fluticasone furoate/umeclidinium/vilanterol vs Vilanterol

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.

NCT01706198 · Phase 3 · completed

The study randomized 4,233 participants to FF/VI or active usual care, but neither participants nor investigators were blinded. Its primary patient-reported asthma-control endpoint was a surrogate/soft measure and was met in favor of FF/VI (71% vs 56%; p<0.001), supporting moderate rather than strong evidence.