Trials / Active Not Recruiting
Active Not RecruitingNCT02570984
Preventing Asthma in High Risk Kids
Controlling and Preventing Asthma Progression and Severity in Kids
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Boston Children's Hospital · Academic / Other
- Sex
- All
- Age
- 24 Months – 47 Months
- Healthy volunteers
- Not accepted
Summary
This trial is a randomized, double-blind, placebo controlled trial designed to test whether two years treatment of preschool children aged 2-3 years of age at high risk for asthma with omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as reflected by a reduction in the prevalence of active asthma in the Final 12 months during 2 year observation period off study drug.
Detailed description
Prevention/ Disease modification of asthma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omalizumab | anti-ige injection |
| DRUG | Placebo | placebo comparator arm, injection similar to active |
Timeline
- Start date
- 2018-11-27
- Primary completion
- 2028-01-31
- Completion
- 2028-03-31
- First posted
- 2015-10-08
- Last updated
- 2025-12-04
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02570984. Inclusion in this directory is not an endorsement.