Efficacy and safety of fluticasone furoate 100 μg once-daily in patients with persistent asthma: A 24-week placebo and active-controlled randomised trial

Abstract

Inhaled corticosteroids (ICSs) improve asthma disease control; once-daily ICS administration may have advantages for patients. Our objective was to assess the efficacy and safety of the novel ICS fluticasone furoate (FF) over 24 weeks versus placebo. This was a 24-week double-blind, double-dummy, placebo- and active-controlled study (NCT01159912) of 343 asthma patients (≥12 years) not controlled by their current ICS. Patients were randomised (1:1:1) to FF100μg, placebo (both administered once-daily [OD] via ELLIPTA™ dry powder inhaler in the evening) or fluticasone propionate (FP) 250μg (administered twice-daily (BD) via DISKUS™/ACCUHALER™). Primary endpoint was change from baseline in pre-dose evening forced expiratory volume in 1s (FEV1) at Week 24; change from baseline in % rescue-free 24-h periods was a powered secondary endpoint. Adverse events (AEs) were assessed. FF100μg OD and FP250μg BD significantly improved pre-dose evening FEV1 compared with placebo at Week 24 (+146ml [p=0.009] and +145ml [p=0.011], respectively). Percentage of rescue-free 24-h periods was increased with FF100μg OD (+14.8%) and FP250μg BD (+17.9%) compared to placebo (both p<0.001). On-treatment AEs were reported by 53% (FF100μg OD), 42% (FP250μg BD) and 40% (placebo) of patients. On-treatment severe asthma exacerbations were lower with FF100μg OD (3%) and FP250μg BD (2%) than placebo (7%). There was significant suppression of urinary cortisol at week 24 with FF100μg OD (p=0.030) and FP250μg BD (p=0.036) relative to placebo. FF100μg OD, administered in the evening, achieves significant improvements in lung function and rescue inhaler use over 24 weeks, comparable to FP250μg BD with similar safety profile.