albuterol sulfate (Amphastar) vs fluticasone furoate/umeclidinium/vilanterol

NCT01581177 · Phase 2 · completed

The study randomized 23 participants and used triple blinding with placebo and active albuterol comparators, but its small sample and unreported results limit the strength of the evidence. The primary outcome was change in FEV1 AUC, a physiological surrogate measure, and the registry does not state whether this comparison was successful.

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.