Comparative study of Anoro Ellipta meets primary endpoint in chronic obstructive pulmonary disease.- GlaxoSmithKline + Innoviva.

GlaxoSmithKline and Innoviva announced positive data from a study comparing Anoro Ellipta (umeclidinium/vilanterol 62.5mcg/25mcg; UMEC/VI) and Stiolto Respimat (tiotropium/olodaterol 5mcg/5mcg; TIO/OLO), for symptomatic patients with chronic obstructive pulmonary disease (COPD). The primary endpoint for this eight-week, open-label, cross-over study of 236 patients with COPD was the demonstration of non-inferiority of UMEC/VI compared to TIO/OLO in improving lung function, as measured by trough FEV1 (Forced Expiratory Volume in 1 second) at week eight. This endpoint was met, and furthermore UMEC/VI demonstrated superiority to TIO/OLO, with a difference in treatment effect of 52mL on trough FEV1 at week eight (UMEC/VI 180mL vs. TIO/OLO 128mL; 95% CI: 28, 77; p<0.001).

Both treatments demonstrated a comparable tolerability and safety profile with an overall incidence of on-treatment adverse events of 25% in the UMEC/VI group and 31% in the TIO/OLO group. The most frequently-reported adverse events were upper respiratory tract infections (UMEC/VI 8%; TIO/OLO 9%), cough (UMEC/VI 1%; TIO/OLO 1%) and diarrhoea (UMEC/VI 1%; TIO/OLO 1%). These data have been published in Advances in Therapy and are being presented at the CHEST annual meeting.