NCT03151395

Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease and During Acute Exacerbations of the Disease, in Asia Pacific

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Disorders

Interventions

Type	Name	Description
OTHER	Sputum and blood sampling	Evaluation of the occurrence of potential bacterial and viral pathogens in the sputum of stable COPD patients and at the time of AECOPD.

Timeline

• Start date: 2017-08-25
• Primary completion: 2020-04-06
• Completion: 2020-04-06
• First posted: 2017-05-12
• Last updated: 2021-06-14
• Results posted: 2021-06-14

Locations

19 sites across 4 countries: Hong Kong, Philippines, South Korea, Taiwan