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Mometasone Plus Formoterol Appears Safe in Severe Persistent Asthma: Presented at ACAAI By Micheal Casasnovas MIAMI BEACH, Fla -- November 13, 2009 -- Therapy with a metered-dose inhaler containing a combination of mometasone furoate and formoterol is safe and well-tolerated for patients with severe persistent asthma, according to a study presented here at the American College of Allergy, Asthma & Immunology (ACAAI) annual scientific meeting. “We didn’t observe any unexpected safety issues when we looked at the results of this phase 3,” said Martha White, MD, Institute for Asthma & Allergy, Wheaton, Maryland, on November 8. Dr. White reported the safety and tolerability results from the trial, which randomised 728 patients aged 12 years or older with severe, persistent asthma that had not responded for at least 1 year to high-dose inhaled corticosteroids alone or in combination with a long-acting beta2-agonist. “When we treat patients, especially those who have been on high-dose steroids for their asthma, we are concerned regarding the emergence of oral candidiasis, or oral thrush, as a drug-related adverse event,” she said. “In this study we only saw 0.7% incidence of thrush, 5 cases among 728 patients.” All patients underwent a 2- to 3-week run-in period with mometasone furoate 400 mcg twice a day. During 12 weeks of blinded treatment, the most common adverse events were nasopharyngitis (4.5%), headache (3.2%), sinusitis (2.5%), upper respiratory tract infection (2.2%), and bronchitis (2.1%). The adverse events were similar across the treatment group. The side-effect profiles for the combination and for formoterol monotherapy were similar, she said. Discontinuations due to adverse events were rare and there were no deaths. Funding for this study was provided by Schering-Plough. [Presentation title: The Safety and Tolerability of High And Medium Doses of Mometasone Furoate/Formoterol Combination Treatment in Subjects With Severe Persistent Asthma. Abstract P88] E-mail this page to a friend or colleague! To print, use this version