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
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 or asthma-like episodes Inclusion Criteria
1. Age range: 6 months to 72 months (5 years)
2. History of wheeze episodes (for children not on daily controller or PRN users, at least 2 wheeze or asthma-like episodes, for children on daily controller, at least 1 wheeze or asthma-like episodes).
3. Up-to-date vaccination status as per applicable State Vaccination Requirements for school/daycare entry.
4. Parents or LAR have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures.
Exclusion Criteria
1. Known anatomic alterations of the respiratory tract.
3. Wheezing documented to be caused by GERD.
4. Children born before 34 weeks of gestational age.
5. Inability to comply with the study requested visit scheduled (e.g. expected relocation within 12 months of the screening for the study).
Locations
Childrens Hospital Colorado
Principal Investigator
Andrew Liu
Study ID
Protocol Number: 23-0534
Categories
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