fluticasone furoate/umeclidinium/vilanterol vs Lodotra

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.

NCT00686335 · Phase 2 · completed

This was a single-group, sequential (not randomized) study with no blinding and no true parallel control arm - patients simply switched from morning to evening dosing of the same drug class, and only 7 of 12 enrolled patients completed both periods for the efficacy analysis. The sponsor describes the study as exploratory with descriptive-only analysis and no statistical hypothesis testing, so despite numbers suggesting fewer nighttime awakenings with the evening formulation, this small, unblinded, uncontrolled design cannot serve as strong evidence.