The immunostimulant OM-85 BV prevents wheezing attacks in preschool children

J Allergy Clin Immunol. 2010 Oct;126(4):763-9. doi: 10.1016/j.jaci.2010.07.038.


Background: No reagents have been shown to be effective in preventing wheezing attacks provoked by acute respiratory tract illnesses (ARTIs) in preschool children. New therapeutic agents and preventive strategies are needed.

Objectives: We assessed the effect of OM-85 BV (Broncho-Vaxom; OM Pharma, Geneva, Switzerland) in preventing ARTI-provoked wheezing attacks in preschool children with recurrent wheezing.

Methods: A randomized, double-blind, placebo-controlled, parallel-group study was carried out between August 2007 and September 2008. The study included 75 children with recurrent wheezing who were 1 to 6 years old. Participants were randomly assigned to groups given either OM-85 BV or a placebo (1 capsule per day for 10 days each month for 3 consecutive months) at the start of the trial. Participants were followed for 12 months, which included the administration period of the test article.

Results: Subjects given OM-85 BV had a lower rate of wheezing attacks. The cumulative difference in wheezing attacks between the 2 groups was 2.18 wheezing attacks per patient in 12 months; there was a 37.9% reduction in the group given OM-85 BV compared with the group given placebo (P < .001). Stepwise multiple (linear) regression analysis showed that the main difference between the OM-85 BV and placebo groups was a reduction the number of ARTIs (R = -0.805, P < .001). The duration of each wheezing attack was 2 days shorter in the group given OM-85 BV than in the group given placebo (P = .001).

Conclusion: Administration of OM-85 BV significantly reduced the rate and duration of wheezing attacks in preschool children with ARTIs.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Adjuvants, Immunologic / therapeutic use*
  • Bacteria
  • Cell Extracts / therapeutic use*
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Humans
  • Infant
  • Recurrence
  • Respiratory Sounds / drug effects*
  • Respiratory Sounds / etiology
  • Respiratory Tract Infections / complications
  • Respiratory Tract Infections / drug therapy*
  • Treatment Outcome


  • Adjuvants, Immunologic
  • Broncho-Vaxom
  • Cell Extracts