(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 Lung-Diseases--Obstructive

BASIS OF TREATMENT: Chronic obstructive pulmonary disease (COPD) is a common condition. Medical, and particularly drug, therapy still provides insufficiently effective relief. Corticosteroid treatment relies on the effect of these drugs on the underlying inflammatory mechanisms. Their efficacy has been demonstrated in asthma which exhibits certain features common with COPD.. Short-term corticosteroid regimens are generally well tolerated. Clinical data favor their use in certain cases of acute decompensation. Long-term systemic regimens are not warranted due to the risk of adverse effects and the difficulty in maintaining appropriate dosages. Inhaled corticosteroids are widely used although the efficacy remains controversial.. Clear evidence of efficacy from large controlled trials is still lacking. The difficulty encountered in obtaining such evidence is an indication of the minimal impact of such treatment and raises the question of its clinical pertinence. Patients exhibiting features similar to those observed in asthma (atopy, eosinophilia, improvement with bronchodilatation, non-smokers...) should be able to benefit from corticosteroids. For others a therapeutic test would be advisable to identify responders who could benefit from a preventive effect on the progression of COPD or associated asthma. A test lasting a few weeks at sufficient dosage is needed for subjective and objective (respiratory function tests) assessment. This costly therapy would not be warranted in non-responders, particularly in light of the expected secondary effects. Current evidence does not point to corticosteroid therapy as the much needed fully effective treatment for COPD.

Topics: Administration, Inhalation; Administration, Oral; Administration, Topical; Adrenal Cortex Hormones; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Beclomethasone; Bronchodilator Agents; Clinical Trials as Topic; Fluticasone; Glucocorticoids; Humans; Lung Diseases, Obstructive; Maximal Expiratory Flow-Volume Curves; Placebos; Risk Factors; Smoking; Sympathomimetics; Time Factors

The role of inhaled corticosteroids in the long term management of chronic obstructive pulmonary disease (COPD) is still unclear. A meta-analysis of the original data sets of the randomised controlled trials published thus far was therefore performed. The main question was: "Are inhaled corticosteroids able to slow down the decline in lung function (FEV1) in COPD?". A Medline search of papers published between 1983 and 1996 was performed and three studies were selected, two of which were published in full and one in abstract form. Patients with "asthmatic features" were excluded from the original data. Ninety five of the original 140 patients treated with inhaled corticosteroids (81 with 1500 micrograms beclomethasone daily, six with 1600 micrograms budesonide daily, and eight with 800 micrograms beclomethasone daily) and 88 patients treated with placebo (of the initial 144 patients) were included in the analysis. The effect on FEV1 was assessed by a multiple repeated measurement technique in which points of time in the study and treatment effects (inhaled corticosteroids compared with placebo) were investigated.. No baseline differences were observed (mean age 61 years, mean FEV1 45% predicted). The estimated two year difference in prebronchodilator FEV1 was +0.034 l/year (95% confidence interval (CI) 0.005 to 0.063) in the inhaled corticosteroid group compared with placebo. The postbronchodilator FEV1 showed a difference of +0.039 l/year (95% CI -0.006 to 0.084). No beneficial effect was observed on the exacerbation rate. Worsening of the disease was the reason for drop out in four patients in the treatment group compared with nine in the placebo group. In the treatment group six of the 95 subjects dropped out because of an adverse effect which may have been related to the treatment compared with two of the 88 patients in the placebo group.. This meta-analysis in patients with clearly defined moderately severe COPD showed a beneficial course of FEV1 during two years of treatment with relatively high daily dosages of inhaled corticosteroids.

Topics: Administration, Inhalation; Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Patient Dropouts; Randomized Controlled Trials as Topic; Time Factors

A 65-year-old man had surgery in June 1995 for femoral neuralgia. The plain films of the spine were normal at the time. In September of the same year, when he was beginning to walk gradually longer distances, he started experiencing back pain. Crush fractures of T8 and L2 were seen on plain films. His pain worsened, and he was admitted in December 1995. A third set of plain films disclosed fractures of all the vertebral bodies from T8 through L5, with increased density of the endplates of the same vertebras. Serum and urinary levels of calcium and phosphate were normal. Dual-energy X-ray absorptiometry demonstrated osteoporosis predominating in the trabecular bone. Evidence of increased bone resorption was seen on the histomorphometric study. Large amounts of dihydroxypyridinoline were found in the urine. Investigations for the classical causes of osteoporosis in males were unrewarding. Careful questioning revealed that the patient had been taking inhaled beclomethasone for seven years to treat chronic obstructive lung disease. Serum levels of cortisol and ACTH were low, consistent with a diagnosis of treatment-induced hypercorticism. To our knowledge, this is the first reported case of osteoporotic vertebral fractures in a male due to inhaled glucocorticoid therapy. Inhaled glucocorticoids are generally believed to induce only minimal systemic effects. However, decreased serum osteocalcin levels and increased urinary excretion of bone resorption markers have been reported in patients under inhaled beclomethasone therapy. Low spinal bone mineral density values correlated with the degree of pituitary-adrenal gland suppression as evaluated using the ACTH test have also been found in several groups of patients treated with inhaled glucocorticoids.

Topics: Administration, Inhalation; Administration, Topical; Aged; Anti-Inflammatory Agents; Beclomethasone; Glucocorticoids; Humans; Lumbar Vertebrae; Lung Diseases, Obstructive; Male; Osteoporosis; Radiography; Spinal Fractures; Thoracic Vertebrae

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

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

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

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

Inhaled corticosteroid therapy has proven efficacy for asthmatics, but the benefit for patients with chronic obstructive pulmonary disease (COPD) is less well supported. We hypothesized that withdrawal of inhaled steroids in elderly patients with severe irreversible airway obstruction would not lead to a deterioration in respiratory function. We designed a prospective, double-blind, randomized, placebo-controlled, crossover study to follow spirometry, quality of life questionnaire, six-minute (6-min) walk test, and sputum markers of inflammation during a 6-wk placebo treatment period and a 6-wk treatment period with beclomethasone dipropionate (BDP), 336 microg/d. There were 24 men receiving BDP who entered the study; 15 completed the study. Their mean age was 66.9 +/- 1.9 yr, and mean FEV(1) was 1.61 +/- 0.1 L (47% of predicted). There was a significant decrease in the mean FEV(1 )while using the placebo inhaler (1.70 L versus 1.60 L, baseline versus placebo: 95% CI, 0.002 to 0.195; p < 0.05). There was a decrease in the mean percentage change in FEV(1) for the study subjects during the placebo treatment period as compared with the BDP treatment period (-6.28 versus 5.03%, placebo versus BDP: 95% CI, -23.38 to 0.76; p = 0.06). Six-minute walk test results and sputum analysis for cell count and differential were not significantly different during placebo and BDP treatment periods. Borg scale assessment of dyspnea after exercise was increased while using the placebo inhaler as compared with baseline, and decreased during the BDP treatment period. Chronic Respiratory Disease Questionnaire (CRQ) scores revealed no significant difference between placebo and BDP. This study has demonstrated that in elderly patients with severe irreversible airway obstruction, withdrawal of inhaled corticosteroid therapy leads to a deterioration in ventilatory function and increased exercise-induced dyspnea.

Topics: Administration, Inhalation; Adult; Aged; Airway Obstruction; Anti-Asthmatic Agents; Beclomethasone; Cross-Over Studies; Double-Blind Method; Dyspnea; Exercise Test; Forced Expiratory Volume; Humans; Lung Diseases, Obstructive; Male; Middle Aged

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

It remains unclear whether inhaled corticosteroids can produce the maximum benefits of corticosteroids in patients with chronic obstructive pulmonary disease (COPD). To assess the additive effects of 30 mg/day prednisolone to high-dose, inhaled beclomethasone dipropionate (BDP), we conducted a randomised double-blind, placebo-controlled cross-over trial. The study population consisted of 21 men with stable COPD. The mean age of the patients was 69.1 +/- 6.8 years, and FEV(1)was 0.86 +/- 0.28 l. Seventeen out of the 21 patients (81%) were considered susceptible to steroids in a previous trial (FEV(1)increased at least 15% from baseline after receiving 14 days of 30 mg/day prednisolone). All of the patients had been on 1600 microg/day BDP for more than 3 months. Spirometry was performed before the entry, and at the end of 3-week placebo and prednisolone periods. The peak expiratory flow (PEF), symptoms, and Guyatt's Chronic Respiratory Disease Questionnaire (CRQ) as a disease specific health-related quality of life over the last seven days of each period were also evaluated. Although a marginal increase in PEF was found during the prednisolone period, no significant differences in FEV(1), FVC, symptoms or CRQ scores were observed between the two treatment periods. We conclude that the therapeutic effects of steroid therapy may be achieved by the long-term use of high-dose, inhaled corticosteroid in some patients with stable COPD.

