fluticasone furoate/umeclidinium/vilanterol vs PT001

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.

NCT03358147 · Phase 2/3 · completed

The study was randomized and quadruple-masked for the placebo comparison, included 1,077 participants, and used placebo and open-label active comparators. Its primary measure was a lung-function surrogate rather than a hard clinical outcome, and although the reported PT001 values were numerically higher than placebo, whether the prespecified primary comparison was statistically significant is not stated.