Dulera mometasone/Formoterol: Phase III data

A double-blind, placebo-controlled Phase III trial in 1,196 patients showed that both doses of Dulera met one co-primary endpoint and missed the other. On the first co-primary endpoint, twice-daily low- and high-dose Dulera (200 µg/10 µg and 400 µg/10 µg mometasone/formoterol, respectively) significantly improved FEV1 from baseline to week 26 vs. 400 µg mometasone alone (139 and 179 mL vs. 53 mL, p<0.001 for each). Formoterol alone and placebo improved FEV1 from baseline to week 26 by 92 and 18 mL, respectively.

On the second co-primary endpoint, low- and high-dose Dulera non-significantly improved pre-dose AM FEV1 from baseline to week 26 vs. formoterol alone (98 and 63 mL vs. 49 mL). Mometasone alone improved pre-dose AM FEV1 by 28 mL, while placebo worsened pre-dose AM FEV1 by 3 mL. ...