Investigation of Chronic Obstructive Pulmonary Disease (COPD) Phenotypes and Endotypes in China
NCT ID: NCT04853225
Last Updated: 2025-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
2005 participants
OBSERVATIONAL
2020-04-22
2024-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
Prospective observational cohort study
Interventions
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Prospective observational cohort study
Prospective observational cohort study
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
80 Years
ALL
Yes
Sponsors
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Guangzhou Institute of Respiratory Health (GIRH)
UNKNOWN
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Dongguan, , China
GSK Investigational Site
Dongguan, , China
GSK Investigational Site
Foshan, , China
GSK Investigational Site
Foshan, , China
GSK Investigational Site
Foshan, , China
GSK Investigational Site
Guangzhou, , China
GSK Investigational Site
Guangzhou, , China
GSK Investigational Site
Guangzhou, , China
GSK Investigational Site
Guangzhou, , China
GSK Investigational Site
Guangzhou, , China
GSK Investigational Site
Guangzhou, , China
GSK Investigational Site
Guangzhou, , China
GSK Investigational Site
Guangzhou, , China
GSK Investigational Site
Heyuan, , China
GSK Investigational Site
Heyuan, , China
GSK Investigational Site
Huizhou, , China
GSK Investigational Site
Huizhou, , China
GSK Investigational Site
Jiangmen, , China
GSK Investigational Site
Jiangmen, , China
GSK Investigational Site
Jieyang, , China
GSK Investigational Site
Jieyang, , China
GSK Investigational Site
Meizhou, , China
GSK Investigational Site
Qingyuan, , China
GSK Investigational Site
Shantou, , China
GSK Investigational Site
Shantou, , China
GSK Investigational Site
Shaoguan, , China
GSK Investigational Site
Shenzhen, , China
GSK Investigational Site
Shenzhen, , China
GSK Investigational Site
Shenzhen, , China
GSK Investigational Site
Shenzhen, , China
GSK Investigational Site
Shenzhen, , China
GSK Investigational Site
Shenzhen, , China
GSK Investigational Site
Shunde, , China
GSK Investigational Site
Wengyuan, , China
GSK Investigational Site
Xiamen, , China
GSK Investigational Site
Yunfu, , China
GSK Investigational Site
Zhangshan, , China
GSK Investigational Site
Zhangshan, , China
GSK Investigational Site
Zhanjiang, , China
GSK Investigational Site
Zhaoqing, , China
GSK Investigational Site
Zhuhai, , China
Countries
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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208630
Identifier Type: -
Identifier Source: org_study_id
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