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Omalizumab Before Onset of Exacerbations | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Omalizumab Before Onset of Exacerbations

NCT05332067•Children's National Research Institute

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.

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must meet the following:
•1. Parent or guardian must be able to understand and provide informed consent in English and participants ≥7 must be able to provide assent
•2. 6-17 years, inclusive at time of screening
•3. Physician-diagnosed persistent asthma
•4. ≥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
•5. Sensitization to ≥1 perennial aeroallergen
•6. Total serum IgE and weight appropriate for omalizumab dosing
•7. Insurance that covers standard of care medications
•8. 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
•9. At least one of the following criteria:
+12 more criteria

Exclusion Criteria

•1. 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
•2. Contraindication to receipt of omalizumab
•3. 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)
•4. Pregnancy or active lactation
•5. History of latex allergy
•6. Treatment with omalizumab or other monoclonal antibody, or aeroallergen immunotherapy in the prior six months
•7. Plan for home schooling during the 90-day outcome period
•8. History of life-threatening asthma defined by requirement for intubation or cardiorespiratory arrest
•9. Inability of primary caregiver and child to speak English
•10. 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
+1 more criteria

Locations (1)

Children's National Hospital

Washington D.C., District of Columbia, United States

Key Dates

Start Date

May 1, 2022

Primary Completion Date

January 1, 2028

Completion Date

March 1, 2028

Last Updated

July 14, 2025

Enrollment

300

ESTIMATED participants

Conditions

Asthma in ChildrenAtopyViral Upper Respiratory Infection

Interventions

Omalizumab

DRUG

Placebo

DRUG

Contacts

William Sheehan, MD

CONTACT

202-476-5000 wsheehan@cnmc.org

Alicia Mathis

CONTACT

202-476-5000 anewcome@childrensnational.org

ASMact: Study on Management of Bronchial Asthma

NCT07412769

Asthma AcuteAsthma Childhood+2 more

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RECRUITINGNA

Reducing Asthma Attacks in Disadvantaged School Children With Asthma

NCT06003569

Asthma in Children

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RECRUITINGPHASE2

Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Omalizumab Before Onset of Exacerbations

Inclusion Criteria

Exclusion Criteria

ASMact: Study on Management of Bronchial Asthma

Reducing Asthma Attacks in Disadvantaged School Children With Asthma

Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study

Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)

PROPULSION SANTE: Inflammometry to Improve the Diagnostic Trajectory in Situations of Suspected Asthma in Children and Adults