Fluticasone furoate/vilanterol (100/25; 200/25 μg) improves lung function in COPD: A randomised trial

Background: Once-daily combination treatment is an attractive maintenance therapy for CORD. However, the dose of inhaled corticosteroid to use in a once-daily combination is unknown. We compared two strengths of fluticasone furoate (FF) plus vilanterol (VI), the same strengths of the individual components, and placebo. Methods: Multicentre, randomised, 24-week, double-blind, placebo-controlled, parallel-group study in stable, moderate-to-severe CORD subjects (N = 1224). Subjects were randomised to FF/VI (200/25 mu g; 100/25 mu g), FF (200 mu g; 100 mu g), VI 25 mu g, or placebo, once daily in the morning. Co-primary efficacy endpoints; 0-4 h weighted mean (wm) FEV1 on day 168, and change from baseline in trough (23-24 h post-dose) FEV1 on day 169. The primary safety objective was adverse events (AEs). Results: There was a statistically significant (p < 0.001) increase in wm FEV1 (209 ml) and trough FEV1 (131 ml) for FF/VI 200/25 mu g vs. placebo; similar changes were seen for FF/VI 100/25 mu g vs. placebo. Whereas the difference between FF/VI 200/25 mu g and VI 25 mu g in change from baseline trough FEV1 (32 ml) was not statistically significant (p = 0.224), the difference between FF/VI 200/25 mu g and FF 200 mu g for wm FEV1 (168 ml) was significantly different (p < 0.001). VI 25 mu g significantly improved wm and trough FEV1 vs. placebo (209 ml and 131 ml, respectively). No increase was seen in on-treatment AEs or serious AEs (SAEs), with active therapy vs. placebo. Conclusions: FE/VI provides rapid and significant sustained improvement in FEV1 in subjects with moderate-to-severe COPD, which was not influenced by the dose of FF. These data suggest that FE/VI may offer clinical efficacy in COPD and warrants additional study. GSK study number: HZC112207. ClinicalTrials.gov: NCT01054885. (c) 2013 Elsevier Ltd. All rights reserved.