Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 5:51 PM
Study NCT ID:
NCT00507234
Status:
COMPLETED
Last Update Posted:
2010-11-11
First Post:
2007-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study in Subjects Greater Than 40 Years of Age With COPD
Sponsor:
Dey
Organization:
Study Overview
Official Title:
A 6-Week Trial to Compare the Efficacy and Safety of Concomitant Treatment With Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2009-07
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:
This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled, parallel-group, comparative study.
The objectives of this study are:
1. To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.
2. To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice daily compared to tiotropium 18 mcg once daily.
The objectives of this study are:
1. To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.
2. To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice daily compared to tiotropium 18 mcg once daily.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: