Actively Recruiting
Omalizumab Before Onset of Exacerbations
Led by Children's National Research Institute · Updated on 2025-07-14
300
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
Sponsors
C
Children's National Research Institute
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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). Recruitment for each of the yearly cohorts of OBOE will begin in February. Each cohort will be followed for a 2-6-month run-in period with the objective to gain control of each participant's asthma and to stabilize the required controller medication step level. Participants will receive routine asthma care every 1-2 months (a total of 2-4 times) during run-in using a previously described algorithm developed by the Inner-city Asthma Consortium and successfully employed in the PROSE study. The primary outcome is the change in the amount of nasal IFN-α recovered by nasal fluid absorption between two time points, within 72 hours of onset of a URI as defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms) and 3-6 days after study drug injection.
CONDITIONS
Official Title
Omalizumab Before Onset of Exacerbations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or guardian can understand and provide informed consent in English; participants aged 7 or older can provide assent
- Age between 6 and 17 years at screening
- Physician-diagnosed persistent asthma
- At least 1 asthma exacerbation needing systemic corticosteroids in past 6 months or 2 in past 12 months before upcoming school year
- Sensitization to at least 1 perennial aeroallergen
- Total serum IgE and weight suitable for omalizumab dosing
- Insurance coverage for standard asthma medications
- Primary residence in a metropolitan area where at least 10% of families have income below the poverty line or have public health insurance
- At least one of the following: peripheral eosinophilia above 300/µL, total serum IgE over 300 kU/L, or sensitization to at least 3 perennial aeroallergens
- Females of childbearing potential must have a negative pregnancy test at study entry
- Females with reproductive potential must agree to use FDA-approved birth control during the study
- For randomization at fall sick visit: onset of URI symptoms within 72 hours confirmed by study physician
- No use of nasal corticosteroids or nasal vaccinations within 14 days before sick visit
- Negative rapid nasal swab test for SARS-CoV-2
- More than 14 days since last asthma exacerbation needing systemic steroids
- No current lower respiratory symptoms requiring systemic corticosteroids
- Complete nasal absorption sample collected within 72 hours of URI symptom onset as assessed by physician
You will not qualify if you...
- Inability or unwillingness of parent/guardian to consent or participant aged 7 or older to assent
- Contraindication to omalizumab
- Presence of other chronic serious medical conditions (e.g., serious heart/lung disorders, cancer, sickle cell disease, uncontrolled seizures, autoimmune disorders, type 1 diabetes)
- Pregnancy or active breastfeeding
- History of latex allergy
- Treatment with omalizumab, other monoclonal antibodies, or aeroallergen immunotherapy in past 6 months
- Planned homeschooling during 90-day outcome period
- History of life-threatening asthma requiring intubation or cardiac arrest
- Inability of caregiver and child to speak English
- Inability to stop nasal steroids or avoid nasal vaccinations during 90-day fall period as judged by investigator
- Other medical or lab findings that could increase risk, interfere with participation, or affect data quality as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Research Team
W
William Sheehan, MD
CONTACT
A
Alicia Mathis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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