Omalizumab Before Onset of Exacerbations (OBOE)

  • STATUS
    Recruiting
  • End date
    Jan 31, 2025
  • participants needed
    300
  • sponsor
    Stephen J. Teach, MD, MPH
Updated on 7 October 2022
congestion
nasal congestion
rhinorrhea
sneezing
asthma

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 IdentifierNCT05332067
SponsorStephen J. Teach, MD, MPH
Last Modified on7 October 2022

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