Randomised, double-blind, placebo-controlled, cross-over single dose study of the bronchodilator duration of action of combination fluticasone furoate/vilanterol inhaler in adult asthma

Abstract Background Fluticasone furoate (FF)/vilanterol (VI) is a once-daily maintenance treatment for asthma and chronic obstructive pulmonary disease. The duration of bronchodilation beyond 24 h has not been determined previously. Methods Adults aged 18–65 (n = 32), with asthma and reversibility to salbutamol (≥15% and ≥200 mL increase in forced expiratory volume in 1 s [FEV 1 ]) participated in a double-blind, placebo-controlled, crossover study. Patients were admitted to a clinical trials unit for 72 h, and inhaled, in random order, placebo or FF/VI 100/25 mcg via ELLIPTA dry powder inhaler on two occasions 7–14 days apart. FEV 1 was measured at baseline, 15 and 30 min, 1, 2, 4, 12, 24, 36, 48, 60, and 72 h. The differences in change in FEV 1 from baseline between treatments and corresponding two-sided 95% confidence intervals (CI) were calculated at each time point. Findings FF/VI produced a rapid onset of bronchodilation (adjusted mean difference in change from baseline in FEV 1 versus placebo at 15 min, 252 mL [95% CI 182–322]). Maximum bronchodilation was observed at 12 h (adjusted mean difference in the change from baseline in FEV 1 , 383 mL [95% CI 285–481]). Bronchodilation was maintained throughout the 72-h assessment period (adjusted mean difference in the change in FEV 1 from baseline at 72 h, 108 mL (95% CI 15–200]). FF/VI was well tolerated and no serious side effects were reported. Interpretation A single dose of FF/VI 100/25 mcg showed evidence of a 72-h bronchodilator duration of action in adults with asthma.