Early COPD for China Pulmonary Health Study Stage II

Study Overview
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Brief Summary
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Discovery of the pathogenesis and targets in the progression of early chronic obstructive pulmonary disease

Detailed Description
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This project is aimed to investigate and explore the heterogeneity during the progression of Chronic Obstructive Pulmonary Disease (COPD) in the early stage, utilizing the large-scale population cohort databases (including China Pulmonary Health study, The Cohort Study for Chronic Obstructive Pulmonary Disease in China and Acute Exacerbation of COPD Patient Registry in China ), biological sample libraries(including blood, sputum, expiratory air, bronchoalveolar lavage fluid(BALF), and lung tissue from COPD patients with different stages and phenotypes), and multi-omics sequencing (including scRNA-seq, metabolomics, proteomics, and metagenome). We propose to establish a new standard for COPD stages and subtypes. By analyzing and mining the multi-omics data, it is expected to illustrate the association between clinical phenotype and molecular, cellular and tissue heterogeneities, thus reveal biomarkers related to the progression, clinical phenotypes, and prognosis of early-stage COPD disease.In addition, we will construct different types and stages of COPD animal models for further mechanism studies, such as the different pathogenic factors, innate and adaptive immunity, and the airway microbial ecosystem, so that we can discovered more potential therapeutic target for early-stage COPD. This project can bring a new insight and scientific evidence for COPD treatment.

Official Title
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A Cohort Study of Early Chronic Obstructive Pulmonary Disease for China Pulmonary Health Study Stage II

Conditions
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Obstructive Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: younger than 50 years smoking more than 10 pack-years early airflow limitation(post-bronchodilator FEV1/FVC< lower limit of normal) Exclusion Criteria: cancer other respiratory diseases mental illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| early COPD patients<br>younger than 50 years with 10 or more pack-years smoking history and any of these abnormalities: 1) early airflow limitation (post-bronchodilator forced expiratory volume in the first second(FEV1)/forced vital capacity(FVC) < lower limit of normal), 2) compatible CT abnormalities, 3) rapid decline in FEV1 (≥60 ml/yr). | |
| Healthy people<br>healthy without any disabling, physical, neurological, or mental disease and were excluded living in a nursing home. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 annual decline in clinical practice | FEV1 measured by portable spirometry can reflect the progression of early COPD. | 2021.1-2024.12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dyspnea symptoms | Severity of dyspnea is positively correlated with COPD severity. | 2021.1-2024.12 | 
| frequency of COPD acute exacerbation | The frequency of COPD acute exacerbation refers to the number of acute exacerbations per year. | 2021.1-2024.12 | 
| chest imaging changes | Emphysema and obstruction in small airway will be evaluated by chest computed tomography(CT). | 2021.1-2024.12 | 
| systemic complications | Whether there are systemic complications is related to the prognosis of patients. | 2021.1-2024.12 |