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Controlling and Preventing Asthma Progression and Severity in Kids with Omalizumab

Primary Objective

1.The diagnosis of current asthma at the end of the observation period compared to placebo. Asthma will be diagnosed using definitions established in the NIAID funded birth cohort study (URECA) 2. Population asthma burden at the end of the observation period compared to placebo. Asthma burden will be defined by the combination of asthma diagnosis and asthma severity (in children diagnosed with asthma) as measured by the average Composite Asthma Severity Index (CASI) score65 over the final three study visits

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Description

Randomized, Double blinded, placebo controlled, multiple-center, parallel arm study with 96 week treatment phase and 96 week observation phase

Details
Age
Child
Eligibility
1. Age range: 24 through 47 months of age at the screening visit; participant must be under 4 years of age at the time of the randomization visit 2. 2 to 4 wheezing episodes in the past year documented on physical examination by a health care provider 3. Report of a diagnosis of asthma or allergy by a medical professional, or a positive test for allergy (skin test or serum test) in a first degree relative
Locations

Childrens Hospital Colorado

Principal Investigator
Photograph of Andrew Liu

Andrew Liu

Study ID

Protocol Number: 18-2286

More information available at ClinicalTrials.gov: NCT02570984

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