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Title: OM-85 May Prevent Exacerbations of Chronic Bronchitis: Presented at ATS

"OM-85 May Prevent Exacerbations of Chronic Bronchitis: Presented at ATS"

By Charlene Laino ORLANDO, FL -- May 27, 2004 -- The oral bacterial extract OM-85, or bronchovaxom, can help to prevent acute exacerbations of chronic bronchitis, suggest the findings of a phase 4 study. Markus Solèr, MD, Lung Specialist and Professor of Medicine, Department of Chest Diseases, Kantonsspital Basel, Basel, Switzerland, presented the results here on May 26th at the 100th International Conference of the American Thoracic Society. To study the protective effect of the oral bacterial lysate OM-85 in patients with recurrent bronchitis, Dr. Solèr and colleagues conducted a double blind, placebo-controlled study with 273 patients, ages 40 years to 75 ears, with a history of chronic bronchitis or mild chronic obstructive pulmonary disease, who were experiencing an acute exacerbation of their disease. The compound is a detoxified extract from 8 bacterial species that can cause upper respiratory tract infections, Dr. Solèr said. Patients were randomized to 1 capsule of OM-85 or placebo daily for the first month, and then 10 days per month for the next 3 months. Additional drugs, including antibiotics, were allowed as required. Of the 142 patients in the active treatment arm, 85 were current or ex-smokers; of the 131 patients in the placebo group, 76 were or had been smokers. "We started the trial in the fall, so we could see if the drug would protect patients throughout the winter season," Dr. Solèr said. By the end of month 5, patients given OM-85 were 29.1% less likely to have suffered an acute exacerbation of chronic bronchitis compared with those on placebo (P =.03), Dr. Solèr said. The difference was even more pronounced in current and ex-smokers, who were 36.8% less likely to have an acute exacerbation if given OM-85 than if given placebo (P <.01), he said. "These results confirm that OM-85 is a valuable drug for reducing the frequency of acute exacerbations of chronic bronchitis," Dr. Solèr said. OM-Pharma, of Geneva, Switzerland, sponsored the trial, which was needed to renew its license in Europe, he added. [Presentation title: "Prevention of exacerbations in chronic bronchitis and COPD with OM-85, a double-blind, placebo-controlled trial." Poster #506]

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