Reducing exacerbations in COPD with OM-85: A multicentre, double-blind, placebo-controlled trial

Background: Acute exacerbations in COPD (AE-COPD) are a key driver of morbidity and mortality. They are mainly triggered by respiratory infections. OM-85 is a bacterial lysate with immunostimulating properties already known to reduce AE-COPD. Aims and objectives: Confirm and further investigate the efficacy and safety of OM-85 (Broncho-Vaxom®, Broncho-Munal®, Ommunal®) with a specific dosage regimen in reducing the rate of acute exacerbations in moderate to severe COPD patients. Methods: This randomised, placebo-controlled, double-blind, multicentre trial was performed with 340 patients from 5 countries, past or active smoker, over 40 years old, with COPD stage II or III, with a history of at least 2 documented AE-COPD in the previous year, and a FEV1 between 30% and 80%. The specific dosage regimen was 1 capsule daily during month 1, and 1 capsule daily for 10 days in months 3 to 5. Results: Preliminary results show that OM-85 significantly reduced the rate of AE-COPD by 35.4% after the 5 months treatment period (p=0.0155). The mean duration of AE-COPD was significantly decreased by 1.4 days in the OM-85 group (2.79 days), as compared to placebo (4.15 days) (p=0.0498).The rate of treatment-emergent adverse events (TEAEs) was similar in both treatment groups (OM-85: 44.1%, placebo: 43.3%). Conclusion: OM-85 significantly reduced the rate and duration of AE-COPD in moderate to severe COPD patients. Safety and tolerance were excellent.