Fluticasone furoate/umeclidinium/vilanterol: Additional Phase III data

Additional data from the double-blind, double-dummy, international Phase III FULFIL trial in 1,810 COPD patients showed that once-daily inhaled fluticasone furoate/umeclidinium/vilanterol delivered in GlaxoSmithKline’s Ellipta dry powder inhaler significantly improved trough FEV1 by 179 mL and significantly reduced SGRQ total score by 2.7 units from baseline to week 52 vs. twice-daily Symbicort Turbohaler budesonide/formoterol. Fluticasone furoate/umeclidinium/vilanterol also significantly reduced the annual rate of moderate/severe exacerbations by 35% at week 24 and by 44% at week 52 vs. Symbicort Turbohaler (p=0.002 and p=0.006, respectively). Data were presented at the European Respiratory Society meeting in London. GSK previously reported that fluticasone furoate/umeclidinium/vilanterol met the co-primary endpoints of improving trough FEV1 (improvement of 171 mL, p<0.001) and SGRQ total score (reduction of 2.2 units, p<0.001) from baseline to week 24 vs. Symbicort Turbohaler (see BioCentury, June 27). ...