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

David I Bernstein, Eric D Bateman, Ashley Woodcock, William T Toler, Richard Forth, Loretta Jacques, Carol Nunn, Paul M O'Byrne

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    OBJECTIVES: Fluticasone furoate (FF; inhaled corticosteroid) combined with vilanterol (VI; long-acting beta2 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/VI 100/25 mcg versus FF 100 mcg (primary objective) and FF/VI 100/25 mcg versus FF/VI 200/25 mcg (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 1 s (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 100 mcg, FF/VI 100/25 mcg significantly improved wmFEV1 (p 


    • Efficacy
    • inhaled corticosteroid
    • long-acting beta-agonist
    • lung function
    • safety


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