COPDNCT06340295
A Multicenter, Prospective Cohort Study of Preserved Ratio Impaired Spirometry(PRISm) in a Population
An observational study of COPD, run by Peking University First Hospital at 6 sites in China.
Trial summary
Chronic obstructive pulmonary disease (COPD) is the most common chronic tract disease and the third leading cause of death worldwide. The treatment effect of COPD is poor, and the disease is progressive, resulting in a serious disease burden. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- COPD
- How many people
- 2,000 participants
- Where
- 6 sitesChina
- Study dates
- 1 Sep 2023to 31 May 2026
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects are 1430 PRISm people from the PIFCOPD cohort in our center and 600 newly enrolled PRISm people in this study, totaling approximately 2000 PRISm people.
Who may be able to join
- 1) Age range from 20 to 75 years old, regardless of gender; 2) Pulmonary function test: After inhaling bronchodilators, FEV1/FVC ≥ 70%, and FEV1<80% of the expected value; 3) Agree to enter this research project and sign an informed consent form 4) Able to comply with research protocols.
Who cannot join
- 1) Confirmed chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis, interstitial lung disease, occupational lung disease, tuberculosis, pulmonary vascular disease, central airway stenosis and other confirmed respiratory diseases.
- 2) Have undergone lobectomy and/or lung transplantation; 3) complicated with serious underlying diseases (including serious mental illness, mental retardation, neurological disease, malignant tumor, chronic liver disease, heart failure, autoimmune disease, chronic kidney disease); 4) accompanied by severe pleural disease and/or lesions of the sternum or ribs; 5) Have active tuberculosis or are receiving anti-tuberculosis treatment; 6) Pregnancy or lactation; 7) Can not be followed up for a long time or poor compliance;
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Jiping Liao, MD., 13521714181, colorfulwing01@163.com
Chunbo Zhang, 13086645758, 2399637945@qq.com
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Guangfa Wang, MD, 13810644029, wangguangfa@hotmail.com
Jiping Liao, MD, 13521714181, colorfulwing01@163.com
- Recruiting
Shandong Provincial Hospital Affiliated to Shandong University
Jing’an
Jian Sun, MD, docbenjaminsun@163.com
- Recruiting
The First Hospital of Qinhuangdao
Qinhuangdao, Hebei
Hua Qiao, MD, 13780358298, qh1202@163.com
- Recruiting
Shanxi Bethune Hospital
Taiyuan
Ruiying Wang, MD, +86 13903436432, wry0526@163.com
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Lixia Dong, MD, 13001385918, luckydonglixia@163.com
About this study
Chronic obstructive pulmonary disease (COPD) is the most common chronic tract disease and the third leading cause of death worldwide. The treatment effect of COPD is poor, and the disease is progressive, resulting in a serious disease burden. The key reason is that early recognition is difficult and the early pathophysiological mechanism is unclear, which leads to the difficulty of early intervention.PRISm is likely to be the precursor stage of COPD, which may provide an important research object for the study of pathophysiological characteristics, inflammation and immunomodulatory mechanisms of early COPD, and may also become a new entry point for early intervention of COPD. This study attempts to establish a PRISm prospective cohort，and collects blood, EBC and urine for analysis of inflammatory factors, metabolomics, proteomics and microbiome, and performs chest HRCT to obtain imaging indicators, and conducts 3-year dynamic follow-up observation to study the evolution characteristics of pulmonary function and the incidence of COPD in the PRISm cohort. To compare the differences in imaging, inflammatory factors, metabolomics, proteomics and microbiome among the three PRISm groups, and establish a risk prediction model for progression to COPD through PRISm. It lays a foundation for understanding the characteristics of COPD at an earlier stage and exploring new early warning indicators.
- Conditions
- COPD
- Keywords
- PRISm, COPD, Imaging omics, Metabolomics, proteomics
- 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.
Other
| Study group | Role | What they receive |
|---|---|---|
| new-onset COPD group | FEV1/FVC<0.7 after bronchodilator inhalation during 3 years of follow-up | |
| Continuous PRISm group | After bronchodilator inhalation, FEV1/FVC≥70% and the percentage of FEV1pred%<80% during 3 years of follow-up | |
| PRISm to normal group | After bronchodilator inhalation, FEV1/FVC≥0.7 and FEV1pred% ≥80% during 3 years of follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and proportion of newly diagnosed COPD
FEV1/FVC<0.7 after bronchodilator inhalation during 3 years of follow-up
Measured: the third year of follow-up
Secondary outcomes (4)
The number and proportion of continuous PRISm population
After bronchodilator inhalation, FEV1/FVC≥70% and the percentage of FEV1pred%<80% during 3 years of follow-up
Measured: the third year of follow-up
The number and proportion of PRISm to normal population
After bronchodilator inhalation, FEV1/FVC≥0.7 and FEV1pred% ≥80% during 3 years of follow-up
Measured: the third year of follow-up
Emerging diseases
Emerging diseases: non-COPD lung diseases (bronchial asthma, ILD), OSA, cardiovascular diseases (such as coronary heart disease, hypertension, etc.), endocrine diseases (such as diabetes), cerebrovascular diseases, digestive diseases, chronic kidney diseases, etc.
