fluticasone furoate/umeclidinium/vilanterol vs Umeclidinium

NCT02164513 · Phase 3 · completed

This was a large randomized, double-blind, active-controlled trial in 10,355 COPD patients at 971 sites in 37 countries; the primary endpoint, annual on-treatment moderate/severe exacerbation rate, is a hard clinical outcome, and triple therapy significantly reduced exacerbations versus both dual-therapy comparators (rate ratio 0.75 vs UMEC/VI and 0.85 vs FF/VI, both p<0.001).

NCT02184611 · Phase 3 · completed

This was a randomized, double-blind, placebo-controlled trial in 308 patients using lung function (trough FEV1) as its primary measure, and umeclidinium produced a significantly greater improvement than placebo (least-squares mean difference 0.154 L, 95% CI 0.113 to 0.194, p<0.001).

NCT02924688 · Phase 3 · completed

This was a large (N=2,436) randomized, triple-blind, active-controlled Phase III trial comparing four fixed-dose combinations of fluticasone furoate/umeclidinium/vilanterol against two fluticasone furoate/vilanterol dual therapy controls in patients with inadequately controlled asthma. The primary endpoint, change from baseline in trough FEV1 at Week 24, was met for every pre-specified triple-therapy versus dual-therapy comparison, with all four least-squares mean differences favoring triple therapy and p<0.001. The combination of randomization, blinding, an active comparator, a large sample, a hard clinical endpoint, and a statistically significant primary result constitutes strong evidence.

No graded featured trial for this indication yet; the grade above reflects that absence, not a judgment.