fluticasone furoate/umeclidinium/vilanterol vs GW642444H

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.

NCT00381667 · Phase 2 · completed

The study was randomized, double-blind, and placebo-controlled, but enrolled only 14 participants. Its primary outcomes included lung-function and safety measurements rather than a hard clinical endpoint, and the primary comparison cannot be assessed because results have not been posted.