Chronic Obstructive Pulmonary DiseaseCOPD STANDARDNCT04664491
Effects of COPD Standardized Management on COPD Exacerbation
A study testing Standardized COPD management and Routine COPD management in people with Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This is a multi-center, parallel-group,cluster randomised trial involving secondary hospitals across China. The objective is to evaluate the effect of COPD on reducing moderate-to-severe exacerbations during 12 months follow-up in primary-level medical institutions. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Standardized COPD management and Routine COPD management
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,456 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2023to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥40 years
- Post-bronchodilator FEV1/FVC <70%
- Baseline CAT score ≥10 or history of exacerbation in previous 12 months, defined as any use of oral antibiotics and/or oral or nebulized corticosteroids for increased cough, sputum and dyspnea, or exacerbation requiring hospitalization/ emergency admission.
- Local residents who live nearby and can be followed up throughout study period
- Written informed consent
Who cannot join
- Pregnancy, breastfeeding, or potential pregnancy
- Primary diagnosis of asthma
- Having severe cognitive dysfunction
- Severely ill with less than 12-month life expectancy
- Patients with alcohol abuse history are excluded as alcoholic individuals may have low adherence to the study. Alcohol abuse is defined as an average alcohol intake >80 g per day within recent two weeks, or daily intake of ≥40 g alcohol in men, and ≥20 g alcohol in women for more than 5 years.
- Have participated in similar trials or are undergoing other clinical trials
Show all 14Show fewer
- Refuses or unable to give informed consent
- Plan to move
- Contraindicated to maintenance medicine.
- Unstable cardiovascular conditions (e.g., angina, myocardial infarction, ascending aortic aneurysm) that may prevent patients performing spirometry.
- Relative contraindications to spirometry, including current pneumothorax or planning to undergo thoracic/abdominal, ophthalmic or brain surgeries within next 6 months.
- Comorbid lung disease including bronchiectasis and tuberculosis, or undergoing anti-tuberculosis treatment
- Recent exacerbation treated with antibiotics and/or oral or nebulized corticosteroids within 30 days prior to enrolment.
- Exacerbation requiring emergency admission or hospitalization within 30 days prior to enrolment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Effect of Standardized Disease Management on Exacerbation of COPD in Primary Health Care in China: a Multicenter, Adjudicator-Blinded, Parallel, Cluster Randomized Clinical Trial
This is a multi-center, parallel-group,cluster randomised trial involving secondary hospitals across China. The objective is to evaluate the effect of COPD on reducing moderate-to-severe exacerbations during 12 months follow-up in primary-level medical institutions.
Read the detailed description
COPD is the most common chronic respiratory disease in China. An effective and standardized condition management strategy is urgently needed to prevent acute exacerbation, improve the quality of life, and avoid premature death due to COPD. COPD management is mainly performed in community-level health institutions. Implementing COPD standardized management in primary care will help improve the level of COPD prevention and treatment in China.
The investigators will carry out a multicenter, adjudicator-blinded, parallel, cluster randomized clinical trial. An estimated number of 96 secondary hospitals across the country will be involved. Each hospital plans to enroll 36 patients with COPD. The hospitals will be randomly allocated into standardized management (SM) group and control group. In SM group, standardized COPD management based-on guidelines will be delivered to patients, including inhaler use for initial and maintenance therapy, regular follow-up, long-term monitoring of lung function and respiratory symptoms, patient education, and favorable lifestyle changes. In control group, patients will receive routine care as usual. In both groups, moderate and severe exacerbations will be collected within 12 months follow-up after randomization. Group difference in annual exacerbation rate will be examined to evaluate the effect of standardized management of COPD on acute exacerbation of COPD in primary care.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Standardized COPD management, Routine COPD management
- Keywords
- COPD, Standardized Management, Maintenance Therapy, Follow-Up and Monitoring, Lung Function, COPD Symptoms
- 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.
Standardized COPD managementBehavioural
Also called COPD management according to GOLD and China's guidelines for COPD care
In standardized management group, patients will receive a multifaceted and integrated disease management that follows recommendations in GOLD 2020 and China Guideline on COPD care. It contains the components below.
- Maintenance therapy after initial treatment. In this study, patients' initial therapy is the prescribed inhalers at baseline. Maintenance therapy is the medications (LABA, LAMA, or ICS) prescribed for regular or long-term use after initial therapy.
- Long-term follow-up and routine monitoring of symptoms measured by CAT, mMRC and SGRQ.
- Regular pulmonary function testing for lung function monitoring
- Strengthened COPD education
- Behavioral modification, eg. encouragement of influenza/pneumococcal vaccination, providing smoking cessation counseling and pulmonary rehabilitation.