Topics: Administration, Inhalation; Administration, Oral; Aged; Anti-Inflammatory Agents; Beclomethasone; Cross-Over Studies; Double-Blind Method; Drug Synergism; Glucocorticoids; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Prednisolone; Respiratory Function Tests; Surveys and Questionnaires; Treatment Outcome

Topics: Administration, Inhalation; Adrenal Cortex Hormones; Beclomethasone; Cross-Over Studies; Double-Blind Method; Humans; Lung Diseases, Obstructive; Lung Volume Measurements; Treatment Outcome

The benefits of inhaled corticosteroids in the management of COPD are less apparent than they are in asthma therapy, and the potential for adverse systemic effects of high-dose inhaled corticosteroids has been recognized recently. It is therefore essential to know the maximal obtainable benefits in order to assess the risk/benefit ratio of this treatment.. The aim of this study was to investigate the maximal obtainable benefits of high-dose inhaled corticosteroids, 3 mg/d of beclomethasone dipropionate (BDP), when used in combination with adequate doses of regular bronchodilators in patients with stable COPD.. Thirty patients with stable COPD completed a randomized, double-blind, placebo-controlled cross-over trial with either 3 mg/d of BDP or with a matching placebo using a metered-dose inhaler with a spacer device for 4 weeks during each treatment period. All of the patients continued to inhale both 400 microg of salbutamol qid and 80 microg of ipratropium bromide qid.. The mean prebronchodilator FEV1 was 0.97+/-0.35 L during the placebo period and 1.08+/-0.38 L during the BDP period (p < 0.001). While on BDP, five patients demonstrated a response in their FEV1 of more than 8.5% of the predicted value, which was above the range that covered 95% of the distribution of the placebo response. The mean absolute improvement in the FEV1 in these 5 objective responders was 0.34+/-0.10 L, compared to 0.06+/-0.09 L in the 25 objective nonresponders. Symptom scores for wheezing and dyspnea were significantly better with BDP than with placebo. Hoarseness and sore throat were associated more with BDP treatment.. Although a considerable minority of patients benefited substantially from this treatment, the overall outcome does not seem to justify the widespread use of this treatment in the light of increasing recognition of the potential adverse systemic effects of high-dose inhaled corticosteroids.

Topics: Administration, Inhalation; Aged; Anti-Asthmatic Agents; Beclomethasone; Bronchodilator Agents; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Treatment Outcome

Treatment of chronic obstructive pulmonary disease (COPD) with inhaled and oral corticosteroids is common, although their exact role is unclear. Previous studies suggest these drugs may reduce decline in lung function in this group of patients. We report a study investigating the effect of inhaled beclomethasone diproprionate (BDP) on lung function and symptoms in a group of patients with COPD. Treatment was given for 2 years, and the decline in FEV1 in individual patients calculated over this period. Ninety-eight patients were randomized for the study, 59 completing 2 years of treatment. Patients withdrawn had more severe airflow obstruction. Decline in FEV1, measured both prior to and after bronchodilator, was less in patients receiving inhaled BDP, although the differences failed to reach statistical significance except in a subgroup of patients with more severe airflow obstruction. Exacerbation rates were also reduced by inhaled BDP, but again the differences failed to reach conventional levels of statistical significance. The results of this study are consistent with previous published work, but further insight into the long-term role of corticosteroids in COPD await the publication of large studies which have recently been completed. Although the changes seen in this study and others are numerically small, the rate of decline in FEV1 returned to normal levels expected from age-related decline, and hence such treatment combined with other strategies may well have a significant role in the long-term treatment of this condition.

Topics: Administration, Inhalation; Aged; Beclomethasone; Bronchial Provocation Tests; Disease Progression; Double-Blind Method; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Lung; Lung Diseases, Obstructive; Male; Nebulizers and Vaporizers; Treatment Outcome

Twenty male outpatients with severe-but-stable chronic obstructive pulmonary disease handicapped by exertional dyspnoea (aged 69.7 +/- 5.68 yrs; forced expiratory volume in one second (FEV1) 1.02 +/- 0.18 L or 34.6 +/- 6.5% of the predicted value; forced vital capacity (FVC) 2.51 +/- 0.34 L; arterial oxygen tension (Pa,O2) 9.11 +/- 0.32 kPa (68.5 +/- 2.4 mmHg); arterial carbon dioxide tension (Pa,CO2) 5.20 +/- 0.23 kPa (39.1 +/- 1.7 mmHg)) completed a randomized double-blind crossover study to evaluate the effects of a 4-week regular treatment with inhaled beclomethasone dipropionate via nebulizers at a dosage of 2 mg twice daily. After active and placebo treatment, no peak expiratory flow rate variation in FEV1, FVC, rescue use of beta 2-agonists, exercise tolerance and dyspnoea was observed. In conclusion, a regular short-term treatment with nebulized beclomethasone dipropionate does not give any improvement in lung function or exercise capacity in severe-but-stable chronic obstructive pulmonary disease patients handicapped by exertional dyspnoea.

Topics: Administration, Inhalation; Aerosols; Aged; Beclomethasone; Cross-Over Studies; Double-Blind Method; Dyspnea; Glucocorticoids; Humans; Lung Diseases, Obstructive; Male; Physical Exertion; Respiratory Function Tests; Statistics, Nonparametric; Treatment Outcome

Withdrawal of inhaled corticosteroids is known to worsen disease control in bronchial asthma but similar data are lacking in chronic obstructive pulmonary disease (COPD). We hypothesized that clinical exacerbations requiring treatment would occur more often in patients whose inhaled corticosteroids were stopped than in other patients not treated with these agents. We studied 272 patients in mean age 65 (SD 0.8) years, mean FEV1 42.8 (SD 12.6)% predicted, entering the run-in phase of the Inhaled Steroids in Obstructive Lung Disease (ISOLDE) trial. All had been clinically stable for at least 6 weeks and there were no differences in the degree of bronchodilator reversibility, baseline lung function or pack-years of smoking between the 160 patients receiving inhaled corticosteroids and those not so treated. Inhaled corticosteroids were withdrawn in the first week of the study and during the remaining 7 weeks of the study 38% of those previously treated with these drugs had an exacerbation compared to 6% of the chronically untreated group. Patients receiving inhaled corticosteroids reported a longer duration of symptoms but neither this or any other recorded variable predicted the risk of exacerbation. These data suggest that abrupt withdrawal of inhaled corticosteroids should be monitored carefully even in patients with apparently irreversible COPD.

Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Aged; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Female; Follow-Up Studies; Forced Expiratory Volume; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Substance Withdrawal Syndrome; Vital Capacity

Topics: Administration, Inhalation; Asthma; Beclomethasone; Bone Density; Budesonide; Female; Glucocorticoids; Humans; Lung Diseases, Obstructive; Male; Pilot Projects

Airways inflammation is a feature of chronic obstructive pulmonary disease (COPD), but the role of corticosteroids in the management of clinically stable patients has yet to be established. A randomised controlled study was carried out to investigate the effect of high dose inhaled beclomethasone dipropionate (BDP) administered for two months to patients with stable, smoking related COPD. Sputum induction was used to evaluate bronchial inflammation response.. 34 patients (20 men and 14 women) were examined on three separate occasions. At the initial clinical assessment (visit 0), spirometry and blood gas analysis were performed. On visit 1 (within one week of visit 0) sputum induction was performed and each patient was randomised to receive either BDP 500 micrograms three times daily (treated group) or nothing (control group). After two months (visit 2), all patients underwent repeat clinical assessment, spirometry, and sputum induction.. There were no differences in sputum cell counts between the groups at baseline. After two months of treatment, induced sputum samples from patients in the treated group showed a reduction in both neutrophils (-27%) and total cells (-42%) with respect to baseline, while the control group did not (neutrophils +9%, total cells +7%). Macrophages increased in the treated group but not in the control group. The mean final value of sputum neutrophils was 52% in the treated group and 73.3% in the control group (95% confidence interval (CI) -27.2 to -15.4). The mean final value of sputum macrophages was 35.8% in treated group and 19.3% in control group (95% CI 10.3 to 22.8). The differences between the treated and control groups for neutrophils (-21.3%), macrophages (+16.5%), and total cells (-65%) were significant. Spirometry and blood gas data did not change from baseline in either patient group.. A two month course of treatment with high dose inhaled BDP reduces significantly neutrophil cell counts in patients with clinically stable, smoking related COPD. Further studies on the effectiveness of inhaled steroids in COPD are needed to confirm the clinical importance of this observation.

