GlaxoSmithKline revealed positive results from two head-to-head studies directly comparing the efficacy and safety of Incruse Ellipta (umeclidinium) to two available bronchodilator treatments, tiotropium (study 201316) or glycopyrronium (study 201315), when used by patients with COPD.
Results from the randomized, blinded study 201316 showed that umeclidinium 62.5 mcg once daily achieved a statistically significant improvement in lung function measured by trough forced expiratory volume in one second (FEV1) at 12 weeks (P<0.001), compared to tiotropium 18 mcg administered once daily. The difference in treatment effect observed was 59ml (95% CI: 29, 88) for umeclidinium compared to tiotropium based on a per protocol analysis. For the intention to treat population, the difference observed was 53 ml (95% CI: 25, 81), which was also statistically significant (P<0.001).
Results from the randomized, open-label study 201315 showed thatumeclidinium 62.5 mcg once daily was non-inferior to glycopyrronium 44 mcg administered once daily, also measured by trough FEV1 at 12 weeks. The difference in treatment effect observed was 24 ml (95% CI: -5, 54) for umeclidinium compared to glycopyrronium based on a per protocol analysis. For the intention to treat population, the difference observed was 33 ml (95% CI: 5, 61).
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