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| |  Combination Therapy Effective, With Few Adverse Events in Moderate Persistent Asthma: Presented at ACAAI By Micheal Casasnovas MIAMI BEACH, Fla -- November 13, 2009 -- A combination asthma treatment under development appears to cause few adverse side effects when compared with treatment with inhaled corticosteroids alone, researchers said here at the American College of Allergy, Asthma & Immunology (ACAAI) annual scientific meeting. Researchers reported tests with a device that allows patients to receive prescribed doses of the inhaled corticosteroid mometasone furoate and the long-acting beta2-agonist formoterol and found that treatment-related adverse events were similar to treatment with the mometasone monotherapy, formoterol monotherapy, or placebo. “Our findings in this clinical trial indicate that we can give these drugs together without significantly increasing the risk of adverse events,” said David Pearlman, MD, Colorado Allergy and Asthma Centers, Denver, Colorado, on November 8. Dr. Pearlman and colleagues randomly assigned 191 patients with moderate persistent asthma that had previously been treated with medium-dose inhaled corticosteroids, with and without additional long-acting beta2-agonist, to treatment with the combined mometasone furoate/formoterol therapy delivered with a pressurised metered dose inhaler with a hydrofluoroalkane propellant. The treatment dose was 200/10 mcg twice a day administered in 2 actuations. Another 192 patients were administered 200 mcg of mometasone furoate twice a day; a third group of 202 patients was assigned to receive 10 mcg of formoterol twice a day; and 196 patients were assigned to receive placebo in the 26-week study. Dr. Pearlman reported that the most common adverse events seen in the study were upper respiratory tract infections, which occurred in 7.2% of the patients. However, when the researchers tried to determine which of those events were caused by the drugs, they found that 1.5% of these infections were attributable to placebo; none were attributable to formoterol monotherapy; and 0.5% was attributable to both mometasone furoate monotherapy and the combination therapy. Nasopharyngitis was observed in 6% of patients, but cases attributable to the drug were 0.5% of those on the combination. Headache was reported in 4.1% of all the patients, but was considered drug-related in 0.5% of the mometasone monotherapy patients and in 1% of the placebo patients. Treatment-related events, dysphonia and oral candidiasis, occurred in 1% of the patients on the combination therapy. Dysphonia and oral candidiasis occurred in 0.5% of mometasone monotherapy and in 0.5% of placebo patients. Dysphonia was seen in 0.5% of formoterol patients and oral candidiasis was observed in 1% of formoterol patients. “In this study, incidences of treatment-related adverse events and discontinuations due to adverse events were low and comparable between the 4 groups,” said Dr. Pearlman. He said 2% of the patients on the combination discontinued treatment due to adverse events compared to 3% on mometasone monotherapy, 4% on formoterol monotherapy, and 4% on placebo. [Presentation title: Safety and Tolerability of Mometasone Furoate/Formoterol for Persistent Asthma Subjects Who Previously Were Treated With Medium-Dose Inhaled Corticosteroid (Alone or With a Long-Acting Beta2-Agonist). Abstract P61]
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