The efficacy of once-daily fluticasone furoate/vilanterol in asthma is comparable with morning or evening dosing

Summary Aim To investigate the effect of time of day of dosing (morning or evening) on lung function following administration of fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg. Methods Double-blind, placebo-controlled, randomised, three-way crossover study. Subjects with persistent asthma ( N  = 26) received FF/VI (morning or evening) or matching placebo once-daily for 14 (±2 days) via dry powder inhaler (DPI). Weighted mean (0–24h) and pre-treatment FEV 1 (morning and evening) were determined after the Day 14 evening dose, together with mean pre-treatment (morning and evening) peak expiratory flow (PEF) on Days 2–12. Results FF/VI 100/25 administered morning or evening produced clinically significant increases in weighted mean FEV 1 : the differences [95% confidence interval (CI)] from placebo were 377 mL [293, 462] and 422 mL [337, 507], respectively; the difference between morning and evening dosing was −44 mL [−125, 36]. Day 14 pre-treatment morning FEV 1 differences [95% CI] from placebo were 403 mL [272, 533] and 496 mL [369, 624] after morning and evening dosing, respectively; the morning:evening treatment difference was −94 mL [−221, 34]. Pre-treatment evening FEV 1 differences [95% CI] from placebo were 275 mL [169, 380] and 309 mL [205, 413] after morning and evening dosing, respectively; the morning:evening treatment difference was −34 mL [−138, 70]. FF/VI (morning or evening) produced rapid increases in PEF with the full effect apparent after the first dose and maintained throughout the 14-day treatment period. Conclusion FF/VI 100/25 produces comparable improvements in lung function whether dosed in the morning or evening in subjects with persistent asthma. [GSK protocol HZA114624, NCT01287065].