drugset / Trial / NCT00163449
Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)
RandomizedParallel-groupTriple-blind
Summary
The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.
Timeline
- Start
- 2005-11
- Primary completion
- 2006-11
- Completion
- 2007-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ciclesonide | Other / unclassified | 40 ug | Inhaled |
| Comparator | Ciclesonide | Other / unclassified | 80 ug | Inhaled |
| Comparator | Ciclesonide | Other / unclassified | 160 ug | Inhaled |