Aclidinium bromide and formoterol: Phase III data

Almirall and partner Forest reported top-line data from the 5-arm, double-blind, international Phase III AUGMENT COPD trial in 1,692 patients with moderate to severe COPD showing that the twice-daily 400/12 µg fixed-dose combination of aclidinium bromide and formoterol delivered via Almirall's Genuair inhaler met the co-primary endpoints of improving morning pre-dose trough FEV1 from baseline to week 24 vs. 12 µg formoterol (p<0.05) and of improving FEV1 from baseline at 1 hour post-dose vs. 400 µg aclidinium bromide (p<0.0001). The twice-daily 400/6 µg fixed-dose combination of aclidinium/formoterol missed the morning pre-dose trough FEV1 co-primary endpoint (p>0.05), but met the FEV1 at 1 hour post-dose co-primary endpoint (p<0.0001).

Compared to 12 µg formoterol, morning pre-dose trough FEV1 improved by 26 mL for twice-daily 400/6 µg aclidinium/formoterol and by 45 mL for twice-daily 400/12 µg aclidinium/formoterol. Both fixed-dose combinations of aclidinium/formoterol significantly improved morning pre-dose trough FEV1 compared to placebo (111 and 130 mL, respectively, p<0.0001 for both). Compared to 400 µg aclidinium bromide, FEV1 at 1 hour post-dose improved by 87 mL for 400/6 µg aclidinium/formoterol and by 108 mL for 400/12 µg aclidinium/formoterol. Both fixed-dose combinations of aclidinium/formoterol significantly improved FEV1 at 1 hour post-dose compared to placebo (263 and 284 mL, respectively, p<0.0001 for both). ...