A randomized, placebo-controlled, double-blinded, single-centre, phase IV trial to assess the efficacy and safety of OM-85 in children suffering from recurrent respiratory tract infections

Susanna Esposito,Samantha Bosis,Claudia Tagliabue,Sonia Bianchini,Alberto Argentiero,Ilaria Coro,Nicola Principi

doi:10.1186/s12967-019-2040-y

Abstract

BackgroundOver many years, OM-85, a lysate of 21 common bacterial respiratory pathogens, has been demonstrated to prevent respiratory recurrences in children. However, further studies are needed to explore the true importance of OM-85 in the prevention of respiratory tract infections (RTIs) in children. This study was planned to further contribute to the evaluation of the role played by OM-85 in prevention of recurrent RTIs in children.MethodsThis study was a randomized (3:3:1), placebo-controlled, double-blind, single-centre, phase IV trial carried out in Italy to assess the efficacy of OM-85 (Broncho-Vaxom®; Vifor Pharma; Meyrin 2/Geneva, Switzerland) in reducing the number of new RTI episodes in 288 children aged 1 to 6 years with a history of recurrent RTIs and to compare the efficacy of the standard 3-month regimen with that of administration of OM-85 for 6 months during a 6-month study period.ResultsThe number of RTIs and of children who experienced at least one RTI were significantly lower among patients receiving OM-85 for 3 months than among those given placebo (33% vs 65.1%, p < 0.0001). Differences were statistically significant for upper RTIs (i.e., common cold/viral pharyngitis and acute otitis media; p < 0.0001 and p = 0.006, respectively). Days of absence from day-care for children and working days lost by parents were significantly lower in the group with children treated with OM-85 for 3 months than in the placebo group (p = 0.007 and p = 0.004, respectively). No difference was seen between children who received OM-85 for 3 and those who received OM-85 for 6 months. The prevalence of atopy as well as the history of recurrent wheezing and age of the study child did not influence the results. Benefit was maximally evident among children with a history of frequent recurrences. OM-85 was well tolerated and safe, even in children who received an influenza vaccination.ConclusionsThe use of OM-85 for 3 months in 3 series of 10 consecutive days each time reduces the risk of recurrent RTIs in children, with a favourable safety profile. The greater effect observed in children prone to several respiratory episodes than in non-prone children seems to indicate that this lysate should be administered especially to children with a proven high susceptibility to RTIs.

Highlights

Over many years, OM-85, a lysate of 21 common bacterial respiratory pathogens, has been demonstrated to prevent respiratory recurrences in children
This study was planned to further contribute to the evaluation of the role played by OM-85 in prevention of recurrent respiratory tract infections (RTIs) in children
In most of the cases (35 out of 42, 83.3%), refusal of parents to continue the study after the first or second month following definitive enrolment was the reason for the study exit

Summary

Introduction

OM-85, a lysate of 21 common bacterial respiratory pathogens, has been demonstrated to prevent respiratory recurrences in children. Further studies are needed to explore the true importance of OM-85 in the prevention of respiratory tract infections (RTIs) in children. In otherwise healthy infants and young children, respiratory tract infections (RTIs) are extremely common. In most cases, they are frequently recurrent and, despite being generally mild and spontaneously resolving in a few days, they cause significant medical, social and economic problems for children, their families and society [1,2,3]. To reduce the total burden of RTIs, prevention of recurrences through elimination of environmental factors and systematic use of available vaccines are strongly suggested [4]. To improve protection, boosting immune system activity has been suggested [8]

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