steroid group was 0.31 +/- 0.04, and 0.30 +/- 0.05 in control group, P = 0.238. (2) The ET-1 and ECE mRNA expressions were 0.22 +/- 0.01 and 0.16 +/- 0.01 respectively in steroid treated group. (3) The naked-eye bronchial mucosal inflammatory score was 6.0 +/- 1.9 in non-steroids treated group, moreover, the expression of ET-1 mRNA was positively correlated with the score (r = 0.78, P < 0.05).. There was markedly higher ET-1 mRNA expression in the bronchial mucosa in asthmatics, but the ECE mRNA expression was unchanged significantly; Inhaled corticosteroids obviously inhibited both ET-1 mRNA and ECE mRNA expressions in bronchial mucosa, which may be one of the anti-inflammatory mechanisms of inhaled-corticosteroid in management of bronchial asthma.

    Topics: Adult; Anti-Asthmatic Agents; Aspartic Acid Endopeptidases; Asthma; Beclomethasone; Endothelin-1; Endothelin-Converting Enzymes; Female; Humans; Male; Metalloendopeptidases; RNA, Messenger

1998
Prevalence of inhaled corticosteroid use among patients with chronic obstructive pulmonary disease: a survey.
    The Annals of pharmacotherapy, 1997, Volume: 31, Issue:2

    To determine the extent of inhaled corticosteroid use among patients with chronic obstructive pulmonary disease (COPD).. Review of medical records.. Tertiary-care university teaching hospital.. Seventy-two consecutive patients prescribed an inhaled corticosteroid during hospitalization.. None.. Patient demographics, inhaled corticosteroid regimen, respiratory diagnosis, and inhaled corticosteroid use before and during hospitalization.. The majority of patients (85%) were receiving their prescribed corticosteroid inhaler prior to admission. Beclomethasone dipropionate 250 micrograms/puff was the most commonly prescribed inhaled corticosteroid formulation accounting for 43% of the total corticosteroid inhaler orders. COPD was the most common respiratory diagnosis (43%) associated with inhaled corticosteroid use, followed by asthma (37%), COPD/asthma (13%), and no diagnosis (7%). During the study period, the proportion of all hospitalized patients with COPD who also received inhaled corticosteroid prescriptions (35%) was not significantly different from all hospitalized patients with asthma who received inhaled corticosteroid prescriptions (33%).. The rate of inhaled corticosteroid use far exceeds the rate expected among the general population of patients with COPD. Educational intervention is needed to encourage compliance with published guidelines for the management of COPD.

    Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Chi-Square Distribution; Drug Utilization; Female; Hospitalization; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Practice Patterns, Physicians'; Pregnenediones

1997
Prehospitalization inhaled corticosteroid use in patients with COPD or asthma.
    Chest, 1997, Volume: 111, Issue:2

    Guidelines for the treatment of obstructive lung diseases suggest a primary role of inhaled corticosteroids (ICs) in asthma, but only a minor role in COPD. However, surveys of physicians' prescribing habits have suggested that there is little difference in the use of ICs between these two conditions.. To determine the prevalence of IC use before and during hospitalization among patients with COPD or asthma.. Retrospective chart review.. Tertiary care university teaching hospital.. Adult inpatients, aged 18 or older, with physician-diagnosed COPD or asthma.. Patient-reported prescription drug use at hospital admission, and medical chart record of in-hospital and discharge prescriptions.. Of 350 charts reviewed, 102 patients were admitted to the hospital for unstable COPD, 133 patients had stable COPD, 36 patients were admitted with unstable asthma, and 79 patients had stable asthma. At hospital admission, 48% of unstable COPD patients, 26% of stable COPD patients, 56% of unstable asthma patients, and 44% of stable asthma patients reported having a current prescription for ICs. The proportion of all asthmatic patients reporting a current prescription for ICs at admission (48%) was significantly higher than the proportion of all COPD patients receiving an IC at admission (35%). However, there was no significant difference in the proportion of COPD and asthma patients with a current prescription of any form of corticosteroid (oral or inhaled). The proportion of COPD patients likely to respond to IC therapy is significantly different from the observed use at hospital admission.. The proportion of patients found to be using ICs is much higher than the proportion expected to respond. There was little difference in the use of ICs for asthma and COPD patients at hospital admission. Most COPD patients using an IC were receiving the regimen on admission to hospital, indicating that there is need for education in the community and in the hospital regarding use of ICs in COPD patients.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Aged; Asthma; Beclomethasone; Drug Utilization; Emergency Service, Hospital; Female; Glucocorticoids; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Ontario

1997
Growth of asthmatic children is slower during than before treatment with inhaled glucocorticoids.
    Acta paediatrica (Oslo, Norway : 1992), 1997, Volume: 86, Issue:2

    Reports on the influence of inhaled glucocorticoids on growth have been controversial. We studied the growth of prepubertal asthmatic children prior to and during glucocorticoid therapy. We collected retrospectively the notes of 201 asthmatic children aged 1-11 years receiving inhaled beclomethasone dipropionate or budesonide. We calculated their height and height velocity standard deviation scores (HSDS and HVSDS, respectively) before the treatment and up to 5 years during the treatment and compared those with the growth of healthy peers. The dose of the medication was calculated and the severity of asthma was assessed. The asthmatic children grew similarly to their healthy peers before treatment with inhaled glucocorticoids: the mean HSDS was +0.02 and the mean HVSDS +0.01 for boys and -0.16 and +0.13 for girls, respectively. Growth retardation took place soon after the start of the treatment, the most profound decrease in the growth velocity (the change in the mean HVSDS from +0.05 to -0.88) occurring during the first year of treatment. The growth-retarding effect of inhaled glucocorticoids was not dose dependent. In the covariance analysis the increasing severity of asthma had a significant interaction with repeated measurements, showing more growth retardation along with more severe asthma, especially during long-term treatment. Asthma per se does not impair growth, but inhaled glucocorticoids may do so. Careful monitoring of the growth of all asthmatic children receiving inhaled glucocorticoids is necessary because the growth-retarding effect of the medication is not dose dependent. Individual sensitivity might explain the differences seen in the growth patterns of children receiving inhaled glucocorticoids.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Budesonide; Child; Child, Preschool; Female; Glucocorticoids; Growth; Humans; Infant; Male; Pregnenediones; Retrospective Studies

1997
Enhanced expression of neutral endopeptidase (NEP) in airway epithelium in biopsies from steroid- versus nonsteroid-treated patients with atopic asthma.
    American journal of respiratory cell and molecular biology, 1997, Volume: 16, Issue:5

    The expression of the endogenous neuropeptide-degrading enzyme, neutral endopeptidase (NEP; CALLA, CD10, E.C.3.4.24.11) on cultured human airway epithelial cells can be upregulated by corticosteroids. We examined whether NEP expression in the airway epithelium or lamina propria in bronchial biopsies is enhanced in atopic asthmatics on regular inhaled steroids as compared with those without steroid treatment. Forty nonsmoking adults (age 19 to 48 yr) with mild to moderate asthma (forced expiratory volume in 1 s > or = 50% pred., histamine PC20 range 0.02 to 7.6 mg/ml) with (n = 23) or without (n = 17) regular inhaled steroids treatment entered the study. Biopsies were taken at (sub)segmental level from the right lower lobe, the middle lobe, and the main carina. Immunohistochemical staining was performed on cryostat sections using the VIL-A1 monoclonal antibody against CD10 (NEP). Intra- and inter-observer repeatability of a semiquantitative scoring method was good as assessed by weighted kappa (kappa(w) ranging from 0.66 to 0.81). In the airway epithelium, NEP-positive sites were within the basal layer and, in contrast with studies applying other antibodies, also at apical sites and within the lamina propria. In both the epithelium and lamina propria, NEP expression was not significantly different between the three biopsy sites (Friedman's nonparametric two-way analysis of variance; P > 0.68), nor was expression in the lamina propria associated with inhaled steroid usage (Mann-Whitney U test; P = 0.98). However, NEP expression was significantly enhanced in the airway epithelium in patients using inhaled steroids as compared with nonsteroid users (mean rank: 23.4 and 15.5, respectively; P = 0.02). Among nonsteroid-using subjects, NEP expression was related to symptoms and the methacholine PC20 (Rs: -0.69 and 0.49, respectively; P < or = 0.04). We conclude that the expression of NEP is enhanced in airway epithelium in bronchial biopsy specimens from patients with atopic asthma who are regularly using inhaled steroids as compared with patients who do not. This fits the hypothesis that the anti-inflammatory effect of corticosteroids within the airways is partially mediated by the upregulation of the endogenous neuropeptide-degrading enzyme NEP.

    Topics: Adrenergic beta-Agonists; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchi; Budesonide; Cross-Sectional Studies; Epithelium; Female; Forced Expiratory Volume; Histamine; Humans; Male; Middle Aged; Neprilysin; Observer Variation; Peak Expiratory Flow Rate; Pregnenediones

1997
Effect of inhaled glucocorticoids on IL-1 beta and IL-1 receptor antagonist (IL-1 ra) expression in asthmatic bronchial epithelium.
    Thorax, 1997, Volume: 52, Issue:5

    Accumulating evidence suggests that the cytokine network is central to the immunopathology of bronchial asthma and the existence of naturally occurring cytokine antagonists has added to this complexity. Upregulation of both interleukin 1 beta (IL-1 beta) and its naturally occurring receptor antagonist, interleukin 1 receptor antagonist (IL-1ra), has previously been observed on asthmatic bronchial epithelium compared with normal airways.. The effect of inhaled beclomethasone dipropionate (BDP) on asthmatic bronchial epithelial expression of IL-1 beta and IL-1ra was studied. Frozen bronchial biopsy specimens from nine asthmatic subjects receiving 1000 micrograms BDP daily for eight weeks and from six asthmatic subjects receiving matching placebo were stained with anti-IL-1 beta and anti-IL-1ra antibodies. Hue-saturation-intensity (HSI) colour image analysis was used to quantify the brown immunoperoxidase reaction colour present on the bronchial epithelium.. There was a significant twofold decrease in the epithelial expression of IL-1 beta after treatment with BDP but no significant change was seen in IL-1ra (P = 0.175).. The selective inhibition of IL-1 beta, without effect on IL-1ra, provides a novel mechanism for the anti-inflammatory action of glucocorticosteroids.

    Topics: Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchi; Epithelium; Female; Humans; Immunohistochemistry; Interleukin-1; Male; Receptors, Interleukin-1

1997
Asthma guidelines.
    Thorax, 1997, Volume: 52, Issue:7

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Albuterol; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Drug Therapy, Combination; Humans; Salmeterol Xinafoate

1997
[Effects of becotide and becodisk glucocorticoid drugs on bronchial reactivity in patients with bronchial asthma].
    Klinicheskaia meditsina, 1997, Volume: 75, Issue:6

    Efficacy of inhalation corticosteroids becotide and becodisk was compared in 24 patients with bronchial asthma. Becodisk has the advantage of not containing freon which irritates upper airways and bronchial mucosa. Clinical, allergological, bronchial resistance, provocative carbacholine tests, external respiration tests, peakflowmetry demonstrated that becodisk reduced the number of asthma attacks, lowered the need in inhalation sympathomimetics, improved external respiration function, decreased bronchial sensitivity to carbacholine. Determination of specific and nonspecific bronchial reactivity is thought essential in comparing efficacy of asthma chemotherapy. Becodisk significantly reduces bronchial reactivity to nonspecific mediator substances, is simple in use and well tolerated. It is recommended for basic therapy in various bronchial asthma forms managed with local corticosteroids.

    Topics: Administration, Inhalation; Adolescent; Adult; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchoconstriction; Female; Glucocorticoids; Humans; Hydroxycorticosteroids; Lung; Male; Middle Aged; Respiration

1997
Bone mineral density in asthmatic patients treated with inhaled corticosteroids: a case-control study.
    The European respiratory journal, 1997, Volume: 10, Issue:9

    Recent studies suggest that inhaled corticosteroids can adversely affect bone metabolism. The objective of this study was to evaluate the importance of these adverse effects in a case-control study. Bone mineral density (BMD) was measured in 48 asthmatic adults (15 males and 33 females) treated with inhaled steroids (beclomethasone or budesonide) and in 48 gender and age-matched healthy subjects at baseline and at 2 yrs. Vertebral BMD was measured by dual energy X-ray densitometry. Patients had been treated with a dose of 662 +/- 278 micrograms (range 300-1,000 micrograms) of beclomethasone dipropionate or budesonide for more than 1 yr (mean duration of treatment 10.6 yrs, range 1-16 yrs). Twenty four patients had needed 1-6 short courses of oral steroids and seven had received oral corticosteroids (mean daily dose 6.2 mg prednisone) for 2-15 yrs more than 4 yrs prior to the BMD measurements. During the follow-up, 14 patients required 1-3 short courses of oral steroids. There was no correlation either between inhaled corticosteroid doses or duration of treatment and BMD values. There were no significant differences in BMD baseline values between patients and healthy controls. BMD significantly decreased in both groups at 2 yrs, from 1.08 +/- 0.19 to 1.05 +/- 0.19 g.cm-2 (p = 0.002) in asthmatics versus 1.12 +/- 0.17 to 1.09 +/- 0.18 g.cm-2 (p = 0.008) in controls. There were no significant differences in BMD loss between patients and healthy controls. Furthermore, no differences were found in bone loss when pre- and postmenopausal women were compared with their healthy control counterparts. No differences in baseline BMD were found between patients who had received regular oral corticosteroid therapy or booster courses of oral corticosteroids and those who had not. Inhaled corticosteroid treatment at a mean dose of 662 micrograms.day-1 and sporadic booster courses of oral corticosteroids do not further increase bone mass loss with respect to that expected from natural bone mass loss.

    Topics: Absorptiometry, Photon; Administration, Inhalation; Administration, Oral; Asthma; Beclomethasone; Bone Density; Budesonide; Case-Control Studies; Cross-Sectional Studies; Female; Glucocorticoids; Humans; Lumbar Vertebrae; Male; Middle Aged; Prednisone

1997
Hospitalization of adults for asthma and inhaled corticosteroid use in an island population.
    Respiratory medicine, 1997, Volume: 91, Issue:7

    Inhaled corticosteroids have been shown to reduce morbidity and the need for hospitalization from asthma. Despite improvements in the therapy of asthma, epidemiologic data from several countries has shown that the hospital admission rates for asthma among adults at a population level are on the increase. The prevalence rate of hospital admission for asthma among Maltese adults aged 15-59 years was determined retrospectively from 1989 to 1993. Concurrent yearly total dispensal of inhaled corticosteroids for the whole population was also calculated. This study was undertaken amongst a well-defined island population served by a single medical facility offering emergency services, and a possible association between these two trends was investigated by means of logistic regression. The age-specific hospital admission rates for asthma decreased from 96.2 (95% CI: 109.7, 82.7) per 100,000 in 1989 to 38.1 (95% CI: 46.4, 29.8) per 100,000 in 1993. The prevalence rates of admission from asthma decreased from 67.6 (95% CI: 78.9, 56.3) per 100,000 in 1989 to 30.6 (95% CI: 38.0, 23.2) per 100,000 in 1993. The dispensal of inhaled beclomethasone dipropionate (BDP) increased from 0.99 defined daily dose (DDD) per 1000 population in 1989 to 3.28 DDD per 1000 in 1993. Logistic regression showed that increasing dispensal of inhaled BDP by 1 DDD per 1000 decreased the odds of an admission from asthma to 0.71 (95% CI: 0.65, 0.78) times their previous value. Similarly, the odds of an individual being hospitalized because of asthma decreased to 0.75 (95% CI: 0.67, 0.83) times their previous value. This study concludes that there was a progressive decrease in hospital admission rates for asthma in adults, and this trend correlates well with increasing use of inhaled corticosteroids at a community level. This must, however, be interpreted with care in light of the fact that increase in utilization of anti-inflammatory therapy probably also reflected improved general and widespread care for asthma.

    Topics: Acute Disease; Administration, Topical; Adolescent; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Drug Utilization; Glucocorticoids; Hospitalization; Humans; Malta; Middle Aged; Prevalence; Retrospective Studies

1997
Central serous chorioretinopathy associated with inhaled or intranasal corticosteroids.
    Ophthalmology, 1997, Volume: 104, Issue:10

    The purpose of the study is to investigate the relationship between inhaled or intranasal adrenergic agonists and corticosteroids and the development of central serous chorioretinopathy (CSC).. The medical records of three patients with CSC who were found to use inhaled adrenergic agents or corticosteroids or both were identified prospectively. A survey of members of the Retina, Macula, and Vitreous societies and the National Registry of Drug-Induced Ocular Side Effects identified three additional cases.. Six patients with CSC were found to be chronic users of corticosteroid (four patients) or both beta adrenergic agonist and corticosteroid (two patients) metered dose inhalers or nasal sprays. In three cases, there was a close temporal correlation between the use of a corticosteroid nasal spray and the development of CSC.. These findings suggest that, in patients who are susceptible, the periocular or systemic absorption of inhaled corticosteroids may be sufficient to produce CSC in humans, supporting previous hypotheses regarding the pathogenesis of the disorder. Further studies are needed to confirm this association and to determine whether inhaled adrenergic agents also contribute to the development of this disorder. Patients in whom CSC develops while using corticosteroid inhalers or nasal sprays should be alerted to the possible relationship between CSC and these agents.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Albuterol; Androstadienes; Asthma; Beclomethasone; Bronchitis; Choroid Diseases; Exudates and Transudates; Female; Fluorescein Angiography; Fluticasone; Fundus Oculi; Glucocorticoids; Humans; Male; Middle Aged; Pigment Epithelium of Eye; Prospective Studies; Retinal Detachment; Retinal Diseases; Rhinitis; Risk Factors; Triamcinolone Acetonide; Visual Acuity

1997
Inhaled beclomethasone dipropionate suppresses the hypothalamo-pituitary-adrenal axis in a dose dependent manner.
    Clinical endocrinology, 1997, Volume: 47, Issue:3

    Little is known about the dose-response relationship of potential, unwanted, effects of inhaled beclomethasone (BDP) on the hypothalamo-pituitary-adrenal (HPA) axis, particularly in nonspecialist clinic settings. The purpose of our study was to investigate the dose-response relationship of inhaled BDP on the HPA axis in a general practice patient population. We also explored the optimal testing strategy in this population and correlated effects of inhaled BDP on the HPA axis with other systemic corticosteroid side effects.. Controlled observational study employing 21 patients on inhaled BDP recruited from general practice, with minimal past and no present exposure to other corticosteroids, and 21 age and gender-matched controls.. Twenty-four-hour urinary free cortisol excretion (UFC), serum cortisol before and 30 minutes after injection of 1 microgram and 250 micrograms of tetracosactrin, serum IGF-I and serum osteocalcin were measured. BDP use was estimated by inhaler weighing and prescription count.. In subjects on inhaled BDP, 24-hour UFC (P < 0.008), serum cortisol 30 minutes after 250 micrograms tetracosactrin (P < 0.05) and the serum cortisol rise after 250 micrograms tetracosactrin (P < 0.04) were significantly lower when compared with controls. Measurements of HPA function correlated inversely with BDP dose estimated by inhaler weighing (all P < 0.03). Serum IGF-I and osteocalcin levels did not differ.. We have demonstrated hypothalamo-pituitary-adrenal axis suppression in nonspecialist-clinic asthma patients on moderate to large doses of inhaled beclomethasone dipropionate. When accurate measurements of inhaled steroid dose are used, there is an exponential relationship between dose and hypothalamo-pituitary-adrenal axis suppression. There appears to be no 'safe' threshold, and around 15% of patients may have clinically significant suppression. However, the significance of hypothalamo-pituitary-adrenal axis suppression as a marker for concomitant corticosteroid effects on other organ systems remains uncertain.

    Topics: Administration, Inhalation; Anti-Inflammatory Agents; Asthma; Beclomethasone; Case-Control Studies; Cosyntropin; Depression, Chemical; Dose-Response Relationship, Drug; Drug Administration Schedule; Family Practice; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Insulin-Like Growth Factor I; Male; Middle Aged; Osteocalcin; Pituitary-Adrenal System

1997
Choosing therapy for childhood asthma.
    The New England journal of medicine, 1997, Dec-04, Volume: 337, Issue:23

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Asthma; Beclomethasone; Child; Glucocorticoids; Humans

1997
Influence of inhaled corticosteroids and dietary intake on bone density and metabolism in patients with moderate to severe asthma.
    Journal of the American Dietetic Association, 1997, Volume: 97, Issue:12

    Compare the effect of high doses of inhaled corticosteroids on bone loss in subjects with moderate to severe asthma or mild asthma, and examine the influence of dietary intake on bone metabolism.. A survey on the effects of corticotherapy and nutrition on bone density was conducted in 74 subjects currently being treated for asthma in the asthma clinic of Hôpital Laval (Sainte-Foy, Quebec, Canada). Fifty-eight subjects completed the study (attrition rate = 15%).. In all subjects expiratory volumes were determined and urinary analysis was conducted for hydroxyproline, calcium, phosphorus, and cortisol levels. Osteocalcin, calcium, phosphorus, cortisol, alkaline phosphatase, and gamma-glutamyltransferase levels were measured in blood samples. Bone density of the lumbar spine was determined by means of dual-energy x-ray absorptiometry. Nutrition evaluation was based on a 3-day food diary analyzed using progiciel Nutri 91. The nutritional parameters examined were calcium; phosphorus; magnesium; zinc; vitamins A, C, and D; protein; total fiber; oxalates; energy; caffeine; and alcohol in relation to bone density.. Thirty-one patients with moderate to severe asthma who had been taking more than 1,000 micrograms beclomethasone per day or the equivalent for more than 2 years and 27 patients with mild asthma who were taking less than 500 micrograms beclomethasone per day or the equivalent.. Four-factor analysis of variance with hierarchized interactions of four levels, Duncan's test, Pearson correlation coefficients.. Blood levels of osteocalcin and protein intake were lower in patients with moderate to severe asthma than in those with mild asthma (P < .05). Significant correlations (P < .02) were observed between bone density and calcium intake (r = .40), phosphorus intake (r = .35), protein intake (r = .30), and serum alkaline phosphatase level (r = -.30). Bone density was not significantly different between the two groups of patients with asthma.. A follow-up of patients with asthma who are taking inhaled corticosteroids is needed to assess bone density, osteocalcin levels, and dietary intakes of calcium. Verify if osteocalcin level decreases over time in patients with moderate to severe asthma, monitor possible modifications in bone density, and verify if the correlation between dietary calcium and bone density is maintained.

    Topics: Absorptiometry, Photon; Administration, Inhalation; Alkaline Phosphatase; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biomarkers; Bone Density; Bone Remodeling; Budesonide; Calcium; Diet; Eating; Female; Follow-Up Studies; Humans; Male; Middle Aged; Osteocalcin; Phosphorus

1997
Cross sectional investigation of the effects of inhaled corticosteroids on bone density and bone metabolism in patients with asthma.
    Thorax, 1997, Volume: 52, Issue:10

    Bone mineral density has been reduced in patients with asthma taking inhaled corticosteroids in some cross sectional studies and this could be important if treatment is continued for several decades. The possibility of confounding by age, menopausal status, physical activity and, especially, past oral steroid use has not been excluded in most studies. The present study was designed to assess the magnitude of any reduction in bone mineral density in relation to inhaled steroid use after adjusting for these factors.. Bone mineral density (BMD), vertebral fractures, and markers of bone metabolism (serum osteocalcin, procollagen peptide I, bone-specific alkaline phosphatase, and urinary deoxypyridinoline cross links) were measured in 81 patients with asthma age 20-40 years; 34 patients (19 men) who had never had inhaled or systemic steroids and 47 (19 men) who had taken inhaled steroids for at least five years with limited exposure to systemic steroids in the past. Data relating to past medication use, physical activity, smoking, and other confounding factors were collected by questionnaire. The relation between inhaled steroid dose and duration and BMD was assessed by linear regression analysis, accounting for potential confounders including weight, exercise, and oral steroid use.. The 47 patients taking an inhaled steroid had a mean current dose of 620 micrograms/day (range 100-3000 micrograms), a mean duration of use of 7.8 years, and had had a mean of 0.85 courses of prednisolone in the past. There was no significant difference in mean BMD values between those who were and those who were not on inhaled steroids in men or women. However, on multivariate analysis, cumulative inhaled steroid dose was associated with a reduction in posterior-anterior (P-A) and lateral lumbar spine bone mineral density in women, equivalent to a 0.11 standard deviation reduction in bone density per 1000 micrograms/day inhaled steroid per year after adjustment for potential confounding factors (95% CI for P-A spine 0.01 to 0.22; for lateral spine 0.02 to 0.21). Previous oral steroid use was not an important confounding factor in these patients. Inhaled steroid use was not related to BMD at the wrist or hip in women or at any skeletal site in men. Women taking an inhaled steroid had lower levels of serum osteocalcin than those not taking them, although this was not dose related. Inhaled steroid use was not associated with differences in other markers of bone metabolism in men or women or with the presence of vertebral fractures.. Although an effect of confounding factors cannot be excluded entirely in a cross sectional study, our findings are in keeping with an effect of inhaled steroid therapy in reducing bone density in the spine in women and provide an estimate of the magnitude of this effect.

    Topics: Administration, Topical; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bone and Bones; Bone Density; Cross-Sectional Studies; Drug Administration Schedule; Female; Glucocorticoids; Humans; Lumbar Vertebrae; Male; Multivariate Analysis; Physical Exertion

1997
[Factors responsible for the course and long-term outcomes of bronchial asthma: chemotherapy].
    Klinicheskaia meditsina, 1997, Volume: 75, Issue:7

    In a 10-year retrospective observational study the authors investigated the effects of antiinflammatory therapy with corticosteroids (CS), broncholytic therapy with theophylline drugs (TD) and of inhalations of short-action sympathomimetics (ISM) on the course and long-terms outcomes of bronchial asthma (BA). The data were processed using actuarial analysis. It was established that long-term CS therapy diminishes the risk of the unfavourable BA outcome (death, life-threatening conditions, invalidism). The protective CS action was maximal in patients with severe persistent BA. The best treatment results were achieved in long-term CS course in doses warranting effective control over respiratory symptoms. Long-term TD administration failed to demonstrate a significant influence on long-term BA outcomes. Overdoses of ISM occasionally observed in the course of relevant treatment placed the exposed patients at higher risk of unfavourable BA outcome. ISM overdoses were associated with severe and uncontrollable BA.

    Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aged; Asthma; Beclomethasone; Bronchodilator Agents; Female; Humans; Male; Middle Aged; Theophylline; Time Factors

1997
[Influence of beclomethason dipropionate inhalation therapy on respiratory bacterial infection in patient with an asthmatic attack].
    Arerugi = [Allergy], 1997, Volume: 46, Issue:11

    The aim of this clinical study was to investigate the influence of beclomethasone dipropionate (BDP) inhalation therapy on respiratory bacterial infection in patient with an asthmatic attack. We studied 267 asthmatic attack episodes of 241 patients with/without BDP inhalation therapy. There was no difference between two groups in %peak flow, body temperature, CRP, WBC count, bacterial culture of sputum on admission. BDP inhalation therapy has little influence on respiratory bacterial infection at an asthmatic attack.

    Topics: Adult; Anti-Asthmatic Agents; Asthma; Bacterial Infections; Beclomethasone; Female; Humans; Male; Respiratory Tract Infections

1997
Asthma treatment costs using inhaled corticosteroids.
    The American journal of managed care, 1997, Volume: 3, Issue:6

    Asthma is a chronic inflammatory disorder of the airways that affects 10 to 17.5 million people and leads to more than $5 billion in treatment costs in the Unites States annually. This retrospective study is an initial step in understanding the beneficial economic outcomes of inhaled corticosteroid therapy by determining whether differences exist in healthcare utilization expenditures for three inhaled corticosteroids available for use in the United States: (1) beclomethasone dipropionate (Vanceril/Schering and Beclovent/Allan & Hanburys); (2) flunisolide (Aerobid/Forest); and (3) and triamcinolone acetonide (Azmacort/Rhône-Poulenc Rorer). This study was based on an analysis of 4,441 patients with at least one pharmaceutical claim for one of the study drugs, using inpatient, outpatient, and prescription drug claims data obtained from The MEDSTAT Group's MarketScan database for calendar years 1990 through 1993. We tested a null hypothesis for no differences in total asthma treatment costs, when drugs were excluded, using multivariate linear regression modeling controlling for patient demographic and clinical characteristics that might affect the study outcome. We found that, after excluding study drug payments and controlling for other contributing factors, total asthma healthcare expenditures to triamcinolone acetonide (Azmacort) users were higher than those for beclomethasone dipropionate (Vanceril and Beclovent) and flunisolide (Aerobid) users. When study drug costs were included in the expenditure measure, both triamcinolone acetonide (Azmacort) and flunisolide (Aerobid) users had higher expenditures than did beclomethasone dipropionate (Vanceril and Beclovent) users. No significant differences in expenditures were detected between Vanceril and Beclovent patients, a finding consistent with the fact that these drugs are the same type of inhaled corticosteroid. Other factors contributing to differences in total asthma healthcare costs included patient age, patterns of switching among and continuing with study drugs, prestudy asthma utilization or drug proxy severity, and comorbidities of precipitating illnesses.

    Topics: Administration, Inhalation; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Cost-Benefit Analysis; Female; Fluocinolone Acetonide; Health Care Costs; Humans; Linear Models; Male; Middle Aged; Retrospective Studies; Triamcinolone Acetonide; United States

1997
Effect on cortical and trabecular bone mass of different anti-inflammatory treatments in preadolescent children with chronic asthma.
    American journal of respiratory and critical care medicine, 1996, Volume: 153, Issue:1

    Bone metabolism and density have been shown to be abnormal in adult asthmatic patients treated with inhaled corticosteroids. Because the largest increases in bone growth and mineral deposition occur during childhood and adolescence, we performed a cross-sectional evaluation of cortical and trabecular bone mass by dual-photon absorptiometry at the proximal one third of the radius (cortical bone) and by dual-energy X-ray absorptiometry at the L2-L4 lumbar spine (trabecular bone) in 64 prepubertal asthmatic children receiving beclomethasone dipropionate (BDP) or cromolyn sodium (CS). Dual-energy X-ray absorptiometry was performed by anteroposterior scan and also by lateral vertebral scan in order to exclude the posterior elements of the vertebrae, which are composed mainly of cortical bone and which are less sensitive to the negative effect of steroids. Furthermore, we calculated "volumetric" bone density, dividing lateral mineral content by the vertebral volume. Bone mineral areal density and volume bone density did not differ in children receiving BDP for 6.7 +/- 1.3 mo at a mean dose of 319.3 +/- 130 micrograms/d compared with those in children treated with CS. Furthermore, anteroposterior bone density in our study population was in agreement with published normative data and with that of normal age-related healthy nonasthmatic children living in the same area and with the same dietary intake of calcium. No normal values are available for lateral and calculated-volume bone density. In conclusion, treatment with BDP does not appear to have an adverse effect on bone mass in prepubertal children with mild moderate asthma. Longitudinal studies should be performed in order to evaluate the effect of early introduction of inhaled corticosteroids in children with mild asthma.

    Topics: Absorptiometry, Photon; Administration, Inhalation; Adult; Age Factors; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bone and Bones; Bone Density; Child; Child, Preschool; Cromolyn Sodium; Cross-Sectional Studies; Female; Humans; Male

1996
Inhaled beclomethasone dipropionate and growth in children with mild asthma.
    American journal of respiratory and critical care medicine, 1996, Volume: 153, Issue:5

    Topics: Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Height; Child; Female; Glucocorticoids; Growth; Humans; Male; Placebos

1996
Asthma treatment in schoolchildren: lung function in different therapeutic groups.
    Acta paediatrica (Oslo, Norway : 1992), 1996, Volume: 85, Issue:2

    Dynamic spirometry and peak expiratory flow were measured in 297 school-aged children with asthma during their control visit at the outpatient clinic in 1993. Sixty (20%) children had no maintenance drugs, 169 (57%) used cromoglycate (n = 97) or nedocromil (n = 72), and 68 (23%) budesonide. The treatment of each child had been selected on clinical grounds according to the principles of the international consensus statement from 1989. The mean values of peak expiratory flow (PEF), forced vital capacity (FVC) and forced expiratory volume in 1 s (FEV1) were over 95% of the height-related reference values in all treatment groups. The lower limits of the 95% confidence intervals were at the level of more than 90% of those predicted. The mean FEV1/FVC ratio (FEV%) was over 85%, and the mean maximal mid-expiratory flow (MMEF) over 75% of the reference values. Decreased PEF values ( < 75%) were present in 10%, decreased FVC, FEV1, or FEV% ( < 75%) values in 4.6%, and decreased MMEF ( < 65%) values in 18%. Only minor differences between the different therapeutic groups were observed. Our results show that the clinical selection of children between the three therapeutical groups was adequate. In our area up to 70% of children requiring maintenance therapy for asthma can be treated with cromones.

    Topics: Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Child; Cromolyn Sodium; Female; Humans; Male; Maximal Expiratory Flow Rate; Nedocromil; Peak Expiratory Flow Rate; Pregnenediones; Respiratory Function Tests; Retrospective Studies; Spirometry

1996
Effect of fluticasone on growth in children with asthma.
    Lancet (London, England), 1996, Jul-06, Volume: 348, Issue:9019

    Topics: Androstadienes; Anti-Asthmatic Agents; Asthma; Beclomethasone; Budesonide; Child; Child, Preschool; Fluticasone; Glucocorticoids; Growth; Humans; Pregnenediones

1996
Acute asthma during pregnancy.
    Thorax, 1996, Volume: 51, Issue:4

    Acute asthma during pregnancy is potentially dangerous to the fetus. The aim of this study was to investigate the effect of an acute attack of asthma during pregnancy on the course of pregnancy or delivery, or the health of the newborn infant, and to identify undertreatment as a possible cause of the exacerbations.. Five hundred and four pregnant asthmatic subjects were prospectively followed and treated. The data on 47 patients with an attack of asthma during pregnancy were compared with those of 457 asthmatics with no recorded acute exacerbation and with 237 healthy parturients.. Of 504 asthmatics, 177 patients were not initially treated with inhaled corticosteroids. Of these, 17% had an acute attack compared with only 4% of the 257 patients who had been on inhaled anti-inflammatory treatment from the start of pregnancy. There were no differences between the groups as to length of gestation, length of the third stage of labour, or amount of haemorrhage after delivery. No differences were observed between pregnancies with and without an exacerbation with regard to relative birth weight, incidence of malformations, hypoglycaemia, or need for phototherapy for jaundice during the neonatal period.. Patients with inadequate inhaled anti-inflammatory treatment during pregnancy run a higher risk of suffering an acute attack of asthma than those treated with an anti-inflammatory agent. However, if the acute attack of asthma is relatively mild and promptly treated, it does not have a serious effect on the pregnancy, delivery, or the health of the newborn infant.

    Topics: Acute Disease; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Birth Weight; Bronchodilator Agents; Budesonide; Female; Gestational Age; Humans; Infant, Newborn; Labor, Obstetric; Pregnancy; Pregnancy Complications; Pregnenediones

1996
Effect of inhaled beclomethasone on serum markers of collagen metabolism in postmenopausal asthmatic women.
    Respiratory medicine, 1996, Volume: 90, Issue:6

    The use of inhaled corticosteroids in bronchial asthma has widened, but there is a lack of data on their effect on bone collagen synthesis and degradation. This paper reports the effect of three dose levels (200, 1000 and 2000 micrograms day-1, 3 weeks each) of inhaled beclomethasone on specific characteristics of bone collagen metabolism in seven postmenopausal women with new asthma without any previous corticosteroid therapy. Serum aminoterminal (PINP) propeptide of human type I procollagen was seen, after an initial increase, to decrease significantly (from 42.2 to 35.5 micrograms l-1, P = 0.001) with the higher doses of inhaled beclomethasone, but no statistical change was found in the carboxyterminal propeptide (PICP) or type I collagen crosslinked telopeptide (ICTP). This data shows that type I collagen synthesis may be disturbed when using high-dose inhaled corticosteroids. However, further studies are needed to assess the effects of inhaled beclomethasone on the ability of the osteoblasts to form bone matrix, and on the density of bone during a longer treatment period with inhaled corticosteroids.

    Topics: Administration, Inhalation; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biomarkers; Bone and Bones; Collagen; Collagen Type I; Drug Administration Schedule; Female; Humans; Middle Aged; Peptide Fragments; Peptides; Postmenopause; Procollagen

1996
Paradoxical bronchospasm and cutaneous rash after metered-dose inhaled bronchodilators.
    Monaldi archives for chest disease = Archivio Monaldi per le malattie del torace, 1996, Volume: 51, Issue:3

    The authors describe a case of paradoxical bronchospasm with laryngospasm and cutaneous rash occurring in an asthmatic woman after the use, via metered-dose inhaler, of different bronchodilators containing soy-derived excipients. It is noteworthy that the patient was not affected by soy allergy. After a short review of the relevant literature, the authors consider the possible aetiopathogenetic factors and outline the importance of this rare adverse reaction in the care of asthmatic patients.

    Topics: Aerosols; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Spasm; Bronchodilator Agents; Drug Eruptions; Excipients; Female; Fenoterol; Glycine max; Humans; Ipratropium; Laryngismus; Middle Aged; Nebulizers and Vaporizers

1996
Skin bruising in asthmatic subjects treated with high doses of inhaled steroids: frequency and association with adrenal function.
    The European respiratory journal, 1996, Volume: 9, Issue:2

    High doses of inhaled corticosteroids (ICS) (budesonide and beclo-methasone > or = 800 micrograms.day-1) are commonly used in the treatment of asthma. Some investigators have presented evidence for cutaneous effects (bruising), which suggests systemic absorption. This study aimed to assess the prevalence of skin bruising, relate the occurrence of skin bruising to adrenocortical function, and determine the risk factors for skin bruising. One hundred adult asthmatic subjects taking high doses (800-2,000 micrograms.day-1) of ICS for 3 months or more were recruited in an asthma clinic, and 100 control subjects paired for sex and age were recruited from an ophthalmology out-patient clinic. A detailed questionnaire on asthma, general habits and cutaneous lesions was administered. A cutaneous examination was performed. Urine cortisol levels were assessed on two consecutive days. Blood cortisol level and the response to Cortrosyn injection (60 min test) were evaluated. One hundred adult asthmatics (66 females and 34 males), 73 on beclomethasone and 27 on budesonide, were included. The prevalence of skin bruising was 71% based on the questionnaire (32% in controls) and 48% (39 out of 81 subjects) based on direct examination of the skin. We found a satisfactory association between the response to questionnaire and examination of the skin. Adrenocortical function testing showed that a minority of subjects (14 with at least one abnormal test) had lower urinary or blood cortisol levels. These low cortisol levels occurred in subjects who reported skin bruising. By multiple logistic regression, being a female (odds ratio (OR) = 20; 95% confidence interval (95% CI) = 13-33) and taking ICS for asthma (OR = 12; 95% CI = 8-18) were significantly (t = 5.4) related to the likelihood of developing skin bruising. In addition, among the asthmatic subjects, being older (OR = 1.6; 95% CI = 1.1-2.4/10 yrs interval) (t = 2.3) and being a female (OR = 22; 95% CI = 7-75) (t = 5.0) influenced the occurrence of skin bruising as documented by questionnaire. In asthmatic subjects, taking high doses of ICS is associated with: 1) increased occurrence of skin bruising by comparison with controls, particularly in older subjects; and 2) a generally normal adrenocortical function, although this function is significantly lower in subjects reporting skin bruising.

    Topics: Administration, Inhalation; Adrenal Cortex Function Tests; Adrenal Glands; Adult; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Female; Humans; Hydrocortisone; Male; Middle Aged; Pregnenediones; Prevalence; Prospective Studies; Regression Analysis; Risk Factors; Skin Diseases, Vascular; Surveys and Questionnaires

1996
[Symptoms, FEV1/FVC, and peak flow as indices of the control of asthma].
    Nihon Kyobu Shikkan Gakkai zasshi, 1996, Volume: 34, Issue:3

    In a cross-sectional study, we evaluated success in the control of asthma as defined by criteria for symptoms, for FEV1/FVC, and for peak flow rates. One hundred and three patients with chronic asthma who had been treated with inhaled steroids were studied. Chest tightness, dyspnea, wheezing, sputum production, and coughing were each scored from 1 (worst) to 5 (best). Symptoms were said to have been controlled if the symptoms scores for the preceding 4 weeks were greater than or equal to 20; FEV1/FVC was said to be under control if it was greater than or equal to 70% when measured in the clinic; peak flow was said to have been controlled if the lowest peak flow in the preceding 4 weeks was greater than or equal to 80% of the highest measured value. Symptoms were controlled in 72% of the patients, FEV/FVC was under control in 83%, and peak flow was controlled in 66%. The patients were grouped by severity of disease into four classes, and these percentages did not differ significantly among the classes. In 22 out of 74 (30%) patients in whom symptoms were controlled, peak flow was not controlled. Furthermore, in 18 out of 64 (28%) patients in whom symptoms and FEV/FVC were controlled, peak flow was not controlled. We concluded that in treating asthma, not should symptoms be controlled, but peak flow should also be measured each day to avoid undertreatment.

    Topics: Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Chronic Disease; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Monitoring, Physiologic; Peak Expiratory Flow Rate; Vital Capacity

1996
Effects of immunotherapy on symptoms, PEFR, spirometry, and airway responsiveness in patients with allergic asthma to house-dust mites (D. pteronyssinus) on inhaled steroid therapy.
    Allergy, 1996, Volume: 51, Issue:4

    The present study was designed to investigate the effects of immunotherapy (IT) with an extract of Dermatophagoides pteronyssinus (Alergo-Merck Depot) during a 27-month period in patients with allergic asthma to house-dust mites. We included 11 patients (mean age 18 years) treated with a combination of IT and inhaled beclomethasone dipropionate (BDP) in comparison to another 11 (mean age 22 years) treated with BDP alone. We evaluated symptom scores, salbutamol use, peak expiratory flow rates (PEFR), spirometry, and bronchial hyperresponsiveness (BHR) during 18 months of therapy with BDP and in the 9 months after BDP interruption. The two kinds of treatment were efficient and comparable in relation to symptom score, salbutamol use, morning PEFR, FVC, and FEV1, but patients treated with IT and BDP had a faster improvement of BHR and PEFR variability. The interruption of BDP after 18 months of therapy was linked to an impairment of all end points, which were more pronounced in patients previously treated only with BDP. These findings suggest that in selected asthmatic patients allergic to house-dust mites, the association of IT and BDP is more effective than therapy with this inhaled steroid alone due to a faster and more striking improvement during the first months of treatment and to a lower rate of relapse after the interruption of therapy with BDP.

    Topics: Administration, Inhalation; Adolescent; Adult; Albuterol; Allergens; Animals; Antigens, Dermatophagoides; Asthma; Beclomethasone; Bronchial Hyperreactivity; Child; Female; Glycoproteins; Humans; Immunotherapy, Active; Male; Mites; Peak Expiratory Flow Rate; Spirometry

1996
Influence of high dose inhaled steroids on hypothalamo-pituitary-adrenal axis function in Japanese patients with asthma: a comparison over the course of time.
    Internal medicine (Tokyo, Japan), 1996, Volume: 35, Issue:5

    Although the influence of high dose inhaled steroids on hypothalamo-pituitary-adrenal (HPA) function in patients with asthma has been extensively studied worldwide, there has been limited information on Japanese asthmatics, especially in terms of a prospective analysis of HPA function in the course of time. We analyzed the changes in HPA function using 2 serial short tetracosactrin tests (STT) separated by an interval of one year in 11 Japanese asthmatics who were treated with high dose inhaled steroids alone [beclomethasone dipropionate (BDP); mean dose 982 micrograms/day] during the period between 2 STTs. Mean values of plasma cortisol before administration of ACTH, maximum cortisol and the rise in cortisol in response to ACTH in the 2 STTs were 7.8, 20.5 and 12.7 micrograms/dl for the 1st test, and 8.9, 23.6 and 14.7 micrograms/dl for the 2nd test, respectively. Overall, there was no significant change in the course of time in each of these 3 values. Although the results of the 1st STT proved to be abnormal in 3 patients who had been receiving systemic steroids before their 1st STT, they improved uniformly in their 2nd STT. In the remaining 8 patients, who had never received systemic steroids, 4 patients showed improvements while the other 4 showed deterioration in HPA function in their serial STTs over the course of time. The dose of BDP was 800 micrograms/day in the former 4 patients, while it was 1,200 micrograms/day in the latter 4. Furthermore, only one patient, in whom BDP had been increased from 800 micrograms/day to 1,200 micrograms/day between the 2 tests, developed an abnormal response in the 2nd STT. On the other hand, one patient whose BDP dose was increased from 800 micrograms/day to 1,600 micrograms/day showed an improvement in HPA function in the 2nd test. These results indicate that the threshold dose of BDP which may cause HPA suppression in Japanese asthmatics lies between 800-1,200 micrograms/day, although there is a large inter-individual variation in terms of such doses.

    Topics: Administration, Inhalation; Adrenal Cortex; Adult; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Cosyntropin; Female; Follow-Up Studies; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Pituitary-Adrenal System; Safety

1996
Health beliefs of adults with asthma: toward an understanding of the difference between symptomatic and preventive use of inhaler treatment.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1996, Volume: 33, Issue:5

    The aim of this study was to examine the potential differences between beliefs relating to symptomatic and preventive inhaler treatment and to analyze the relationship between these beliefs and the use of inhalers by adult patients with asthma in general practice. Unstructured interviews with a stratified sample of 8 patients, taking a combination of salbutamol and beclomethasone inhalers, were used to develop themes for a structured interview, where questions relating to 8 main areas of interest were measured on a 5-point Likert scale. Forty patients prescribed the same combination of inhalers were randomly selected for the structured interview. All agreed to participate (100% response). Correlations between the responses to the 8 themes and measures of inhaler use were analyzed. High use of salbutamol for the relief of symptoms and low use of beclomethasone for the prevention of asthma were common. Perceived benefits of the inhalers, a positive attitude to using the inhalers, and concern about side effects had strong influences on the use of both inhalers. Uncertainty about the inhalers, a negative attitude to using the inhalers, and the involvement of others in asthma management had less influence on inhaler use. Satisfaction with the doctor and the ease of obtaining an inhaler were more important issues for beclomethasone use than for salbutamol use. There are important differences in the beliefs that patients hold in relation to symptomatic and preventive use of inhaler treatment. These findings suggest that focusing on very specific attitudes to treatment may be of benefit in the health education of adults with asthma. Further work is planned to refine the themes so that doctors will be able to explore patients' views about their inhaler treatment by asking a few direct questions.

    Topics: Albuterol; Anti-Asthmatic Agents; Asthma; Attitude to Health; Beclomethasone; Bronchodilator Agents; Female; Health Knowledge, Attitudes, Practice; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Patient Compliance; Physician-Patient Relations; Sampling Studies

1996
Ex vivo pharmacologic modulation of basophil histamine release in asthmatic patients.
    Allergy, 1996, Volume: 51, Issue:6

    Histamine is one of a range of mediators which play an important role in asthma, and the "releasability" of basophils has been shown to be upregulated in this disease. In vitro, beta 2-agonists and to a lesser extent corticosteroids have been shown to reduce histamine release. The ex vivo effects of salmeterol and inhaled corticosteroids on histamine release were studied in 78 asthmatic patients with variable disease severity and 20 control subjects. Spontaneous and anti-IgE-induced histamine release was measured in all subjects. Fifteen patients were not receiving any form of treatment, 42 were treated with inhaled corticosteroids, and 21 received inhaled corticosteroids and salmeterol. Seven patients treated with inhaled corticosteroids and seven patients treated with inhaled corticosteroids and salmeterol were tested twice to assess the effect of salmeterol on histamine release. Nine patients treated with inhaled corticosteroids were tested before and after 1 month of salmeterol treatment to determine the possible inhibition by salmeterol. Patients who were treated with inhaled corticosteroids and salmeterol showed significantly lower levels of spontaneous histamine release (median: 2.5%) than untreated (5.2%) and inhaled corticosteroids-treated asthmatics (3.4%). No tachyphylaxis to salmeterol was observed when patients were tested twice at a 3-month interval. This study suggests that salmeterol may have an additive anti-inflammatory effect with inhaled corticosteroids, although this hypothesis must be tested by further studies involving cells obtained by bronchoalveolar lavage and studies with bronchial biopsies.

    Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Anti-Inflammatory Agents; Asthma; Basophils; Beclomethasone; Bronchodilator Agents; Budesonide; Female; Histamine Release; Humans; In Vitro Techniques; Male; Middle Aged; Pregnenediones; Salmeterol Xinafoate

1996
Glucocorticoid resistant asthma: T-lymphocyte steroid metabolism and sensitivity to glucocorticoids and immunosuppressive agents.
    The European respiratory journal, 1996, Volume: 9, Issue:10

    We have previously shown that T-lymphocytes from clinically glucocorticoid (GC) resistant asthmatics are more refractory to dexamethasone suppression in vitro than those of GC sensitive asthmatics. We wished to extend these observations to compare three GCs used topically for asthma therapy (budesonide, beclomethasone dipropionate and fluticasone 17 alpha-propionate) and three immunosuppressive drugs (cyclosporin A, FK506 (tacrolimus) and mycophenolate mofetil) with dexamethasone for their antiproliferative effects on T-lymphocytes from GC sensitive and resistant asthmatics, and also to compare the rates of steroid metabolism by T-lymphocytes from these patients. Antiproliferative activity of the drugs was measured on peripheral blood T-lymphocytes activated with phytohaemagglutinin (PHA) and anti-CD3 antibody in vitro. The rates of total steroid metabolism and 20 alpha-hydroxylation by T-cell homogenates were measured using radiolabelled progesterone as an established probe substrate. Over a wide concentration range, T-lymphocytes from GC resistant asthmatics were significantly less inhibited by all four GCs as compared with cells from GC sensitive asthmatics. The median inhibitory concentrations (IC50) for inhibition of T-lymphocytes from the GC resistant asthmatics exceeded those likely to be achieved therapeutically by systemic administration (although higher concentrations might in theory be achieved locally in the bronchial mucosa by inhaled administration). In contrast, all three immunosuppressive drugs at putative therapeutic concentrations inhibited T-lymphocytes both from GC sensitive and resistant asthmatics with equivalent potency. The rates of total metabolism and 20 alpha-hydroxylation of steroid by homogenates of T-lymphocytes from GC sensitive and resistant asthmatics were equivalent. Thus, relative GC resistance in T-lymphocytes from GC resistant as compared with sensitive asthmatics is: 1) manifest with GC molecules of variable molecular structure; 2) not accompanied by elevated intracellular metabolism of steroids; and 3) overcome by immunosuppressive drugs which inhibit T-lymphocytes by non-GC-mediated mechanisms. We conclude that current anti-asthma glucocorticoids at therapeutic concentrations are unlikely to be of benefit for the therapy of glucocorticoid resistant asthma, and that other immunosuppressive drugs may have potential as therapeutic agents in these patients.

    Topics: Administration, Topical; Adult; Aged; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; CD3 Complex; Cell Division; Cyclosporine; Dexamethasone; Drug Resistance; Female; Fluticasone; Glucocorticoids; Humans; Hydroxylation; Immunosuppressive Agents; Lymphocyte Activation; Male; Middle Aged; Molecular Structure; Mycophenolic Acid; Phytohemagglutinins; Pregnenediones; T-Lymphocytes; Tacrolimus

1996
[Effects of reducing or stopping inhaled beclomethasone dipropionate on airway hyperresponsiveness in stable chronic asthma].
    Nihon rinsho. Japanese journal of clinical medicine, 1996, Volume: 54, Issue:11

    Effects of reducing or stopping inhaled beclomethasone dipropionate (BDP) on airway hyperresponsiveness (AHR) were evaluated in stable chronic asthma. In 16 patients, after the best control (no symptoms, peak expiratory flow rate [PEF] > 80% best) was achieved for at least 3 months, the dose of BDP was reduced to 2/3 to 1/2. No differences were observed in the mean FEV1, PEF and AHR between before and 3 months after the reduction of BDP. In 7 patients, after the almost normal level of AHR was achieved, the dose of BDP was gradually reduced and then discontinued. Three out of the 7 patients had maintained the adequate level of AHR over 14 months, but in the other 4 patients AHR deteriorated below normal level and re-administration of BDP was needed due to worsening of symptoms and PEF. In conclusion, a gradual reduction of the dose of BDP is possible, if the best control is achieved for at least 3 months. The possibility of discontinuation of BDP may exist in some patients after achieving adequate AHR.

    Topics: Administration, Inhalation; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Chronic Disease; Female; Humans; Male; Middle Aged; Peak Expiratory Flow Rate

1996
Effect of long-term administration of theophylline on serum immunoglobulin E level in asthmatic children--preliminary study.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 1996, Volume: 26 Suppl 2

    Topics: Adolescent; Asthma; Beclomethasone; Child; Child, Preschool; Cromolyn Sodium; Dose-Response Relationship, Drug; Dust; Humans; Immunoglobulin E; Radioallergosorbent Test; Theophylline

1996
Effects of glucocorticoids on lymphocyte activation in patients with steroid-sensitive and steroid-resistant asthma.
    The Journal of allergy and clinical immunology, 1996, Volume: 98, Issue:6 Pt 1

    Glucocorticoids are important medications used to control the airway inflammation associated with asthma. Synthetic glucocorticoids vary in their binding affinity for the glucocorticoid receptor (GCR).. We compared hydrocortisone, beclomethasone dipropionate, triamcinolone acetonide, flunisolide, and budesonide with regard to their capacity to inhibit phytohemagglutinin-induced peripheral blood mononuclear cell proliferation from six patients with steroid-sensitive asthma and seven patients with steroid-resistant asthma. Peripheral blood mononuclear cell GCR binding affinities for dexamethasone and budesonide were also determined for both patient groups by using a radioligand binding assay and Scatchard analysis.. Dose-dependent inhibition was demonstrated for all glucocorticoids in both patient groups, with the steroid-resistant group requiring approximately 2 log-fold more glucocorticoids for an equivalent degree of inhibition. The mean concentrations necessary to cause 50% inhibition of lymphocyte proliferation (IC50s) for the steroid-sensitive group ranged from 2 x 10(-10) mol/L for budesonide to 7 x 10(-8) mol/L for hydrocortisone, whereas the mean IC50s for the steroid-resistant group ranged from approximately 2 x 10(-8) mol/L for budesonide to greater than 10(-6) mol/L for hydrocortisone. In addition, a significant correlation was noted between the degree of inhibition of lymphocyte proliferation (IC50) and the binding affinity of dexamethasone to the GCR. Patients with steroid-resistant asthma have been shown to have a reduced GCR binding affinity. The GCR binding affinity for budesonide was significantly higher in both groups (i.e., lower dissociation constant) than that obtained for dexamethasone.. These data suggest that glucocorticoids such as budesonide, by virtue of their high GCR binding affinities and greater ability to suppress lymphocyte proliferation, may therefore be beneficial in the management of difficult-to-control asthma.

    Topics: Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Drug Resistance; Forced Expiratory Volume; Glucocorticoids; Humans; Hydrocortisone; Lymphocyte Activation; Pregnenediones; Receptors, Glucocorticoid; T-Lymphocytes; Triamcinolone Acetonide

1996
[Effect of long-term treatment with an inhaled corticosteroid on bronchial hyper-responsiveness and clinical asthma in asthmatic subjects].
    Arerugi = [Allergy], 1996, Volume: 45, Issue:12

    We studied retrospectively the effect of long-term treatment with an inhaled corticosteroid on bronchial hyperresponsiveness (BHR) and clinical asthma in moderate-severe asthmatic subjects. Fifty-eight patients who had used beclomethasone dipropionate (BDP) over one year, were enrolled in this study. BHR was measured before and after treatment with BDP by the methods recommended by Japanese Society of Allergology. Moreover we examined the clinical factors and the frequency of acute exacerbations. The results as follows: 1) The mean age was 48.8 years and the mean asthma history was 9.2 years. The mean dose and mean time of BDP administration was 801 micrograms/day and 28.1 months, respectively. 2) Patients during BDP treatment over one year showed about 6-fold mean improvements in BHR, but there were many patients who showed no improvements in BHR. 3) We retrospectively divided all the patients into two groups. Namely, the improved group (n = 25) showed more than 4 fold improvement in BHR and unchanged group (n = 33), less than 4-fold. But there were no significant differences in clinical characteristics and %FEV1 during treatment with BDP. 4) The unchanged group had more near fatal episodes in the past than the improved group. 5) There was significant decrease in acute exacerbation during treatment with BDP, but the unchanged group had more acute exacerbations than the improved group during treatment with BDP. These results indicates that there are many patients who had no improvement on BHR with long term BDP treatment and they have more acute exacerbations due to various stimuli. In conclusion, asthma is recognized chronic inflammatory disease and inhaled corticosteroid therapy has been recommended as the first line therapy. We must further study the clinical problems and underlying mechanisms concerning about treatment with an inhaled corticosteroid.

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Female; Glucocorticoids; Humans; Long-Term Care; Male; Middle Aged; Retrospective Studies

1996
[Anti-inflammatory drugs for the treatment of bronchial hyperresponsiveness].
    Nihon Kyobu Shikkan Gakkai zasshi, 1996, Volume: 34 Suppl

    To evaluate the effects of anti-inflammatory drugs on bronchial hyperresponse in patients with mild asthma, We examined inhaled beta 2-agonists, beclomethasone dipropionate (BDP) and suplatast tosilate. The results were as follows: 1. Inhaled beta 2-agonists, which have no direct anti-inflammatory effect, significantly improved bronchial hyperresponsiveness with inhalation of less than 6 puffs/day except tenoterol, but not with more than 6 puffs/day for two years. Patients with asthma therefore should use no more than 6 puffs/day of inhaled beta 2-agonists. Combined use of BDP and inhaled beta 2-agonists further improved bronchial hyperresponsiveness. This can be achieved by concurrent use of BDP, which has a potent anti-inflammatory effect. 2. Low dose BDP (200 micrograms/day), which is recommend in the Japanese guidelines for asthma treatment increased peak expiratory flow and improved bronchial hyperresponsivenss significantly during 8 weeks of treatment, but by 4 weeks after the end of BDP treatment, peak expiratory flow and bronchial hyperresponsiveness had worsened. Because we don't know the detail past history of patients with mild asthma, the patients must be treated with a relatively high dose of BDP (800 micrograms/day), which did improved bronchial hyperresponsiveness and significantly reduced the numbers of eosinophils and EG2 positive cells in the bronchial mucosa of patients with mild asthma. 3. Suplatast tosilate, which exerts its anti-inflammatory effect by suppressing IL-4 and IL-5 was given to patients with mild asthma for 6 weeks. Suplatast tosilate significantly increased peak expiratory flow and significantly improved bronchial hyperresponsiveness. It also signiticantly reduced the number of eosinophils and EG2 positive cells in the bronchial mucosa of eight patients with mild asthma. Therefore this drug may be useful for the treatment of patients with mild asthma.

    Topics: Administration, Inhalation; Administration, Oral; Adult; Aged; Anti-Allergic Agents; Anti-Inflammatory Agents; Arylsulfonates; Asthma; Beclomethasone; Bronchial Hyperreactivity; Female; Humans; Male; Middle Aged; Sulfonium Compounds

1996
Preventive therapy for asthma in children; a 9-year experience in eastern Finland.
    The European respiratory journal, 1995, Volume: 8, Issue:8

    The long-term treatment modalities of bronchial asthma were studied in children from a defined Finnish population from 1985 to 1993, with special reference to changes during the study period. The data on maintenance drugs in children with asthma from five years (1985, 1987, 1989, 1991 and 1993) were retrospectively retrieved from the computerized registers. The reliability of the data for the diagnosis and basic treatment of asthma was checked by one of the authors, who compared the data with the patient cards from the hospital. The number of children with doctor-diagnosed asthma increased continuously during the surveillance period. The proportion of children receiving preventive medication increased concomitantly; this increase was most pronounced between 1987 and 1989. The most common preventive drug was sodium cromoglycate; its use increased from 14% in 1985 to 58% in 1993. The use of inhaled steroids remained stable at 17-19% in all surveillance years. Our treatment policy is in accordance with the international consensus statement published in 1989; however, the change towards preventive medication occurred before its publication.

    Topics: Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Cromolyn Sodium; Finland; Humans; Pregnenediones; Theophylline

1995
Dose-related decrease in bone density among asthmatic patients treated with inhaled corticosteroids.
    The Journal of allergy and clinical immunology, 1995, Volume: 96, Issue:5 Pt 1

    Inhaled corticosteroids are being prescribed more commonly and in higher doses than previously in the management of asthma. Although these topically active compounds have less potential for systemic impact than oral steroids, biochemical markers suggest that they are not devoid of systemic side effects. We conducted this study to investigate the effect of commonly prescribed doses of inhaled steroids on bone density.. We studied 36 patients with asthma. Those in group A (n = 18) had been taking inhaled beclomethasone dipropionate or budesonide in a dosage of 800 micrograms or more per day for at least 1 year. Those in group B (n = 18) had used only bronchodilator therapy. Adrenal function was assessed by morning serum cortisol level and by short adrenocorticotropic hormone stimulation test. Bone turnover was assessed by measurement of serum osteocalcin, alkaline phosphatase, and urinary pyridinium cross-links. Bone mineral density was measured by dual-energy x-ray absorptiometry with a Hologic QDR-1000 densitometer (Hologic Inc., Waltham, Mass.).. Group A, mean age (SD) = 36.6 (8.4) years, had used inhaled corticosteroids at a mean dose of 1323 micrograms/day (range, 800 to 2000 micrograms/day) for a median duration of 24 months. Group B, mean age (SD) = 33.4 (8.1) years, had not been taking any form of steroid. Four patients from group A had suppressed morning serum cortisol; three of these had abnormal adrenocorticotropic hormone stimulation test results. All patients in group B had normal baseline adrenal function and an appropriate response to adrenocorticotropic hormone. Mean serum osteocalcin level in group A was significantly lower than that in group B (8.8 vs 14.2 ng/ml, p = 0.0003). Bone density measurements showed parallel changes: in group A the mean Z score (SD) of the femoral neck was -0.78 (1.02), significantly below predicted normal values (p = 0.0025). Mean Z scores of the lumbar spine and of femoral Ward's triangle were not significantly reduced. In group B the mean Z scores of the lumbar spine, femoral neck, and femoral Ward's triangle were all within normal limits. In group A the dose duration of inhaled corticosteroid therapy corrected for body mass index correlated negatively with bone density and adrenal function measurements.. We conclude that the regular use of conventional doses of inhaled corticosteroids by patients with asthma can suppress adrenal function and decrease bone density in a dose-related fashion.

    Topics: Administration, Inhalation; Adolescent; Adrenal Glands; Adrenocorticotropic Hormone; Adult; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bone and Bones; Bone Density; Budesonide; Cross-Sectional Studies; Dose-Response Relationship, Drug; Female; Humans; Hydrocortisone; Male; Middle Aged; Osteocalcin; Pregnenediones

1995
IL-5 production by CD4+ T cells of asthmatic patients is suppressed by glucocorticoids and the immunosuppressants FK506 and cyclosporin A.
    International immunology, 1995, Volume: 7, Issue:3

    IL-5 was produced in vitro by peripheral blood mononuclear cells (PBMC) of mite-sensitive atopic patients upon challenge with specific allergen, while PBMC of healthy controls produced essentially no IL-5. Stimuli delivered by the combination of phorbol ester and Ca2+ ionophore induced marked IL-5 production by PBMC obtained from atopic and non-atopic asthmatics, suggesting that both protein kinase C and Ca2+ influx are required for IL-5 production. CD2- or CD4-bearing cell depletion almost completely removed IL-5-producing cells while CD8-bearing cell depletion rather enriched them. These findings indicate that CD4+ T cells are the principal source of IL-5 in PBMC. The capacity of PBMC of atopic asthmatics, non-atopic asthmatics and healthy controls to produce IL-2, IL-4, IL-5 and IFN-gamma was compared, to find that cytokine-producing capacities other than that of IL-5 (IL-2, IL-4 and IFN-gamma) were not significantly different among the three groups. Dexamethasone, FK506 and cyclosporin A suppressed IL-5 production in vitro in a dose-dependent manner. Clear dose-dependent suppression of IL-5 gene expression by FK506 was also observed. Treatment of asthmatic patients with inhaled glucocorticoid (beclomethasone dipropionate) ameliorated clinical symptoms, improved lung function and markedly suppressed IL-5 production by PBMC, suggesting the essential role of IL-5 in the pathogenesis of bronchial asthma and the clinical importance of its regulation.

    Topics: Adult; Animals; Antigens, Dermatophagoides; Asthma; Base Sequence; Beclomethasone; Calcium; CD4-Positive T-Lymphocytes; Cells, Cultured; Cyclosporine; Dexamethasone; Dose-Response Relationship, Drug; Glucocorticoids; Glycoproteins; Humans; Hypersensitivity, Immediate; Interferon-gamma; Interleukin-2; Interleukin-4; Interleukin-5; Ionomycin; Lymphocyte Activation; Mites; Molecular Sequence Data; Protein Kinase C; Signal Transduction; Tacrolimus; Tetradecanoylphorbol Acetate

1995
The change in the distribution of Tc-99m human serum albumin radioaerosols in asthma after a 1-week course of corticosteroid inhalation treatment.
    Clinical nuclear medicine, 1995, Volume: 20, Issue:7

    This study evaluated the effects of corticosteroid inhalation on the deposition pattern of Tc-99m HSA radioaerosols in 24 patients with asthma. The homogeneous degree of depositing radioaerosol was quantitatively evaluated using a modified standard score system over both lungs. The baseline scores were calculated before inhalation therapy of 0.05 mg beclomethasone dipropionate four times daily for 1 week. The studies were then repeated after treatment to evaluate the effects of inhalation therapy. After treatment, the scores decreased in 16 of 24 cases (67%), which means that the degree of the bronchial obstruction decreased. The statistical results revealed significant differences in the total homogeneity score (P < 0.001) before and after therapy. Thus, a 1-week course of beclomethasone dipropionate inhalation therapy improves the bronchial obstruction in asthma patients as shown by the quantitative homogeneity score system of the Tc-99m HSA radioaerosol inhalation lung scintigraphy.

    Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Aged; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Humans; Lung; Male; Middle Aged; Radionuclide Imaging; Technetium Tc 99m Aggregated Albumin

1995
Inhaled beclomethasone and bone metabolism in young asthmatic children: a six month study.
    The Journal of allergy and clinical immunology, 1995, Volume: 96, Issue:4

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Bone and Bones; Child, Preschool; Female; Humans; Infant; Male; Osteocalcin

1995
Effects of corticosteroid inhalation therapy on the deposition pattern of Tc-99m human serum albumin radioaerosols in asthma.
    Lung, 1995, Volume: 173, Issue:5

    This study evaluated the effects of steroid inhalation on the deposition pattern of Tc-99m human serum albumin (Tc-99m HSA) radioaerosols in 25 asthma patients. A total of 12 normal controls also underwent the same examination. The pattern of radioaerosol deposition was quantitatively evaluated as the percentage of total deposition (PTD) in the central, intermediate, and peripheral regions of the right lung. The baseline PTD was calculated before and after the administration of a 1-week course of inhalation therapy of 0.05 mg beclomethasone dipropionate four times daily. There were significant differences in PTD between normal controls and asthma patients. Significant differences were also found before and after corticosteroid inhalation therapy in asthma patients. In conclusion, a week-long course of beclomethasone dipropionate inhalation therapy does influence the deposition patterns of aerosols in asthma patients, based on the findings of Tc-99m HSA radioaerosol inhalation lung scintigraphy.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Airway Resistance; Anti-Asthmatic Agents; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Radionuclide Imaging; Technetium Tc 99m Aggregated Albumin

1995
[Effects of inhaled beclomethasone on height growth and bone metabolism in children with asthma].
    Arerugi = [Allergy], 1995, Volume: 44, Issue:7

    To evaluate the influences of inhaled beclomethasone dipropionate (BDP), 7.3-30.9 (15.5 +/- 6.5) micrograms/kg/day, on bone metabolism and height growth, we performed a longitudinal study for 6 months in 34 children with asthma aged between 3 and 15 years. Bone mineral density estimated by digital image processing method (DIP) and serum level of osteocalcin did not show any significant change, but height growth was slightly suppressed in the patients who inhaled more than 15 micrograms/kg/day of BDP. We concluded that the decision to prescribe inhaled BDP should be made on the balance of the clinical effects and the improvement of quality of life against the possibility of side effects.

    Topics: Administration, Inhalation; Adolescent; Anti-Asthmatic Agents; Asthma; Beclomethasone; Body Height; Bone and Bones; Bone Density; Child; Child, Preschool; Female; Growth; Humans; Longitudinal Studies; Male

1995
Recent trends in the use of inhaled beta 2-adrenergic agonists and inhaled corticosteroids in Saskatchewan.
    CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 1995, Nov-15, Volume: 153, Issue:10

    To examine recent trends in the use of inhaled beta 2-adrenergic agonists and inhaled corticosteroids for the treatment of asthma among Saskatchewan residents and to determine whether these trends are in keeping with widely publicized guidelines recommending a reduction in the use of agents to treat symptoms (i.e., inhaled beta 2-adrenergic agonists) and increased use of prophylactic agents (i.e., inhaled corticosteroids).. Descriptive pharmacoepidemiologic study conducted with the use of data from the computerized database of the Saskatchewan Prescription Drug Plan.. Saskatchewan.. Saskatchewan residents 5 to 54 years of age who received one or more outpatient prescriptions for drugs to treat asthma (inhaled drugs, ingested beta 2-adrenergic agonists and ingested methylxanthines) from 1989 to 1993.. Epidemiologic trends, calculated for each year: number of prescriptions per 1,000 persons; number of patients who received prescriptions for inhaled corticosteroids, inhaled beta 2-adrenergic agonists and any type of drug to treat asthma; mean number of such prescriptions per patient; and weighted mean amount of salbutamol, fenoterol and beclomethasone dispensed per patient.. There has been an increase in the proportion of the population receiving prescriptions for drugs to treat asthma. The number of patients receiving these drugs per 1,000 people rose during the study period from 33.38 to 46.59 for any drug to treat asthma, from 24.70 to 33.77 for inhaled beta 2-adrenergic agonists and from 6.1 to 19.9 for inhaled corticosteroids. The mean number of prescriptions per patient decreased steadily for all drugs to treat asthma (from 5.34 in 1989 to 3.88 in 1993), for inhaled beta 2-adrenergic agonists (from 4.35 to 3.09) and for inhaled corticosteroids (from 2.98 to 2.25). The weighted mean amount of inhaled salbutamol dispensed per patient per year decreased by 40%, from 178.08 mg in 1989 to 109.14 mg in 1993. The weighted amount of fenoterol dispensed per patient per year declined even more, by 58%, from 387.91 mg in 1989 to 164.00 mg in 1993. Conversely, the weighted amount of inhaled beclomethasone dispensed per patient per year increased by 35% from 46.95 mg in 1989 to 63.50 mg in 1992, then dropped to 56.17 mg per year in 1993.. These data demonstrate a substantial change in Saskatchewan in the prescribing of drugs to treat asthma; they suggest that many physicians responded to current guidelines advocating increased attention to prevention of airway inflammation in the treatment of asthma.

    Topics: Administration, Inhalation; Administration, Topical; Adolescent; Adrenergic beta-Agonists; Adult; Aerosols; Albuterol; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Drug Prescriptions; Drug Utilization Review; Fenoterol; Fluocinolone Acetonide; Glucocorticoids; Humans; Isoproterenol; Metaproterenol; Middle Aged; Pregnenediones; Procaterol; Saskatchewan; Triamcinolone

1995
Inflammatory bronchial polyps associated with asthma: resolution with inhaled corticosteroid.
    The European respiratory journal, 1995, Volume: 8, Issue:7

    In a 50 year old man who complained of cough and sputum, a small endobronchial tumour was found in the left main bronchus and was biopsied via bronchoscopy. The histological diagnosis was inflammatory polyp with marked infiltration of eosinophils. Six years later, the patient developed asthma. At the same time, another polyp was found in the posterior basal bronchus of the right lower lobe. The appearance of the first polyp was unchanged endoscopically and histologically. Inhalation of beclomethasone dipropionate, 200 micrograms b.i.d., was started and symptoms of asthma soon subsided. In addition, the two polyps regressed and eventually disappeared after one year of treatment. Inhaled corticosteroids, being noninvasive and relatively safe, appear to be a possible therapeutic option in inflammatory bronchial polyps, especially in cases where the patient has asthma as an underlying condition, or the polyps are small and their management is not urgent.

    Topics: Administration, Inhalation; Administration, Topical; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchi; Bronchial Neoplasms; Glucocorticoids; Humans; Male; Middle Aged; Polyps; Time Factors

1995
[Circadian rhythms in peak expiratory flow rate of asthmatic patients before and after treatment with beclomethasone dipropionate].
    Nihon Kyobu Shikkan Gakkai zasshi, 1995, Volume: 33, Issue:5

    Asthmatic patients have a circadian rhythm in peak expiratory flow rate (PEFR). The present study was done to measure the effect of inhaled beclomethasone dipropionate (BDP) on the circadian rhythm of PEFR in asthmatic patients. After two weeks of observation, BDP (400 micrograms) was given by metered dose inhaler to nine asthmatic patients. The dose of inhaled BDP (800-1200 micrograms) was increased every two weeks until PEFR varied by no more than 20% each day. PEFR was measured four times daily: on waking, around noon, in the evening, and at bedtime. Nine asthmatic patients had a significant (p < 0.05) rhythm detectable by single cosinor analysis, both during the observation period and during treatment. Analysis by the group mean-cosinor method showed that the mean mesor was 397.3 +/- 6.8 l/min, the mean amplitude was 54.3 +/- 7.1 l/min, and the mean acrophase was at 16:31 +/- 0.27 before treatment. After treatment, the mean mesor was 543.8 +/- 4.4 l/min, the mean amplitude was 30.5 +/- 4.9 l/minm, and the mean acrophase was at 16:25 +/- 0.31. The mean mesor had increased significantly (p < 0.05), and the mean amplitude had decreased significantly (p < 0.05) after treatment. The mean acrophase did not change. These data indicate that inhaled BDP increases PEFR at a constant acrophase in asthmatic patients.

    Topics: Adolescent; Adult; Aged; Asthma; Beclomethasone; Circadian Rhythm; Data Interpretation, Statistical; Female; Humans; Lung; Male; Middle Aged; Peak Expiratory Flow Rate

1995
Expired nitric oxide levels during treatment of acute asthma.
    American journal of respiratory and critical care medicine, 1995, Volume: 152, Issue:2

    Nitric oxide (NO) is known to be present in measurable quantities in the exhaled air of normal subjects and at higher concentrations in asthmatic subjects not treated with glucocorticoids. We confirmed these findings by analyzing the mean mixed expired NO concentrations of 43 stable asthmatics and 90 normal subjects; NO levels were higher in the asthmatic population (13.9 parts per billion [ppb] versus 6.2 ppb, p < 0.001). Although the effects of glucocorticoids on the NO content of mixed expired air are known, it is not known if beginning systemic glucocorticoid therapy reduces exhaled NO levels in a given individual. To examine this question, seven patients needing emergency therapy for asthma underwent repeated measurements of mixed expired NO levels during their course of treatment with glucocorticoids. All patients had a reduction in mixed expired NO concentration (p = 0.002) and an accompanying improvement in airway obstruction. The decrease in exhaled NO was evident as early as 48 h after the initiation of therapy (p = 0.05). These data suggest mixed expired NO concentrations may prove useful as an index of asthma severity and treatment efficacy for an individual patient.

    Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Airway Obstruction; Asthma; Beclomethasone; Case-Control Studies; Cohort Studies; Emergencies; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Methylprednisolone; Middle Aged; Nitric Oxide; Peak Expiratory Flow Rate; Prednisone; Respiration; Smoking; Triamcinolone

1995
Fos immunoreactivity assessment on human normal and pathological bronchial biopsies.
    Respiratory medicine, 1995, Volume: 89, Issue:5

    The transcription factor Fos is involved in cell proliferation and differentiation. Its expression in normal and pathological adult human tissues and cells has rarely been studied. We therefore studied bronchial biopsies obtained from 14 normal subjects (NS), 18 non-steroid-treated asthmatics, 10 corticosteroid-treated asthmatics and 10 patients with chronic bronchitis (CB), in addition to 34 patients with lung cancer (LC), by immunofluorescence for Fos immunoreactivity, using a highly specific polyclonal antibody. Bronchial tissue of 0/10 NS, 11/18 non-steroid-treated asthmatics, 1/10 steroid-treated asthmatics, 0/10 CB and 1/34 LC expressed Fos. In asthmatic patients, the expression was heterogeneous, localized to epithelial cells and correlated with the epithelium shedding (tau = 0.45, P = 0.0001). Corticosteroid-treated patients rarely expressed Fos, suggesting a role for this proto-oncogene in asthmatic bronchial inflammation. Fos was rarely expressed in the normal and pathological (CB, LC) proliferative compartment of the human bronchi, suggesting its low role in cell proliferation of the large airways.

    Topics: Adenocarcinoma; Adolescent; Adult; Aged; Aged, 80 and over; Asthma; Beclomethasone; Bronchi; Bronchitis; Budesonide; Carcinoma, Small Cell; Carcinoma, Squamous Cell; Chronic Disease; Female; Fluorescent Antibody Technique; Humans; Lung Neoplasms; Male; Middle Aged; Pregnenediones; Proto-Oncogene Mas; Proto-Oncogene Proteins c-fos

1995
Posterior subcapsular cataract and inhaled corticosteroid therapy.
    Thorax, 1995, Volume: 50, Issue:6

    Although posterior subcapsular cataract complicates both systemic and topical corticosteroid therapy, the literature on the effects of inhaled corticosteroids is conflicting.. One hundred and forty children and young adults on inhaled corticosteroids were examined by slit lamp ophthalmoscopy after pupillary dilatation; 103 had received one or more short courses (< or = 7 days) of oral corticosteroids in the management of acute asthmatic attacks and four had also received one or more prolonged courses (> or = 4 weeks) of alternate day oral corticosteroid therapy.. Bilateral posterior subcapsular cataract was identified in one girl who had received several prolonged courses of oral corticosteroids, but was not identified in any other patient.. There is no evidence to support the contention that inhaled corticosteroid therapy on its own, or in association with short courses of oral corticosteroid therapy, might cause cataracts. Although children receiving long term systemic corticosteroid therapy should be screened for cataracts, this is unnecessary in children on inhaled corticosteroids alone.

    Topics: Administration, Inhalation; Administration, Topical; Adolescent; Adult; Age Distribution; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Cataract; Child; Child, Preschool; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Pregnenediones

1995
Frequency of voice problems and cough in patients using pressurized aerosol inhaled steroid preparations.
    The European respiratory journal, 1995, Volume: 8, Issue:4

    The aim of the study was to assess the prevalence of throat and voice symptoms in asthma patients using pressurized aerosol, metered-dose, inhaled corticosteroid preparations. A questionnaire was administered to hospital out-patients in an asthma clinic and to a control group attending a diabetic clinic. Two hundred and fifty five consecutive out-patients using pressurized aerosol inhaled corticosteroids and 100 controls were surveyed. One hundred and forty seven (58%) patients taking inhaled steroids reported voice dysphonia or throat symptoms compared with 13% of control patients. Women admitted to symptoms more frequently than men. Throat symptoms were more prevalent in patients using higher doses of inhaled steroid. Aerosol inhaler-induced cough was reported by 87 (34%) patients. Local side-effects were equally prevalent both with beclomethasone dipropionate and budesonide aerosol inhalers. The use of a large volume spacing device with either steroid aerosol did not appear to protect against these symptoms. Local side-effects are common in asthmatics taking pressurized aerosol, metered-dose, inhaled steroids.

    Topics: Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Case-Control Studies; Cough; Female; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Outpatient Clinics, Hospital; Pregnenediones; Prevalence; Surveys and Questionnaires; Voice Disorders

1995
Effects of corticosteroid inhalation therapy on lung ventilation and alveolar permeability in asthma using TC-99M DTPA radioaerosol inhalation lung scintigraphy.
    Gaoxiong yi xue ke xue za zhi = The Kaohsiung journal of medical sciences, 1995, Volume: 11, Issue:8

    This study evaluates the effects of steroid inhalation on lung ventilation (LV) and alveolar permeability (AP) in 26 patients with asthma. The homogeneity of LV was evaluated as the inhalated Tc-99m diethylene triamine pentaacetic acid (DTPA) radioaerosol depositing ratios of the central 1/3 over peripheral 1/3 of the left lung. It is shown as a distribution factor (DF) in this study. The damage in AP was measured from the speed of Tc-99m DTPA radioaerosol clearance curves from the peripheral alveoli of the left lung and is represented as a slope in this study. The baseline LV and AP were calculated before an inhalation therapy of 0.05 mg beclomethasone dipropionate four times daily for one week, then the studies were repeated after treatment to evaluate the effects of inhalation therapies. The results revealed a significantly improved homogeneity of LV in 16/26 (62%) cases (DF: 0.79 +/- 0.32 vs 0.59 +/- 0.22, P = 0.0001), but no apparent change in AP (slope: 1.18 +/- 0.78 vs 1.25 +/- 0.88, P = 0.052) after the treatment. In conclusion, a corticosteroid inhalation therapy for asthma can improve the peripheral LV, but can not change the AP according to the findings of Tc-99m DTPA radioaerosol inhalation lung scintigraphy. We suggest that the widely available Tc-99m DTPA radioaerosol inhalation lung scintigraphy, coupled with the evaluation of LV and AP could contribute to any disorder involving both alveoli and airways.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Asthma; Beclomethasone; Female; Humans; Lung; Male; Middle Aged; Permeability; Pulmonary Alveoli; Radionuclide Imaging; Technetium Tc 99m Pentetate

1995
Effect of prolonged use of inhaled steroids on the cellular immunity of children with asthma.
    The Journal of allergy and clinical immunology, 1995, Volume: 95, Issue:4

    Systemic corticosteroids may affect the cellular immunity, but there is no available controlled data on such effects associated with a prolonged use of inhaled corticosteroids.. The investigation was designed to study the effect of long-term inhaled beclomethasone dipropionate in daily doses of up to 600 micrograms on cellular immune functions.. Twenty-four children with asthma treated with inhaled beclomethasone dipropionate for a mean of 22.6 months were compared with 16 children with asthma not treated with an inhaled steroid and with 20 healthy adults. Cellular immune parameters included differential white blood count, T- and B-cell numbers, T helper and suppressor counts, T-cell mitogenic transformation, and interleukin-1 and interleukin-2 secretion.. There was no difference in any of the studied cellular immune functions among the three study groups.. Long-term use of inhaled beclomethasone dipropionate by children with asthma, at daily doses of up to 600 micrograms, has no effect on certain parameters of cellular immunity.

    Topics: Administration, Inhalation; Adolescent; Asthma; Beclomethasone; Child; Child, Preschool; Female; Humans; Immunity, Cellular; Leukocyte Count; Male; Reference Values; Time Factors

1995
[Astute in vivo observations discover anti-asthma medication].
    Nordisk medicin, 1995, Volume: 110, Issue:6-7

    Will the new reductive biology write the book of revelation of all progress as concerns the pathophysiology and pharmacology of asthma? The early and recent medical history of anti-asthma drugs supports the possibility that exploratory in vivo research involving patients and disease-like test systems may "unexpectedly" provide leap discoveries in pathophysiology and pharmacology. New treatments based on defined molecular disease mechanisms will no doubt emerge. However, the future may also hold novel important anti-asthma drugs where the exact mode of action remains a challenge. Indeed, many aspects of the efficacies of the already long established anti-asthma drug principles have yet to be explained at the end-organ, cellular and molecular levels.

    Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Asthma; Beclomethasone; Epinephrine; History, 19th Century; History, 20th Century; History, Ancient; Humans; Research

1995
Intraocular pressure elevation associated with inhalation and nasal corticosteroids.
    Ophthalmology, 1995, Volume: 102, Issue:2

    The ocular hypertensive response to corticosteroids is well established. Elevated intraocular pressure (IOP) secondary to corticosteroids by nasal spray or inhalation has rarely been reported.. Three patients showed a possible ocular hypertensive response to beclomethasone dipropionate by nasal spray or inhalation. In two patients, the IOP returned to pretreatment levels after discontinuing nasal corticosteroid spray. One patient required medication to control IOP with continued inhaled corticosteroid. One patient later demonstrated an ocular hypertensive response to oral steroids.. Corticosteroids by nasal spray or inhalation may cause ocular hypertension in susceptible patients. The authors recommend surveillance of IOP in patients using these medications.

    Topics: Administration, Inhalation; Administration, Intranasal; Aged; Asthma; Beclomethasone; Female; Humans; Intraocular Pressure; Male; Middle Aged; Nebulizers and Vaporizers; Ocular Hypertension; Rhinitis

1995
Use of spacer devices with inhaled steroids.
    Archives of internal medicine, 1995, Mar-13, Volume: 155, Issue:5

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Equipment Design; Humans; Nebulizers and Vaporizers

1995
Generic inhalers for asthma. Money saved could be spent on patient education.
    BMJ (Clinical research ed.), 1995, Mar-04, Volume: 310, Issue:6979

    Topics: Asthma; Beclomethasone; Drugs, Generic; Humans; Nebulizers and Vaporizers; Patient Education as Topic

1995
Cross-sectional study of bone density in asthmatic children.
    Pediatric pulmonology, 1995, Volume: 20, Issue:3

    The emphasis in treatment of asthma in children has shifted from bronchodilators to inhaled anti-inflammatory medications, including inhaled corticosteroids (ICS). Children with chronic asthma and moderate to severe symptoms have been targeted as particularly deserving of maintenance therapy with ICS. We have previously reported a cross-sectional study of bone density in children treated with ICS. There was no significant difference between the total bone density of asthmatic patients and controls. We sought to extend the information available on bone density in asthmatic children by evaluating 15 asthmatic subjects taking daily ICS (beclomethasone dipropionate) and comparing them with age- and sex-matched controls. We compared total and regional bone density, bone age, and calcium intakes in these subjects. Asthmatic subjects were on ICS for 4-60 months, with doses ranging from 200 to 450 micrograms/day. There was no significant difference between asthmatics and matched controls for height, weight, % RDA Ca2+, or bone age. The asthmatic subjects had bone density (total and regional measurements) equivalent to their controls. These results provide additional support for the safety of low-dose ICS on bone density in asthmatic children.

    Topics: Absorptiometry, Photon; Administration, Inhalation; Adolescent; Age Determination by Skeleton; Asthma; Beclomethasone; Bone Density; Calcium; Child; Cross-Sectional Studies; Female; Humans; Male

1995
Compliance with inhaled asthma medication in preschool children.
    Thorax, 1995, Volume: 50, Issue:12

    Previous studies have shown poor compliance with regular drug therapy in children and adults with asthma. In preschool children the parents supervise and are responsible for drug administration, but little is known of compliance in this group. In addition, there are few data on the patterns of drug use of inhaled prophylactic asthma therapy or of the relation between compliance and symptom control. A study was undertaken to address these issues with the hypothesis that parental supervision would result in good compliance.. The subjects were 29 asthmatic children aged 15 months to five years already established on inhaled prophylactic medication delivered through a large volume spacer. The prescribed drug regimens varied between subjects. This was an observational study using an electronic inhaler timer device to record the date and time of each actuation of the aerosol canister. Diary cards were used for parallel recording of symptoms and parentally reported compliance with a drug regimen.. Variable and generally poor compliance was demonstrated with a median of 50% of study days with full compliance (subject range 0-94%) and an overall median of 77% of prescribed doses of therapy taken during the study period. No relation was found between frequency of prescribed regimen and good compliance. Day care was associated with poorer compliance. No relation between good compliance and low symptom scores was found.. Compliance with inhaled prophylactic therapy is poor in preschool children with asthma whose medication is administered under parental supervision.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child, Preschool; Cromolyn Sodium; Humans; Infant; Parents; Patient Compliance; Pregnenediones

1995
Severe varicella after low dose inhaled corticosteroids.
    The Pediatric infectious disease journal, 1995, Volume: 14, Issue:9

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Chickenpox; Child, Preschool; Female; Glucocorticoids; Humans; Immunocompromised Host

1995
[Treating steroids dependent asthmatic patients with high dose beclomethasone dipropionate aerosol].
    Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases, 1995, Volume: 18, Issue:3

    In order to provide a more effective alternative therapy for the steroid dependent asthmatic (SDA) patients, 23 SDA patients replaced their oral steroids with high dose beclomethasone dipropionate (1500 micrograms/d) inhalation were investigated. The changes of clinical features, pulmonary function and the Synacthen test were recorded. The results showed that about 82% of the patients replaced their oral steroids completely or partially with the inhalation therapy, the clinical features were improved in 13% of the patients and the failure rate was only 4.4%, the results also revealed that, after replacement, the pulmonary function of the patients were improved (P < 0.05); according to the results of Synacthen test, after alternative therapy for 3-6 months, the damaged reserve power and secretive ability of adrenal cortex of the patients were also partially improved (P < 0.01).

    Topics: Administration, Inhalation; Adult; Aerosols; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Follow-Up Studies; Humans; Hydrocortisone; Male; Middle Aged; Prednisone; Substance-Related Disorders

1995
Do inhaled steroids have similar efficacy? A case of bronchial asthma suggesting different efficacy of inhaled glucocorticosteroids.
    Allergy, 1995, Volume: 50, Issue:7

    We report a 35-year-old woman who had had bronchial asthma for 17 years. Her asthma worsened and became unstable on treatment with beclomethasone dipropionate (BDP), budesonide (BUD), and oral glucocorticosteroids (GC). At the age of 31, she had participated in a clinical trial with fluticasone propionate (FP), and after 2 weeks' treatment her asthma was well controlled. Because of pregnancy, her participation was terminated and treatment continued with available inhaled GC; however, the disease deteriorated and treatment with FP was resumed 2 years ago. Lung function normalized after 3 weeks and she has remained clinically stable since.

    Topics: Administration, Inhalation; Administration, Oral; Administration, Topical; Adult; Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Female; Fluticasone; Glucocorticoids; Humans; Pregnancy; Pregnenediones; Treatment Outcome

1995
[Effect of inhaled corticosteroids on serum eosinophil cationic protein and sIL-2R levels in asthmatics pulmonary hypertension].
    Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases, 1995, Volume: 18, Issue:5

    To study the influence of corticosteroid and beta 2-agonist on eosinophil and T lymphocyte functioning state in the asthmatics, we measured the serum ECP sIL-2R levels and airway reactivity before and after 6-week treatment with beclometasone and terbutalin. The result revealed that after inhalation of steroid, the serum ECP sIL-2R levels decreased, whereas the lung function improved and MCH-PC20 values increased. It suggested that steroid could inhibit activation of eosinophil and T lymphocyte as well as show the effect of anti-inflammation and reducing AHR.

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Blood Proteins; Eosinophil Granule Proteins; Female; Humans; Hypertension, Pulmonary; Male; Middle Aged; Receptors, Interleukin-2; Respiratory Function Tests; Ribonucleases; Terbutaline

1995
[Clinical study of bronchial asthma in adult, intractable asthmatics after introduction of guideline therapy].
    Arerugi = [Allergy], 1995, Volume: 44, Issue:12

    Introduction of Guideline for asthma treatment proposed by the committee of Japanese allergology have a tremendous impact on patients with bronchial asthma. Intractable asthmatics who have had to take some oral steroid to overcome disease severity, may have also some merit by this treatment, so that some of them might be no longer considered as intractable asthmatics. To clarify this, multicenter study was conducted. In this study, a case who have had more than 5 mg of prednisolone and/or 800 mu g of beclomethasone dipropionate throughout the year, was diagnosed as intractable asthmatics. In 845 case, 14.7%, 123 cases were diagnosed as intractable. These cases were significantly to be non-atopic and adult onset. Also, they have a significant tendency to be deteriorated by infection and careless drug administrations. Using the multiquantification method to examine the most powerful factor on intractable asthmatics, type of asthmatics was the most important and the past history of severe attack was the second. When intractable asthmatics diagnosed mainly by their BDP usage (BDP-intractable) were compared with intractable diagnosed by oral PSL (PSL-intractables), BDP-intractables were significantly atopic compared to PSL-intractables.

    Topics: Asthma; Beclomethasone; Female; Humans; Male; Middle Aged; Practice Guidelines as Topic; Prednisolone; Respiratory Hypersensitivity; Surveys and Questionnaires

1995
Recurrent herpes zoster and high-dose inhaled steroids for asthma.
    South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 1994, Volume: 84, Issue:12

    Topics: Adult; Asthma; Beclomethasone; Female; Herpes Zoster; Humans; Immunocompromised Host; Recurrence

1994
[Effect of inhaled steroid on bone metabolism in the treatment of bronchial asthma].
    Arerugi = [Allergy], 1994, Volume: 43, Issue:12

    In order to clarify the effects of longterm inhaled steroid therapy on bone metabolism, we examined 72 patients with bronchial asthma treated mainly with BDP (beclomethasone dipropionate). Multiple scanning X-ray photodensitometry was used to evaluate the degree of bone mineral loss. Osteocalcin, alkaline phosphatase (total and type III) was measured as a marker of bone synthesis and urinary pyridinoline, and deoxy-pyridinoline was measured as a marker of bone resorption. There was age related bone mineral loss. Urinary pyridinoline increased with aging. Treatment related bone mineral loss was not observed either in cases treated with BDP or in cases treated with continual oral steroids. Urinary pyridinoline and deoxy-pyridinoline decreased in patients treated with larger doses of for longer periods with BDP. Serum osteocalcin levels were lower in patients on continual oral corticosteroids. We conclude that inhaled steroid do not deteriorate bone metabolism in patients with bronchial asthma, when used appropriately.

    Topics: Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Bone and Bones; Bone Density; Female; Humans; Male; Middle Aged

1994
Better medication compliance is associated with improved control of childhood asthma.
    Monaldi archives for chest disease = Archivio Monaldi per le malattie del torace, 1994, Volume: 49, Issue:6

    Our previous studies have shown that medication compliance in children prescribed continuous treatment for asthma is poor, and that an intervention can improve the level of compliance. The present study examined the effects of an intervention on the clinical course of moderately severe asthma. At each of six clinic visits, spirometry was performed, medication compliance was assessed by questionnaire, and the physicians made an overall assessment of asthma severity (Severity Score) and provided a score for asthma control (Control of Asthma Score). Peak expiratory flow rates were measured twice daily for one month prior to each clinic visit, and the coefficient of variation (% CV) was calculated. Subjects received the intervention after at least two visits, and 53 of the 78 recruits completed the study. Following the intervention, % CV, Control of Asthma Score, Severity Score and % compliance improved, showing that better medication compliance was associated with better control of moderately severe asthma.

    Topics: Adolescent; Asthma; Beclomethasone; Child; Child, Preschool; Female; Humans; Male; Patient Compliance; Peak Expiratory Flow Rate

1994
[Investigation of treating steroids dependent asthmatic patients with kidney-tonifying herbs and high dose beclomethasone dipropionate aerosol].
    Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine, 1994, Volume: 14, Issue:8

    The steroids dependent asthmatic(SDA) patients need prolonged oral steroids administration. Because of the significant adverse effects with long-term use of steroids, especially the damage of the hypothalamus-pituitary-adrenocortical(HPA) axis, long-term steroids administration should be avoided or withdrawn gradually. Many modes of withdrawing the oral steroids have be used. But, the results were not satisfactory. So far, recently, investigations have revealed that high dose corticosteroids inhalation, such as beclomethasone dipropionate (BDP), could provide an effective alternative; they were delivered locally in the airway and had minimal systemic absorption as well as side effects. On the other hand, it has been shown that the Kidney-Tonifying herbs (KTH) exert protective effect on the adrenocortical cells of the SDA patients by suppressing the exogenous steroids and could regulate the disorders in different levels on HPA axis in the patients. In order to provide the more effective alternative therapy for the patients, 30 SDA patients replaced their oral steroids with KTH and high dose BDP (1500 micrograms/day) inhalation were investigated. The changes of clinical features, pulmonary function and the Synacthen Test were followed up. The results showed that about 70% of the patients replaced their oral steroids successfully with the new therapy, the clinical features were improved in 16% of the patients and the ineffective rate was only 6.6%; the results also revealed that, after replacement, the pulmonary function of the patients were improved (P < 0.05); the data of Synacthen Test indicated, after alternative therapy for 3-6 months, the damaged reserve power and secretive ability of adrenal cortex of the patients were also improved partially (P < 0.001).

    Topics: Aerosols; Asthma; Beclomethasone; Drugs, Chinese Herbal; Female; Humans; Male; Prednisone; Respiratory Function Tests; Substance Withdrawal Syndrome

1994
Strongyloides stercoralis infestation masquerading as steroid resistant asthma.
    Monaldi archives for chest disease = Archivio Monaldi per le malattie del torace, 1994, Volume: 49, Issue:5

    A 42 year old man presented with steroid resistant asthma of 6 months duration. Serial chest radiographs showed migrating interstitial shadowing. Electrocardiographs showed decreasing R-wave progression in the precordial leads, and endomyocardial biopsy showed eosinophil infiltration with fibrosis. Bronchoscopy revealed inflammatory changes and lavage showed filariform larvae of Strongyloides stercoralis in the washings. This confirms the diagnosis of parasitic infection with eosinophilic cardiomyopathy.

    Topics: Adult; Animals; Asthma; Beclomethasone; Diagnosis, Differential; Drug Resistance; Humans; Male; Prednisone; Strongyloides stercoralis; Strongyloidiasis

1994
Platelet-derived growth factor-beta mRNA in human alveolar macrophages in vivo in asthma.
    The European respiratory journal, 1994, Volume: 7, Issue:11

    Collagen deposition and myofibroblast proliferation beneath the epithelial basement membrane in patients with asthma is now increasingly recognized, although the molecular pathogenesis remains obscure. We have evaluated messenger ribonucleic acid (mRNA) expression of the profibrotic cytokine, platelet-derived growth factor-beta (PDGF-beta), in alveolar macrophages obtained following fibreoptic bronchoscopy and bronchoalveolar lavage in patients with asthma. Three subject groups were studied: 1) asthmatics using regular inhaled glucocorticoid medication (ASTST, n = 9), 2) asthmatics using intermittent inhaled beta 2-agonist therapy only (ASTBR, n = 10); 3) nonasthmatic control volunteers (n = 10). Alveolar macrophage mRNA was extracted and PDGF-beta mRNA quantified by reverse-transcriptase polymerase chain reaction (PCR) (RT-PCR) and expressed as the ratio to that of a control gene glyceraldehyde-3-phosphate dehydrogenase (GAPDH). There were no significant differences in PDGF-beta mRNA expression between the groups, or between all asthmatic (n = 19) and control subjects. Furthermore, there was no correlation between alveolar macrophage PDGF-beta mRNA expression and airway spirometry, or duration of glucocorticoid usage or dose. Thus, in contrast to other fibrotic lung diseases, we found little evidence of enhanced expression of PDGF-beta mRNA in alveolar macrophages in clinically stable bronchial asthma.

