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

Primary Objective

The EAGLE (Efficacy Assessment in recurrent wheezinG chiLdrEn) Study is looking at how safe and effective a 6-month daily course of a study drug, Broncho-Vaxom, is for reducing the number of wheezing/asthma-like episodes (WEs) in young children who have recurrent wheezing.

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Description

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study with 6 month treatment phase and 6 month observation phase.

Details
Age

Child

Eligibility

1. Age range: 6 months to 72 months (5 years) 2. History of wheeze episodes

Locations

Childrens Hospital Colorado

Principal Investigator
Photograph of Andrew Liu

Andrew Liu

Study ID

Protocol Number: 23-0534

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