Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073814
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2003-12-09
Brief Title:
Study of Daily Dosing With Levalbuterol Racemic Albuterol and Placebo in Pediatric Subjects With Asthma
Sponsor:
Sumitomo Pharma America Inc
Organization:
Sumitomo Pharma America Inc
Study Overview
Official Title:
An Efficacy Safety and Tolerability Study of Daily Dosing With Levalbuterol Racemic Albuterol and Placebo in Pediatric Subjects With Asthma
Status:
COMPLETED
Status Verified Date:
2012-02
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:
Study of Daily Dosing with Levalbuterol Racemic Albuterol and Placebo in Pediatric Subjects with Asthma
Detailed Description:
This was a Phase III double-blind randomized placebo- and active-controlled multicenter parallel-group study of up to 6 weeks in duration Seven days of QID single-blind placebo administration via HFA MDI was followed by 28 days of QID double-blind treatment A follow-up visit was required only for subjects who had in the opinion of the investigator a clinically significant finding at Visit 6 ET that would put the subject at risk A final follow up phone evaluation was conducted 7 days after the completion of Visit 6ET This study was previously posted by Sepracor Inc In October 2009 Sepracor Inc was acquired by Dainippon Sumitomo Pharma and in October 2010 Sepracor Incs name was changed to Sunovion Pharmaceuticals Inc
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