Relovair fluticasone furoate/vilanterol: Phase III data

Top-line data from a double-blind, Phase III trial in about 2,000 patients with moderate to severe asthma showed that 100/25 µg Relovair fluticasone furoate/vilanterol met the primary endpoint of superiority in increasing time to first asthma exacerbation vs. 100 ug fluticasone furoate alone (p=0.036). Relovair also met the secondary endpoint of significantly decreasing the annual rate of severe exacerbations vs. fluticasone (p=0.014).

Relovair also improved trough FEV1 at all pre-defined time points over the 76 week treatment period (p<0.001). Adverse events include headache, nasopharyngitis, upper respiratory tract infection, bronchitis, cough, oropharyngeal pain and influenza. ...