Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504062
Status:
COMPLETED
Last Update Posted:
2011-08-24
First Post:
2007-07-17
Brief Title:
Open-label Safety and Efficacy Study of Pulmicort Turbuhaler in Japanese Children With Bronchial Asthma
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Randomized Open-label Parallel-group 6 Week Treatment Multi-center Phase III Study to Investigate the Efficacy and Safety of 100ug and 200ug Twice Daily of Budesonide Turbuhaler and 50ug and 100umg Twice Daily of Fluticasone Diskus in Japanese Children With Bronchial Asthma Aged 5-15
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the effect and safety of budesonide Turbuhaler 100 μgdose and 200 μgdose 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 μgdose and 200 μgdose twice daily for 6 weeks to that of fluticasone Diskus 50 μgdose and 100 μgdose twice daily for 6 week
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None