Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424528
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2007-01-17
Brief Title:
Efficacy Safety Study of ArformoterolTiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease COPD
Sponsor:
Sumitomo Pharma America Inc
Organization:
Sumitomo Pharma America Inc
Study Overview
Official Title:
A Two-Week Randomized Modified-Blind Double-Dummy Parallel-Group Efficacy and Safety Study of Arformoterol Tartrate Inhalation Solution Twice-Daily Tiotropium Once-Daily and Arformoterol Tartrate Inhalation Solution Twice-Daily and Tiotropium Once Daily in Subjects With Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2012-05
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 and compare the efficacy of arformoterol twice a day and tiotropium once a day dosed sequentially versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease COPD
Detailed Description:
This study is a multicenter randomized modified-blind double-dummy two-week parallel-group efficacy and safety study of arformoterol tartrate inhalation solution twice daily tiotropium inhalation powder once daily and arformoterol tartrate inhalation solution twice daily and tiotropium inhalation powder once daily dosed sequentially in subjects with COPD 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