(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 Acute-Disease

Although new salicylates are now available for the treatment of ulcerative colitis, sulphasazaline still has an important therapeutic role. The role of salicylates in Crohn's disease is limited to the mild activity phase; further data are required to clarify its role in maintenance on remission. New steroids are a real alternative to traditional steroids in active ulcerative colitis and Crohn's disease.

Topics: Acute Disease; Aspirin; Beclomethasone; Budesonide; Colitis, Ulcerative; Crohn Disease; Drug Therapy, Combination; Glucocorticoids; Humans; Inflammatory Bowel Diseases; Prednisolone; Randomized Controlled Trials as Topic; Salicylates; Sulfasalazine

Results from two randomized trials have shown that oral beclomethasone dipropionate (BDP) is effective for treatment of acute gastrointestinal graft-versus-host disease. Here, we report results of a double-blind, randomized placebo-controlled phase II study designed to test the hypothesis that acute graft-versus-host disease could be prevented by administration of oral BDP, beginning before hematopoietic cell transplantation and continuing until day 75 after hematopoietic cell transplantation after myeloablative conditioning. Study drug (BDP or placebo) was administered as 1-mg immediate-release formulation plus 1-mg delayed-release formulation orally four times daily. According to the primary endpoint, systemic glucocorticoid treatment for graft-versus-host disease was given to 60 of the 92 participants (65%) in the BDP arm, versus 31 of 46 participants (67%) in the placebo arm. The secondary efficacy endpoints showed no statistically significant differences between the two arms. The proportion of participants who took at least 90% of the prescribed study drug during the first 4 weeks after hematopoietic cell transplantation was 54% overall. Lower severity of mucositis strongly correlated with higher adherence to the schedule of study drug administration. Inconsistent adherence related to mucositis during recovery after myeloablative conditioning may have obscured a beneficial therapeutic effect in the current study.

Topics: Acute Disease; Administration, Oral; Adolescent; Adult; Antineoplastic Agents; Beclomethasone; Child; Double-Blind Method; Drug Administration Schedule; Female; Gastrointestinal Tract; Glucocorticoids; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Leukemia; Male; Middle Aged; Mucositis; Myelodysplastic Syndromes; Patient Compliance; Placebos; Transplantation, Homologous

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

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

Post-infectious persistent cough may be caused by an underlying inflammation in the airways. Due to its antiinflammatory properties, inhaled corticosteroids (ICS) may be a rational therapeutic approach to reduce cough symptoms. In this randomized, double-blind study, the efficacy of treatment with inhaled extra-fine HFA beclomethasone diproprionate (HFA-BDP) was compared with placebo in patients with post-infectious persistent cough. A total of 72 patients with persistent cough lasting at least 3 days (max. 14 days) following an acute respiratory tract infection were randomized to treatment with extra-fine HFA-BDP (400 microg twice daily for 7 days followed by 200 microg twice daily for 4 days) or placebo. The efficacy was measured by tussometry. The primary endpoint was defined as a reduction of frequency of cough epochs/h at the end of treatment (Day 11) in relation to the baseline level and in comparison to placebo, calculated as the area under the curve (AUC). The treatment with extra-fine HFA-BDP resulted in a greater reduction of cough frequency in patients with post-infectious persistent cough in comparison to placebo. The AUC from Day 1 to Day 11 for the frequency of cough epochs/h between 7:00 am and 11:00 pm was calculated as 605.8 for HFA-BDP and 847.9 for placebo, respectively (P<0.05). There is evidence that extra-fine HFA-BDP leads to a more rapid reduction of cough frequency at the beginning of treatment. A short-term treatment with extra-fine HFA-BDP could be an effective and well tolerated therapeutic option in the treatment of post-infectious persistent cough.

Topics: Acute Disease; Administration, Inhalation; Adrenal Cortex Hormones; Adult; Aerosol Propellants; Antitussive Agents; Beclomethasone; Chemistry, Pharmaceutical; Cough; Double-Blind Method; Drug Administration Schedule; Female; Germany; Humans; Hydrocarbons, Fluorinated; Male; Middle Aged; Patient Compliance; Powders; Respiratory Tract Infections; Treatment Outcome

Asthma self-management plans that include doubling the dose of inhaled corticosteroid when the condition deteriorates improve asthma control. Whether doubling the dose of corticosteroid in isolation is effective is unknown. We undertook a randomised controlled trial to investigate the effects of doubling the dose of inhaled corticosteriods when asthma deteriorates.. 390 individuals with asthma who were at risk of an exacerbation monitored their morning peak flow and asthma symptoms for up to 12 months. When peak flow or symptoms started to deteriorate, participants added an active or placebo corticosteroid inhaler to their usual corticosteroid for 14 days to produce a doubling or no change in dose. The primary outcome was the number of individuals starting oral prednisolone in each group.. During 12 months, 207 (53%) started their study inhaler and 46 (12%) started prednisolone--22 (11%) of 192 and 24 (12%) of 198 in the active and placebo groups, respectively. The risk ratio for starting prednisolone was therefore 0.95 (95% CI 0.55-1.64, p=0.8).. We recorded little evidence to support the widely recommended intervention of doubling the dose of inhaled corticosteroid when asthma control starts to deteriorate.