Topics: Administration, Inhalation; Aged; Beclomethasone; Cell Count; Double-Blind Method; Drug Administration Schedule; Female; Glucocorticoids; Humans; Leukocyte Count; Lung Diseases, Obstructive; Macrophages; Male; Middle Aged; Spirometry; Sputum; Statistics, Nonparametric

Topics: Administration, Inhalation; Beclomethasone; Bronchitis; Bronchodilator Agents; Female; Glucocorticoids; Humans; Ipratropium; Lung Diseases, Obstructive; Male; Maximal Expiratory Flow Rate; Middle Aged; Mucus; Prednisolone; Pulmonary Emphysema; Smoking; Smoking Cessation; Smoking Prevention; Vital Capacity

There is less unanimity about the effects of inhaled corticosteroid in patients with non-asthmatic chronic obstructive pulmonary disease(COPD). The aim of this study is to determine whether patients with non-asthmatic COPD have favorable responses to inhaled corticosteroid (ICS).. A randomized, placebo-controlled, single-blind trial of inhaled beclomethasone dipropionate(BDP 1000 micrograms daily for 6 weeks) was carried out in 61 patients with stable non-asthmatic COPD. Before and after the therapy, the scores of clinical symptoms and the scores of quality of life were recorded, and the pulmonary function and plasma level of endothelin-1 (ET-1) were measured.. 58 patients finished the study. Compared with the placebo-group, after receiving 6 weeks of ICS therapy, the BDP group showed significant improvement in clinical symptoms (P < 0.05), but not in the quality of life (P > 0.05). There was also an improvement in FEV1(P < 0.001), but not in MMEF (P > 0.05). The plasma concentration of ET-1 was not changed significantly in both groups.. The study suggested that the therapy of ICS (1000 micrograms daily for 6 weeks) can improve clinical symptoms and pulmonary function in patients with stable non-asthmatic COPD, but cannot affect the quality of life and the plasma concentration of ET-1.

Topics: Administration, Inhalation; Anti-Inflammatory Agents; Beclomethasone; Female; Humans; Lung Diseases, Obstructive; Male; Single-Blind Method

Bone mass and biochemical bone markers were prospectively studied in 33 patients with chronic obstructive pulmonary disease treated for 1 year with inhaled beclomethasone 200 micrograms/q.i.d. (group A, 8 men and 4 women), inhaled budesonide 200 micrograms/q.i.d. (group B, 6 men and 5 women), or not requiring steroids (group C, 6 men and 4 women). Both inhaled corticosteroids decreased serum concentrations of the osteoblastic markers, osteocalcin and carboxy-terminal propeptide of type I collagen (PICP). The osteoclastic marker cross-linked carboxy-terminal telopeptide of type I collagen (ICTP) increased significantly more in patients on beclomethasone than in those on budesonide. The decrease in bone mineral density was more pronounced in patients treated with beclomethasone (1.1% in the spine 1.7% in the hip P < 0.05) compared to those treated with budesonide (0.6% in both spine and hip) or in the control group. Inhaled corticosteroids affect biochemical bone markers and bone mineral density, but there is a different effect for the two corticosteroids evaluated in the present study.

Topics: Administration, Inhalation; Adult; Aged; Alkaline Phosphatase; Beclomethasone; Biomarkers; Bone Density; Budesonide; Calcium; Collagen; Collagen Type I; Female; Glucocorticoids; Homeostasis; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Osteocalcin; Osteoporosis; Peptide Fragments; Peptides; Pregnenediones; Procollagen; Prospective Studies

The aims of this investigation were to evaluate the efficacy of regular inhaled beclomethasone in the control of symptoms and lung function with non-asthmatic smoking related obstructive pulmonary disease and to evaluate the relationship between clinical responses to a short course of oral prednisone and longer term outcomes using inhaled steroid.. The study was a randomised, double blind, placebo controlled, crossover investigation in 18 patients. The active treatment was inhaled beclomethasone 1000 micrograms given twice daily for three months by metered dose inhaler. At the end of each treatment period, patients received oral prednisone 30 mg/day for ten days. The two treatment phases were separated by a one month washout interval. Peak flow rates, symptom scores and "rescue" bronchodilator use were recorded twice daily. Lung function (FEV1, FVC and lung volumes) and bronchial hyperresponsiveness (PC20 methacholine) were measured at monthly visits. The number of exacerbations requiring intervention therapy were also recorded.. There were no consistent benefits attributable to beclomethasone. Lung function was not significantly better as a result of active treatment. Sputum production improved but other symptom scores were similar during active and placebo therapy. Three patients exhibited an increase in FEV1 of 15% or more during active treatment but did not do so when oral prednisone was administered immediately after the period of placebo treatment. A further three patients showed an improvement in FEV1 of 15% or more with oral prednisone but failed to improve during treatment with inhaled beclomethasone. The predictive value of the "trial of steroid" was 0% and 81.3% for positive and negative outcomes respectively.. Our results indicate that in non-asthmatic chronic obstructive pulmonary disease inhaled corticosteroid fails to achieve significant improvements in either lung function or symptoms. The response to a "trial of steroid" using oral prednisone is not clinically helpful in selecting the small number of patients who may subsequently benefit from this form of therapy.

Topics: Administration, Inhalation; Administration, Oral; Beclomethasone; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Glucocorticoids; Humans; Lung Diseases, Obstructive; Prednisone; Respiratory Function Tests; Smoking; Treatment Outcome

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

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

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

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

To study the role of inhaled steroids in treating patients with chronic obstructive pulmonary disease (COPD), 1.6 mg of beclomethasone dipropionate (BDP) were given for 2 weeks after 0.5 mg/kg of oral prednisolone (PSL) for 2 weeks to 43 patients with COPD (mean age 68.7 +/- 5.2 years, mean baseline FEV1, 1.13 +/- 0.44 L). When responders to a corticosteroid (PSL or BDP) were defined as those with a post-steroid EFV1/baseline FEV1 > or = 115% and a post-steroid FEV1-baseline FEV1 > or = 0.2 L, 12 out of 43 patients responded to 30 mg of PSL for 2 weeks and 13 responded to 1.6 mg of BDP for 2 weeks. We considered those 17 patients who responded to 2 weeks of PSL or 2 weeks of BDP or both, to be possible steroid responders, and they continued inhaling BDP for 4 more weeks. In 8 of these 17 patients (19%), FEV1 had increased by the end of the 6 weeks. Inhaled BDP was considered useful in treating some patients with COPD.

Topics: Administration, Inhalation; Administration, Oral; Aged; Beclomethasone; Drug Therapy, Combination; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Peak Expiratory Flow Rate; Prednisolone

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

High doses of inhaled beclomethasone dipropionate (BDP) are effective in some patients with chronic obstructive pulmonary disease (COPD). However, dose-response data for this agent are limited. To determine whether patients receive maximum benefit from 1600 micrograms of BDP, we performed a randomized, double-blind, placebo-controlled, cross-over trial. Twenty-one patients with stable COPD [mean +/- SD: age, 69.1 +/- 6.8 yrs; FEV1, 0.86 +/- 0.28 L] were treated with both inhaled bronchodilators and 1600 micrograms of BDP daily for at least 3 months. Each patient received 30 mg of oral prednisolone or a placebo for 3 weeks. In addition to end-point spirometric assessments daily peak expiratory flow rate, symptom scores, and scores on a chronic respiratory disease questionnaire were recorded for the last week of each 3-week period. Oral prednisolone did not improve FEV1, FVC, symptoms or scores on the questionnaire. We conclude that 1600 micrograms of BDP in addition to inhaled bronchodilators produces maximal improvements in stable patients with COPD.

Topics: Administration, Inhalation; Aged; Anti-Inflammatory Agents; Beclomethasone; Bronchodilator Agents; Cross-Over Studies; Double-Blind Method; Female; Humans; Lung Diseases, Obstructive; Male

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

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

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

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

The efficacy of 8 weeks of treatment with 4 mg of nedocromil sodium 4 times daily in the management of partially reversible chronic airflow obstruction was evaluated in a randomized, double-blind, placebo-controlled crossover trial at Repatriation General Hospital, Western Australia. Sixty-seven patients with a mean forced expiratory volume in 1 s (FEV1) of 0.99 L, which improved by 21.8 percent after beta 2-adrenergic bronchodilator, took part in the full 24-week study. After a 4-week run-in period, in addition to their regular therapy comprised of inhaled or oral bronchodilators and steroids (which remained unchanged), patients were randomly allocated to receive treatment with nedocromil sodium or placebo for 8 weeks. This was followed by a 4-week washout, and then the patients were given the alternative test treatment to that given in the first period for another 8 weeks. Compared with placebo, patients receiving nedocromil sodium had improvement in their morning and evening peak flow rates, symptom scores for cough, sleep disturbance, and overall treatment efficacy. Hence, treatment with nedocromil sodium should be considered for patients with partially reversible chronic airflow obstruction not fully controlled with bronchodilators and steroids.

Topics: Adult; Aged; Aged, 80 and over; Albuterol; Anti-Inflammatory Agents, Non-Steroidal; Beclomethasone; Double-Blind Method; Forced Expiratory Volume; Humans; Ipratropium; Lung Diseases, Obstructive; Middle Aged; Nebulizers and Vaporizers; Nedocromil; Patient Satisfaction; Peak Expiratory Flow Rate; Placebos; Prednisolone; Quinolones; Theophylline; Treatment Outcome; Vital Capacity

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

The effect of treatment with inhaled corticosteroids in patients with non-asthmatic chronic airflow obstruction is still disputed. Whether any physiological improvements seen are accompanied by changes in bronchial responsiveness and symptoms and quality of life is also still unclear.. A sequential placebo controlled, blinded parallel group study investigating the effect of three weeks of treatment with inhaled beclomethasone dipropionate (BDP), 750 micrograms or 1500 micrograms twice daily, and oral prednisolone, 40 mg per day, was carried out in 105 patients with severe non-asthmatic chronic airflow obstruction (mean age 66 years, mean forced expiratory volume in one second (FEV1) 1.05 litres [40% predicted], geometric mean PD20 0.52 mumol). End points assessed were FEV1, forced vital capacity (FVC), and peak expiratory flow (PEF), bronchial responsiveness to inhaled histamine, and quality of life as measured by a formal quality of life questionnaire.. Both doses of BDP produced equivalent, small, but significant improvements in FEV1 (mean 48 ml), FVC (mean 120 ml), and PEF (mean 12.4 l/min). The addition of oral prednisolone to the treatment regime in two thirds of the patients did not produce any further improvement in these parameters. Inhaled BDP produced a treatment response in individual patients (defined as an improvement in FEV1, FVC, or mean PEF of at least 20% compared with baseline values) more commonly than placebo (34% v 15%). The two doses of BDP were equally effective in this respect and again no further benefit of treatment with oral prednisolone was noted. Treatment with BDP for up to six weeks did not affect bronchial responsiveness to histamine. Small but significant improvements were seen in dyspnoea during daily activities, and the feeling of mastery over the disease.. High dose inhaled BDP is an effective treatment for patients with chronic airflow obstruction not caused by asthma. Both objective and subjective measures show improvement. Unlike asthma, no improvement in bronchial responsiveness was detected after six weeks of treatment.

Topics: Administration, Inhalation; Administration, Oral; Aged; Beclomethasone; Bronchi; Drug Administration Schedule; Female; Forced Expiratory Volume; Histamine; Humans; Lung; Lung Diseases, Obstructive; Male; Middle Aged; Peak Expiratory Flow Rate; Prednisolone; Quality of Life; Single-Blind Method; Smoking; Vital Capacity

The morbidity from obstructive airways disease (asthma and chronic obstructive pulmonary disease) is considerable, and the mortality rate is rising in several countries. It has been hypothesized that long-term improvement in prognosis might result from vigorous bronchodilator or antiinflammatory therapy.. In a multicenter trial we compared three inhalation regimens in which a beta 2-agonist (terbutaline, 2000 micrograms daily) was combined with a corticosteroid (beclomethasone, 800 micrograms daily), an anticholinergic bronchodilator (ipratropium bromide, 160 micrograms daily), or placebo. Patients with airways hyperresponsiveness and obstruction who were 18 to 60 years old were followed for 2 1/2 years.. Of the 274 patients enrolled, 56 percent had allergies. The mean forced expiratory volume in one second (FEV1) was 64 percent of the predicted value. The mean PC20 (the concentration of inhaled histamine causing a 20 percent decrease in FEV1, a measure of hyperresponsiveness) was 0.26 mg per milliliter. Withdrawal from the study, due mainly to pulmonary symptoms, was less frequent in the corticosteroid group (12 of 91 patients) than in the anticholinergic-drug group (45 of 92 patients) or the placebo group (44 of 91 patients; P < 0.001). The mean FEV1 (+/- SE) increased by 10.3 +/- 1.3 percent of the predicted value in the corticosteroid group within three months and remained stable thereafter, whereas it did not change in the other two groups (P < 0.001). The PC20 increased by 2.0 doubling concentrations in the corticosteroid group but did not change in the other groups (P < 0.001). In the corticosteroid group, patients who did not smoke, who had allergies, or who were less than 40 years old benefited more from their treatment than did those who smoked, did not have allergies, or were over 40, but all subgroups of the corticosteroid group had improvement as compared with the anticholinergic-drug or placebo group.. The addition of an inhaled corticosteroid--but not an inhaled anticholinergic agent--to maintenance treatment with a beta 2-agonist (terbutaline) substantially reduced morbidity, hyperresponsiveness, and airways obstruction in patients with a spectrum of obstructive airways disease.

Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Beclomethasone; Double-Blind Method; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Ipratropium; Lung Diseases, Obstructive; Male; Middle Aged; Patient Dropouts; Respiratory Hypersensitivity; Terbutaline

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

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

We have studied the relationship between emphysema and airways collapse, and response to corticosteroids in patients with chronic airflow obstruction. One hundred and seven patients completed a placebo-controlled trial comparing 2 wks treatment with oral prednisolone 40 mg.day-1 to inhaled beclomethasone dipropionate 500 micrograms t.d.s. Response to corticosteroids was defined on the basis of changes in forced expiratory volume in one second (FEV1), and/or forced vital capacity (FVC), and/or mean peak expiratory flow (PEF) after treatment. Patients were categorized as those with physiologically defined emphysema (carbon monoxide transfer coefficient (KCO) less than 70% predicted and total lung capacity greater than 120% predicted), and those with pressure dependent airways collapse on the flow-volume loop (ratio of inspiratory to expiratory flow at 50% vital capacity [I:E50] greater than 10). The response to placebo showed a significant order effect, probably due to a carry-over effect of active treatment of at least 3 wks. Hence, the efficacy of active treatment over placebo in the subgroups defined was assessed by analysis of data generated from the first treatment phase of the trial. The presence or absence of physiologically defined emphysema did not affect the response to oral prednisolone. Inhaled beclomethasone dipropionate, however, was less effective in the emphysema group. Pressure dependent airways collapse did not affect the response to either prednisolone or beclomethasone. However, when data from all three treatment phases were analysed there was no significant difference in the response to either drug in any of the subgroups defined.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Inhalation; Aged; Beclomethasone; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Prednisolone; Pulmonary Emphysema; Pulmonary Ventilation; Vital Capacity

One hundred and twenty seven adults considered on clinical grounds to have non-asthmatic chronic airflow obstruction entered a randomised, double blind, placebo controlled, crossover trial comparing the physiological response to inhaled beclomethasone dipropionate 500 micrograms thrice daily with oral prednisolone 40 mg a day, both given for two weeks. One hundred and seven patients completed the study. Response was assessed as change in FEV1 and FVC measured on the last treatment day, and as change in mean peak expiratory flow (PEF) over the final seven days of treatment from home PEF recordings performed five times daily. A full response to treatment was defined as an increase in FEV or FVC, or an increase in mean daily PEF over the final seven days of treatment, of at least 20% from baseline values. An improvement in one measurement of at least 15%, or of 10% in any two measurements, was defined as a partial treatment response. Response to placebo showed a significant order effect, suggesting a carry over effect of active treatment of at least three weeks. Response to active treatment was therefore related to initial baseline values, and compared with placebo by considering responses in the first treatment phase only. A full response to oral prednisolone (16/38) was significantly more common than to placebo (3/35). The number of full responses to inhaled beclomethasone (8/34) did not differ significantly from the number responding to oral prednisolone or placebo in the first treatment phase, though full and partial responses to inhaled beclomethasone (12/34) were significantly more common than those to placebo (4/35). When all three treatment phases were considered 44/107 patients showed a full response to one or both forms of corticosteroid treatment, a response to prednisolone (39) occurring more frequently than to inhaled beclomethasone (26). Only 21 of the 44 responders showed a response to both forms of treatment. Inhaled beclomethasone dipropionate 500 micrograms thrice daily was inferior to oral prednisolone 40 mg per day, but better than placebo, in producing improvement in physiological measurements in patients thought to have nonasthmatic chronic airflow obstruction. It was, however, an effective alternative in over half of those showing a response to prednisolone.