Routine COPD managementOther
Patients will undergo usual care according to current clinical practice in study sites. Usual care is the routine care provided to patients. Prescription and dispense of medicine for COPD initial and maintenance therapy will be at the discretion of doctors.
| Study group | Role | What they receive |
|---|---|---|
| Standardized management | Experimental | Patients will be managed according to recommendations in GOLD guideline and China's guidelines for COPD care. Receives: Behavioral: Standardized COPD management |
| Usual care | Other | Patients will undergo usual care according to current clinical practice in study sites. Receives: Other: Routine COPD management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
The primary outcome is annual rate of moderate and severe exacerbation, which will be identified from medical records on the HIS system and patient report at 6 and 12 months assessments
Measured: 12 months from baseline
Secondary outcomes (8)
Exacerbation events
Time to first moderate exacerbation in days, time to first severe exacerbation in days, time to first exacerbation-related hospitalization in days, time to first exacerbation-related emergency admissions in days, time elapsed from patient enrollment until first admission for acute exacerbation in days
Measured: 12 months from baseline
Hospital readmissions
Number of readmissions within 30 days after discharge, time to first readmission within 30 days after discharge in days, number of readmissions within 90 days after discharge, time to first readmission within 90 days after discharge in days
Measured: 12 months from baseline
Hospital stay
Average length of hospital stay in days
Measured: 12 months from baseline
Healthcare cost
Total COPD-related health care cost in rmb
Measured: 12 months from baseline
Lung function change
Change in FEV1 from baseline to 12 months in liter
Measured: 12 months from baseline
Symptom change
Units on SGRQ-C score change from baseline to 12 months, units on CAT score change from baseline to 12 months, units on mMRC score change from baseline to 12 months
Measured: 12 months from baseline
Patients' care-seeking behaviors
Number of patients' contacting physicians for medical advice, number of patients' hospital visits to seek care
Measured: 12 months from baseline
Patients' adherence to treatment
Time of patients' adherence to inhaler medication use in days
Measured: 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start4 Feb 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel, cluster randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Wang, China-Japan Friendship Hospital
- Investigators
- Chen Wang, MD, Ph.D, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664491
- Sponsor's protocol ID
- 2019-41-K29
- Other IDs
- 2020-HX-17/214373
- Acronym
- COPD STANDARD
- Status last verified
- Apr 2025
- First submitted
- 6 Dec 2020
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khakban A, Sin DD, FitzGerald JM, McManus BM, Ng R, Hollander Z, Sadatsafavi M. The Projected Epidemic of Chronic Obstructive Pulmonary Disease Hospitalizations over the Next 15 Years. A Population-based Perspective. Am J Respir Crit Care Med. 2017 Feb 1;195(3):287-291. doi: 10.1164/rccm.201606-1162PP. No abstract available.
PubMed 27626508Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
PubMed 17132052Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9.
PubMed 29650248Dong F, Su R, Ren Y, Huang K, Li W, Yang L, Li X, Hu X, Ye T, Jin D, Yang T, Jones PW, Wang C. Real-world effectiveness study of guideline-directed COPD STANDARDized management in patients with chronic obstructive pulmonary disease: a cluster randomised trial design. BMJ Open Respir Res. 2025 Jul 7;12(1):e002768. doi: 10.1136/bmjresp-2024-002768.
PubMed 40623795
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Standardized Disease Management on Exacerbation of COPD in Primary Health Care in China: a Multicenter, Adjudicator-Blinded, Parallel, Cluster Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04664491
- Acronym / sponsor ID
- COPD STANDARD / 2019-41-K29
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Standardized Management, Maintenance Therapy, Follow-Up and Monitoring, Lung Function, COPD Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,456 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 4 Feb 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 11 Dec 2020 (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.
This is a multi-center, parallel-group,cluster randomised trial involving secondary hospitals across China. The objective is to evaluate the effect of COPD on reducing moderate-to-severe exacerbations during 12 months follow-up in primary-level medical institutions.
Detailed description
COPD is the most common chronic respiratory disease in China. An effective and standardized condition management strategy is urgently needed to prevent acute exacerbation, improve the quality of life, and avoid premature death due to COPD. COPD management is mainly performed in community-level health institutions. Implementing COPD standardized management in primary care will help improve the level of COPD prevention and treatment in China.