    Topics: Adult; Aerosols; Albuterol; Asthma; Beclomethasone; Blotting, Northern; Bronchodilator Agents; Budesonide; Female; Gene Expression; Humans; Macrophages, Alveolar; Male; Middle Aged; Platelet-Derived Growth Factor; Polymerase Chain Reaction; Pregnenediones; RNA, Messenger; Smoking; Terbutaline

1994
[Individual patient sensitivity to glucocorticoids and hormone resistance in bronchial asthma].
    Terapevticheskii arkhiv, 1994, Volume: 66, Issue:12

    The paper reports glucocorticoid actions in bronchial asthma, covers problems of individual sensitivity to glucocorticoids and resistance to hormones, illustrates the dependence of beclometasone dipropionate efficacy on condition of glucocorticoid receptors in alveolar macrophages and clinical appearance of the disease, describes physiological features of patients with hormone-resistant bronchial asthma and its new treatment (extracorporeal photohemotherapy) allowing reduction of prednisolone dose in 14 of 15 patients from 29.6 to 11.4 mg/day, on the average.

    Topics: Adult; Aged; Asthma; Beclomethasone; Blood; Blood Transfusion, Autologous; Combined Modality Therapy; Drug Resistance; Drug Tolerance; Extracorporeal Circulation; Female; Glucocorticoids; Humans; Laser Therapy; Male; Middle Aged; Time Factors

1994
Compliance with pharmacologic prophylaxis and therapy in bronchial asthma.
    Annals of allergy, 1994, Volume: 73, Issue:2

    Between January 1 and December 31, 1988, 288 children [185 boys and 103 girls, mean age 8.75 +/- 4.98 years (range 2.50 to 16.83)], followed at the Outpatient Clinic for Lung Diseases of the University of Milan 5th Pediatric Department, were interviewed blindly in order to assess their compliance with pharmacologic therapy. All children were suffering from episodic, frequent, or chronic asthma requiring therapy as needed and preventive drugs for at least 30 days. Prophylaxis (including cromolyn, beclomethasone, theophylline retard, ketotifen, oxatomide, albuterol, and prednisone, alone or in combinations) and therapy in case of symptoms (albuterol, with or without theophylline prompt or beclomethasone) were prescribed. A study questionnaire was completed 30 to 45 days after the prescription with no advance warning by a physician unaware of the prophylactic and therapeutic prescriptions. Out of the 288 patients, 31 (10.8%) failed to return for the second visit. Understanding of prophylaxis was full in 61.1% of cases, partial in 23.3% and nil in 4.9%. Therapy as needed was fully remembered by 77.1% of parents, partially by 9.4% and totally forgotten by 2.8%. Compliance with single-drug prophylaxis was full in 60.1% of cases, partial in 22.2% and nil in 6.4%. Statistical analysis showed compliance was significantly better for ketotifen than for disodium cromoglycate (chi squared 9.85, P < .02), for ketotifen than for theophylline (chi squared 9.98, P < .02), and for beclomethasone than for theophylline (chi squared 8.77, P < .05).(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Administration, Inhalation; Adolescent; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Child; Child, Preschool; Cromolyn Sodium; Female; Histamine H1 Antagonists; Humans; Male; Patient Compliance; Surveys and Questionnaires; Theophylline

1994
Asthma control.
    Lancet (London, England), 1994, Sep-10, Volume: 344, Issue:8924

    Topics: Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Drug Administration Schedule; Humans; Salmeterol Xinafoate

1994
Asthma control.
    Lancet (London, England), 1994, Sep-10, Volume: 344, Issue:8924

    Topics: Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Drug Tolerance; Humans; Nebulizers and Vaporizers; Salmeterol Xinafoate

1994
Common measures of asthma severity lack association for describing its clinical course.
    The Journal of allergy and clinical immunology, 1994, Volume: 94, Issue:4

    To address the problems of increasing asthma morbidity and mortality rates, reliable severity measures must be identified. Accordingly, we compared three measures and their relationship to beclomethasone compliance.. Three clinical measures (symptom scores, morning peak expiratory flow rates, and number of as needed albuterol inhalations with Nebulizer Chronologs [Forefront Technologies, Inc., Lakewood, Colo.]) were assessed daily in 13 adults with asthma for 8.9 +/- 2.1 weeks. The relationships among these three variables were analyzed in terms of Pearson correlation coefficients. These were evaluated for each of the three possible pairs of the three clinical measures for each of the 13 patients. The relationship between inhaled beclomethasone compliance and the pairwise correlations was studied with the use of nonparametric statistical procedures.. In four of the 13 patients, no pairwise correlations between any of the three severity measures were observed. The peak expiratory flow rate-symptom score relationship was observed in eight patients, whereas peak expiratory flow rate-albuterol use and albuterol use-symptom score correlations were each seen in four patients. Mean beclomethasone compliance was 64% and was greatest in those patients whose albuterol use increased concurrently with symptom scores (94% vs 50%, p = 0.02).. The commonly used measures of asthma severity, symptom scores, peak flow rate, and beta-agonist use may not be interchangeable in describing the clinical course. Patients whose beta-agonist use is driven by symptoms tend to be more compliant with use of inhaled corticosteroids.

    Topics: Administration, Inhalation; Adult; Albuterol; Asthma; Beclomethasone; Humans; Medical Records; Patient Compliance; Peak Expiratory Flow Rate

1994
Clinical trials of high-dose fluticasone propionate.
    Respiratory medicine, 1994, Volume: 88 Suppl A

    Topics: Androstadienes; Asthma; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Fluticasone; Humans; Multicenter Studies as Topic

1994
Fluticasone propionate in children.
    Respiratory medicine, 1994, Volume: 88 Suppl A

    Topics: Androstadienes; Asthma; Beclomethasone; Child; Clinical Trials as Topic; Cromolyn Sodium; Drug Administration Schedule; Fluticasone; Humans

1994
Does beclomethasone dipropionate suppress dehydroepiandrosterone sulphate in postmenopausal women?
    Australian and New Zealand journal of medicine, 1994, Volume: 24, Issue:4

    Patients with chronic obstructive airways disease and asthma are at special risk of developing osteoporosis. Previous research has indicated that adrenal androgen levels in postmenopausal women are suppressed by short term high dose inhaled corticosteroids. Such an effect, if sustained, may be a causative factor for long term bone loss. We tested the hypothesis that postmenopausal women receiving > or = 1 mg/day inhaled beclomethasone dipropionate, long term, have suppressed dehydroepiandrosterone sulphate levels when compared to postmenopausal controls.. As part of a larger study, we studied 36 postmenopausal subjects, recruited from regional pharmacies and a hospital chest clinic, who had been receiving treatment for asthma. Subjects were selected if they were receiving > or = 1 mg/day inhaled beclomethasone dipropionate (n = 27) or receiving no beclomethasone dipropionate (n = 9). The two groups were compared for dehydroepiandrosterone sulphate levels, age and potential confounders.. Mean dehydroepiandrosterone sulphate levels were 35% lower in the high dose beclomethasone dipropionate group than the control group (p < 0.01).. This is the first report of suppression of dehydroepiandrosterone sulphate in postmenopausal women receiving long term inhaled beclomethasone dipropionate. Further research is needed to clarify whether or not there is any associated clinically important adverse effect on bone density.

    Topics: Age Distribution; Aged; Asthma; Beclomethasone; Confounding Factors, Epidemiologic; Dehydroepiandrosterone; Dehydroepiandrosterone Sulfate; Female; Humans; Middle Aged; Postmenopause; Radioimmunoassay; Regression Analysis; Treatment Outcome

1994
Effect of beclomethasone dipropionate on bone mineral content assessed by X-ray densitometry in asthmatic children: a longitudinal evaluation.
    The European respiratory journal, 1994, Volume: 7, Issue:4

    There is little information on bone turnover in asthmatic children taking long-term treatment with inhaled steroids (ICS). The aim of this longitudinal study was to determine the effects of inhaled beclomethasone dipropionate (BDP) on bone mineral density (BMD), in asthmatic children treated over a period of six months. BMD and growth were studied in two age- and sex-matched groups of asthmatic children. These comprised: 14 asthmatic children (Group 1) who had taken BDP in a dosage of 300-400 micrograms daily through a 145 ml spacer device for at least 6 months (mean age 9.1 yrs); and a control group of 16 age- and sex-matched asthmatic patients (Group 2) not treated with ICS (mean age 9.5 yrs). Mean duration of asthma was 5.7 yrs in Group 1 and 5.5 yrs in Group 2. Vertebral BMD (L2-L4) was measured by dual energy X-ray absorptiometry (DEXA) at the beginning (baseline) of the study and 6 months later. There were no significant differences in the baseline bone mass (mean +/- SEM) between the two groups (0.63 +/- 0.03 and 0.64 +/- 0.02 g.cm-2 in Group 1 and 2, respectively). During the observation period, bone density increased, by 4% (95% confidence interval (95% CI) 2-6) in the control group and by 2.3% (95% CI 0.4-4.2) in the group under BDP treatment, showing no significant influence of the treatment. No difference was found in height velocity evaluated before starting BDP and after 6 months of therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Absorptiometry, Photon; Adolescent; Asthma; Beclomethasone; Bone Density; Child; Child, Preschool; Female; Forced Expiratory Volume; Humans; Longitudinal Studies; Male

1994
Should supplemental estrogens be used as steroid-sparing agents in asthmatic women?
    Chest, 1994, Volume: 106, Issue:1

    To determine if supplemental estrogens should be used as steroid-sparing agents in asthmatic women.. Case series.. Ambulatory care, community hospital.. Volunteer sample of three steroid-dependent asthmatic women.. Addition of conjugated estrogens to existing asthma treatment.. Ability to decrease oral steroid requirement.. The mean age of the women was 55 +/- 11 years; two were former smokers (cases 1 and 2) and one was a nonsmoker (case 3). One women (case 3) was premenopausal and noted worsening of her asthma before and during menses. The other two women (cases 1 and 2) were postmenopausal. All three had been symptomatic from their asthma for 13.2 +/- 7.6 years. Each woman was being treated with maximal doses of inhaled albuterol, inhaled steroids, and therapeutic theophylline doses. Despite this aggressive management, all three women required daily supplemental steroids (mean dose, 26.7 +/- 11.5 mg of prednisone). Case 3 was started on a regimen of norethindrone/ethinyl estradiol 1/35, and cases 2 and 3 were begun on regimens of daily conjugated estrogen, 0.625 mg. Over the next 12 to 24 weeks, the conditions of all three women were symptomatically improved and their steroid therapy was discontinued. In addition, steroid-associated side effects of hypertension, weight gain, osteoporosis, and easy bruising lessened.. Although this new observation of the steroid-sparing effect of estrogens remains preliminary, further study may help advance understanding of the mechanisms and treatment of asthma in women.

    Topics: Administration, Oral; Asthma; Beclomethasone; Estrogens, Conjugated (USP); Female; Humans; Middle Aged; Prednisone

1994
Anaesthetic management of an asthmatic child for appendicectomy.
    Canadian journal of anaesthesia = Journal canadien d'anesthesie, 1994, Volume: 41, Issue:6

    A 13-yr-old boy was scheduled for emergency appendicectomy because of abdominal pain. His preoperative medical history was complicated by a recent hospital admission for management of asthma. He had presented to hospital seven days earlier because of dyspnoea, tachypnoea and oxygen desaturation to 77% on room air. Following admission, he required intensive nonventilatory management of his asthma, including intravenous salbutamol, methylprednisolone, and aminophylline, as well as use of an ipratroprium bromide inhaler and 100% oxygen by mask. He was discharged to the ward, and continued on prednisone (delta-cortisone), beclomethasone inhaler, ipratroprium inhaler, and salbutamol inhaler. During his ICU stay, he complained of nonspecific abdominal pain, interpreted as gastro-oesophageal reflux. After four days, he was discharged to the ward. On his sixth hospital day, he began to experience right-sided lower abdominal pain and right shoulder pain. A surgeon was consulted, and the patient was found to have a very tender right lower quadrant with guarding and rebound pain. He was therefore scheduled for appendicectomy; antibiotic therapy with ampicillin, gentamicin, and metronidazole was initiated.

    Topics: Adolescent; Albuterol; Anesthesia, Epidural; Appendectomy; Asthma; Beclomethasone; Bupivacaine; Fentanyl; Humans; Lidocaine; Male; Methylprednisolone; Morphine; Pain, Postoperative; Prednisone

1994
[Can patients with chronic asthma discontinue inhaled corticosteroid?].
    Nihon Kyobu Shikkan Gakkai zasshi, 1994, Volume: 32, Issue:6

    As an initial investigation to determine whether or not inhaled corticosteroids can be discontinued, we evaluated the results of discontinuation in patients who had been well controlled with inhaled corticosteroids for more than one year prior to this study. The average dose of BDP which the patients had been inhaling at the start of this study was 365 micrograms/day. To determine the effect of discontinuing inhaled corticosteroids, we compared the patients' peak expiratory flow rates and the frequency of beta-agonist use between the 4-week observation period and follow-up periods of varying duration. Only three out of twenty patients enrolled were able to maintain their discontinuation of BDP, while the remaining seventeen patients restarted after a mean period of 30.8 days. Mean peak flow values began to fall during the first week after discontinuation, and decreased morning peak flow values became significant in the 2nd, 3rd and 4th weeks. The mean peak flow value during the observation period was 85.2% of each patient's personal best, but had dropped to 68.8% of this level just before restarting inhaled corticosteroid. The frequency of beta-agonist use during the study period (2.99 +/- 3.39 times a day) was significantly higher than during the observation period (1.94 +/- 2.95 times a day). This finding strongly suggests that the patients' asthmatic conditions had become unstable during the study period. These results suggest that any decision to discontinue the use of inhaled corticosteroid, even in well controlled patients with chronic asthma, should be taken with great care.

    Topics: Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Chronic Disease; Female; Follow-Up Studies; Humans; Male; Middle Aged

1994
Inhaled beclomethasone dipropionate downregulates airway lymphocyte activation in atopic asthma.
    American journal of respiratory and critical care medicine, 1994, Volume: 149, Issue:1

    It is widely known that inhaled corticosteroids are highly efficacious in the prophylactic treatment of asthma, but the mechanism of this action is not known. In this study we have investigated the effect of 6 wk of therapy with inhaled beclomethasone dipropionate (BDP; daily dose 2,000 micrograms for 2 wk and 1,000 micrograms for 4 wk) in a group of symptomatic individuals with asthma on clinical and physiologic indices of disease activity and on T cell numbers and state of activation in peripheral blood and bronchoalveolar lavage (BAL). This course of treatment had a marked effect of improving all indices of disease activity including symptom scores, morning peak expiratory flow (PEF), variation in PEF, and methacholine PC20 (from a geometric mean of 0.62 to 4.6 mg/ml) but did not alter the total numbers of T cells, identified by the CD3 receptor, or the CD4+ and CD8+ subsets when analyzed in peripheral blood or BAL using flow cytometry. However, BDP treatment had a marked effect in reducing the expression of the activation markers CD25 and HLA-DR (p < 0.02) in T cells recovered by BAL in which these markers were upregulated. A small but significant (p < 0.02) downregulation of HLA-DR expression was also observed on peripheral blood T cells. These data add to the view that T cells are upregulated in the airways of individuals with asthma and are susceptible to inhibition by topical corticosteroids.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Bronchial Provocation Tests; Bronchoalveolar Lavage Fluid; Female; HLA-DR Antigens; Humans; Hypersensitivity, Immediate; Immunophenotyping; Leukocyte Count; Lymphocyte Activation; Male; Methacholine Chloride; Peak Expiratory Flow Rate; Receptors, Interleukin-2; Regression Analysis; Severity of Illness Index; T-Lymphocytes

1994
[Successful combination therapy in bronchial asthma. Anti-obstructive and anti-inflammatory treatment].
    Fortschritte der Medizin, 1994, Jan-20, Volume: 112, Issue:1-2

    In a post-marketing surveillance study, patient data were documented with the aim of assessing the effect of a combination of both anti-inflammatory and bronchodilatory treatment with inhaled beclomethasone dipropionate and a sustained-release theophylline preparation. A total of 2,166 patients with mild-to-moderate bronchial asthma (FEV1 about 60%) were included in the multicenter open study.. It was found that treatment with inhaled glucocorticoid and sustained-release theophylline resulted in a clear improvement in symptom scores. More than 90% of the physicians and patients rated the treatment "very good" or "good". Only 4.6% of the participants had side effects.. It may be concluded that combination therapy with inhaled glucocorticoid and sustained release theophylline is a safe and effective form of treatment of mild-to-moderate asthma.

    Topics: Administration, Inhalation; Administration, Oral; Asthma; Beclomethasone; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Product Surveillance, Postmarketing; Theophylline

1994
Pituitary-adrenal function in asthmatic patients treated with high dose of beclomethasone.
    Allergie et immunologie, 1994, Volume: 26, Issue:1

    Ten asthmatic patients receiving long term treatment with high dose of inhaled beclomethasone dipropionate (BDP) (750 to 2,250 micrograms/die, average 1,400 +/- 474 micrograms) underwent evaluation of hypothalamic-pituitary-adrenal (HPA) axis under basal conditions (serum cortisol and ACTH levels at 8.00 AM and 8.00 PM, 24-hours free urinary cortisol) and by means of pharmacological tests (short tetracosactide and Corticotrophin Releasing Factor Tests). Basal ACTH serum levels at 8.00 PM were lower than the normal values in all patients: three patients had reduced 24-hr free urinary cortisol and six subjects showed lower cortisol serum levels at 8.00 PM. A normal response to the short tetracosactide test was observed in all patients, whilst Corticotrophin Releasing Factor (CRF) induced an increase in ACTH and cortisol levels (expressed as delta AUC) that was significantly lower in the BPD treated patients compared with a control group of five healthy subjects (p < 0.05). Thus BPD, in high doses, may cause a partial inhibition of HPA axis. Our results show that determination of basal ACTH level and CRF test are more sensitive than serum cortisol levels and short tetracosactide test to evaluate a suppression of HPA axis in patients receiving long term inhaled high doses of BDP.

    Topics: Adrenocorticotropic Hormone; Adult; Asthma; Beclomethasone; Circadian Rhythm; Corticotropin-Releasing Hormone; Cosyntropin; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Pituitary-Adrenal System

1994
Inhaled steroids and severe viral infections.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1994, Volume: 31, Issue:1

    In summary, the blanket inclusion of inhaled corticosteroids in the recent FDA label warning of an association between severe varicella infection and corticosteroid therapy without reference to dosage, and proof of immunosuppression and subsequent increased risk, dose not appear warranted. To date, no link has been established between inhaled steroids and pulmonary or systemic infections. Certainly, with the recent trend of use of higher doses of inhaled corticosteroids, a potential association is possible, but so far, this is only theoretical. Since inhaled corticosteroids have become the recommended drug of choice for many patients with asthma of varying disease severity, according to new recommendations from the National Heart Lung and Blood Institute (38), it is imperative that a sound basis of proof be provided to support this labeling change. It must be realized that this new warning may lead to adverse consequences resulting from the withholding by the patient or physician of a valuable mode of therapy for fear of adverse effects to the patient. Avoidance of inhaled steroid usage, in turn, could result in overuse of other medication that has more definite and frequent deleterious effects than the theoretical risks associated with inhaled steroids. Given the above information and arguments, a number of constructive recommendations about how to proceed at this time can be proposed.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adverse Drug Reaction Reporting Systems; Asthma; Beclomethasone; Chickenpox; Child; Drug Labeling; Humans; Measles; Risk Factors; United States; United States Food and Drug Administration

1994
Cushing's syndrome from an inhaled glucocorticoid.
    The Medical journal of Australia, 1994, May-16, Volume: 160, Issue:10

    To report a case of significant systemic side effects from an inhaled glucocorticoid at a reported dose in the upper recommended therapeutic range.. A 25-year-old white man with asthma treated with inhaled glucocorticoid (beclomethasone 1500 micrograms daily), and primary testicular failure with inadequate androgen replacement, was referred with back pain. He was found to have osteoporosis, clinical features of Cushing's syndrome and complete suppression of endogenous adrenocorticotrophic hormone adrenal function.. He was recommended to receive adequate androgen replacement and to use a spacer device with the inhaled beclomethasone, or to change to budesonide via a Turbuhaler (AB Astra, Sweden).. Inhaled glucocorticoids should not be regarded as entirely safe, as serious systemic side effects may occur at doses at the upper level of the recommended therapeutic range.

    Topics: Administration, Intranasal; Adult; Asthma; Beclomethasone; Cushing Syndrome; Humans; Male

1994
Effect of magnitude of airway responsiveness and therapy with inhaled corticosteroid on histamine tachyphylaxis in asthma.
    Chest, 1994, Volume: 105, Issue:5

    Histamine challenge testing is used to measure airway responsiveness in asthma. Histamine tachyphylaxis has been demonstrated after repeated challenges in mild asthmatics not using inhaled corticosteroid. Other studies, using subjects with variable severity of asthma, have not demonstrated histamine tachyphylaxis. Forty patients with stable asthma were studied and stratified according to severity of airway hyperresponsiveness and use of inhaled corticosteroid, to examine the effects of these factors on histamine tachyphylaxis. Airway responsiveness was measured as the histamine provocative concentration causing a 20 percent fall in FEV1 (PC20). Twenty subjects had mildly increased airway hyperresponsiveness (PC20 > 1 mg/ml), of whom 10 were using inhaled corticosteroid. Twenty subjects had moderate to severely increased airway hyperresponsiveness (PC20 < 1 mg/ml), of whom 10 were using inhaled corticosteroid. On each of two study days, 1 week apart, two histamine challenges were performed 1 h apart. Histamine tachyphylaxis was found for the entire group on both study days. The geometric mean PC20 increased from 1.0 mg/ml (percent SEM 1.2) to 1.3 mg/ml (percent SEM 1.2) 1 h later on day 1 (p < 0.0005), and 1.1 mg/ml (percent SEM 1.2) to 1.3 mg/ml (percent SEM 1.2) 1 h later on day 2 p < 0.05). Subgroup analysis demonstrated that tachyphylaxis only occurred consistently in subjects with mildly increased airway hyperresponsiveness not receiving inhaled corticosteroid. In this group, the PC20 increased from 2.2 mg/ml (percent SEM 1.2) to 3.2 mg/ml (percent SEM 1.2) on day 1 (p < 0.001), and from 2.5 mg/ml (percent SEM 1.3) to 3.4 mg/ml (percent SEM 1.2) on day 2 (p < 0.05). This study confirms that histamine tachyphylaxis occurs in asthmatics, but is consistently present only in mild, noncorticosteroid-dependent asthmatics.

    Topics: Administration, Inhalation; Administration, Topical; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Budesonide; Female; Forced Expiratory Volume; Glucocorticoids; Histamine; Humans; Male; Pregnenediones; Tachyphylaxis

1994
Impaired growth in children with asthma during treatment with conventional doses of inhaled corticosteroids.
    Acta paediatrica (Oslo, Norway : 1992), 1994, Volume: 83, Issue:2

    We describe 6 (4F, 2M) prepubertal children with moderate asthma diagnosed at a mean age of 2.8 years. All patients were treated with inhaled corticosteroids in a dose of between 300 and 800 mcg of beclomethasone dipropionate (becotide) daily, given either as an aerosol or rotahaler. Mean height velocity SDS decreased from -0.8 (range +0.5 to -2.0) to -3.2 (range -1.3 to -4.8) when the dose was increased. Alternatively, when the dose was reduced or stopped, mean height velocity SDS increased from -3.2 (range -2.0 to -4.8) to +0.8 (range -1.2 to +2.7). Careful assessment of height velocity is indicated in all children receiving treatment with inhaled corticosteroids.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Body Height; Child, Preschool; Female; Growth Disorders; Humans; Infant; Male

1994
[Bronchial asthma: use of combination therapy. Anti-obstructive and anti-inflammatory treatment--result of treatment].
    Fortschritte der Medizin, 1994, Apr-20, Volume: 112, Issue:11

    On the basis of a single case report, combined antiobstructive and anti-inflammatory treatment of bronchial asthma is described. The anti-obstructive component used was a sustained-release theophylline preparation (Euphylong, 750 mg/day), and as anti-inflammatory drug, the inhalant beclomethasone diproprionate (Viarox, 300 mg/day). During the 4-week treatment period, obvious improvements in lung function parameters (FEV1 from 21 prior to to 31 after treatment; FVC from 2.81 to 3.31) were seen. At a daily dose of 750 mg theophylline, a favorable therapeutic concentration of 16.5 micrograms/ml was achieved. It was found that the combination of sustained-release theophylline and the low-dose glucocorticoid inhalant resulted in an impressive improvement in bronchial asthma.

    Topics: Adult; Asthma; Beclomethasone; Drug Therapy, Combination; Female; Humans; Rhinitis, Allergic, Perennial; Theophylline

1994
Fluticasone propionate v beclomethasone dipropionate (BDP) in moderate to severe asthma.
    Thorax, 1994, Volume: 49, Issue:4

    Topics: Androstadienes; Anti-Inflammatory Agents; Asthma; Beclomethasone; Fluticasone; Humans

1994
Glucocorticoid-induced bone loss: a neglected problem.
    Chest, 1994, Volume: 105, Issue:6

    Topics: Administration, Inhalation; Aerosols; Asthma; Beclomethasone; Bone Density; Bronchodilator Agents; Budesonide; Female; Humans; Male; Pregnenediones

1994
Decreased bone mineral density in premenopausal asthma patients receiving long-term inhaled steroids.
    Chest, 1994, Volume: 105, Issue:6

    Inhaled corticosteroids have become a key element in the maintenance treatment of bronchial asthma. It is well-known that long-term systemic steroid use causes osteoporosis, whereas its inhaled counterpart has been believed to be devoid of such a side-effect. However, recent studies showed that administration of inhaled corticosteroids was associated with biochemical evidence of derangement in bone turnover. We therefore studied bone mineral density (BMD) by dual energy x-ray absorptiometry in 30 patients (18 females, 12 males) with bronchial asthma treated with steroids, essentially by the inhaled route only (both nasal and tracheobronchial), and compared them with healthy subjects individually matched for age, sex, menopausal status, and body mass index (BMI). There was a significant decrease in BMD in the patient group at the hip (neck of femur, p = 0.007; trochanter of femur, p = 0.034; Ward's triangle, p = 0.016) and the lumbar area of the spine (L2-4, p = 0.041). Further analysis showed that this difference from control subjects was mainly seen in the female patients and not in the male patients (neck of femur, p = 0.049; Ward's triangle, p = 0.025; lumbar spine, p = 0.039). In the female patients, there was significant negative correlation of BMD of the lumbar area of the spine and the trochanter of femur with daily inhaled steroid dose and positive correlation of BMD of the trochanter with BMI.

    Topics: Absorptiometry, Photon; Administration, Inhalation; Adult; Aerosols; Asthma; Beclomethasone; Bone Density; Bronchodilator Agents; Budesonide; Female; Humans; Male; Osteoporosis; Pregnenediones; Premenopause; Risk Factors; Time Factors

1994
[Current treatment of bronchial asthma].
    Medicina, 1993, Volume: 53, Issue:1

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Asthma; Beclomethasone; Bone Density; Bone Diseases, Metabolic; Humans

1993
Young patients on inhaled steroids and cataract.
    Lancet (London, England), 1993, Nov-20, Volume: 342, Issue:8882

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Cataract; Female; Humans

1993
[Inhalation therapy of patients with asthma].
    Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine, 1993, Sep-10, Volume: 82, Issue:9

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Asthma; Beclomethasone; Cromolyn Sodium; Humans; Middle Aged; Nebulizers and Vaporizers; Parasympatholytics; Particle Size

1993
Inhaled steroid maintenance treatment of severe asthma.
    Lancet (London, England), 1993, Feb-13, Volume: 341, Issue:8842

    Topics: Asthma; Beclomethasone; Humans; Lung Diseases, Obstructive

1993
Overnight urine growth hormone, cortisol and adenosine 3' 5' cyclic monophosphate excretion in children with chronic asthma treated with inhaled beclomethasone dipropionate.
    Respiratory medicine, 1993, Volume: 87, Issue:6

    Overnight urine samples were obtained from 34 asthmatic children, 24 of whom were receiving inhaled beclomethasone dipropionate (BDP), and 30 controls. The urine volume of the children receiving inhaled steroids was significantly greater than that of the other asthmatic children and of the controls (P < 0.05). Urine growth hormone was within the normal range for all of the subjects and there was no demonstrable relationship between urine growth hormone and height or height standard deviation score. Urine steroid output was significantly reduced in the BDP receiving group when the results were expressed in U l-1 but there was no difference between the groups when the results were expressed per specimen. Urine adenosine 3' 5' cyclic monophosphate (cAMP) results were similar for all groups. We conclude that use of BDP increases overnight urine volume but, in our study, does not appear to influence the output of urine cortisol. Urine free cortisol measurements may not be a very sensitive tool for the detection of small changes in endogenous steroid production. The use of BDP does not adversely affect the output of urine growth hormone.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Child; Cyclic AMP; Female; Growth Hormone; Humans; Hydrocortisone; Male; Urine

1993
Reversal of acute resistant asthma by beclomethasone.
    South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 1993, Volume: 83, Issue:8

    Topics: Acute Disease; Asthma; Beclomethasone; Humans

1993
Differences between inhaled and oral glucocorticoid therapy.
    The New England journal of medicine, 1993, Dec-02, Volume: 329, Issue:23

    Topics: Administration, Inhalation; Administration, Oral; Adult; Asthma; Beclomethasone; Budesonide; Child; Glucocorticoids; Humans; Pregnenediones

1993
Inhaled steroid use and glaucoma.
    The New England journal of medicine, 1993, Dec-09, Volume: 329, Issue:24

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Chronic Disease; Female; Glaucoma, Open-Angle; Humans; Middle Aged

1993
Effects of glucocorticoids on humoral and cellular immunity and on airway inflammation in patients with steroid-dependent intractable asthma.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1993, Volume: 30, Issue:6

    The effects of glucocorticoids on the proportion of lymphocytes in bronchoalveolar lavage (BAL) fluid in relation to humoral and cellular immunity were studied in 56 patients with steroid-dependent intractable asthma. To analyze the mechanism responsible for reduced numbers of BAL lymphocytes, we divided the subjects into 4 groups according to their BAL lymphocyte proportions: 0-4.9%, 5.0-9.9%, 10.0-14.9%, and 15.0-20.0%. Serum IgG levels and the peripheral lymphocyte count were significantly reduced in patients with a low proportion of BAL lymphocytes (less than 9.9%) than in those with more than 10% BAL lymphocytes. Delayed cutaneous reactivity to purified protein derivative was suppressed in patients with a low proportion of BAL lymphocytes (less than 4.9%). The mean proportion of BAL neutrophils tended to increase as the proportion of BAL lymphocytes decreased. These results show that the reduction in BAL lymphocytes produced by glucocorticoids is associated with suppressed humoral and cellular immunity, and that under such conditions the proportion of BAL neutrophils increases.

    Topics: Adult; Aged; Antibody Formation; Asthma; Beclomethasone; Bronchoalveolar Lavage Fluid; Female; Humans; Immunity, Cellular; Immunoglobulins; Leukocyte Count; Lymphocytes; Lymphopenia; Male; Middle Aged; Neutrophils; Prednisolone

1993
[Comparison of beta-2-agonist and beclomethasone effects on potassium levels, heart action and pulmonary ventilation parameters in patients with chronic asthmatic bronchitis].
    Wiadomosci lekarskie (Warsaw, Poland : 1960), 1993, Volume: 46, Issue:5-6

    The main goal of asthma treatment has usually been to maintain normal air potency with bronchodilators. A prompt improvement in physiologic measures of expiratory flow can be observed after administration beta-2-agonists or steroids. The present study aimed to assay the influence of fenoterol or beclomethasone therapy on the pulmonary ventilation (VC, FEV1, FEV1%), the heart action (heart rate, QT interval, 24 hours ECG) and the potassium balance in examined group. 20 patients with chronic asthmatic bronchitis were divided on two group (A and B). Group A consisted 10 subjects and patients were treated with fenoterol, the second group (Group B) consisted 10 subjects too, and patients were treated with beclomethasone. After five days treatment in all subjects an increase VC, FEV1 and FEV1% were observed. In group A (inhalation of fenoterol) we observed: 1--the significant increase of heart rate, QT interval, and frequency of cardiac arrhythmias and 2--significant decrease plasma potassium levels. In group B we didn't observed a significant changes in heart function and potassium levels. We concluded that nebulization of fenoterol, even in low doses, required control of the plasma potassium concentration and the evaluation of the heart action.

    Topics: Asthma; Beclomethasone; Bronchitis; Chronic Disease; Female; Fenoterol; Forced Expiratory Volume; Heart; Humans; Male; Middle Aged; Potassium; Respiratory Function Tests

1993
[High dose steroid inhalation therapy using a large spacer: laboratory and clinical study on usefulness of the 4-puffs/inhalation method].
    Nihon Kyobu Shikkan Gakkai zasshi, 1993, Volume: 31, Issue:10

    We investigated whether or not the inhalation method of beclomethasone dipropionate (BDP) influences patient compliance and the clinical effects of therapy in chronic bronchial asthma, together with a basic study on the lung deposition of BDP using a twin Impinger when various numbers of puffs were discharged into three different spacers (Volumatic, InspirEase, Aerochamber). It was clearly shown that only the spacer, Volumatic maintained a high deposition rate of BDP in the lung model with a dose of 4-puffs/inhalation. Eighteen chronic asthmatic patients were studied. The patients inhaled BDP (800-1600 micrograms/day) by 1-puff/inhalation using a large spacer, Volumatic, for 12 weeks, and they then inhaled the same dose of BDP as given in the previous period by 4-puffs/inhalation using the spacer for 16 weeks. We compared the compliance of BDP, attack score, %PEFR and frequency of beta-agonist inhalation between these two periods. The compliance of BDP was markedly improved after changing from 1-puff/inhalation (92.8%) to 4-puffs/inhalation (99.8%). In the 4-puffs/inhalation period, attack score and %PEFR were significantly improved as compared to the 1-puff/inhalation period. The frequency of beta-agonist inhalation use in the 4-puffs/inhalation period was significantly lower than that in the 1-puff/inhalation period. These results indicate that when high dose steroid inhalation is given with a large spacer in chronic asthmatic patients, we should advice them of the appropriate inhalation method in order to obtain good compliance and clinical effects.

    Topics: Adult; Asthma; Beclomethasone; Chronic Disease; Evaluation Studies as Topic; Female; Humans; Lung; Male; Middle Aged; Respiratory Therapy

1993
Current concepts in asthma management.
    Australian family physician, 1993, Volume: 22, Issue:10

    This short paper investigates the effects of prophylaxis on re-admission rates at the Royal Alexandra Hospital for Children, Camperdown, New South Wales.

    Topics: Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Cromolyn Sodium; Hospitalization; Humans; Pregnenediones; Recurrence

1993
Reversal of acute resistant asthma by beclomethasone.
    South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 1993, Volume: 83, Issue:8

    Topics: Acute Disease; Asthma; Beclomethasone; Humans

1993
Influence of airway inflammatory changes on airway hyperresponsiveness in asthmatics.
    Chinese medical journal, 1993, Volume: 106, Issue:4

    The effect of changes of airway inflammation on airway nonspecific reactivity were studied in 29 patients with chronic asthma. Detailed examinations of bronchial lavage (BAL) fluid and airway responses to histamine, propranolol and exercise were performed before and after treatment. The patients treated with steroids had significant improvements in parameters of BAL fluid cells and mediators with consistent changes of decreasing airway reactivities to propranolol and exercise after treatment. Whereas no significant changes occurred in the patients treated with B2-agonist either in inflammatory parameters or airway responses. On the other hand, airway response to histamine changed little in all asthmatic patients. Our study implied that inhibiting the airway inflammation in asthmatics may lead to marked decrease of airway response to non-mediator stimuli but fail to attenuate bronchial hyperresponse to mediator stimuli like histamine.

    Topics: Adult; Albuterol; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Bronchoalveolar Lavage Fluid; Exercise Test; Forced Expiratory Volume; Histamine; Humans; Inflammation; Middle Aged; Propranolol

1993
Effects of high doses of inhaled corticosteroids on adrenal function in children with severe persistent asthma.
    Thorax, 1993, Volume: 48, Issue:6

    Childhood asthma generally responds well to inhaled corticosteroids within the dosage range recommended by the manufacturers, but it is sometimes necessary to use higher doses--that is, above 400 micrograms/day--a practice which has become more widespread recently. Whereas the lack of adrenal suppression in children given inhaled corticosteroids in normal doses is well documented, little is known about the effects of higher doses.. The effects on adrenal function of high dose (above 400 micrograms/day) inhaled corticosteroids were evaluated by measuring cortisol concentration in the morning and performing a short tetracosactrin test in 49 children taking budesonide (mean age 9.2 years (range 4 to 16 years) and 28 children taking beclomethasone dipropionate (10.2 years (5 to 13 years)). Twenty three non-asthmatic children (8.9 years (4.9 to 13 years)) who were under investigation for short stature served as controls for the study.. Compared with controls mean basal cortisol concentration was lower in children taking budesonide and beclomethasone dipropionate (control 401 (26.8) nmol/l, budesonide 284 (22) nmol/l, beclomethasone dipropionate 279 (23.2) nmol/l). Sixteen of the 49 children taking budesonide had subnormal basal cortisol concentrations compared with seven of the 28 taking beclomethasone dipropionate. Mean stimulated cortisol concentrations were lower in children taking inhaled corticosteroids than in controls, with no difference between those taking budesonide or beclomethasone dipropionate.. Adrenal suppression occurs in some children who are given inhaled corticosteroids in doses greater than 400 micrograms/day. It may therefore be advisable to try alternative treatments before such doses are used.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex; Asthma; Beclomethasone; Body Height; Body Weight; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Female; Humans; Hydrocortisone; Male; Pregnenediones; Time Factors

1993
[Effect of nedocromil sodium on bronchial reactivity, selected lung function tests and demand for glucocorticosteroid inhalation in patients with bronchial asthma].
    Pneumonologia i alergologia polska, 1993, Volume: 61, Issue:7-8

    In a group of 14 patients with non-atopic asthma the effect on nedocromil sodium (8 mg/day) on bronchial reactivity, lung function parameters and doses of glucocorticosteroid in inhalation was studied. There was the significant reduction in beclomethasone doses, a rise in FEV1, FEF25-75 and decrease of PC20 histamine during 6 weeks of nedocromil therapy.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Bronchial Hyperreactivity; Female; Humans; Male; Middle Aged; Nedocromil; Respiratory Function Tests

1993
[The investigation on 100 bronchial asthma and asthmatic bronchitis cases treated with high dose beclomethasone dipropionate aerosol].
    Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases, 1993, Volume: 16, Issue:1

    100 cases, of which sixty four bronchial asthma patients and forty two asthmatic bronchitis patients sufficiently severe to be treated with inhaled corticosteroids, were investigated. All were treated with high dose beclomethasone dipropionate (BDP) inhaler aerosol (1500-2000 micrograms/day) for three months. The results showed the total effective rate was 98.4% in bronchial asthma patients and 62.5% in asthmatic bronchitis patients. The pulmonary functions and bronchial hyperresponsiveness of most bronchial asthmatic patients were improved significantly after 1-2 weeks treatment. It is recommendable to treat the oral cortisone-depending patients with BDP inhaler. After 3 months treatment, the adrenocortical secretive ability and reserve power of the patients could be slightly damaged. The investigation also showed 8 percent subjects complained of dysphonia and 25 percent suffered from oropharyngeal candidiasis. Finally, the asthmatic relapse rate was high after cessation of the therapy.

    Topics: Administration, Inhalation; Adult; Aerosols; Asthma; Beclomethasone; Bronchitis; Female; Humans; Male; Middle Aged

1993
Paradoxical bronchoconstriction in patients with stable asthma.
    The Medical journal of Australia, 1993, Oct-18, Volume: 159, Issue:8

    Topics: Asthma; Beclomethasone; Bronchoconstriction; Humans; Nebulizers and Vaporizers

1993
Bone metabolism in children with asthma treated with inhaled beclomethasone dipropionate.
    The Journal of pediatrics, 1993, Volume: 122, Issue:2

    Previous studies have shown that inhaled corticosteroids can affect bone metabolism in adults. A study to assess the effect of inhaled beclomethasone, 300 to 800 micrograms/day for at least 6 months (mean 25 months), was therefore undertaken in children. In part 1 of the study, 18 children with asthma, aged 4 to 17 years (mean 10.1 years), were compared with an age- and sex-matched group of children with asthma not treated with corticosteroids. In part 2, eight more pairs were compared. Comparisons were also made with 61 healthy children. Bone mineral density measured by radiographic absorptiometry, and bone mineral content measured by single-photon absorptiometry and by dual-energy x-ray absorptiometry, showed no significant differences. Serum levels of calcium, magnesium, zinc, total alkaline phosphatase, bone specific alkaline phosphatase, parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D also showed no differences. The activity of tartrate-resistant acid phosphatase, a marker of bone resorption, was significantly lower in the beclomethasone group than in both the asthma control and the normal control groups, but urine calcium excretion did not differ. Patients with asthma had lower serum osteocalcin and higher serum copper levels than control subjects without asthma, but treatment with beclomethasone did not affect these values. We conclude that inhaled beclomethasone (up to 800 micrograms/day) does not reduce bone mineralization or increase bone resorption. Effects on bone formation were difficult to assess because asthma per se caused a significant reduction in osteocalcin, a sensitive marker of bone formation.

    Topics: Acid Phosphatase; Administration, Inhalation; Adolescent; Asthma; Beclomethasone; Bone and Bones; Bone Density; Case-Control Studies; Child; Child, Preschool; Copper; Female; Humans; Male; Minerals; Osteocalcin; Phosphorus; Time Factors

1993
Advances in the management of childhood asthma.
    The Western journal of medicine, 1993, Volume: 158, Issue:2

    Topics: Administration, Topical; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Cromolyn Sodium; Fluocinolone Acetonide; Humans; Theophylline; Triamcinolone Acetonide

1993
[Efficacy of long-term beclomethasone dipropionate inhalation therapy in pediatric patients with asthma, and its effect on height growth and adrenocortical functions].
    Arerugi = [Allergy], 1993, Volume: 42, Issue:1

    Seventy-eight pediatric patients with moderate to severe chronic asthma, aged 6 to 16 years, who failed to respond well to inhaled DSCG and theophylline RTC, were treated with beclomethasone dipropionate inhaler (BDI) for 0.5 to 10 years (mean: 4.2 +/- 2.4 years). The efficacy rate gradually increased with time: 61.1% at one year after the start of the treatment and 89.5% at three years. Long-term BDI therapy over five years did not cause suppression of height growth or adrenocortical functions (early morning cortisol level and rapid ACTH test). However, the safety of long-term BDI therapy in children still needs to be studied more thoroughly and established. Further investigation will be necessary since some cases did not respond to BDI therapy while others died of exacerbated asthmatic symptoms soon after the start of BDI therapy.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex; Adrenal Cortex Function Tests; Asthma; Beclomethasone; Body Height; Child; Chronic Disease; Female; Humans; Hydrocortisone; Male

1993
Acne induced by inhaled corticosteroids.
    Clinical and experimental dermatology, 1993, Volume: 18, Issue:2

    Four cases of acne apparently induced by inhalation of potent corticosteroids prescribed for the treatment of asthma are described. In one case there appeared to be a dose-dependent relationship. While acne induced by topical or systemic administration of corticosteroids is well recognized, acne following inhaled corticosteroids has not previously been reported.

    Topics: Acne Vulgaris; Administration, Inhalation; Adult; Asthma; Beclomethasone; Drug Eruptions; Female; Humans; Male; Middle Aged

1993
Changes in bronchoalveolar lavage inflammatory cells in asthmatic patients treated with high dose inhaled beclomethasone dipropionate.
    The European respiratory journal, 1993, Volume: 6, Issue:4

    Using serial bronchoalveolar lavage (BAL), we have studied changes in the airway inflammatory cell populations in 20 asthmatic patients, before and after treatment with inhaled beclomethasone dipropionate (BDP), 2,000 micrograms daily in an uncontrolled study. There was a significant improvement in asthma severity, as measured by symptom score and airways responsiveness, and there were significant reductions in the total BAL eosinophil, epithelial cell and mast cell counts, with a significant increase in the percentage BAL lymphocyte count. No significant correlations were found between the changes in airway inflammatory cell numbers and the reduction in asthma severity. In contrast, the fall in ROS generation by the pulmonary macrophage and granulocyte populations was nonsignificant, but the improvement in airways responsiveness was positively correlated to the reduction in the unstimulated pulmonary macrophage activity. Although these data are uncontrolled, the results are compatible with previous studies in suggesting an effect of steroids on the eosinophil, mast cell and epithelial cell in asthmatic airways. They also highlight the probable importance of the luminal lymphocyte population and pulmonary macrophage activation within the asthmatic airway, the beneficial modulatory effect of inhaled BDP treatment upon them, and the relative steroid-resistance of pulmonary inflammatory cell activity.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Bronchi; Bronchoalveolar Lavage Fluid; Cell Count; Eosinophils; Female; Humans; Lymphocytes; Macrophages, Alveolar; Male; Mast Cells; Middle Aged; Reactive Oxygen Species

1993
Comparison of the effects on bronchial hyperresponsiveness of antiallergic agents and beclomethasone dipropionate in long-term bronchial asthma. A retrospective study.
    Allergy, 1993, Volume: 48, Issue:3

    The effect of antiallergic agents (DSCG) (disodium cromoglycate, ketotifen, and ibudilast) and beclomethasone dipropionate inhaler (BDI) on bronchial hyperresponsiveness to histamine inhalation was retrospectively assessed in 72 asthmatic patients with more than a year's duration of the disease. Decrease in bronchial hyperresponsiveness to histamine was observed in 10 out of the 33 (30%) antiallergic-agents-treated patients (group A, mean duration = 7.8 months), in 12 of 19 (63.2%) BDI-treated patients (group B, 6.2 months), but only 2 of the 20 (10%) control patients (group C, 7.8 months). Improvement of histamine PC20 was from 310 to 597 micrograms/ml (P < 0.01) in group A, from 308 to 1622 micrograms/ml (P < 0.0005) in group B, and from 575 to 525 micrograms/ml (NS) in group C. A significant decrease in the peripheral eosinophil count was observed only in group B. The improvement in bronchial hyperresponsiveness was parallel with that of asthmatic symptoms; the percentage of patients becoming symptom-free rose from 12 to 42%, 5 to 89%, and 5 to 20% in groups A, B, and C, respectively. Out of 11 unimproved patients in group A, 7 showed a significant improvement in their histamine PC20 by BDI treatment (mean PC20: 311-->1828 micrograms/ml). These results suggest that BDI might be more effective than antiallergic agents in the treatment of patients with long-standing bronchial asthma.

    Topics: Adolescent; Adult; Aged; Asthma; Beclomethasone; Bronchial Hyperreactivity; Bronchial Provocation Tests; Cromolyn Sodium; Female; Forced Expiratory Volume; Histamine; Humans; Immunoglobulin E; Ketotifen; Male; Middle Aged; Pyridines; Retrospective Studies; Vasodilator Agents; Vital Capacity

1993
Stepping up the treatment of children with asthma.
    Pediatrics, 1993, Volume: 92, Issue:1

    Topics: Adolescent; Adrenal Cortex Hormones; Asthma; Beclomethasone; Child; Chronic Disease; Drug Therapy, Combination; Humans

1993
[A new steroid therapy for difficult asthmatics--an induction and maintenance, two-step therapy].
    Arerugi = [Allergy], 1992, Volume: 41, Issue:12

    Beclomethasone dipropionate (BDP) administered by inhaler is a very useful drug for the treatment of bronchial asthma. In this therapy, it is very important to use steroids systematically to induce a complete remission of asthma attack (first step) and then begin to use BDP a dose of more than 800 micrograms to maintain remission (second step). We treated 27 difficult asthmatics with this therapy and found this new method very useful. The characteristics of asthmatics were as follows. 1) The age ranged from 37 to 82, and the mean age (+/- S.E.) was 58.9 (+/- 2.6) years old. 2) The onset age ranged from 27 to 74 with a mean age (+/- S.E.) of 46.9 (+/- 2.6) year old. 3) The number of non-atopy was 22 cases. 4) The follow-up duration ranged from 5 to 45 months with a mean (+/- S.E.) of 15 (+/- 2.0) months. The results were as follows. 1) The complete remission rate was 48%, partial remission 37% and unchanged 15%. 2) There was a significant increase only in %VC. 3) The peripheral eosinophil count was decreased significantly. 4) The log value of PC20 concentration by acetylcholine increased significantly by a factor of 2.94 to 3.28. 5) After this therapy, the mean serum cortisol level at 9:00 a.m. was 10.1 (+/- 3.8, S.E.) micrograms/ml. There were only 2 cases whose cortisol level were under the normal. 6) There were many oral side effects, namely stomatitis with 5 cases and hoarseness with 8.

