Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291382
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2006-02-13
Brief Title:
Airway Hyper-responsiveness Study In Asthma Using SalmeterolFluticasone Propionate Combination Product
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multicentre Stratified Randomised Double Blind Parallel Group Trial to Evaluate Whether a Treatment Strategy Based on Aiming for Total Control Results in Better AHR Than a Treatment Strategy Based on Maintaining Well Control
Status:
COMPLETED
Status Verified Date:
2017-05
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:
This double-blind stratified parallel group study is to determine whether aiming for Total control results in better airway hyper-responsiveness than maintaining the treatment level at which Well-controlled asthma was achieved The primary endpoint is the mean change in PC20 methacholine Well controlled subjects as assessed after a 12 week run-in period will enter a 24 week treatment period during which they will record PEFPeak Expiratory Flow symptoms rescue beta2-agonist use over 24 hours night time awakenings asthma exacerbations emergency visits due to asthma and Adverse Events At every visit lung function measurements and airway hyper-responsiveness will be measured
Detailed Description:
A multi-centre randomised double blind stratified and parallel group study to evaluate whether a treatment strategy based on aiming for Total control results in better airway hyper-responsiveness than a treatment strategy based on maintaining the treatment level at which Well-controlled asthma was achieved
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