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 Prednisone Dose | ||||
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