Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064402
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2003-07-08
Brief Title:
Determine the Safety and Efficacy of RR-Formoterol in the Treatment of Subjects With COPD
Sponsor:
Sumitomo Pharma America Inc
Organization:
Sumitomo Pharma America Inc
Study Overview
Official Title:
A Double-Blind Double-Dummy Randomized Placebo- and Active-Controlled Multicenter Parallel-Group Study of RR-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
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 assess the bronchodilator effect and safety of multiple daily doses of arformoterol administered for 12 weeks as maintenance treatment in patients with COPD
Detailed Description:
This was a double-blind double-dummy randomized placebo- and active-controlled multicenter parallel-group study of adult subjects with COPD The study was double blinded through the use of both unit dose vial UDV and metered-dose inhaler MDI placebos as appropriate The primary efficacy analysis utilized the placebo control Secondary analyses of the primary efficacy endpoint utilized the active control and included comparisons between the placebo and active control 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