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NCT05332067 · ClinicalTrials.gov registry record · Phase 2
Omalizumab Before Onset of Exacerbations
A Phase 2 study of Asthma in Children and Atopy, sponsored by Children's National Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT05332067: Recruiting Phase 2 study of Asthma in Children and Atopy, sponsored by Children's National Research Institute.
NCT05332067 is a Phase 2 study of Asthma in Children and Atopy that is actively recruiting participants, run by Children's National Research Institute. The registered enrollment target is 300 participants, above the 198-participant average among 44 other Asthma in Children trials with a reported enrollment target (52% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05332067, a Phase 2 study of Asthma in Children and Atopy, is actively recruiting participants, sponsored by Children's National Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Omalizumab
Study Locations (1)
District of Columbia
- Children's National Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2022-05-01 |
| Est. Completion | 2028-03-01 |
| Phase | Phase 2 |
What NCT05332067 shows while recruiting
NCT05332067 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 198-participant average among 44 other Asthma in Children trials with a reported enrollment target (52% higher).
The record links to 3 conditions, with Asthma in Children appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05332067 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05332067 about?
NCT05332067 is a clinical study titled "Omalizumab Before Onset of Exacerbations". 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. OB...
What is the current status of trial NCT05332067?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2022-05-01. Estimated completion is 2028-03-01.
What conditions does trial NCT05332067 study?
This clinical trial studies the following conditions: Asthma in Children, Atopy, Viral Upper Respiratory Infection.
What interventions are being tested in trial NCT05332067?
The interventions under investigation include: Placebo (DRUG), Omalizumab (DRUG).
Who is sponsoring clinical trial NCT05332067?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05332067 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma in Children
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05332067's enrollment target sits among peer trials
300 13th of 44 higher than 31 of 44 other Asthma in Children trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma in Children trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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