Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-24 @ 8:25 AM
Study NCT ID:
NCT03151395
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2017-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease and During Acute Exacerbations of the Disease, in Asia Pacific
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease (COPD) and During Acute Exacerbations of COPD (AECOPD), in Asia Pacific
Status:
COMPLETED
Status Verified Date:
2021-05
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:
Since the infectious aetiology of AECOPD has been suggested to vary according to geographical region, the primary purpose of this study (which will be conducted in several countries in Asia Pacific) is to evaluate the occurrence of bacterial and viral pathogens in the sputum of stable COPD patients and at the time of AECOPD. Given the increasing and projected burden of COPD in the Asia Pacific region, this study will also evaluate the frequency, severity and duration of AECOPD, as well as the impact of AECOPD on health-related quality of life (HRQOL), healthcare utilisation and lung function.
Detailed Description:
The protocol has been amended to implement the following changes:
* Alignment of the protocol to the updated GOLD consensus report of 2017 and the COPD fact sheet.
* Alignment of the study endpoints to the study objectives.
* Alignment of the protocol to the updated GOLD consensus report of 2017 and the COPD fact sheet.
* Alignment of the study endpoints to the study objectives.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: