Relovair fluticasone furoate/vilanterol: Phase III data

Top-line data from a pair of 52-week, double-blind, Phase III trials in 1,620 patients showed that Relovair fluticasone furoate/vilanterol did not exhibit a dose-response on the primary endpoint of reducing the annual rate of moderate and severe exacerbations vs. vilanterol alone. In the first study, Relovair significantly reduced exacerbations at 200/25 µg (p<0.001), 100/25 µg (p=0.040) and 50/25 µg (p=0.040) vs. 25 µg vilanterol. However, only the middle dose reached significance in a second, identical trial (p<0.001). The second trial is thus considered a failure because the trial prespecified a hierarchical statistical analysis and the highest dose did not meet the primary endpoint.

Also, GSK is investigating reports of fatal pneumonia with the highest dose. Theravance said GSK's regulatory submissions of Relovair for COPD would focus on the 100/25 µg dose. Adverse events in the trials included nasopharyngitis, upper respiratory tract infection, oral candidiasis, headache, COPD, back pain, pneumonia, bronchitis and sinusitis. ...