Merck & Co. (Westpoint, PA) Announces Presentation of Phase III Investigational Studies Evaluating DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol in Chronic Obstructive Pulmonary Disease (COPD)
Published: Oct 25, 2011
HONOLULU--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from two 26-week investigational Phase III clinical studies evaluating the efficacy and safety of two dose strengths of DULERA® (mometasone furoate and formoterol fumarate dihydrate) in adults 40 years and older with moderate to very severe chronic obstructive pulmonary disease (COPD). The two dose strengths evaluated in the studies were DULERA 100 mcg/5 mcg and DULERA 200 mcg/5 mcg, both administered as two inhalations twice daily (i.e. 200 mcg/10 mcg and 400 mcg/10 mcg, twice daily). In both studies, DULERA 200 mcg/10 mcg and DULERA 400 mcg/10 mcg significantly improved lung function as measured by forced expiratory volume in one second (FEV1) area under the curve over 0-12 hours (AUC0-12hr) at Week 13 (one of the co-primary endpoints) compared to treatment with mometasone furoate 400 mcg (administered as two inhalations of mometasone furoate 200 mcg twice daily), the primary treatment comparison for this endpoint, or placebo alone.