fluticasone furoate/umeclidinium/vilanterol vs Salmeterol (DISKUS)

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.

NCT00395304 · Phase 3 · completed

This was a rigorously designed, fully blinded, randomized crossover trial with a clinically meaningful composite primary measure, but the results available here do not show how the fluticasone-plus-salmeterol arm specifically compared with the other step-up therapies, so the salmeterol-specific effect cannot be confirmed from this data.