Ignite Creation Date:
2024-05-06 @ 1:11 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01751113
Status:
COMPLETED
Last Update Posted:
2017-03-08
First Post:
2012-12-13
Brief Title:
A 3 Way Cross-over Study Evaluating the Effects of ADOAIR Twice Daily Plus Tiotropium Bromide Once Daily Compared With the Individual Treatments of Japanese Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomised Double-blind Double Dummy 3 Way Cross-over Study Evaluating the Effects of ADOAIR 50250mcg Twice Daily Plus Tiotropium Bromide 18mcg Once Daily Compared With the Individual Treatments Tiotropium Bromide 18mcg Alone and ADOAIR 50250mcg Alone in the Treatment of Japanese Subjects With COPD
Status:
COMPLETED
Status Verified Date:
2017-01
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:
SCO116572
Brief Summary:
The purpose of this study is to evaluate the effects on lung function of a combination of ADOAIR 50250mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments tiotropium bromide 18mcg once daily alone and ADOAIR 50250mcg twice daily alone in Japanese subjects with COPD The study will utilize a three-way cross-over design with a 2-week wash-out period between each 4-week consecutive treatment period The aim is to support the rationale for triple combination therapy by demonstrating that treatment with both ADOAIR and tiotropium can potentially produce improved clinically relevant effects compared with either treatment alone
This study will utilize a range of lung function measures in order to fully assess the benefits of triple therapy The primary endpoint will be based on airways conductance measured using plethysmography sGaw measured over 4hours post dose AUC 0-4hr on Day 28 Secondary endpoints will include lung function measures based on plethysmography and spirometry The lung function measures will be supported by measurement of the use of relief salbutamol
This study will utilize a range of lung function measures in order to fully assess the benefits of triple therapy The primary endpoint will be based on airways conductance measured using plethysmography sGaw measured over 4hours post dose AUC 0-4hr on Day 28 Secondary endpoints will include lung function measures based on plethysmography and spirometry The lung function measures will be supported by measurement of the use of relief salbutamol
Detailed Description:
None
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