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.
Phase:
Phase 2
Details
Lead Sponsor:
Stephen J. Teach, MD, MPH
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)