Randomized, Double blinded, placebo controlled, multiple-center, parallel arm study with 96 week treatment phase and 96 week observation phase
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
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.
Childrens Hospital Colorado
Andrew Liu, MD
Protocol Number: 18-2286
More information available at ClinicalTrials.gov: NCT02570984
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