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NCT00392288 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 528
- Enrollment target
NCT00392288: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00392288 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 528 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00392288, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 528 participants
- Enrollment target
Study Summary
Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma. Secondary objective: To assess the safety and tolerability of ciclesonide.
Primary Outcome
Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to \<12 years only. Least Squares Mean were adjusted for Baseline FEV1, age \[yrs\], pooled center, previous corticosteroid therapy and holding chamber.
Interventions
- DRUG Placebo
- DRUG Ciclesonide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 528 participants |
| Start Date | 2006-09 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
What the finished NCT00392288 record still lists
NCT00392288 is an interventional study that assigns participants to a tested intervention. The registered 528 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00392288 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00392288 about?
NCT00392288 is a clinical study titled "Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.". Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma. Secondary objective: To assess the safety and tolerability of ciclesonide.
What is the current status of trial NCT00392288?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 528 participants. The study started on 2006-09. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00392288?
The interventions under investigation include: Placebo (DRUG), Ciclesonide (DRUG).
Who is sponsoring clinical trial NCT00392288?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00392288's enrollment target sits among peer trials
528 711th of 2000 higher than 1,286 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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