Topics: Administration, Inhalation; Administration, Oral; Beclomethasone; Double-Blind Method; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Prednisolone; Randomized Controlled Trials as Topic; Respiratory Function Tests

One hundred and twenty one patients considered on clinical grounds to have non-asthmatic chronic airflow obstruction completed a double blind, crossover trial comparing oral prednisolone 40 mg per day with inhaled beclomethasone dipropionate 500 micrograms thrice daily, each given for 14 days, with a 14 day washout period between treatments. The time course of response was analysed for the 57 occasions where there was a significant increase in mean daily peak expiratory flow (PEF) over the treatment period. Mean daily PEF was still rising at day 14 on 12 occasions. After withdrawal of treatment mean daily PEF remained above pretreatments levels for more than two weeks in half the responses analysed. The peak response occurred earlier with inhaled beclomethasone (median 9.5 (range 3-14) days) than with oral prednisolone (median 12 (range 1-14) days), though both treatments produced a response that was sustained for a similar period. The results suggest that a trial of treatment with corticosteroids in this group of patients should last more than 14 days, and that in a study with a crossover design the washout period should be longer than two weeks.

Topics: Administration, Inhalation; Administration, Oral; Beclomethasone; Double-Blind Method; Humans; Lung Diseases, Obstructive; Peak Expiratory Flow Rate; Prednisolone; Randomized Controlled Trials as Topic; Time Factors

The objective of this study was to examine the effectiveness of inhaled beclomethasone in the treatment of stable chronic obstructive airway disease (COAD). Eight patients completed a randomized, double-blind, placebo-controlled, crossover trial of inhaled beclomethasone and oral prednisone. Each patient received 3 treatment regimens given for 14 days: inhaled beclomethasone, prednisone, and placebo. There were no statistically significant differences in pulmonary function tests, oxygen cost diagram, or 12-minute walking distance test among the regimens. The only improvement in arterial blood gasses was partial pressure of oxygen, which was negligibly increased during prednisone treatment compared with beclomethasone and with placebo (p less than 0.05). Evaluation of 95% confidence intervals indicated that clinically significant mean differences were unlikely with either beclomethasone or prednisone. Larger studies are required to determine if a responsive subgroup exists, and to determine if this form of therapy has a role in treatment of COAD.

Topics: Administration, Inhalation; Administration, Oral; Aged; Beclomethasone; Blood Gas Analysis; Double-Blind Method; Female; Humans; Hydrocortisone; Lung Diseases, Obstructive; Lung Volume Measurements; Male; Prednisone; Random Allocation

The use of high dose inhaled beclomethasone dipropionate (BDP) as a means of assessing steroid responsiveness in chronic obstructive airways disease (COAD) was assessed in 22 patients in a study involving three consecutive 2-week periods of placebo, inhaled BDP (1500 micrograms daily), and oral prednisolone (30 mg daily). Five of the 22 patients were considered steroid responsive following the course of oral corticosteroids and in each case this responsiveness had been identified by inhaled BDP therapy. It is concluded that high dose inhaled BDP (1500 micrograms daily) may be used to assess corticosteroid responsiveness in COAD.

Topics: Administration, Inhalation; Administration, Oral; Adult; Aged; Aged, 80 and over; Beclomethasone; Clinical Trials as Topic; Female; Humans; Lung; Lung Diseases, Obstructive; Male; Middle Aged; Peak Expiratory Flow Rate; Prednisolone

Forty four children with recurrent obstructive episodes after acute bronchiolitis in infancy were treated with nebulised beclomethasone dipropionate or placebo for eight weeks in a randomised double-blind study. They were seen monthly for a year afterwards, and also if they had acute respiratory illnesses with or without bronchopulmonary obstruction. The two treatment groups were well matched. The children receiving active treatment had significantly fewer symptomatic respiratory illnesses and fewer episodes of bronchopulmonary obstruction during the follow up period. The children given placebo had significantly higher obstructive scores during the study period, and they were treated with inhaled beta 2 agonists and theophylline for longer periods of time during the follow up period. The results suggest that nebulised beclomethasone dipropionate may have prolonged effects on subsequent asthmatic symptoms after termination of treatment in children with recurrent obstructive episodes after acute bronchiolitis.

Topics: Acute Disease; Administration, Inhalation; Beclomethasone; Bronchiolitis; Child, Preschool; Clinical Trials as Topic; Double-Blind Method; Follow-Up Studies; Humans; Infant; Lung Diseases, Obstructive; Nebulizers and Vaporizers; Random Allocation; Recurrence; Time Factors

A double-blind cross-over trial was carried out on 83 sequential out-patients presenting with adult onset chronic airflow obstruction who were not clearly asthmatic. The study consisted of three treatment phases each lasting two weeks with a two week interval between each phase. The treatment phases were prednisolone 40 mg daily, beclomethasone dipropionate 500 ug three times a day and placebo, administered in a random order. FEV1 and FVC were measured at the end of each of the treatment phases and peak expiratory flow rate five times a day throughout. Over the study period 25 (30%) patients responded with an improvement of greater than or equal to 20% in at least one of the parameters measured as compared with the best of either baseline or placebo measurements. A further eight patients were classified as partial responders with an improvement of greater than 15% in any single parameter or greater than 10% in any two parameters. A similar number responded to beclomethasone [15] as responded to prednisolone [16]. Only six patients, however, responded fully to both forms of steroid therapy. A number of patients responded to one form of steroid treatment only which was also comparable between the two groups (prednisolone 10, beclomethasone 9). For full and partial responders mean improvement in FEV1, FVC and PEFR was greater during the prednisolone phase than during the beclomethasone phase, however, the difference did not achieve statistical significance.

Topics: Aged; Beclomethasone; Double-Blind Method; Female; Humans; Lung; Lung Diseases, Obstructive; Male; Middle Aged; Prednisolone

Thirty patients suffering from acute exacerbations of chronic obstructive lung disease were divided on a random basis into two groups and allocated, for purposes of comparison, to treatment either with a combination of salbutamol plus beclomethasone dipropionate or with fenoterol. The two treatments being compared were evaluated on the basis of ventilatory function parameters (FEV1, FVC), bronchodilatation tests and subjective and objective clinical investigations regarding the bronchopulmonary picture and the tolerance of the drugs. All investigations and tests were performed according to identical procedures both before and after 4 weeks' treatment, and the data obtained evaluated by statistical analysis. The results proved positive for both preparations, though the combination of salbutamol plus beclomethasone dipropionate produced a greater bronchodilator effect, facilitated a more sensitive response to the bronchodilator on the part of bronchial beta2-adrenergic receptors, and was characterized by better tolerance.

Topics: Aged; Albuterol; Beclomethasone; Clinical Trials as Topic; Drug Combinations; Ethanolamines; Fenoterol; Forced Expiratory Volume; Humans; Lung Diseases, Obstructive; Middle Aged; Time Factors

Some patients with chronic obstructive pulmonary disease have favorable responses to treatment with oral corticosteroids with increase in one-second forced expiratory volume of 30 percent or more above the baseline. The benefit of long-term steroid therapy may be outweighed by the side effects. Twelve patients who had previously demonstrated a response to oral corticosteroids were studied in a double-blind randomized crossover trial comparing prednisone (30 mg daily) with beclomethasone (metered-dose inhaler, 16 puffs daily) for two weeks each with a two-week washout period between the two regimens. Those who were taking prednisone tapered the dose to 5 mg daily and those taking beclomethasone discontinued it for two weeks before the beginning of the study. History, physical examination, and pulmonary function were monitored. The mean one-second forced expiratory volume increased from 0.65 to 1.00 liter after prednisone therapy and it increased from 0.63 to 0.81 liter after aerosol beclomethasone (difference significant, p less than 0.01 by paired t test). Only five of 12 patients had an increase in one-second forced expiratory volume with steroid aerosol, an increase that was at least 50 percent that achieved by prednisone. In most patients with steroid-responsive chronic obstructive pulmonary disease, aerosol beclomethasone is not an adequate substitute for oral steroids.

