Omalizumab Before Onset of Exacerbations

Phase 2

Recruiting

• Conditions: Asthma in Children; Atopy; Viral Upper Respiratory Infection
• Interventions: Drug: Placebo; Drug: Omalizumab

• Registration Number: NCT05332067
• Lead Sponsor: Stephen J. Teach, MD, MPH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-18
• Study Start: 2022-05-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14
• Primary Completion: 2025-06-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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
11. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo for omalizumab	Placebo	Single dose of placebo for omalizumab at the start of a viral upper respiratory infection as defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms) during the fall outcome season (defined as the 90-day period beginning on each child's return to school)
Omalizumab	Omalizumab	Single dose of omalizumab at the start of a viral upper respiratory infection as defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms) during the fall outcome season (defined as the 90-day period beginning on each child's return to school)

Primary Outcome Measures

Name	Time	Method
Nasal interferon-α (IFN-α)	3-6 day period after injection of study drug/placebo	The change in the amount of nasal IFN-α recovered by nasal fluid absorption between two time points, when study drug/placebo is injected and 3-6 days later

Secondary Outcome Measures

Name	Time	Method
Nasal Type 2 Cytokines	3-6 day period after injection of study drug/placebo	Change in the amount of nasal type 2 cytokines recovered by nasal fluid absorption between two time points, when study drug/placebo is injected and 3-6 days later
Asthma Exacerbations	two weeks after injection of study drug/placebo	Rate of exacerbations of asthma requiring systemic steroids in the two weeks following study drug/placebo injection.
Change in type 2 cytokine levels as a function of nasal airway microbiome	3-6 day period after injection of study drug/placebo	Change in type 2 cytokine levels between two time points (when study drug/placebo is injected and 3-6 days later) as a function of nasal airway microbiome phenotypes based on the abundance of Moraxella catarrhalis and Streptococcus pneumoniae and other microbial species recovered by nasal wash

Trial Locations

Locations (1)

Children's National Hospital; 🇺🇸 Washington, District of Columbia, United States