The China National COPD Screening Program

China-Japan Friendship Hospital

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Comprehensive intervention and management Ⅲ; Other: Comprehensive intervention and management Ⅰ; Other: Comprehensive intervention and management Ⅱ

Study type: Observational

Funder types: Other

Identifiers

NCT05480176

2021-145-K103

Details and patient eligibility

About

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.

Enrollment: 800,000 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

800,000 participants in 3 patient groups

Non-COPD high-risk population

Description:

The local residents gain a COPD-SQ score \< 16.

Treatment:

Other: Comprehensive intervention and management Ⅰ

COPD high-risk population

Description:

The participants have a COPD-SQ score ≥ 16 with a FEV1/FVC ≥ 0.70 either with or without bronchodilator administration.

Treatment:

Other: Comprehensive intervention and management Ⅱ

Confirmed COPD patients

Description:

The participants have a COPD-SQ score ≥ 16 with a FEV1/FVC ≥ 0.70 after administration of bronchodilators.

Treatment:

Other: Comprehensive intervention and management Ⅲ