OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness

Respiratory Tract Infections Clinical Trial

Official title: A Randomised, Placebo-Controlled, 3-Arm, Double-Blind, Multicentre, Phase 4 Study to Assess the Efficacy of OM-85 (Broncho-Vaxom) Short- and Long-Term Treatment vs. Placebo in the Prevention of Respiratory Tract Infections in Children Aged Between 6 Months and 5 Years With Wheezing Lower Respiratory Illness

Status Recruiting

Clinical Trial Summary

This study will assess the efficacy and safety of OM-85 compared to placebo in reducing the number of respiratory tract infections (RTIs) in children aged between 6 months and 5 years.

Clinical Trial Description

This is a Phase 4, randomised, double-blind, placebo-controlled study to assess the efficacy and safety of short- and long-term treatment with OM-85.

The study will consist of screening (up to 20 days before randomisation), Treatment period of 12 months, and an Observational period of 6 months.

A total of 426 subjects will be randomised in the study.

The subjects will be randomised in a ratio of 1:1:1 ratio to receive either OM-85 for 12 consecutive months (BV-12 arm), or OM-85 for 3 consecutive months followed by matching placebo for 9 consecutive months (BV-3 arm), or placebo for 12 consecutive months (Placebo arm).

The expected duration of subject participation is 18 months (+20 days) ;

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Sounds
• Respiratory Tract Infections

• NCT number: NCT05677763
• Study type: Interventional
• Source: OM Pharma SA
• Contact: Lorenz Lehr
• Phone: +41 22 783 14 59
• Email: lorenz.lehr@ompharma.com
• Status: Recruiting
• Phase: Phase 4
• Start date: December 12, 2022
• Completion date: June 30, 2025