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Controlling and Preventing Asthma Progression and Severity in Kids with Omalizumab
Primary Objective
Studies show that up to 80% of children ages 2 to 3 years old who have allergies and multiple wheezing episodes will eventually develop asthma. What if there were a way to reduce the risk of asthma developing in young children? Researchers across the United States are studying weather Xolair can help prevent lasting, severe asthma and new allergies from developing, or reduce the severity of existing ones, in preschool-age children. If your child is 2 or 3 years old, he or she may be eligible to participate in this clinical study.
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
Phase
II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
Type of Study
Treatment
Scope
National
Location
Childrens Hospital Colorado
Principal Investigator
Andrew Liu, MD
Study ID
Protocol Number: 18-2286
More information available at ClinicalTrials.gov: NCT02570984
Categories
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