fluticasone furoate/umeclidinium/vilanterol vs Olodaterol

NCT02164513 · Phase 3 · completed

This was a large randomized, double-blind, active-controlled trial in 10,355 COPD patients at 971 sites in 37 countries; the primary endpoint, annual on-treatment moderate/severe exacerbation rate, is a hard clinical outcome, and triple therapy significantly reduced exacerbations versus both dual-therapy comparators (rate ratio 0.75 vs UMEC/VI and 0.85 vs FF/VI, both p<0.001).

NCT00782210 · Phase 3 · completed

This was a randomized, double-blind, placebo-controlled phase 3 trial in 624 patients with COPD comparing two doses of olodaterol (5 mcg and 10 mcg once daily) against placebo. Both pre-specified co-primary endpoints—FEV1 AUC 0-3h and trough FEV1 at 12 weeks—were met for both doses, with large, statistically significant differences versus placebo (p<0.0001 for all primary comparisons). The trial was adequately powered, used a regulator-accepted lung function endpoint for COPD, and the primary results were clearly positive.

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.

NCT00467740 · Phase 2 · completed

The study randomized 296 participants to placebo or one of four olodaterol doses, but the registry does not clearly report whether treatment assignment was blinded. Its primary outcome was a lung-function surrogate rather than a hard clinical outcome, and results were mixed across doses: only olodaterol 20 micrograms significantly improved trough FEV1 versus placebo at 4 weeks.