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NCT00189436 · ClinicalTrials.gov registry record · Phase 4
Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children
A Phase 4 study of Asthma, sponsored by Deborah Gentile.
- Completed
- Registry status
- Phase 4
- Development phase
- 61
- Enrollment target
- 2
- Study locations
NCT00189436: Completed Phase 4 study of Asthma, sponsored by Deborah Gentile.
NCT00189436 is a Phase 4 study of Asthma that has completed, run by Deborah Gentile. The registered enrollment target is 61 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00189436, a Phase 4 study of Asthma, has completed, sponsored by Deborah Gentile.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 61 participants
- Enrollment target
- 2
- Study locations
Study Summary
Subjects aged 1-8 years who have been discharged from the emergency department/outpatient care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates during the 21-day follow-up period.
Primary Outcome
This was defined as the percentage of subjects in each group (treatment with budesonide versus usual care) having an unscheduled acute visit to primary care, urgent care or an emergency department during the study period.
Conditions Studied
Interventions
- DRUG Nebulized Budesonide
- DRUG Usual care (albuterol with or without oral steroid)
Study Locations (2)
Pennsylvania
- Bellevue Pediatric Associates - Bellevue
- Allegheny General Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2003-03 |
| Est. Completion | 2009-01 |
| Phase | Phase 4 |
What the finished NCT00189436 record still lists
NCT00189436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Nebulized Budesonide is the first listed.
NCT00189436 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00189436 about?
NCT00189436 is a clinical study titled "Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children". Subjects aged 1-8 years who have been discharged from the emergency department/outpatient care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of nebulized budesonide a...
What is the current status of trial NCT00189436?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2003-03. Estimated completion is 2009-01.
What conditions does trial NCT00189436 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT00189436?
The interventions under investigation include: Nebulized Budesonide (DRUG), Usual care (albuterol with or without oral steroid) (DRUG).
Who is sponsoring clinical trial NCT00189436?
This trial is sponsored by Deborah Gentile, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00189436 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00189436's enrollment target sits among peer trials
61 247th of 374 higher than 128 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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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