Topics: Acute Disease; Administration, Inhalation; Administration, Oral; Adrenal Cortex Hormones; Asthma; Beclomethasone; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Male; Metered Dose Inhalers; Middle Aged; Prednisolone; Treatment Outcome

There seems to be a strong causal relationship between allergy and the origins of asthma. Susceptibility to both is determined by a combination of genetics and environment acting through a complex network of cytokines. Nearly 90% of affected children have positive skin tests indicating the presence of specific immunoglobulin E (IgE), with sensitivity to house dust mite, Alternaria, cockroach, cat, and dog most closely linked to the disease. Greater exposure to house dust mite during infancy leads to earlier onset of wheezing, and elevated serum IgE levels correlate with the appearance of asthma symptoms. Specific IgE binds to high-affinity (FcepsilonRI) receptors on mast cells and basophils. The IgE-mediated reactions that follow exposure of sensitized mast cells to an allergen are designated early- and late-phase asthmatic responses (EAR and LAR). EAR is characterized by release of histamine and other preformed mediators within 1 hour of allergen exposure. It is often followed by LAR, an infiltration of the airways by inflammatory cells associated with an episode of more prolonged, and usually more severe airflow obstruction, 4 to 8 hours after antigen exposure. Chronic airway symptoms result from persistent LAR caused by continuous allergen exposure. IgE antibodies are capable of passive transfer of both EAR and LAR sensitivity. IgE-mediated mast cell activation contributes to chronic tissue eosinophilia and airway remodeling, with permanent loss in pulmonary function. Omalizumab (rhuMAb-E25) is a recombinant, humanized, monoclonal anti-IgE antibody of mouse origin developed for the treatment of IgE-mediated diseases. Omalizumab binds to free IgE at the same site as the high-affinity receptor. Although it attaches to free IgE, it does not bind to IgA, IgG, or cell-bound IgE. It therefore does not induce cross-linking of cell-bound IgE, which would lead to the release of allergic mediators. It has been reported to decrease serum IgE levels in a dose-dependent manner, inhibit EAR and LAR, and cause a down-regulation of FcepsilonRI receptors on basophils. Omalizumab has been reported to be safe and effective in improving asthma control and reducing the requirement for oral and inhaled corticosteroids. This double-blind, randomized, placebo-controlled study evaluated the safety, steroid-sparing effects, and impact on disease exacerbations of omalizumab in the treatment of childhood asthma. Methods. Participants were 334 males and premenarchal females aged 6. More participants in the omalizumab group decreased their BDP dose, and their reduction was greater than that of the placebo group (median reduction 100% vs 66.7%). BDP was withdrawn completely in 55% of the omalizumab group versus 39% of the placebo group. The incidence and the frequency of asthma exacerbations requiring treatment with doubling of BDP dose or systemic corticosteroids were lower in the omalizumab group. The treatment differences were statistically significant during the steroid-reduction phase, during which fewer participants in the omalizumab group had asthma exacerbation episodes (18.2% vs 38.5%), and the mean number of episodes per patient was smaller than with placebo (0.42 vs 2.72). Five asthma exacerbations requiring hospitalization all occurred in the placebo group. Participants' and investigators' global evaluations of treatment effectiveness were more favorable for omalizumab than placebo. Investigators rated effectiveness excellent for 31.5% of the omalizumab group versus 16.3% of the placebo group and good for 44.7% of the omalizumab group versus 32.7% of the placebo group. There was little change in asthma symptom scores or spirometry measurements during either the stable-steroid or steroid dose-reduction phase, with minimal differences between the treatment groups. The requirement for rescue medication in the omalizumab group during both the stable-steroid and steroid dose-reduction phases was consistently lower than at baseline. At week 28, the median number of puffs of rescue medication taken daily was 0 in the omalizumab group and 0.46 in the placebo group. The change from baseline was significant in favor of omalizumab. (ABSTRACT TRUNCATED)

Topics: Acute Disease; Anti-Allergic Agents; Anti-Asthmatic Agents; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Beclomethasone; Child; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Injections, Subcutaneous; Male; Omalizumab; Placebos; Treatment Outcome

