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Clinical Trial Summary

This study will assess the efficacy and safety of daily OM-85 treatment compared to placebo in children aged 6 months to 5 years with recurrent wheezing


Clinical Trial Description

This study is a 12-months phase 2, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of daily treatment with OM-85 compared to placebo, when given on top of standard of care treatment, in reducing wheezing/asthma like episodes (WEs) during the 6-month treatment period in children aged 6 months to 5 years with previous recurrent WEs. Patients will be randomized in a 1:1 ratio to OM-85 or placebo. The study consists of screening period (Day -20 to Day -1), a treatment period of 6 months, and an observational period of 6 months without treatment. Thus, the total duration of the study for each patient will be 12 months (±10 days) + up to 20 days for screening. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05857930
Study type Interventional
Source OM Pharma SA
Contact Lorenz Lehr
Phone +41 22 7831459
Email lorenz.lehr@ompharma.com
Status Recruiting
Phase Phase 2
Start date June 20, 2023
Completion date February 28, 2026

See also
  Status Clinical Trial Phase
Completed NCT01072552 - Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants N/A
Completed NCT01545245 - Effects of Preventive Treatment for Respiratory Syncytial (RS) Virus Infection During Infancy on Later Atopic Asthma in Preterm Infants N/A