GSK573719/vilanterol: Phase IIIa data

A 24-week, double-blind, international Phase IIIa trial in 846 COPD patients showed that once-daily 62.5/25 and 125/25 µg doses of GSK573719/vilanterol each met the co-primary endpoints of improving trough FEV1 from baseline to the end of treatment on day 169 vs. 25 µg vilanterol alone and Spiriva HandiHaler tiotropium. Specifically, both doses of GSK573719/vilanterol led to control-adjusted improvements in trough FEV1 of 88-90 mL in each arm (p<0.001 for all). The most common adverse events reported in all treatment arms were headache, nasopharyngitis, upper respiratory tract infection, cough, oropharyngeal pain and back pain. The incidence of cardiovascular and serious adverse events was similar across all treatment arms. ...