The China National COPD Screening Program

NCT ID: NCT05480176

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-09

Study Completion Date

2025-12-31

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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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Chronic Obstructive Pulmonary Disease Screening Spirometry

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-COPD high-risk population

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

Comprehensive intervention and management Ⅰ

Intervention Type OTHER

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.

Comprehensive intervention and management Ⅱ

Intervention Type OTHER

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.

Comprehensive intervention and management Ⅲ

Intervention Type OTHER

Pharmaceutical and non-pharmaceutical (e.g. health advisory, rehabilitation, etc.) interventions according to standardized clinical guidelines, with regular follow-ups.

Interventions

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Comprehensive intervention and management Ⅰ

Mainly health advisory.

Intervention Type OTHER

Comprehensive intervention and management Ⅱ

Health advisory and regular follow-ups.

Intervention Type 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.

Intervention Type OTHER

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ting YANG

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ting YANG, M.D.

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

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China-Japan Friendship Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jieping LEI, Ph.D.

Role: CONTACT

Phone: 010-84206408

Email: [email protected]

Facility Contacts

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Ke HUANG, M.D.

Role: primary

Other Identifiers

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2021-145-K103

Identifier Type: -

Identifier Source: org_study_id