The clinical benefit and steroid-sparing effect of treatment with the anti-immunoglobulin-E (IgE) antibody, omalizumab, was assessed in patients with moderate-to-severe allergic asthma. After a run-in period, 546 allergic asthmatics (aged 12-76 yrs), symptomatic despite inhaled corticosteroids (500-1,200 microg daily of beclomethasone dipropionate), were randomized to receive double-blind either placebo or omalizumab every 2 or 4 weeks (depending on body weight and serum total IgE) subcutaneously for 7 months. A constant beclomethasone dose was maintained during a 16-week stable-steroid phase and progressively reduced to the lowest dose required for asthma control over the following 8 weeks. The latter dose was maintained for the next 4 weeks. Asthma exacerbations represented the primary variable. Compared to the placebo group, the omalizumab group showed 58% fewer exacerbations per patient during the stable-steroid phase (p<0.001). During the steroid-reduction phase, there were 52% fewer exacerbations in the omalizumab group versus the placebo group (p<0.001) despite the greater reduction of the beclomethasone dosage on omalizumab (p<0.001). Treatment with omalizumab was well tolerated. The incidence of adverse events was similar in both groups. These results indicate that omalizumab therapy safely improves asthma control in allergic asthmatics who remain symptomatic despite regular use of inhaled corticosteroids and simultaneous reduction in corticosteroid requirement.

Topics: Acute Disease; Adolescent; Adult; Aged; Anti-Asthmatic Agents; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Beclomethasone; Child; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Immunoglobulin E; Male; Middle Aged; Omalizumab; Peak Expiratory Flow Rate; Recurrence; Severity of Illness Index; Time Factors; Treatment Outcome

The aim of the present study was to investigate the efficacy and safety of nebulized fluticasone propionate (FP Nebules) compared with oral soluble prednisolone in children with an acute exacerbation of asthma. The study used an international, multi-centre, randomized, double-blind, parallel group design. Three hundred and twenty-one patients, aged 4-16 years old, who presented with an acute exacerbation of asthma, were randomly allocated to either nebulized FP (1 mg b.d.) or oral prednisolone (2 mg kg(-1) day(-1) for 4 days then 1 mg kg(-1) day(-1) for 3 days) for 7 days. Patients in the FP group showed a significantly greater increase in diary card morning peak expiratory flow (PEF) over 7 days compared with patients in the prednisolone group (difference = 9.51 min(-1), CI = 2.1, 16.8, P = 0.034). Similar increases for both treatments were shown for evening PEF. Clinic PEF improved with both treatments, but was significantly greater in patients taking FP after 7 days (difference = 11.41 min(-1), CI = 2.8, 20.0, P = 0.029). Both treatments reduced symptom scores to a similar extent. The two treatments were well tolerated, and there was no difference in the incidence of adverse events. The present study demonstrated that nebulized FP is at least as effective as oral prednisolone in the treatment of children presenting with an acute exacerbation of asthma.

Topics: Acute Disease; Administration, Inhalation; Administration, Oral; Adolescent; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Child; Child, Preschool; Double-Blind Method; Female; Fluticasone; Humans; Male; Peak Expiratory Flow Rate; Prednisolone; Treatment Outcome

Following otitis media, 10% to 50% of children develop residual middle ear effusion with concurrent hearing loss and potential cognitive, behavioral, and language impairment. Prophylactic antibiotics and tympanostomy tubes are currently recommended treatments for chronic middle ear effusion.. In a double-blind, placebo-controlled, randomized study of chronic middle ear effusion, we assessed the effectiveness of topical intranasal beclomethasone as an adjunct to prophylactic antibiotic therapy.. Sixty-one children, aged 3 to 11 years with persistent middle ear effusion greater than 3 months, were randomized into three treatment groups: (1) prophylactic antibiotics; (2) prophylactic antibiotics plus intranasal beclomethasone (336 micrograms/day); and (3) prophylactic antibiotics plus intranasal placebo. Patients were evaluated with aeroallergen skin tests at entry; and tympanogram, otoscopic examination, and symptom questionnaire at 0, 4, 8, and 12 weeks.. While middle ear pressures, otoscopic examinations, and symptom scores were improved for each treatment group over 12 weeks of therapy, the beclomethasone plus antibiotics group improved all three measures more rapidly than the antibiotics-alone and placebo nasal spray plus antibiotics groups over the first 8 weeks. Only the beclomethasone group significantly improved left (P = .004) and right (P = .01) middle ear pressures over 12 weeks. Resolution of chronic middle ear effusions was more frequent in the beclomethasone group (P < or = .05 at 4 and 8 weeks). No difference in response to nasal steroids was observed between atopic and nonatopic subjects.. We conclude that intranasal beclomethasone may be a useful adjunct to prophylactic antibiotic treatment of chronic middle ear effusion.

