Investigation of Chronic Obstructive Pulmonary Disease (COPD) Phenotypes and Endotypes in China

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Other: Prospective observational cohort study

• Registration Number: NCT04853225
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is a non-drug interventional cohort study, which aims to investigate the clinical, radiological and biological factors associated with disease progression in COPD in China. Participants will be recruited from multiple hospitals across Guangdong province categorized as Type A hospitals (those at prefecture-level and above) and Type B hospitals (those below prefecture-level).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-22
• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-21
• Primary Completion: 2024-06-25
• Study Completion: 2024-06-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sub-cohort	Prospective observational cohort study	COPD, chronic bronchitis and healthy participants (never smoker) from selected Type A hospitals will be included.
Main cohort	Prospective observational cohort study	COPD, chronic bronchitis and healthy participants (never smoker) from Type A and Type B hospitals will be included.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Forced expiratory volume in 1 second (FEV1) and Forced vital capacity (FVC) (Milliliters)	Baseline and Up to 2.5 years	FEV1 and FVC will be measured using spirometry.
Rate of moderate and severe exacerbations per year	Up to 2.5 years	Moderate exacerbations require antibiotics and/or corticosteroids. Severe exacerbations require hospital admission.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in COPD assessment test (CAT) score	Baseline and Up to 2.5 years	The CAT is an 8-item questionnaire used to measure the health status of participants with COPD. The experience is rated by participants on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0- 40. Higher scores indicates greater disease impact.
Change from Baseline in lung density	Baseline and Up to 2.5 years	Lung density will be measured using High-resolution Computed tomography (HRCT).
Change from Baseline in airway wall thickness	Baseline and Up to 2.5 years	Airway wall thickness will be measured.
Change from Baseline in daily step count	Baseline and Up to 1.5 years	Daily step count will be measured using activity monitor.
Number of participants with changes in sputum microbiome	Up to 2.5 years	Sputum samples will be collected for the assessment of sputum microbiome.

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇳 Zhuhai, China