therapy. Patients were randomized to receive 1 inhalation twice a dayof fluticasone propionate and salmeterol inhalation powder (referred to as fluticasonepropionate/salmeterol MDPI), fluticasone propionate MDPI alone, or placebo. Maintenanceasthma therapies were discontinued at randomization.
Trial 1: In this trial, adolescents and adult patients with persistent symptomatic asthma despitelow-dose or mid-dose inhaled corticosteroid (ICS) or ICS/LABA therapy were included. After completing a run-in period where patients were treated with beclomethasone dipropionateinhalation aerosol 40 mcg twice daily and a single blind placebo MDPI, the patients who met therandomization criteria were randomized to 1 inhalation twice a day of the following treatments:
placebo MDPI (n=130)fluticasone propionate MDPI 55 mcg (n=129)
fluticasone propionate MDPI 113 mcg (n=130)
fluticasone propionate/salmeterol MDPI 55/14 mcg (n=129), or
fluticasone propionate/salmeterol MDPI 113/14 mcg (n=129)
Baseline FEV1 measurements were similar across treatments: fluticasone propionate MDPI55 mcg 2.132 L, fluticasone propionate MDPI 113 mcg 2.166 L, fluticasone
propionate/salmeterol MDPI 55/14 mcg 2.302 L, fluticasone propionate/salmeterol MDPI113/14 mcg 2.162 L, and placebo 2.188 L.
The primary endpoints for this trial were the change from baseline in trough FEV1 at week 12 forall patients and standardized baseline-adjusted FEV1 AUEC0-12h at week 12 analyzed for a subsetof 312 patients who performed postdose serial spirometry.
Patients in both fluticasone propionate/salmeterol MDPI treatment groups had significantlygreater improvements in trough FEV1 compared with both fluticasone propionate MDPItreatment groups and the placebo group:
Fluticasone propionate/salmeterol MDPI 113/14 mcg: LS mean change of 0.315 L at12 weeks
Fluticasone propionate/salmeterol MDPI 55/14 mcg: LS mean change of 0.319 L at12 weeks
Fluticasone propionate MDPI 113 mcg: LS mean change of 0.204 L at 12 weeks
Fluticasone propionate MDPI 55 mcg: LS mean change of 0.172 L at 12 weeks
Placebo: LS mean change of 0.053 L at 12 weeks
The estimated mean differences between:
Fluticasone propionate/salmeterol MDPI 55/14 mcg and fluticasone
propionate/salmeterol MDPI 113/14 mcg compared to placebo were 0.266 L (95% CI:0.172, 0.360) and 0.262 L (95% CI: 0.168, 0.356), respectively.
Fluticasone propionate MDPI 55 mcg and fluticasone propionate MDPI 113 mcg
compared to placebo were 0.119 L (95% CI: 0.025, 0.212) and 0.151 L (95% CI: 0.057,0.244), respectively.
Fluticasone propionate/salmeterol MDPI 113/14 mcg and fluticasone propionate MDPI113 mcg was 0.111 L (95% CI: 0.017, 0.206).
Fluticasone propionate/salmeterol MDPI 55/14 mcg and fluticasone propionate MDPI 55mcg was 0.147 L (95% CI: 0.053, 0.242).
In addition, the mean FEV1 results at each visit are displayed in Figure 3.
Figure 3: Mean Change from Baseline in Trough FEV1 at Each Visit by Treatment Group
Trial 1 (FAS)
FS MDPI = fluticasone propionate/salmeterol multidose dry powder inhaler: FP MDPI = fluticasone propionatemultidose dry powder inhaler; FAS = full analysis set; FEV1 = forced expiratory volume in 1 secondSupportive evidence of efficacy for fluticasone propionate/salmeterol MDPI compared withplacebo was derived from secondary endpoints such as the weekly average of daily troughmorning peak expiratory flow and total daily use of rescue medication. T |
