COPDNCT03314077
Quality Control and Evaluation in Standard COPD Management
An observational study of COPD, run by Tongji Hospital at 2 sites in China.
Trial summary
There is lack of quality control and evaluation indexes for standard COPD management in hospitals in China, leading to nonstandard in COPD management and discrepancy in therapeutic efficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- GOLD 2017
- How many people
- 210 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2017to 31 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinic-based population
Who may be able to join
- 1.Clinical manifestation of COPD; post bronchodilator FEV1/FVC<0.70
Who cannot join
- 1. lung cancer. 2. Any history of psychiatric disorders. 3.HIV positive. 4.Breastfeeding, pregnancy or planning to be pregnant. 5.Estimated lifetime less than 1 years due to underlying diseases.
Trial locations and contacts
2 sites in 1 country.
About this study
There is lack of quality control and evaluation indexes for standard COPD management in hospitals in China, leading to nonstandard in COPD management and discrepancy in therapeutic efficiency. This study focuses on establishing quality control and evaluation indexes for standard COPD management in hospitals in China, and evaluating the therapeutic efficiency after standard COPD management. This part is a prospective cohort which lasts 2 years. After standard COPD management according to GOLD 2017 by doctors in hospitals in China, patients will be followed up for their outcome after 1 year. Several indexes will be selected to evaluate the quality control of standard COPD management and its efficiency. The controls are from hospital-based subjects with a retrospective cohort study.
- Conditions
- COPD
- Being tested
- GOLD 2017
- 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.
GOLD 2017Other
Standard COPD management according to GOLD 2017, and control the quality of management in one-year follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Standard managed subjects | COPD patients accepted standard COPD management. Receives: Other: GOLD 2017 | |
| Controls | COPD patients didn't accepted standard COPD management or quality control, who are from hospital subjects with a retrospective cohort study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spirometry
Spirometry will be assessed at baseline and through study completion
Measured: 1 years
Secondary outcomes (1)
Morbidity of acute exacerbation in 1 years
Morbidity of acute exacerbation completion will be assessed at baseline and through study
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 posted19 Oct 2017
- Study start1 Nov 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guilin Medical University, China, University hospital of Hubei university for nationalities,China, TongjiChibi hospital,China, Central health center in Yongjiahe Town,China, Chinses PLA general hospital, Second Xiangya Hospital of Central South University, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, First Hospital of China Medical University, Peking University Third Hospital, Huashan Hospital, First Affiliated Hospital Xi'an Jiaotong University, Shanghai Zhongshan Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Yiwu Central Hospital, Xuhui Central Hospital, Shanghai, Sijing hospital of Songjiang District in Shanghai, Youxian People's Hospital, Tong Ren hospital Shanghai Jiao Tong university school of medicine, Zhejiang Putuo Hospital, Jing-An District Center Hospital of Shanghai (Huashan Hospital Fudan University Jing-An Branch), Shanghai Medical College, Fudan University
- Responsible party
- Principal investigator, Weining Xiong, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314077
- Sponsor's protocol ID
- TongjiHospitalResp.
- Status last verified
- Mar 2020
- First submitted
- 15 Oct 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Control and Evaluation in Standard COPD Management
- ClinicalTrials.gov ID
- NCT03314077
- Acronym / sponsor ID
- TongjiHospitalResp.
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Guilin Medical University, China, University hospital of Hubei university for nationalities,China, TongjiChibi hospital,China, Central health center in Yongjiahe Town,China, Chinses PLA general hospital, Second Xiangya Hospital of Central South University, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, First Hospital of China Medical University, Peking University Third Hospital, Huashan Hospital, First Affiliated Hospital Xi'an Jiaotong University, Shanghai Zhongshan Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Yiwu Central Hospital, Xuhui Central Hospital, Shanghai, Sijing hospital of Songjiang District in Shanghai, Youxian People's Hospital, Tong Ren hospital Shanghai Jiao Tong university school of medicine, Zhejiang Putuo Hospital, Jing-An District Center Hospital of Shanghai (Huashan Hospital Fudan University Jing-An Branch), Shanghai Medical College, Fudan University
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Oct 2017 (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.
There is lack of quality control and evaluation indexes for standard COPD management in hospitals in China, leading to nonstandard in COPD management and discrepancy in therapeutic efficiency. This study focuses on establishing quality control and evaluation indexes for standard COPD management in hospitals in China, and evaluating the therapeutic efficiency after standard COPD management. This part is a prospective cohort which lasts 2 years. After standard COPD management according to GOLD 2017 by doctors in hospitals in China, patients will be followed up for their outcome after 1 year. Several indexes will be selected to evaluate the quality control of standard COPD management and its efficiency. The controls are from hospital-based subjects with a retrospective cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard managed subjects | – | Other: GOLD 2017COPD patients accepted standard COPD management. |
| Controls | – | –COPD patients didn't accepted standard COPD management or quality control, who are from hospital subjects with a retrospective cohort study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinic-based population
Key inclusion criteria (1 listed)
- 1.Clinical manifestation of COPD; post bronchodilator FEV1/FVC<0.70
Key exclusion criteria (1 listed)
- 1. lung cancer. 2. Any history of psychiatric disorders. 3.HIV positive. 4.Breastfeeding, pregnancy or planning to be pregnant. 5.Estimated lifetime less than 1 years due to underlying diseases.
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 |
|---|---|---|
| GOLD 2017Standard COPD management according to GOLD 2017, and control the quality of management in one-year follow-up. | Other | Standard managed subjects |
Primary outcome
Change in spirometry
Time frame: 1 years
Spirometry will be assessed at baseline and through study completion
1 secondary outcome
Morbidity of acute exacerbation in 1 years
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 25 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Tongji Hospital at 2 sites 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 1 inclusion and 1 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 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in spirometry (time frame: 1 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 25 Mar 2020; AzTrials last refreshed its copy on 1 Nov 2026.