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

NCT ID: NCT04853225

Last Updated: 2025-08-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2005 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-22

Study Completion Date

2024-06-25

Brief Summary

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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

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Main cohort

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

Prospective observational cohort study

Intervention Type OTHER

Prospective observational cohort study

Sub-cohort

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

Prospective observational cohort study

Intervention Type OTHER

Prospective observational cohort study

Interventions

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Prospective observational cohort study

Prospective observational cohort study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangzhou Institute of Respiratory Health (GIRH)

UNKNOWN

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Dongguan, , China

Site Status

GSK Investigational Site

Dongguan, , China

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GSK Investigational Site

Foshan, , China

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GSK Investigational Site

Foshan, , China

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GSK Investigational Site

Foshan, , China

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GSK Investigational Site

Guangzhou, , China

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GSK Investigational Site

Guangzhou, , China

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GSK Investigational Site

Guangzhou, , China

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GSK Investigational Site

Guangzhou, , China

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GSK Investigational Site

Guangzhou, , China

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GSK Investigational Site

Guangzhou, , China

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GSK Investigational Site

Guangzhou, , China

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GSK Investigational Site

Guangzhou, , China

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GSK Investigational Site

Heyuan, , China

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GSK Investigational Site

Heyuan, , China

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GSK Investigational Site

Huizhou, , China

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GSK Investigational Site

Huizhou, , China

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GSK Investigational Site

Jiangmen, , China

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GSK Investigational Site

Jiangmen, , China

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GSK Investigational Site

Jieyang, , China

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GSK Investigational Site

Jieyang, , China

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GSK Investigational Site

Meizhou, , China

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GSK Investigational Site

Qingyuan, , China

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GSK Investigational Site

Shantou, , China

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GSK Investigational Site

Shantou, , China

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GSK Investigational Site

Shaoguan, , China

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GSK Investigational Site

Shenzhen, , China

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GSK Investigational Site

Shenzhen, , China

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GSK Investigational Site

Shenzhen, , China

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GSK Investigational Site

Shenzhen, , China

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GSK Investigational Site

Shenzhen, , China

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GSK Investigational Site

Shenzhen, , China

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GSK Investigational Site

Shunde, , China

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GSK Investigational Site

Wengyuan, , China

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GSK Investigational Site

Xiamen, , China

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GSK Investigational Site

Yunfu, , China

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GSK Investigational Site

Zhangshan, , China

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GSK Investigational Site

Zhangshan, , China

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GSK Investigational Site

Zhanjiang, , China

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GSK Investigational Site

Zhaoqing, , China

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GSK Investigational Site

Zhuhai, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 37315325 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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208630

Identifier Type: -

Identifier Source: org_study_id

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