drugset / Trial / NCT00392288
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2006-09
- Primary completion
- 2008-02
- Completion
- 2008-02
Outcome
Missed primary endpoint
registry Placebo Metered Dose Inhaler (MDI) vs Ciclesonide MDI 80 µg BID; p = 0.0703; ANCOVA NCT00392288 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ciclesonide | Other / unclassified | 40 ug | Inhaled |
| Subject | Ciclesonide | Other / unclassified | 80 ug | Inhaled |