Omalizumab Before Onset of Exacerbations

Recruiting Phase 2 Interventional Study
Asthma in Children Atopy Viral Upper Respiratory Infection
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 – 17
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Children's National Research Institute · Other
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About This Trial
OBOE is a prospective, pilot, parallel group RCT with the overall aim of examining the effect of a single dose of anti-IgE (omalizumab) vs. placebo administered at the onset of URIs in the fall season among highly exacerbation-prone, urban, and atopic youth aged 6-17 years with persistent asthma. OBOE will recruit and randomize participants over 3 years (3 annual cohorts of participants). Recruitm…
Trial Locations
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Eligibility Criteria
Inclusion Criteria at Study Entry: Participants must meet the following: 1. Parent or guardian must be able to understand and provide informed consent in English and participants ≥7 must be able to provide assent 2. 6-17 years, inclusive at time of screening 3. Physician-diagnosed persistent asthm…
Contacts

William Sheehan, MD

202-476-5000

wsheehan@cnmc.org

CONTACT

Alicia Mathis

202-476-5000

anewcome@childrensnational.org

CONTACT