Topics: Acoustic Impedance Tests; Acute Disease; Administration, Intranasal; Anti-Bacterial Agents; Anti-Inflammatory Agents; Beclomethasone; Child; Child, Preschool; Chronic Disease; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Otitis Media; Otitis Media with Effusion; Otoscopes; Patient Compliance; Severity of Illness Index; Sinusitis; Treatment Outcome

To investigate the efficacy of an increased dose of inhaled steroid used within the context of an asthma self management plan for treating exacerbations of asthma.. Randomised, double blind, placebo controlled, crossover trial.. Twenty eight children aged 6-14 years with asthma of mild to moderate severity were studied for six months. Eighteen pairs of exacerbations were available for analysis, during which subjects took an increased dose of inhaled steroids or continued on the same dose.. There was no significant difference between increasing inhaled steroids or placebo on morning or evening peak expiratory flow rates (PEFRs), diurnal peak flow variability, or symptom scores in the two weeks following an asthma exacerbation. Difference (95% confidence intervals) in baseline PEFR on days 1-3 were 3.4% (-3.5% to 10.4%) and -0.9% (-4.7% to 2.9%) for inhaled steroid and placebo, respectively. Spirometric function and the parents' opinion of the effectiveness of asthma medications at each exacerbation were also not significantly different between inhaled steroid or placebo.. This study suggests that increasing the dose of inhaled steroids at the onset of an exacerbation of asthma is ineffective and should not be included in asthma self management plans.

Topics: Acute Disease; Albuterol; Asthma; Beclomethasone; Bronchodilator Agents; Child; Cross-Over Studies; Double-Blind Method; Drug Administration Schedule; Drug Delivery Systems; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Lung; Male; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Treatment Failure

To test whether the use of fluticasone dipropionate nasal spray after endoscopic ethmoidectomy for multiple polyps is associated with a high incidence of infection. DESIGN. Randomized control study comparing the incidence of infection with the use of beclomethasone dipropionate or fluticasone propionate nasal spray after functional endoscopic sphenoethmoidectomy. Patients were followed up for 6 to 12 months.. Sixty patients with recurrent bilateral nasal polyps underwent functional endoscopic sphenoethmoidectomy and were then randomly allocated into 2 groups of 30 patients each. One group received beclomethasone dipropionate spray (100 micrograms in each nostril every 12 hours), and the other group received fluticasone propionate spray (100 micrograms/d in each nostril).. In the fluticasone propionate group, 6 patients (20%) developed acute gram-positive pansinusitis requiring hospitalization and discontinuation of treatment.. The use of fluticasone dipropionate aqueous nasal spray for the postoperative control of recurrent nasal polyps seems to be associated with a high incidence of acute pansinusitis.

Topics: Acute Disease; Adult; Aerosols; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Combined Modality Therapy; Endoscopy; Female; Fluticasone; Humans; Incidence; Male; Middle Aged; Nasal Polyps; Postoperative Care; Postoperative Complications; Sinusitis

Our purpose was to study the effect of inhaled corticosteroids on asthma exacerbations in pregnancy.. We prospectively studied 84 pregnant women with 105 asthma exacerbations. Women were hospitalized if the forced expiratory volume in 1 second was < 70% after sequential bronchodilator therapy. They were randomly assigned to receive either intravenous aminophylline and inhaled beta 2-adrenergic receptor agonist or intravenous methylprednisolone and a beta 2-adrenergic receptor agonist. At discharge women were randomly assigned to receive either inhaled beclomethasone, beta 2-adrenergic receptor agonist, and an oral corticosteroid taper or a beta 2-adrenergic receptor agonist and a corticosteroid taper.. Sixty-five (62%) of 105 women with exacerbation required hospitalization. Aminophylline did not shorten response time or decrease hospital stay. Readmission rate was decreased by 55% in women given inhaled beclomethasone (33% vs 12%, p < 0.05, odds ratio 3.63, 95% confidence interval 1.01 to 13.08). Pregnancy-induced hypertension and cesarean delivery were increased over those of the general population.. Intravenous aminophylline offers no therapeutic advantages. Continuous inhaled corticosteroids reduced the need for subsequent admissions.

Topics: Acute Disease; Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Albuterol; Aminophylline; Asthma; Beclomethasone; Bronchodilator Agents; Drug Therapy, Combination; Female; Humans; Infusions, Intravenous; Methylprednisolone; Obstetric Labor Complications; Pregnancy; Pregnancy Complications; Prospective Studies; Treatment Outcome

Topics: Acute Disease; Administration, Oral; Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Double-Blind Method; Glucocorticoids; Humans; Middle Aged; Placebos; Prednisolone; Pregnenediones; Respiratory Function Tests; Respiratory Therapy; Time Factors

We retrospectively studied the use of inhaled corticosteroids in patients who experienced near fatal episodes (NFE) to determine whether such therapy reduces the risk of death. Forty-eight patients who had near fatal episodes of asthma between January 1981 and December 1989 were divided into two groups. Group A comprised 19 patients who received beclomethasone dipropionate (BDP) daily (mean dose of BDP:687 micrograms/day: 200-2,000) following NFE, and Group B, 28 patients who did not take BDP or who took less than 6 mg BDP/month. During the follow-up period (Group A:82.9 months, Group B:66.2 months), no patients in Group A died, but eight deaths occurred in Group B (mean period between near fatal episode and death was 31.5 months: 12-66). These results suggest that the regular use of inhaled corticosteroids, even at low doses, may reduce the risk of death in patients who experience NFE.

