fluticasone furoate/umeclidinium/vilanterol vs GW642444M

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.

NCT00600171 · Phase 2 · completed

The study was randomized and double-blind, compared five GW642444M doses with placebo, and included 614 randomized participants. Its primary lung-function endpoint was a surrogate measure rather than a direct clinical outcome, and the results were mixed across doses: the 12.5, 25, and 50 microgram doses outperformed placebo, while the 3 and 6.25 microgram doses did not.