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

Type of Study

Treatment

Scope

National

Locations

Childrens Hospital Colorado

Principal Investigator
Photograph of Andrew Liu,  MD

Andrew Liu, MD

Study ID

Protocol Number: 23-0534

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