GlaxoSmithKline has announced data from two studies demonstrating that the Incruse Ellipta umeclidinium DPI produced statistically significant increase in FEV1 at 12 weeks in COPD patients compared to tiotropium and was non-inferior to glycopyrronium. GSK said that data from both 12-week randomized, blinded head-to-head studies will be presented at a future scientific meeting.
The study comparing umeclidinium to tiotropium involved 1,259 patients, and the observed difference in FEV1 was 59 ml between umeclidinium and tiotropium. The study comparing umeclidinium to glycopyrronium involved 1,352 patients, with a difference of 24 ml.
The FDA approved Incruse Ellipta for the treatment of COPD in April 2014, shortly after the inhaler’s approval in Europe.
Read the GSK press release.
