Omalizumab Before Onset of Exacerbations
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Nasal interferon-α (IFN-α)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The study site's research pharmacy will dispense the study drug as per the randomization schedule provided by REDCap. Prior to injection, an unblinded site pharmacist will confirm the expiration date, the dose, and randomization assignment. The injections will be administered in the Clinical Research Center at the study site by unblinded and trained nursing staff. The product will remain blinded to the investigators, other site staff, the participant, and legal guardians.
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Arms & Interventions
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)
Intervention: Omalizumab (Drug)
Placebo for omalizumab
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)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Nasal interferon-α (IFN-α)
Time Frame: 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 Outcomes
- Nasal Type 2 Cytokines(3-6 day period after injection of study drug/placebo)
- Asthma Exacerbations(two weeks after injection of study drug/placebo)
- Change in type 2 cytokine levels as a function of nasal airway microbiome(3-6 day period after injection of study drug/placebo)
Investigators
William Sheehan
Associate Professor or Pediatrics
Children's National Research Institute