Double-blind study of OM-85 in patients with chronic bronchitis or mild chronic obstructive pulmonary disease
Abstract
BACKGROUND: Interventions against acute exacerbations (AEs) of chronic obstructive pulmonary disease (COPD) are increasingly called for to reduce morbidity, mortality and costs. OM-85, a detoxified immunoactive bacterial extract, has been shown to prevent recurrent exacerbations of bronchitis and COPD.
OBJECTIVES: It was the aim of this study to demonstrate the protective effect of OM-85 against recurrent bronchitic exacerbations in patients with chronic bronchitis or mild COPD. The primary end point was the mean rate of AEs occurring within the study period.
METHODS: This double-blind multi-centre study enrolled adult outpatients>40 years old of both sexes with a history of chronic bronchitis or mild COPD at the time of an AE. The treatment consisted of one capsule of OM-85 or placebo per day for 30 days, followed by three 10-day courses for months 3, 4 and 5, with a 6-month study duration and monthly control visits.
RESULTS: One hundred and forty-two patients were treated with OM-85 and 131 received placebo. By the end of the treatment period, the mean number of AEs in the OM-85 group was 0.61 per patient versus 0.86 per patient in the placebo group (-29%; p=0.03). The difference between treatments was most notable in patients with a history of current or past smoking (-40%; p<0.01). No serious adverse events were attributed to the medication and no significant laboratory changes were reported.
CONCLUSIONS: OM-85 significantly reduced the frequency of AEs in patients with…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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