Twelve-week efficacy and safety study of mometasone furoate/formoterol 200/10 μg and 400/10 μg combination treatments in patients with persistent asthma previously receiving high-dose inhaled corticosteroids
A significant unmet medical need exists in patients with uncontrolled asthma. The purpose of this study was to evaluate the efficacy and safety of mometasone furoate/formoterol (MF/F) 400/10 μg versus MF 400 μg administered twice-daily (b.i.d.) via metered-dose inhaler in patients with asthma uncontrolled on high-dose inhaled corticosteroids (ICS). In a 12-week, randomized, multicenter, double-blind, parallel-group study, patients (≥12 years of age) were randomized to MF/F 200/10 μg, MF/F 400/10 μg, or MF 400 μg, b.i.d. after a 2- to 3-week open-label run in with MF 400 μg b.i.d. The primary end point was mean change in area under the curve from 0 to 12 hours in forced expiratory volume in 1 second (FEV1 AUC0‐12h) from baseline to week 12 for MF/F 400/10 μg versus MF 400 μg. Effects of MF/F on asthma control and symptoms were evaluated and adverse events recorded. Seven hundred twenty-eight patients were randomized. Significant improvement from baseline to week 12 occurred for mean change in FEV1 AUC0‐12h with MF/F 400/10 μg (4.19 L × hour) versus MF 400 μg (2.04 L × hour; p < 0.001). Both MF/F doses resulted in rapid (5 minutes) and sustained improvement in lung function throughout 12 weeks. Both MF/F doses were superior to MF in improving asthma control and reducing nocturnal awakenings due to asthma requiring short-acting β2-agonist use. All treatments were well tolerated. Asthma patients who were poorly controlled on high-dose ICS experienced significant improvement in asthma control, lung function, and symptoms when treated with MF/F compared with MF.
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Document Type: Research Article
Affiliations: Allergy and Asthma Specialists Medical Group, 17742 Beach Boulevard, Huntington Beach, CA 92647, USA. [email protected]
Publication date: 01 July 2010
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