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NCT01028560 · ClinicalTrials.gov registry record · Phase 1
Allergy Immunotherapy for the Reduction of Asthma
A Phase 1 study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT01028560: Completed Phase 1 study, sponsored by Albert Einstein College of Medicine.
NCT01028560 is a Phase 1 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 58 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01028560, a Phase 1 study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study Summary
In this clinical study we aim to determine the effect of allergy immunotherapy in decreasing asthma and allergy related disease in children who had multiple episodes of wheezing and who are at high risk for developing persisting asthma. These risks include a history of asthma in the parents, allergies to environmental allergens (such as dust mite, cockroach or mouse) and other allergic diseases such as eczema or food allergies. Allergy Immunotherapy is not new and has been practiced for many years to treat asthma and environmental allergies in older children and adults, but has not yet been systematically studied in young children.
Primary Outcome
The Asthma Severity Score is a customized score created for this study due to the lack of standardized instruments for this age group. It takes into account asthma symptom severity and frequency, as well as asthma medication dosing and potency. Data was collected at baseline and every 2 weeks through interviews conducted over the phone. If the caregiver could not be reached by the phone, the interview was conducted at the next face-to face opportunity (study or injection visit). The minimum scor
Interventions
- OTHER Standard of care
- BIOLOGICAL Allergen extracts (subcutaneous injections)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2008-10 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
What the finished NCT01028560 record still lists
NCT01028560 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.
NCT01028560 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01028560 about?
NCT01028560 is a clinical study titled "Allergy Immunotherapy for the Reduction of Asthma". In this clinical study we aim to determine the effect of allergy immunotherapy in decreasing asthma and allergy related disease in children who had multiple episodes of wheezing and who are at high risk for developing persisting asthma. These risks include a history of asthma in the parents, allergi...
What is the current status of trial NCT01028560?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2008-10. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01028560?
The interventions under investigation include: Standard of care (OTHER), Allergen extracts (subcutaneous injections) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01028560?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01028560's enrollment target sits among peer trials
58 895th of 2000 higher than 1,100 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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