Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthma

Objectives: Fluticasone furoate (FF; inhaled corticosteroid) combined with vilanterol (VI; long-acting beta(2) agonist) is a once-daily therapy for asthma and chronic obstructive pulmonary disease. This 12-week phase III study compared the efficacy and safety of once-daily (evening dosing) FF/VI100/25mcg versus FF 100mcg (primary objective) and FF/VI100/25mcg versus FF/VI200/25mcg (descriptive comparison only) in patients (n=1039) 12 years with moderate-to-severe persistent asthma. Methods: The primary end point was weighted mean (wm) 0-24-h serial forced expiratory volume in 1s (FEV1) at week 12. Secondary end points (change from baseline) were trough FEV1 and the proportion (%) of rescue-free 24-h periods (both powered), the proportion (%) of symptom-free 24-h periods, and morning and evening peak expiratory flow (PEF). Safety data (adverse events, AEs) were collected throughout. Results: Compared with FF 100mcg, FF/VI100/25mcg significantly improved wmFEV(1) (p<0.001), trough FEV1 (p=0.014), % rescue-free (p<0.001), % symptom-free (p=0.002) 24-h periods, and morning and evening PEF (p<0.001). FF/VI 200/25mcg produced small numerical improvements versus FF/VI 100/25mcg for all end points. Incidence of AEs was similar across groups. Conclusions: FF/VI 100/25mcg resulted in significant improvements in all primary and secondary end points versus FF 100mcg. Numerical improvements occurred with FF/VI 200/25mcg versus FF/VI 100/25mcg. All treatments were well tolerated.