Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073827
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2003-12-09
Brief Title:
Study of Levalbuterol Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
Sponsor:
Sumitomo Pharma America Inc
Organization:
Sumitomo Pharma America Inc
Study Overview
Official Title:
An Efficacy and Safety Study of Levalbuterol Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older 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:
The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma with all treatments administered 4 times a day QID
Detailed Description:
This was a Phase III multicenter randomized double-blind placebo- and active-controlled parallel-group study of up to 9 weeks in duration Seven days of QID single-blind placebo administration via MDI was followed by 56 days of QID double-blind active treatment Following the run-in period each subject was randomized to one of the following three treatments levalbuterol HFA MDI 90 mcg 2 actuations of 45 mcg racemic albuterol HFA MDI 180 mcg 2 actuations of 90 mcg or placebo 2 actuations Subjects were randomized in a 211 ratio of levalbuterol to racemic albuterol to placebo In order to maintain blinding of the device a placebo dose was administered with each treatment 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