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NCT00346398 · ClinicalTrials.gov registry record · Phase 2
Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT00346398: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00346398 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00346398, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether early childhood exposure to common allergens (substances that can trigger allergies and asthma) can prevent the development of asthma in children at high risk for developing the disease.
Primary Outcome
Allergic sensitization is defined as a positive serum allergen specific Immunoglobulin E (IgE) CAP test\[1\] or a positive allergy skin prick test\[2\]. Not experiencing allergic sensitization is the better outcome for this measure. 1. A positive serum allergen specific IgE CAP (ImmunoCAP) test result is defined by a result \>= 0.35 kU/L. Higher scores indicate greater allergic sensitization. 2. A positive skin prick test is defined as a wheal diameter that is 3 mm larger than that produced by
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Oral mucosal immunoprophylaxis (OMIP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2006-05 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
What the finished NCT00346398 record still lists
NCT00346398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00346398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00346398 about?
NCT00346398 is a clinical study titled "Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study". The purpose of this study is to determine whether early childhood exposure to common allergens (substances that can trigger allergies and asthma) can prevent the development of asthma in children at high risk for developing the disease.
What is the current status of trial NCT00346398?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2006-05. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00346398?
The interventions under investigation include: Placebo (BIOLOGICAL), Oral mucosal immunoprophylaxis (OMIP) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00346398?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00346398's enrollment target sits among peer trials
51 1190th of 2000 higher than 806 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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