Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073840
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 objective of this study is to investigate the efficacy of levalbuterol 90 ug 2 actuations 45 ug each versus placebo 2 actuations 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:
A double-blind randomized placebo- and active-controlled multicenter parallel-group trial of levalbuterol in subjects 12 years of age and older with asthma Study participation will include one 1-week single-blind placebo run-in and an 8-week randomizeddouble-blind active-treatment period with four treatment groups 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