Measured: the third year of follow-up
Death and cause of death
Death and cause of death
Measured: the third year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Sep 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
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
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Bethune Hospital, First Affiliated Hospital Xi'an Jiaotong University, Tianjin Medical University General Hospital, The First Hospital of Qinhuangdao, Shandong Provincial Hospital, Second Hospital of Jilin University, People's Hospital of Xinjiang Uygur Autonomous Region, MinDong Hospital of Ningde City
- Responsible party
- Sponsor
- Investigators
- Guangfa Wang, MD., Study chair, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340295
- Sponsor's protocol ID
- 2023313
- Status last verified
- Oct 2023
- First submitted
- 25 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Cohort Study of Preserved Ratio Impaired Spirometry(PRISm) in a Population
- ClinicalTrials.gov ID
- NCT06340295
- Acronym / sponsor ID
- 2023313
- Conditions
- COPD
- Keywords
- PRISm, COPD, Imaging omics, Metabolomics, proteomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Shanxi Bethune Hospital, First Affiliated Hospital Xi'an Jiaotong University, Tianjin Medical University General Hospital, The First Hospital of Qinhuangdao, Shandong Provincial Hospital, Second Hospital of Jilin University, People's Hospital of Xinjiang Uygur Autonomous Region, MinDong Hospital of Ningde City
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 1 Apr 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.
Chronic obstructive pulmonary disease (COPD) is the most common chronic tract disease and the third leading cause of death worldwide. The treatment effect of COPD is poor, and the disease is progressive, resulting in a serious disease burden. The key reason is that early recognition is difficult and the early pathophysiological mechanism is unclear, which leads to the difficulty of early intervention.PRISm is likely to be the precursor stage of COPD, which may provide an important research object for the study of pathophysiological characteristics, inflammation and immunomodulatory mechanisms of early COPD, and may also become a new entry point for early intervention of COPD. This study attempts to establish a PRISm prospective cohort，and collects blood, EBC and urine for analysis of inflammatory factors, metabolomics, proteomics and microbiome, and performs chest HRCT to obtain imaging indicators, and conducts 3-year dynamic follow-up observation to study the evolution characteristics of pulmonary function and the incidence of COPD in the PRISm cohort. To compare the differences in imaging, inflammatory factors, metabolomics, proteomics and microbiome among the three PRISm groups, and establish a risk prediction model for progression to COPD through PRISm. It lays a foundation for understanding the characteristics of COPD at an earlier stage and exploring new early warning indicators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| new-onset COPD group | – | –FEV1/FVC<0.7 after bronchodilator inhalation during 3 years of follow-up |
| Continuous PRISm group | – | –After bronchodilator inhalation, FEV1/FVC≥70% and the percentage of FEV1pred%<80% during 3 years of follow-up |
| PRISm to normal group | – | –After bronchodilator inhalation, FEV1/FVC≥0.7 and FEV1pred% ≥80% during 3 years of follow-up |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects are 1430 PRISm people from the PIFCOPD cohort in our center and 600 newly enrolled PRISm people in this study, totaling approximately 2000 PRISm people.
Key inclusion criteria (1 listed)
- 1) Age range from 20 to 75 years old, regardless of gender; 2) Pulmonary function test: After inhaling bronchodilators, FEV1/FVC ≥ 70%, and FEV1<80% of the expected value; 3) Agree to enter this research project and sign an informed consent form 4) Able to comply with research protocols.
Key exclusion criteria (2 listed)
- 1) Confirmed chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis, interstitial lung disease, occupational lung disease, tuberculosis, pulmonary vascular disease, central airway stenosis and other confirmed respiratory diseases.
- 2) Have undergone lobectomy and/or lung transplantation; 3) complicated with serious underlying diseases (including serious mental illness, mental retardation, neurological disease, malignant tumor, chronic liver disease, heart failure, autoimmune disease, chronic kidney disease); 4) accompanied by severe pleural disease and/or lesions of the sternum or ribs; 5) Have active tuberculosis or are receiving anti-tuberculosis treatment; 6) Pregnancy or lactation; 7) Can not be followed up for a long time or poor compliance;
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 |
|---|---|---|
| Other | Continuous PRISm group, PRISm to normal group, new-onset COPD group |
Primary outcome
The number and proportion of newly diagnosed COPD
Time frame: the third year of follow-up
FEV1/FVC<0.7 after bronchodilator inhalation during 3 years of follow-up
4 secondary outcomes
The number and proportion of continuous PRISm population
Time frame: the third year of follow-up
The number and proportion of PRISm to normal population
Time frame: the third year of follow-up
Emerging diseases
Time frame: the third year of follow-up
Death and cause of death
Time frame: the third year of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- 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.
Guangfa Wang, MD. study chair
Peking University First Hospital
6 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 Peking University First Hospital at 6 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 2 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 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiping Liao, MD. (13521714181, colorfulwing01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and proportion of newly diagnosed COPD (time frame: the third year of follow-up). 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 1 Apr 2024.