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NCT00124176 · ClinicalTrials.gov registry record · Phase 4
Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
A Phase 4 study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 4
- Development phase
- 81
- Enrollment target
NCT00124176: Completed Phase 4 study, sponsored by Children's Hospital of Philadelphia.
NCT00124176 is a Phase 4 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 81 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00124176, a Phase 4 study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 81 participants
- Enrollment target
Study Summary
This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Primary hypothesis * Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol. Secondary hypotheses * Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol. * Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol.
Primary Outcome
standard intention to treat (ITT) analysis
Interventions
- DRUG Racemic albuterol (R+S albuterol)
- DRUG Levalbuterol (R albuterol)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2004-04 |
| Est. Completion | 2006-02 |
| Phase | Phase 4 |
What the finished NCT00124176 record still lists
NCT00124176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Racemic albuterol (R+S albuterol) is the first listed.
NCT00124176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00124176 about?
NCT00124176 is a clinical study titled "Continuous Levalbuterol for Treatment of Status Asthmaticus in Children". This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Primary hypothesis * Chi...
What is the current status of trial NCT00124176?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 81 participants. The study started on 2004-04. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00124176?
The interventions under investigation include: Racemic albuterol (R+S albuterol) (DRUG), Levalbuterol (R albuterol) (DRUG).
Who is sponsoring clinical trial NCT00124176?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00124176's enrollment target sits among peer trials
81 940th of 2000 higher than 1,055 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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