fluticasone furoate/umeclidinium/vilanterol vs Tiotropium bromide

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).

NCT02172287 · Phase 3 · completed

This is a large, randomized, double-blind trial with both an active comparator and a placebo arm, using trough FEV1 lung function, the regulator-accepted physiological measure for COPD, as one of its primary endpoints. Registry results were not posted at the time of grading; the key result shown was recovered from the cited external source.

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.

NCT00772538 · Phase 3 · completed

The trial randomized 459 participants to double-blind tiotropium or matching placebo, with 237 receiving tiotropium and 222 placebo. The primary comparisons favored tiotropium, including significant improvements in peak and trough FEV1 at 24 weeks and a significant reduction in time to first severe asthma exacerbation in the pooled twin-trial analysis.