This trial is a randomized, double-blind, placebo controlled trial designed to test whether two years treatment of preschool children aged 2-3 years of age at high risk for asthma with omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as reflected by a reduction in the prevalence of active asthma in the Final 12 months during 2 year observation period off study drug.
Prevention/ Disease modification of asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
anti-ige injection
placebo comparator arm, injection similar to active
Phoenix Children's Hospital
Phoenix, Arizona, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
active asthma diagnosis
questionnaire
Time frame: Final 12 months during 2 year observation period off study drug
asthma severity
questionnaire
Time frame: Final 12 months during 2 year observation period off study drug
number of positive new allergic sensitization
skin prick test
Time frame: Final 12 months during 2 year observation period off study drug
decrease in number of wheezing episodes
questionnaires
Time frame: Final 12 months during 2 year observation period off study drug
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Connecticut Children's Hospital
Hartford, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Indiana University/Riley Children's Hospital
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
...and 3 more locations