COPDNCT03604146
Quality Control for Chronic Obstructive Pulmonary Disease
An observational study of COPD, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
This is a 1 year longitudinal study to establish a related index system for chronic obstructive pulmonary disease(COPD) quality control.Clinical and economic data of COPD patients will be collected and analyzed. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2018to 30 Dec 2020
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Grade II - III hospital in Guangdong Province
Who may be able to join
- Patients was diagnosed as COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines older than 40 years old.Patients was hospitalized for AECOPD or visiting outpatient department for COPD.
- A signed and dated written informed consent is obtained prior to participation.
- Able to comply with the requirements of the protocol and be available for study visits over 1 years.
Who cannot join
- A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Known respiratory disorders, or disorders identified at screening/visit
- 1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis)
- Having undergone lung surgery (e.g. lung reduction, lung transplant)
- Severe liver and kidney dysfunction
- Have cancer or have had cancer in the 5 years prior to study entry
- Taking part in a blinded drug study
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
Official title: Establishment of Quality Control Index System and Strategy for Chronic Obstructive Pulmonary Disease in China
This is a 1 year longitudinal study to establish a related index system for chronic obstructive pulmonary disease(COPD) quality control.Clinical and economic data of COPD patients will be collected and analyzed.
Read the detailed description
Sixteen hospitals in Guangdong Province were randomly divided into control group and intervention group.Doctors and nurses of intervention group were trained treat chronic obstructive pulmonary disease according to the GOLD(Global InitiaTive of Chronic Obstructive Lung Disease) guidelines，while those in the control group will not receive any training from research team. Hospital patient cohort and outpatient cohort will be setted. Subjects were interviewed and received pulmonary function tests.All patients will be followed and events of acute exacerbation will be recorded.Factors that influence patient prognosis and economic-health benefits will be analyzed.
- Conditions
- COPD
- Being tested
- Medical quality control intervention strategy
- Keywords
- COPD, Quality Control
- 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.
Medical quality control intervention strategyBehavioural
Training and education for diagnosis, treatment and management of COPD for doctors and nurses; Regular inspection and supervision of medical quality
| Study group | Role | What they receive |
|---|---|---|
| control group | Doctors and nurses were trained to treat chronic obstructive pulmonary disease according to the GOLD guidelines.Hospital patient cohort and outpatient cohort will be setted. Subjects were interviewed and received pulmonary function tests. | |
| Intervention group | Doctors and nurses will not receive any training from research team. Hospital patient cohort and outpatient cohort will be setted. Subjects were interviewed and received pulmonary function tests. Receives: Behavioral: Medical quality control intervention strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of exacerbations of COPD (AECOPD)
The rate of exacerbations within 1 year in the intervention group and the control group will be tracked.
Measured: 1 year
Secondary outcomes (2)
rate of readmission for AECOPD
The rate of readmission for AECOPD within 1 year in the intervention group and the control group will be tracked.
Measured: 1 year
change of Forced expiratory volume in one second(FEV1)
The difference in FEV1 after bronchodilator between baseline and 1 year later
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start20 Mar 2018
- Primary completion30 Jun 2020
- Study completion30 Dec 2020
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 COPDStudies of the same condition, open and under way.
- 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
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengyan Wang, Guangzhou Institute of Respiratory Disease
- Investigators
- Rongchang Chen, MD, Study director, Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604146
- Sponsor's protocol ID
- C2017050
- Status last verified
- Feb 2021
- First submitted
- 10 Jul 2018
- Last updated
- 10 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang F, Wang M, Chen X, Song A, Zeng H, Chen J, Wang L, Jiang W, Jiang M, Shi W, Li Y, Zhong H, Chen R, Liang Z. Quality of Care and Outcomes of Inpatients with COPD: A Multi-Center Study in China. Int J Chron Obstruct Pulmon Dis. 2025 May 31;20:1787-1795. doi: 10.2147/COPD.S510613. eCollection 2025.
PubMed 40470524
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Quality Control Index System and Strategy for Chronic Obstructive Pulmonary Disease in China
- ClinicalTrials.gov ID
- NCT03604146
- Acronym / sponsor ID
- C2017050
- Conditions
- COPD
- Keywords
- COPD, Quality Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 27 Jul 2018 (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 1 year longitudinal study to establish a related index system for chronic obstructive pulmonary disease(COPD) quality control.Clinical and economic data of COPD patients will be collected and analyzed.
Detailed description
Sixteen hospitals in Guangdong Province were randomly divided into control group and intervention group.Doctors and nurses of intervention group were trained treat chronic obstructive pulmonary disease according to the GOLD(Global InitiaTive of Chronic Obstructive Lung Disease) guidelines，while those in the control group will not receive any training from research team. Hospital patient cohort and outpatient cohort will be setted. Subjects were interviewed and received pulmonary function tests.All patients will be followed and events of acute exacerbation will be recorded.Factors that influence patient prognosis and economic-health benefits will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –Doctors and nurses were trained to treat chronic obstructive pulmonary disease according to the GOLD guidelines.Hospital patient cohort and outpatient cohort will be setted. Subjects were interviewed and received pulmonary function tests. |
| Intervention group | – | Behavioral: Medical quality control intervention strategyDoctors and nurses will not receive any training from research team. Hospital patient cohort and outpatient cohort will be setted. Subjects were interviewed and received pulmonary function tests. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Grade II - III hospital in Guangdong Province
Key inclusion criteria (3 listed)
- Patients was diagnosed as COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines older than 40 years old.Patients was hospitalized for AECOPD or visiting outpatient department for COPD.
Key exclusion criteria (7 listed)
- A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Known respiratory disorders, or disorders identified at screening/visit
- 1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis)
- Having undergone lung surgery (e.g. lung reduction, lung transplant)
- Severe liver and kidney dysfunction
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 |
|---|---|---|
| Medical quality control intervention strategyTraining and education for diagnosis, treatment and management of COPD for doctors and nurses; Regular inspection and supervision of medical quality | Behavioural | Intervention group |
Primary outcome
rate of exacerbations of COPD (AECOPD)
Time frame: 1 year
The rate of exacerbations within 1 year in the intervention group and the control group will be tracked.
2 secondary outcomes
rate of readmission for AECOPD
Time frame: 1 year
change of Forced expiratory volume in one second(FEV1)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 40470524Wang F, Wang M, Chen X, Song A, Zeng H, Chen J, Wang L, Jiang W, Jiang M, Shi W, Li Y, Zhong H, Chen R, Liang Z. Quality of Care and Outcomes of Inpatients with COPD: A Multi-Center Study in China. Int J Chron Obstruct Pulmon Dis. 2025 May 31;20:1787-1795. doi: 10.2147/COPD.S510613. eCollection 2025.
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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.
Rongchang Chen, MD study director
Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University,China
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 COPD, run by Guangzhou Institute of Respiratory Disease 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 7 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: finished, as of the sponsor's last update on 10 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
rate of exacerbations of COPD (AECOPD) (time frame: 1 year). 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 NCT03604146, 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 10 Feb 2021.