Once-daily fluticasone furoate/vilanterol <i>versus</i> twice-daily fluticasone propionate/salmeterol in patients with asthma well controlled on ICS/LABA

<p><i>Objective</i>: We aimed to demonstrate non-inferiority of once-daily fluticasone furoate/vilanterol 100/25 µg (FF/VI) to twice-daily fluticasone propionate/salmeterol 250/50 µg (FP/SAL) in adults/adolescents with asthma well controlled on inhaled corticosteroid/long-acting β₂ agonist (ICS/LABA). <i>Methods</i>: This was a randomized, double-blind, double-dummy, parallel-group, 24-week study (NCT02301975/GSK study 201378). Patients whose asthma met study-defined criteria for control were randomized 1:1:1 to receive FF/VI, FP/SAL or twice-daily FP 250 µg for 24 weeks. Primary endpoint was change from baseline in evening trough forced expiratory volume in 1 second (FEV₁). Secondary endpoints included rescue-/symptom-free 24-hour periods. Safety was also assessed. <i>Results</i>: The intent-to-treat (ITT) population included 1504 randomized and treated patients (504 FF/VI; 501 FP/SAL; 499 FP); mean age 43.5 years, 64% female. FF/VI demonstrated non-inferiority (using a margin of −100 mL) to FP/SAL for evening trough FEV₁ at Week 24 (ITT: 19 mL [95% confidence interval (CI) −11 to 49]; per protocol population [<i>N</i> = 1336]: 6 mL [95% CI −27 to 40]). Improvement in evening trough FEV₁ at Week 24 for both FF/VI (123 mL; <i>p</i> < 0.001) and FP/SAL (104 mL; <i>p</i> < 0.001) was greater than FP. FF/VI increased rescue-/symptom-free 24-hour periods by 1.2%/1.2% compared with FP/SAL. All treatments were well tolerated. On-treatment adverse event (AE) rates were 43% to 45% across arms; there were no drug-related serious AEs. <i>Conclusions</i>: FF/VI was non-inferior to FP/SAL for evening trough FEV₁ at 24 weeks. These data suggest that patients well controlled on FP/SAL could step across to FF/VI without loss of control.</p

Additional file 2: Figure S1. of Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma

Plot of pneumonia incidence per 1000 patient-years and 95% CI by treatment group (integrated clinical studies). BD, twice daily; CI, confidence interval; FF, fluticasone furoate; FP, fluticasone propionate; OD, once daily. (TIF 465 kb

Additional file 3: Figure S2. of Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma

Plot of serious pneumonia incidence per 1000 patient-years and 95% CI by treatment group (integrated clinical studies). BD, twice daily; CI, confidence interval; FF, fluticasone furoate; FP, fluticasone propionate; OD, once daily. (TIF 427 kb