Topics: Administration, Oral; Aerosols; Aged; Beclomethasone; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Prednisone; Random Allocation; Vital Capacity

Topics: Albuterol; Beclomethasone; Clinical Trials as Topic; Drug Therapy, Combination; Humans; Lung Diseases, Obstructive; Random Allocation; Research Design; Respiratory Function Tests

Topics: Adolescent; Adult; Aged; Beclomethasone; Circadian Rhythm; Dexamethasone; Dexamethasone Isonicotinate; Female; Humans; Hydrocortisone; Lung Diseases, Obstructive; Male; Methylprednisolone; Middle Aged; Pituitary-Adrenal System; Respiratory Therapy

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

Topics: Administration, Oral; Adrenal Cortex Hormones; Aerosols; Asthma; Beclomethasone; Betamethasone; Clinical Trials as Topic; Humans; Lung Diseases, Obstructive; Particle Size; Propionates; Triamcinolone; Valerates

Topics: Administration, Oral; Aerosols; Beclomethasone; Bronchi; Clinical Trials as Topic; Eosinophils; Humans; Lung Diseases, Obstructive; Methylprednisolone; Mucous Membrane

To investigate possible changes in cells and molecular mediators of airway inflammation following inhaled steroid treatment of stable COPD patients.. Six-week open preliminary prospective study.. A university respiratory disease clinic.. : Stable COPD patients with mild disease.. Six-week treatment with inhaled beclomethasone (1.5 mg die).. The levels of interleukin (IL)-8, myeloperoxidase, eosinophilic cationic protein and tryptase, and cell numbers in bronchial lavage specimens were determined, and the symptom score, the endoscopic bronchitis index, and functional parameters were recorded.. After treatment there were significant reductions in the lavage levels of IL-8 ([mean +/- SEM] 1,603.4 +/- 331.2 vs 1,119.2 +/- 265.3 pg/mL, respectively; p = 0. 01) and myeloperoxidase (1,614.5 +/- 682.3 vs 511.2 +/- 144.2 microg/L, respectively; p = 0.05), in cell numbers (250.6 +/- 27.7 vs 186.3 +/- 11.5 cells x 10(3)/mL, respectively; p = 0.04), neutrophil proportion (59.7 +/- 14.3% vs 31.5 +/- 10.1%; p = 0.01), symptom score (4.5 +/- 0.6 vs 1.4 +/- 0.5; p = 0.01), and bronchitis index (8.5 +/- 0.8 vs 5.5 +/- 0.7; p = 0.007).. In stable patients with COPD, inhaled steroid treatment may induce changes on some cellular and molecular parameters of airway inflammation.

Topics: Administration, Inhalation; Administration, Topical; Aged; Anti-Inflammatory Agents; Beclomethasone; Bronchoalveolar Lavage Fluid; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Inflammation Mediators; Leukocyte Count; Lung Diseases, Obstructive; Male; Middle Aged; Neutrophils; Prospective Studies

We investigated the relationship between the reversibility of airflow limitation, the concentration of nitric oxide (NO) in exhaled air, and the inflammatory cells in the sputum of patients with stable chronic obstructive pulmonary disease (COPD). We examined nine normal healthy control subjects and 20 nonatopic patients with COPD. Ten patients had no reversibility of airflow limitation (increase in FEV(1) of < 12% and < 200 ml after 200 microg of inhaled salbutamol), and 10 patients had partial reversibility of airflow limitation (increase in FEV(1) of < 12% but > 200 ml after 200 microg of inhaled salbutamol). Exhaled NO levels were higher in COPD patients with partial reversibility of airflow limitation than in those with no reversibility of airflow limitation (median 24 [interquartile range 15.3 to 32] ppb versus 8.9 [4.6 to 14.7] ppb; p < 0.01). Compared with healthy control subjects, only COPD patients with partial reversibility of airflow limitation had increased concentrations of sputum eosinophils. We conclude that, in patients with stable COPD, even a partial bronchodilator response to inhaled salbutamol is associated with increased exhaled NO and sputum eosinophilia, suggesting that these patients may have a different response to treatment than do those without reversible airflow limitation.

Topics: Administration, Inhalation; Aged; Albuterol; Beclomethasone; Breath Tests; Bronchodilator Agents; Eosinophils; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Leukocyte Count; Lung Diseases, Obstructive; Male; Middle Aged; Nitric Oxide; Pulmonary Ventilation; Sputum; Vital Capacity

The aim of this clinical study was to investigate the influence of beclomethasone dipropionate (BDP) inhalation therapy on respiratory bacterial infections in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD). We studied 30 patients who had been admitted twice, (before and after the beginning BDP inhalation therapy) to our hospital because of an exacerbation of COPD by respiratory tract infection. No differences were observed before and after BDP inhalation therapy in values for PaO2, PaCO2, body temperature, CRP, WBC count, number of admission days, and bacterial culture of sputum on admission. These results suggest that BDP inhalation therapy has little influence on respiratory bacterial infection during exacerbation of COPD.

Topics: Administration, Inhalation; Aged; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Bacterial Infections; Beclomethasone; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Respiratory Tract Infections; Retrospective Studies

Topics: Administration, Inhalation; Atrophy; Beclomethasone; Bronchodilator Agents; Budesonide; Female; Humans; Long-Term Care; Lung Diseases, Obstructive; Middle Aged; Skin

Topics: Beclomethasone; Follow-Up Studies; Forced Expiratory Volume; Glucocorticoids; Humans; Lung Diseases, Obstructive

Although recent guidelines for managing chronic obstructive pulmonary disease (COPD) recommend a trial of oral corticosteroids in the initial assessment, its prognostic value remains unclear. We prospectively studied 127 adults (64% men) with stable COPD (FEV1/FVC < 60%) over 1 year. At entry, we measured lung volumes, gas transfer factor, respiratory symptoms (by questionnaire), and peripheral blood eosinophil count. Skin-prick testing was done, and spirometry after nebulized 5 mg salbutamol and, after 2 weeks, oral prednisolone. Physician A gave all patients inhaled beclomethasone dipropionate (800 mcg/day), whereas physician B prescribed this only to those with a positive oral corticosteroid trial. At 1 year, spirometry and respiratory questionnaire were repeated, with an estimate of overall symptom severity on a visual analogue scale. Follow-up data were available in 104 (82%) patients. Of these, 32 (31%) were unresponsive to salbutamol and prednisolone; 48 (46%) were responsive to beta agonists but not to corticosteroids, and 24 (23%) responded to corticosteroids and salbutamol. Patients in all groups were comparable, except that the prednisolone responders had a higher mean eosinophil count (p < 0.001) and more were ex-smokers (p < 0.001). Only the response to oral prednisolone correlated with the change in prebronchodilator FEV1 over 1 year. Oral prednisolone responders had higher FEV1 at 1 year (p < 0.02) and significantly lower symptom scores (p < 0.02). In COPD, corticosteroid trials contribute information additional to that gained from nebulized bronchodilator reversibility testing. Patients with a positive response to a corticosteroid trial are more likely to have improved symptomatically and spirometrically at 1 year.

