Omalizumab Before Onset of Exacerbations (OBOE)
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- STATUS
- Recruiting
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- End date
- Jan 31, 2025
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- participants needed
- 300
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- sponsor
- Stephen J. Teach, MD, MPH
Summary
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.
Details
| Condition | Asthma in Children, Atopy, Viral Upper Respiratory Infection |
|---|---|
| Treatment | Placebo, omalizumab |
| Clinical Study Identifier | NCT05332067 |
| Sponsor | Stephen J. Teach, MD, MPH |
| Last Modified on | 7 October 2022 |
Eligibility
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