NCT05677763

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

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: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 525 (actual)
• Sponsor: OM Pharma SA · Industry
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. 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).

Conditions

• Respiratory Tract Infections
• Wheezing Lower Respiratory Illness

Interventions

Type	Name	Description
DRUG	OM-85	Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month)
DRUG	Placebo	Subjects will be administered Placebo once daily. (10 days per month)

Timeline

• Start date: 2022-12-12
• Primary completion: 2026-03-10
• Completion: 2026-09-16
• First posted: 2023-01-10
• Last updated: 2026-03-24

Locations

42 sites across 6 countries: Germany, Hungary, Italy, Poland, Switzerland, United Kingdom