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NCT03541187 · ClinicalTrials.gov registry record · Phase 2
Cockroach Immunotherapy in Children and Adolescents
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
NCT03541187: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03541187 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03541187, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
Study Summary
Scientific evidence has shown that, over the past two decades, the combination of cockroach allergy and cockroach exposure is one of the most important factors contributing to the dramatic increase in asthma morbidity seen in inner city children with asthma. Therefore, a major goal of the Inner City Asthma Consortium (ICAC) is to evaluate the efficacy of cockroach immunotherapy in inner city asthma. The primary objective of the study is to determine if the response to nasal allergen challenge (NAC) will be changed with treatment with cockroach subcutaneous immunotherapy (SCIT) treatment.
Primary Outcome
The study's primary endpoint is the mean TNSS change from baseline to 12 months, calculated as the difference between baseline and 12-month mean TNSS up to baseline responsive dose. TNSS (0-12) is the sum of three participant-assessed scores for rhinorrhea, congestion, itching, and staff-monitored sneezing, rated 0=None, 1=Mild, 2=Moderate, 3=Severe. Analysis uses ANCOVA modeling mean TNSS difference with factors for treatment arm, site, and baseline mean TNSS. Least square means (LSmeans), SEs,
Interventions
- BIOLOGICAL German cockroach allergenic extract
- BIOLOGICAL Placebo for German cockroach allergenic extract
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2018-07-16 |
| Est. Completion | 2022-06-03 |
| Phase | Phase 2 |
What the finished NCT03541187 record still lists
NCT03541187 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which German cockroach allergenic extract is the first listed.
NCT03541187 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03541187 about?
NCT03541187 is a clinical study titled "Cockroach Immunotherapy in Children and Adolescents". Scientific evidence has shown that, over the past two decades, the combination of cockroach allergy and cockroach exposure is one of the most important factors contributing to the dramatic increase in asthma morbidity seen in inner city children with asthma. Therefore, a major goal of the Inner City...
What is the current status of trial NCT03541187?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2018-07-16. Estimated completion is 2022-06-03.
What interventions are being tested in trial NCT03541187?
The interventions under investigation include: German cockroach allergenic extract (BIOLOGICAL), Placebo for German cockroach allergenic extract (BIOLOGICAL).
Who is sponsoring clinical trial NCT03541187?
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 NCT03541187's enrollment target sits among peer trials
82 830th of 2000 higher than 1,167 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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