A randomised trial of fluticasone furoate/vilanterol (50/25 μg; 100/25 μg) on lung function in COPD

Background: Fluticasone furoate (FF)/vilanterol (VI) is a novel once-daily inhaled corticosteroid/long-acting beta(2)-agonist combination therapy for COPD. We aimed to assess the efficacy and safety of two strengths of FF/VI (100/25 mu g; 50/25 mu g) vs. individual components (FF 100 mu g, VI 25 mu g) and placebo over 24 weeks. Methods: Multicentre, randomised, placebo-controlled, double-blind, parallel-group study of patients (N = 1030) with moderate-to-severe COPD. All medication was administered once daily in the morning. Co-primary efficacy endpoints were: (1) weighted mean (wm) FEV1 (0-4 h post-dose on day 168) to assess acute lung function effects; and (2) trough FEV1 (23-24 h post-dose on day 169) to assess long-lasting effects. Symptom-related outcomes were analysed and adverse events (AEs) assessed. Results: Main findings were: (1) the combination of FF/VI at a strength of 100/25 mu g significantly (p < 0.001) improved wm FEV1 (173 ml) and trough FEV1 (115 ml) vs. placebo. Similar effects were observed with FF/VI 50/25 mu g; (2) no significant difference was seen between FF/VI 100/25 mu g and VI 25 mu g for trough FEV1 (48 ml, p = 0.082), while an effect was observed between FF/VI 100/25 mu g and FF 100 mu g for wm FEV1 (120 ml, p < 0.001); (3) VI 25 mu g over 24 weeks improved lung function vs. placebo significantly for wm FEV1 (103 ml, p < 0.001) and trough FEV1 (67 ml, p = 0.017); and (4) no safety signal was observed. Conclusions: In subjects with moderate-to-severe COPD, FF/VI 100/25 mu g provides rapid and significant sustained bronchodilation at 24 weeks. Lung function is improved to a similar extent with FE/VI 50/25 mu g and to a somewhat lesser extent with VI 25 mu g. All treatments were well tolerated. GSK study number: HZC112206. ClinicalTrials.gov: NCT01053988. (c) 2013 Elsevier Ltd. All rights reserved.