Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064389
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2003-07-08
Brief Title:
Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma
Sponsor:
Sumitomo Pharma America Inc
Organization:
Sumitomo Pharma America Inc
Study Overview
Official Title:
Long Term Safety Study of Levalbuterol and Racemic Albuterol 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 purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma
Detailed Description:
This was a randomized open-label active controlled multicenter parallel-group safety study in subjects 12 years of age and older with asthma Subjects of appropriate age who completed the Phase III levalbuterol HFA MDI trials Studies 051-353 or 051-355 were eligible to participate Studies 051-353 and 051-355 both entitled An Efficacy and Safety Study of Levalbuterol Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma were multicenter randomized double-blind placebo- and active-controlled parallel-group studies of up to nine weeks in duration a one-week single-blind placebo run in period followed by an eight-week double-blind treatment period Subjects who completed Studies 051 353 and 051 355 but who were not immediately eligible to rollover into the current study could also participate but only after a 30-day washout New subjects and subjects who participated in the Phase III trials who were not immediately eligible ie had a 30-day washout were considered to be de novo subjectsStudy participation included 10 study visits over a 12 month period
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
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