    Topics: Adult; Aged; Aged, 80 and over; Asthma; Beclomethasone; Female; Humans; Hydrocortisone; Male; Methylprednisolone; Middle Aged

1992
Integrated plasma cortisol concentration in children with asthma receiving long-term inhaled corticosteroids.
    Pediatric pulmonology, 1992, Volume: 12, Issue:2

    We assessed the effect of long-term therapy with inhaled beclomethasone dipropionate (BDP) on the pituitary-adrenal axis, by measuring the integrated concentration (IC) of plasma cortisol in eight children with asthma (age, 6-16 years) who regularly used inhaled BDP in doses ranging from 8 to 26.5 micrograms/kg (200-450 micrograms/day) for 6 months to 4 years. The control group included six children (age, 6-16 years) who had the IC of plasma cortisol measured as part of an endocrinological evaluation and were found to be healthy. Cortisol concentration was measured in blood samples collected continuously over a 24-hr period. Mean IC of plasma cortisol in the study group was significantly lower than in the healthy controls (mean +/- SD, 4.9 +/- 3.3 vs 9.1 +/- 1.9 micrograms/mL; P less than 0.02). Cortisol response to 0.25 mg ACTH (iv) was abnormal in one of the eight BDP-treated patients. No correlation was found between IC of plasma cortisol and the BDP dose, severity of asthma, height percentile, or the Tanner stage. We conclude that long-term therapy, even with relatively conventional doses of inhaled BDP may cause reduction in the normal physiological secretion of cortisol. The clinical relevance of low IC of plasma cortisol is not clear, but it may reflect partial suppression of the pituitary-adrenal axis.

    Topics: Administration, Inhalation; Adolescent; Adrenocorticotropic Hormone; Aerosols; Asthma; Beclomethasone; Child; Depression, Chemical; Female; Humans; Hydrocortisone; Male; Pituitary-Adrenal System; Time Factors

1992
[The long-term effect of high-dose beclomethasone dipropionate on the pituitary-adrenal function].
    Arerugi = [Allergy], 1992, Volume: 41, Issue:6

    The pituitary-adrenal function was studied in seven asthmatic subjects who had been received daily inhalations of 800 to 1,000 micrograms of beclomethasone dipropionate (BDP) over a year. None of the subjects had taken oral corticosteroids for at least six months prior to the study. As indices of pituitary-adrenal function, 1) circadian rhythm of plasma ACTH and cortisol, 2) urine 17-OHCS and 17-KS, and 3) the response of cortisol in rapid ACTH test were examined. All subjects showed normal circadian rhythms of plasma ACTH and cortisol levels. Urinary 17-OHCS and 17-KS excretions over a 24-hour period were also within the normal range. Plasma cortisol levels in the rapid ACTH test were significantly increased and judged as normal responses in all subjects. These results indicate that long-term treatment with BDP ranging from 800 to 1,000 micrograms/day induces no suppressive effect on the pituitary-adrenal function.

    Topics: Adrenocorticotropic Hormone; Adult; Asthma; Beclomethasone; Circadian Rhythm; Female; Humans; Hydrocortisone; Male; Middle Aged; Pituitary-Adrenal System

1992
[Regular use of inhaled beta-agonist and steroid in the therapy of asthma].
    Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine, 1992, Jun-10, Volume: 81, Issue:6

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Asthma; Beclomethasone; Chronic Disease; Cromolyn Sodium; Humans; Nebulizers and Vaporizers; Parasympatholytics

1992
[Asthma in the elderly].
    Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine, 1992, Jun-10, Volume: 81, Issue:6

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Asthma; Beclomethasone; Cromolyn Sodium; Diagnosis, Differential; Humans; Lung; Lung Compliance; Lung Volume Measurements; Oxygen Inhalation Therapy; Patient Education as Topic; Status Asthmaticus; Theophylline

1992
[Necessity and limitations of effectiveness of oral beta-stimulants, theophylline and oral antiallergic drugs in asthma treatment].
    Nihon Kyobu Shikkan Gakkai zasshi, 1992, Volume: 30, Issue:9

    Oral beta-stimulants, theophylline and oral antiallergic drugs are frequently used for asthma treatment in Japan. However, inhaled beta-stimulants and inhaled steroids are becoming the first and second choice of drugs in asthma treatment in European countries, and these three categories of drugs are becoming third or fourth-line therapeutic choices. Accordingly, we investigated the effectiveness of these drugs, which is limited by their pharmacological actions and effects. As found in this study many cases of bronchial asthma cannot be well controlled by their agents, either alone or in combination. The necessity of these drugs for the treatment of chronic bronchial asthma was investigated. Substitution of inhaled beta-stimulant for oral beta-stimulant was possible in 8 of 15 cases. However, in 7 cases, substitution was impossible because of the patient's complaints, and it could not be concluded that oral beta-stimulants are necessary for asthma treatment. Theophylline was substituted by inhaled corticosteroids in 6 of 8 cases. Oral antiallergic drugs were substituted by inhaled corticosteroids in 5 of 6 cases. These results do not conclusively indicate that theophylline and oral antiallergic drugs are not necessary for asthma treatment.

    Topics: Administration, Oral; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Asthma; Beclomethasone; Histamine Antagonists; Humans; Theophylline

1992
Intercellular adhesion molecule-1 (ICAM-1) and endothelial leucocyte adhesion molecule-1 (ELAM-1) expression in the bronchial mucosa of normal and asthmatic subjects.
    The European respiratory journal, 1992, Volume: 5, Issue:7

    Bronchial lavage and biopsy studies suggest the involvement of eosinophils and T-lymphocytes in allergic inflammation in asthma. There is evidence suggesting that the expression of adhesion molecules on endothelial cells and of their receptors on leucocytes is involved in this process. To investigate these mechanisms we have obtained bronchial mucosal biopsies from 10 normal subjects and from 10 symptomatic atopic asthmatics. Six of the asthmatics were re-biopsied after 6 weeks of inhaled beclomethasone dipropionate (BDP) during which time their clinical response was monitored. Frozen sections were stained by the immunoperoxidase method using monoclonal antibody (MoAb) 6.5B5 to identify expression of intercellular adhesion molecule (ICAM-1) and MoAb 1.2B6 for endothelial leucocyte adhesion molecule (ELAM-1). Araldite-embedded sections were also stained for eosinophils using MoAb EG2 to identify eosinophilic cationic protein (ECP). A significant mucosal eosinophilia was apparent in the asthmatic but not in the normal biopsies. Immunostaining for ICAM-1 was observed in both the epithelium and endothelium and ELAM-1 in endothelium, with no significant differences being apparent between the asthmatic and normal subjects. Topical BDP markedly reduced the mucosal eosinophilia without affecting the expression of either adhesion molecule. Using this method, we conclude that there is basal expression of ICAM-1 and ELAM-1 in normal human bronchial mucosa, which is not significantly different from that in asthmatics, and that it is insensitive to suppression with corticosteroids at an inhaled dose that causes clinical improvement.

    Topics: Adult; Antigens, CD; Asthma; Beclomethasone; Bronchi; Cell Adhesion Molecules; E-Selectin; Female; Humans; Immunoenzyme Techniques; Intercellular Adhesion Molecule-1; Male; Mucous Membrane; Receptors, Immunologic

1992
Inhaled beclomethasone decreases serum osteocalcin in postmenopausal asthmatic women.
    Bone, 1992, Volume: 13, Issue:4

    There are very few data as yet to quantify the effect of inhaled corticosteroids on bone metabolism, although the use of these drugs as a first-line treatment in bronchial asthma has widened. We determined the effect of three dose levels (200, 1000, 2000 micrograms/day, three weeks each) of inhaled beclomethasone on specific characteristics of bone metabolism in nine postmenopausal women with new asthma without any previous corticosteroid therapy. Significant decrease was noted in the mean serum morning osteocalcin concentration between the baseline and after nine weeks of beclomethasone (from 4.4 to 3.1 micrograms/l, p = 0.005). Significant increase in serum total and ionised calcium was found, although the parameters measuring bone resorption itself did not change. The results show that especially high-dose inhaled beclomethasone decreases serum osteocalcin in post-menopausal asthmatic women. Further studies are needed to assess the effects of inhaled beclomethasone, both on the ability of the osteoblasts to form bone matrix and on the density of bone during a longer treatment period on inhaled corticosteroids.

    Topics: Administration, Inhalation; Aged; Asthma; Beclomethasone; Calcium; Female; Humans; Menopause; Middle Aged; Osteocalcin; Risk Factors

1992
[Application of adrenal cortex hormones in the treatment of asthma].
    Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine, 1992, Jun-10, Volume: 81, Issue:6

    Topics: Administration, Inhalation; Arachidonic Acid; Asthma; Beclomethasone; Bronchi; Bronchial Hyperreactivity; Humans; Prednisolone; SRS-A

1992
An evaluation of severity-modulated compliance with q.i.d. dosing of inhaled beclomethasone.
    Chest, 1992, Volume: 102, Issue:5

    Although the asthmatic subject's compliance with a regimen of inhaled corticosteroids is often poor, it has been suggested this may improve during periods of increased severity. To test this, we measured daily peak expiratory flow rates (PEFRs), asthma symptoms, and the use of an albuterol inhaler over nine weeks period in ten patients with moderately severe asthma. The effect of changes in these severity indices on compliance with a q.i.d. regimen of inhaled beclomethasone was evaluated. The PEFR was measured in the morning before bronchodilator administration, and symptoms were graded on a scale of 4 to 16, while albuterol and beclomethasone inhalations were electronically recorded. Three measures of compliance with the beclomethasone regimen were used: (1) mean daily compliance ([number of inhalations/number of prescribed inhalations] x 100); (2) underuse, ie, the percentage of days with less than the prescribed number of inhalations; and (3) overuse, ie, the percentage of days with greater than the prescribed number of inhalations. Mean daily compliance was 67 +/- 36 percent, while underuse was observed in 69 percent and overuse in 11 percent of the days. Despite clinical exacerbations in six of the ten patients and considerable variation in the severity indices, no significant relationship was found between the change in asthma severity and compliance with the beclomethasone regimen. These findings do not support the concept of severity-modulated compliance with inhaled corticosteroids.

    Topics: Administration, Inhalation; Adult; Albuterol; Asthma; Beclomethasone; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Patient Compliance; Peak Expiratory Flow Rate

1992
Inhaled steroids modify bronchial responses to hyperosmolar saline.
    The European respiratory journal, 1992, Volume: 5, Issue:8

    We investigated the effects of inhaled beclomethasone dipropionate (BDP) on airway sensitivity (provocative dose producing a 20% fall in forced expiratory volume in one second (FEV1) from baseline (PD20)) and reactivity (slope of the dose-response curve) to inhaled aerosols of hyperosmolar (4.5%) saline, and histamine or methacholine. This was an open study on 13 patients referred to the laboratory by their respiratory physician for investigation of their asthma. These challenges were performed on separate days before (initial visit) and 8.8 +/- 0.8 (SD) weeks (range 5.6-12.4 weeks) after (visit 1) a treatment period with BDP (dose range 600-1,500 micrograms.day-1). At visit 1 there was a significant reduction in sensitivity to 4.5% NaCl and histamine/methacholine and in reactivity. The PD20 increased 5.6 fold for 4.5% NaCl and 4.1 fold for histamine/methacholine. All patients remained responsive to histamine/methacholine and a fall in FEV1 > 20% to 4.5% saline was documented in 10 of the 13 patients. We conclude that treatment with BDP reduces sensitivity and reactivity to both osmotic and pharmacological challenge.

    Topics: Administration, Inhalation; Adolescent; Adult; Asthma; Beclomethasone; Bronchi; Bronchial Provocation Tests; Dose-Response Relationship, Drug; Female; Forced Expiratory Volume; Histamine; Humans; Male; Methacholine Chloride; Osmolar Concentration; Pilot Projects; Sodium Chloride

1992
[An evaluation of the efficacy of Beclometh in bronchial asthma patients].
    Terapevticheskii arkhiv, 1992, Volume: 64, Issue:3

    Fifteen bronchial asthma patients were followed-up for 6 months. They were administered beclomet-250 in a daily dose 1000 micrograms. The patients' clinical status was characterized by positive changes, ventilation function of the lungs improved. The drug was discovered to produce no suppressive action on adrenal function. Besides, the patients did not develop oropharyngeal candidiasis.

    Topics: Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Chronic Disease; Drug Evaluation; Female; Humans; Hydrocortisone; Male; Middle Aged; Respiration; Time Factors

1992
Pulmonary tuberculosis in patients treated with inhaled beclomethasone.
    Allergy, 1992, Volume: 47, Issue:4 Pt 1

    Inhaled beclomethasone dipropionate (BDP) has been used with few side-effects in the treatment of bronchial asthma for 2 decades. Until now the manifestation of tuberculosis (TB) in patients on inhaled BDP has not been reported. Eight patients with allergic asthma, of a total of 548 asthmatics (1.46%) seen over a 2-year period, developed active TB following the use of inhaled BDP. All were sputum-positive for acid-fast bacilli (AFB) on smear and/or culture, all responded well to a combination of anti-TB drugs, and none showed evidence of immunological or pituitary-adrenal suppression. Two patients agreed to a repeat administration of BDP; both developed TB again within 2 weeks and are again on anti-TB treatment.

    Topics: Administration, Inhalation; Adolescent; Adult; Antitubercular Agents; Asthma; Beclomethasone; Female; Humans; Male; Mycobacterium tuberculosis; Tuberculosis, Pulmonary

1992
[Peripheral airway obstruction and treatment].
    Nihon Kyobu Shikkan Gakkai zasshi, 1992, Volume: 30, Issue:9

    The effect of medication on peripheral airway obstruction was examined in cases of bronchial asthma. Subjects were 1) patients with exercise-induced asthma, 2) an animal model of hyperventilation-induced asthma and 3) patients with chronic asthma. Peripheral airway obstruction was induced in 30 of 51 patients with exercise-induced asthma. Induction of peripheral airway obstruction was protected significantly by procaterol. Cromoglycate was effective in 12 of 17 patients but ipratropium was not effective against induction of peripheral airway obstruction. In the animal model, humid air inhalation, procaterol and ipratropium completely prevented hyperventilation-induced bronchoconstriction, but cromoglycate caused only partial prevention. In cases of chronic asthma with peripheral airway obstruction, beclomethasone inhalation reduced the symptom rating rapidly, but no changes were observed in pulmonary function and threshold of airway responsiveness. Cromoglycate was started in patients with chronic asthma who had been treated with beclomethasone. After cromoglycate administration, therapeutic rating decreased, but increased again after 8 weeks of cromoglycate therapy. Peripheral airway obstruction induced by exercise or hyperventilation could be prevented by adequate premedication, but chronic peripheral airway obstruction was difficult to treat.

    Topics: Administration, Inhalation; Airway Obstruction; Animals; Asthma; Asthma, Exercise-Induced; Beclomethasone; Cromolyn Sodium; Histamine; Humans; Ipratropium; Procaterol; Rabbits

1992
Mood variability in asthmatic patients: a case report.
    The British journal of general practice : the journal of the Royal College of General Practitioners, 1992, Volume: 42, Issue:362

    Topics: Adult; Affect; Asthma; Beclomethasone; Female; Humans; Lung; Peak Expiratory Flow Rate

1992
Hypothalamo-pituitary-adrenal axis suppression in asthmatic adults taking high dose beclomethasone dipropionate.
    The British journal of clinical practice, 1992,Summer, Volume: 46, Issue:2

    Inhaled corticosteroids control symptoms of chronic asthma in most patients. Use of drugs such as beclomethasone dipropionate (BDP) and budesonide is being encouraged as the importance of airways inflammation in asthma is increasingly appreciated. Beclomethasone dipropionate is used in doses of up to 2000 micrograms daily (equivalent to eight puffs of Beclorforte inhaler) and the Data Sheet warns that systemic absorption sufficient to cause suppression of the hypothalamo-pituitary-adrenal (HPA) axis may occur in some patients taking 2000 micrograms. HPA suppression to an extent which is clinically relevant has not been reported in asthmatic adults taking lower doses of BDP. We report six cases of HPA hypofunction occurring in patients on long-term treatment with BDP, in a dose of 1500 micrograms daily. Patients taking BDP in a dose of 1500 micrograms daily might be at risk of adrenal crisis and should carry steroid cards unless HPA function has been assessed and found normal.

    Topics: Adult; Asthma; Beclomethasone; Female; Humans; Hypothalamo-Hypophyseal System; Male; Middle Aged; Pituitary-Adrenal System

1992
High dose inhaled steroid therapy and the cortisol stress response to acute severe asthma.
    Respiratory medicine, 1992, Volume: 86, Issue:6

    Systemic absorption of inhaled corticosteroids taken in high doses (> or = 1500 micrograms beclomethasone dipropionate or budesonide daily), may cause suppression of the hypothalamo-pituitary-adrenal axis. Patients taking long-term high dose inhaled steroid therapy might therefore be at risk of adrenal crisis at times of stress. Plasma cortisol levels were measured in 24 adults with severe acute asthma who had not received treatment with systemic corticosteroids prior to hospital attendance. Seven were not taking inhaled steroids, four were taking 600-1200 micrograms and 13 were taking 1500-2400 micrograms beclomethasone dipropionate or budesonide daily. Plasma cortisol levels in these 13 (median 594 nmol l-1, interquartile range 399-620 nmol l-1) were similar to levels in those taking lower dose/no inhaled steroids (median 512 nmol l-1, interquartile range 287-1050 nmol l-1): there was no relationship between inhaled steroid dose and cortisol level. Nine of the 24 patients failed to achieve plasma cortisol values > 500 nmol l-1 (the normal response to an insulin stress test). When compared with the remaining 15, they had less severe asthma as indicated by higher arterial oxygen tension (P < 0.01) and peak expiratory flow (P < 0.03). Patients taking long-term high dose inhaled corticosteroids appear to be able to mount an appropriate adrenocortical response to the stress of severe acute asthma.

    Topics: Acute Disease; Administration, Inhalation; Administration, Topical; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Drug Administration Schedule; Female; Humans; Hydrocortisone; Male; Pregnenediones; Stress, Physiological

1992
Adrenal function of children with bronchial asthma treated with beclomethasone dipropionate.
    Annals of allergy, 1992, Volume: 69, Issue:6

    The function of the hypothalamic-pituitary-adrenal (HPA) axis was investigated in nine asthmatic children treated by inhalation of beclomethasone dipropionate (300 micrograms/day) for 12 weeks. The trial was designed as a prospective study. The 24-hour urinary free cortisol, serum cortisol, response to ACTH, and nocturnal serum cortisol followed by 20-minute sampling were measured before and after the study period. No significant changes were found, suggesting that inhaled beclomethasone, in a daily dose of 300 micrograms, does not cause suppression of the HPA axis.

    Topics: Administration, Inhalation; Adolescent; Adrenal Glands; Asthma; Beclomethasone; Child; Female; Humans; Hypothalamo-Hypophyseal System; Male; Pituitary-Adrenal System

1992
Bone density in asthmatic patients taking high dose inhaled beclomethasone dipropionate and intermittent systemic corticosteroids.
    Thorax, 1992, Volume: 47, Issue:6

    Asthmatic patients taking low to moderate doses of inhaled topical corticosteroids have been shown to have lower bone density than those taking bronchodilators only. There is little information on bone density in asthmatic patients taking high dose inhaled corticosteroids.. Bone mass was studied in three age matched groups of asthmatic patients. These comprised: 17 asthmatic patients who had never taken inhaled or systemic corticosteroids (group 1); 20 patients who had taken beclomethasone diproprionate in a dosage of 1000-2000 micrograms daily for at least a year, who had also received courses of systemic corticosteroids in the past (group 2); and 20 patients who were taking both high dose inhaled corticosteroids and regular low dose prednisolone, at a median dose of 7 mg daily (group 3). Vertebral bone density was measured by quantitative computed tomography. Biochemical indices of bone formation and resorption were also measured.. Mean bone density in group 2 (127.5(22.6) mg/ml) was similar to that in group 3 (114.5 (36.0) mg/ml). Bone density was significantly lower in both of these groups than in group 1 (160.4 (27.4) mg/ml). There were no significant differences between groups for any of the markers of bone formation and resorption.. Asthmatic patients receiving high dose inhaled beclomethasone and intermittent courses of systemic corticosteroids have reduced vertebral bone density. The bone loss is similar in degree to that seen in patients taking high dose inhaled topical corticosteroids and continuous low dose systemic corticosteroids.

    Topics: Administration, Inhalation; Administration, Oral; Adrenal Cortex Hormones; Asthma; Beclomethasone; Bone Density; Dose-Response Relationship, Drug; Female; Forced Expiratory Volume; Humans; Lumbar Vertebrae; Male; Middle Aged

1992
Treatment with inhaled steroids in asthma and chronic bronchitis: long-term compliance and inhaler technique.
    Family practice, 1992, Volume: 9, Issue:2

    We investigated compliance and inhaler technique in 50 patients with airway obstruction (26 asthma, 24 chronic bronchitis) being treated with inhaled steroid (beclomethasone dipropionate, BDP) via a dry powder inhaler (Rotahaler omega). Patients had already participated for one year in a 2-year trial of BDP in general practice. They were treated daily with two dry powder inhalations of 400 micrograms BDP in combination with a bronchodilator. Compliance with BDP was measured by counting capsules (single-blind) at the end of a 4-month period and through a questionnaire. Counting capsules revealed non-compliance in 46% of the patients. Compliance was not related to age, sex, diagnosis or side-effects of BDP. In chronic bronchitis, but not in asthma, compliance was related to the outcome parameters of steroid treatment (pulmonary symptoms, change in lung function and non-specific bronchial responsiveness). The inhaler technique was judged insufficient in 27% of the patients. This study stresses the importance of regular instruction in inhaler technique and proper information about prophylactic steroid treatment by the general practitioner during the treatment of asthma and chronic bronchitis.

    Topics: Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Bronchitis; Chronic Disease; Evaluation Studies as Topic; Female; Humans; Male; Middle Aged; Patient Compliance; Patient Education as Topic; Treatment Outcome

1992
On growth of children under inhaled steroid treatment.
    Pediatric pulmonology, 1992, Volume: 13, Issue:4

    Topics: Administration, Inhalation; Adolescent; Asthma; Beclomethasone; Child; Child, Preschool; Female; Growth; Humans; Male

1992
[Inhaled glucocorticoids. Slight side effects at high effectiveness].
    Deutsche medizinische Wochenschrift (1946), 1992, Mar-06, Volume: 117, Issue:10

    Topics: Administration, Oral; Adolescent; Adult; Asthma; Beclomethasone; Child; Glucocorticoids; Humans; Prognosis; Quality of Life; Respiratory Therapy; Theophylline

1992
Methotrexate treatment of severe asthma in children.
    Pediatrics, 1992, Volume: 89, Issue:4 Pt 1

    Seven children from 3 to 14 years old with chronic steroid-dependent asthma were treated with methotrexate (MTX). Asthma in all of the patients had been poorly controlled for at least 2 years despite the use of oral theophylline and inhaled corticosteroids, cromolyn and albuterol. All presented with significant side effects as a result of chronic systemic steroid therapy. Five patients were atopic and had been unable to tolerate immunotherapy because of systemic reactions. Forced expiratory volume in 1 second and forced expiratory flow, mid-expiratory phase, improved in four patients after 4 to 6 months of treatment with doses of MTX ranging from 7.5 to 17.5 mg/wk. Three patients were able to discontinue their systemic corticosteroids. Laboratory values including complete blood cell count with differential and liver enzymes remained at baseline in all except one patient, who had transient elevation in alanine aminotransferase and aspartate aminotransferase. One patient experienced side effects sufficient to require discontinuation of MTX. It is concluded that MTX is effective for reducing the need for systemic corticosteroids and for improving pulmonary functions in some individuals. The benefits of MTX in this group of severe asthmatics appear to justify the potential risks involved in its use.

    Topics: Adolescent; Albuterol; Asthma; Beclomethasone; Body Height; Body Weight; Child; Child, Preschool; Cromolyn Sodium; Female; Forced Expiratory Volume; Humans; Male; Maximal Expiratory Flow Rate; Methotrexate; Prednisone; Spirometry; Theophylline; Vital Capacity

1992
Inhaled glucocorticoid therapy in children: how much is safe?
    Pediatric pulmonology, 1992, Volume: 12, Issue:2

    Topics: Administration, Inhalation; Aerosols; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Depression, Chemical; Humans; Hypothalamo-Hypophyseal System; Pituitary-Adrenal System; Pregnenediones

1992
Inhaled steroids in asthma.
    Comprehensive therapy, 1992, Volume: 18, Issue:3

    Inhaled corticosteroids provide a relatively trouble free means of treating the airway inflammation of asthma and can allow for the reduction of both oral steroid use and the symptoms in asthmatics using bronchodilators. Conventional doses may not be sufficient to provide control in many patients, and dosing should be tailored to the individual. These higher doses may cause systemic side effects, but these are less than those incurred by using oral prednisone.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchial Hyperreactivity; Fluocinolone Acetonide; Humans; Triamcinolone Acetonide

1992
[Long-term tolerance of inhaled corticosteroids].
    Revue des maladies respiratoires, 1992, Volume: 9 Suppl 1

    The effect of inhaled steroids on adrenal glands of asthmatic subjects are often difficult to assess because subjects may have received oral steroids before. Moreover, even if the Synacthen test is abnormal, it does not necessarily mean that the adrenals are clinically inefficient. Adrenal insufficiency can certainly occur at high doses of inhaled steroids. Possible long term effects on bone are under study. Ecchymosis has been described. Oropharyngeal candidiasis is frequent but rarely symptomatic and responds well to treatment. Hoarseness is rare but troublesome. In children, inhaled steroids, even taken at low dose, can induce growth impairment. After cessation of inhaled steroids, adrenal insufficiency is only theoretical. Asthmatic flare-ups are more of a threat. Although inhaled steroids are of remarkable efficacy and tolerance, one should not exclude the possibility of long-term negative effects, especially in children.

    Topics: Administration, Inhalation; Administration, Topical; Adrenal Glands; Adult; Age Factors; Anti-Inflammatory Agents; Asthma; Beclomethasone; Budesonide; Child; Cosyntropin; Drug Tolerance; Glucocorticoids; Growth Disorders; Humans; Pregnenediones

1992
Asthma knowledge and management in primary schools in south Auckland.
    The New Zealand medical journal, 1992, Jul-08, Volume: 105, Issue:937

    to examine the management of asthma in primary schools and the school teachers' knowledge, confidence and attitude in managing the pupils with asthma.. forty-two primary schools in south Auckland were randomly selected to participate. Questionnaires were posted out to the principals and another questionnaire was given randomly to 253 teachers from these primary schools.. 76% of the school principals surveyed returned the questionnaire; and 66% of the school teachers surveyed returned a separate questionnaire. The average incidence of asthma reported by school principals and school teachers was 9.9% and 12.6% respectively, which suggests underreporting of the diagnosis of asthma. In 81% of the schools a questionnaire was used to identify students with asthma when they first join the school. School teachers had good basic knowledge on asthma, however 33% of teachers did not know that Ventolin (salbutamol) is for symptomatic treatment and 58% and 65% of teachers did not know that Becotide (beclomethasone) and Intal (sodium cromoglycate) are prophylactic medications.. we suggest that primary school teachers should receive further education on asthma, especially on practical aspects of asthma management.

    Topics: Albuterol; Asthma; Beclomethasone; Child; Cromolyn Sodium; Evaluation Studies as Topic; Faculty; Health Knowledge, Attitudes, Practice; Humans; Incidence; New Zealand; School Health Services; Surveys and Questionnaires

1992
Asthma, inhaled corticosteroid treatment, and growth.
    Archives of disease in childhood, 1992, Volume: 67, Issue:6

    To evaluate the effects on growth of inhaled corticosteroid treatment (ICT) and of the quality of control of asthma, height velocity was studied in 58 prepubertal children attending a specialist asthma clinic because of chronic asthma that was difficult to control. The height velocity standard deviation (SD) score was maximal when the asthma was well controlled both before (0.01) and after (-0.07) starting ICT. It was least when the asthma was poorly controlled both before (-1.50) and after (-1.55) starting ICT. The effectiveness of control correlated significantly with the height velocity SD score, both before and after ICT was started. No evidence was found that the administration of ICT has an adverse effect on growth.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Body Height; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Female; Humans; Male; Nebulizers and Vaporizers; Pregnenediones

1992
Suppression of adrenal function in children on inhaled steroids.
    Journal of paediatrics and child health, 1991, Volume: 27, Issue:4

    Inhaled steroid therapy is one of the mainstays of treatment of asthma in children. Side effects, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis, have been noted with high doses of inhaled steroids. Most studies concerning side effects have been done with mechanical nebulization devices or hand-held metered-dose inhalers. The present study attempts to ascertain if dry powder inhalation of beclomethasone dipropionate is associated with any significant suppression of the HPA axis. Fifteen children (10 male and 5 female) between the ages of 4 and 14 years were followed for several years in our outpatient department. They were on inhaled beclomethasone dipropionate at dosages ranging from 6.9 to 25 micrograms/kg per day for 4-24 months. The short adrenocorticotrophic hormone (ACTH) test was used to evaluate function of the HPA axis. Mild suppression of the HPA axis was noted in one of the cases. The study therefore concludes that at therapeutic doses of dry powder beclomethasone dipropionate, suppression of the HPA axis can occur. However, the extent of this complication does not appear to be greater than with hand-held or mechanical nebulization devices.

    Topics: Administration, Inhalation; Adolescent; Adrenocorticotropic Hormone; Asthma; Beclomethasone; Child; Child, Preschool; Female; Follow-Up Studies; Humans; Hypothalamo-Hypophyseal System; Male; Pituitary-Adrenal System

1991
Cutaneous vasoconstrictor response to glucocorticoids in asthma.
    Lancet (London, England), 1991, Mar-09, Volume: 337, Issue:8741

    The aim of the study was to find out whether asthma patients whose airways obstruction is sensitive (CS) or resistant (CR) to corticosteroid treatment also differ in their cutaneous vasoconstrictor response to a potent topical glucocorticoid. Corticosteroid resistance was defined by failure of forced expiratory volume in 1 s (FEV1) and peak expiratory flow rate to improve by at least 15% after a 2-week trial of corticosteroids (prednisolone 20 mg daily for 1 week, then 40 mg daily for 1 week) despite more than 15% improvement with inhaled beta agonists. Beclomethasone dipropionate in concentrations of 3 micrograms/ml, 10 micrograms/ml, 30 micrograms/ml, and 100 micrograms/ml was applied to forearm skin; the site was occluded under plastic and the degree of blanching assessed after 18 h. CS asthmatic subjects (n = 31), asthma patients with mild airways obstruction (n = 26), asthma patients taking long-term prednisolone (n = 13), and healthy volunteers showed similar vasoconstrictor responses. In CR asthmatic subjects (n = 15), the response (expressed in terms of either blanching intensity or the proportion of patients showing a positive response) was significantly lower than that in the CS group at concentrations of 3 micrograms/ml (p less than 0.01), 10 micrograms/ml (p less than 0.01), and 30 micrograms/ml (p less than 0.05), but not at 100 micrograms/ml. This resistance to glucocorticoids in the skin, together with reported evidence of glucocorticoid resistance in peripheral blood leucocytes, suggests a general defect in the ability of tissues to respond to glucocorticoids in CR asthma.

    Topics: Administration, Oral; Administration, Topical; Adult; Aged; Airway Obstruction; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Middle Aged; Prednisolone; Pregnenediones; Skin; Vasoconstriction

1991
Growth retardation in children on steroids for asthma.
    Lancet (London, England), 1991, Dec-14, Volume: 338, Issue:8781

    Topics: Administration, Inhalation; Adrenal Glands; Asthma; Beclomethasone; Child; Child, Preschool; Drug Administration Schedule; Female; Growth Disorders; Humans; Male

1991
Effect of a volumatic spacer and mouth rinsing on systemic absorption of inhaled corticosteroids from a metered dose inhaler and dry powder inhaler.
    Thorax, 1991, Volume: 46, Issue:12

    High doses of inhaled corticosteroids are absorbed systemically and may cause long term side effects. As rinsing the mouth out after use and inhaling through a spacing device may reduce systemic absorption this has been further investigated.. Three crossover studies were carried out to assess the effect of budesonide given by dry powder inhaler (Turbuhaler) with and without mouth rinsing and beclomethasone dipropionate given by metered dose inhaler with or without a spacing device (Volumatic) on serum cortisol concentrations and urinary cortisol excretion in patients with asthma taking an inhaled corticosteroid. Each treatment period was two weeks with in a two week washout period. Serum cortisol concentrations at 0800 hours on day 14 and the 24 hour urinary excretion of cortisol were measured. In study 1 24 patients taking beclomethasone dipropionate 500 micrograms twice a day inhaled with (n = 10) or without (n = 14) a Volumatic spacing device were switched to a budesonide dry powder inhaler, 600 micrograms to be taken twice a day without mouth rinsing. In study 2 10 patients took budesonide 800 micrograms twice a day with and without mouth rinsing and without swallowing the rinsing water. In study 3 17 patients took budesonide 800 micrograms twice daily with mouth rinsing and beclomethasone dipropionate 500 micrograms twice daily with the spacing device and mouth rinsing.. In study 1 no difference was seen between budesonide without mouth rinsing and beclomethasone dipropionate without a spacer: beclomethasone with spacer caused less suppression of cortisol (mean (SD) serum cortisol concentration: beclomethasone and spacer 487(148), budesonide 368(145) nmol/l). In study 2 mouth rinsing caused less suppression of morning serum cortisol concentrations (rinsing 440(63), no rinsing 375(56) nmol/1). In study 3 there was no difference in serum or urinary cortisol concentrations between twice daily beclomethasone dipropionate 500 micrograms inhaled by Volumatic spacer or budesonide by Turbuhaler 800 micrograms twice daily, both with mouth rinsing. Individual serum cortisol values were within the normal range in all patients except one in study 1.. Systemic absorption of a corticosteroid inhaled from a metered dose inhaler is reduced by using a spacing device and that from a dry powder inhaler by mouth rinsing.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Budesonide; Female; Humans; Hydrocortisone; Intestinal Absorption; Male; Mouth; Nebulizers and Vaporizers; Powders; Pregnenediones; Therapeutic Irrigation

1991
Angina bullosa haemorrhagica--a possible relation to steroid inhalers.
    Clinical and experimental dermatology, 1991, Volume: 16, Issue:4

    Angina bullosa haemorrhagica (ABH) is a recently recognized condition, characterized by benign subepithelial blood-filled blisters in the mouth. The history is characteristic and distinction from other causes of oral blistering can be made by simple clinical signs or on histological grounds. This condition does not appear in standard dermatology texts, yet patients with ABH usually present to a dermatology clinic. A case with typical history is reported in an asthmatic patient who very regularly used a steroid inhaler. The possible aetiological role of such steroid-based inhalers is discussed.

    Topics: Adult; Asthma; Beclomethasone; Blister; Female; Humans; Mouth Diseases; Nebulizers and Vaporizers; Oral Hemorrhage

1991
T cell receptor gamma delta bearing cells are decreased in the peripheral blood of patients with atopic diseases.
    Clinical and experimental immunology, 1991, Volume: 86, Issue:3

    The biological role of T cell receptor (TCR) gamma delta bearing cells is currently not fully understood. Recently, a monoclonal antibody (TCR delta 1) reacting against the whole molecule became available which facilitates the direct analysis of TCR-gamma delta+ cells. We studied 11 children with atopic dermatitis, 20 children with atopic asthma, 18 adults with atopic dermatitis and 38 healthy age matched controls aged 4-51 years. Lymphocytes were isolated from heparinized peripheral blood and the proportion of TCR-gamma delta+ lymphocytes was determined by FACS analysis. Patients with atopic diseases yielded a significantly (P less than 0.01) lower proportion of TCR-gamma delta+ cells compared with normal controls (median 4.8% versus 7.1%). The percentage of TCR-gamma delta+ cells showed an age-dependent decline in both the patient group (r = -0.49, P less than 0.01) and the control group (r = -0.40, P less than 0.01). In addition, the proportion of cells which expressed CD8, TCR-gamma delta or CD4, TCR-gamma delta simultaneously was determined by double labelling immunofluorescence. Whereas CD4+, TCR-gamma delta+ cells could be identified in only a few individuals, CD8+, TCR-gamma delta+ cells were found in nearly all controls (median 2.4%, range 0.0-10.8%); atopic patients displayed significantly (P less than 0.01) lower proportions of CD8+, TCR-gamma delta+ cells.

    Topics: Adolescent; Adult; Albuterol; Antibodies, Monoclonal; Asthma; Beclomethasone; CD8 Antigens; Child; Child, Preschool; Cromolyn Sodium; Dermatitis, Atopic; Flow Cytometry; Humans; Hypersensitivity, Immediate; Receptors, Antigen, T-Cell, gamma-delta; Theophylline

1991
Intestinal calcium absorption and parathyroid hormone secretion in asthmatic patients on prolonged oral or inhaled steroid treatment.
    The European respiratory journal, 1991, Volume: 4, Issue:4

    A secondary hyperparathyroidism resulting from decreased intestinal calcium (Ca) absorption has been proposed as a contributory factor to glucocorticoid-induced osteoporosis. Inhaled steroids do not usually suppress adrenal gland function unless daily doses above 1,500 microgram are used. A recent study, however, has shown a reduced total body calcium in patients on regular beclomethasone treatment. In theory, osteopenia in these patients could be due to a direct effect of inhaled steroids on bone or due to an impaired intestinal calcium absorption. In this study, Ca absorption and parathyroid hormone (PTH) secretion were evaluated in three groups: 1) asthmatics on continuous oral and inhaled steroid treatment (11.3 +/- 4.4, range 5-33.5 mg.day-1 prednisone and 660 +/- 265, range 400-1,600 microgram.day-1 beclomethasone, respectively); 2) asthmatics on regular beclomethasone therapy (585 +/- 210, range 400-1,200 microgram.day-1); and 3) healthy subjects. The prevalence of vertebral fractures was evaluated by a spinal X-ray. No differences were found in either Ca absorption or PTH serum levels between asthmatics and healthy subjects (analysis of variance-ANOVA). Vertebral fractures were significantly more frequent in patients from group 1 (14 of 25) than in those from group 2 (2 or 25). We conclude that both prolonged oral steroid treatment and inhaled steroids, at doses lower than 1,600 microgram.day-1 do not cause Ca malabsorption, and that hyperparathyroidism does not contribute to osteoporosis in these patients.

    Topics: Administration, Inhalation; Administration, Oral; Asthma; Beclomethasone; Calcium; Female; Humans; Intestinal Absorption; Male; Middle Aged; Osteoporosis; Parathyroid Hormone; Prednisone; Time Factors

1991
Cyclosporin for steroid-dependent asthma.
    Allergy, 1991, Volume: 46, Issue:4

    We used cyclosporin to treat 12 adult patients with severe bronchial asthma who had been on systemic steroids for an average of 16 years. During the baseline period, lasting 4-6 months, therapy with high doses of inhaled beclamethasone, aminophylline and salbutamol was standardized and a minimum necessary dose of systemic steroids was established. After 9 months' treatment with low-dose cyclosporin (average whole-blood trough levels of 105 ng/ml), in six patients the daily dose of oral prednisone could be reduced from mean 30 mg to mean 11 mg, while daily symptom scores and peak expiratory flows improved significantly. This was accompanied by a reduction in exacerbations of asthma. However, in six other patients attempts to taper the steroid doses were unsuccessful, and cyclosporin was stopped after 4 to 7 months. These preliminary results suggest that cyclosporin might be of benefit in some patients with steroid-dependent asthma.

    Topics: Adult; Albuterol; Aminophylline; Asthma; Beclomethasone; Cyclosporins; Female; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Prednisone

1991
Unexpected side-effects of inhaled steroids: a case report.
    European journal of pediatrics, 1991, Volume: 150, Issue:6

    An asthmatic child is presented who developed a cushingoid appearance with evidence of adrenal suppression and growth impairment while on low dose inhaled topical steroids. When the inhaled steroids were replaced by inhaled sodium cromoglycate his adrenal function recovered while his appearance and growth returned to normal. This report indicates that there are some children who are at risk of developing side-effects on doses of inhaled topical steroids normally considered to be entirely safe.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Child, Preschool; Cromolyn Sodium; Cushing Syndrome; Humans; Male

1991
Growth of asthmatic children.
    BMJ (Clinical research ed.), 1991, Aug-17, Volume: 303, Issue:6799

    Topics: Asthma; Beclomethasone; Body Height; Bronchodilator Agents; Budesonide; Child; Humans; Pregnenediones

1991
A comparative study on effect of inhaled beclomethasone dipropionate and sodium cromoglycate on pulmonary functions in bronchial asthma.
    The Journal of the Association of Physicians of India, 1991, Volume: 39, Issue:5

    Topics: Adolescent; Adult; Asthma; Beclomethasone; Child; Cromolyn Sodium; Female; Humans; Lung Volume Measurements; Male; Middle Aged

1991
Diurnal cortisol secretion during therapy with inhaled beclomethasone dipropionate in children with asthma.
    The Journal of pediatrics, 1991, Volume: 118, Issue:2

    Topics: Adolescent; Asthma; Beclomethasone; Child; Circadian Rhythm; Female; Humans; Hydrocortisone; Male; Nebulizers and Vaporizers

1991
Adrenocortical suppression following treatment with beclomethasone and budesonide.
    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 1991, Volume: 21, Issue:1

    The study was carried out to compare the adrenocortical suppression caused by inhaled beclomethasone dipropionate (BDP) with the suppression caused by budesonide (Bu). The study was of an open cross-over design. Sixteen children with asthma were treated with high-dose inhaled BDP and Bu via a 750 ml spacer (Nebuhaler). Each drug was used for periods of 6 weeks. The 24-hr urinary cortisol excretion was unchanged in 11 subjects. A reproducible suppression of the urinary cortisol excretion was shown in three subjects following BDP and in two subjects following treatment with Bu. The results of the study indicate the occurrence of interpersonal variations of the sensitivity to the adrenocortical suppressive effect of BDP and Bu.

    Topics: Adolescent; Adrenal Cortex; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Humans; Hydrocortisone; Pregnenediones

1991
[The clinical benefit of high dose inhalation therapy with beclomethasone dipropionate for patients with chronic bronchial asthma].
    Nihon Kyobu Shikkan Gakkai zasshi, 1991, Volume: 29, Issue:1

    Conventional doses of aerosolized beclomethasone dipropionate (BDP) of up to 400 micrograms/day by inhalation has often failed to normalize the pulmonary function of chronic adult patients. Therefore it may be necessary to administer the individual maximum dose of BDP to reduce bronchial inflammation. In 13 patients (2 males and 11 females, mean age 49.2 +/- 3.7 years old) with chronic asthma whose minimum %PEFRs were lower than 80% under treatment with conventional doses of BDP, the clinical benefit of high dose inhalation therapy with BDP was studied for four consecutive weeks by comparing % peak expiratory flow rate (%PEFR) measured four times a day both before and 10 minutes after inhaled procaterol (PCR) in a cross-over fashion. Mean morning %PEFRs before inhaled PCR during the first two weeks with a lower dose of BDP (419 +/- 24 micrograms/day) and during the following two weeks with a higher dose of BDP (904 +/- 55 micrograms/day) were 60.6 +/- 3.1% and 77.5 +/- 4.1%, respectively (p less than 0.01). Average increases in %PEFR during the higher dose period before and after inhaled PCR were 12.1% and 12.4%, respectively, which was observed by the end of the first week after the start of higher dose of BDP in 12 out of 13 patients. Since there were no adverse reactions such as hoarseness, oral thrush and candidiasis during the period with higher doses of BDP, it was concluded that we should promptly employ higher doses of BDP in patients who did not respond satisfactorily to conventional doses of BDP.

    Topics: Administration, Inhalation; Adolescent; Adult; Aged; Asthma; Beclomethasone; Chronic Disease; Drug Administration Schedule; Female; Humans; Male; Middle Aged

1991
Occupational asthma due to styrene.
    Thorax, 1991, Volume: 46, Issue:5

    In a patient with asthma who was exposed to styrene serial self recorded measurements of peak expiratory flow showed the asthma to be work related, and inhalation tests with styrene reproducibly provoked a dual asthmatic response and increased responsiveness to inhaled histamine.

    Topics: Adult; Albuterol; Asthma; Beclomethasone; Forced Expiratory Volume; Humans; Male; Military Personnel; Occupational Diseases; Peak Expiratory Flow Rate; Styrenes

1991
[Regular inhalation therapy with antiasthmatic agents].
    Kokyu to junkan. Respiration & circulation, 1990, Volume: 38, Issue:10

    Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aerosols; Asthma; Beclomethasone; Female; Humans; Male; Respiratory Therapy; Time Factors

1990
Nedocromil sodium.
    Respiratory medicine, 1990, Volume: 84, Issue:1

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Asthma; Beclomethasone; Cromolyn Sodium; Humans; Nedocromil; Quinolones

1990
Do large volume spacer devices reduce the systemic effects of high dose inhaled corticosteroids?
    Thorax, 1990, Volume: 45, Issue:10

    When used in high doses, inhaled corticosteroids may cause suppression of the hypothalamo-pituitary-adrenal axis. The influence of the mode of drug inhalation on the degree of this suppression is not clear. Hypothalamo-pituitary-adrenal function was assessed by measurement of 0900 h serum cortisol concentrations, a short tetracosactrin test, and 24 hour urine free cortisol excretion in 48 adults with asthma taking 1500-2500 micrograms beclomethasone dipropionate daily via a metered dose aerosol. Twelve patients had hypothalamo-pituitary-adrenal suppression, as judged by subnormal results from at least two of the three tests or (in one patient) by an abnormal insulin stress test response. These patients then changed to inhaling the same dose of beclomethasone dipropionate through a 750 ml spacer device (Volumatic). The endocrine tests were repeated from nine days to eight weeks later in 10 patients. Comparison with initial values showed that adding the spacing device caused an increase in the median 0900 h cortisol concentration from 126 nmol/l to 398 nmol/l, in the post-tetracosactrin cortisol concentration from 402 nmol/l to 613 nmol/l and in 24 hour urine free cortisol excretion from 54 nmol to 84 nmol. The rise in serum cortisol concentration in response to tetracosactrin did not change. Evidence of persisting hypothalamo-pituitary-adrenal axis suppression was present in only four of the 10 patients; the most pronounced improvements in function tended to occur in those who had never required long term oral corticosteroids. The results from this uncontrolled study suggest that asthmatic patients taking high dose beclomethasone dipropionate may minimise adverse effects by using a large volume spacer device.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Nebulizers and Vaporizers; Pituitary-Adrenal System

1990
Asthma and pregnancy: responsibility of physicians and patients.
    Annals of allergy, 1990, Volume: 65, Issue:6

    The successful management of asthma during pregnancy requires a cooperative approach between the obstetrician, the physician managing the asthma, and the patient. This is emphasized by a case report describing a patient with uncontrolled asthma subsequently managed with appropriate medical and obstetrical care. Concern for maternal and fetal health and reassurance of patients are primary concerns. Guidelines for physicians and patients are outlined as are the safety of drugs and therapy in pregnant patients. Physicians must have knowledge of appropriate use of medications during pregnancy.

    Topics: Administration, Inhalation; Adult; Asthma; Beclomethasone; Ephedrine; Fear; Female; Health Planning Guidelines; Humans; Maternal-Fetal Exchange; Physician-Patient Relations; Pregnancy; Pregnancy Complications; Theophylline

1990
[Corticosteroid--effects of beclomethasone dipropionate 800 micrograms/day].
    Nihon Kyobu Shikkan Gakkai zasshi, 1990, Volume: 28, Issue:11

    The effects of beclomethasone dipropionate (BD) 800 micrograms on steroid-dependent adult asthmatics were examined. The study consisted of two groups; 20 patients on 800 micrograms and another 20 patients on 400 micrograms. In addition, 800 micrograms was administered to an additional 12 patients receiving 400 micrograms with insufficient effects. After two weeks of observation period, BD was administered for 12 weeks, and its effects adverse reactions were analyzed on the basis of asthma patients' diary etc. As the results, effects appeared earlier in the 800 micrograms group than in the 400 micrograms group and marked efficacy was seen. The 800 micrograms group was much better than the 400 micrograms group in the achievement of weaning from or of dose reduction of systemic steroid. A significant increase of serum cortisol levels which was considered to be due to the decrease of the systemic steroid usage was noted. Considerable efficacy was also observed in patients whose dosage had been increased from 400 micrograms to 800 micrograms. High dose administration usually increases topical side effects such as hoarseness and stomatitis, however the use of spacers was effective in the prophylaxis and treatment of those symptoms.

