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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

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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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Keywords: Asthma deterioration; bronchodilation; combination; efficacy; exacerbation; formoterol; mometasone furoate; nocturnal awakening; severe asthma; spirometry

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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  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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