Topics: Acute Disease; Administration, Inhalation; Adult; Aged; Asthma; Beclomethasone; Female; Follow-Up Studies; Humans; Male; Middle Aged; Retrospective Studies; Survival Analysis; Treatment Outcome

In a double blind, controlled trial, the effect of high dose beclomethasone dipropionate (750 micrograms three times daily for five days) administered by metered dose inhaler and valved spacer, was compared with placebo, during 70 paired episodes of acute asthma in 24 preschool children. Treatment commenced at home at the first sign of an attack. Parents' blind preference for active treatment was significant. Data from 17 pairs of treatment, however, were affected by interventions such as hospital admission or oral corticosteroid treatment. These events occurred similarly in active and control periods. An intrasubject comparison was made of diary scores from the 18 pairs of episodes in which no intervention occurred in either the active or placebo treatment. Both daytime and night symptoms over the first week of the attack were significantly reduced by active treatment. Intermittent high dose inhaled beclomethasone dipropionate is beneficial in modifying the severity of acute episodic asthma in preschool children able to use a spacer device.

Topics: Acute Disease; Administration, Inhalation; Asthma; Beclomethasone; Child, Preschool; Clinical Trials as Topic; Double-Blind Method; Home Nursing; Humans; Infant

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 compound consisting of a beta-stimulant, salbutamol (Ventolin; Allen & Hanburys) (100 micrograms/puff), and a steroid, beclomethasone dipropionate (Becotide; Allen & Hanburys) (50 micrograms/puff), was studied to test the hypothesis that the corticosteroid could enhance the bronchodilator properties of the beta-stimulant during chronic asthma and simulated acute attacks (antigen challenge). Conventional doses (200 micrograms and 100 micrograms of salbutamol and beclomethasone respectively) were compared using a schedule which included a second administration 1 hour later. The results obtained on the baseline bronchial responsiveness of chronic asthmatics and during the delayed asthmatic response (simulated acute asthma) were similar. The compound was as effective as salbutamol alone but not more so. A significantly greater bronchodilator response was recorded in all patients after the second administration of both the compound and salbutamol alone. The practical advantages of having one rather than two inhalers are evident, but the appropriate application of this compound agent, probably in a prophylactic role, must be defined.

Topics: Acute Disease; Adolescent; Adult; Albuterol; Asthma; Beclomethasone; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Female; Humans; Lung Volume Measurements; Male; Middle Aged; Random Allocation; Time Factors

100 patients with acute tracheitis, tracheobronchitis or bronchitis were randomly allocated to receive inhaled beclomethasone dipropionate (BDP) 100 micrograms qds or placebo as an adjunct to oral antihistamine and a tetracycline antibiotic. 2 patients were withdrawn from analysis, leaving 49 patients in each group. There was no evidence that inhaled BDP conferred any benefit or detriment on the progress of the condition as assessed by daily symptom scores and weekly clinic visits for up to 2 weeks. The same conclusion maintains when the patients were subdivided into two grades of severity as assessed by the physician when the patient first presented. Inhaled BDP would seem to have no role in the inflammatory process associated with those acute infections of presumed viral origins.

Topics: Acute Disease; Adult; Aerosols; Beclomethasone; Blood Sedimentation; Female; Humans; Leukocyte Count; Male; Middle Aged; Peak Expiratory Flow Rate; Radiography, Thoracic; Respiratory Tract Infections

Many drugs are used for unapproved indications in Japan for post hematopoietic stem cell transplant (HCT) complications. To investigate unapproved or off-label drug usage for graft-versus-host disease (GVHD) and virus infections after allogeneic HCT, we analyzed the data of Japanese HCT registry. Between 2006 and 2017, 39,941 adults and children received HCT for a variety of disease and their transplant data were captured in the registry. Among them, 14,687 and 8914 patients receiving treatment for acute and/or chronic GVHD, 24,828 patients with cytomegalovirus (CMV) infection or receiving therapies for CMV, and 4943 who received treatment for other viral infections were included in the analyses of off-label or unapproved drugs. For GVHD, mycophenolate mofetil was the most frequently used off-label drug, followed by beclomethasone, infliximab, and etanercept. For viral infections other than CMV, foscarnet was the most frequently used off-label drug. Cidofovir, which is not approved for use in Japan, was mainly used for adenovirus infection. This study demonstrated that numerous off-label and unapproved drugs have been used as key drugs for GVHD and post-transplant viral infection, and the real world date in the transplant registry may serve as an important asset to regulatory purposes.

