Four randomized, double-blind, parallel-group, placebo-controlled, U.S. clinical trials were conducted in 1,036 adult and adolescent subjects (aged 12 years and older) with asthma to assess the efficacy and safety of fluticasone propionate DISKUS in the treatment of asthma. Fixed dosages of 100, 250, and 500 mcg twice daily were compared with placebo to provide information about appropriate dosing to cover a range of asthma severity. Subjects in these trials included those inadequately controlled with bronchodilators alone and those already maintained on daily ICS. All doses were delivered by inhalation of the contents of 1 or 2 blisters from fluticasone propionate DISKUS twice daily.

Figures 1 through 4 display results of pulmonary function tests (mean percent change from baseline in FEV1 prior to AM dose) for 3 recommended dosages of fluticasone propionate DISKUS (100, 250, and 500 mcg twice daily) and placebo from the four 12-week trials in adolescents and adults. These trials used predetermined criteria for lack of efficacy (indicators of worsening asthma), resulting in withdrawal of more patients in the placebo group. Therefore, pulmonary function results at Endpoint (the last evaluable FEV1 result, including most patients’ lung function data) are also displayed. Pulmonary function, as determined by percent change from baseline in FEV1 at recommended dosages of fluticasone propionate DISKUS improved significantly compared with placebo by the first week of treatment, and improvement was maintained for up to 1 year or more. 

Figure 1. A 12-Week Clinical Trial Evaluating Fluticasone Propionate DISKUS 100 mcg Twice Daily in Adults and Adolescents Receiving Bronchodilators Alone

Figure 2. A 12-Week Clinical Trial Evaluating Fluticasone Propionate DISKUS 100 mcg Twice Daily in Adults and Adolescents Receiving Inhaled Corticosteroids

Figure 3. A 12-Week Clinical Trial Evaluating Fluticasone Propionate DISKUS 250 mcg Twice Daily in Adults and Adolescents Receiving Inhaled Corticosteroids or Bronchodilators Alone

Figure 4. A 12-Week Clinical Trial Evaluating Fluticasone Propionate DISKUS 500 mcg Twice Daily in Adults and Adolescents Receiving Inhaled Corticosteroids or Bronchodilators Alone

In all 4 efficacy trials, measures of pulmonary function (FEV1) were statistically significantly improved as compared with placebo at all twice-daily doses. Subjects on all dosages of fluticasone propionate DISKUS 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 subject-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma) compared with placebo. 

In a clinical trial of 111 subjects with severe asthma requiring chronic oral prednisone therapy (average baseline daily prednisone dose was 14 mg), fluticasone propionate given by inhalation powder at doses of 500 and 1,000 mcg twice daily was evaluated. Both doses enabled a statistically significantly larger percentage of subjects to wean from oral prednisone as compared with placebo (75% of the subjects on 500 mcg twice daily and 89% of the subjects on 1,000 mcg twice daily as compared with 9% of subjects on placebo). Accompanying the reduction in oral corticosteroid use, subjects treated with fluticasone propionate had significantly improved lung function and fewer asthma symptoms as compared with the placebo group.