Asthma and lower airway disease
The immunostimulant OM-85 BV prevents wheezing attacks in preschool children

https://doi.org/10.1016/j.jaci.2010.07.038Get rights and content

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.

Section snippets

Patients

The study included children who were 1 to 6 years old with 3 or more acute wheezing attacks induced by respiratory tract illness in the previous 6 months (according to medical records from outpatient clinics). Exclusion criteria were as follows: anatomic alterations of the respiratory tract; chronic respiratory diseases (tuberculosis and cystic fibrosis); autoimmune disease; liver or kidney failure; malnutrition; cancer; treatment with inhaled or systemic corticosteroids within the previous

Results

Eighty of 100 children were selected to participate in the trial. All participants in the placebo group completed the trial, but 5 patients in the OM-85 BV group did not. In the OM-85 BV group 1 patient refused to take the drug at the beginning of the study and was excluded from the study, 2 patients moved to another city (within the first 3 months of the study), and 2 patients did not attend any follow-up visits. The remaining 75 subjects (35 in the OM-85 BV group and 40 in the placebo group)

Discussion

We investigated the effects of OM-85 BV treatment on virus-provoked wheezing in preschool children with recurrent wheezing. We demonstrated in our study that treatment with OM-85 BV significantly reduced the incidence of acute wheezing attacks. The effects seem to be secondary to a reduction in respiratory tract illnesses. Much of the difference in the placebo group in terms of the rates of illness is certainly due to the seasonal fluctuations in respiratory tract illnesses. The rate of illness

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    Disclosure of potential conflict of interest: The authors have declared that they have no conflict of interest.

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