The China National COPD Screening Program

Study Overview
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Brief Summary
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The national COPD screening program is in a cross-sectional manner at the baseline, planning to recruit a total of 800,000 participants from 160 districts or counties (5,000 for each site on average) from 31 provinces, autonomous regions or municipalities directly under the central government of China. The filtered COPD high-risk population and confirmed COPD patients will be managed and followed up according to the standardized clinical guidelines. The major aims of the program are to estimate the prevalences of COPD high-risk population and under- or miss- diagnosed COPD patients, and to manage the development and outcomes of the disease.

Official Title
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The National Chronic Obstructive Pulmonary Disease Screening Program in China

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Comprehensive intervention and management Ⅰ
* Other: Comprehensive intervention and management Ⅱ
* Other: Comprehensive intervention and management Ⅲ


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults aged between 35 and 75 years; residents living in the survey area with more than 6 months in the past year. Exclusion Criteria: experienced myocardial infarction, stroke or shock in the past 3 months; experienced severe cardiac insufficiency, severe arrhythmia or unstable angina pectoris in the past 4 weeks; experienced massive hemoptysis in the past 4 weeks; received chest, abdominal or ophthalmic surgery in the past 3 months; have mental disorders (e.g. auditory hallucinations, visual hallucinations, taking antipsychotics, seizures requiring medication, etc.); have cognitive impairment (e.g. dementia, comprehension impairment, etc.); have uncontrolled hypertension (i.e. systolic blood pressure > 200 mmHg, diastolic blood pressure > 100 mmHg); present with heart rate >120 beats/min; have aortic aneurysm; have severe hyperthyroidism; are pregnant or lactating women; experienced respiratory infectious diseases (e.g. tuberculosis, influenza, etc.) in the past month.

Ages Eligible for Study
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Minimum Age: 35 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 |
| --- | --- |
| Non-COPD high-risk population<br>The local residents gain a COPD-SQ score < 16. | Other: Comprehensive intervention and management Ⅰ<br>* Mainly health advisory.<br>|
| COPD high-risk population<br>The participants have a COPD-SQ score ≥ 16 with a FEV1/FVC ≥ 0.70 either with or without bronchodilator administration. | Other: Comprehensive intervention and management Ⅱ<br>* Health advisory and regular follow-ups.<br>|
| Confirmed COPD patients<br>The participants have a COPD-SQ score ≥ 16 with a FEV1/FVC ≥ 0.70 after administration of bronchodilators. | Other: Comprehensive intervention and management Ⅲ<br>* Pharmaceutical and non-pharmaceutical (e.g. health advisory, rehabilitation, etc.) interventions according to standardized clinical guidelines, with regular follow-ups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function | The changes of lung function (e.g. FEV1, FVC, FEV1/FVC, etc.) (P.S.: it is hard to assume that the lung function would be improved or decling, especially for the pre- or early-COPD population) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory symptoms | The appearance frequencies of respiratory symptoms (e.g. cough, sputum, wheeze, dyspnea, etc.) | 2 years | 
| Exacerbations | The numbers of exacerbations (e.g. emergency department visit, hospital admission, etc.) that related to COPD | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, Screening, Spirometry