Topics: Acute Disease; Adult; Beclomethasone; Chronic Disease; Cidofovir; Cytomegalovirus Infections; Etanercept; Female; Foscarnet; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Infliximab; Japan; Male; Middle Aged; Mycophenolic Acid; Off-Label Use; Postoperative Complications; Registries; Transplantation, Homologous; Virus Diseases

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Allografts; Anti-Inflammatory Agents; Beclomethasone; Cord Blood Stem Cell Transplantation; Female; Gastrointestinal Diseases; Graft vs Host Disease; Hematologic Neoplasms; Humans; Male; Middle Aged

Topics: Acute Disease; Albuterol; Anti-Asthmatic Agents; Asthma; Beclomethasone; Child; Cystitis; Hematuria; Humans; Male

Topics: Acute Disease; Administration, Inhalation; Anti-Asthmatic Agents; Asthma; Beclomethasone; Drug Combinations; Ethanolamines; Formoterol Fumarate; Humans; Long-Term Care

Topics: Acute Disease; Administration, Inhalation; Adrenal Insufficiency; Androstadienes; Beclomethasone; Budesonide; France; Humans; Retrospective Studies; Steroids

Topics: Acute Disease; Administration, Oral; Adult; Aged; Beclomethasone; Cord Blood Stem Cell Transplantation; Feasibility Studies; Female; Gastrointestinal Diseases; Graft vs Host Disease; Humans; Male; Middle Aged; Treatment Outcome

Topics: Acute Disease; Administration, Inhalation; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Follow-Up Studies; Humans; Male; Sarcoidosis, Pulmonary; Theophylline

Inhaled corticosteroids have been shown to reduce morbidity and the need for hospitalization from asthma. Despite improvements in the therapy of asthma, epidemiologic data from several countries has shown that the hospital admission rates for asthma among adults at a population level are on the increase. The prevalence rate of hospital admission for asthma among Maltese adults aged 15-59 years was determined retrospectively from 1989 to 1993. Concurrent yearly total dispensal of inhaled corticosteroids for the whole population was also calculated. This study was undertaken amongst a well-defined island population served by a single medical facility offering emergency services, and a possible association between these two trends was investigated by means of logistic regression. The age-specific hospital admission rates for asthma decreased from 96.2 (95% CI: 109.7, 82.7) per 100,000 in 1989 to 38.1 (95% CI: 46.4, 29.8) per 100,000 in 1993. The prevalence rates of admission from asthma decreased from 67.6 (95% CI: 78.9, 56.3) per 100,000 in 1989 to 30.6 (95% CI: 38.0, 23.2) per 100,000 in 1993. The dispensal of inhaled beclomethasone dipropionate (BDP) increased from 0.99 defined daily dose (DDD) per 1000 population in 1989 to 3.28 DDD per 1000 in 1993. Logistic regression showed that increasing dispensal of inhaled BDP by 1 DDD per 1000 decreased the odds of an admission from asthma to 0.71 (95% CI: 0.65, 0.78) times their previous value. Similarly, the odds of an individual being hospitalized because of asthma decreased to 0.75 (95% CI: 0.67, 0.83) times their previous value. This study concludes that there was a progressive decrease in hospital admission rates for asthma in adults, and this trend correlates well with increasing use of inhaled corticosteroids at a community level. This must, however, be interpreted with care in light of the fact that increase in utilization of anti-inflammatory therapy probably also reflected improved general and widespread care for asthma.

Topics: Acute Disease; Administration, Topical; Adolescent; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Beclomethasone; Drug Utilization; Glucocorticoids; Hospitalization; Humans; Malta; Middle Aged; Prevalence; Retrospective Studies

Acute myopathy occurred in a 49-year-old woman hospitalized in the intensive care unit for status asthmaticus. She was given high-dose intravenous steroid therapy and intubated. Pancuronium bromide was used for prolonged curarization. Flaccid quadriplegia developed with preservation of the deep tendon reflexes. Muscle biopsy showed a myogenic process with disorganized myofibrils and selective loss of thick myosin filaments. This mainly myogenic process would result from the toxic effect of corticosteroids favored by prolonged curarization although the effect of other factors still remains unknown.

Topics: Acute Disease; Administration, Topical; Albuterol; Anti-Inflammatory Agents; Beclomethasone; Critical Care; Drug Therapy, Combination; Emergencies; Female; Glucocorticoids; Humans; Middle Aged; Muscular Diseases; Neuromuscular Agents; Prednisolone; Status Asthmaticus