    Topics: Administration, Inhalation; Administration, Oral; Adrenal Cortex Hormones; Asthma; Beclomethasone; Drug Administration Schedule; Humans; Hydrocortisone

1990
Acute topical steroid administration blocks mast cell increase and the late asthmatic response of the canine peripheral airways.
    The American review of respiratory disease, 1990, Volume: 141, Issue:2

    Previous studies indicated that mast cell number increased after airway exposure to Ascaris suum antigen (Ag). The following two series of experiments were performed to test the hypothesis that this phenomenon may be associated with the Ag-induced late-phase bronchoconstriction (LAR). In the first, two bronchoscopes wedged in airway segments of two contralateral lobes of 16 dogs were used to deliver 0.26, 2.6, or 26 micrograms of Ag to one lobe; the other served as a control. After the observation of a LAR, Ag and control lobes plus one unexposed tissue sample were collected and prepared for histologic examination. The data showed that the incidence, time of onset, and magnitude of the LAR were dose-related. In the second series of experiments, performed in 14 dogs, the tracheal mucosal surface was surgically exposed to allow 80 micrograms of beclomethasone dipropionate to be sprayed on one half while the other half was left untreated. Pledgets saturated with 0.2 microgram of Ag were placed on both sides 1 h later. Then two bronchoscopes were used to pretreat airways of two contralateral lobes to 40 micrograms of either the steroid or the vehicle. One hour later, both airways were exposed to 2.6 micrograms of aerosolized Ag. Of these 14 dogs monitored for peripheral airway responses, seven demonstrated a LAR in the vehicle-treated airway. In all seven dogs, the LAR was absent in the steroid-treated airway even though the cellular profiles of the two airways did not significantly differ. In seven additional dogs, the bronchoscopic procedure was performed as previously described. However, these dogs were killed 1 h after Ag exposure.(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Administration, Topical; Aerosols; Animals; Antigens, Helminth; Ascaris; Asthma; Beclomethasone; Bronchi; Bronchoscopy; Cell Count; Dogs; Dose-Response Relationship, Immunologic; Mast Cells; Time Factors; Trachea

1990
Adrenal cortical function after long-term beclomethasone aerosol therapy in early childhood.
    Annals of allergy, 1990, Volume: 64, Issue:4

    Ten asthmatic children were studied by tetracosactrin stimulation tests after receiving beclomethasone dipropionate aerosol (BDA) for periods of up to 12 months. Clinical improvement occurred in all children while receiving BDA. No change in adrenal function could be demonstrated by comparing the tetracosactrin stimulation tests before and after treatment with BDA.

    Topics: Adrenal Cortex; Aerosols; Asthma; Beclomethasone; Humans; Infant

1990
Compliance with inhaled therapy and morbidity from asthma.
    Respiratory medicine, 1990, Volume: 84, Issue:1

    Patient compliance with a standardized incremental regimen of inhaled anti-asthma therapy has been assessed in a large, prospective study in general practice. Urine salbutamol estimations were made in 30 patients who had the largest improvement with therapy (mean increase in FEV1 0.45 l above baseline: Responsive) and in 30 patients whose airflow obstruction failed to improve (FEV1-0.14 l: Nonresponsive). The urine salbutamol concentrations rose over the 9 month period in the responsive patients as expected with the incremental doses prescribed, and were significantly higher than urine levels in nonresponsive patients at two dose levels. Poor compliance with prescribed inhaled therapy is an important cause of persistent morbidity from asthma.

    Topics: Administration, Inhalation; Adult; Albuterol; Asthma; Beclomethasone; Female; Forced Expiratory Volume; Humans; Male; Patient Compliance; Peak Expiratory Flow Rate

1990
Adrenal function in asthma.
    Archives of disease in childhood, 1990, Volume: 65, Issue:8

    A dose dependent suppression of daily cortisol excretion was shown in 25 children with asthma being treated with beclomethasone dipropionate. Cortisol metabolites tended to occur below the normal range when doses of beclomethasone of more than 400 micrograms/m2/day were given. Androgen excretion below the normal range was apparent in asthmatic children aged 8-13 years regardless of whether they were receiving inhaled steroids. This may be the reason for growth delay often seen in asthmatic children. These side effects of beclomethasone are not enough reason to discourage its prescription for the treatment of asthma, but endocrine assessment is desirable when the dose exceeds 400 micrograms/m2/day.

    Topics: Adolescent; Adrenal Glands; Androsterone; Asthma; Beclomethasone; Body Height; Child; Child, Preschool; Dose-Response Relationship, Drug; Etiocholanolone; Female; Humans; Hydrocortisone; Male

1990
Late asthmatic response to allergen challenge (LAR), its clinical feature and pharmacological modulation.
    Agents and actions, 1989, Volume: 26, Issue:1-2

    Topics: Albuterol; Allergens; Asthma; Beclomethasone; Bronchial Provocation Tests; Cromolyn Sodium; Humans; Ketotifen; Theophylline; Time Factors

1989
Steroid aerosols and cataract formation.
    BMJ (Clinical research ed.), 1989, Aug-12, Volume: 299, Issue:6696

    Topics: Administration, Oral; Adult; Aerosols; Asthma; Beclomethasone; Cataract; Female; Humans; Middle Aged; Prednisolone

1989
Steroid dependent asthma.
    BMJ (Clinical research ed.), 1989, Sep-09, Volume: 299, Issue:6700

    Topics: Asthma; Beclomethasone; Humans; Hypnosis; Mental Disorders

1989
Treatment of the recalcitrant asthmatic.
    Annals of allergy, 1989, Volume: 63, Issue:4

    Treatment of "difficult" asthma requires good doctor-patient communication, patient education, and attention to precipitating factors as well as an aggressive drug regimen. Specific medications include inhaled sympathomimetic and anti-cholinergic bronchodilators, inhaled, oral and/or intravenous corticosteroids and, in certain circumstances, mast cell stabilizing drugs such as cromolyn sodium. The use of systemic theophyllines is currently undergoing critical reevaluation. There have been a number of recent developments in the search for steroid-sparing agents and drugs that inhibit inflammatory mediators felt to be important in the pathophysiology of asthma. Most of these drugs are still undergoing evaluation in multicentre clinical trials. The newer antiinflammatory agents, methotrexate and gold, should probably not be used on a routine basis except as part of randomized, ethically approved clinical trials.

    Topics: Administration, Inhalation; Aerosols; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Drug Therapy; Histamine H1 Antagonists; Humans; Injections, Intravenous; Methylprednisolone; Physician-Patient Relations; Respiratory Therapy

1989
Exercise-induced allergic syndromes on the increase.
    Cleveland Clinic journal of medicine, 1989, Volume: 56, Issue:7

    Topics: Adolescent; Adult; Albuterol; Anaphylaxis; Asthma; Asthma, Exercise-Induced; Beclomethasone; Exercise; Humans; Hydroxyzine; Ketotifen; Urticaria

1989
Fatal asthma in a young patient with severe bronchial hyperresponsiveness but stable peak flow records.
    The European respiratory journal, 1989, Volume: 2, Issue:10

    We report the sudden death of a 16 yr old boy with asthma. At presentation, the patient had symptoms of active asthma, mild bronchoconstriction, severe airway hyperresponsiveness to methacholine, and increased variability of peak expiratory flow records. After the patient was placed on inhaled beclomethasone (1 mg b.i.d preceded by inhaled fenoterol 0.4 mg b.i.d) he rapidly felt better, lung function improved, but airway responsiveness remained severe. Four months later, on the day he died, he was well until a fatal attack of asthma occurred around midnight without identifiable precipitating factors. Taken to hospital, he was dead on arrival. Necroscopy and microscopy showed the characteristic features of asthma death. This case report suggests that; a) asthma death may occur suddenly and unexpectedly; b) asthma death may not be prevented by long-term treatment with high-dose inhaled beclomethasone; c) severe bronchial hyperresponsiveness, even in the presence of stable peak flow records, may identify asthmatic patients at risk of sudden death.

    Topics: Adolescent; Asthma; Beclomethasone; Bronchi; Death, Sudden; Fenoterol; Humans; Male

1989
Glucocorticosteroids attenuate aspirin-precipitated adverse reactions in aspirin-intolerant patients with asthma.
    Annals of allergy, 1989, Volume: 63, Issue:2

    We evaluated the effects of corticosteroid pretreatment on the intensity of adverse reactions to aspirin during carefully controlled aspirin challenges in 13 aspirin-sensitive asthmatics. Two studies were performed. First, using a double-blind crossover design, we administered to five patients 75 mg prednisone daily or placebo for two days preceding the challenge. No consistent protection against adverse reactions was achieved. In the second study, a 10-day pretreatment with 15 mg oral prednisolone and topical intrabronchial and intranasal beclomethasone offered total clinical protection against bronchospasm produced by threshold doses of aspirin in five of eight patients. In two others, the bronchospasm provoked was less severe, and only in one patient did its intensity remained unchanged. There was a significant reduction in fall of mean pulmonary function tests following the second aspirin challenge, which was performed after ten days of steroid treatment. Steroids given for ten days also prevented significantly nasal discharge and nasal blockade. When diagnostic challenge tests with aspirin are carried out in asthmatic patients on long-term corticosteroid therapy, there is an increased possibility of false negative results.

    Topics: Adult; Aspirin; Asthma; Beclomethasone; Double-Blind Method; Drug Hypersensitivity; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Prednisolone; Prednisone; Random Allocation

1989
High-dose inhaled corticosteroids.
    The New Zealand medical journal, 1989, Feb-22, Volume: 102, Issue:862

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Humans

1989
Growth retardation in asthmatic children treated with inhaled beclomethasone dipropionate.
    Lancet (London, England), 1988, Jan-16, Volume: 1, Issue:8577

    Topics: Asthma; Beclomethasone; Child; Female; Growth Disorders; Humans; Male

1988
Growth retardation in asthmatic children treated with inhaled beclomethasone dipropionate.
    Lancet (London, England), 1988, Feb-27, Volume: 1, Issue:8583

    Topics: Asthma; Beclomethasone; Child; Growth; Humans; Male

1988
Fixed dose combination therapy in the treatment of asthma--the case against it.
    Progress in clinical and biological research, 1988, Volume: 263

    Topics: Aerosols; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Drug Combinations; Fenoterol; Humans; Ipratropium

1988
Effect of drugs used in the treatment of asthma on the production of eosinophil-activating factor by monocytes.
    International archives of allergy and applied immunology, 1988, Volume: 85, Issue:2

    The cytotoxic activity of eosinophils, as measured by their ability to kill antibody-coated schistosomula of Schistosoma mansoni, is enhanced by a factor (eosinophil-activating factor, EAF) which is secreted by peripheral blood monocytes from certain moderately eosinophilic individuals. The secretion of this factor by monocytes is inhibited by methylprednisolone (1 microgram/ml), beclomethasone (10 micrograms/ml) and theophylline (100 micrograms/ml), but not by sodium cromoglycate or salbutamol. Methylprednisolone, beclomethasone and theophylline do not inhibit either eosinophil cytotoxic activity or enhancement of eosinophil cytotoxic activity by EAF at these concentrations.

    Topics: Albuterol; Asthma; Beclomethasone; Cromolyn Sodium; Eosinophils; Humans; Lymphokines; Methylprednisolone; Monocytes; Theophylline

1988
Effects of disodium cromoglycate and beclomethasone dipropionate on the asthmatic response to allergen challenge I. Immediate response (IAR).
    Annals of allergy, 1988, Volume: 60, Issue:3

    This study deals with comparative investigation of the protective effects of disodium cromoglycate (DSCG, Lomudal, Intal) and beclomethasone dipropionate aerosol (BDA, Aldecin, Becotide, Beclovent) on 103 immediate asthmatic responses (IARs) to allergen challenge recorded in 103 patients with an allergic bronchial asthma. Disodium cromoglycate demonstrated highly significant protective effects on the IAR in patients investigated (P less than .01). The protective effects of BDA on the IAR were found to be non-significant (P greater than .01). It is suggested that DSCG should be the first choice in controlling allergic bronchial asthma when the immediate asthmatic response to allergen plays the predominant role.

    Topics: Adolescent; Adult; Aerosols; Allergens; Asthma; Beclomethasone; Bronchial Provocation Tests; Cromolyn Sodium; Forced Expiratory Volume; Humans; Hypersensitivity, Immediate; Middle Aged

1988
Effects of disodium cromoglycate and beclomethasone dipropionate on the asthmatic response to allergen challenge II. Late response (LAR).
    Annals of allergy, 1988, Volume: 60, Issue:3

    The protective effects of disodium cromoglycate (DSCG; Lomudal, Intal) and beclomethasone dipropionate (BDA; Aldecin, Becotide, Beclovent) on the late asthmatic response to allergen challenge (LAR) were investigated in 61 patients with allergic bronchial asthma. The 61 patients developed a total of 83 late asthmatic responses, 35 isolated late responses (ILAR), and 48 dual late responses (DLAR), which is a combination of an immediate response (IDLAR) and a late response (LDLAR). Disodium cromoglycate demonstrated significant protective effects on the LAR (P less than .01), however, the LDLAR as part of the DLAR was decreased by DSCG to a slightly higher degree than the ILAR. The BDA also showed significant protective effects on the LAR (P less than .01), but the ILAR was protected by BDA to a slightly higher degree than the LDLAR as part of the DLAR. The immediate asthmatic response as part of the DLAR was prevented by DSCG significantly (P less than .01) while the BDA was ineffective (P greater than .05). It can be concluded that both DSCG and BDA demonstrated significant effects on the LAR. It is suggested that DSCG should be used as a drug of the first choice to control bronchial asthma with an allergy component where the LAR plays a role. The BDA should be added temporarily at the beginning of the treatment of patients in whom the isolated late asthmatic response plays the predominant role, or of patients in whom the DSCG does not provide full control of the LAR during a certain period, eg, during the peak of the pollen season.(ABSTRACT TRUNCATED AT 250 WORDS)

    Topics: Allergens; Asthma; Beclomethasone; Bronchial Provocation Tests; Cromolyn Sodium; Humans; Hypersensitivity, Delayed

1988
[Effect of the diagnosis and prevention of exercise-induced bronchial obstruction on sports participation by asthmatic school children].
    Monatsschrift Kinderheilkunde : Organ der Deutschen Gesellschaft fur Kinderheilkunde, 1988, Volume: 136, Issue:12

    To assess the sport activities and the previous management of asthmatic children with an exercise-induced bronchial obstruction (EIB), we studied 124 children, aged 8-17 years, with a history of EIB, which was confirmed in a free-running exercise test. Participation in school sports was regular in 38% of the children, irregular in 45% and absent in 17%. Participation in sports outside the school was even lower: In 26% regularly, 18% irregularly and absent in 56%. 17% of all children were not active in any sport. EIB had previously been diagnosed in 38 (31%) children, and 20 (16%) of these had received an appropriate prophylactic medication. Children who received prophylaxis participated significantly more often in school sports (p less than 0.01) and in other sports (p less than 0.05), compared with those who had been diagnosed but had not received prophylaxis. After exercise, peak expiratory flow decreased by a mean of 41% of the preexercise values, but following a prophylactic administration of 0.2 mg Salbutamol-aerosol it decreased only by 2%. A complete protection of EIB was achieved in 94% of the children and the mean %-protection was 95%. The protective effect of 2 mg DNCG-aerosol in 21 children was significantly lower (53%, p less than 0.05) than that of salbutamol and a complete protection was achieved in only 71% (p less than 0.025) of the children.

    Topics: Airway Resistance; Albuterol; Asthma; Asthma, Exercise-Induced; Beclomethasone; Child; Cromolyn Sodium; Drug Therapy, Combination; Exercise Test; Female; Humans; Male; Sports; Theophylline

1988
[A clinical analysis of 200 cases of aspirin-induced asthma].
    Zhonghua nei ke za zhi, 1988, Volume: 27, Issue:10

    Topics: Adolescent; Adult; Aerosols; Aged; Aspirin; Asthma; Beclomethasone; Child; Female; Humans; Male; Middle Aged

1988
An assessment of methacholine inhalation tests in elderly asthmatics.
    Age and ageing, 1988, Volume: 17, Issue:2

    We have assessed the feasibility and value of measuring nonspecific bronchial responsiveness to methacholine in investigation of asthma in the elderly. Results from duplicated tests in 20 subjects aged 65-82 years were expressed as dose provoking a 20% decrement in 1 second forced expiratory volume (PD20.FEV1) or peak expiratory flow (PD20.PEF). Repeatability for PD20.FEV1 was satisfactory but less good than in younger subjects, 95% confidence limits being 0.39-2.57 and 0.52-1.91, respectively, x initial PD20. For PD20.PEF, confidence limits were wider (0.26-3.91 x initial PD20) but multiple PEF measurements were better tolerated than those of FEV1, which commonly caused fatigue and dizziness. PD20.FEV1 and PD20.PEF correlated closely (r = 0.95, P less than 0.0001) and both predicted bronchodilatation following a 6-week course of inhaled corticosteroid and beta agonist. This was not predicted by the response to a single dose of beta agonist. We conclude that measurement of bronchial responsiveness is feasible and clinically valuable in elderly subjects.

    Topics: Aged; Aged, 80 and over; Albuterol; Asthma; Beclomethasone; Bronchial Provocation Tests; Dizziness; Fatigue; Female; Forced Expiratory Volume; Humans; Male; Methacholine Chloride; Methacholine Compounds; Peak Expiratory Flow Rate

1988
Oropharyngeal candidiasis in patients treated with beclomethasone dipropionate delivered by metered-dose inhaler alone and with Aerochamber.
    The Journal of allergy and clinical immunology, 1988, Volume: 81, Issue:2

    We compared the incidence of Candida infection, Candida colonization, and reduction in oral prednisone dose in patients with asthma treated with beclomethasone dipropionate delivered by metered-dose inhaler (MDI) alone and MDI plus Aerochamber. Group M contained 18 patients treated with beclomethasone, four actuations four times a day (672 micrograms/day), delivered by MDI alone. Group A contained 18 patients treated with the same dose of beclomethasone delivered by MDI plus Aerochamber. In group M, four of 18 patients had Candida infection, 12 of 18 patients had Candida colonization, and six of 18 patients were completely removed from oral prednisone. In group A, 0 of 18 patients had Candida infection (p = 0.05), six of 18 patients had Candida colonization (p less than 0.05), and 12 of 18 patients were completely removed from oral prednisone (p less than 0.05). We conclude that beclomethasone delivered by MDI plus Aerochamber is more efficacious in reducing oral prednisone dependency and produces less Candida infection and colonization than beclomethasone delivered by MDI alone.

    Topics: Administration, Oral; Adult; Aerosol Propellants; Aerosols; Asthma; Beclomethasone; Candidiasis, Oral; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Nebulizers and Vaporizers; Pharyngitis; Prednisone

1988
Aerosol treatment abuse.
    Archives of disease in childhood, 1988, Volume: 63, Issue:1

    A 4 year old boy with excellent inhaler technique was found to be abusing his salbutamol and beclomethasone dipropionate inhalers. This resulted in aggressive behaviour and probable hallucinations.

    Topics: Aerosols; Albuterol; Asthma; Beclomethasone; Child, Preschool; Chlorofluorocarbons, Methane; Humans; Male; Substance-Related Disorders

1988
Effect of therapy on bronchial hyperresponsiveness in the long-term management of asthma.
    Clinical allergy, 1988, Volume: 18, Issue:2

    The aim of this study was to determine if prophylactic therapy leads to a reduction in the severity of bronchial hyperresponsiveness (BHR) in subjects with severe asthma. Measurements of bronchial responsiveness to histamine were made in two groups of subjects for periods up to 2 years. Thirteen subjects in the study group took regular medication and used a home monitor of airway function to determine the medication requirements needed to maintain optimal airway function. A control group of eleven subjects was managed with the same drugs but without daily monitoring and without any attempt to keep daily lung function at optimal levels. Subjects in the study group had a 10- to 100-fold decrease in the severity of BHR, which was independent of the improvement in baseline lung function. All but one subject in the study group became symptom free and six were able to maintain the improvement in BHR and symptoms on reduced medication. There was no change in the severity of BHR or in the baseline lung function in the control group. It is concluded that it is possible to reduce the severity of BHR in subjects with severe asthma by the use of pharmacological agents. This reduction in severity appears to require the long-term use of medications, including aerosol corticosteroids, with daily home monitoring to allow adjustment of the amount of treatment required.

    Topics: Adult; Albuterol; Asthma; Beclomethasone; Bronchi; Female; Forced Expiratory Volume; Humans; Male; Middle Aged

1988
Muscle atrophy in severe exacerbation of asthma requiring mechanical ventilation.
    Respiration; international review of thoracic diseases, 1988, Volume: 53, Issue:3

    An unusual case of acute muscular atrophy in a patient with a severe exacerbation of asthma requiring mechanical ventilation is reported. High doses of pancuronium bromide and 6-methylprednisolone were administered. It is suggested that the conditions of mechanical ventilation increase in some way the potential of corticosteroids to cause myopathy. The possible implication of myorelaxant drugs in the development of this complication is also suggested.

    Topics: Albuterol; Asthma; Beclomethasone; Humans; Male; Methylprednisolone; Middle Aged; Muscular Atrophy; Respiration, Artificial

1988
Asthma death due to ibuprofen.
    Lancet (London, England), 1987, May-09, Volume: 1, Issue:8541

    Topics: Acute Disease; Aged; Albuterol; Asthma; Beclomethasone; Drug Interactions; Female; Humans; Ibuprofen

1987
Nocturnal adrenal suppression in children inhaling beclomethasone dipropionate.
    Lancet (London, England), 1987, Jun-06, Volume: 1, Issue:8545

    Topics: Administration, Inhalation; Adrenal Glands; Asthma; Beclomethasone; Circadian Rhythm; Dose-Response Relationship, Drug; Humans; Hydrocortisone

1987
Treating infantile asthma in general practice.
    Drug and therapeutics bulletin, 1987, Aug-10, Volume: 25, Issue:16

    Topics: Adrenergic beta-Agonists; Asthma; Beclomethasone; Humans; Infant; Ipratropium

1987
[Progress of therapeutic agents for asthma--1) Progress of anti-asthmatic agents].
    Nihon rinsho. Japanese journal of clinical medicine, 1987, Volume: 45, Issue:8

    Topics: Adrenergic beta-Agonists; Asthma; Beclomethasone; Cromolyn Sodium; Delayed-Action Preparations; Humans; Parasympatholytics; Theophylline

1987
[Therapy of allergic rhinitis in childhood].
    Laryngologie, Rhinologie, Otologie, 1987, Volume: 66, Issue:2

    Allergic rhinitis is the most common of all allergic disorders. After summarising the clinical features and diagnostic approach with regard to differential diagnosis, we will discuss the therapeutic modalities. As with all long-term therapy measures, it is essential to persuade both the child and the parents to participate in the treatment and to get their co-operation.

    Topics: Asthma; Beclomethasone; Child; Cromolyn Sodium; Desensitization, Immunologic; Humans; Ketotifen; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

1987
Prolonged evaluation of patients with corticosteroid-dependent asthma stage of allergic bronchopulmonary aspergillosis.
    The Journal of allergy and clinical immunology, 1987, Volume: 80, Issue:5

    Eight cases with stage IV allergic bronchopulmonary aspergillosis (ABPA) (corticosteroid-dependent asthma stage) were observed for a total of 82 patient years with individual patients observed for 7 to 19 years (mean 10.2) years. One case is the first case of ABPA diagnosed in the United States in 1967. A second case has been observed through four stages of ABPA. None of these eight cases has demonstrated pulmonary deterioration by clinical, chest roentgenogram, or pulmonary function analysis. After diagnosis, the maintenance dose of prednisone in seven of eight cases was a low to moderate dose alternate-day prednisone. These results suggest that continuous observation and management of episodes of pulmonary consolidation or asthma exacerbations may prevent the progression of ABPA to stage V (fibrotic end stage). The total IgE may remain elevated in these patients, and therapy should not attempt to reduce total serum IgE to normal levels. After prolonged therapy with prednisone for asthma and control of ABPA, the IgE and IgG antibody indices against Aspergillus fumigatus may remain elevated or may be below the levels that are of diagnostic value.

    Topics: Adolescent; Adult; Aged; Aspergillosis, Allergic Bronchopulmonary; Aspergillus fumigatus; Asthma; Beclomethasone; Bronchi; Female; Humans; Immunoglobulin E; Immunoglobulin G; Longitudinal Studies; Male; Middle Aged; Prednisone; Respiratory Function Tests

1987
Jet-nebulized beclomethasone dipropionate in the management of bronchial asthma. Topical steroids for asthmatic children younger than 4 years.
    Allergy, 1987, Volume: 42, Issue:4

    The efficacy of jet nebulized beclomethasone dipropionate (BDP) in the management of asthma was evaluated in 18 children, 2-26 months old (mean 10 months). The children were selected on the basis of the severity of their symptoms and the lack of effect of conventional treatment. The effect of BDP was evaluated by comparing clinical data before and after the initiation of treatment. Fifteen of the 18 patients experienced a significant clinical improvement during treatment with BDP. BDP "nebulizer solution" is a valuable contribution to the management of severe asthma in young asthmatics.

    Topics: Administration, Inhalation; Asthma; Beclomethasone; Child, Preschool; Female; Humans; Infant; Male

1987
Reactions to bronchoconstrictor drugs.
    Chest, 1987, Volume: 92, Issue:5

    Topics: Airway Resistance; Asthma; Beclomethasone; Bronchi; Humans

1987
Extrapulmonary effects of maintenance corticosteroid therapy with alternate-day prednisone and inhaled beclomethasone in children with chronic asthma.
    The Journal of allergy and clinical immunology, 1987, Volume: 80, Issue:4

    Extrapulmonary effects of alternate-day prednisone and inhaled beclomethasone dipropionate therapy were examined in 24 and 32 children with asthma, respectively. Early morning serum cortisol values were significantly lower among patients receiving alternate-day prednisone than among patients receiving inhaled beclomethasone dipropionate and control subjects at 24 hours but not at 48 hours after an alternate-day prednisone dose. Urinary-free cortisol output during the second 24 hours of the alternate-day prednisone regimen were similar to values among patients receiving inhaled beclomethasone and were significantly lower than among control subjects for both groups. Mean heights among patients before being placed on maintenance corticosteroids were at the thirty-fifth percentile and were similar for both regimens. This was significantly lower than initial measurements for control subjects who, on average, were near the fiftieth percentile for both children with asthma not requiring maintenance corticosteroids and normal healthy Iowa children. Mean heights for both corticosteroid-treated groups remained at the thirty-fifth percentile after more than a 2-year average duration of follow-up. Heights of children with chronic asthma not requiring maintenance corticosteroids were initially significantly higher (fifty-first percentile) than the patients who subsequently required maintenance corticosteroids and increased significantly to the sixty-first percentile during a mean 2.7-year follow-up. Heights of healthy Iowa children remained near the fiftieth percentile during a mean 7-year follow-up. Disproportionate weight gain, although it was not consistently present, was significantly more likely with the alternate-day prednisone. Other extrapulmonary effects of the corticosteroid regimens appeared not to be of clinical importance during the time period of the study.

    Topics: Administration, Inhalation; Adolescent; Asthma; Beclomethasone; Blood Cell Count; Body Height; Body Weight; Candidiasis; Cataract; Child; Female; Growth; Hematocrit; Hemoglobins; Humans; Hydrocortisone; Immunoglobulins; Male; Prednisone

1987
[Therapy and control of intractable bronchial asthma].
    Nihon rinsho. Japanese journal of clinical medicine, 1987, Volume: 45, Issue:8

    Topics: Administration, Inhalation; Adult; Aged; Allergens; Asthma; Beclomethasone; Humans; Middle Aged

1987
Adrenocortical function in children on high-dose steroid aerosol therapy. Results of serum cortisol, ACTH stimulation test and 24 hour urinary free cortical excretion.
    Allergy, 1987, Volume: 42, Issue:7

    The adrenocortical function was investigated in 18 children treated with high-doses of inhaled glucocorticoid aerosol (mean: 1965 micrograms/1.73 m2 body surface a day). Basal serum cortisol was only below the normal range in patients treated with doses exceeding 2500 micrograms/1.73 m2 body surface. 15 of 18 children had normal 24 h urinary free cortisol excretion, compared with 27 normal children matched for age, sex and body surface. Three patients taking more than 2400 micrograms/1.73 m2 body surface showed excretion values below the range for the normal controls. 10 of 12 patients showed a normal response to a short ACTH stimulation test. One patient treated with 3300 micrograms/1.73 m2 body surface showed no response and one patient gave a borderline response to ACTH. We concluded that doses up to 2000 micrograms/1.73 m2 body surface/24 can be administered by pressurized aerosol with little risk of adrenocortical suppression.

    Topics: Administration, Inhalation; Adolescent; Adrenal Cortex; Asthma; Beclomethasone; Budesonide; Child; Cosyntropin; Female; Glucocorticoids; Humans; Hydrocortisone; Male; Pregnenediones

1987
Beclomethasone dipropionate aerosol therapy in childhood asthma.
    Indian pediatrics, 1987, Volume: 24, Issue:7

    Topics: Administration, Inhalation; Airway Resistance; Asthma; Beclomethasone; Child; Drug Therapy, Combination; Humans

1987
Nocturnal adrenal suppression in asthmatic children taking inhaled beclomethasone dipropionate.
    Lancet (London, England), 1986, Apr-26, Volume: 1, Issue:8487

    Plasma cortisol was measured every 20 min and sleep was monitored in nineteen asthmatic children, twelve of whom were receiving various doses of inhaled beclomethasone dipropionate (BDP). Children receiving inhaled BDP had lower cortisol secretion during the night than those who were not taking inhaled BDP, a delayed rise from the nocturnal nadir, and low early morning levels. Inhaled BDP produces a dose-dependent adrenal suppression.

    Topics: Adolescent; Adrenal Glands; Asthma; Beclomethasone; Child; Circadian Rhythm; Dose-Response Relationship, Drug; Female; Humans; Hydrocortisone; Male; Monitoring, Physiologic; Sleep

1986
Nocturnal adrenal suppression in children inhaling beclomethasone dipropionate.
    Lancet (London, England), 1986, May-31, Volume: 1, Issue:8492

    Topics: Adrenal Glands; Adult; Aerosols; Asthma; Beclomethasone; Child; Circadian Rhythm; Humans; Hydrocortisone

1986
Systemic effects and inhaled beclomethasone dipropionate.
    Lancet (London, England), 1986, Jun-14, Volume: 1, Issue:8494

    Topics: Aerosols; Asthma; Beclomethasone; Circadian Rhythm; Dose-Response Relationship, Drug; Humans

1986
Exacerbation of asthma after nebulised beclomethasone diproprionate.
    Lancet (London, England), 1986, Sep-06, Volume: 2, Issue:8506

    Topics: Aerosols; Asthma; Beclomethasone; Child, Preschool; Drug Hypersensitivity; Humans; Male

1986
The diagnosis and management of asthma in childhood.
    The Practitioner, 1986, Volume: 230, Issue:1416

    Topics: Asthma; Beclomethasone; Child; Cromolyn Sodium; England; Female; Home Nursing; Humans; Infant; Prednisolone

1986
Growth and childhood asthma.
    Archives of disease in childhood, 1986, Volume: 61, Issue:11

    Height and weight were measured every six months in a long term prospective study of 66 children with chronic perennial asthma for a mean 13.1 years. There was no evidence of growth retardation on entry into the study. Growth developed along normal lines in all 66 children until about 10 years, and in 35 of these children growth continued along normal lines throughout the whole period of follow up. Thirty children showed the physiological decelerating growth velocity pattern seen in children with delay in the onset of puberty, and one child had an early menarche. The tendency for delay in the onset of puberty was significant for both boys and girls and was noted to be independent of severity of asthma. Once puberty finally began in these children, complete catch up growth resulted in the attainment of the predicted adult height. Long term prophylactic inhalation of beclomethasone dipropionate in 26 children in a dosage up to 600 mcg/day before puberty and 400 mcg/day during puberty was shown not to affect growth. It is concluded that asthma had no direct influence on growth in height but was associated with delay in the onset of puberty. The pre-adolescent physiological deceleration of growth velocity that occurs in these children gives the impression of growth retardation.

    Topics: Asthma; Beclomethasone; Body Height; Body Weight; Child; Chronic Disease; Cromolyn Sodium; Female; Growth; Humans; Male; Prednisolone; Prospective Studies; Puberty, Delayed; Time Factors

1986
[Inhalation corticosteroids in asthma].
    Nederlands tijdschrift voor geneeskunde, 1986, May-17, Volume: 130, Issue:20

    Topics: Asthma; Beclomethasone; Humans; Lung

1986
Outcome of pregnancy in women requiring corticosteroids for severe asthma.
    The Journal of allergy and clinical immunology, 1986, Volume: 78, Issue:2

    We report on the outcome of 56 pregnancies in 51 women with severe asthma requiring prednisone and/or beclomethasone dipropionate. There were no malformations, neonatal deaths, or maternal deaths. The overall incidence of premature (less than 37 weeks gestational age) and low birth-weight infants (less than or equal to 2500 gr) was slightly higher than would be expected in the general population. These findings appeared attributable in part to infants of gravidas whose asthma was complicated by emergency room visits or status asthmaticus. There was a statistically increased incidence of low birth weight and small size for gestational age infants in the eight infants born to women who experienced status asthmaticus when these infants were compared to the 41 infants born to women who did not require emergency room therapy or develop status asthmaticus. Our data confirm that prednisone and beclomethasone dipropionate are appropriate therapy for pregnant women with severe asthma and suggest that the prevention of status asthmaticus may result in a favorable outcome for the fetus. The current study confirms previous evaluations of pregnant women with severe asthma conducted by Northwestern University Allergy Service and extends the series to 171 pregnancies.

    Topics: Adrenal Cortex Hormones; Adult; Asthma; Beclomethasone; Birth Weight; Female; Humans; Infant, Newborn; Infant, Small for Gestational Age; Prednisone; Pregnancy; Pregnancy Complications

1986
[Method of decreasing oral corticosteroids by adding a beclomethasone dipropionate inhaler for steroid-dependent asthmatic patients].
    Nihon Kyobu Shikkan Gakkai zasshi, 1986, Volume: 24, Issue:5

    Topics: Administration, Inhalation; Administration, Oral; Asthma; Beclomethasone; Humans; Prednisolone

1986
Severe bronchoconstriction after inhalation of beclomethasone and budesonide.
    Singapore medical journal, 1986, Volume: 27, Issue:3

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Bronchial Diseases; Budesonide; Constriction, Pathologic; Female; Humans; Pregnenediones

1986
Ventide--a useful combination?
    Drug and therapeutics bulletin, 1986, Feb-24, Volume: 24, Issue:4

    Topics: Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Drug Combinations; Humans

1986
Natural history of asthma in patients requiring long-term systemic corticosteroids.
    Archives of internal medicine, 1986, Volume: 146, Issue:12

    To study the natural history of corticosteroid-dependent asthma, we evaluated 40 randomly selected adult patients with severe asthma who were refractory to management with inhaled corticosteroids and bronchodilators and who required long-term prednisone therapy (mean duration, 6.2 +/- 5.1 years). During long-term observation, 13 patients (32.5%) significantly improved; ten (25%) of these tolerated discontinuation of long-term prednisone use and three (7.5%) had decreased prednisone requirements. Three patients (7.5%) had increased requirements for prednisone. Twenty-four patients (60%) had generally unchanged, long-term prednisone requirements; of note, eight of these had significant, but temporary intervals (mean, 3.2 years) when they could be managed without prednisone. Patients with mixed asthma were more likely to tolerate discontinuation of long-term prednisone; no other factors studied were predictive of the course of asthma. Although prior to our care many patients had a history of numerous emergency room visits and hospitalizations (some for life-threatening episodes of status asthmaticus), there were few emergency room visits and hospitalizations while under strict management by our service. Variations observed in the natural history of corticosteroid requirements in asthma must be considered in designing studies seeking to evaluate efficacy of new experimental therapies for asthma.

    Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Asthma; Beclomethasone; Drug Administration Schedule; Drug Therapy, Combination; Emergencies; Female; Hospitalization; Humans; Male; Middle Aged; Prednisone; Random Allocation; Time Factors

1986
Beclomethasone dipropionate aerosols in Thai asthmatic children.
    Journal of the Medical Association of Thailand = Chotmaihet thangphaet, 1986, Volume: 69 Suppl 2

    Topics: Adolescent; Aerosols; Asthma; Beclomethasone; Child; Chronic Disease; Female; Humans; Hydrocortisone; Male

1986
[Comparative evaluation of the effectiveness of different methods of prophylactic treatment for children with bronchial asthma].
    Pediatriia, 1985, Issue:4

    Topics: Adjuvants, Immunologic; Adolescent; Asthma; Beclomethasone; Child; Child, Preschool; Cromolyn Sodium; Drug Combinations; Drug Therapy, Combination; gamma-Globulins; Histamine; Humans; Immunoglobulins; Levamisole; T-Lymphocytes; Time Factors

1985
Adequacy of management and severity of asthma in children attending a summer camp.
    The Medical journal of Australia, 1985, Mar-04, Volume: 142, Issue:5

    To assess the adequacy of therapy in asthma, 46 children with asthma attending a summer camp were asked to complete a questionnaire about their symptoms and the treatment that they had received. Each child's height, weight, forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) were measured. According to defined criteria of symptom severity the children were categorized as suffering from severe (48%) or mild (52%) asthma. The mean FEV1/FVC ratio (P less than 0.05) and the mean FEV1 were lower (P less than 0.02) in the children with severe asthma compared with those with mild asthma. In the group with severe asthma, 68% of the children were considered to be receiving suboptimal therapy; 45% had never had their FEV1 or FVC measured. Among those who were receiving suboptimal therapy, 40% had measurable airflow obstruction compared with 17% of children with mild asthma. Because poor management of asthma remains common in children, the need to make doctors and parents aware of the fact that suboptimal therapy may contribute significantly to the morbidity of the condition is emphasized.

    Topics: Adolescent; Adrenergic beta-Agonists; Asthma; Beclomethasone; Bronchodilator Agents; Child; Child, Preschool; Cromolyn Sodium; Forced Expiratory Volume; Humans; Respiratory Therapy; Theophylline; Vital Capacity

1985
The outpatient management of asthma.
    Annals of allergy, 1985, Volume: 55, Issue:3

    Topics: Acupuncture Therapy; Adrenergic beta-Agonists; Aerosols; Ambulatory Care; Asthma; Beclomethasone; Cromolyn Sodium; Humans; Hypnosis; Injections, Intravenous; Ipratropium; Medical History Taking; Methylprednisolone; Self Administration; Theophylline

1985
The bronchial late response in the pathogenesis of asthma and its modulation by therapy.
    Annals of allergy, 1985, Volume: 55, Issue:6

    Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Air Pollutants, Occupational; Allergens; Asthma; Beclomethasone; Bronchodilator Agents; Cromolyn Sodium; Humans; Hypersensitivity, Delayed; Hypersensitivity, Immediate; Time Factors

1985
[The effect of beclomethasone dipropionate as inhalation therapy on the pituitary-adrenal axis in children].
    Tijdschrift voor kindergeneeskunde, 1985, Volume: 53, Issue:2

    The function of the pituitary-adrenal axis was investigated in ten asthmatic children (5-14 years of age) before and after administration of beclomethasone-dipropionate as inhalation therapy in a dose of 300-600 micrograms/24 hrs, during six months. Cortisol diurnal rhythm, excretion of free cortisol in 24 hours urine and stimulation of plasma-cortisol after ACTH-administration were determined. The same investigations were carried out in a comparable group of ten asthmatic children already using this inhalation therapy for more than one year. Significant differences were found comparing 08.00 h. cortisol values of the children from the first group and those who used medication for more than one year. In this first group, the ability of the adrenal glands to be stimulated by ACTH-administration after six months of medication, decreased significantly as well. These results indicate an impairment of the function of pituitary-adrenal axis during long-term treatment with inhaled beclomethasone-dipropionate. This implicates a decreased ability of the adrenal glands to react in an optimum way in stress-situations. In these patients oral or parenteral administrations of steroids should be considered earlier in stress situations like a severe asthma attack.

    Topics: Adrenocorticotropic Hormone; Asthma; Beclomethasone; Child; Child, Preschool; Humans; Hydrocortisone; Pituitary-Adrenal System; Respiratory Therapy

1985
Asthma in a country hospital.
    The New Zealand medical journal, 1985, Apr-10, Volume: 98, Issue:776

    All 39 adult asthma admissions to Kaitaia Hospital in 1983 were surveyed. Of 15 patients treated by a doctor prior to admission, only one received treatment likely to abort the attack. Twenty-four patients were supposed to be taking beclomethasone or cromoglycate but only six were taking it regularly with an adequate inhaler technique. The possibility of erratic use of beclomethasone being a contributing factor in the high mortality from asthma in New Zealand is raised. Of 15 patients not taking beclomethasone or cromoglycate, 10 gave a history suggesting they could have benefited from such medication. Twenty-eight of the admissions were thought to have been potentially preventable.

    Topics: Adolescent; Adult; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Cromolyn Sodium; Female; Humans; Male; Prednisone

1985
Beclomethasone dipropionate and betamethasone valerate with sodium cromoglycate in steroid-dependent asthma in adults.
    Asian Pacific journal of allergy and immunology, 1985, Volume: 3, Issue:1

    Topics: Adult; Asthma; Beclomethasone; Betamethasone; Cromolyn Sodium; Female; Humans; Male; Steroids; Substance-Related Disorders

1985
[Bronchial hyperreactivity to pneumo-allergens].
    Anales espanoles de pediatria, 1985, Nov-30, Volume: 23, Issue:7

    Topics: Adolescent; Albuterol; Allergens; Asthma; Beclomethasone; Bronchi; Bronchial Provocation Tests; Bronchial Spasm; Child; Child, Preschool; Cromolyn Sodium; Female; Humans; Hypersensitivity, Immediate; Immunoglobulin E; Male

1985
High dose inhaled budesonide in the treatment of severe steroid-dependent asthmatics. A two-year study.
    Allergy, 1985, Volume: 40, Issue:1

    Thirty-eight patients with chronic asthma requiring continuous oral corticosteroid treatment took part in a 2-year study. Budesonide, a new inhalation steroid with high topical activity and low systemic effects, was given in stepwise increasing doses from 200 micrograms daily up to 800-1600 micrograms daily and prednisolone doses were decreased gradually on an individual basis. After 2 years, 18 patients had been able to cease oral prednisolone treatment, 11 had decreased the dose by greater than or equal to 50%, three by less than or equal to 50% and two patients had increased their dose. At the end of the study the majority of patients (26) were using 800 micrograms budesonide daily and seven, 1200 micrograms or more daily. There were two dropouts, one due to local side effects and one to a severe pulmonary eosinophilia. Ten patients had local side effects in the form of hoarseness and/or sore throat, and 13 patients had steroid withdrawal symptoms such as arthralgia and myalgia. The asthma condition in all patients was improved, as indicated by the reduced need for hospital admissions. The results indicate that high doses of budesonide should be tried before starting maintenance therapy with oral steroids.

    Topics: Administration, Intranasal; Adrenal Cortex Hormones; Adult; Aged; Arthritis; Asthma; Beclomethasone; Budesonide; Female; Humans; Male; Middle Aged; Prednisolone; Pregnenediones; Substance Withdrawal Syndrome

1985
How well do asthma clinic patients understand their asthma?
    British journal of diseases of the chest, 1985, Volume: 79, Issue:1

    Fifty asthmatic patients attending a hospital asthma clinic were interviewed to determine their understanding of their asthma and its treatment. Serious defects were found in their ability to judge the severity of their asthma, in their knowledge of medication, and in the correct action to take when deterioration in control occurred. Several risk factors previously identified in studies of asthma deaths were also present in this living population--in particular, delay in seeking medical help until critically ill, and lack of awareness of danger signs. There was evidence of poor patient-doctor contact and unsuccessful patient education.

    Topics: Adrenal Cortex Hormones; Adult; Aerosols; Aged; Anti-Bacterial Agents; Asthma; Attitude to Health; Beclomethasone; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Physician-Patient Relations; Self Administration

1985
Effects of aerosol corticosteroids on the voice: triamcinolone acetonide and beclomethasone dipropionate.
    Journal of speech and hearing research, 1985, Volume: 28, Issue:2

    The present investigation compared the effects of triamcinolone acetonide (Aristocort Aerosol) and beclomethasone dipropionate (Vanceril Inhaler) on the vocal functioning of 11 chronic asthmatics. Using conventional aero-acoustic techniques, subjects' vocal fundamental frequency, maximum phonation time, and oral air volume velocity were sampled at baseline (oral corticosteroid use) and at the end of the first and second year of aerosol triamcinolone acetonide use. At the end of the second year of aerosol triamcinolone acetonide use, all subjects discontinued use of this compound and began use of aerosol beclomethasone dipropionate. Subjects' vocal performance then was sampled after 1 year of aerosol beclomethasone dipropionate use. Results of this study suggest that aerosol triamcinolone acetonide reduced the vocal dysfunction observed during the baseline period. When aerosol beclomethasone dipropionate was used, however, subjects' vocal performance was similar to that observed during the baseline period (oral steroid use).

    Topics: Aerosols; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Phonation; Triamcinolone Acetonide; Voice; Voice Quality

1985
[Defining the position of steroid aerosol in the treatment of bronchial asthma--studies of steroid withdrawal methods with beclomethasone dipropionate inhaler].
    Nihon Kyobu Shikkan Gakkai zasshi, 1985, Volume: 23, Issue:2

    Topics: Adrenal Cortex Hormones; Adult; Aerosols; Asthma; Beclomethasone; Female; Humans; Male; Middle Aged; Substance-Related Disorders

1985
[Adverse effects of long-term beclomethasone dipropionate (Becotide) inhalation therapy].
    Vnitrni lekarstvi, 1985, Volume: 31, Issue:11

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Female; Humans; Male; Middle Aged

1985
[Asthma therapy and pregnancy].
    Deutsche medizinische Wochenschrift (1946), 1984, May-11, Volume: 109, Issue:19

    Topics: Adrenergic beta-Agonists; Asthma; Beclomethasone; Bronchodilator Agents; Female; Histamine Antagonists; Humans; Pregnancy; Risk

1984
Inhaled therapy reduces morning dips in asthma.
    Lancet (London, England), 1984, May-26, Volume: 1, Issue:8387

    14 asthmatic patients with nocturnal symptoms and morning dips in peak expiratory flow rate (PEFR) were treated with regular inhaled salbutamol for 1 or 2 weeks, followed by regular inhaled beclomethasone dipropionate, in addition to salbutamol, for a further 2 weeks. Mean PEFR rose to normal values in all but 1 patient. Morning dips in PEFR were substantially reduced in 8 patients. There was an equivalent rise in mean PEFR in the other 6 patients, but their morning dips did not improve. Inhaled salbutamol reduced the dips in the responsive patients, but addition of inhaled steroid produced further improvement. Inhaled beta agonist alone improved mean PEFR in these patients, but inhaled steroids produced most of the improvement in the other subgroup. No patient experienced side-effects. Thus mean PEFR can be improved and morning dips in PEFR reduced in a high proportion of asthmatic patients by the use of regular inhaled therapy without resorting to less-well-tolerated oral agents.

    Topics: Adolescent; Adult; Aerosols; Albuterol; Asthma; Beclomethasone; Child; Circadian Rhythm; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Random Allocation

1984
Suppression of pituitary-adrenal axis in children on beclomethasone dipropionate inhalation therapy.
    Lancet (London, England), 1984, Jul-21, Volume: 2, Issue:8395

    Topics: Adolescent; Asthma; Beclomethasone; Child; Child, Preschool; Humans; Pituitary-Adrenal System

1984
Medication compliance in children with asthma.
    Australian paediatric journal, 1984, Volume: 20, Issue:1

    A questionnaire to assess compliance with prescribed therapy was completed by 200 children with asthma. The validity of the questionnaire was assessed objectively by measuring plasma theophylline concentrations in 37 subjects and by weighing metered dose aerosol canisters before and after use in 19 subjects. The average compliance was 67.9%. The close agreement between answers to the questionnaire and the objective measurements of compliance indicated that most participants recalled the drug regimens accurately. Good compliance was related to whether Australia was the parents' country of origin, to knowledge of the disorder and to comprehension of medication but was not related to perception of the severity of the illness. This study demonstrates that compliance is relatively poor even in a clinic population which attends regularly and appears well-motivated.

    Topics: Administration, Intranasal; Adolescent; Adrenergic beta-Agonists; Aerosols; Asthma; Beclomethasone; Child; Child, Preschool; Cromolyn Sodium; Humans; Patient Compliance; Theophylline

1984
Persisting airflow limitation in asthmatics receiving routine self-adjusted medication.
    European journal of respiratory diseases, 1984, Volume: 65, Issue:5

    Sixty-two patients with moderate asthma adjusted their routine medication (bronchodilator aerosol 59/62, beclomethasone dipropionate 55/62) to control their symptoms to their own and their doctor's satisfaction. They recorded peak expiratory flow (PEF) 3 times daily over about 8 months. PEF and spirometry were performed before and after aerosolised salbutamol on hospital attendances at monthly intervals. The subjects were classified as having Persistent Airflow Limitation (PAL) if every measurement, including that following a bronchodilator, persistently failed to reach a value of at least the predicted minus 2 SD. PAL was present in 7/62 by using FEV1 and in 27/62 using PEF. PAL was related to patient's age (p less than 0.02) and to duration of asthma (p less than 0.02). Flow-volume curves (available in 46/62 patients) correlated closely with PEF recorded at home on the same morning. Maximum expiratory flows at 50% and 25% of FVC were significantly lower in patients with PAL (assessed by PEF) than in those without PAL, suggesting more severe small airways dysfunction in those with PAL.