The investigators will carry out a multicenter, adjudicator-blinded, parallel, cluster randomized clinical trial. An estimated number of 96 secondary hospitals across the country will be involved. Each hospital plans to enroll 36 patients with COPD. The hospitals will be randomly allocated into standardized management (SM) group and control group. In SM group, standardized COPD management based-on guidelines will be delivered to patients, including inhaler use for initial and maintenance therapy, regular follow-up, long-term monitoring of lung function and respiratory symptoms, patient education, and favorable lifestyle changes. In control group, patients will receive routine care as usual. In both groups, moderate and severe exacerbations will be collected within 12 months follow-up after randomization. Group difference in annual exacerbation rate will be examined to evaluate the effect of standardized management of COPD on acute exacerbation of COPD in primary care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel, cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Standardized management | Experimental | Behavioral: Standardized COPD managementPatients will be managed according to recommendations in GOLD guideline and China's guidelines for COPD care. |
| Usual care | Other | Other: Routine COPD managementPatients will undergo usual care according to current clinical practice in study sites. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥40 years
- Post-bronchodilator FEV1/FVC <70%
- Baseline CAT score ≥10 or history of exacerbation in previous 12 months, defined as any use of oral antibiotics and/or oral or nebulized corticosteroids for increased cough, sputum and dyspnea, or exacerbation requiring hospitalization/ emergency admission.
- Local residents who live nearby and can be followed up throughout study period
- Written informed consent
Key exclusion criteria (14 listed)
- Pregnancy, breastfeeding, or potential pregnancy
- Primary diagnosis of asthma
- Having severe cognitive dysfunction
- Severely ill with less than 12-month life expectancy
- Patients with alcohol abuse history are excluded as alcoholic individuals may have low adherence to the study. Alcohol abuse is defined as an average alcohol intake >80 g per day within recent two weeks, or daily intake of ≥40 g alcohol in men, and ≥20 g alcohol in women for more than 5 years.
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 |
|---|---|---|
| Standardized COPD managementAlso: COPD management according to GOLD and China's guidelines for COPD careIn standardized management group, patients will receive a multifaceted and integrated disease management that follows recommendations in GOLD 2020 and China Guideline on COPD care. It contains the components below. 1. Maintenance therapy after initial treatment. In this study, patients' initial therapy is the prescribed inhalers at baseline. Maintenance therapy is the medications (LABA, LAMA, or ICS) prescribed for regular or long-term use after initial therapy. 2. Long-term follow-up and routine monitoring of symptoms measured by CAT, mMRC and SGRQ. 3. Regular pulmonary function testing for lung function monitoring 4. Strengthened COPD education 5. Behavioral modification, eg. encouragement of influenza/pneumococcal vaccination, providing smoking cessation counseling and pulmonary rehabilitation. | Behavioural | Standardized management |
| Routine COPD managementPatients will undergo usual care according to current clinical practice in study sites. Usual care is the routine care provided to patients. Prescription and dispense of medicine for COPD initial and maintenance therapy will be at the discretion of doctors. | Other | Usual care |
Primary outcome
Effectiveness
Time frame: 12 months from baseline
The primary outcome is annual rate of moderate and severe exacerbation, which will be identified from medical records on the HIS system and patient report at 6 and 12 months assessments
8 secondary outcomes
Exacerbation events
Time frame: 12 months from baseline
Hospital readmissions
Time frame: 12 months from baseline
Hospital stay
Time frame: 12 months from baseline
Healthcare cost
Time frame: 12 months from baseline
Lung function change
Time frame: 12 months from baseline
Symptom change
Time frame: 12 months from baseline
Patients' care-seeking behaviors
Time frame: 12 months from baseline
Patients' adherence to treatment
Time frame: 12 months from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Background: PubMed 27626508Khakban A, Sin DD, FitzGerald JM, McManus BM, Ng R, Hollander Z, Sadatsafavi M. The Projected Epidemic of Chronic Obstructive Pulmonary Disease Hospitalizations over the Next 15 Years. A Population-based Perspective. Am J Respir Crit Care Med. 2017 Feb 1;195(3):287-291. doi: 10.1164/rccm.201606-1162PP. No abstract available.
- Background: PubMed 17132052Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
- Background: PubMed 29650248Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9.
- Derived from this study: PubMed 40623795Dong F, Su R, Ren Y, Huang K, Li W, Yang L, Li X, Hu X, Ye T, Jin D, Yang T, Jones PW, Wang C. Real-world effectiveness study of guideline-directed COPD STANDARDized management in patients with chronic obstructive pulmonary disease: a cluster randomised trial design. BMJ Open Respir Res. 2025 Jul 7;12(1):e002768. doi: 10.1136/bmjresp-2024-002768.
- GOLD guidelinesLink provided by the sponsor.
- 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.
Chen Wang, MD, Ph.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?
A study testing Standardized COPD management and Routine COPD management in people with 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 31 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Yang, MD, Ph.D (13651380809, dryangting@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: 12 months from baseline). 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 NCT04664491, which also lists 4 linked publications.
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 31 May 2025.