Acute asthma during pregnancy is potentially dangerous to the fetus. The aim of this study was to investigate the effect of an acute attack of asthma during pregnancy on the course of pregnancy or delivery, or the health of the newborn infant, and to identify undertreatment as a possible cause of the exacerbations.. Five hundred and four pregnant asthmatic subjects were prospectively followed and treated. The data on 47 patients with an attack of asthma during pregnancy were compared with those of 457 asthmatics with no recorded acute exacerbation and with 237 healthy parturients.. Of 504 asthmatics, 177 patients were not initially treated with inhaled corticosteroids. Of these, 17% had an acute attack compared with only 4% of the 257 patients who had been on inhaled anti-inflammatory treatment from the start of pregnancy. There were no differences between the groups as to length of gestation, length of the third stage of labour, or amount of haemorrhage after delivery. No differences were observed between pregnancies with and without an exacerbation with regard to relative birth weight, incidence of malformations, hypoglycaemia, or need for phototherapy for jaundice during the neonatal period.. Patients with inadequate inhaled anti-inflammatory treatment during pregnancy run a higher risk of suffering an acute attack of asthma than those treated with an anti-inflammatory agent. However, if the acute attack of asthma is relatively mild and promptly treated, it does not have a serious effect on the pregnancy, delivery, or the health of the newborn infant.

Topics: Acute Disease; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Birth Weight; Bronchodilator Agents; Budesonide; Female; Gestational Age; Humans; Infant, Newborn; Labor, Obstetric; Pregnancy; Pregnancy Complications; Pregnenediones

Nitric oxide (NO) is known to be present in measurable quantities in the exhaled air of normal subjects and at higher concentrations in asthmatic subjects not treated with glucocorticoids. We confirmed these findings by analyzing the mean mixed expired NO concentrations of 43 stable asthmatics and 90 normal subjects; NO levels were higher in the asthmatic population (13.9 parts per billion [ppb] versus 6.2 ppb, p < 0.001). Although the effects of glucocorticoids on the NO content of mixed expired air are known, it is not known if beginning systemic glucocorticoid therapy reduces exhaled NO levels in a given individual. To examine this question, seven patients needing emergency therapy for asthma underwent repeated measurements of mixed expired NO levels during their course of treatment with glucocorticoids. All patients had a reduction in mixed expired NO concentration (p = 0.002) and an accompanying improvement in airway obstruction. The decrease in exhaled NO was evident as early as 48 h after the initiation of therapy (p = 0.05). These data suggest mixed expired NO concentrations may prove useful as an index of asthma severity and treatment efficacy for an individual patient.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Airway Obstruction; Asthma; Beclomethasone; Case-Control Studies; Cohort Studies; Emergencies; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Methylprednisolone; Middle Aged; Nitric Oxide; Peak Expiratory Flow Rate; Prednisone; Respiration; Smoking; Triamcinolone

Forty-one children, aged six to 36 months (mean, 23.3 months), with a past history of acute bronchiolitis with or without recurrent wheezing episodes were treated with either a beclomethasone dipropionate metered dose inhaler 150 microgram twice daily, or a placebo for 12 weeks. Aerosols were inhaled through an AeroChamber (Trudell, Canada) using a mask. The patients were followed up biweekly. The two groups were well matched in anthropometric data and frequency of wheezing prior to the study being undertaken. At the end of four to six weeks, the beclomethasone dipropionate treatment group showed a significant improvement in both wheezing and sleep patterns, and systemic steroid therapy was able to be tapered. No significant side effect could be ascribed to this treatment.

Topics: Acute Disease; Administration, Inhalation; Adolescent; Beclomethasone; Bronchitis; Child, Preschool; Female; Humans; Male; Recurrence; Respiratory Sounds

Topics: Acute Disease; Asthma; Beclomethasone; Humans

Topics: Acute Disease; Asthma; Beclomethasone; Humans

Systemic absorption of inhaled corticosteroids taken in high doses (> or = 1500 micrograms beclomethasone dipropionate or budesonide daily), may cause suppression of the hypothalamo-pituitary-adrenal axis. Patients taking long-term high dose inhaled steroid therapy might therefore be at risk of adrenal crisis at times of stress. Plasma cortisol levels were measured in 24 adults with severe acute asthma who had not received treatment with systemic corticosteroids prior to hospital attendance. Seven were not taking inhaled steroids, four were taking 600-1200 micrograms and 13 were taking 1500-2400 micrograms beclomethasone dipropionate or budesonide daily. Plasma cortisol levels in these 13 (median 594 nmol l-1, interquartile range 399-620 nmol l-1) were similar to levels in those taking lower dose/no inhaled steroids (median 512 nmol l-1, interquartile range 287-1050 nmol l-1): there was no relationship between inhaled steroid dose and cortisol level. Nine of the 24 patients failed to achieve plasma cortisol values > 500 nmol l-1 (the normal response to an insulin stress test). When compared with the remaining 15, they had less severe asthma as indicated by higher arterial oxygen tension (P < 0.01) and peak expiratory flow (P < 0.03). Patients taking long-term high dose inhaled corticosteroids appear to be able to mount an appropriate adrenocortical response to the stress of severe acute asthma.

