drugset / Trial / NCT00504062
Open-label, Safety and Efficacy Study of Pulmicort® Turbuhaler® in Japanese Children With Bronchial Asthma
RandomizedParallel-groupOpen-labelTreatment
Summary
To investigate the effect and safety of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment. To compare the efficacy of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks to that of fluticasone Diskus® 50 μg/dose and 100 μg/dose twice daily for 6 week.
Timeline
- Start
- 2006-10
- Primary completion
- —
- Completion
- 2007-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 100 ug | Inhaled |
| Subject | Budesonide | Small molecule | 200 ug | Inhaled |
| Subject | Fluticasone | Other / unclassified | 50 ug | Inhaled |
| Subject | Fluticasone | Other / unclassified | 100 ug | Inhaled |