NCT05857930

A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess the Efficacy and Safety of Daily OM-85 Treatment vs. Placebo Given in Children Aged 6 Months to 5 Years With Recurrent Wheezing

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 296 (actual)
• Sponsor: OM Pharma SA · Industry
• Sex: All
• Age: 6 Months – 72 Months
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Recurrent Wheezing
• Wheezing Lower Respiratory Illness

Interventions

Type	Name	Description
DRUG	OM-85	OM-85 capsule (3.5mg) contents will be mixed with adequate quantity of water, fruit juice or milk/formula and orally administered once a day for 6 consecutive months.
DRUG	Placebo	Placebo capsule contents will be mixed with adequate quantity of water, fruit juice or milk/formula and orally administered once a day for 6 consecutive months.

Timeline

• Start date: 2023-06-20
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2023-05-15
• Last updated: 2026-02-23

Locations

38 sites across 4 countries: United States, Australia, Hungary, Poland

Regulatory

• FDA-regulated drug study