Topics: Acute Disease; Administration, Inhalation; Administration, Topical; Adult; Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Drug Administration Schedule; Female; Humans; Hydrocortisone; Male; Pregnenediones; Stress, Physiological

Topics: Acute Disease; Aged; Albuterol; Asthma; Beclomethasone; Drug Interactions; Female; Humans; Ibuprofen

Topics: Acute Disease; Aerosols; Asthma; Beclomethasone; Budesonide; Child; Child, Preschool; Cromolyn Sodium; Humans; Infant; Prednisolone; Pregnenediones; Self Care; Theophylline

Topics: Acute Disease; Adrenal Cortex Hormones; Adult; Beclomethasone; Cromolyn Sodium; Eosinophilia; Female; Histamine H1 Antagonists; Humans; Nasal Polyps; Prednisone; Pregnancy; Pregnancy Complications; Rhinitis; Rhinitis, Allergic, Seasonal; Vasoconstrictor Agents

Oral corticosteroids may be life-saving for symptoms of acute asthma, and short courses are often useful to relieve even less serious acute exacerbations when the patient has become inadequately responsive to bronchodilators. Adverse effects are rarely if ever associated with short courses of steroids used for this purpose. Long-term use of oral corticosteroids, however, are associated with a variety of well-established toxic effects. The safe and effective use of oral corticosteroids in substantial doses given every other morning for various steroid-responsive diseases has been described in numerous studies since 1963. Among children with chronic asthma, suppression of the hypothalamic-pituitary-adrenal axis by alternate day prednisone in mean doses of 30 mg was found not to exceed that which occurred with inhaled beclomethasone dipropionate at doses averaging 550 micrograms/day. Growth was also similar in the 2 groups of patients. A few patients receiving alternate-day prednisone gained excessive weight, but this was not a clinical problem for most. Alternate-day prednisone is easier to administer, is associated with better compliance, and costs less than the inhaled steroid. Inhaled beclomethasone dipropionate is more bother, causes cough and throat irritation in some patients, and cannot be administered to very young children. Alternate-day prednisone, given as a single dose every other morning, and the new generation of inhaled steroids such as inhaled beclomethasone dipropionate are alternative means of providing safe and effective treatment with long-term corticosteroid therapy.

Topics: Acute Disease; Administration, Oral; Adolescent; Asthma; Beclomethasone; Child; Child, Preschool; Humans; Prednisolone

Asthma complicates pregnancy with the same frequency as cardiac disease (1%) does. Although the incidence of severe asthma during pregnancy is low, its effect on the mother and fetus can be disastrous. Recent advances have improved the management of this problem. Representative cases and a review of asthma treatment in pregnancy are presented.

Topics: Acute Disease; Adolescent; Adrenergic beta-Agonists; Adult; Asthma; Beclomethasone; Cromolyn Sodium; Ephedrine; Epinephrine; Female; Humans; Pregnancy; Pregnancy Complications; Theophylline

The first step in management of bronchial asthma is to exclude other diseases which may present as wheezing dyspena. Once the diagnosis is confirmed beyond a reasonable doubt, therapy can be initiated. Treatment depends on the type, severity, and duration of the disease. Other factors which dictate the choice of drug are the patient's response, metabolism of the drug, and complications of the disease. Theophylline forms the backbone of asthma therapy. Because of the wide variation in half-life of theophylline in different individuals due to variation in rate of metabolism and elimination, serum levels of theophylline should be monitored whenever possible. Newer antiasthmatic drugs, such as cromolyn sodium and inhaled steroids, are playing an increasing role in treatment of selected patients.

Topics: Acute Disease; Aminophylline; Asthma; Beclomethasone; Cromolyn Sodium; Dehydration; Diagnosis, Differential; Epinephrine; Heart Failure; Humans; Infections; Methylprednisolone; Pulmonary Edema; SRS-A; Theophylline

Topics: Acute Disease; Adolescent; Asthma; Beclomethasone; Bronchodilator Agents; Child; Child, Preschool; Chronic Disease; Cromolyn Sodium; Female; Hospitalization; Humans; Male; Psychotherapy; Respiratory Hypersensitivity

After the administration of intravenous salbutamol (100-300 mug) to 11 patients admitted to hospital with a severe exacerbation of asthma there was a mean increase in peak expiratory flow of 44% accompanied by a rise in pulse rate of 24 beats/min. Blood gas tensions showed a trend to improvement and there were no serious side effects. It is concluded that intravenous salbutamol is an effective and apparently safe bronchodilator in the management of acutely ill patients with severe asthma.

Topics: Acute Disease; Adolescent; Adult; Albuterol; Asthma; Beclomethasone; Carbon Dioxide; Female; Humans; Injections, Intravenous; Isoproterenol; Male; Middle Aged; Oxygen; Prednisone; Pulmonary Ventilation; Pulse; Spirometry; Theophylline

Topics: Acute Disease; Adolescent; Adrenal Cortex Hormones; Adult; Aerosols; Asthma; Beclomethasone; Bronchodilator Agents; Child; Child, Preschool; Cromolyn Sodium; Drug Evaluation; Humans