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NCT00995904 · ClinicalTrials.gov registry record · Phase 2
Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma
A Phase 2 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT00995904: Completed Phase 2 study, sponsored by Allergan.
NCT00995904 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00995904, a Phase 2 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery.
Primary Outcome
The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).
Interventions
- DRUG 84ug MAP0020
- DRUG 42ug MAP0020
- DRUG 21ug MAP0020
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2009-09 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
What the finished NCT00995904 record still lists
NCT00995904 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which 84ug MAP0020 is the first listed.
NCT00995904 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00995904 about?
NCT00995904 is a clinical study titled "Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma". This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery.
What is the current status of trial NCT00995904?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2009-09. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00995904?
The interventions under investigation include: 84ug MAP0020 (DRUG), 42ug MAP0020 (DRUG), 21ug MAP0020 (DRUG).
Who is sponsoring clinical trial NCT00995904?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00995904's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 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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