Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232648
Status:
COMPLETED
Last Update Posted:
2009-03-25
First Post:
2005-09-30
Brief Title:
Long Term Safety Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Investigation of Safety and Efficacy of Budesonide Inhalation Suspension in the Long-Term Use in Japanese Children With Bronchial Asthma Open Long-Term Extension Study Following Study SD-004-0765
Status:
COMPLETED
Status Verified Date:
2009-03
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:
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 025 to 10 mg per day administered once or twice daily according to the symptoms
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