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| |  Asthma Exacerbations Decreased by Metered-Dose Mometasone Furoate, Formoterol Combo: Presented at EAACI By Sara Freeman LONDON -- June 11, 2010 -- Twice-daily use of a single, metered-dose inhaler containing mometasone furoate (MF) 100 mcg and formoterol 10 mcg reduces the risk of moderate to severe asthma exacerbations, researchers said here at the 29th European Congress of the European Academy of Allergy and Clinical Immunology (EAACI). Data showed that the inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) combination produces "positive outcomes" regardless of how such exacerbations are described. "A joint statement from the American Thoracic Society [ATS] and the European Respiratory Society [ERS] in 2009 recommended criteria for the assessment and categorisation of asthma exacerbations in clinical trials," said Eli O. Meltzer, MD, Allergy and Asthma Medical Group and Research Center, San Diego, California, here on June 8. These recommendations were issued after the completion of a multinational, 26-week, randomised, double-blind, placebo-controlled study looking at the efficacy of the mometasone furoate /formoterol metered-dose inhaler. "The study included assessments on which the ATS/ERS statement definitions of severe and moderate asthma exacerbations are based," said Dr. Meltzer. It was therefore possible to re-evaluate the study data in a post hoc analysis. A total of 746 patients (aged >=12 years) had participated in the original study, but only those experiencing moderate or severe exacerbations according to the ATS/ERS criteria were included in the current analysis. Dr. Meltzer and colleagues found that fewer patients treated with the mometasone furoate/formoterol inhaler (n==181) than those treated with either the ICS (n=188) or LABA alone (n=188) or placebo (n=188), experienced moderate or severe exacerbations. Moderate exacerbations are defined by the ATS/ERS as deterioration in symptoms, deterioration in lung function, and/or increased bronchodilator use for >=2 days but is not severe enough to warrant systemic corticosteroid and/or hospital treatment. Less than one-third (32%) of patients treated with the mometasone furoate/formoterol inhaler experienced a moderate exacerbation. In comparison, moderate exacerbations were experienced by 48% of patients given the ICS alone, in 54% of those given the LABA alone, and in 64% of patients receiving placebo. Severe exacerbations are defined by the ATS/ERS as those that require systemic corticosteroid use for >=3 days, or an asthma-related hospitalisation or emergency visit requiring systemic corticosteroid use. Just 2% of patients treated with the mometasone furoate/formoterol inhaler experienced a severe exacerbation. Severe exacerbations in the other treatment groups were 2% for the ICS alone, 9% for the LABA alone, and in 9% for placebo. "These outcomes demonstrate the positive treatment effects of mometasone furoate/formoterol 100/10 mcg twice-daily, regardless of asthma severity definition," Dr. Meltzer and team concluded. Funding for this study was provided by Merck & Co. [Presentation title: Effects of Combined Mometasone Furoate and Formoterol Administered via a Single Metered-Dose Inhaler on Moderate and Severe Asthma Exacerbations as Defined by the American Thoracic Society and the European Respiratory Society. Abstract 1450]
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