Topics: Administration, Oral; Adrenergic beta-Agonists; Albuterol; Analysis of Variance; Beclomethasone; Drug Therapy, Combination; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Lung; Lung Diseases, Obstructive; Male; Middle Aged; Nebulizers and Vaporizers; Prednisolone; Prognosis; Prospective Studies; Smoking

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

Osteoporosis is a major complication of long-term corticosteroid administration, but the magnitude of the effect in patients with chronic obstructive pulmonary disease (COPD) is not well defined. In a cross-sectional study, we evaluated the association between steroid use and vertebral fractures in 312 men, 50 yr of age or older, with COPD. Subjects were evaluated according to their corticosteroid use: Never Steroid Users (NSU) (n = 117), Inhaled Steroid Users (ISU) (n = 70), and Systemic Steroid Users (SSU) (n = 125). The prevalence of one or more vertebral fractures was 48.7% in the NSU group, 57.1% in the ISU group, and 63.3% in the SSU group. Compared with NSU, SSU were two times as likely to have one or more vertebral fractures: age-adjusted odds ratio (OR) = 1.80; 95% CI, 1.08 to 3.07. This relationship was primarily due to a strong association between continuous systemic steroid use and vertebral fractures: age-adjusted OR = 2.36; 95% CI, 1.26 to 4.38. In addition, fractures in SSU were more likely to be multiple and more severe. A weaker relationship existed between inhaled steroid use and vertebral fractures: age-adjusted OR = 1.35; 95% CI, 0.77 to 2.56 compared with NSU. These data indicate that vertebral fractures are common in older men with COPD; the likelihood of these fractures is greatest in those men using continuous systemic steroids.

Topics: Administration, Inhalation; Administration, Oral; Adrenergic beta-Agonists; Age Factors; Aged; Anti-Inflammatory Agents; Beclomethasone; Confidence Intervals; Cross-Sectional Studies; Evaluation Studies as Topic; Forced Expiratory Volume; Glucocorticoids; Humans; Logistic Models; Lung Diseases, Obstructive; Male; Middle Aged; Odds Ratio; Osteoporosis; Prednisone; Prevalence; Smoking; Spinal Fractures; Triamcinolone Acetonide; Vital Capacity

The effects of beclomethasone dipropionate on pulmonary function and arterial blood gas values were investigated in horses with chronic obstructive pulmonary disease (COPD). Six mature mares, diagnosed as having COPD based on clinical signs, cytological examination of bronchoalveolar lavage and pulmonary function testing, were used. Beclomethasone dipropionate (3750 microg) was administered b.i.d. for a 2 week period with a metered dose inhaler using a mask. Pulmonary function tests and arterial blood gas analyses were performed at weekly intervals, starting before beclomethasone administration and for 4 weeks thereafter. Upper airway endoscopy and nasopharyngeal fungal cultures were performed before and after treatment. Maximal variations in transpulmonary pressure (deltaPL) were elevated in all horses at baseline. Beclomethasone administration resulted in a significant decrease in deltaPL in 5 horses, and deltaPL fell to within the normal range in 4 horses. Two weeks after the end of treatment, deltaPL was at or above baseline values in all horses. Total pulmonary resistance and elastance decreased significantly during treatment and returned to or above baseline values after the administration of beclomethasone was discontinued. At baseline, PaO2 range was 53-90 mmHg. In 4 horses with pronounced laboured breathing, PaO2 increased with treatment. One horse became reluctant to inhale the beclomethasone after one week, and only a transient improvement in respiratory function was noted in this animal. One horse developed a mild lower airway infection 24 h after the beginning of treatment, but no other possible side effects were noticed. Pharyngeal fungal cultures were negative before and after treatment. It can be concluded from the results of this study that inhaled beclomethasone dipropionate causes a marked improvement of respiratory function in horses with COPD.

Topics: Administration, Inhalation; Animal Husbandry; Animals; Anti-Asthmatic Agents; Beclomethasone; Blood Gas Analysis; Female; Fungi; Horse Diseases; Horses; Lung Diseases, Obstructive; Nasopharynx; Nebulizers and Vaporizers; Respiration; Respiratory Function Tests

Glucocorticoids (gcs) are known to be effective in the treatment of asthma. In chronic obstructive pulmonary disease (COPD), however, no beneficial effects are demonstrated in most patients. Hypothetically, this may be explained by an overexpressed beta-glucocorticoid receptor (GR) compared to the alpha-GR. The aim of this study was to investigate alpha- and beta-GR mRNA levels and ratios in patients with COPD with or without glucocorticoid treatment. GR and, as a control, metallothionein (MT) 2 mRNA levels were compared between patients with COPD receiving glucocorticoids (COPD + gcs), glucocorticoid naive COPD-patients (COPD - gcs) and non-COPD control patients not using gcs. Bronchoscopy was performed and bronchial epithelial cells were sampled with brushing. Smoking did not influence alpha- and beta-GR levels and ratios, nor the MT2 mRNA expression level. The alpha-GR mRNA expression was lower in the COPD - gcs group than in controls. Both GR forms were higher in the COPD + gcs patients than in the COPD - gcs patients, but not different from the levels measured in the controls. alpha 1/beta-GR mRNA ratios did not differ between the groups and averaged 1.7, suggesting no inhibitory effect of the beta-GR on the alpha 1 form. MT2 levels were upregulated in the COPD + gcs patients as compared to the COPD - gcs group, indicating a pharmacological glucocorticoid effect. In the present study it is demonstrated that basal GR mRNA levels are lower in patients with COPD. Although this needs to be investigated further, this might explain, in part, the non-responsiveness of patients with COPD to gcs.

Topics: Adult; Aged; Beclomethasone; Blotting, Northern; Bronchi; Budesonide; Chi-Square Distribution; Cross-Sectional Studies; Epithelial Cells; Female; Gene Expression; Glucocorticoids; Humans; Isomerism; Lung Diseases, Obstructive; Male; Middle Aged; Receptors, Glucocorticoid; RNA, Messenger; Statistics, Nonparametric

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

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

Testosterone has importance both as a sex hormone and as an anabolic steroid promoting bone formation. Osteoporosis is associated with both hypogonadism and corticosteroid therapy. Testosterone levels are reduced by long term prednisolone treatment. Although high dose inhaled corticosteroid therapy may cause a variety of systemic effects including adrenal suppression, dermal thinning and a reduction in total bone calcium, its effect on testosterone levels is not known. Testosterone, luteinizing hormone, follicle stimulating hormone and sex hormone binding globulin were therefore measured in 35 male patients with respiratory disease attending an outpatient clinic (median age 58, range 21-75 years). They were grouped according to steroid therapy and compared with 19 age matched controls. Mean (SD) testosterone levels were 33% lower in 12 men on long term oral prednisolone [14.5 (6.0) nmol 1-1] than in controls [21.7 (6.3) nmol 1-1], but were not significantly reduced in 10 patients on low dose inhaled beclomethasone [200-800 micrograms day-1: 19.7 (3.7)] nor in 13 men taking high dose inhaled beclomethasone [1500-2,250 micrograms day-1: 17.9 (5.6)]. Levels of luteinizing hormone, follicle stimulating hormone and sex hormone binding globulin were similar in all four groups. These cross sectional data confirm that long term systemic corticosteroid therapy reduces testosterone levels. However, testosterone was reduced by only 18% (NS) by long term inhaled corticosteroids. Other mechanisms to explain the disordered bone metabolism should now be explored.

Topics: Administration, Inhalation; Administration, Oral; Adrenal Cortex Hormones; Adult; Aged; Beclomethasone; Cross-Sectional Studies; Drug Administration Schedule; Follicle Stimulating Hormone; Humans; Lung Diseases, Obstructive; Luteinizing Hormone; Male; Middle Aged; Prednisolone; Sex Hormone-Binding Globulin; Testosterone; Time Factors

Topics: Asthma; Beclomethasone; Humans; Lung Diseases, Obstructive

Topics: Adult; Albuterol; Beclomethasone; Child; Dose-Response Relationship, Drug; Humans; Lung Diseases, Obstructive; Nebulizers and Vaporizers

Topics: Administration, Inhalation; Beclomethasone; Humans; Lung Diseases, Obstructive; Patient Compliance

Topics: Administration, Inhalation; Beclomethasone; Humans; Lung Diseases, Obstructive

106 chronic obstructive pulmonary disease (COPD) cases were divided into two groups, 53 cases treated with Shou Er Kang (SEK) pill (Kidney-reinforcing regimen) and high dose beclomethasone dipropionate inhaler, and 53 cases in the control group with high dose beclomethasone dipropionate aerosol alone. 64 patients were suffering from bronchial asthma and 42 patients from asthmatic bronchitis, sufficiently severe to be treated with inhaled corticosteroids. The results showed that the total effective rate was 100% and 96.9% in asthmatic patients of both groups; the total effective rates for asthmatic bronchitis patients were 85.7% in the SEK group and 52.4% in the control group. The Synacthen test showed that after the treatment, the adrenal cortex reserve power and secretive ability of the SEK group not only was intact but also improved markedly under high dose exogenous steroids. The adrenocortical secretive ability and reserve power of the control group were damaged with the inhalation of the newer steroids. The difference between the two groups was very significant (P less than 0.001); the relapse rate in the SEK group was 26.9%, but 40% in the control group. The results suggested that there were some occult disorders in COPD patients, especially asthmatic bronchitis patients at different levels on hypothalamus-pituitary-adrenocortical axis.

