Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-01 @ 11:30 AM
Study NCT ID:
NCT00995904
Status:
COMPLETED
Last Update Posted:
2014-01-09
First Post:
2009-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma
Sponsor:
Allergan
Organization:
Study Overview
Official Title:
A Randomized, Open-Label, 3-Dose, 3-Period, Crossover Phase 2 Study Investigating the Tolerability and Pharmacokinetics of MAP0010 in Children 4 Through 11 Years Old With a History of Mild-To-Moderate Stable Asthma
Status:
COMPLETED
Status Verified Date:
2013-12
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 Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery.
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?: