Relovair fluticasone furoate/vilanterol: Phase III data

Top-line data from a 12-week Phase III trial in about 500 patients with COPD showed that once-daily 100/25 µg Relovair fluticasone furoate/vilanterol met the primary endpoint of superiority to twice-daily 250/50 µg Advair fluticasone propionate/salmeterol in 24-hour weighted mean FEV1 (p<0.001). Earlier this year, the partners reported that Relovair missed the primary endpoint of superiority to 500/50 µg Advair in 24-hour weighted mean FEV1 in a separate 12-week Phase III trial (see BioCentury, Jan. 16). Last year, the companies reported data from a pair of 6-month, double-blind Phase III trials showing that Relovair met 5 of the 6 co-primary endpoints (see BioCentury, June 6, 2011). ...