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ARTICLE | Clinical News

Dulera mometasone/Formoterol: Phase III data

November 21, 2011 8:00 AM UTC

A double-blind, placebo-controlled Phase III trial in 1,055 patients showed that both doses of Dulera met the two co-primary endpoints. 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 (126 and 166 mL vs. 57 mL, p=0.007 and p<0.001). Formoterol alone and placebo improved FEV1 from baseline to week 26 by 77 and 3 mL, respectively.

On the second co-primary endpoint, low- and high-dose Dulera significantly improved pre-dose AM FEV1 from baseline to week 26 vs. 10 µg formoterol alone (58 and 111 mL vs. 0 mL, p=0.029 and p<0.001). Mometasone alone improved pre-dose AM FEV1 by 27 mL, while placebo worsened the measure by 17 mL. ...