Pulmonary DiseaseNCT06573580
Primary Health Management for Chronic Obstructive Pulmonary Disease
A study testing The essential public health service（EPHS）for COPD in people with Pulmonary Disease and Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The core objective of the "Pilot Project for the Primary Health Management of Chronic Obstructive Pulmonary Disease (COPD)" is to explore a primary health management model and service standards that are suitable for COPD patients and aligned with grassroots realities. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive Pulmonary Disease
- What is being tested?
- The essential public health service（EPHS）for COPD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2024to 31 Aug 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 35 years.
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the 2024 GOLD guidelines.
- Post-bronchodilator FEV1(Forced Expiratory Volume in one second) predicted ≥ 30%.
Who cannot join
- Inability to provide informed consent.
- Contraindications for pulmonary function tests, including:
- Recent myocardial infarction, stroke, or shock within the past 3 months.
- Severe heart failure, severe arrhythmias, or unstable angina within the past 4 weeks.
- Recent major hemoptysis within the past 4 weeks.
- Major thoracic, abdominal, or ophthalmic surgery within the past 3 months.
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- Psychiatric disorders requiring antipsychotic medication or with a history of seizures requiring medication.
- Cognitive impairment, including dementia or severe comprehension deficits.
- Uncontrolled hypertension (systolic blood pressure > 200 mmHg, diastolic blood pressure > 100 mmHg).
- Resting heart rate > 120 beats per minute.
- Presence of aortic aneurysm.
- Severe hyperthyroidism.
- Pregnancy or lactation.
- Respiratory tract infections (e.g., tuberculosis, influenza, pneumonia) within the past month.
- Presence of pneumothorax, large pulmonary bullae not scheduled for surgery, or tympanic membrane perforation.
- Currently participating in, or planning to participate in, any other COPD health management or clinical intervention projects during the study period.
Trial locations and contacts
1 site in 1 country.
China1 site
China-japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Pilot Project for the Primary Health Management of Chronic Obstructive Pulmonary Disease
The core objective of the "Pilot Project for the Primary Health Management of Chronic Obstructive Pulmonary Disease (COPD)" is to explore a primary health management model and service standards that are suitable for COPD patients and aligned with grassroots realities. It also aims to enhance the capability of primary healthcare institutions in the prevention and management of chronic respiratory diseases. The primary outcomes are to evaluate the efficacy and cost-effectiveness of COPD Essential Public Health Services (EPHS) intervention in communities in China.
Participants are already receiving intervention B, "Usual primary health care," as part of their regular medical care under the current health policy. Researchers will compare intervention A, which is"the EPHS for COPD", with intervention B to determine if intervention A performs better in COPD management.
- Being tested
- The essential public health service（EPHS）for COPD
- Keywords
- Primary Health Management, Health Economic Evaluation, Efficacy, Community-based
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The essential public health service（EPHS）for COPDOther
Each group plans to recruit 3,000 participants. For the intervention group, the community-based management includes adding COPD management-related content to the primary public health service. This includes: Providing at least four follow-ups during the project at the 3rd, 6th, 9th, and 12th months. During each follow-up, patients must complete the "COPD Patient Follow-up Questionnaire" and receive oral health education and targeted clinical advice from the general practitioner (GP). In addition, the GPs must also distribute educational booklets and materials, record symptom assessment results and acute exacerbation situations, and provide targeted clinical advice and clinical decisions to the COPD patients according to the checklist of Chinese guideline for management of COPD in primary care. At the baseline and the last follow-up, patients need to undergo a routine physical examination, pulmonary function test, and bronchodilator test at their community health centers
| Study group | Role | What they receive |
|---|---|---|
| Usual primary health care for COPD | No intervention | Not described |
| The essential public health primary care for COPD | Experimental | Not described Receives: Other: The essential public health service（EPHS）for COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute exacerbation frequency
The number of exacerbations occurred
Measured: 12 months
Self-rated Quality of Life
Quality of life measured by the EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) questionnaire. It consists of two parts:
Descriptive System: This includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, ranging from no problems to extreme problems.
Visual Analog Scale (VAS): This is a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.
Scores from the descriptive system can be combined into a single health index value, while the VAS provides an immediate self-assessment of the respondent's health status. Higher scores indicate better health-related quality of life.
Measured: 12 months
Secondary outcomes (3)
Change in lung function
Decline in forced expiratory rate in one second (FEV1) before use of bronchodilator.
Measured: 6 months 12 months
Degree of dyspnea (daily activity)
Measured by Modified Medical Research Council (mMRC) Dyspnea Questionnaire Minimum Value: 0 (no dyspnea) Maximum Value: 4 (severe dyspnea) It specifically assesses dyspnea based on the activity level at which shortness of breath occurs, ranging from 0 to 4. A score of 4 indicates that the patient experiences dyspnea with minimal activity, representing the most severe breathlessness.
Measured: 12 months
Oxygen desaturation
SpO2 measured by a pulse oximeter.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start4 Jul 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,000 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, Principal investigator, China-Japan Friendship HospitalChen Wang, Study chair, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573580
- Sponsor's protocol ID
- 2024-HX-59
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu Y, Ren X, Chu X, Yan J, Guo F, Wan Q, Huang K, Lei J, Tang X, Qi X, Zheng J, Li Y, Fang F, Pan J, Jia C, Yang T, Wang C. Primary Care Integrated Management of chronic obstructive pulmonary disease (PRIM-COPD): study protocol for a cluster-randomised controlled trial. BMJ Open Respir Res. 2026 Jul 8;13(1):e003771. doi: 10.1136/bmjresp-2025-003771.
PubMed 42419819
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project for the Primary Health Management of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06573580
- Acronym / sponsor ID
- 2024-HX-59
- Keywords
- Primary Health Management, Health Economic Evaluation, Efficacy, Community-based
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 27 Aug 2024 (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 core objective of the "Pilot Project for the Primary Health Management of Chronic Obstructive Pulmonary Disease (COPD)" is to explore a primary health management model and service standards that are suitable for COPD patients and aligned with grassroots realities. It also aims to enhance the capability of primary healthcare institutions in the prevention and management of chronic respiratory diseases. The primary outcomes are to evaluate the efficacy and cost-effectiveness of COPD Essential Public Health Services (EPHS) intervention in communities in China.
Participants are already receiving intervention B, "Usual primary health care," as part of their regular medical care under the current health policy. Researchers will compare intervention A, which is"the EPHS for COPD", with intervention B to determine if intervention A performs better in COPD management.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual primary health care for COPD | No intervention | – |
| The essential public health primary care for COPD | Experimental | Other: The essential public health service（EPHS）for COPD |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 35 years.
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the 2024 GOLD guidelines.
- Post-bronchodilator FEV1(Forced Expiratory Volume in one second) predicted ≥ 30%.
Key exclusion criteria (16 listed)
- Inability to provide informed consent.
- Contraindications for pulmonary function tests, including:
- Currently participating in, or planning to participate in, any other COPD health management or clinical intervention projects during the study period.
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 |
|---|---|---|
| The essential public health service（EPHS）for COPDEach group plans to recruit 3,000 participants. For the intervention group, the community-based management includes adding COPD management-related content to the primary public health service. This includes: Providing at least four follow-ups during the project at the 3rd, 6th, 9th, and 12th months. During each follow-up, patients must complete the "COPD Patient Follow-up Questionnaire" and receive oral health education and targeted clinical advice from the general practitioner (GP). In addition, the GPs must also distribute educational booklets and materials, record symptom assessment results and acute exacerbation situations, and provide targeted clinical advice and clinical decisions to the COPD patients according to the checklist of Chinese guideline for management of COPD in primary care. At the baseline and the last follow-up, patients need to undergo a routine physical examination, pulmonary function test, and bronchodilator test at their community health centers | Other | The essential public health primary care for COPD |
Primary outcome
Acute exacerbation frequency
Time frame: 12 months
The number of exacerbations occurred
Self-rated Quality of Life
Time frame: 12 months
Quality of life measured by the EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) questionnaire. It consists of two parts: Descriptive System: This includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, ranging from no problems to extreme problems. Visual Analog Scale (VAS): This is a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. Scores from the descriptive system can be combined into a single health index value, while the VAS provides an immediate self-assessment of the respondent's health status. Higher scores indicate better health-related quality of life.
3 secondary outcomes
Change in lung function
Time frame: 6 months 12 months
Degree of dyspnea (daily activity)
Time frame: 12 months
Oxygen desaturation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 42419819Yu Y, Ren X, Chu X, Yan J, Guo F, Wan Q, Huang K, Lei J, Tang X, Qi X, Zheng J, Li Y, Fang F, Pan J, Jia C, Yang T, Wang C. Primary Care Integrated Management of chronic obstructive pulmonary disease (PRIM-COPD): study protocol for a cluster-randomised controlled trial. BMJ Open Respir Res. 2026 Jul 8;13(1):e003771. doi: 10.1136/bmjresp-2025-003771.
- Individual participant dataSharing planned: No
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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 principal investigator
China-Japan Friendship Hospital
Chen Wang study chair
Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The essential public health service（EPHS）for COPD in people with Pulmonary Disease and 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 3 inclusion and 16 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 27 Aug 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute exacerbation frequency (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06573580, which also lists 1 linked publication.
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 27 Aug 2024.