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RecruitingNCT05480176Updated Jul 29, 2022

The China National COPD Screening Program

An observational study in Chronic Obstructive Pulmonary Disease, sponsored by China-Japan Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-29.

Sponsored by China-Japan Friendship Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2022, 3 years 9 months ago, but the record still lists the study as recruiting.
  • Started Oct 2021; still recruiting 4 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800,000
Ages
35 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • Chronic Obstructive Pulmonary Disease
  • Screening
  • Spirometry
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 800,000 is above the median of 157 across 929 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherComprehensive intervention and management Ⅰ

    Mainly health advisory.

  • OtherComprehensive intervention and management Ⅱ

    Health advisory and regular follow-ups.

  • OtherComprehensive intervention and management Ⅲ

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

06

What researchers measure

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)

    Time frame: 2 years

Secondary outcomes

  1. Respiratory symptoms

    The appearance frequencies of respiratory symptoms (e.g. cough, sputum, wheeze, dyspnea, etc.)

    Time frame: 2 years

  2. Exacerbations

    The numbers of exacerbations (e.g. emergency department visit, hospital admission, etc.) that related to COPD

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • China-Japan Friendship Hospital
    Beijing, China
    • Ke HUANG, M.D. · Contact · 010-84206408
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Data would be available on reasonable request from the principal investigator.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05480176
Lead sponsor
China-Japan Friendship Hospital
Responsible party
Ting YANG (Prof., China-Japan Friendship Hospital) — Principal investigator
First posted
Jul 29, 2022
Start date
Oct 9, 2021
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jul 29, 2022

Study contacts

Jieping LEI, Ph.D.
Contact
jiepinglei@126.com
010-84206408
Ting YANG, M.D.
principal investigator · China-Japan Friendship Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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