The Cohort Study for Chronic Obstructive Pulmonary Disease (COPD) in China

Study Overview
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Brief Summary
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The purpose of this study is to establish the large COPD cohort and biological database in China, aiming for precision medicine to optimize diagnosis and treatment choices and to monitor and improve clinical outcomes in this disease.

Detailed Description
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This is a 5-year multi-center observational prospective longitudinal cohort study to to establish the large COPD cohort and biological database in China, including COPD subjects( n= 3000) and GOLD 0 subjects (n= 800).Sites Investigators will be respiratory physicians working in the respiratory department of our sites, which must be tier 2 or tier 3 hospitals in China, with the equipment and ability to conduct pulmonary function test, HRCT.Patients must meet all the inclusion criteria and none of the exclusion criteria.No additional investigational drugs will be applied to the patients. Full analysis set will be used for all analyses. Missing data will be analysed as it is. Statistical analysis will be conducted by epidemiology & statistics work group from Chinese Academy of Sciences, using SAS and SUDAAN software. An electronic data capture system will be used in this study. Paper-based questionnaire administration will also be used.Questionnaire variables will be checked before data entry.During the study, PI will be in charge of the monitoring of the whole procedure. Two working group will do the data cleaning and data analysing.

Official Title
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The Cohort Study for Chronic Obstructive Pulmonary Diseases (COPD) in China---- Observation of the Disease Outcome and Identification of Prognostic Biomarkers for the Disease Outcome

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Other: COPD group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 40-75 years COPD group: baseline post-bronchodilator FEV1/FVC < 0.7 GOLD 0 group: individuals with chronic respiratory symptoms and/or high risk factors Signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years Exclusion Criteria: Acute exacerbation in the past 3 months Having other respiratory diseases with massive lung tissue destruction such as severe bronchiectasis and tuberculosis, etc The usual criteria of serious uncontrolled diseases thoracic or abdominal surgery in the last 3 months eye surgery in the last three months retinal detachment myocardial infarction in the last 3 months admission to hospital for any cardiac condition in the last month heart rate over 120 beats per minute antibacterial chemotherapy for tuberculosis pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD group<br>The post-bronchodilator FEV1/FVC ratio < 0.70 was used as definition of COPD, which was proposed by the Global Initiative for Chronic Obstructive Lung Disease | Other: COPD group<br>* The treatments will be determined by their treating physicians and no additional investigational drugs will be applied to the patients included in this study.<br>|
| GOLD 0 group<br>GOLD 0 is defined as having chronic respiratory symptoms and/or high risk factors, but without airflow (post-BD FEV1/FVC ≥ 0.7). Chronic respiratory symptoms is defined as chronic cough, phlegm production, chest tightness, short of breath, dyspnea, wheeze, ect. High risk factors is defined as cigarette smoking, passive smoking, occupational exposures, bio-fuels exposures ect. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD-related mortality and all-cause mortality | COPD-related mortality and all-cause mortality | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD exacerbation rate per year | COPD exacerbation rate per year | 10 years |