drugset / Trial / NCT00232648
Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma
RandomizedSingle-groupOpen-labelTreatment
Summary
This study is as an extension study of SD-004-0765, to assess the safety profile of long-term use of budesonide inhalation suspension in Japanese young children with bronchial asthma. Children completing study SD-004-0765 continued administration of budesonide inhalation suspension as judged by the investigator; the dose is adjusted as appropriate within the range of 0.25 to 1.0 mg per day administered once or twice daily, according to the symptoms.
Timeline
- Start
- 2004-01
- Primary completion
- 2006-11
- Completion
- 2006-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 0.25 mg | Inhaled |
| Subject | Budesonide | Small molecule | 1 mg | Inhaled |