GlaxoSmithKline has unveiled positive results from two head-to-head studies pitting the efficacy and safety of its bronchodilator umeclidinium (Incruse Ellipta) against tiotropium (Boehringer Ingelheim’s Spiriva) and glycopyrronium (Novartis’ Seebri) when used by patients with COPD.
In study 201316, once-daily administration of umeclidinium achieved a statistically significant improvement in lung function as measured by trough forced expiratory volume in one second (FEV1) at 12 weeks compared to tiotropium once-daily. The difference in treatment effect observed was 59ml between the drugs on per protocol analysis.
Results from study 201315 showed that umeclidinium was non-inferior to glycopyrronium administered once daily, also measured by trough FEV1 at 12 weeks. The difference in treatment effect observed was 24ml between the drugs, GSK said.
Safety profiles also seemed relatively similar, with the overall incidence of on-treatment adverse events 32% in the umeclidinium group and 30% in the tiotropium arm in study 201316, and 37% in the umeclidinium group and 36% in the glycopyrronium arm in study 201315.
Incruse Ellipta was approved in the EU as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD in May last year.