Topics: Adult; Aerosols; Aged; Beclomethasone; Cosyntropin; Drugs, Chinese Herbal; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged

The aim of the study was to assess the effect of chronic steroid inhalation therapy on the upper airways in patients with chronic obstructive pulmonary disease (COPD). 44 patients with a first time diagnosis of COPD were evaluated. 22 (11 males, 11 females) were treated with Beclomethasone (1 mg per day) for 6 months. 22 patients that were not treated made up the control group. All had a laryngological and phonic examination carried out, including stroboscopy of the vocal cords, bacteriological and mycological examination of the oral flora. Prior therapy in all patients abnormal findings were present. The six months therapy produced only further increase of hypo-tonus of the vocal cords, without significantly affecting the phonation time and voice pattern. An increase of voice hoarseness, fungal and bacteriological infections were not found.

Topics: Administration, Inhalation; Adult; Aged; Beclomethasone; Drug Administration Schedule; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Vocal Cords

In 95 patients with severe chronic airway obstruction (FEV1 33.2 +/- 12% of predicted; mean +/- SE), we investigated whether drug therapy had any influence on serum Mg levels. 11/95 patients had a serum Mg less than 1.45 mEq/l (lower normal limit). Multiple-regression analysis showed that the use of diuretics was associated with a significantly lower serum Mg level (1.59 +/- CI 0.06 mEq/l vs. an adjusted mean of 1.71 mEq/l; F = 11, 2, p less than 0.001). There was a significant negative correlation between serum Mg and the length of oral steroid therapy (1.64 +/- CI 0.02 mEq/l for less than 24 months of therapy vs. 1.52 +/- CI 0.06 mEq/l for greater than 24 months of therapy; F = 7, 3, p less than 0.005). No effect of theophylline, inhaled steroids or beta 2-agonists on serum Mg was observed. Because of potential negative effects of hypomagnesemia on respiratory function, routine serum magnesium determination is recommended in patients with chronic obstructive lung disease taking diuretic drugs or corticosteroids.

Topics: Administration, Inhalation; Administration, Oral; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Aged; Beclomethasone; Diuretics; Female; Furosemide; Humans; Hydrochlorothiazide; Lung Diseases, Obstructive; Magnesium; Magnesium Deficiency; Male; Methylprednisolone; Middle Aged; Theophylline

To assess the effect of high dose inhaled corticosteroids on skin.. Cross sectional study of patients receiving treatment for chest diseases.. Outpatient chest clinic in a teaching hospital.. 68 Patients divided into four groups of similar age--namely, 15 receiving long term oral prednisolone, 21 receiving high dose inhaled corticosteroids, 15 receiving low dose inhaled corticosteroids, and 17 controls.. Skin thickness at three sites measured by A scan ultrasound and clinical assessment of purpura.. Compared with controls patients in both the oral prednisolone treated group and the high dose inhaled corticosteroid treated group had significantly thinner skin at all three sites (group median thicknesses: prednisolone treated group 28-33% less than controls; high dose inhaled corticosteroid treated group 15-19% less than controls). Differences in skin thicknesses between the low dose inhaled corticosteroid treated group and the controls were trivial. The prevalence of purpura was significantly greater in patients receiving oral prednisolone (12/15 patients) and high dose inhaled corticosteroids (10/21) than in controls (2/17).. Skin thinning and purpura represent further evidence of systemic effects of high dose inhaled corticosteroids.

Topics: Administration, Inhalation; Administration, Oral; Adult; Aged; Atrophy; Beclomethasone; Cross-Sectional Studies; Drug Administration Schedule; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Prednisolone; Purpura; Skin

Topics: Aged; Beclomethasone; Bipolar Disorder; Humans; Lung Diseases, Obstructive; Male

Topics: Adrenal Cortex Hormones; Aged; Beclomethasone; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Time Factors

Topics: Adrenal Cortex Hormones; Aerosols; Beclomethasone; Chemical Phenomena; Chemistry; Dexamethasone Isonicotinate; Humans; Lung Diseases, Obstructive

Topics: Aerosols; Asthma; Beclomethasone; Bronchitis; Glucocorticoids; Humans; Lung Diseases, Obstructive; Respiratory Therapy

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

The compliance of 114 patients with chronic airways disease to therapy with aerosol salbutamol and beclomethasone dipropionate was examined over two consecutive periods of approximately four weeks. Values ranging from 90-110 percent compliance were recorded for the two agents and a further increase in compliance was noted with both aerosols during the second month of surveillance. Over-use of salbutamol occurred in those patients who had been recently discharged from hospital. It was concluded that the high level of compliance was due to the symptomatic nature of the illness and the over-use of the bronchodilator was attributed to the usually prompt relief it provided.

Topics: Adolescent; Adult; Aerosols; Aged; Albuterol; Beclomethasone; Bronchodilator Agents; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Outpatients; Patient Compliance; Patient Discharge; Patient Education as Topic

Topics: Aged; Anti-Bacterial Agents; Beclomethasone; Bronchitis; Bronchodilator Agents; Diagnosis, Differential; Diuretics; Evaluation Studies as Topic; Expectorants; Humans; Hypoxia; Lung Diseases, Obstructive; Middle Aged; Oxygen Inhalation Therapy; Prednisone; Pulmonary Emphysema

Topics: Administration, Oral; Adult; Aged; Beclomethasone; Blood Glucose; Blood Pressure; Body Weight; Eosinophils; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Pituitary-Adrenal Function Tests; Prednisolone; Respiratory Function Tests; Respiratory Therapy

Topics: Adrenergic beta-Agonists; Albuterol; Aminophylline; Animals; Beclomethasone; Cats; Chlorofluorocarbons, Methane; Cilia; Cricetinae; Dogs; Ethanolamines; Expectorants; Humans; In Vitro Techniques; Isoproterenol; Lung Diseases, Obstructive; Mucus; Parasympatholytics; Prostaglandins E; Rats; Smoking; Terbutaline; Trachea

Cromolyn sodium, oral and inhaled corticosteroids, antibiotics, and mucolytic agents all have a place in treatment of the reversible components of obstructive pulmonary disease. Patient education about the particular condition causing airflow obstruction and the chosen treatment program is extremely important in promoting patient acceptance.

Topics: Anti-Bacterial Agents; Beclomethasone; Cromolyn Sodium; Expectorants; Glucocorticoids; Humans; Lung Diseases, Obstructive

Topics: Adolescent; Adult; Aged; Asthma; Beclomethasone; Bronchitis; Drug Evaluation; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged; Respiratory Function Tests

Topics: Adolescent; Adult; Aerosols; Aged; Beclomethasone; Child; Female; Humans; Lung Diseases, Obstructive; Male; Middle Aged

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

Topics: Aerosols; Beclomethasone; Bronchodilator Agents; Humans; Ipratropium; Lung Diseases, Obstructive; Parasympatholytics; Respiratory Therapy

Topics: Adult; Beclomethasone; Bis-Trimethylammonium Compounds; Bronchial Neoplasms; Carcinoma, Small Cell; Cromolyn Sodium; Cyclophosphamide; Drowning; Female; Granulomatosis with Polyangiitis; Humans; Lung Diseases; Lung Diseases, Obstructive; Male; Middle Aged; Positive-Pressure Respiration; Prednisolone; Procarbazine; Promethazine; Respiratory Distress Syndrome; Vincristine

Topics: Aerosols; Asthma; Barbiturates; Beclomethasone; Dose-Response Relationship, Drug; Humans; Lung Diseases, Obstructive; Patient Compliance; Regression Analysis; Smoking; Statistics as Topic

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

Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Aminophylline; Asthma; Beclomethasone; Betamethasone; Bronchodilator Agents; Chronic Disease; Cromolyn Sodium; Humans; Hydrocortisone; Lung Diseases, Obstructive; Prednisone

Topics: Aerosols; Beclomethasone; Blood Gas Analysis; Bronchitis; Chronic Disease; Humans; Hydrocortisone; Lung Diseases, Obstructive; Methylprednisolone; Pulmonary Emphysema; Respiratory Function Tests