The China National COPD Screening Program

NCT05480176 | Unknown DMC

• 1 other identifier: 2021-145-K103
• Study Type: observational
• Target: 800,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Screening; Spirometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Respiratory symptoms

  2 years

• Exacerbations

  2 years

Study Arms (3)

Non-COPD high-risk population

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

Other: Comprehensive intervention and management Ⅰ

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

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

Interventions

Comprehensive intervention and management Ⅰ OTHER

Mainly health advisory.

Non-COPD high-risk population

Comprehensive intervention and management Ⅱ OTHER

Health advisory and regular follow-ups.

COPD high-risk population

Comprehensive intervention and management Ⅲ OTHER

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

Confirmed COPD patients

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• adults aged between 35 and 75 years;
• residents living in the survey area with more than 6 months in the past year.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ting YANG, M.D.

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieping LEI, Ph.D.

CONTACT

010-84206408; jiepinglei@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 29, 2022
• Study Start: October 9, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)