Omalizumab Before Onset of Exacerbations
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-17
SponsorChildren's National Research Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Omalizumab
DrugOmalizumab dose for each specific participant is based on that participant's weight and total IgE level. Omalizumab is provided by the manufacturer in two strengths: • For Injection: 75 mg/0.5 mL and 150 mg/mL solution in a single-dose prefilled syringe
Placebo
DrugMatching placebo for omalizumab will be provided in 0.5 mL and 1 mL solution for injection in pre-filled syringes.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: OmalizumabExperimental treatment 1 intervention
Group B: Placebo for omalizumabPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Nasal interferon-α (IFN-α)
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
Time frame
3-6 day period after injection of study drug/placeboSecondary outcomes
1
Nasal Type 2 Cytokines
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
Time frame
3-6 day period after injection of study drug/placebo2
Asthma Exacerbations
Rate of exacerbations of asthma requiring systemic steroids in the two weeks following study drug/placebo injection.
Time frame
two weeks after injection of study drug/placebo3
Change in type 2 cytokine levels as a function of nasal airway microbiome
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
Time frame
3-6 day period after injection of study drug/placeboOther outcomes
1
Local and systemic immune responses as measured by immune cellular phenotyping
To examine the effect of single-dose omalizumab vs placebo on nasal and systemic immune responses as measured by immune cellular phenotyping
Time frame
3-6 day period after injection of study drug/placebo2
Local and systemic immune responses as measured by gene expression profiling
To examine the effect of single-dose omalizumab vs placebo on nasal and systemic immune responses as measured by gene expression profiling
Time frame
3-6 day period after injection of study drug/placebo3
Local and systemic immune responses as measured by proteome
To examine the effect of single-dose omalizumab vs placebo on nasal and systemic immune responses as measured by proteome
Time frame
3-6 day period after injection of study drug/placebo4
Local and systemic immune responses as measured by metabolome
To examine the effect of single-dose omalizumab vs placebo on nasal and systemic immune responses as measured by metabolome
Time frame
3-6 day period after injection of study drug/placeboSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's National Research Institute
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov