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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Omalizumab 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
Matching placebo for omalizumab will be provided in 0.5 mL and 1 mL solution for injection in pre-filled syringes.
Children's National Hospital
Washington D.C., District of Columbia, United States
RECRUITINGNasal 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/placebo
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/placebo
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/placebo
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/placebo
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