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news.Merck has reported the positive data from Phase III clinical studies to assess the efficacy and safety of two dose strengths of Dulera (mometasone furoate and formoterol fumarate dihydrate) to treat severe chronic obstructive pulmonary disease (COPD).
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Dulera Inhalation Aerosol, which is used to treat asthma combines mometasone furoate, an inhaled corticosteroid, and formoterol fumarate, a long-acting beta2-agonist.
The two 26-week, multicenter, double-blind, placebo controlled trials comprising 2,251 with moderate to very severe COPD were randomized to receive inhaled Dulera 400 mcg/10 mcg, Dulera 200 mcg/10mcg, mometasone furoate 400 mcg, formoterol 10 mcg or placebo, each administered twice daily.
In the two studies, Dulera showed improved lung function as compared to treatment with mometasone furoate.