The China National COPD Screening Program

The National Chronic Obstructive Pulmonary Disease Screening Program in China

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Comprehensive intervention and management Ⅰ; Other: Comprehensive intervention and management Ⅱ; Other: Comprehensive intervention and management Ⅲ

• Study Type: Observational
• Enrollment (Anticipated): 800000

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • China-Japan Friendship Hospital
    • Contact: Ke HUANG, M.D.; Phone Number: 010-84206408

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults who are potentially under a high risk of suffering COPD with an age between 35 and 75 years are eligible to be recruited. The participants should be residents who were living in the survey area with more than six months in the past year.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-COPD high-risk population; The local residents gain a COPD-SQ score < 16.	Other: Comprehensive intervention and management Ⅰ; Mainly health advisory.
COPD high-risk population; 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; Health advisory and regular follow-ups.
Confirmed COPD patients; The participants have a COPD-SQ score ≥ 16 with a FEV1/FVC ≥ 0.70 after administration of bronchodilators.	Other: Comprehensive intervention and management Ⅲ; Pharmaceutical and non-pharmaceutical (e.g. health advisory, rehabilitation, etc.) interventions according to standardized clinical guidelines, with regular follow-ups.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 9, 2021
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (ACTUAL): July 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Screening; Chronic Obstructive Pulmonary Disease; Spirometry
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2021-145-K103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data would be available on reasonable request from the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No