Once-daily combination treatment is an attractive maintenance therapy for COPD. 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.

Multicentre, randomised, 24-week, double-blind, placebo-controlled, parallel-group study in stable, moderate-to-severe COPD subjects (N = 1224). Subjects were randomised to FF/VI (200/25 μg; 100/25 μg), FF (200 μg; 100 μg), VI 25 μg, 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).

There was a statistically significant (p < 0.001) increase in wm FEV₁ (209 ml) and trough FEV₁ (131 ml) for FF/VI 200/25 μg vs. placebo; similar changes were seen for FF/VI 100/25 μg vs. placebo. Whereas the difference between FF/VI 200/25 μg and VI 25 μg in change from baseline trough FEV₁ (32 ml) was not statistically significant (p = 0.224), the difference between FF/VI 200/25 μg and FF 200 μg for wm FEV₁ (168 ml) was significantly different (p < 0.001). VI 25 μg 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.

FF/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 FF/VI may offer clinical efficacy in COPD and warrants additional study.

GSK study number: HZC112207.

ClinicalTrials.gov: NCT01054885.