Omalizumab Before Onset of Exacerbations

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Asthma in Children, Atopy, Viral Upper Respiratory Infection

In brief

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.

Key facts

Study ID: NCT05332067
Run by: Children's National Research Institute
People needed: 300
Starts: 2022-05-01
Expected to finish: 2028-03-01
Last updated by the study team: 2025-07-14

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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
Inability of primary caregiver and child to speak English
In the opinion of the investigator, participant will not be able to wean from nasal steroids or to avoid nasal vaccinations during the 90-day fall outcome period
Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Where it is running

Children's National Hospital — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.