Omalizumab Before Onset of Exacerbations (NCT05332067) | Clinical Trial Compass
RecruitingPhase 2
Omalizumab Before Onset of Exacerbations
United States300 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range6 Years – 17 Years
SexALL
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Inclusion criteria
✓. Parent or guardian must be able to understand and provide informed consent in English and participants ≥7 must be able to provide assent
✓. 6-17 years, inclusive at time of screening
✓. Physician-diagnosed persistent asthma
✓. ≥1 exacerbation of asthma requiring systemic corticosteroids in the 6-month period before the planned start of the participant's upcoming school year or ≥2 exacerbations of asthma requiring systemic corticosteroids in the 12-month period before the planned start of the participant's upcoming school year
✓. Sensitization to ≥1 perennial aeroallergen
✓. Total serum IgE and weight appropriate for omalizumab dosing
✓. Insurance that covers standard of care medications
✓. Primary family residence (home where child sleeps a majority of nights) in a Metropolitan Statistical Area where ≥10% of families have income below poverty line and/or publicly funded health insurance
Exclusion criteria
What they're measuring
1
Nasal interferon-α (IFN-α)
Timeframe: 3-6 day period after injection of study drug/placebo
. Inability or unwillingness of a participant's parent or guardian to give written informed consent or comply with study protocol or inability or unwillingness of a participant ≥7 to provide assent
✕. Contraindication to receipt of omalizumab
✕. Presence of a second chronic medical condition (including but not limited to serious cardiorespiratory disorders, cancer, sickle cell disease, uncontrolled seizure disorder, auto-immune disorders, or type 1 diabetes)
✕. Pregnancy or active lactation
✕. History of latex allergy
✕. Treatment with omalizumab or other monoclonal antibody, or aeroallergen immunotherapy in the prior six months
✕. Plan for home schooling during the 90-day outcome period
✕. History of life-threatening asthma defined by requirement for intubation or cardiorespiratory arrest