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Omalizumab Before Onset of Exacerbations

Study acronym: OBOE
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Stephen J. Teach, MD, MPH to Children's National Research Institute Primary completion date: Jun 1, 2025 to Jan 1, 2028 · Site contact updatedv4 Show 2 more changesShow less
    • Primary completion date: Jun 1, 2025 to Jan 1, 2028
    • Site contact updated
  2. Primary completion date: Jan 31, 2025 to Jun 1, 2025 Completion date: Jan 31, 2025 to Mar 1, 2028v3 Show 1 more changeShow less
    • Completion date: Jan 31, 2025 to Mar 1, 2028
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 15, 2022 to May 1, 2022 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Apr 15, 2022 to May 1, 2022
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05332067
Lead Sponsor Children's National Research Institute
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Asthma in Children, Atopy, Viral Upper Respiratory Infection
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov