Chronic Obstructive Pulmonary DiseaseNCT05480176
The China National COPD Screening Program
An observational study of Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Comprehensive intervention and management Ⅰ, Comprehensive intervention and management Ⅱ and Comprehensive intervention and management Ⅲ
- How many people
- 800,000 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- adults aged between 35 and 75 years;
- residents living in the survey area with more than 6 months in the past year.
Who cannot join
- 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.);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing
Ke HUANG, M.D., 010-84206408
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Comprehensive intervention and management Ⅰ, Comprehensive intervention and management Ⅱ, Comprehensive intervention and management Ⅲ
- Keywords
- Chronic Obstructive Pulmonary Disease, Screening, Spirometry
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive intervention and management ⅠOther
Mainly health advisory.
Comprehensive intervention and management ⅡOther
Health advisory and regular follow-ups.
Comprehensive intervention and management ⅢOther
Pharmaceutical and non-pharmaceutical (e.g. health advisory, rehabilitation, etc.) interventions according to standardized clinical guidelines, with regular follow-ups.
| Study group | Role | What they receive |
|---|---|---|
| Non-COPD high-risk population | The local residents gain a COPD-SQ score < 16. Receives: 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. Receives: 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. Receives: Other: Comprehensive intervention and management Ⅲ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Secondary outcomes (2)
Respiratory symptoms
The appearance frequencies of respiratory symptoms (e.g. cough, sputum, wheeze, dyspnea, etc.)
Measured: 2 years
Exacerbations
The numbers of exacerbations (e.g. emergency department visit, hospital admission, etc.) that related to COPD
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start9 Oct 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting YANG, China-Japan Friendship Hospital
- Investigators
- Ting YANG, M.D., Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480176
- Sponsor's protocol ID
- 2021-145-K103
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data would be available on reasonable request from the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Chronic Obstructive Pulmonary Disease Screening Program in China
- ClinicalTrials.gov ID
- NCT05480176
- Acronym / sponsor ID
- 2021-145-K103
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Screening, Spirometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800,000 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 9 Oct 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-COPD high-risk population | – | Other: Comprehensive intervention and management ⅠThe local residents gain a COPD-SQ score < 16. |
| COPD high-risk population | – | Other: Comprehensive intervention and management ⅡThe participants have a COPD-SQ score ≥ 16 with a FEV1/FVC ≥ 0.70 either with or without bronchodilator administration. |
| Confirmed COPD patients | – | Other: Comprehensive intervention and management ⅢThe participants have a COPD-SQ score ≥ 16 with a FEV1/FVC ≥ 0.70 after administration of bronchodilators. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- adults aged between 35 and 75 years;
- residents living in the survey area with more than 6 months in the past year.
Key exclusion criteria (12 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive intervention and management ⅠMainly health advisory. | Other | Non-COPD high-risk population |
| Comprehensive intervention and management ⅡHealth advisory and regular follow-ups. | Other | COPD high-risk population |
| Comprehensive intervention and management ⅢPharmaceutical and non-pharmaceutical (e.g. health advisory, rehabilitation, etc.) interventions according to standardized clinical guidelines, with regular follow-ups. | Other | Confirmed COPD patients |
Primary outcome
Lung function
Time frame: 2 years
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 secondary outcomes
Respiratory symptoms
Time frame: 2 years
Exacerbations
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No. Data would be available on reasonable request from the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting YANG, M.D. principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jieping LEI, Ph.D. (010-84206408, jiepinglei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.