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

NCT04853225 | Completed Results

• 1 other identifier: 208630
• Study Type: observational
• Target: 2,005
• Locations: 1 country
• Sites: 41

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).

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; Phenotypes; Endotypes; Chronic bronchitis; China; Healthy control

Outcome Measures

Primary Outcomes (2)

• Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30

  FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Change from Baseline was calculated as the value at Month 30 minus the value at Baseline. Change from Baseline in pre- and post-bronchodilator FEV1 was assessed and summarized. Also, yearly rate of change in FEV1 (pre- and post-bronchodilator) was analyzed using random coefficients models.

  Baseline (Day 1 of Month 1) and at Month 30

• Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30

  FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Change from Baseline was calculated as the value at Month 30 minus the value at Baseline. Change from Baseline in pre- and post-bronchodilator FVC was assessed and summarized. Also, yearly rate of change in FVC (pre- and post-bronchodilator) was analyzed using random coefficients models.

  Baseline (Day 1 of Month 1) and at Month 30

Secondary Outcomes (66)

• Main Cohort: Rate of Moderate/Severe Exacerbations in COPD and Chronic Bronchitis Cohorts

  Up to 30 months

• Main Cohort: Change From Baseline in COPD Assessment Test (CAT) Score at Month 30

  Baseline (Day 1 of Month 1) and at Month 30

• Main Cohort: Absolute Values of CAT Score at Month 30

  At Month 30

• Main Cohort: Total Score of COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) at Baseline

  At Baseline (Day 1 of Month 1)

• Main Cohort: Total Score of CAPTURE at Month 18

  At Month 18

Study Arms (2)

Main cohort

COPD, chronic bronchitis and healthy participants (never smoker) from Type A and Type B hospitals will be included.

Other: Prospective observational cohort study

Sub-cohort

COPD, chronic bronchitis and healthy participants (never smoker) from selected Type A hospitals will be included.

Other: Prospective observational cohort study

Interventions

Prospective observational cohort study OTHER

Prospective observational cohort study

Main cohort; Sub-cohort

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with COPD, chronic bronchitis without fixed airflow limitation and never smoker healthy participants will be included in the study.

You may qualify if:

• Male or female participants, aged 50-80 years inclusive. A female is eligible only if she is of non-child bearing potential.
• Body mass index (BMI) less than (\<)35.
• A signed and dated written informed consent is obtained prior to participation.
• A Baseline (post-bronchodilator) (FEV1/FVC) ratio \<70 percent (%).
• Clinically stable and has no exacerbations for at least 1 month prior to recruitment.
• Ever smoker or never smoker.
• Free from other significant diseases.
• Baseline post-bronchodilator FEV1/FVC ratio more than (\>)70%.
• Chronic bronchitis is defined as at least 3 months of cough and phlegm in a year in the past 2 years.
• Clinically stable and has no exacerbations for at least 1 month prior to recruitment.
• Ever smoker or never smoker
• Free from any significant diseases
• Baseline post-bronchodilator FEV1/FVC ratio \>70%.
• A CAT score \<10.
• Never smoker. Passive smoker is not eligible.

You may not qualify if:

• Having undergone lung surgery.
• Known respiratory disorders or significant inflammatory disease other than COPD.
• Serious, uncontrolled disease (including serious psychological disorders)
• Confirmed cancer, unless participants in remission for more than or equal to (\>=)5 years.
• Participating or plan to participant in any clinical studies where investigational drugs were tested.
• Unable or unwilling to use required digital devices (sub- cohort only).
• Have evidence of alcohol or drug abuse.
• Have received a blood transfusion in the 4 weeks prior to study start.
• On long-term oral corticosteroids.
• Unable to walk.
• Unable to read and understand Mandarin Chinese.
• Current primary diagnosis of asthma (participants with a primary diagnosis of COPD but who also had asthma \[Asthma COPD overlap {ACO}\] could be included).
• Known disorders other than COPD that may significantly impact clinical assessments
• Known disorders that may significantly impact clinical assessments.
• FVC \<80% Predicted.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Guangzhou Institute of Respiratory Health (GIRH): collaborator

Study Sites (41)

GSK Investigational Site

Dongguan, 523059, China

Location

GSK Investigational Site

Dongguan, 523326, China

Location

GSK Investigational Site

Foshan, 528000, China

Location

GSK Investigational Site

Foshan, 528041, China

Location

GSK Investigational Site

Foshan, 528200, China

Location

GSK Investigational Site

Guangzhou, 510080, China

Location

GSK Investigational Site

Guangzhou, 510120, China

Location

GSK Investigational Site

Guangzhou, 510150, China

Location

GSK Investigational Site

Guangzhou, 510220, China

Location

GSK Investigational Site

Guangzhou, 510260, China

Location

GSK Investigational Site

Guangzhou, 510515, China

Location

GSK Investigational Site

Guangzhou, 510700, China

Location

GSK Investigational Site

Guangzhou, 511400, China

Location

GSK Investigational Site

Heyuan, 517199, China

Location

GSK Investigational Site

Heyuan, 517300, China

Location

GSK Investigational Site

Huizhou, 516000, China

Location

GSK Investigational Site

Huizhou, 516001, China

Location

GSK Investigational Site

Jiangmen, 529000, China

Location

GSK Investigational Site

Jiangmen, 529700, China

Location

GSK Investigational Site

Jieyang, 515300, China

Location

GSK Investigational Site

Jieyang, 522000, China

Location

GSK Investigational Site

Meizhou, 514700, China

Location

GSK Investigational Site

Qingyuan, 510030, China

Location

GSK Investigational Site

Shantou, 515031, China

Location

GSK Investigational Site

Shantou, 515041, China

Location

GSK Investigational Site

Shaoguan, 512026, China

Location

GSK Investigational Site

Shenzhen, 518005, China

Location

GSK Investigational Site

Shenzhen, 518020, China

Location

GSK Investigational Site

Shenzhen, 518100, China

Location

GSK Investigational Site

Shenzhen, 518101, China

Location

GSK Investigational Site

Shenzhen, 518104, China

Location

GSK Investigational Site

Shenzhen, 518116, China

Location

GSK Investigational Site

Shunde, 528300, China

Location

GSK Investigational Site

Wengyuan, 512600, China

Location

GSK Investigational Site

Xiamen, 361004, China

Location

GSK Investigational Site

Yunfu, 527400, China

Location

GSK Investigational Site

Zhangshan, 528400, China

Location

GSK Investigational Site

Zhangshan, 528415, China

Location

GSK Investigational Site

Zhanjiang, 524001, China

Location

GSK Investigational Site

Zhaoqing, 526400, China

Location

GSK Investigational Site

Zhuhai, 519000, China

Location

Related Publications (1)

• Li Y, Wen F, Ma Q, Chen R, Sun Y, Liu T, Gu C, Hu S, Song J, Compton C, Zheng J, Zhong N, Jones P. Use of CAPTURE to Identify Individuals Who May or May Not Require Treatment for Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2023 Aug 15;208(4):435-441. doi: 10.1164/rccm.202303-0504OC.

  PMID: 37315325 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: April 22, 2020
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: August 20, 2025
• Results First Posted: August 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (41)