    Topics: Adult; Aerosols; Age Factors; Albuterol; Asthma; Beclomethasone; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Piperazines; Pulmonary Ventilation; Respiratory Therapy; Spirometry; Time Factors

1984
A new treatment for asthma: promotional expediency versus pharmaceutical responsibility.
    British medical journal (Clinical research ed.), 1984, Jan-07, Volume: 288, Issue:6410

    Topics: Albuterol; Asthma; Beclomethasone; Drug Combinations; Humans

1984
In-the-first-person. Ill and well, with or without doctors.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1984, Volume: 21, Issue:1

    Topics: Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Child; Child, Preschool; Humans; Infant; Long-Term Care; Male; Psychotherapy; Triamcinolone Acetonide

1984
ABC of asthma. Asthma in children: treatment.
    British medical journal (Clinical research ed.), 1984, Jun-23, Volume: 288, Issue:6434

    Topics: Acute Disease; Aerosols; Asthma; Beclomethasone; Budesonide; Child; Child, Preschool; Cromolyn Sodium; Humans; Infant; Prednisolone; Pregnenediones; Self Care; Theophylline

1984
Beclomethasone dipropionate and betamethasone valerate with sodium cromoglycate in steroid-dependent asthma in children.
    The Journal of the Association of Physicians of India, 1984, Volume: 32, Issue:3

    Topics: Adolescent; Asthma; Beclomethasone; Betamethasone; Betamethasone Valerate; Child; Child, Preschool; Cromolyn Sodium; Drug Therapy, Combination; Female; Humans; Male; Prospective Studies

1984
[Studies on the effect of beclomethasone dipropionate (BD) on airway hyperreactivity of patients with bronchial asthma].
    Arerugi = [Allergy], 1984, Volume: 33, Issue:7

    Topics: Adult; Aged; Asthma; Beclomethasone; Bronchi; Drug Hypersensitivity; Female; Humans; Male; Middle Aged

1984
Multiparametrical approach to fog-challenge-induced bronchial hyperreactivity in asthmatics--protective effects of salbutamol plus beclomethasone dipropionate.
    International journal of clinical pharmacology, therapy, and toxicology, 1984, Volume: 22, Issue:9

    A multiparametrical method was used in order to evaluate the characteristics of fog-challenge-induced bronchoreactivity. The effects of the bronchial stimulation were measured by means of spirometrical tests; determination of ventilatory resistances using a new method by interruption and rapid analysis of the expiratory gases, CO2 and He, according to the "multiple single breath" method. The protective efficacy of salbutamol and the salbutamol plus beclomethasone dipropionate combination was evaluated. The results obtained indicate that the combination exerts a greater protective effect, probably related to the stabilizing action of beclomethasone on the bronchial mucosa.

    Topics: Aerosols; Albuterol; Asthma; Beclomethasone; Drug Therapy, Combination; Humans; Male; Middle Aged; Random Allocation; Respiratory Function Tests; Water

1984
Effect of inhaled beclomethasone dipropionate on saliva cortisol concentrations.
    Archives of disease in childhood, 1984, Volume: 59, Issue:6

    Serial saliva cortisol measurements were used to assess pituitary-adrenal function in a group of asthmatic children treated with beclomethasone dipropionate (400 micrograms daily). Asthmatic children who were not being treated with steroids and normal children were also studied for comparison. A diurnal cortisol rhythm was observed in all three groups. Early morning cortisol concentrations were significantly higher in the group treated with beclomethasone dipropionate than in the normal children; this may indicate a stress induced response to decreased morning peak expiratory flow. In both groups, plasma and salivary cortisol responses after adrenocorticotrophic hormone stimulation test were normal but peak cortisol concentrations showed a 7 fold increase over basal values in saliva compared with a three fold increase in plasma. Beclomethasone dipropionate does not suppress pituitary-adrenal function in children when used in recommended doses. Serial measurement of the salivary cortisol concentration is a simple, safe, and sensitive method for the routine monitoring of adrenal function in children treated with this steroid. Monitoring may be supplemented with an assessment of the adrenal response to adrenocorticotrophic hormone stimulation, if necessary.

    Topics: Adolescent; Asthma; Beclomethasone; Child; Circadian Rhythm; Female; Humans; Hydrocortisone; Male; Pituitary-Adrenal Function Tests; Pituitary-Adrenal System; Saliva

1984
Glucocorticoids and asthma. Studies of resistance and systemic effects of glucocorticoids.
    European journal of respiratory diseases. Supplement, 1984, Volume: 136

    Glucocorticoid resistance in asthma is genetically determined in a few individuals. Preliminary data are presented from a study showing interaction with a drug as another explanation for glucocorticoid resistance. In 6 healthy individuals, prednisolone concentrations were measured during 9 h after oral intake of 15 mg before and after 10 days' intake of 450 mg of rifampicin daily. An increased clearance of prednisolone was demonstrated. Systemic effects of inhaled glucocorticoids have also been studied. Comparison in healthy individuals between beclomethasone dipropionate given as a spray and as powder showed similar systemic effects with the two modes of administration. A new glucocorticoid for inhalation therapy, budesonide, was shown to have a weaker systemic effect than beclomethasone dipropionate. By rinsing the mouth with water after inhalation, it was possible to reduce the amount of drug swallowed, and our data showed a tendency towards less systemic effects after mouth-rinsing.

    Topics: Asthma; Beclomethasone; Budesonide; Dose-Response Relationship, Drug; Drug Interactions; Drug Resistance; Forced Expiratory Volume; Glucocorticoids; Humans; Hydrocortisone; Metabolic Clearance Rate; Prednisolone; Pregnenediones

1984
The use of inhaled high dose beclomethasone in the Waikato region.
    The New Zealand medical journal, 1984, Aug-22, Volume: 97, Issue:762

    Topics: Asthma; Beclomethasone; Humans; New Zealand

1984
Adrenocortical function during high-dose beclomethasone aerosol therapy.
    Clinical allergy, 1984, Volume: 14, Issue:1

    Prolonged observation of eight steroid-dependent asthmatics show that the dose of beclomethasone dipropionate aerosol may be increased in some cases up to 2000 micrograms daily without significant impairment in the results of serial tetracosactrin tests of adrenocortical function. These findings contrast sharply with the results of such tests during oral prednisolone therapy.

    Topics: Adrenal Glands; Aerosols; Asthma; Beclomethasone; Cosyntropin; Dose-Response Relationship, Drug; Humans; Hydrocortisone

1984
Dosing of inhaled corticosteroids and therapeutic goals in asthmatic patients.
    European journal of respiratory diseases, 1984, Volume: 65, Issue:5

    Topics: Aerosols; Asthma; Beclomethasone; Budesonide; Drug Administration Schedule; Glucocorticoids; Humans; Pregnenediones; Pulmonary Ventilation; Respiratory Therapy; Time Factors

1984
High-dose beclomethasone inhaler in the treatment of asthma.
    Lancet (London, England), 1983, Feb-05, Volume: 1, Issue:8319

    The effects of long-term use of high-dose inhaled beclomethasone dipropionate (BDP) were studied retrospectively in 293 asthmatic patients who were not adequately controlled on conventional doses of BDP or who required oral corticosteroids to control their asthma. The higher doses of BDP were administered in a high-dose beclomethasone aerosol (BDP 250) containing 250 micrograms BDP per metered dose. 27% of the steroid-dependent asthmatics were able to stop oral steroids altogether after the introduction of BDP 250, and a further 39% were able to reduce their daily dosage. Improvement in asthma control was achieved in 62% of all patients and was accompanied by a reduction in the number of severe acute exacerbations and a significant increase in mean peak expiratory flow rate. Oropharyngeal candidiasis was not significantly more common with the BDP 250 inhaler than with conventional inhalers and appears to have been related to the number and frequency of inhalations and not solely to the total dosage. Other side-effects were very rare.

    Topics: Aerosols; Asthma; Beclomethasone; Candidiasis, Oral; Drug Therapy, Combination; Female; Humans; Male; Prednisolone; Respiratory Therapy; Retrospective Studies; Time Factors

1983
High-dose beclomethasone inhaler in the treatment of asthma.
    Lancet (London, England), 1983, Apr-16, Volume: 1, Issue:8329

    Topics: Aerosols; Asthma; Beclomethasone; Humans

1983
Decreased mononuclear cell beta-adrenergic receptors in bronchial asthma: parallel studies of lymphocyte and granulocyte desensitization.
    The Journal of allergy and clinical immunology, 1983, Volume: 72, Issue:5 Pt 1

    To assess the interaction of bronchial asthma and beta-agonist drugs, beta-adrenergic receptors were measured in human mixed leukocyte, mononuclear cell, and polymorphonuclear leukocyte cell membranes simultaneously. The densities and affinities of beta-adrenergic receptors were determined, by Scatchard analysis, with a potent beta-antagonist 125I-hydroxybenzylpindolol (125I-HYP) and compared among 12 nonatopic controls (group I), 13 mild asthmatics not taking drugs (group II), and eight asthmatics receiving long-term beta-agonist therapy (group III). Our findings were as follows. (1) Asthmatics not taking drugs (group II) have significantly lower mean mononuclear leukocyte beta-adrenergic receptor density (p less than 0.05) but no significant difference in mean polymorphonuclear leukocyte beta-adrenergic receptor density than the control group. (2) Asthmatics receiving long-term beta-agonist treatment (group III) had significantly lower mean beta-adrenergic receptor density in all three cell fractions (p less than 0.05). (3) Group I and II females had a higher mean beta-adrenergic receptor density in mixed leukocyte and polymorphonuclear cell fractions than males (p less than 0.05). (4) Terbutaline sulfate clearly caused desensitization of beta-adrenergic receptors in human leukocyte membranes in vivo. These results show that beta-adrenergic receptor density is influenced by cell type, beta-adrenergic agonist administration, and sex; they also show that bronchial asthma itself is associated with lower lymphocyte beta-receptor density.

    Topics: Administration, Oral; Adolescent; Adult; Aged; Asthma; Beclomethasone; Cyclic AMP; Desensitization, Immunologic; Female; Granulocytes; Humans; Lymphocytes; Male; Middle Aged; Monocytes; Neutrophils; Receptors, Adrenergic, beta; Respiratory Function Tests

1983
Neutrophil chemotactic activity in milk-induced asthma.
    The Journal of allergy and clinical immunology, 1983, Volume: 72, Issue:1

    Four subjects with clinical histories of milk-induced asthma were studied (three allergic to cow's milk; one to soya milk). In each instance, skin prick tests, RAST (IgE and IgG4), the basophil histamine release, and serum precipitins, using appropriate milk extracts, were negative. After the ingestion of milk all the subjects developed a reproducible and dose-dependent increase in airflow limitation. Three patients (two allergic to cow's milk; one to soya milk) gave a characteristic immediate-type reaction, which was maximal at 30 min after challenge. The fourth individual developed an isolated late-phase response, with maximal airways obstruction 3 hr after ingesting milk. In the three subjects who gave an early reaction, wheezing was accompanied by an elevation in circulating neutrophil chemotactic activity (NCA). This was not observed in the individual with the isolated late reaction. By Sephacryl S-400 gel-filtration chromatography it was shown that NCA of the early reactions eluted with proteins having an estimated molecular weight of 600,000 daltons. The immediate asthmatic response in peak expiratory flow rate and the elevation in NCA were inhibited by the prior oral administration of either disodium cromoglycate (DSCG) or oral beclomethasone dipropionate (BDP). In contrast, DSCG had no effect on airways obstruction in the subject with the isolated late asthmatic response, although inhibition was achieved by BDP.

    Topics: Adult; Animals; Asthma; Beclomethasone; Chemotaxis, Leukocyte; Cromolyn Sodium; Female; Food Hypersensitivity; Humans; Male; Middle Aged; Milk; Neutrophils

1983
Addiction to aerosol treatment: the asthmatic alternative to glue sniffing.
    British medical journal (Clinical research ed.), 1983, Nov-19, Volume: 287, Issue:6404

    Topics: Adolescent; Aerosol Propellants; Aerosols; Albuterol; Asthma; Beclomethasone; Female; Humans; Substance-Related Disorders

1983
Resolution of pulmonary cyst after steroid therapy of asthma.
    Southern medical journal, 1983, Volume: 76, Issue:11

    Emphysematous lung cysts in rare instances are associated with bronchial asthma, as evidenced by our patient and possibly another. Particularly in young patients, a trial period of steroid therapy should be instituted to confirm this possible association, to avoid unwarranted surgery and its attendant morbidity.

    Topics: Asthma; Beclomethasone; Cysts; Female; Humans; Lung Diseases; Middle Aged; Respiratory Therapy

1983
Effects of long term inhaled high dose beclomethasone dipropionate on adrenal function.
    Thorax, 1983, Volume: 38, Issue:9

    Studies of adrenal function were performed on 54 asthmatic patients who were taking long term high doses of inhaled beclomethasone dipropionate ranging from 500 to 2000 micrograms/day for between six and 60 months. Of the 43 patients taking up to 1500 micrograms/day, 39 (91%) had normal basal plasma cortisol concentrations and normal short tetracosactrin responses and 24 hour urinary free cortisol excretion was within the normal range in eight of nine patients tested. Some evidence of adrenal suppression was found in patients taking 2000 micrograms/day, with basal plasma cortisol below the normal range in four out of 11 patients and 24 hour urinary free cortisol excretion below the normal range in five out of six patients tested. Only one of the 11 patients taking 2000 micrograms/day had a short tetracosactrin response below the normal range: the mean rise in plasma cortisol was, however, significantly lower in this group than in those taking 1000 micrograms/day (328 (SE 30) and 506 (34) nmol/l respectively) (p less than 0.01). Patients taking more than 1500 micrograms/day of inhaled beclomethasone may require systemic corticosteroids during prolonged stress.

    Topics: Adolescent; Adrenal Cortex; Adrenal Cortex Function Tests; Adrenal Cortex Hormones; Adult; Aged; Asthma; Beclomethasone; Circadian Rhythm; Cosyntropin; Drug Administration Schedule; Female; Humans; Hydrocortisone; Male; Middle Aged; Respiratory Therapy

1983
Beclomethasone diproprionate for severe asthma during pregnancy.
    Annals of internal medicine, 1983, Volume: 98, Issue:4

    The safety of using inhaled beclomethasone dipropionate for the treatment of severe asthma during pregnancy was evaluated during 45 pregnancies in 40 women. Despite chronic administration of theophylline and, in some women, ephedrine, the asthma was so severe that corticosteroids were essential to prevent emergency room visits and status asthmaticus. At conception, beclomethasone dipropionate was being used regularly during 38 pregnancies and was initiated during the first trimester in 4 other pregnancies. The range of beclomethasone dipropionate inhalations was 4 to 16/d with a mean of 9.5/d (336 micrograms). Prednisone administration was necessary during 37 pregnancies. Status asthmaticus occurred in five women but no mothers or fetuses died. Cardiac malformations occurred in an infant born to a woman who was diabetic and schizophrenic whose pregnancy was complicated by diabetic ketoacidosis and status asthmaticus. It is not known whether beclomethasone dipropionate was the cause of these malformations. The prevalence of congenital malformations (1 of 43 live births) is within the normal range and shows that treatment with beclomethasone dipropionate is safe during pregnancy when recommended doses are used.

    Topics: Abnormalities, Drug-Induced; Adult; Aerosols; Asthma; Beclomethasone; Drug Therapy, Combination; Female; Humans; Middle Aged; Pregnancy; Pregnancy Complications; Prospective Studies; Retrospective Studies

1983
Tactics for clinical trials of therapy in patients with chronic asthma.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1983, Volume: 20 Suppl 1

    Asthma can be conceptualized as a disease system ranging from the molecular to the social level. It is important to monitor both subjective and objective indices appropriate to different parts of the system. Objective indices alone are not enough. It is also important to distinguish disability from symptom severity or frequency and pulmonary impairment. The personality of the patient or the duration of follow-up can profoundly affect the perceived outcome of a particular treatment. It is important in controlled trials, and also in clinical practice, to take these factors into account.

    Topics: Asthma; Beclomethasone; Chronic Disease; Clinical Trials as Topic; Humans; Patient Compliance; Pulmonary Ventilation

1983
Revisited: aerosol corticosteroids in the treatment of childhood asthma.
    Pediatrics, 1983, Volume: 72, Issue:1

    Topics: Adrenal Cortex Hormones; Adrenal Glands; Aerosols; Asthma; Beclomethasone; Child; Humans; Hydrocortisone; Respiratory Therapy

1983
Effect of inhaled beclomethasone dipropionate on hypothalamic-pituitary-adrenal axis function in children with asthma.
    Pediatrics, 1983, Volume: 72, Issue:1

    The hypothalamic-pituitary-adrenal axis was investigated in 15 asthmatic children treated with inhaled beclomethasone dipropionate (mean 490 micrograms/day) and 11 asthmatic control subjects receiving no corticosteroid therapy. Measurements of 24-h urinary free cortisol and 17 hydroxy corticosteroids, serum cortisol, response to ACTH, and the oral metyrapone test showed no significant difference between the two groups. All the patients' results were within normal limits, and carbohydrate metabolism, as shown by blood glucose and hemoglobin A1c, was not affected by beclomethasone therapy. Thus, in the above dose, inhaled beclomethasone does not cause suppression of the hypothalamic-pituitary-adrenal axis.

    Topics: 17-Hydroxycorticosteroids; Adolescent; Asthma; Beclomethasone; Blood Glucose; Child; Child, Preschool; Cosyntropin; Female; Glycated Hemoglobin; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Metyrapone; Pituitary-Adrenal System; Respiratory Therapy

1983
[Use of beclomethasone dipropionate in allergic rhinosinusopathies].
    Voenno-meditsinskii zhurnal, 1983, Issue:3

    Topics: Aerosols; Asthma; Beclomethasone; Humans; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

1983
The use of corticosteroids in asthma, bronchitis and chronic obstructive pulmonary disease.
    Connecticut medicine, 1983, Volume: 47, Issue:7

    Topics: Aerosols; Asthma; Beclomethasone; Bronchitis; Glucocorticoids; Humans; Lung Diseases, Obstructive; Respiratory Therapy

1983
Outpatient treatment of asthma.
    Comprehensive therapy, 1982, Volume: 8, Issue:3

    Topics: Asthma; Beclomethasone; Cromolyn Sodium; Humans; Sympathomimetics; Theophylline

1982
Steroids and cormolyn for treatment of chronic asthma.
    Chest, 1982, Volume: 82, Issue:1 Suppl

    Topics: Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Cromolyn Sodium; Drug Administration Schedule; Humans; Patient Compliance

1982
Drugs for asthma.
    The Medical letter on drugs and therapeutics, 1982, Sep-17, Volume: 24, Issue:618

    Topics: Asthma; Beclomethasone; Cromolyn Sodium; Drug Combinations; Epinephrine; Humans; Isoproterenol; Theophylline

1982
The effects of corticosteroids on the immediate asthmatic reaction.
    European journal of respiratory diseases. Supplement, 1982, Volume: 122

    Topics: Adrenal Cortex Hormones; Asthma; Beclomethasone; Cromolyn Sodium; Fluocortolone; Humans; Hypersensitivity, Immediate; Prednisolone

1982
Comparison between inhaled and oral corticosteroids in patients with chronic asthma.
    European journal of respiratory diseases. Supplement, 1982, Volume: 122

    Corticosteroid inhalants, beclomethasone dipropionate (BDP) and budesonide, were compared with each other and with oral prednisolone in patients with steroid dependent chronic bronchial asthma. In a first study in 23 patients the PEF values during 2 weeks' therapy with a supplementary dose of 200 or 800 micrograms of budesonide or 400 micrograms of BDP were found to be better than those noted during a preceding week with a supplementary dose of 30 mg prednisolone. In a following open study 31 patients on an initial maintenance therapy consisting of a standard dose of BDP and a mean daily dose of 9 mg prednisolone were treated with increasing (when necessary) doses of budesonide instead of BDP and decreasing (if possible) dose of prednisolone. After one year's treatment 21 patients were well controlled without oral prednisolone, and the mean prednisolone dose for the entire group was 2.5 mg a day. During the study lung function significantly improved in the subgroup of patients who were initially on the highest dose of oral prednisolone. In a third study in 17 patients the effects on lung function and on symptom scores were compared after a supplementary therapy with 10 or 20 mg oral prednisolone, or 400 or 800 micrograms budesonide. During such treatment the effect of 400 micrograms budesonide on PEF was the same as that of 10 mg prednisolone, and 800 micrograms budesonide and 20 mg prednisolone seemed to be equipotent. For corticosteroid dependent patients with severe asthma the introduction of budesonide seems to offer an improvement, allowing substantial reduction or withdrawal of oral prednisolone. This had not been possible earlier in such patients without deterioration of lung function and their clinical state. During treatment with budesonide lung function remained unchanged or improved.

    Topics: Administration, Oral; Adrenal Cortex Hormones; Adult; Aerosols; Aged; Asthma; Beclomethasone; Budesonide; Chronic Disease; Female; Humans; Male; Middle Aged; Prednisolone; Pregnenediones

1982
Safety of inhaled corticosteroids.
    European journal of respiratory diseases. Supplement, 1982, Volume: 122

    Corticosteroids effectively suppress asthma but have unwanted systemic side-effects which can be avoided if taken by inhalation. Inhaled corticosteroids are effective and although sensitive tests can occasionally detect some systemic activity with a daily dose of beclomethasone diproprionate of 400--800 micrograms, in clinical practice systemic side-effects are not seen. If this daily dose is raised above 1.5--2.0 mg systemic activity is more easily detected and is more likely to be of clinical significance. Local side-effects include occasional hoarseness and oropharyngeal thrush. There have been no reports of opportunistic pulmonary infections or bronchial epithelial damage following prolonged use. Inhaled corticosteroids are now in widespread us in over 100 countries throughout the world. They have also been employed for nearly a decade and this extensive clinical experience has not revealed significant systemic side-effects. This safety compares favourably with other asthma treatment and suggests that inhaled corticosteroids may be used when bronchodilators are failing to control symptoms and higher doses are thought necessary or being taken. Better asthma control should reduce bronchodilator consumption and the net incidence of side-effects. Inhaled corticosteroids can therefore safely provide effective treatment and steer a path between the risk of intensive bronchodilator treatment and those produced by systemic steroids.

    Topics: Asthma; Beclomethasone; Betamethasone; Betamethasone Valerate; Humans

1982
Safety of oral corticosteroids.
    European journal of respiratory diseases. Supplement, 1982, Volume: 122

    Oral corticosteroids may be life-saving for symptoms of acute asthma, and short courses are often useful to relieve even less serious acute exacerbations when the patient has become inadequately responsive to bronchodilators. Adverse effects are rarely if ever associated with short courses of steroids used for this purpose. Long-term use of oral corticosteroids, however, are associated with a variety of well-established toxic effects. The safe and effective use of oral corticosteroids in substantial doses given every other morning for various steroid-responsive diseases has been described in numerous studies since 1963. Among children with chronic asthma, suppression of the hypothalamic-pituitary-adrenal axis by alternate day prednisone in mean doses of 30 mg was found not to exceed that which occurred with inhaled beclomethasone dipropionate at doses averaging 550 micrograms/day. Growth was also similar in the 2 groups of patients. A few patients receiving alternate-day prednisone gained excessive weight, but this was not a clinical problem for most. Alternate-day prednisone is easier to administer, is associated with better compliance, and costs less than the inhaled steroid. Inhaled beclomethasone dipropionate is more bother, causes cough and throat irritation in some patients, and cannot be administered to very young children. Alternate-day prednisone, given as a single dose every other morning, and the new generation of inhaled steroids such as inhaled beclomethasone dipropionate are alternative means of providing safe and effective treatment with long-term corticosteroid therapy.

    Topics: Acute Disease; Administration, Oral; Adolescent; Asthma; Beclomethasone; Child; Child, Preschool; Humans; Prednisolone

1982
Development of new glucocorticosteroids with a very high ratio between topical and systemic activities.
    European journal of respiratory diseases. Supplement, 1982, Volume: 122

    The very potent topical anti-inflammatory glucocorticosteroids (GCS) most widely used are either 17 alpha-esters of halogenated 16-methyl-17 alpha-hydroxycorticosteroids (e.g. beclomethasone 17 alpha, 21-dipropionate = BDP) or 16 alpha, 17 alpha-acetals of halogenated 16 alpha, 17 alpha-dihydroxy corticosteroids (e.g. triamcinolone acetonide = TA). The purpose of the present investigation was to increase the ratio between the topical anti-inflammatory (TAIP) and the systemic potencies (SP) of GCS 16 alpha, 17 alpha-acetals, as such compounds are not biotransformed in the lung. Structure-activity investigations in rodents showed that fluoro substituents in positions 6 alpha or 9 alpha or both 6 alpha, 9 alpha 9 alpha increased SP more than TAIP. On the other hand, nonsymmetrical 16 alpha, 17 alpha-acetal substitution increased TAIP more than SP. The best TAIP:SP ratio was obtained with budesonide, which contains this new type of acetal substituent, but has no halogen atoms in the steroid nucleus. In the rat and the mouse budesonide has a 5--10 times better TAIP:SP ratio than 16 alpha, 17 alpha-acetonides, like TA, as well as 17 alpha-ester GCS, like BDP. The improved ratio for budesonide is probably due to a high intrinsic GCS activity at the site of application combined with an effective inactivation by biotransformation after systemic absorption. The importance of the inactivation in the liver was verified by experiments in which the biotransformation capacity of the liver was blocked by SKF-525 A.

    Topics: Animals; Asthma; Beclomethasone; Budesonide; Glucocorticoids; Humans; Inflammation; Male; Mice; Mice, Inbred Strains; Pregnenediones; Rats; Rats, Inbred Strains

1982
Clinical use of dry powder systems.
    European journal of respiratory diseases. Supplement, 1982, Volume: 122

    The first successful dry powder inhalation system (Spinhaler) was introduced in 1969. The majority of patients unable to use pressurised aerosols efficiently were found to have no difficulty using the Spinhaler. The dry powder delivery system was, therefore, developed for the inhalation of a selective beta 2-agonist (salbutamol) and also beclomethasone dipropionate. The original designs of this device (Rotahaler) were found difficult to use by many patients. Recent major modifications to this device (Rotahaler Mark III) have improved it considerably and this has been confirmed in an acceptability study in 300 patients. The latest development in dry powder systems is the design of a device which is loaded with 8 capsules and is extremely simple to use. Presently dry powder systems are reserved for those patients who cannot use pressurised aerosols efficiently, but if in the future further improvements in design are made this type of delivery system may become a serious competitor to the pressurised inhaler.

    Topics: Albuterol; Asthma; Beclomethasone; Fenoterol; Humans; Powders; Respiratory Therapy

1982
Beclomethasone dipropionate aerosol: hematologic and immunologic effects.
    Annals of allergy, 1982, Volume: 48, Issue:4

    Inhaled beclomethasone dipropionate aerosol is a topically active corticosteroid that has proved to be of great value in treating asthma. The authors have examined the effect of inhaled beclomethasone dipropionate aerosol on circulating leukocytes and on immunological measurements in normal adult subjects. Subjects inhaled either 400 micrograms or 1600 micrograms as a single dose. White blood cell counts, total neutrophil counts, total eosinophil counts and total lymphocyte counts were determined at 0, 2, 4 and 6 hours following an 8:00 a.m. inhalation. Among the 11 subjects who inhaled 400 micrograms, the total white blood cell count increased significantly at six hours (p less than 0.05). The total neutrophil count was increased significantly at 2, 4 and 6 hours (p less than 0.05). Total eosinophil counts and total lymphocyte counts were diminished but not significantly. Among the five subjects inhaling 1600 micrograms similar findings were observed. Seventeen volunteers inhaled 200 micrograms of beclomethasone dipropionate qid for 24 hours. In addition to the above studies, T and B cell numbers were determined and lymphocyte transformation studies were performed. Although trends similar to those observed with single larger dose inhalations were seen, the changes were not statistically significant. The results of these studies indicate that inhaled beclomethasone dipropionate does have the potential to affect circulating leukocytes.

    Topics: Aerosols; Asthma; B-Lymphocytes; Beclomethasone; Eosinophils; Humans; Leukocyte Count; Leukocytes; Lymphocyte Activation; Neutrophils; T-Lymphocytes

1982
Aerosol corticosteroids and asthma.
    Annals of internal medicine, 1982, Volume: 96, Issue:2

    Topics: Aerosols; Asthma; Beclomethasone; Humans

1982
Adrenal effects of beclomethasone inhalation therapy in asthmatic children.
    The Journal of pediatrics, 1982, Volume: 100, Issue:4

    Topics: Adolescent; Adrenal Glands; Aerosols; Asthma; Beclomethasone; Blood Glucose; Child; Humans; Hydrocortisone

1982
Beclomethasone thrush.
    The Medical journal of Australia, 1982, Jan-23, Volume: 1, Issue:2

    Topics: Aerosols; Aged; Asthma; Beclomethasone; Candidiasis, Oral; Humans

1982
Management of asthma with beclomethasone dipropionate. A comparison of pressurized aerosol and rotahaler powder inhalation.
    The Practitioner, 1982, Volume: 226, Issue:1363

    Topics: Adult; Aerosols; Aged; Asthma; Beclomethasone; Female; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Powders; Respiratory Therapy

1982
Beclomethasone dipropionate for chronic asthma in children: the Kings County Hospital experience.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1982, Volume: 19, Issue:1

    Topics: Adrenal Cortex Hormones; Asthma; Beclomethasone; Child; Chronic Disease; Female; Hospitalization; Humans; Male

1982
Beclomethasone dipropionate aerosol in the treatment of asthma in steroid-independent adults.
    Clinical therapeutics, 1982, Volume: 4, Issue:6

    A total of 128 corticosteroid-independent adults with chronic allergic asthma were treated for six weeks with 400 micrograms/day of beclomethasone dipropionate aerosol. Most patients (114 or 89%) had a good to excellent response, characterized by a marked improvement in the signs and symptoms of asthma. Substantial improvement in respiratory function, as evaluated by spirometry, was seen in 86 (67.2%) patients; 31 (24.2%) patients exhibited some improvement; and in 11 (8.6%) patients, respiratory function decreased. Overall, mean FEV improved by 57.2%; mean VC, by 53.5%; and mean FEV%, by 25%. Patients also were able to eliminate completely or reduce by half their use of cromolyn sodium, bronchodilators, and/or other antasthmatic drugs. With one exception, early morning plasma cortisol levels in patients with normal pretherapy levels were not adversely affected by the dosage used. No signs of oral candidiasis developed.

    Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aerosols; Aged; Asthma; Beclomethasone; Female; Forced Expiratory Volume; Humans; Hydrocortisone; Male; Middle Aged; Respiratory Function Tests

1982
Hazards of prolonged use of beclomethasone spray.
    JAMA, 1982, Sep-24, Volume: 248, Issue:12

    Topics: Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Child; Humans; Hypothalamo-Hypophyseal System; Pituitary-Adrenal System; Risk

1982
Long-term stability of bronchial responsiveness to histamine.
    Thorax, 1982, Volume: 37, Issue:4

    Bronchial responsiveness to histamine was measured in 35 adult asthmatics whose symptoms were controlled on a minimum of medication. The tests were carried out on two occasions separated by 10-30 months. On each occasion the subjects had no symptoms of respiratory infection and no exposure to relevant allergens for at least six weeks. Bronchial responsiveness did not change in those who required no medication or inhaled salbutamol only to control their symptoms, but was significantly improved in those who required continuous treatment with both beclomethasone and salbutamol (p = 0.03). The results suggest that non-specific bronchial responsiveness remains similar over long periods when exacerbating factors are not present and that treatment with beclomethasone may reduce hyperresponsiveness.

    Topics: Adult; Albuterol; Asthma; Beclomethasone; Bronchi; Bronchial Provocation Tests; Female; Forced Expiratory Volume; Histamine; Humans; Male; Middle Aged; Time Factors

1982
The effect of beclomethasone diproprionate on bronchial hyperreactivity.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1982, Volume: 19, Issue:2

    BDP is a useful treatment for asthma, but the mechanism of its action is unknown. Routine estimations of bronchial sensitivity to histamine aerosols showed that there was a decrease in bronchial hyperreactivity in 11 out of 14 cases given BDP as a routine treatment. The results are significant by Student's t-test (P less than .001) and reveal one mechanism by which BDP can act in the lungs.

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Female; Forced Expiratory Volume; Histamine; Humans; Male; Middle Aged; Respiratory Hypersensitivity

1982
Adrenal function after beclomethasone inhalation therapy.
    The Journal of pediatrics, 1982, Volume: 101, Issue:4

    Topics: Adrenal Glands; Asthma; Beclomethasone; Child; Humans

1982
Steroids in respiratory disease.
    British journal of hospital medicine, 1982, Volume: 28, Issue:4

    Topics: Alveolitis, Extrinsic Allergic; Asthma; Beclomethasone; Bronchitis; Humans; Hydrocortisone; Lung Neoplasms; Prednisolone; Pulmonary Eosinophilia; Pulmonary Fibrosis; Respiratory Tract Diseases; Sarcoidosis; Steroids; Tuberculosis, Pulmonary

1982
[Changes in the local reactivity of the bronchi in patients with bronchial asthma treated with beclamet].
    Klinicheskaia meditsina, 1982, Volume: 60, Issue:11

    Topics: Adult; Asthma; Beclomethasone; Bronchi; Female; Humans; Male

1982
[Successful replacement of encorton and kenalog with inhalations of beclomethasone dipropionate in 2 girls with asthma and drug-induced growth inhibition].
    Wiadomosci lekarskie (Warsaw, Poland : 1960), 1982, Oct-15, Volume: 35, Issue:18

    Topics: Adolescent; Asthma; Beclomethasone; Bronchodilator Agents; Child; Female; Growth Disorders; Hormones; Humans; Prednisone; Respiratory Therapy; Triamcinolone Acetonide

1982
Techniques of administration of metered-dose aerosolized drugs in asthmatic children.
    American journal of diseases of children (1960), 1981, Volume: 135, Issue:3

    The use of medications in metered-dose aerosol form in children with asthma has increased dramatically with the development of safer, inhaled beta 2-adrenergic agents and the inhaled corticosteroid, beclomethasone dipropionate. However, the most appropriate techniques of administration of these agents are presently unclear, and frequent inefficient use of these metered-dose inhalers results. We review the aerosol physiology literature to determine and recommend a most efficient inhalation technique for the use of these metered-dose aerosol devices.

    Topics: Adrenergic beta-Agonists; Aerosols; Asthma; Beclomethasone; Child; Forced Expiratory Flow Rates; Humans; Lung Volume Measurements; Respiratory Therapy; Work of Breathing

1981
Combined vs. sequential vs. single-entity therapy.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1981, Volume: 18, Issue:1

    Topics: Albuterol; Aminophylline; Asthma; Beclomethasone; Drug Therapy, Combination; Ephedrine; Epinephrine; Expectorants; Histamine H1 Antagonists; Humans; Ipratropium; Phenobarbital; Terbutaline; Theophylline

1981
Asthma: special challenge in the elderly.
    Geriatrics, 1981, Volume: 36, Issue:6

    Topics: Aerosols; Aged; Asthma; Beclomethasone; Bronchodilator Agents; Cromolyn Sodium; Drug Administration Schedule; Humans; Middle Aged; Respiratory Sounds

1981
Beclomethasone dipropionate.
    Annals of internal medicine, 1981, Volume: 95, Issue:4

    Experience with beclomethasone dipropionate during the past 5 years has confirmed and extended the original observation that it is an effective, topically active corticosteroid of great value in treating asthma. Most steroid-dependent asthmatic patients can be successfully controlled with the drug, at least most of the time, and the therapeutic effect is dose dependent. Although high doses may be associated with some adrenal suppression such doses do not cause systemic symptoms, and side effects are of little consequence. It is important that patients treated with steroid aerosols continue to receive other effective therapeutic agents, notably adrenergic drugs, particularly by aerosol, and theophylline compounds; that they learn how to inhale the aerosol properly; and, most important, that they promptly start taking oral steroids when they experience an exacerbation of asthma.

    Topics: Aerosols; Asthma; Beclomethasone; Candidiasis, Oral; Humans; Long-Term Care; Lung Diseases, Obstructive

1981
Case report: mycotic gingivitis.
    The journal of the Bergen County Dental Society. Bergen County Dental Society, 1981, Volume: 48, Issue:1

    Topics: Adolescent; Asthma; Beclomethasone; Erythromycin; Female; Gingivitis; Humans; Mycoses

1981
[Evaluation of the immune system in children with bronchial asthma treated with beclomethasone dipropionate].
    Minerva pediatrica, 1981, Jun-30, Volume: 33, Issue:12

    Topics: Asthma; Beclomethasone; Child; Female; Humans; Immunity, Cellular; Immunoglobulins; Lymphocytes; Male; Rosette Formation; T-Lymphocytes

1981
Incidence of fungal precipitins in patients treated with beclomethasone dipropionate aerosol.
    Annals of allergy, 1981, Volume: 46, Issue:3

    The authors followed the development of serum precipitins to aspergillus and Candida albicans in 14 asthmatic patients placed on beclomethasone dipropionate inhalation at a mean duration of five months. Three sera positive for aspergillus precipitins became negative during treatment. One patient had clinical oropharyngeal candidiasis and another patient's serum became positive for candida precipitin. The authors conclude that the incidence of oropharyngeal candidiasis and candida or aspergillus precipitins are rare among patients treated with beclomethasone.

    Topics: Adult; Aerosols; Aged; Antibodies, Fungal; Aspergillus; Asthma; Beclomethasone; Candida albicans; Female; Humans; Male; Middle Aged; Mycoses; Precipitins; Respiratory Tract Infections; Time Factors

1981
Adrenergic compounds and corticosteroids.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1981, Volume: 18, Issue:1

    Topics: Administration, Oral; Adrenal Cortex Hormones; Aerosols; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Dose-Response Relationship, Drug; Humans; Injections, Intravenous; Prednisolone; Sympathomimetics; Terbutaline

1981
Effect of an inhaled corticosteroid on methacholine airway reactivity.
    The Journal of allergy and clinical immunology, 1981, Volume: 67, Issue:5

    Methacholine airway reactivity was studied in seven asthmatic patients before and at the end of 4 mo of beclomethasone dipropionate therapy, as well as in a control group. There was no statistically significant change in reactivity in either group, suggesting that a change in airway cholinergic receptor activity is not part of the mechanism of action of corticosteroids in asthma.

    Topics: Administration, Intranasal; Adolescent; Adrenal Cortex Hormones; Adult; Airway Resistance; Asthma; Beclomethasone; Child; Female; Forced Expiratory Volume; Humans; Male; Maximal Midexpiratory Flow Rate; Methacholine Compounds

1981
Treatment of asthma in pregnancy.
    Obstetrics and gynecology, 1981, Volume: 57, Issue:6

    Topics: Aminophylline; Asthma; Beclomethasone; Female; Humans; Pregnancy; Pregnancy Complications

1981
Atopic dermatitis, asthma and eye changes in children.
    The Journal of asthma : official journal of the Association for the Care of Asthma, 1981, Volume: 18, Issue:1

    Topics: Adolescent; Asthma; Beclomethasone; Child; Chronic Disease; Dermatitis, Atopic; Eye Diseases; Female; Humans; Male

1981
Corticosteroid-sensitive lymphocytes are normal in atopic asthma.
    The Journal of allergy and clinical immunology, 1981, Volume: 68, Issue:1

    Corticosteroids, well known to increase susceptibility to infection, are often administered to atopic patients. Atopy may be associated with lymphocyte abnormalities and increased susceptibility to infections caused by intracellular organisms. We sought to determine whether atopic and nonatopic subjects respond in a similar manner to corticosteroids administered both systemically and locally. We compared the response of peripheral blood leukocytes of 15 atopic asthmatics and 10 nonatopic control subjects to prednisone or beclomethasone dipropionate. We determined leukocyte number, total eosinophil count, T-cell number, complement receptor lymphocyte number, and concanavalin A (Con A)- and phytohemagglutinin (PHA)-induced lymphocyte proliferation before and 5 hr after administration of 20 mg of prednisone orally or 336 micrograms of beclomethasone dipropionate by aerosol inhalation. Baseline values of the groups differed. The atopic asthmatic group had higher total eosinophil count, lower percent lymphocyte count, and slightly lower Con A- and PHA (high concentration)-induced lymphocyte proliferation. T-cell and complement receptor lymphocyte number were equivalent in both groups. Prednisone caused a profound eosinopenia, monocytopenia, T lymphopenia, depression of mitogen-induced lymphocyte proliferation, and increase in leukocyte number and complement receptor lymphocyte percent. Beclomethasone dipropionate was associated with little or no change in these parameters. We conclude that atopic asthma is not associated with a defect in corticosteroid-sensitive leukocyte populations and that beclomethasone dipropionate aerosol, as opposed to prednisone, does not alter peripheral blood mononuclear cell populations.

    Topics: Adrenal Cortex Hormones; Adult; Asthma; Beclomethasone; Double-Blind Method; Female; Humans; Hypersensitivity, Immediate; Lymphocytes; Male; Prednisone

1981
Geriatric asthma: treatment with beclomethasone dipropionate aerosol.
    Southern medical journal, 1981, Volume: 74, Issue:10

    Topics: Adrenal Cortex Hormones; Aerosols; Aged; Asthma; Beclomethasone; Drug Evaluation; Female; Humans; Hypothalamo-Hypophyseal System; Male; Middle Aged; Pituitary-Adrenal System

1981
Abnormal immunologic measurements in asthmatic children and adults.
    Annals of allergy, 1981, Volume: 47, Issue:4

    Several immunologic measurements were evaluated in 128 asthmatic patients (81 pediatric and 47 adults) in an effort to examine the question of altered cell-mediated immunity in asthmatics. Both pediatric and adult patients showed alterations in some but not all measurements. The results indicate that there are differences among subgroups of asthmatics and in some cases between pediatric and adult patients.

    Topics: Adolescent; Adult; Antigens, Bacterial; Asthma; Beclomethasone; Child; Child, Preschool; Concanavalin A; Humans; Immunity, Cellular; Immunoglobulin A; Immunoglobulin E; Leukocyte Count; Lymphocytes; Middle Aged; Phytohemagglutinins; Pokeweed Mitogens; Rosette Formation; Skin Tests; Streptodornase and Streptokinase; Tetanus Toxoid

1981
Clinical and therapeutic aspects of sinusitis in children with bronchial asthma.
    International journal of pediatric otorhinolaryngology, 1981, Volume: 3, Issue:4

    Eighty children between 4 and 14 years of age suffering from bronchial asthma were investigated. Fifty-five of them showed clinical and radiological findings of sinusitis. Of these, 13 patients with purulent postnasal drip were treated with ampicillin, phenylephrine and triprolidine (therapy A) and for the other 42 ampicillin was replaced by beclomethasone (therapy B). Thirty-four of 55 children showed improvement in sinus X-rays; 20 children had a considerable decrease in the severity of asthma and many symptoms cleared up after the therapy for sinusitis (P less than 0.001). In conclusion, owing to the high prevalence of sinusitis in children with bronchial asthma, all asthmatic children should be investigated to check for a sinus disease.

    Topics: Adolescent; Ampicillin; Asthma; Beclomethasone; Child; Child, Preschool; Female; Humans; Male; Maxillary Sinus; Phenylephrine; Sinusitis; Triprolidine

1981
Current concepts in clinical immunology--asthma therapy, immune complex disorders and antireceptor antibodies.
    Journal of chronic diseases, 1980, Volume: 33, Issue:3

    Topics: Aminophylline; Asthma; Autoantibodies; Beclomethasone; Cromolyn Sodium; Histamine H1 Antagonists; Humans; Immune Complex Diseases; Myasthenia Gravis; Plasmapheresis; Receptors, Neurotransmitter; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

1980
Steroids in asthma.
    Lancet (London, England), 1980, Feb-09, Volume: 1, Issue:8163

    Topics: Asthma; Beclomethasone; Child, Preschool; Drug Therapy, Combination; Female; Humans; Prednisone; Pregnancy

1980
Asthma in pregnancy: current concepts.
    Obstetrics and gynecology, 1980, Volume: 55, Issue:6

    Asthma complicates pregnancy with the same frequency as cardiac disease (1%) does. Although the incidence of severe asthma during pregnancy is low, its effect on the mother and fetus can be disastrous. Recent advances have improved the management of this problem. Representative cases and a review of asthma treatment in pregnancy are presented.

    Topics: Acute Disease; Adolescent; Adrenergic beta-Agonists; Adult; Asthma; Beclomethasone; Cromolyn Sodium; Ephedrine; Epinephrine; Female; Humans; Pregnancy; Pregnancy Complications; Theophylline

1980
Histamine release from blood of asthmatics.
    Clinical allergy, 1980, Volume: 10, Issue:4

    A group of forty-two steroid-dependent perennial asthmatics was studied over a 13-week period incuding the 8 weeks of a double-blind controlled trial of oral sodium cromoglycate. Given at a dose of 200 mg four times per day the drug provided no significant benefit to the patients when compared with results for those on placebo. Blood from eleven patients consistently failed to release more than 25% of the total cellular histamine when challenged with a range of concentrations of antibody to IgE. All six of the cryptogenic (intrinsic) asthmatics in the trial fell within this group, together with 2/12 asthmatics with negative skin tests but suggestive clinical histories implicating common alergens, and 3/24 extrinsic asthmastics with positive skin prick tests. There was no correlation between drug usage and histamine release in response to challenge with antibody to IgE.

    Topics: Adult; Aged; Asthma; Beclomethasone; Cromolyn Sodium; Double-Blind Method; Female; Hemoglobins; Histamine Release; Humans; Leukocyte Count; Male; Middle Aged; Placebos; Prednisolone

1980
Oesophagitis--a complication of inhaled steroid therapy.
    Clinical allergy, 1980, Volume: 10, Issue:6

    The hazards of steroid therapy, both inhaled and oral, in the asthmatic patient are well recognized. The following case report presents an unusual complication of steroid therapy, namely, that of a concomitant Candida and Herpes simplex oesophagitis occurring in a steroid-dependent 15-year-old asthmatic who had been maintained on inhaled beclomethasone for approximately 15 monts. Oesophagoscopy revealed a 'cottage cheese' appearance of the distal oesophagus. Cultures of the biopsy specimens obtained during oesophagoscopy grew Candida and Herpes simplex virus. Lymphocyte stimulation studies were consistent with a primary cellular response, although the neutralizing antibody titres to the Herpes simplex virus were initially high and remained stable throughout the illness and convalescent period. The patient responded well to oral nystatin therapy and developed no evidence of disseminated herpes. Eleven months after the initial episode, the patient's oropharynx cultured Herpes simplex virus but not Candida. Doctors who care for asthmatic patients need to be aware of the possibility of a herpetic as well as a candidal oesophagitis as a significant complication of inhaled steroid therapy.

    Topics: Administration, Intranasal; Adolescent; Antibody Formation; Asthma; Beclomethasone; Candida; Esophagitis; Humans; Male; Phytohemagglutinins; Simplexvirus

1980
Management of childhood asthma.
    The Journal of the Arkansas Medical Society, 1980, Volume: 76, Issue:11

    Topics: Adrenal Cortex Hormones; Allergens; Asthma; Beclomethasone; Child; Cromolyn Sodium; Dust; Humans; Immunotherapy; Theophylline

1980
Salivary immunoglobulins in children with asthma.
    Journal of periodontal research, 1980, Volume: 15, Issue:3

    Topics: Albumins; Asthma; Beclomethasone; Child; Cromolyn Sodium; Humans; Immunoglobulins; Saliva

1980
Long-term follow-up of infants and children treated with beclomethasone aerosol by a special inhalation device.
    Annals of allergy, 1980, Volume: 45, Issue:1

    A special inhalation device is described which enables young asthmatic children to inhale aerosols. Eighty children who were either too young or were otherwise handicapped to learn to inhale standard aerosols effectively took part in this study. The study period extended from three months to 41 months of treatment in patients ranging in age from 12 months to 15 years. Beclomethasone dipropionate aerosol (BDA) in doses up to 400 microgram/day were utilized. All children were observed to have an excellent response. There were no side effects such as moniliasis or growth failure. It was felt that age was no contraindication to the use of BDA and that better utilization of the aerosol was obtained by the use of the specal inhalation device.

    Topics: Administration, Intranasal; Administration, Oral; Adolescent; Aerosols; Animals; Asthma; Beclomethasone; Child; Child, Preschool; Female; Follow-Up Studies; Humans; Infant; Long-Term Care; Male; Milk

1980
Surface basophilic cells and allergic airway diseases.
    Clinical otolaryngology and allied sciences, 1980, Volume: 5, Issue:5

    Topics: Asthma; Basophils; Beclomethasone; Cromolyn Sodium; Humans; Hypersensitivity; Rhinitis

1980
Outpatient treatment of asthma in children.
    The Journal of the Indiana State Medical Association, 1980, Volume: 73, Issue:4

    Topics: Adrenal Cortex Hormones; Ambulatory Care; Asthma; Beclomethasone; Child; Cromolyn Sodium; Humans; Lung; Theophylline

1980
Simple models of pharmacological protection against induced bronchial obstruction.
    Czechoslovak medicine, 1980, Volume: 3, Issue:4

    The authors assessed the action of drugs against bronchial obstruction induced by inhalation of pollen allergen in 54 patients during the symptom-free period of bronchial asthma. Protection against pollen allergen was provided by disodium cromoglycate (Intal-nasal)--20 mg--in 96% of patients (P less than 0.001), by beclomethasone dipropionate (Becotide)--400 microgram--only in 17% of the investigated subjects (effect is not statistically significant) and by the antihistamine preparation Dithiaden administered by the i. v. route, 1 mg, in 46% of the patients (P less than 0.01). The authors made a detailed statistical analysis and discuss the causes of different results as regards the protective action of the investigated drugs.

    Topics: Adolescent; Adult; Asthma; Beclomethasone; Benzothiepins; Bronchi; Cromolyn Sodium; Female; Humans; Male; Maximal Midexpiratory Flow Rate; Middle Aged; Respiratory Hypersensitivity; Vital Capacity

1980
The effect of drugs on inhalatory provocation tests in children with bronchial asthma.
    Folia medica, 1980, Volume: 22, Issue:4

    Topics: Asthma; Beclomethasone; Bronchial Provocation Tests; Child; Cromolyn Sodium; Humans

1980
[Administration of ultrasonic aerosol inhalation of beclomethasone dipropionate compound in the treatment of chronic bronchial asthma: a report of 54 cases (author's transl)].
    Zhonghua jie he he hu xi xi ji bing za zhi = Chinese journal of tuberculosis and respiratory diseases, 1980, Volume: 3, Issue:3

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Child; Chronic Disease; Female; Humans; Male; Middle Aged; Ultrasonics

1980
Intranasal inhalation of beclomethasone dipropionate in the treatment of perennial rhinitis in adults.
    Annals of allergy, 1980, Volume: 44, Issue:2

    Forty-eight perennial rhinitis patients completed a six weeks' open trial of intranasal beclomethasone dipropionate aerosol. Each received a daily dose of 400 micrograms. Thirty-five responded excellently, seven reported satisfactory improvement and six failed. This study indicated that patients with a demonstrable allergic component responded favorably. However, due to the wide margin of safety the authors suggest that it be tried on the non-infective perennial rhinitis with no demonstrable allergic component as well.

    Topics: Administration, Intranasal; Adolescent; Adult; Asthma; Beclomethasone; Eosinophils; Female; Humans; Immunoglobulin E; Male; Middle Aged; Nasal Mucosa; Nose; Radiography; Rhinitis, Allergic, Perennial; Skin Tests

1980
Use of inhaled beclomethasone dipropionate and optimized theophylline doses in asthmatic children at Camp Bronco Junction, 1977-1978.
    Annals of allergy, 1980, Volume: 44, Issue:2

    During both the 1977 and 1978 eight-week summer sessions at Bronco Junction the effect of oral inhalation of beclomethasone dipropionate and optimum dose theophylline therapy in 56 chronically severe, corticosteroid dependent asthmatic children was evaluated. By the end of the two summer camp sessions 10 of the 56 were able to discontinue the beclomethasone dipropionate therapy, and 33 others were able to reduce their dosage. All but one child were able to discontinue oral prednisone therapy.

    Topics: Administration, Intranasal; Adolescent; Asthma; Beclomethasone; Child; Dose-Response Relationship, Drug; Female; Humans; Male; Prednisone; Respiratory Function Tests; Theophylline

1980
[Problems of indication and execution of long-term steroid therapy in advanced disabling bronchial asthma].
    Schweizerische medizinische Wochenschrift, 1980, Feb-09, Volume: 110, Issue:6

    In the management of severe chronic asthma, extensive avoidance of known precipitating factors and optimum betastimulation supported by theophylline have pride of place. In combination with sodium cromoglycate they sufficiently relieve symptoms and lung function disturbances in most cases of adult extrinsic allergic asthma. The cases with chronic disabling intrinsic asthma need, in our experience, additional long-term use of corticosteroids. The intrinsic type (late onset, severe perennial course, aspirin intolerance, nasal polyps) is in many cases recognised only with difficulty. Detailed history-taking, reversibility of the lung function disturbances and eosinophilia in the sputum may in general differentiate it from chronic obstructive bronchitis and extrinsic asthma. The aim of the long-term use of steroids in asthma is to achieve the best effect with minimal risk. In this respect the following treatment schedule has proved its worth: daily administration of prednisone in a single morning dose, beginning with high doses of 40 to 50 mg with rapid reduction by 5 to 10 mg every 4 days to a dose of 15 mg, then gradual withdrawal in steps of 1 mg at longer and longer intervals with becotide support to achieve a daily maintenance dose of 2 to 6 mg prednisone or complete withdrawal. The response to the treatment under discussion is often excellent and the dangerous side effects are low. However, too rapid reduction of cortisone inhibits the success of this treatment plan. High doses of steroids over a long time (more than 10 mg prednisone daily), prescriptions in daily divided doses, depot administrations, self-medication, and repeated high pushes are the most common causes of the dangerous cortisone side effects and are therefore to be avoided.

    Topics: Adrenal Cortex Hormones; Albuterol; Altitude; Asthma; Beclomethasone; Humans; Prednisone; Respiratory Therapy; Theophylline

1980
[Corticosteroid treatment of asthma].
    Schweizerische medizinische Wochenschrift, 1980, Feb-09, Volume: 110, Issue:6

    Inhaled beclomethasone dipropionate (BDP) has proved to be an effective corticosteroid in the treatment of asthma, acting as if it were equivalent to about 5 to 10 mg of prednisolone per day but without the systemic side effects that may accompany oral treatment. The effectiveness of inhaled BDP is not associated with significant local side effects, the most common of which has proved to be oral candidiasis. There is no evidence to date that inhaled BDP promotes lung infection or damages the bronchial epithelium.

    Topics: Asthma; Beclomethasone; Candidiasis, Oral; Humans; Prednisolone; Respiratory Therapy

1980
[Role of becotide in the treatment of bronchial asthma].
    Terapevticheskii arkhiv, 1980, Volume: 52, Issue:3

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Female; Humans; Immunity; Male; Myocardial Contraction; Respiration

1980
[Changes in various factors of general local and humoral immunity in bronchial asthma treated with becotide].
    Terapevticheskii arkhiv, 1980, Volume: 52, Issue:3

    Topics: Adult; Asthma; Beclomethasone; Bronchi; Female; Humans; Immunoglobulins; Male; Middle Aged

1980
Asthma and depression.
    Hospital practice, 1980, Volume: 15, Issue:4

    Topics: Adolescent; Asthma; Beclomethasone; Child; Depression; Humans; Male; Prednisone; Theophylline

1980
Possible association between beclomethasone diproprionate aerosol and cataracts.
    Australian paediatric journal, 1980, Volume: 16, Issue:2

    Topics: Aerosols; Asthma; Beclomethasone; Cataract; Child; Female; Humans

1980
Beclomethasone dipropionate aerosols in the treatment of asthma in childhood.
    The Practitioner, 1980, Volume: 224, Issue:1346

    Topics: Adolescent; Aerosols; Asthma; Beclomethasone; Child; Child, Preschool; Drug Administration Schedule; Female; Humans; Male; Seasons; Time Factors

1980
[Longtime corticoid therapy of asthma without risk?].
    Deutsche medizinische Wochenschrift (1946), 1980, Sep-26, Volume: 105, Issue:39

    Topics: Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Humans; Time Factors

1980
Beclomethasone dipropionate aerosol: patient consultation recommendations.
    Drug intelligence & clinical pharmacy, 1979, Volume: 13, Issue:12

    Patient administration errors in the use of beclomethasone dipropionate aerosol are frequent. Asthmatics once labeled "treatment failures" on this aerosol may only need adequate consultation to achieve therapeutic results. Pharmacists should monitor for patient noncompliance and provide instruction and follow-up on the use of beclomethasone dipropionate aerosol. Common administration errors associated with this drug are described, along with information patients should receive to obtain optimal benefits.

    Topics: Aerosols; Asthma; Beclomethasone; Humans; Patient Compliance; Patient Education as Topic; United States

1979
Are steroid inhalers safer than tablets.
    Lancet (London, England), 1979, Mar-17, Volume: 1, Issue:8116

    Topics: Administration, Oral; Adult; Aerosols; Asthma; Beclomethasone; Betamethasone; Betamethasone Valerate; Child; Drug Evaluation; Humans; Respiratory Therapy; Safety; Tablets

1979
Are steroid inhalers safer than tablet?
    Lancet (London, England), 1979, Apr-14, Volume: 1, Issue:8120

    Topics: Administration, Oral; Aerosols; Asthma; Beclomethasone; Drug Therapy, Combination; Humans; Prednisolone

1979
Inhaled steroid aerosols and alternate-day prednisone.
    Lancet (London, England), 1979, Apr-21, Volume: 1, Issue:8121

    Topics: Aerosols; Asthma; Beclomethasone; Child; Chronic Disease; Depression, Chemical; Dose-Response Relationship, Drug; Humans; Hypothalamo-Hypophyseal System; Pituitary-Adrenal System; Prednisone

1979
Corticosteroid aerosols for asthma.
    Lancet (London, England), 1979, Apr-28, Volume: 1, Issue:8122

    Topics: Aerosols; Asthma; Beclomethasone; Drug Evaluation; Humans; Prednisone; Triamcinolone Acetonide

1979
Inhaled steroid aerosols and alternate-day prednisone.
    Lancet (London, England), 1979, May-05, Volume: 1, Issue:8123

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Child; Cromolyn Sodium; Drug Evaluation; Humans; Prednisone; Theophylline

1979
Inhaled steroid aerosols and alternate-day prednisone.
    Lancet (London, England), 1979, Jul-07, Volume: 2, Issue:8132

    Topics: Aerosols; Asthma; Beclomethasone; Humans; Methods; Prednisone; Risk

1979
Steroids in asthma.
    Lancet (London, England), 1979, Dec-01, Volume: 2, Issue:8153

    Topics: Asthma; Beclomethasone; Humans; Hydrocortisone; Methods; Prednisone

1979
The preventive treatment of asthma.
    The West Virginia medical journal, 1979, Volume: 75, Issue:2

    Topics: Aerosols; Asthma; Beclomethasone; Cromolyn Sodium; Humans; Metaproterenol; Sympathomimetics; Terbutaline; Theophylline

1979
Prophylactic drugs in the management of childhood asthma.
    Annals of allergy, 1979, Volume: 43, Issue:1

    Recurrences of explosive, severe asthma in children can often be prevented by immunotherapy and constant surveillance of environmental and dietary control. In addition, judicious and preserving use of pharmaceuticals may be employed for prophylaxis in childhood asthma. These include cromolyn sodium by inhalation, beclomethasone dipropionate aerosols, round-the-clock methylxanthines and beta 2 adrenergic bronchodilator agents. Their application is discussed.

    Topics: Adolescent; Aerosols; Asthma; Beclomethasone; Child; Child, Preschool; Cromolyn Sodium; Female; Humans; Infant; Male; Metaproterenol; Patient Education as Topic; Terbutaline; Theophylline

1979
Advances in the pharmacologic management of asthma.
    Journal of the Medical Association of Georgia, 1979, Volume: 68, Issue:12

    Topics: Asthma; Beclomethasone; Bronchodilator Agents; Cromolyn Sodium; Humans; Terbutaline; Theophylline

1979
A simple standardized approach to childhood asthma.
    The Practitioner, 1979, Volume: 223, Issue:1337

    Topics: Albuterol; Asthma; Beclomethasone; Child; Child Health Services; Child, Preschool; Cromolyn Sodium; Drug Therapy, Combination; Humans; Prednisone; Theophylline

1979
New drugs for the treatment of asthma.
    Delaware medical journal, 1979, Volume: 51, Issue:10

    Topics: Asthma; Beclomethasone; Bronchodilator Agents; Cromolyn Sodium; Humans; Theophylline

1979
"Steroid-phobia" in asthma management.
    Annals of allergy, 1979, Volume: 42, Issue:3

    Excellent clinical results were obtained in 85 patients with chronic asthma who took corticosteroids (mostly triamcinolone) on a long-term basis for periods varying from one to 26 years. There was a minimum of side-effects, none serious; the most discomforting were ecchymosis and a tendency to easy bruising. The results of this and previous studies have convinced the author that corticosteroids, if judiciously used, are the most valuable adjunct we have in the treatment of acute and chronic asthma.

    Topics: Acne Vulgaris; Adrenal Cortex Hormones; Asthma; Beclomethasone; Betamethasone; Body Weight; Dose-Response Relationship, Drug; Ecchymosis; Edema; Hirsutism; Humans; Prednisone; Triamcinolone

1979
Long-term treatment with beclomethasone dipropionate aerosol in asthmatic children with special reference to growth.
    Allergy, 1979, Volume: 34, Issue:1

    Thirty-one children, 19 boys and 12 girls, aged 3.4--10.8 years, with severe perennial bronchial asthma were treated with beclomethasone dipropionate aerosol (BDA) for 16-40 months. The dose was initially 400 micrograms a day and was gradually reduced to the lowest level giving control of symptoms. Earlier steroid or ACTH-treatment in six children was stopped during the BDA-treatment. At the start of the treatment the mean deviation of height compared with normal values for Swedish children was -0.10 s.d. for the boys and -0.51 s.d. for the girls. At the end of the observation period the deviation was -0.22 s.d. and -0.58 s.d., respectively. The increase in deviation was not significant. Bone age was also slightly retarded before beclomethasone treatment but this deviation was not accentuated during the observation period. It is concluded that treatment with BDA does not retard growth or skeletal maturation in children. The number of acute admissions to hospital was reduced by more than 50% during the first year of treatment.

    Topics: Aerosols; Age Determination by Skeleton; Asthma; Beclomethasone; Body Height; Child; Child, Preschool; Drug Evaluation; Female; Growth; Humans; Male; Time Factors

1979
A prospective study of respiratory infection in adult asthmatics and their normal spouses.
    Clinical allergy, 1979, Volume: 9, Issue:3

    A prospective study of respiratory infections was performed in nineteen married asthmatics and their normal spouses who were examined at monthly intervals during a 1-year period. The colds described were associated with nasal symptoms, sore throat and usually malaise, fever, cough and hoarseness. The asthamtics reported a larger number of these symptomatic episodes than the non-asthmatics but significantly fewer of the episodes in the asthmatics were objectively confirmed by viral isolation or rise in serum titre of viral antibody. The frequency of respiratory infections was not influenced by the long term use of inhaled beclomethasone dipropionate and oral corticosteroid drugs. Less than 10% of the exacerbations of asthma were associated with respiratory infection. The disability resulting from respiratory infections in the asthmatics did not significantly exceed that in the non-asthmatics.

    Topics: Adult; Aged; Asthma; Beclomethasone; Common Cold; Female; Humans; Lung Diseases; Male; Marriage; Middle Aged; Parainfluenza Virus 2, Human; Prospective Studies; Rhinovirus; Seasons; Staphylococcus; Virus Diseases

1979
Prednisone and beclomethasone for treatment of asthma.
    The New England journal of medicine, 1979, Apr-26, Volume: 300, Issue:17

    Topics: Asthma; Beclomethasone; Child; Humans; Prednisone

1979
Prednisone and beclomethasone for treatment of asthma.
    The New England journal of medicine, 1979, Apr-26, Volume: 300, Issue:17

    Topics: Aerosols; Asthma; Beclomethasone; Humans; Respiratory Therapy

1979
Prednisone and beclomethasone for treatment of asthma.
    The New England journal of medicine, 1979, Apr-26, Volume: 300, Issue:17

    Topics: Asthma; Beclomethasone; Drug Therapy, Combination; Humans; Prednisone; Respiratory Therapy; Time Factors

1979
[Histological examination of the bronchial mucosa after 31-months' inhalation therapy with beclometasone-dipropionate (author's transl)].
    Praxis und Klinik der Pneumologie, 1979, Volume: 33, Issue:3

    Topics: Aerosols; Asthma; Beclomethasone; Bronchi; Female; Humans; Male; Middle Aged; Mucous Membrane

1979
Gastroesophageal reflux in steroid-dependent asthmatic youths.
    Pediatrics, 1979, Volume: 63, Issue:2

    The aims of this study were to evaluate the incidence of gastroesophageal reflux (GER) in chronic allergic steroid-dependent asthmatic children and to assess whether a medical antireflux regimen might improve pulmonary status of asthmatics found to have reflux. Nineteen patients had a determination of lower esophageal sphincter (LES) pressure, pH assessment after acid instillation into the stomach (acid reflux test), and esophagram. After the reflux evaluation, an antireflux regimen was instituted for three weeks; patients were followed with asthma symptom diaries and weekly pulmonary function tests for this period and for another three weeks after finishing the regimen. Gastroesophageal reflux, diagnosed by positive acid reflux test, occurred in nine patients. Five patients had low LES pressure (less than or equal to 12 mm Hg), and two patients had an abnormal esophagram. There were no significant changes in asthma symptoms or pulmonary function tests with the medical antireflux regimen. Although GER does exist in a high percentage of this patient sample (47%), a short-term antacid and positional antireflux regimen does not improve the pulmonary status of these patients.

    Topics: Adolescent; Adrenal Cortex Hormones; Antacids; Asthma; Beclomethasone; Child; Gastroesophageal Reflux; Humans; Lung Volume Measurements; Manometry; Posture; Theophylline

1979
Cloprednol therapy in steroid-dependent asthma.
    Pediatrics, 1979, Volume: 63, Issue:5

    Cloprednol is a new oral corticosteroid with a short half-life that is presently under investigation for use in asthma. Seventeen steroid-dependent children and adolescents were switched from daily treatment with prednisone to cloprednol for a one-year study. Patients showed a statistically significant improvement in symptoms while receiving cloprednol therapy. Two patients had extraordinarily good responses. Growth trends, bone age, and chest roentgenograms were not remarkably changed by cloprednol. Pulmonary function was stable. There was a significant improvement in fasting morning cortisol levels and ability to respond to metyrapone and adrenocorticotropic hormone (ACTH) challenge. Cloprednol appears to be a promising drug for steroid-dependent patients who require oral corticosteroid therapy.

    Topics: Adolescent; Asthma; Beclomethasone; Child; Drug Evaluation; Female; Glucocorticoids; Humans; Male; Pituitary-Adrenal Function Tests; Pituitary-Adrenal System; Prednisone; Pregnenediones; Respiratory Function Tests

1979
Posterior subcapsular cataracts in steroid-requiring asthmatic children.
    The Journal of allergy and clinical immunology, 1979, Volume: 63, Issue:6

    Slit-lamp examinations were performed on 24 children and adolescents with severe asthma, all of whom had received steroids for at least 365 days. Posterior subcapsular cataracts (PSCC) were detected in 7 (29.1%). None of the patients had been treated with beclomethasone. All 7 of the patients with PSCC were in the subgroup of 14 patients who had been on the highest doses of corticosteroid, 10 mg or more per day, for the longest period of time. The 7 children with PSCC were all below the fifth percentile for height and had fallen away from their normal growth curve. Of the 17 children in whom PSCC were not detected, only 1 was below the fifth percentile for height. It would seem from our results that the steroid-requiring asthmatic who is growth-suppressed is at an increased risk for developing PSCC. We have documented the reversal of PSCC in 2 children. Both of these children had been placed on beclomethasone, which allowed for the discontinuation of daily prednisone in one case and a reduction to less than 10 mg per day of prednisone in the other. The reversal occurred within 6 months of starting on beclomethasone.

    Topics: Adolescent; Adrenal Cortex Hormones; Asthma; Beclomethasone; Body Height; Cataract; Child; Child, Preschool; Female; Humans; Male; Prednisone

1979
Pulmonary eosinophilia in a patient receiving beclomethasone dipropionate aerosol.
    Annals of allergy, 1979, Volume: 42, Issue:5

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Eosinophilia; Female; Humans; Lung Diseases

1979
[Steroid therapy for collagen diseases and allergic diseases--indications and methods of administration].
    Nihon rinsho. Japanese journal of clinical medicine, 1979, Jun-10, Volume: 37, Issue:6

    Topics: Adult; Arthritis, Rheumatoid; Asthma; Beclomethasone; Collagen Diseases; Female; Humans; Lupus Erythematosus, Systemic; Prednisolone

1979
Beclomethasone dipropionate aerosol in the treatment of asthma in steroid-independent children.
    The Journal of international medical research, 1979, Volume: 7, Issue:5

    Sixty-eight steroid-independent children, whose asthma was poorly controlled by bronchodilators and other anti-asthmatic drugs, were treated for six weeks with 200 to 400 mcg per day of beclomethasone dipropionate aerosol. Symptoms of wheezing, blockage, and cough, reported by the children in a daily diary, improved in 80% of cases. Use of other anti-asthmatic medications, which the children were free to modify as they wished, decreased. Objective measurements of pulmonary function, VC, FEV1, and FEV%, evaluated by weekly spirometry, also improved in almost 80% of cases. The dosages used here had no effect on early morning plasma cortisol levels and none of the children developed signs of oral candidiasis.

    Topics: Administration, Intranasal; Aerosols; Asthma; Beclomethasone; Child; Female; Humans; Male

1979
Indications for use of beclomethasone dipropionate (Vanceril).
    The Western journal of medicine, 1979, Volume: 131, Issue:4

    Topics: Adrenal Insufficiency; Asthma; Beclomethasone; Candidiasis; Candidiasis, Oral; Child; Humans; Pharyngeal Diseases

1979
Corticosteroids in children.
    International journal of dermatology, 1979, Volume: 18, Issue:9

    Topics: Asthma; Beclomethasone; Child; Humans; Hydrocortisone; Pituitary-Adrenal System; Prednisone

1979
[Predicting beclomethasone aerosol dose requirements in chronic asthma (proceedings)].
    Bulletin of the International Union against Tuberculosis, 1979, Volume: 54, Issue:2

    Topics: Aerosols; Asthma; Beclomethasone; Humans

1979
[Preliminary results of a multicenter study of 1000 asthmatic patients treated with beclomethasone dipropionate (proceedings)].
    Bulletin of the International Union against Tuberculosis, 1979, Volume: 54, Issue:2

    Topics: Aerosols; Asthma; Beclomethasone; Chronic Disease; Humans

1979
Salbutamol and beclomethasone in chronic asthma.
    Lancet (London, England), 1978, Aug-26, Volume: 2, Issue:8087

    Topics: Aerosols; Albuterol; Asthma; Beclomethasone; Chronic Disease; Drug Therapy, Combination; Humans

1978
Salbutamol and beclomethasone in chronic asthma.
    Lancet (London, England), 1978, Sep-09, Volume: 2, Issue:8089

    Topics: Albuterol; Asthma; Beclomethasone; Chronic Disease; Drug Therapy, Combination; Humans

1978
Beclomethasone dipropionate powder in childhood asthma.
    Lancet (London, England), 1978, Sep-09, Volume: 2, Issue:8089

    Topics: Adolescent; Asthma; Beclomethasone; Child; Child, Preschool; Female; Humans; Male; Powders; Respiratory Therapy

1978
Drugs for asthma.
    The Medical letter on drugs and therapeutics, 1978, Aug-11, Volume: 20, Issue:16

    Topics: Adrenal Cortex Hormones; Asthma; Beclomethasone; Cromolyn Sodium; Drug Combinations; Drug Therapy, Combination; Humans; Sympathomimetics; Theophylline

1978
An approach to the treatment of asthma.
    The Western journal of medicine, 1978, Volume: 128, Issue:5

    Topics: Adolescent; Asthma; Beclomethasone; Bronchodilator Agents; Cromolyn Sodium; Female; Humans; Respiratory Therapy; Theophylline

1978
Rational management of bronchial asthma.
    Archives of internal medicine, 1978, Volume: 138, Issue:9

    Topics: Asthma; Beclomethasone; Cromolyn Sodium; Humans; Metaproterenol; Sympathomimetics; Terbutaline; Theophylline

1978
Asthma in adult patients.
    The New Zealand medical journal, 1978, Sep-13, Volume: 88, Issue:619

    Topics: Adrenal Cortex Hormones; Adult; Asthma; Beclomethasone; Bronchodilator Agents; Cromolyn Sodium; Female; Health Education; Humans; Male; Middle Aged

1978
The asthmatic.
    American family physician, 1978, Volume: 18, Issue:6

    Topics: Adolescent; Adrenal Cortex Hormones; Adult; Asthma; Beclomethasone; Child; Child, Preschool; Cromolyn Sodium; Expectorants; Humans; Hypnotics and Sedatives; Immunotherapy; Respiratory Function Tests; Skin Tests; Sympathomimetics; Water; Xanthines

1978
[Comparative studies of alpha-1-antitrypsin and other protein fractions in the blood and sputum of asthmatic children treated with aerosols].
    La Pediatria, 1978, Dec-31, Volume: 86, Issue:4

    Topics: Aerosols; alpha 1-Antitrypsin; Asthma; Beclomethasone; Child; Child, Preschool; Cromolyn Sodium; Female; Fibrinogen; Humans; Immunoglobulins; Male; Serum Albumin; Sputum

1978
[Adrenal function after long term treatment with beclomethasone dipropionate in childhood asthma (author's transl)].
    Monatsschrift fur Kinderheilkunde, 1978, Volume: 126, Issue:2

    Evaluating plasma levels of cortisol and corticosterone after ACTH-stimulation, and the urinary metabolites tetrahydrocortisone and tetrahydrocortisol in asthmatic children it could be demonstrated, that in most cases there was no suppression of adrenal function following treatment over 6 to 18 months with a daily dose of 200 to 300 microgram beclomethasone dipropionate. Since in a few patients suppression was found, an ACTH stimulation after a six months treatment is recommended.

    Topics: Adolescent; Adrenal Cortex; Asthma; Beclomethasone; Child; Child, Preschool; Corticosterone; Humans; Hydrocortisone; Tetrahydrocortisol; Tetrahydrocortisone

1978
[Beclomethasone dipropionate in bronchial obstructive syndromes].
    Minerva medica, 1978, Mar-17, Volume: 69, Issue:13

    Topics: Adolescent; Adult; Aged; Asthma; Beclomethasone; Bronchitis; Drug Evaluation; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Respiratory Function Tests

1978
Beclomethasone dipropionate: a new and valuable tool in the management of severe asthma.
    Journal of the Medical Association of Georgia, 1978, Volume: 67, Issue:5

    Topics: Aerosols; Asthma; Beclomethasone; Drug Evaluation; Humans

1978
Minimum dose requirements of steroid-dependent asthmatic patients for aerosol beclomethasone and oral prednisone.
    The Journal of allergy and clinical immunology, 1978, Volume: 61, Issue:6

    In 34 steroid-dependent asthma patients who improved markedly during 2 mo of treatment when progressively larger doses of beclomethasone aerosol were added to their oral prednisone regimen, we subsequently reduced both steroids to ascertain the minimum dose of each needed to prevent recurrence of significant asthmatic disability. After 80 wk of follow-up, 15 patients had successfully terminated oral prednisone; 19 were better controlled with a combination of aerosol plus oral steroid than with either drug alone; all patients previously unable to convert to alternate-day prednisone did so successfully during the combined therapy. The minimum effective maintenance dosage varied greatly among these patients-the median values being 2.5 mg prednisone and 1,200 microgram beclomethasone per day. The latter ranged from 200 to 1,8000 microgram. Only 4 patients were satisfactorily controlled without prednisone on 400 microgram beclomethasone per day or less. Seven needed extra intranasal beclomethasone to help control the nasal polyps which worsened after prednisone withdrawal. Suppression of plasma cortisol levels, apparently attributable to the beclomethasone, persisted in most patients, but on the average this was no worse than before commencing this treatment and valuable clinical improvement accrued. There were no other important complications of the regimen. In most of these patients with severe chronic asthma, optimum control of the disease required combined aerosol-oral therapy and maintenance doses of beclomethasone higher than those usually recommended. In some patients, effective control of chronic asthma by beclomethasone treatment may require acceptance of some persisting suppression of adrenal function as a considered risk.

    Topics: Administration, Oral; Aerosols; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Female; Humans; Hydrocortisone; Male; Middle Aged; Prednisone

1978
Aerosol beclomethasone treatment of chronic severe asthma. A one-year experience.
    JAMA, 1978, Sep-15, Volume: 240, Issue:12

    After one year's use of beclomethasone dipropionate aerosol, 43 of 61 asthmatic patients who were originally dependent on oral corticosteroids were able to reduce and 38 to completely eliminate use of oral corticosteroids. Most patients maintained or improved their pulmonary functions. Exacerbation of rhinitis during oral corticosteroid withdrawal and emergence of nasal polyps were problems for 25 patients. Exacerbation of asthma with upper respiratory infection was an important event: 21 patients required supplemental oral corticosteroids to control asthma. Oral candidiasis occurred in only three patients.

    Topics: Administration, Oral; Aerosols; Asthma; Beclomethasone; Humans; Nasal Polyps; Pharyngitis; Prednisone; Respiratory Function Tests; Rhinitis; Substance Withdrawal Syndrome

1978
Adverse reaction after aerosol inhalation.
    The Medical journal of Australia, 1978, Jun-03, Volume: 1, Issue:11

    Topics: Aerosols; Asthma; Beclomethasone; Bronchodilator Agents; Female; Humans

1978
Aerosol corticosteroids in the treatment of bronchial asthma.
    Archives of internal medicine, 1978, Volume: 138, Issue:9

    Topics: Aerosols; Asthma; Beclomethasone; Humans; Triamcinolone Acetonide

1978
[Corticotropic testing during long-term beclomethasone dipropionate treatment in asthmatic children].
    Le Poumon et le coeur, 1978, Volume: 34, Issue:4

    The authors looked for undesirable side-effects in prolonged treatment with beclomethasone dipropionate aerosol (BDP) at the daily dose of 400 microgram in asthmatic children. Growth in height was not impaired, the height gain (5.35 +/- 4.06 cm) not being statistically different from the theoretical gain (5.46 +/- 2.94 cm) (t : 1.33 0.20 less than p less than 0.01). Testing the corticotropic chain at pituitary level by the L8VP test did not reveal any decrease in patients treated by BDP alone (delta of elevation of cortisolemia; 9.08 +/- 2.79 microgram/100 ml, not very different from the controls 9.79 +/- 4.32 microgram/100 ml). On the other hand, the results in patients with continuous or alternating conventional corticotherapy showed a corticotropic decrease (delta of elevation : 5.39 +/- 4.53 microgram/100 ml, a significant difference from the controls t : 7.54 p less than 0.001). In 5 of these observations, the repetition of L8VP testing revealed the progressive restauration of the corticotropic function together with the decrease and the stopping of conventional corticotherapy. The average cortisolemia of patients definitively off corticotherapy, before and after L8VP, was not significantly different from that of controls. The elevation delta of cortisolemia of deprived patients (9.30 +/- 4.92 microgram/100 ml) become comparable to that of normal controls (9.79 +/- 4.32 microgram/100 ml. The analysis of the main literature data, in agreement with the results presented here, showed that prolonged treatment with BDP had no harmful effect on height growth. There was no corticotropic decrease in a child unsubjected to previously conventional corticotherapy or after completely stopping the treatment.

    Topics: Administration, Intranasal; Adolescent; Aerosols; Asthma; Beclomethasone; Body Height; Child; Child, Preschool; Female; Humans; Infant; Lypressin; Male; Pituitary-Adrenal System; Time Factors

1978
[Short-term use of beclomethasone dipropionate in the treatment of spasmodic obstructive bronchopneumopathies].
    Le Poumon et le coeur, 1978, Volume: 34, Issue:4

    Forty-two patients were treated with beclomethasone dipropionate in doses of 400 microgram daily for no longer than three months. There were three main indications : attempt to withdraw corticosteroids or sympathomimetics ; treatment prior to desensitization ; treatment of asthma with severe permanent dyspnea. In 8 patients, systemic steroids of sympathomimetic drugs could be withdrawn. Dosage could be reduced by 50% or more in 21 cases, and by less than 50% in 9 cases. There were 3 failures, and results were unassessable in one case. No major side-effects were observed.

    Topics: Administration, Intranasal; Aerosols; Asthma; Beclomethasone; Bronchial Diseases; Bronchial Spasm; Humans; Lung Diseases, Obstructive; Time Factors

1978
Refinements in maintenance therapy benefit asthmatics.
    Hospital practice, 1978, Volume: 13, Issue:9

    Topics: Asthma; Beclomethasone; Hospital Bed Capacity, 500 and over; Humans; New York City; Outpatient Clinics, Hospital

1978
A three- to five-year follow-up of the use of the aerosol steroid, beclomethasone dipropionate, in childhood asthma.
    The Journal of allergy and clinical immunology, 1978, Volume: 62, Issue:6

    Nineteen asthmatic children treated with the aerosol steroid, beclomethasone dipropionate, were followed 3 to 5 yr. Good control was maintained in all but one child throughout, although 73% have needed 1 or 2 wk of supplementary oral steroids per year for exacerbations. Growth has been along the percentile on which the child entered the study. No serious side effects have been encountered among 41 children treated between 1 and 5 yr with beclomethasone dipropionate. Seventeen percent needed prolonged alternate-day oral steroids, although all but one child did eventually return to good control with beclomethasone dipropionate.

    Topics: Administration, Oral; Adolescent; Aerosols; Asthma; Beclomethasone; Body Height; Body Weight; Child; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Steroids; Time Factors

1978
[Use of aerosol of a new hormonal drug "Bekotid" for treatment of bronchial asthma].
    Terapevticheskii arkhiv, 1978, Volume: 50, Issue:12

    Topics: Adult; Aerosols; Aged; Asthma; Beclomethasone; Drug Evaluation; Humans; Middle Aged

1978
Topical steroids in asthma.
    Lancet (London, England), 1977, Oct-01, Volume: 2, Issue:8040

    Topics: Aerosols; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Drug Evaluation; Humans

1977
[Use of a peak flowmeter in evaluation of changes in nasal obstruction associated with rhinitis or asthma].
    Duodecim; laaketieteellinen aikakauskirja, 1977, Volume: 93, Issue:1

    Topics: Allergens; Asthma; Beclomethasone; Humans; Peak Expiratory Flow Rate; Respiration; Rheology; Rhinitis

1977
[Mechanisms of action of glucocorticoids in the treatment of asthma. Comparative effects of glucocorticods via the general route and beclomethasone dipropionate via aerial route on plasma levels of cyclic AMP].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: Adult; Aerosols; Aged; Asthma; Beclomethasone; Child; Cyclic AMP; Female; Humans; Hydrocortisone; Injections, Intravenous; Male; Middle Aged; Respiratory Insufficiency; Spirometry; Terbutaline

1977
The effect of prolonged administration of beclomethasone dipropionate inhaler on adrenocortical functions in bronchial asthma.
    Journal of medicine, 1977, Volume: 8, Issue:1

    Topics: Administration, Intranasal; Adolescent; Adrenocorticotropic Hormone; Adult; Aerosols; Aged; Asthma; Beclomethasone; Female; Humans; Hydrocortisone; Male; Middle Aged; Pituitary-Adrenal System; Prednisolone; Time Factors; Triamcinolone Acetonide

1977
Scanning electron microscopic studies of bronchial mucosa before and during treatment with beclomethasone dipropionate inhalations.
    Scandinavian journal of respiratory diseases. Supplementum, 1977, Volume: 101

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Biopsy; Bronchi; Bronchoscopy; Epithelium; Female; Fiber Optic Technology; Humans; Male; Microscopy, Electron, Scanning; Middle Aged; Mucous Membrane

1977
Immunological investigations of Candida albicans in respiratory disease.
    British journal of clinical pharmacology, 1977, Volume: 4 Suppl 3

    1. Tests against rabbit antiserum to Candida albicans showed about 40 protein antigens in cytoplasmic extract compared with two in a commercial test extract, which contained mainly polysaccharide (mannan) antigens. 2. Positive precipitin tests to the mannan preparation were recorded in 40% of 56 asthmatics on systemic corticosteroids and 37% of 56 rhinitis patients not so treated. The titres were slightly higher in the corticosteroid group. There was no increase in precipitins over 0-9 months in asthmatics treated with beclomethasone dipropionate aerosol (BDA) by inhalation, or over 0-12 months in rhinitis patients treated with BDA nasal spray. No positive reactions to the purified protein fraction were recorded. 3. Radioallergosorbent tests for specific IgE antibody showed a higher incidence of positive results with whole C. albicans yeast cells than with purified cytoplasmic protein. There was a higher incidence of positive results to protein in patients on systemic corticosteroids than in the other patients. No change in incidence occurred in asthmatics on BDA. The number of positive results in 56 rhinitis patients increased on BDA from 28 to 37 for yeast cells, and from 7 to 16 for cytoplasmic protein. This was attributed to C. albicans challenge tests. 4. Specific IgA antibodies to yeast cells were detected in 48/56 asthmatics on systemic corticosteroids, and there were no significant changes over 0-9 months on BDA. The corresponding figures for rhinitis patients were 25/56, and again there were no significant changes over 0-12 months on BDA.

    Topics: Antigens; Asthma; Beclomethasone; Candida albicans; Humans; Immunoglobulin A; Immunoglobulin E; Precipitin Tests; Radioallergosorbent Test; Respiratory Tract Diseases

1977
Beclomethasone dipropionate aerosol in the treatment of steroid-dependent asthmatic patients. An assessment of 18 months of therapy.
    Chest, 1977, Volume: 71, Issue:6

    Twenty-nine of 33 steroid-dependent asthmatic patients received 18 months of therapy with beclomethasone dipropionate. Only four of 29 subjects required concurrent oral therapy with steroids. Twenty-six of 29 patients noted a marked improvement in their asthma; three of 29 described an indeterminate response. A statistically significant improvement in many of the symptoms, the plasma cortisol level, the first-second forced expiratory volume, and the forced expiratory flow at 50 percent of the observed forced vital capacity was present only at the end of three months of therapy with beclomethasone dipropionate. Steroid-withdrawal symptoms, particularly those related to the nose and sinuses, were initially troublesome but decreased with the passage of time. No oropharyngeal fungal infections were observed. At a dose below the hypothalamic-pituitary-adrenal suppressive level, therapy with beclomethasone dipropionate appears to be safe and effective for treating patients with steroid-dependent asthma.

    Topics: Adrenal Cortex Hormones; Adult; Aerosols; Aged; Asthma; Beclomethasone; Bronchodilator Agents; Drug Therapy, Combination; Female; Humans; Long-Term Care; Male; Middle Aged; Respiratory Function Tests; Substance Withdrawal Syndrome; Substance-Related Disorders

1977
A prospective study of respiratory infection in asthmatic patients treated with beclomethasone dipropionate and sodium cromoglycate.
    Clinical allergy, 1977, Volume: 7, Issue:2

    A prospective study of forty adult asthmatic patients attending two chest clinics in the City of Liverpool was undertaken. All patients had reversible airways obstruction and were under treatment with either beclomethasone dipropionate or sodium cromoglycate. Satisfactory symptomatic control was achieved in both groups of patients on a subjective basis, but there was a statistically significant (P less than 0-001) reduction in the number of admissions to hospital in the treatment year compared to the preceding 12 months in the beclomethasone aerosol group. No increased incidence of lower respiratory tract infections or non-specific sore throats was found in either group studied. No cases of clinical oral Candida infection occurred in the beclomethasone aerosol treated patients. It is concluded that beclomethasone dipropionate in aerosol form is not only a safe and effective method for symptomatic control of adult bronchial asthma but is also economically worthwhile as a means of reducing hospital admissions in this vulnerable group of patients.

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Candidiasis, Oral; Cromolyn Sodium; Female; Hospitalization; Humans; Lung Diseases; Male; Middle Aged; Pharyngitis; Prospective Studies; Respiratory Tract Infections

1977
Bronchial asthma: some aspects of pathogenesis and therapy.
    Postgraduate medicine, 1977, Volume: 62, Issue:1

    The first step in management of bronchial asthma is to exclude other diseases which may present as wheezing dyspena. Once the diagnosis is confirmed beyond a reasonable doubt, therapy can be initiated. Treatment depends on the type, severity, and duration of the disease. Other factors which dictate the choice of drug are the patient's response, metabolism of the drug, and complications of the disease. Theophylline forms the backbone of asthma therapy. Because of the wide variation in half-life of theophylline in different individuals due to variation in rate of metabolism and elimination, serum levels of theophylline should be monitored whenever possible. Newer antiasthmatic drugs, such as cromolyn sodium and inhaled steroids, are playing an increasing role in treatment of selected patients.

    Topics: Acute Disease; Aminophylline; Asthma; Beclomethasone; Cromolyn Sodium; Dehydration; Diagnosis, Differential; Epinephrine; Heart Failure; Humans; Infections; Methylprednisolone; Pulmonary Edema; SRS-A; Theophylline

1977
Lenticular complications of long-term steroid therapy in children with asthma and eczema.
    The Journal of allergy and clinical immunology, 1977, Volume: 60, Issue:4

    Forty-two chronic asthmatic children, including 10 with associated eczema, were examined for lenticular complications. The children had received oral corticosteroids for a minimum of 3 years. Twelve were treated with beclomethasone inhalant therapy, and the children with eczema had had topical corticosteroids. Only one child was found to have cataracts commensurate with corticosteroid therapy. Possible reasons for the low incidence of cataracts in this study are discussed.

    Topics: Adolescent; Adrenal Cortex Hormones; Asthma; Beclomethasone; Cataract; Child; Child, Preschool; Cromolyn Sodium; Drug Therapy, Combination; Eczema; Female; Humans; Male; Prednisone

1977
[Therapy in bronchial asthma].
    Fortschritte der Medizin, 1977, Dec-15, Volume: 95, Issue:47-48

    A division into two main groups is made: causal and symptomatic treatment. The first group includes elimination and avoidance of allergens and the specific hyposensitization according to own experiences. The second group is divided into medicamentous treatment (bronchodilatators, DNCG, corticosteroids, secretolytics, antibiotics, tranquilizers) and into a nonmedicamentous treatment like physiotherapy, climate therapy and psychotherapy.

    Topics: Adrenal Cortex Hormones; Anti-Bacterial Agents; Asthma; Beclomethasone; Bronchodilator Agents; Cromolyn Sodium; Desensitization, Immunologic; Expectorants; Humans; Psychotherapy; Respiratory Therapy

1977
Severe asthma in childhood.
    The New Zealand medical journal, 1977, May-25, Volume: 85, Issue:588

    Topics: Acute Disease; Adolescent; Asthma; Beclomethasone; Bronchodilator Agents; Child; Child, Preschool; Chronic Disease; Cromolyn Sodium; Female; Hospitalization; Humans; Male; Psychotherapy; Respiratory Hypersensitivity

1977
[Modification of skin tests under the influence of inhaled beclomethasone dipropionate aerosol].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: Acari; Adolescent; Adult; Aerosols; Animals; Asthma; Beclomethasone; Dust; Feathers; Female; Humans; Hypersensitivity; Male; Middle Aged; Pollen; Skin Tests; Vaccines

1977
Empty beclomethasone cartridge.
    JAMA, 1977, Jul-11, Volume: 238, Issue:2

    Topics: Asthma; Beclomethasone; Humans; Male

1977
Beclomethasone dipropionate aerosol in treatment of chronic asthma.
    British journal of clinical pharmacology, 1977, Volume: 4 Suppl 3

    Topics: Aerosols; Asthma; Beclomethasone; Chronic Disease; Humans

1977
Beclomethasone dipropionate aerosol in the treatment of chronic bronchial asthma: A preliminary study in Thai subjects.
    Journal of the Medical Association of Thailand = Chotmaihet thangphaet, 1977, Volume: 60, Issue:12

    Topics: Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Chronic Disease; Female; Humans; Male; Middle Aged; Organization and Administration; Prednisolone; Thailand

1977
Bronchial biopsies after belcomethasone dipropionate aerosol.
    British journal of diseases of the chest, 1977, Volume: 71, Issue:1

    Topics: Aerosols; Asthma; Beclomethasone; Bronchi; Humans; Microscopy, Electron

1977
Cortisol secretion rate during beclomethasone dipropionate aerosol therapy in bronchial asthma.
    International journal of clinical pharmacology and biopharmacy, 1977, Volume: 15, Issue:1

    Beclomethasone dipropionate is a new synthetic corticosteroid for the inhalatory treatment of bronchial asthma. The effect of beclomethasone dipropionate aerosol (400 mug/day/j weeks) on the cortisol secretion rate in comparison with prednisone per os (10 mg/day/4 weeks) was investigated in 12 patients with allergic bronchial asthma. There was no suppression of the adrenal cortex in the course of beclomethasone dipropionate inhalation, while prednisone significantly suppressed adrenal cortex function.

    Topics: Adrenal Cortex; Aerosols; Asthma; Beclomethasone; Humans; Hydrocortisone; Prednisone; Secretory Rate

1977
Asthma deaths in children--a continuing problem.
    Thorax, 1977, Volume: 32, Issue:1

    The clinical and pathological features of five children who died of asthma over a recent 12-month period are reported. All had severe, chronic asthma requiring maintenance corticosteroid therapy. Three had been receiving beclomethasone dipropionate by inhalation and these had acute inflammation of the tracheobronchial tree at necropsy. Adrenal atrophy was found in all four cases examined histologically, despite normal short tetracosactrin tests in three of these shortly before they died. The need for high-dose corticosteroid by mouth for exacerbations of asthma in those weaned from oral steroids is emphasized by these deaths. The introduction of beclomethasone dipropionate by inhalation has led to an increase in the number of children in this high-risk group.

    Topics: Adolescent; Adrenal Cortex Hormones; Aerosols; Asthma; Australia; Beclomethasone; Child; Chronic Disease; Female; Humans; Male

1977
The long-term use of beclomethasone dipropionate for the control of severe asthma in children.
    Annals of allergy, 1977, Volume: 38, Issue:4

    Thirty-nine children with severe asthma who had been treated with aerosol inhalations of beclomethasone dipropionate for 33 to 34 months were studied. Twenty-eight were still benefitting from the drug, thrush had occurred in three, and only six of the 20 originally steroid-dependent now required steroid orally. The authors feel that this is an efficacious, safe medication but stress that systemic steroid therapy should be promptly reinstituted during acute exacerbations in steroid-dependent patients.

    Topics: Adolescent; Adult; Asthma; Beclomethasone; Child; Humans; Time Factors

1977
Steroid aerosols for asthma.
    Annals of internal medicine, 1977, Volume: 86, Issue:5

    Topics: Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Humans; Triamcinolone Acetonide

1977
Subsittution of inhaled beclomethasone dipropionate for ingested prednisone in steroid-dependent asthmatics.
    Canadian Medical Association journal, 1977, Apr-23, Volume: 116, Issue:8

    The effect of inhaled beclomethasone dipropionate (dose, 400 mug daily) was investigated in 31 prednisone-dependent asthmatics. In a double-blind noncrossover study of 25 patients dependent on a daily prednisone dose of 17.5 mg or less, the dose of ingested prednisone was significantly diminished through the use of beclomethasone as compared with placebo (P < 0.001). In a subsequent single-blind study of the 12 patients who had received placebo, a similar decrease in prednisone dose was possible when these patients received beclomethasone. In all 25 patients the effect of beclomethasone was maintained for 2 years; 9 came to require less beclomethasone and 1 required more. In an additional single-blind study of six patients with severe asthma, dependent on prednisone in a dose of 20 to 25 mg/d, the response to beclomethasone was more variable and less significant (P < 0.01). However, at 2 years there was no significant benefit (P > 0.05) and there were two treatment failures.In patients in whom reduction of dose or discontinuation of prednisone was possible plasma cortisol values before and after corticotropin administration increased significantly (P < 0.001). Prednisone reduction was associated with the appearance of mild musculoskeletal steroid-withdrawal symptoms of short duration in 15 patients, and recurrence of symptoms of rhinitis in 15 patients. Side effects of beclomethasone included episodes of hoarseness in 6 and easily treated oropharyngeal Candida albicans infection in 14.

    Topics: Administration, Oral; Adolescent; Adult; Aged; Asthma; Beclomethasone; Candidiasis; Female; Humans; Male; Middle Aged; Prednisone; Respiratory Therapy; Substance-Related Disorders

1977
Clinical pulmonary tuberculosis in an asthmatic patient using a steroid aerosol.
    Chest, 1977, Volume: 71, Issue:4

    A patient who was receiving a steroid aerosol for treatment of asthma developed clinical pulmonary tuberculosis. Continued administration of the steroid aerosol along with antituberculosis chemotherapy did not adversely influence healing of the pulmonary lesion.

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Dexamethasone; Humans; Isoniazid; Tuberculosis, Pulmonary

1977
The endocrinometabolic effects of beclomethasone dipropionate in asthmatic patients.
    Chest, 1977, Volume: 71, Issue:6

    The endocrinometabolic effects of the aerosol administration of beclomethasone dipropionate (100 microng four times daily) were evaluated in 20 asthmatic patients (11 corticodependent and nine noncorticodependent) during one month. In the noncorticodependent group, aerosol administration of beclomethasone had no statistically significant effect on the results of the glucose tolerance test and the plasma levels of insulin; there was a slight decrease in basal levels of cortisol, but the response of the cortisol level to administration of ACTH remained quite normal. In corticodependent patients, after substitution of aerosol therapy with beclomethasone for the oral therapy with steroids, the depression of adrenal function disappeared, usually quickly (in less than one month), whereas the abnormalities in the results of the glucose tolerance test persisted. Thus, at the dosage used, beclomethasone dipropionate might have minor systemic endocrinometabolic effects.

