Dose effect of once-daily fluticasone furoate in persistent asthma: A randomized trial

Abstract

This randomized, double-blind, multicenter study was designed to evaluate the efficacy of inhaled once-daily fluticasone furoate (FF) administered in the evening in patients with persistent asthma not controlled by short-acting beta(2) agonists, and to determine the dose(s) suitable for further development. Of 1459 patients screened, 598 received one of six treatments: placebo, FF (25μg, 50μg, 100μg or 200μg) once daily each evening, or fluticasone propionate (FP) 100μg twice daily for 8 weeks. The primary endpoint was change from baseline in pre-dose evening forced expiratory volume in 1s (FEV(1)). A dose-response effect was observed for once-daily FF 25-200μg including (p<0.001) and excluding placebo (p=0.03). FF 50-200μg once daily significantly increased FEV(1) from baseline (p<0.05 vs placebo), by >200mL for FF 100μg and 200μg. Significant improvements were also achieved for peak expiratory flow, and percentage symptom-free and rescue-free 24h periods. The magnitude of effect was at least as good as twice-daily FP. Overall, once-daily FF was well tolerated with no systemic corticosteroid effects. FF 50-200μg/day once daily in the evening demonstrated dose-related efficacy in asthma with 100-200μg appearing to be the optimal doses for further evaluation. ClinicalTrials.gov: NCT00603382.