• Thomas M Siler, Atsushi Nagai, Catherine A Scott-Wilson, Dawn A Midwinter, and Courtney Crim.
• Midwest Chest Consultants, PC, St Charles, MO, USA. Electronic address: Thomas.siler.md@midwestchest.com.
• Respir Med. 2017 Feb 1; 123: 8-17.

BackgroundThe contribution of fluticasone furoate (FF) on lung function in the FF/vilanterol (VI) 100/25 μg combination has been demonstrated numerically, but not statistically.MethodsThis multicentre, randomised, double-blind, controlled trial (GlaxoSmithKline study number 200820; clinicaltrials.gov NCT02105974) enrolled ≥40-year-old patients with chronic obstructive pulmonary disease (COPD), a ≥10-pack-year smoking history, a post-bronchodilator forced expiratory volume in 1 s (FEV1) 30-70% of the predicted value, a FEV1/forced vital capacity ratio of ≤0.70, ≥1 COPD exacerbation in the previous 12 months requiring corticosteroids, antibiotics and/or hospitalisation, and current COPD symptoms. Participants received FF/VI 100/25 μg or VI 25 μg once daily. The primary endpoint was the change from baseline in trough FEV1 at day 84.Findings1620 patients were randomised and received at least one dose of FF/VI 100/25 μg (n = 806) or VI 25 μg (n = 814). At day 84, the FF/VI 100/25 μg group showed an adjusted mean treatment difference of 34 mL over VI 25 μg in change from baseline trough FEV1 (95% confidence interval [CI] 14-55; p = 0.001). There was no significant difference between the groups in the percentage of rescue medication-free 24-h periods. The FF/VI 100/25 μg group demonstrated a 42% risk reduction compared with the VI 25 μg group in time to first moderate/severe COPD exacerbation (95% CI 22-57; nominal p < 0.001). The incidence of on-treatment adverse events was similar between the groups.InterpretationThe contribution of FF in the FF/VI 100/25 μg combination on lung function in COPD was statistically significant.FundingGlaxoSmithKline.Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

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