drugset / Trial / NCT00504062

Open-label, Safety and Efficacy Study of Pulmicort® Turbuhaler® in Japanese Children With Bronchial Asthma

NCT00504062

Phase 3 Completed 240 enrolled AstraZeneca
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

EvaluationDrugModalityDoseRoute
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

Indications