The China National COPD Screening Program

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Comprehensive intervention and management Ⅲ; Other: Comprehensive intervention and management Ⅰ; Other: Comprehensive intervention and management Ⅱ

• Registration Number: NCT05480176
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-09
• Status Verified: 2022-07
• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-07-28
• Last Update Submitted: 2022-07-28
• Study First Posted: 2022-07-29
• Last Update Posted: 2022-07-29
• Primary Completion: 2022-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Confirmed COPD patients	Comprehensive intervention and management Ⅲ	The participants have a COPD-SQ score ≥ 16 with a FEV1/FVC ≥ 0.70 after administration of bronchodilators.
Non-COPD high-risk population	Comprehensive intervention and management Ⅰ	The local residents gain a COPD-SQ score \< 16.
COPD high-risk population	Comprehensive intervention and management Ⅱ	The participants have a COPD-SQ score ≥ 16 with a FEV1/FVC ≥ 0.70 either with or without bronchodilator administration.

Primary Outcome Measures

Name	Time	Method
Lung function	2 years	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China