Clinical efficacy of OM-85 BV in COPD and chronic bronchitis: A systematic review

Mark D. Sprenkle, Dennis E. Niewoehner, Roderick MacDonald, Indulis Rutks, Timothy J. Wilt

Research output: Contribution to journalArticlepeer-review

25 Scopus citations


OM-85 BV is an immunomodulatory agent used for prevention of exacerbations in persons with chronic lung disease. We conducted a systematic review of OM-85 BV to evaluate its efficacy and safety. A systematic search for relevant articles was performed. Studies were included if they involved persons with chronic obstructive pulmonary disease or chronic bronchitis and were randomized to OM-85 BV or placebo. Investigators extracted data on study design, participant characteristics, and clinical outcomes. Thirteen trials involving 2066 individuals met inclusion criteria. Three trials enrolled an older, more homogenous population with chronic obstructive pulmonary disease. Utilizing quantitative pooled analysis in these studies, with one or more acute exacerbations as the endpoint, we found a non-statistically significant trend in favor of OM-85 BV [relative risk 0.83, 95% confidence interval 0.65-1.05]. Ten trials enrolled a heterogeneous population with chronic bronchitis. In these trials, exacerbation rates were less with OM-85 BV in 4 of 9 trials reporting this outcome. Varied results in the outcomes of hospitalization, symptom scores, and antibiotic or steroid use were found across studies. Withdrawals and adverse events were similar between OM-85 BV and placebo. While OM-85 BV is used to prevent exacerbations in persons with chronic lung disease, consistent evidence across multiple important outcomes does not exist to clearly demonstrate clinical benefit. Further randomized controlled trials enrolling large numbers of persons with well-defined COPD are necessary to confirm the effectiveness of this agent.

Original languageEnglish (US)
Pages (from-to)167-175
Number of pages9
JournalCOPD: Journal of Chronic Obstructive Pulmonary Disease
Issue number1
StatePublished - 2005


  • Broncho vaxom
  • Chronic bronchitis
  • Chronic obstructive pulmonary disease
  • Meta-analysis
  • OM-85 BV


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