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Figure 1 displays results of pulmonary function tests for the recommended starting dosage of FLOVENT Inhalation Aerosol (88 mcg twice daily) and placebo from a 12-week trial in patients with asthma inadequately controlled on bronchodilators alone. Because this trial used predetermined criteria for lack of efficacy, which caused more patients in the placebo group to be withdrawn, pulmonary function results at Endpoint, which is the last evaluable FEV1 result and includes most patients' lung function data, are also provided. Pulmonary function improved significantly with FLOVENT Inhalation Aerosol compared with placebo by the second week of treatment, and this improvement was maintained over the duration of the trial. Figure 1. A 12-Week Clinical Trial in Patients Inadequately Controlled on Bronchodilators Alone: Mean Percent Change
From Baseline in FEV1 Prior to AM Dose Text Continues Below
In clinical trials of 924 patients with asthma already receiving daily inhaled corticosteroid therapy (doses of at least 336 mcg/ day of beclomethasone dipropionate) in addition to as-needed albuterol and theophylline (46% of all patients), 22-to 440-mcg twice-daily doses of FLOVENT Inhalation Aerosol were also evaluated. All doses of FLOVENT Inhalation Aerosol were efficacious when compared to placebo on major endpoints including lung function and symptom scores. Patients treated with FLOVENT Inhalation Aerosol were also less likely to discontinue study participation due to asthma deterioration (as defined by predetermined criteria for lack of efficacy including lung function and patient-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma). Figure 2 displays results of pulmonary function from a 12-week clinical trial in patients with asthma already receiving daily inhaled corticosteroid therapy (beclomethasone dipropionate 336 to 672 mcg/ day). The mean percent change from baseline in lung function results for FLOVENT Inhalation Aerosol dosages of 88, 220, and 440 mcg twice daily and placebo are shown over the 12-week trial. Because this trial also used predetermined criteria for lack of efficacy, which caused more patients in the placebo group to be withdrawn, pulmonary function results at Endpoint are included. Pulmonary function improved significantly with FLOVENT Inhalation Aerosol compared with placebo by the first week of treatment, and the improvement was maintained over the duration of the trial. Analysis of the endpoint results that adjusted for differential withdrawal rates indicated that pulmonary function significantly improved with FLOVENT Inhalation Aerosol compared with placebo treatment. Similar improvements in lung function were seen in the other 2 trials in patients treated with inhaled corticosteroids at baseline. Figure 2. A 12-Week Clinical Trial With Patients Already Receiving Inhaled Corticosteroids: Mean Percent Change
From Baseline in FEV1 Prior to AM Dose In a clinical trial of 96 patients with severe asthma requiring chronic oral prednisone therapy (average baseline daily prednisone dose was 10 mg), twice-daily doses of 660 and 880 mcg of FLOVENT Inhalation Aerosol were evaluated. Both doses enabled a statistically significantly larger percentage of patients to wean successfully from oral prednisone as compared with placebo (69% of the patients on 660 mcg twice daily and 88% of the patients on 880 mcg twice daily as compared with 3% of patients on placebo). Accompanying the reduction in oral corticosteroid use, patients treated with FLOVENT Inhalation Aerosol had significantly improved lung function and fewer asthma symptoms as compared with the placebo group.
Figure 3. A 16-Week Clinical Trial in Patients Requiring Chronic Oral Prednisone Therapy: Change in Maintenance
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