NCT05332067: OBOE

Omalizumab Before Onset of Exacerbations

Recruiting now Phase 2 Last updated 14 July 2025

What this trial tests

Phase 2 trial testing Omalizumab in Asthma in Children in 300 participants. Currently enrolling.

Timeline

1 May 2022

Primary endpoint
1 January 2028

1 March 2028

Quick facts

Lead sponsor	Children's National Research Institute
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	300
Start date	1 May 2022
Primary completion	1 January 2028
Estimated completion	1 March 2028
Sites	1 location across United States

Drugs / interventions tested

• Omalizumab (omalizumab) — full drug profile →
• Placebo

Conditions studied

• Asthma in Children — all drugs for Asthma in Children →
• Atopy — all drugs for Atopy →
• Viral Upper Respiratory Infection — all drugs for Viral Upper Respiratory Infection →

Sponsor

Children's National Research Institute

Who can join

Adults 6 to 17, any sex, with Asthma in Children or Atopy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The common cold: The need for an effective treatment amid the FDA discussion on oral phenylephrine.
   Išerić E, Verster JC. · · 2024 · cited 2× · PMID 39253103 · DOI 10.1016/j.jacig.2024.100318