Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT00325169
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2006-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SERETIDE Plus Tiotropium Versus Individual Components
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Randomised, Double-blind, Double Dummy, 3 Way Crossover Study Evaluating the Effects of a Combination of Seretide 50/500mcg Twice Daily Plus Tiotropium Bromide 18mcg Once Daily Compared With the Individual Agents (Tiotropium Bromide 18mcg Alone and Seretide50/500mcg Alone) in the Treatment of Subjects With COPD
Status:
COMPLETED
Status Verified Date:
2016-10
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 study was designed to evaluate the effects on lung function of a combination of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily alone) in subjects with COPD. The study will utilise a three-way cross-over design with a 2-week wash-out period between each 2-week consecutive treatment period.
Detailed Description:
A randomised, double-blind, double dummy, 3 way cross-over study evaluating the effects of SERETIDE™ 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg alone and SERETIDE 50/500mcg alone) in the treatment of subjects with COPD
Study Oversight
Has Oversight DMC:
False
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?: