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NCT00308685 · ClinicalTrials.gov registry record · Phase 3
Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 95
- Enrollment target
NCT00308685: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT00308685 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 95 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00308685, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 95 participants
- Enrollment target
Study Summary
This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.
Primary Outcome
The baseline FEV1 was defined as the average of the two predose measurements ( at -0.5 and 0.0 hour) on the test day (Day 22). The mean was obtained from the analysis of covariance (ANCOVA) adjusted for baseline FEV1 and the pooled investigational center.
Interventions
- DRUG Placebo
- DRUG Albuterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2006-06-10 |
| Est. Completion | 2006-12-04 |
| Phase | Phase 3 |
What the finished NCT00308685 record still lists
NCT00308685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00308685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00308685 about?
NCT00308685 is a clinical study titled "Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics". This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.
What is the current status of trial NCT00308685?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 95 participants. The study started on 2006-06-10. Estimated completion is 2006-12-04.
What interventions are being tested in trial NCT00308685?
The interventions under investigation include: Placebo (DRUG), Albuterol (DRUG).
Who is sponsoring clinical trial NCT00308685?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00308685's enrollment target sits among peer trials
95 1719th of 2000 higher than 282 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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