Omalizumab for Childhood Asthma
(OBOE Trial)
Trial Summary
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it does mention that you should not use nasal corticosteroids or nasal vaccinations within 14 days before a specific visit. It's best to discuss your current medications with the study team.
What data supports the effectiveness of the drug Omalizumab for childhood asthma?
Is omalizumab safe for children with asthma?
How is the drug omalizumab different from other asthma treatments?
Omalizumab is unique because it is a monoclonal antibody that targets and reduces IgE (a protein involved in allergic reactions), helping to control severe allergic asthma in children who do not respond well to standard treatments like inhaled steroids. It can also reduce the need for oral corticosteroids and decrease asthma attacks and hospital visits.211121314
What is the purpose of 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). 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.
Research Team
Stephen Teach, MD. MPH.
Principal Investigator
Children's National Research Institute
Eligibility Criteria
This trial is for urban youth aged 6-17 with persistent asthma, who have had at least one severe asthma attack in the past six months. They must be sensitive to certain allergens, meet specific IgE levels and eosinophil counts, and not currently need steroids for respiratory symptoms. Participants can't join if they're pregnant or lactating, have a latex allergy, plan to homeschool during the study period, or have been treated with omalizumab recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants are followed for a 2-6 month run-in period to gain control of asthma and stabilize medication levels
Treatment
Single dose of omalizumab or placebo administered at the onset of a viral upper respiratory infection
Follow-up
Participants are monitored for safety and effectiveness after treatment, including unscheduled healthcare utilization and asthma control
Treatment Details
Interventions
- Omalizumab
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stephen J. Teach, MD, MPH
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator