Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-02-02 @ 10:35 PM
Study NCT ID:
NCT00642161
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2008-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Version Pulmicort Turbuhaler USA Children
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Placebo-controlled Comparison of the Efficacy, Safety and Pharmacokinetics of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Children and Adolescents.
Status:
COMPLETED
Status Verified Date:
2011-01
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:
A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| D5254C00726 | None | None | View |