The China National COPD Screening Program

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The National Chronic Obstructive Pulmonary Disease Screening Program in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480176
• Other study ID #: 2021-145-K103
• Status: Recruiting
• Start date: October 9, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2022
• Source: China-Japan Friendship Hospital
• Contact: Jieping LEI, Ph.D.
• Phone: 010-84206408
• Email: jiepinglei[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Comprehensive intervention and management ?
Mainly health advisory.
• Comprehensive intervention and management ?
Health advisory and regular follow-ups.
• Comprehensive intervention and management ?
Pharmaceutical and non-pharmaceutical (e.g. health advisory, rehabilitation, etc.) interventions according to standardized clinical guidelines, with regular follow-ups.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Respiratory symptoms	The appearance frequencies of respiratory symptoms (e.g. cough, sputum, wheeze, dyspnea, etc.)	2 years
Secondary	Exacerbations	The numbers of exacerbations (e.g. emergency department visit, hospital admission, etc.) that related to COPD	2 years