    Topics: Adrenal Glands; Asthma; Beclomethasone; Blood Glucose; Glucose; Humans; Hydrocortisone; Hypothalamus; Insulin; Pituitary Gland; Prednisolone; Respiratory Function Tests; Substance-Related Disorders

1977
Beclomethasone diproprionate aerosol in treatment of corticosteroid-dependent asthma.
    Minnesota medicine, 1977, Volume: 60, Issue:5

    Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aerosols; Aged; Asthma; Beclomethasone; Child; Humans; Middle Aged

1977
[Becotide (beclomethasone dipropionate) in the treatment of asthma in children].
    Pediatria polska, 1977, Volume: 52, Issue:4

    Topics: Adolescent; Age Factors; Asthma; Beclomethasone; Child; Humans; Time Factors

1977
[Respiratory function in children after 2 months of beclomethasone dipropionate treatment of asthma].
    Pediatria polska, 1977, Volume: 52, Issue:4

    Topics: Age Factors; Asthma; Beclomethasone; Child; Humans; Lung; Respiration; Respiratory Function Tests; Time Factors

1977
[General and local anti-inflammatory effects of beclomethasone dipropionate].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: Animals; Asthma; Beclomethasone; Humans

1977
[Development and pharmacology of beclomethasone dipropionate].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: Aerosols; Asthma; Beclomethasone; Humans; Hydrocortisone; Infections; Prednisolone; Vasoconstrictor Agents

1977
[Bronchial cytology after prolonged treatment with beclomethasone dipropionate].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: Asthma; Beclomethasone; Bronchi; Female; Humans; Hypersensitivity; Male

1977
[Beclomethasone dipropionate in the treatment of bronchial obstructions of asthmatic origin. Clinical and functional study].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: Adrenal Cortex Hormones; Asthma; Beclomethasone; Drug Synergism; Female; Humans; Male; Spirometry; Time Factors

1977
[Supplementation of long-term corticoid therapy by beclomethasone dipropionate (DPB)].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Female; Humans; Male; Time Factors

1977
[Advantage of beclomethasone dipropionate in treatment of bronchospasm. Physiopathological and clinical study].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: Adolescent; Adult; Aerosols; Aged; Airway Resistance; Asthma; Beclomethasone; Bronchi; Bronchial Spasm; Drug Tolerance; Female; Humans; Male; Middle Aged; Plethysmography; Time Factors

1977
[Results obtained with beclomethasone dipropionate in induction of desensitization treatments for rhinitis, tracheitis and asthma].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Desensitization, Immunologic; Humans; Hypersensitivity; Respiratory Insufficiency; Rhinitis, Allergic, Seasonal; Tracheitis

1977
[Tolerance and action of beclomethasone dipropionate used for prolonged treatment in asthmatic children].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: Adolescent; Adrenal Cortex Hormones; Anti-Bacterial Agents; Asthma; Beclomethasone; Child; Child, Preschool; Cosyntropin; Drug Tolerance; Female; Humans; Hydrocortisone; Male; Respiratory Tract Infections; Time Factors

1977
[Results obtained with beclomethasone dipropionate in children with 4 year follow-up].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: Adolescent; Asthma; Beclomethasone; Bronchi; Bronchial Diseases; Bronchitis; Child; Child, Preschool; Cough; Drug Tolerance; Female; Follow-Up Studies; Humans; Male; Nasal Cavity; Rhinitis, Allergic, Seasonal; Spasm

1977
[The corticotropic axis during prolonged treatment with beclomethasone dipropionate in children].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: 17-Hydroxycorticosteroids; Adolescent; Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Child; Child, Preschool; Circadian Rhythm; Cosyntropin; Female; Growth Disorders; Humans; Hydrocortisone; Male; Pituitary-Adrenal System; Time Factors

1977
[Use of intranasal beclomethasone dipropionate for allergic rhinitis].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: Asthma; Beclomethasone; Drug Tolerance; Humans; Nasal Cavity; Rhinitis; Rhinitis, Allergic, Seasonal

1977
[Changes in the buccopharyngeal mycological population under the effect of treatment with beclomethasone dipropionate].
    La Nouvelle presse medicale, 1977, Apr-13, Volume: 6, Issue:15

    Topics: Adult; Antifungal Agents; Asthma; Beclomethasone; Candida; Candidiasis; Humans; Mouth; Pharynx

1977
[Inhalation and intranasal therapy with beclomethasone dipropionate in allergic asthma and rhinitis].
    Monatsschrift fur Kinderheilkunde, 1977, Volume: 125, Issue:5

    Topics: Adolescent; Asthma; Beclomethasone; Child; Child, Preschool; Drug Evaluation; Female; Humans; Male; Nose; Respiratory Therapy; Rhinitis, Allergic, Seasonal

1977
Aerosol beclomethasone: an important new steroid treatment of chronic, severe asthma.
    Wisconsin medical journal, 1977, Volume: 76, Issue:7

    Topics: Aerosols; Asthma; Beclomethasone; Chronic Disease; Humans

1977
A case of intrinsic asthma.
    British medical journal, 1977, Jul-23, Volume: 2, Issue:6081

    Topics: Aged; Albuterol; Asthma; Beclomethasone; Humans; Male; Prednisone

1977
The use of beclomethasone diproprionate inhaler complicated by the development of an eosinophilic pneumonia reaction.
    Annals of allergy, 1977, Volume: 39, Issue:2

    As an insoluble steroid aerosol, beclomethasone diproprionate was recently made available in the United States. Only minor complications have been reported previously. A more serious development of adrenal insufficiency may occur upon the improper replacement of systemic steroids. We report on a patient who developed the clinical findings of pulmonary eosinophilia. The possible mechanisms for this complication in out patient are discussed. While a lower systemic steroid dosage may have been the provoking factor, we feel that an adverse reaction to oleic acid, a dispersing agent in the aerosol freon vehicle, is a strong possibility.

    Topics: Aerosol Propellants; Aerosols; Aged; Asthma; Beclomethasone; Female; Humans; Oleic Acids; Pulmonary Eosinophilia

1977
Pulmonary infiltration with eosinophila. Recurrence in an asthmatic patient treated with beclomethasone dipropionate.
    Chest, 1977, Volume: 72, Issue:3

    We present the findings in a young woman diagnosed as having pulmonary infiltration with eosinophilia and asthma who was treated with beclomethasone dipropionate. Although the aerosol corticosteroid controlled bronchospasm, it did not prevent recurrent pulmonary infiltration with eosinophilia when the patient was not receiving oral therapy with corticosteroids. It is postulated that when administered in the usual dosage, an adequate amount of beclomethasone dipropionate does not reach the alveoli or interstitium to prevent or resolve the process of pulmonary infiltration with eosinophilia. This case suggests that patients with pulmonary infiltration and eosinophilia who are treated with inhaled corticosteroids for asthma must be closely observed physiologically or roentgenographically for pulmonary infiltration. These patients may need to be protected from recurrent pulmonary infiltration by the concurrent oral use of corticosteroids.

    Topics: Adult; Aerosols; Asthma; Beclomethasone; Eosinophilia; Eosinophils; Female; Humans; Lung; Prednisone; Pulmonary Alveoli

1977
Efficacy of intranasal beclomethasone dipropionate in patients with perennial rhinitis and asthma.
    Clinical allergy, 1977, Volume: 7, Issue:3

    Topics: Administration, Intranasal; Adult; Aged; Airway Obstruction; Asthma; Beclomethasone; Humans; Middle Aged; Peak Expiratory Flow Rate; Rhinitis, Allergic, Seasonal; Seasons

1977
Beclomethasone dipropionate aerosol in the treatment of steroid-dependent chronic bronchial asthma in adults.
    Monographs in allergy, 1977, Volume: 12

    15 adult chronic asthmatic patients who were on daily maintenance dose of oral steroid for at least 6 months were studied. Following an investigation period of 2 weeks, the patients were started on BDA, 100 microgram four times daily. The daily oral steroid dose, which averaged 12 mg of prednisone or its equivalent, was gradually reduced by about 1 mg per day. The trial lasted 8 weeks, at the end of which, ten patients were as good or better on BDA than on oral steroids. Two patients had to return to oral corticosteroid therapy before the trial ended and three patients were unable to discontinue their oral steroid treatment. The lack of systemic effects of BDA was demonstrated by the appearance of symptoms which were apparently previously suppressed by the oral steroids and the excretion of normal amounts of 17-OHCS in the urine in some to the patients who had evidence of adrenal suppression while on oral steroids.

    Topics: 17-Ketosteroids; Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Chronic Disease; Humans; Respiratory Function Tests; Substance-Related Disorders

1977
Beclomethasone dipropionate aerosol in treatment of chronic asthma.
    The Quarterly journal of medicine, 1977, Volume: 46, Issue:183

    Topics: Adolescent; Adult; Aerosols; Asthma; Beclomethasone; Child; Chronic Disease; Female; Humans; Male; Prednisolone

1977
New method of beclomethasone aerosol administration to children under 4 years of age.
    Canadian Medical Association journal, 1977, Dec-03, Volume: 117, Issue:11

    Topics: Aerosols; Asthma; Beclomethasone; Child, Preschool; Humans; Hypothalamo-Hypophyseal System; Infant; Pituitary-Adrenal System; Respiratory Therapy

1977
Determinants of the response to beclomethasone aerosol at various dosage levels: a multiple regression analysis to identify clinically useful predictors.
    The Journal of allergy and clinical immunology, 1977, Volume: 60, Issue:6

    Topics: Aerosols; Asthma; Barbiturates; Beclomethasone; Dose-Response Relationship, Drug; Humans; Lung Diseases, Obstructive; Patient Compliance; Regression Analysis; Smoking; Statistics as Topic

1977
Aerosol beclomethasone in steroid dependent asthmatics.
    Nigerian medical journal : journal of the Nigeria Medical Association, 1976, Volume: 6, Issue:1

    Aerosol beclomethasone dipropionate was effective in maintaining airway patency in 14 out of 16 steroid-dependent asthmatics. In 3 patients who had significant adrenal suppression on systemic corticosteroid therapy substitution with aerosol beclomethasone led to recovery of adrenal function. From the evidence obtained it is concluded that this aerosol steroid represents a modest advance in the therapy of asthma.

    Topics: Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Female; Glucocorticoids; Humans; Hydrocortisone; Male; Middle Aged

1976
[Drug therapy of asthma syndrome].
    Monatsschrift fur Kinderheilkunde, 1976, Volume: 124, Issue:5

    Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Aminophylline; Asthma; Beclomethasone; Child; Cromolyn Sodium; Humans; Theophylline

1976
The role of beclomethasone (Vanceril) in the therapy of asthma.
    The Journal of pediatrics, 1976, Volume: 89, Issue:5

    Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Asthma; Beclomethasone; Bronchodilator Agents; Humans

1976
[Therapy of Childhood Asthma with Beclomethasone Dipropionate (author's transl)].
    Monatsschrift fur Kinderheilkunde, 1976, Volume: 124, Issue:8

    In addition to the usual mangement of asthma the introduction of Beclomethasone-dipropionate aerosol can be considered as a progress in the long-term treatment of asthma, because in most cases oral and parenteral application of corticosteroids is no longer necessary. According to the results of many authors the wellknown side effects of steriod therapy have so far not been observed. We report our experiences with Beclomethasone in the treatment of 19 chronically asthmatic children.

    Topics: 17-Ketosteroids; Adolescent; Adrenocorticotropic Hormone; Aerosols; Asthma; Beclomethasone; Child; Child, Preschool; Cortisone; Female; Humans; Long-Term Care; Male; Respiration

1976
Beclomethasone dipropionate and chronic asthma. The effect of long-term aerosol administration on the hypothalamic-pituitary-adrenal axis after substitution for oral therapy with corticosteroids.
    Chest, 1976, Volume: 70, Issue:1

    Beclomethasone dipropionate aerosol at a dose of 100 mug four times a day was administered to 32 patients suffering from chronic perennial asthma. Twenty-three of these patients had previously received prolonged treatment with corticosteroids, causing various degrees of adrenal suppression in some patients. Almost complete recovery of adrenal function was observed within a period of six months in most patients. Treatment with beclomethasone dipropionate did not affect the hypothalamic-pituitary-adrenal axis in the other nine asthmatic patients who had not received prolonged corticosteroid therapy previously and who served as a control group.

    Topics: Administration, Oral; Adrenal Cortex; Adrenal Glands; Adult; Aerosols; Asthma; Beclomethasone; Cosyntropin; Depression, Chemical; Drug Evaluation; Female; Humans; Hydrocortisone; Hydroxycorticosteroids; Hypothalamus; Long-Term Care; Male; Methylprednisolone; Middle Aged; Pituitary Gland; Pituitary Gland, Anterior; Prednisone

1976
Recent advances in bronchial asthma.
    American journal of diseases of children (1960), 1976, Volume: 130, Issue:8

    Bronchial asthma in childhood is a major pediatric problem for the physician, both as an acute emergency and as a chronic disease. To adequately manage asthma, one must have a firm understanding of its pathogenesis, and the clinical aspects of diagnosis and therapy. We review important developments in the area of the basic mechanisms causing bronchial obstruction, and methods of measuring the abnormalities present. This presentation includes the fields of neuropharmacology, biochemistry, immunology, and pulmonary physiology. With this background, the clinical aspects of diagnosis and therapy are explored. The role of the allergy history, skin testing, measurement of serum IgE antibodies, and target organ provocation testing are placed in perspective. Therapy involving avoidance measures, use of pharmacologic agents and injection therapy with inhalant allergens are discussed in detail.

    Topics: Asthma; Beclomethasone; Child; Child, Preschool; Cromolyn Sodium; Desensitization, Immunologic; Growth; Humans; Immunoglobulin E; Immunoglobulin G; Lung; Parasympatholytics; Prognosis; Respiration; Sympathomimetics; Theophylline

1976
Beclomethasone dipropionate (Vanceril) for asthma.
    The Medical letter on drugs and therapeutics, 1976, Aug-27, Volume: 18, Issue:19

    Topics: Adult; Asthma; Beclomethasone; Child; Humans; Methylprednisolone

1976
Beclomethasone dipropionate use in chronic asthmatic patients. Effect on adrenal function after substitution for oral glucocorticosteroids.
    JAMA, 1976, Oct-25, Volume: 236, Issue:17

    The clinical effectiveness of beclomethasone dipropionate (BDP) aerosol and adrenal function after withdrawal of oral corticosteroid therapy were evaluated in 32 severely steroid-dependent asthmatic patients. Twenty-four of 28 patients were able to discontinue oral glucocorticosteroid therapy, while four failed to do so. Ventilatory studies showed no substantial changes at the end of six months' BDP treatment. In 24 patients, adrenal insufficiency was present before BDP therapy was started. In 20 of those patients, the response of cosyntropin returned to normal two months after discontinuation of systemic steroid treatment and administration of BDP.

    Topics: Administration, Oral; Adrenal Glands; Adrenal Insufficiency; Adult; Aerosols; Aged; Asthma; Beclomethasone; Chronic Disease; Drug Evaluation; Female; Glucocorticoids; Humans; Male; Methylprednisolone; Middle Aged; Respiratory Function Tests

1976
Clinical aspects of allergy and asthma. The Second Charles Blackley Symposium. Nottingham 21-24 March, 1976.
    Acta allergologica, 1976, Volume: 31, Issue:5

    Topics: Asthma; Beclomethasone; Humans; Hypersensitivity

1976
Important new drugs in asthma.
    American family physician, 1976, Volume: 14, Issue:6

    Topics: Albuterol; Asthma; Beclomethasone; Humans

1976
[Effect of beclomethasone dipropionate in aerosol form on the suprarenal function in asthmatic patients under prolonged treatment].
    Revista clinica espanola, 1976, Dec-31, Volume: 143, Issue:6

    Topics: Adolescent; Adrenal Glands; Adult; Aerosols; Asthma; Beclomethasone; Child; Child, Preschool; Cushing Syndrome; Drug Evaluation; Female; Humans; Male; Middle Aged; Stimulation, Chemical

1976
Evaluation of a new aerosolized steroid for asthma therapy: beclomethasone dipropionate (Vanceril inhaler).
    JAMA, 1976, Dec-20, Volume: 236, Issue:25

    Beclomethasone dipropionate, an esterified derivative of betamethasone, can be given in small doses in aerosol form to patients with severe asthma whose symptoms cannot be controlled with nonsteroidal agents (bronchodilators and cromolyn). Many asthmatic patients who previously required systemic steroids can be transferred to this safer anti-inflammatory agent. In usual doses, beclomethasone produces few, if any, systemic side effects. The only susbstantial reaction is Candida infections of the oropharynx and larynx.

    Topics: Administration, Oral; Adult; Aerosols; Asthma; Beclomethasone; Child; Drug Administration Schedule; Drug Evaluation; Humans; Prednisone; Substance Withdrawal Syndrome

1976
[Clinical experience with metered aerosol of beclometasone in patients with obstructive lung disease (author's transl)].
    Arzneimittel-Forschung, 1976, Volume: 26, Issue:12

    142 patients suffering from chronic obstructive lung disease were treated with 9-chloro-11beta,17,21-trihydroxy-16beta-methyl-pregna-4,4-diene-3,20-dione-17,21-dipropionate (beclometasone) metered aerosal. Between 3 subgroups: chronic infectious obstructive lung disease, allergic obstructive lung disease and chronic bronchitis without airway obstruction, there was no difference in the results. Three times per day three puffs of the metered aerosol can substitute about 6 mg prednisolone p.o. The systemic effects of the beclometasone therapy with metered aerosols are clearly less than those which are seen with a comparable oral dosage. Side effects are seen dose dependently as hoarseness and as relatively harmless Candida infection of the throat. For most of the patients with obstructive lung disease who are dependent on glucocorticosteroids beclometasone as metered aerosol should be given as basic therapy. In case higher dosages are necessary they should be given orally or parenterally.

    Topics: Aerosols; Asthma; Beclomethasone; Bronchitis; Humans; Lung Diseases, Obstructive

1976
[Drug information for nurses. Beclomethasone dipropionate NFN. Therapeutic action group: asthma agents].
    Sygeplejersken, 1976, Jun-09, Volume: 76, Issue:22

    Topics: Asthma; Beclomethasone; Humans; Methylprednisolone

1976
Beclomethasone aerosol for the steroid-dependent patient with asthma.
    The Journal of the Medical Society of New Jersey, 1976, Volume: 73, Issue:7

    Topics: Aerosols; Asthma; Beclomethasone; Humans; Methylprednisolone; Substance-Related Disorders

1976
Beclomethasone dipropionate aerosol and oropharyngeal candidiasis.
    British journal of diseases of the chest, 1976, Volume: 70, Issue:1

    In a survey of 400 consecutive patients with chronic asthma treated with beclomethasone dipropionate aerosol (up to 400 mug/day) the prevalence of oropharyngeal thrush was 4-5%. The prevalence of this complication was not significantly related to sex, age, duration of treatment with beclomethasone or concurrent treatment with prednisolone. Yeasts were isolated from throat swabs in about 60% of all patients and in 48% of normal controls. Thus, although a diagnosis of oropharyngeal thrush was recorded only when the presence of characteristic lesions in the pharynx was associated with a positive culture, there was a large number of patients and controls without thrush who harboured yeasts in the throat. One in 3 patients with thrush complained of sore throat or hoarseness, but 1 in 4 patients without thrush had similar symptoms. These findings suggest that, although treatment with beclomethasone dipoprionate aerosol undoubtedly can cause oropharyngeal thrush, this condition is not an inevitable result of colonization of the oropharynx by yeasts, nor is it necessarily associated with symptoms.

    Topics: Adolescent; Adult; Aerosols; Aged; Asthma; Beclomethasone; Candida; Candidiasis, Oral; Female; Humans; Male; Methylprednisolone; Middle Aged; Mouth; Pharyngeal Diseases; Pharynx; Prednisolone

1976
[Treatment of chronic asthma with dose-aerosol beclomethasone dipropionate].
    Lakartidningen, 1976, Apr-07, Volume: 73, Issue:15

    Topics: Adult; Aerosols; Aged; Asthma; Beclomethasone; Chronic Disease; Female; Follow-Up Studies; Humans; Male; Methylprednisolone; Middle Aged

1976
Beclomethasone dipropionate in paediatric asthma.
    The Medical journal of Australia, 1976, Jan-17, Volume: 1, Issue:3

    An investigation into the use of beclomethasone dipropionate aerosol in the management of 42 severe asthmatic children, ranging in age from two-and-a-half to 16 years with a mean age of seven years is presented.

    Topics: Adolescent; Aerosols; Asthma; Beclomethasone; Chickenpox; Child; Child, Preschool; Cosyntropin; Humans; Methylprednisolone; Prednisolone

1976
[Beclomethasone dipropionate -becotide) aerosol in the treatment of asthma and spastic bronchitis].
    Pneumonologia polska, 1976, Volume: 44, Issue:4

    Topics: Aerosols; Asthma; Beclomethasone; Bronchitis; Chronic Disease; Female; Humans; Male; Methylprednisolone

1976
Steroid aerosols in asthma.
    Lancet (London, England), 1975, Oct-25, Volume: 2, Issue:7939

    Topics: Adrenal Cortex Hormones; Adrenal Glands; Aerosols; Asthma; Beclomethasone; Humans

1975
Editorial: Treatment of asthmatic children with steroids.
    British medical journal, 1975, Feb-22, Volume: 1, Issue:5955

    Topics: Adrenocorticotropic Hormone; Aerosols; Albuterol; Asthma; Beclomethasone; Child; Child, Preschool; Cromolyn Sodium; Humans; Prednisone; Steroids

1975
Corticotrophin after corticosteroids in children with asthma and growth retardation.
    British journal of diseases of the chest, 1975, Volume: 69

    A study of the growth patterns of 19 children with chronic asthma, whose growth had become retarded while they were receiving regular treatment with prednisolone, showed that this trend was reversed after the substitution of corticotrophin.

    Topics: Adolescent; Adrenocorticotropic Hormone; Asthma; Beclomethasone; Body Height; Child; Child, Preschool; Chronic Disease; Female; Growth; Growth Disorders; Humans; Male; Prednisolone; Time Factors

1975
Some aspects of the management of bronchial asthma and chronic obstructive lung disease.
    The Medical journal of Australia, 1975, May-17, Volume: 1, Issue:20

    Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Aminophylline; Asthma; Beclomethasone; Betamethasone; Bronchodilator Agents; Chronic Disease; Cromolyn Sodium; Humans; Hydrocortisone; Lung Diseases, Obstructive; Prednisone

1975
Treatment of steroid-dependent asthma with beclomethaxone dipropionate administered by aerosol.
    Current therapeutic research, clinical and experimental, 1975, Volume: 17, Issue:5

    Topics: Adrenal Cortex; Aerosols; Asthma; Beclomethasone; Methylprednisolone; Placebos; Respiratory Function Tests

1975
[Beclomethasone dipropionate in long-term corticoid therapy].
    Le Poumon et le coeur, 1975, Volume: 31, Issue:1

    Topics: Adolescent; Adult; Aged; Asthma; Beclomethasone; Bronchitis; Child; Chronic Disease; Drug Evaluation; Female; Humans; Long-Term Care; Male; Methylprednisolone; Middle Aged

1975
Effects of disodium cromoglycate and beclomethasone dipropionate on asthmatic reactions to bronchial provocation tests.
    Acta allergologica, 1975, Volume: 30 suppl 12

    Topics: Allergens; Asthma; Beclomethasone; Cromolyn Sodium; Drug Therapy, Combination; Humans; Methylprednisolone; Physical Exertion

1975
Pulmonary eosinophilia after substitution of aerosol for oral corticosteroid therapy.
    British journal of diseases of the chest, 1975, Volume: 69

    Three patients with chronic asthma developed pulmonary eosinophilia while oral prednisolone was being withdrawn after the introduction of treatment with beclomethasone dipropionate aerosol. These observations suggest that the development of pulmonary eosinophilia in patients with chronic asthma can be prevented by the systemic administration of corticosteroids, but not by a corticosteroid aerosol given by inhalation. It is considered that radiological examination of the chest should be carried out at frequent intervals during and for a few months after the substitution of corticosteroid aerosol therapy for oral corticosteroid therapy in order to ensure that those patients who are liable to develop pulmonary eosinophilia will be identified at an early stage. These precautions are even more essential when there is a previous history of pulmonary eosinophilia.

    Topics: Administration, Oral; Aerosols; Aspergillus fumigatus; Asthma; Beclomethasone; Bronchoscopes; Eosinophils; Female; Humans; Lung; Male; Methylprednisolone; Middle Aged; Prednisolone; Pulmonary Eosinophilia; Radiography; Respiratory Therapy

1975
Intravenous salbutamol in management of status asthmaticus.
    British medical journal, 1975, Jan-11, Volume: 1, Issue:5949

    After the administration of intravenous salbutamol (100-300 mug) to 11 patients admitted to hospital with a severe exacerbation of asthma there was a mean increase in peak expiratory flow of 44% accompanied by a rise in pulse rate of 24 beats/min. Blood gas tensions showed a trend to improvement and there were no serious side effects. It is concluded that intravenous salbutamol is an effective and apparently safe bronchodilator in the management of acutely ill patients with severe asthma.

    Topics: Acute Disease; Adolescent; Adult; Albuterol; Asthma; Beclomethasone; Carbon Dioxide; Female; Humans; Injections, Intravenous; Isoproterenol; Male; Middle Aged; Oxygen; Prednisone; Pulmonary Ventilation; Pulse; Spirometry; Theophylline

1975
Sounding board. Unapproved drugs in the practice of medicine.
    The New England journal of medicine, 1975, May-15, Volume: 292, Issue:20

    Topics: Asthma; Beclomethasone; Child; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Humans; Legislation, Drug; United Kingdom; United States; United States Food and Drug Administration

1975
Beclomethasone dipropionate. Trial of a new inhalational steroid preparation in the treatment of steroid-dependent chronic asthmatics.
    The Medical journal of Australia, 1975, Feb-15, Volume: 1, Issue:7

    Topics: Adolescent; Adult; Aerosols; Age Factors; Aged; Asthma; Beclomethasone; Child, Preschool; Chronic Disease; Female; Humans; Immunoglobulin E; Male; Methylprednisolone; Middle Aged; Prednisone; Skin Tests; Spirometry

1975
[Beclomethasone dipropionate aerosol use in treatment of brochial asthma].
    Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke, 1975, Feb-10, Volume: 95, Issue:4

    Topics: Adrenal Cortex Function Tests; Adult; Aerosols; Asthma; Beclomethasone; Chronic Disease; Female; Humans; Hydrocortisone; Male; Methylprednisolone; Middle Aged; Prednisone; Propionates; Time Factors

1975
Treatment of steroid-dependent asthma patients with beclomethasone dipropionate aerosol.
    Scandinavian journal of respiratory diseases, 1975, Volume: 56, Issue:1

    Fifty-two steroid-dependent adults with chronic perennial asthma were transferred to beclomethasone dipropionate aerosol. The tests demonstrated a significant improvement with beclomethasone in terms of the diary score, bronchodilator use, and PEF and FEV1.0 measurements, as compared with the previous period of prednisolone treatment. Before the transfer, 26 of the patients displayed one or more diseases or symptoms which were probably due to systemic steroid medication. Morning cortisol levels, along with the response to tetracosactrin had in all cases returned to normal when tests were carried out 41 days after transfer to beclomethasone dipropionate. In a group of 12 patients with the lowest 11-OHCS basal values, the mean of their 11-OHCS values during prednisolone treatment was as low as 0.14 plus or minus 0.06 mumol/l, but tetracosactrin challenge induced an elevation to a normal level, 0.33 plus or minus 0.13 mumol/l. After 41 days of beclomethasone treatment, the corresponding values were 0.56 plus or minus 0.90 plus or minus 0.28 mumol/l. Thirty-seven patients experienced one or more disturbing symptoms after transfer to beclomethasone. In many cases, the symptoms of allergic rhinitis were troublesome and persistent leading to a sixfold increase in the use of antihistaminic tablets. When the patients had learned to exhale through the nose following beclomethasone inhalation, the use of antihistaminic tablets again diminished to some extent. Moreover, two cases of ulcerative colitis were encountered during the beclomethasone treatment. During a follow-up period of one year, 14 patients were again receiving prednisolone; most often, this was due to worsening of the asthma because of respiratory infections. During the beclomethasone treatment, a continuous significant improvement in PEF was noted after isoprenaline inhalation, suggesting that further benefit may be obtained by the employment of bronchodilator aerosols as an essential part of the treatment.

    Topics: 11-Hydroxycorticosteroids; Adult; Aerosols; Asthma; Beclomethasone; Chronic Disease; Cosyntropin; Drug Therapy, Combination; Female; Follow-Up Studies; Forced Expiratory Volume; Humans; Hydrocortisone; Male; Methylprednisolone; Middle Aged; Peak Expiratory Flow Rate; Prednisolone; Respiratory Therapy

1975
[17,21-beclomethasone dipropionate in the treatment of asthma].
    Gruzlica i choroby pluc; tuberculosis et pneumonologia, 1975, Volume: 43, Issue:9

    Topics: Adult; Aged; Asthma; Beclomethasone; Drug Evaluation; Female; Humans; Male; Methylprednisolone; Middle Aged; Respiratory Therapy

1975
[Beclomethasone aerosol in chronic asthma].
    Harefuah, 1975, Aug-15, Volume: 89, Issue:4

    Topics: Aerosols; Asthma; Beclomethasone; Chronic Disease; Humans; Methylprednisolone

1975
New tests to assess lung function. inhalation challenge tests in asthma.
    The New England journal of medicine, 1975, Oct-09, Volume: 293, Issue:15

    Topics: Adrenal Cortex Hormones; Aerosols; Allergens; Asthma; Beclomethasone; Bronchodilator Agents; Dust; Forced Expiratory Volume; Gases; Humans; Occupational Diseases; Peak Expiratory Flow Rate; Respiratory Function Tests; Skin Tests; Time Factors; Vital Capacity

1975
Steroid aerosols for asthma.
    The Medical letter on drugs and therapeutics, 1975, Oct-10, Volume: 17, Issue:21

    Topics: Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Betamethasone Valerate; Humans

1975
The place of beclomethasone dipropionate aerosol in the treatment of asthma.
    Drugs, 1975, Volume: 10, Issue:3

    Topics: Aerosols; Airway Obstruction; Asthma; Beclomethasone; Humans; Methylprednisolone

1975
Further experiences with beclomethasone dipropionate.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adolescent; Asthma; Beclomethasone; Child; Humans; Methylprednisolone; Prednisolone

1975
Clinical trial of beclomethasone dipropionate in Filipino asthmatics.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Bronchodilator Agents; Child; Female; Humans; Male; Methylprednisolone; Philippines

1975
Experience with beclomethasone dipropionate aerosol in treatment of chronic asthma.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Humans; Methylprednisolone

1975
The effects of beclomethasone dipropionate aerosol given in high doses to patients with asthma.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Aerosols; Asthma; Beclomethasone; Candidiasis, Oral; Humans; Intestinal Absorption; Methylprednisolone; Pituitary-Adrenal Function Tests; Prednisolone

1975
The long-term evaluation of beclomethasone dipropionate in childhood asthma.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Asthma; Beclomethasone; Child; Humans; Male; Methylprednisolone; Prednisone; Time Factors

1975
Beclomethasone dipropionate aerosol: a substitute for systemic corticosteroid treatment in bronchial asthma.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adrenal Cortex Hormones; Aerosols; Aged; Asthma; Beclomethasone; Female; Humans; Male; Methylprednisolone; Middle Aged

1975
Treatment of childhood asthma with a local steroid in aerosol form.
    Postgraduate medical journal, 1975, Volume: 51 Suppl 4

    Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aerosols; Asthma; Beclomethasone; Child; Child, Preschool; Female; Humans; Male; Methylprednisolone; Substance-Related Disorders

1975
Effect of atropine on sputum production.
    Thorax, 1975, Volume: 30, Issue:5

    The effect of atropine on sputum production has been studied in patients with asthama, chronic bronchitis, and bronchiectasis in some of whom there was bronchorrhoea. In three patients a reduction in sputum volume was observed after atropine but it would seem that the decrease was mainly due to the inhibitory effect on salivary secretion which facilitates spitting. The one patient treated with long-term oral atropine showed a marked reduction in sputum volume although chemical constituents and viscosity levels remained unchanged, suggesting that in this case atropine had an inhibitory effect on bronchial gland secretion.

    Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aged; Airway Obstruction; Asthma; Atropine; Beclomethasone; Bronchi; Bronchiectasis; Bronchitis; Fucose; Humans; Male; Middle Aged; Neuraminic Acids; Prednisone; Saliva; Salivation; Sputum; Viscosity

1975
[Beclomethasonedipropionate for corticoid inhalation therapy in bronchial asthma].
    Schweizerische medizinische Wochenschrift, 1975, May-24, Volume: 105, Issue:21

    Beclomethasone dipropionate, a new corticosteroid for inhalation in the form of a pressurised aerosol with a daily dosage of 300-400/mug, has been given to 130 adult asthmatics. In 56% of the steroid-dependent asthmatics, oral or parenteral corticosteroids were reduced and in a further 28% discontinued entirely. In 16% of patients a reduction of systemic corticosteroids could not be achieved. 12 patients suffering from an obstructive airway disease who had not previously been on systemic corticosteroids were treated successfully with inhalation of beclomethasone dipropionate alone. The reduced dosage of systemic corticosteroids as a result of the use of beclomethasone dipropionate was 4.24 mg of prednisone daily. Side effects, in the form of mouth candidiasis, were noted in only 2 patients.

    Topics: Adult; Asthma; Beclomethasone; Drug Evaluation; Humans; Methylprednisolone; Respiratory Therapy

1975
[Prospects of inhalation therapy in infantile bronchial asthma].
    La Pediatria, 1975, Mar-31, Volume: 83, Issue:1

    Topics: Aerosols; Albuterol; Asthma; Beclomethasone; Child; Drug Evaluation; Humans; Metaproterenol; Methylprednisolone

1975
[Treatment of asthma with beclomethasone dipropionate aerosols].
    Revue medicale de Liege, 1975, Dec-15, Volume: 30, Issue:24

    Topics: Adult; Aerosols; Aged; Asthma; Beclomethasone; Drug Evaluation; Female; Humans; Male; Methylprednisolone; Middle Aged

1975
Letter: Beclomethasone aerosol in chronic bronchial asthma.
    Lancet (London, England), 1974, Oct-05, Volume: 2, Issue:7884

    Topics: Administration, Topical; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Candidiasis, Oral; Chronic Disease; Glucocorticoids; Humans; Prednisone

1974
Editorial: Management of childhood asthma.
    JAMA, 1974, Aug-12, Volume: 229, Issue:7

    Topics: Adrenergic beta-Antagonists; Aerosols; Age Factors; Asthma; Beclomethasone; Child; Cromolyn Sodium; Desensitization, Immunologic; Humans; Substance-Related Disorders; Sympathomimetics

1974
Editorial: Drugs in asthma.
    The New Zealand medical journal, 1974, Mar-27, Volume: 79, Issue:511

    Topics: Acute Disease; Adolescent; Adrenal Cortex Hormones; Adult; Aerosols; Asthma; Beclomethasone; Bronchodilator Agents; Child; Child, Preschool; Cromolyn Sodium; Drug Evaluation; Humans

1974
Management of childhood asthma in Britain.
    JAMA, 1974, Aug-12, Volume: 229, Issue:7

    Topics: Asthma; Beclomethasone; Child; Cromolyn Sodium; Drug Therapy, Combination; Humans; Methods; Propionates; Respiratory Therapy; Sympathomimetics; Time Factors; United Kingdom

1974
The effects of inhaled beclomethasone dipropionate (Becotide) and sodium cromoglycate on asthmatic reactions to provocation tests.
    Clinical allergy, 1974, Volume: 4, Issue:1

    Topics: Administration, Topical; Adult; Aerosols; Allergens; Ampicillin; Anti-Inflammatory Agents; Asthma; Beclomethasone; Cromolyn Sodium; Cyanates; Edible Grain; Female; Flour; Glucocorticoids; Humans; Hypersensitivity, Delayed; Hypersensitivity, Immediate; Male; Methylprednisolone; Middle Aged; Penicillanic Acid; Plant Extracts; Respiratory Function Tests; Skin Tests; Toluene; Triticum; Wine

1974
Asthma due to inhaled chemical agents: ampicillin, benzyl penicillin, 6 amino penicillanic acid and related substances.
    Clinical allergy, 1974, Volume: 4, Issue:3

    Topics: Administration, Intranasal; Administration, Oral; Adult; Ampicillin; Asthma; Beclomethasone; Blood Cell Count; Body Temperature; Cromolyn Sodium; Drug Eruptions; Drug Hypersensitivity; Drug Industry; Environmental Exposure; Eosinophils; Humans; Isoproterenol; Male; Middle Aged; Neutrophils; Occupational Diseases; Penicillanic Acid; Penicillin G; Penicillins; Skin Tests; Spirometry

1974
Response of patients receiving high dose beclomethasone dipropionate.
    Thorax, 1974, Volume: 29, Issue:5

    Topics: Administration, Oral; Administration, Topical; Adolescent; Adrenocorticotropic Hormone; Adult; Aerosols; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Female; Humans; Hydrocortisone; Male; Middle Aged; Propionates; Respiratory Therapy; Skin Tests; Spirometry

1974
[Letter: Beclomethasone dipropionate in bronchial asthma].
    Ugeskrift for laeger, 1974, Jul-29, Volume: 136, Issue:31

    Topics: Administration, Topical; Anti-Inflammatory Agents; Asthma; Beclomethasone; Glucocorticoids; Respiratory Therapy

1974
The effect of a new steroid aerosol--beclomethasone dipropionate (Becotide) in chronic asthma.
    Singapore medical journal, 1974, Volume: 15, Issue:2

    Topics: Administration, Topical; Adolescent; Adult; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Female; Glucocorticoids; Humans; Male; Middle Aged; Prednisolone; Time Factors

1974
The effect of intra-nasal beclomethasone dipropionate on adrenal function.
    Clinical allergy, 1974, Volume: 4, Issue:3

    Topics: Administration, Intranasal; Adrenal Glands; Adrenal Insufficiency; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Humans; Hydrocortisone; Male; Propionates; Respiratory Therapy; Rhinitis, Allergic, Seasonal

1974
Letter: Beclomethasone dipropionate aerosol.
    The Medical journal of Australia, 1974, Nov-16, Volume: 2, Issue:20

    Topics: Aerosols; Asthma; Beclomethasone; Child, Preschool; Chronic Disease; Humans; Methylprednisolone; Respiratory Therapy

1974
[Corticoid inhalation therapy using beclomethasone-dipropionate].
    Praxis der Pneumologie, 1974, Volume: 28 Suppl

    Topics: Asthma; Beclomethasone; Chemical Phenomena; Chemistry; Humans; Methylprednisolone; Propionates; Respiratory Therapy

1974
Some observations on the use of corticosteroid aerosols in asthma.
    Postgraduate medical journal, 1974, Volume: 50 suppl 4

    Topics: Aerosols; Aged; Asthma; Beclomethasone; Betamethasone; Betamethasone Valerate; Female; Humans; Male; Methylprednisolone; Middle Aged

1974
An investigation of the bronchial mucous membrane after long-term treatment with beclomethasone dipropionate (Becotide).
    Acta allergologica, 1974, Volume: 29, Issue:5

    Topics: Administration, Topical; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Biopsy; Bronchi; Bronchitis; Bronchoscopy; Cilia; Eosinophils; Epithelium; Female; Glucocorticoids; Humans; Lymphocytes; Male; Middle Aged; Mucous Membrane; Time Factors

1974
Letter: Steroid aerosols in asthma.
    British medical journal, 1974, Mar-16, Volume: 1, Issue:5906

    Topics: Administration, Topical; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Candida albicans; Candidiasis; Glucocorticoids; Humans; Methylprednisolone

1974
[Treatment of asthma in children with steroids in aerosol form].
    Lakartidningen, 1974, Mar-13, Volume: 71, Issue:11

    Topics: Administration, Topical; Adolescent; Adrenal Glands; Adult; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Methylprednisolone

1974
Letter: Steroid aerosols and candidiasis.
    British medical journal, 1974, May-18, Volume: 2, Issue:5915

    Topics: Administration, Topical; Adolescent; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Candidiasis; Child; Female; Glucocorticoids; Humans; Male; Methylprednisolone

1974
[Beclomethasone dipropionate aerosol (Becotide) in severe bronchial asthma].
    Ugeskrift for laeger, 1974, May-27, Volume: 136, Issue:22

    Topics: Administration, Topical; Adult; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Female; Glucocorticoids; Humans; Male; Methylprednisolone; Middle Aged; Prednisone; Respiratory Therapy; Time Factors

1974
[The bronchial mucosa after long-term treatment with beclomethsone dipropionate (Becotide)].
    Ugeskrift for laeger, 1974, May-27, Volume: 136, Issue:22

    Topics: Aged; Asthma; Beclomethasone; Biopsy; Bronchi; Bronchoscopy; Female; Glucocorticoids; Humans; Male; Methylprednisolone; Middle Aged; Mucous Membrane; Time Factors

1974
[Editorial: Beclomethasone].
    Ugeskrift for laeger, 1974, May-27, Volume: 136, Issue:22

    Topics: Aerosols; Asthma; Beclomethasone; Glucocorticoids; Humans; Methylprednisolone; Respiratory Therapy; Rhinitis, Allergic, Seasonal

1974
Editorial: Steroid aerosol for the treatment of bronchial asthma.
    The Journal of the Association of Physicians of India, 1974, Volume: 22, Issue:2

    Topics: Administration, Topical; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Glucocorticoids; Humans; Methylprednisolone

1974
Asthma--treatment with the aerosol steroid beclomethasone dipropionate.
    Annals of allergy, 1974, Volume: 33, Issue:3

    Topics: Administration, Topical; Adrenal Glands; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Candida; Child; Growth; Humans; Hydrocortisone; Pharynx; Pulmonary Ventilation

1974
Letter: Beclomethasone dipropionate.
    The Medical journal of Australia, 1974, Jun-22, Volume: 1, Issue:25

    Topics: Administration, Topical; Anti-Inflammatory Agents; Asthma; Beclomethasone; Glucocorticoids; Humans; Methylprednisolone; Propionates

1974
Beclomethasone aerosol in bronchial asthma.
    Lancet (London, England), 1973, Feb-17, Volume: 1, Issue:7799

    Topics: Administration, Topical; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Glucocorticoids; Humans; Methylprednisolone

1973
Aerosol beclomethasone dipropionate: a dose-response study in chronic bronchial asthma.
    Lancet (London, England), 1973, Aug-11, Volume: 2, Issue:7824

    Topics: Administration, Topical; Adult; Aerosols; Aged; Airway Obstruction; Anti-Inflammatory Agents; Asthma; Beclomethasone; Female; Humans; Hydrocortisone; Male; Methylprednisolone; Middle Aged; Spirometry

1973
Proceedings: Treatment of perennial childhood asthma.
    Archives of disease in childhood, 1973, Volume: 48, Issue:10

    Topics: Administration, Topical; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Cromolyn Sodium; Glucocorticoids; Humans; Thiocarbamates

1973
The effect of frequent administration of sodium cromoglycate to asthmatic children who previously responded poorly.
    Clinical allergy, 1973, Volume: 3, Issue:4

    Topics: Administration, Oral; Adolescent; Aerosols; Asthma; Beclomethasone; Child; Child, Preschool; Cromolyn Sodium; Dose-Response Relationship, Drug; Drug Evaluation; Female; Humans; Male; Respiratory Therapy; Spirometry; Time Factors

1973
Corticosteroid withdrawal in asthma.
    British medical journal, 1973, Feb-03, Volume: 1, Issue:5848

    Topics: Adrenal Gland Diseases; Adrenocorticotropic Hormone; Adult; Asthma; Beclomethasone; Female; Humans; Male; Middle Aged; Prednisone; Substance Withdrawal Syndrome

1973
Recovery of adrenal function after substitution of beclomethasone dipropionate for oral corticosteroids.
    British medical journal, 1973, Mar-31, Volume: 1, Issue:5856

    Of 16 steroid-dependent asthmatic patients oral treatment has been discontinued in six and reduced in four after the introduction of beclomethasone dipropionate. Substitution of inhaled beclomethasone for oral steroids was unsuccessful in the remaining six patients. Serial adrenal function studies in the patients whose oral treatment was discontinued showed progressive recovery, and five out of six had a normal response to tetracosactrin stimulation after two months.

    Topics: Administration, Oral; Administration, Topical; Adrenal Insufficiency; Adrenocorticotropic Hormone; Adult; Aerosols; Aged; Anti-Inflammatory Agents; Asthma; Beclomethasone; Female; Glucocorticoids; Humans; Male; Methylprednisolone; Middle Aged; Pituitary-Adrenal Function Tests; Prednisone; Respiratory Function Tests; Spirometry; Substance Withdrawal Syndrome

1973
Adrenal failure in bronchial asthma.
    British medical journal, 1973, Jun-02, Volume: 2, Issue:5865

    Topics: Adrenal Insufficiency; Adult; Asthma; Beclomethasone; Gastroenteritis; Humans; Male; Prednisolone

1973
Adrenal failure in bronchial asthma.
    British medical journal, 1973, Aug-04, Volume: 3, Issue:5874

    Topics: Adrenal Cortex Hormones; Adrenal Gland Diseases; Asthma; Beclomethasone; Humans; Hydrocortisone; Prednisolone

1973
Letter: Adrenal failure in bronchial asthma.
    British medical journal, 1973, Nov-17, Volume: 4, Issue:5889

    Topics: Administration, Oral; Adrenal Insufficiency; Aerosols; Asthma; Beclomethasone; Humans; Prednisolone

1973
Beclomethasone dipropionate corticosteroid inhaler: a preliminary report of its pharmacological properties and therapeutic efficacy in asthma.
    Drugs, 1973, Volume: 6, Issue:2

    Topics: Administration, Topical; Adrenal Glands; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Glucocorticoids; Humans; Methylprednisolone; Steroids; Substance Withdrawal Syndrome

1973
Letter: Adrenal failure in bronchial asthma.
    British medical journal, 1973, Oct-06, Volume: 4, Issue:5883

    Topics: Adrenal Gland Diseases; Adult; Asthma; Beclomethasone; Body Weight; Humans; Hydrocortisone; Male; Prednisolone; Substance Withdrawal Syndrome

1973
[Beclomethasone-dipropionate aerosol (Becotide)].
    Ugeskrift for laeger, 1973, Oct-22, Volume: 135, Issue:43

    Topics: Administration, Topical; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Glucocorticoids; Humans; Methylprednisolone

1973
The effect of oral and inhaled beclomethasone dipropionate on adrenal function.
    Clinical allergy, 1973, Volume: 3, Issue:3

    Topics: 11-Hydroxycorticosteroids; 17-Ketosteroids; Administration, Oral; Administration, Topical; Adrenal Glands; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Circadian Rhythm; Dexamethasone; Humans; Hydrocortisone; Male; Methylprednisolone; Respiratory Therapy; Time Factors

1973
Beclomethasone dipropionate and betamethasone valerate aerosols.
    Drug and therapeutics bulletin, 1973, Dec-21, Volume: 11, Issue:26

    Topics: Administration, Topical; Aerosols; Anti-Inflammatory Agents; Asthma; Atrophy; Beclomethasone; Betamethasone; Glucocorticoids; Humans; Methylprednisolone

1973
Effect of beclomethasone dipropionate on the diurnal variations in plasma cortisol level.
    Acta allergologica, 1973, Volume: 28, Issue:2

    Topics: Administration, Topical; Adolescent; Adult; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Circadian Rhythm; Female; Fluorometry; Humans; Hydrocortisone; Male; Methylprednisolone; Middle Aged; Respiratory Therapy

1973
Beclomethasone dipropionate aerosol (Becotide) in severe bronchial asthma.
    Acta allergologica, 1973, Volume: 28, Issue:5

    Topics: Administration, Topical; Adult; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Female; Glucocorticoids; Humans; Male; Methylprednisolone; Middle Aged; Respiration; Spirometry; Stimulation, Chemical; Time Factors; Vital Capacity

1973
Beclomethasone dipropionate aerosol in asthma.
    Lancet (London, England), 1972, Dec-09, Volume: 2, Issue:7789

    Topics: Administration, Topical; Aerosols; Anti-Inflammatory Agents; Asthma; Beclomethasone; Glucocorticoids; Humans; Methylprednisolone

1972
Respiratory function on asthmatic patients using beclomethasone dipropionate administered by pressurised aerosol.
    Current medical research and opinion, 1972, Volume: 1, Issue:3

    Topics: Administration, Oral; Adolescent; Adrenocorticotropic Hormone; Adult; Aerosols; Aged; Airway Resistance; Asthma; Beclomethasone; Blood Chemical Analysis; Female; Glucocorticoids; Humans; Hydrocortisone; Male; Methylprednisolone; Middle Aged; Plethysmography, Whole Body; Respiration; Respiratory Function Tests; Respiratory Therapy; Spirometry; Time Factors; Vital Capacity

1972