Obstructive Pulmonary DiseaseEC-CPHSNCT05028985
Early COPD for China Pulmonary Health Study Stage II
An observational study of Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 6 sites in China.
Trial summary
Discovery of the pathogenesis and targets in the progression of early chronic obstructive pulmonary disease Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Pulmonary Disease
- How many people
- 400 participants
- Where
- 6 sitesChina
- Study dates
- 1 Jan 2021to Dec 2025
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: early COPD patients and healthy controls
Who may be able to join
- younger than 50 years
- smoking more than 10 pack-years
- early airflow limitation(post-bronchodilator FEV1/FVC< lower limit of normal)
Who cannot join
- cancer
- other respiratory diseases
- mental illness
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Capital Medical University
Beijing
Wei Wang
- Recruiting
China-Japan Friendship Hospital
Beijing
Ting Yang
- Recruiting
Institue of Basic Medical Sciences Chinese Academy of Medical Sciences
Beijing
Jing Wang
- Recruiting
Peking University Third Hospital
Beijing
Yahong Chen
- Recruiting
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
HuaHao Shen
- Recruiting
Shanghai Ninth People's Hospital, Shanghai JiaoTong university school of medicine
Shanghai
Weining Xiong
About this study
Official title: A Cohort Study of Early Chronic Obstructive Pulmonary Disease for China Pulmonary Health Study Stage II
Discovery of the pathogenesis and targets in the progression of early chronic obstructive pulmonary disease
Read the detailed description
This project is aimed to investigate and explore the heterogeneity during the progression of Chronic Obstructive Pulmonary Disease (COPD) in the early stage, utilizing the large-scale population cohort databases (including "China Pulmonary Health study", "The Cohort Study for Chronic Obstructive Pulmonary Disease in China" and "Acute Exacerbation of COPD Patient Registry in China" ), biological sample libraries(including blood, sputum, expiratory air, bronchoalveolar lavage fluid(BALF), and lung tissue from COPD patients with different stages and phenotypes), and multi-omics sequencing (including scRNA-seq, metabolomics, proteomics, and metagenome). We propose to establish a new standard for COPD stages and subtypes. By analyzing and mining the multi-omics data, it is expected to illustrate the association between clinical phenotype and molecular, cellular and tissue heterogeneities, thus reveal biomarkers related to the progression, clinical phenotypes, and prognosis of early-stage COPD disease.In addition, we will construct different types and stages of COPD animal models for further mechanism studies, such as the different pathogenic factors, innate and adaptive immunity, and the airway microbial ecosystem, so that we can discovered more potential therapeutic target for early-stage COPD. This project can bring a new insight and scientific evidence for COPD treatment.
- Conditions
- Obstructive Pulmonary Disease
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| early COPD patients | younger than 50 years with 10 or more pack-years smoking history and any of these abnormalities: 1) early airflow limitation (post-bronchodilator forced expiratory volume in the first second(FEV1)/forced vital capacity(FVC) < lower limit of normal), 2) compatible CT abnormalities, 3) rapid decline in FEV1 (≥60 ml/yr). | |
| Healthy people | healthy without any disabling, physical, neurological, or mental disease and were excluded living in a nursing home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 annual decline in clinical practice
FEV1 measured by portable spirometry can reflect the progression of early COPD.
Measured: 2021.1-2024.12
Secondary outcomes (4)
dyspnea symptoms
Severity of dyspnea is positively correlated with COPD severity.
Measured: 2021.1-2024.12
frequency of COPD acute exacerbation
The frequency of COPD acute exacerbation refers to the number of acute exacerbations per year.
Measured: 2021.1-2024.12
chest imaging changes
Emphysema and obstruction in small airway will be evaluated by chest computed tomography(CT).
Measured: 2021.1-2024.12
systemic complications
Whether there are systemic complications is related to the prognosis of patients.
Measured: 2021.1-2024.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start1 Jan 2021
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Second Affiliated Hospital, Zhejiang University, School of Medicine, Capital Medical University, Peking University Third Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Responsible party
- Principal investigator, Chen Wang, China-Japan Friendship Hospital
- Investigators
- Chen Wang, Study chair, Institue of Basic Medical Sciences Chinese Academy of Medical SciencesTing Yang, Principal investigator, China-Japan Friendship HospitalJing Wang, Principal investigator, Institue of Basic Medical Sciences Chinese Academy of Medical SciencesHuahao Shen, Principal investigator, Second Affiliated Hospital of Zhejiang University School of MedicineWei Wang, Principal investigator, Capital Medical UniversityYahong Chen, Principal investigator, Peking University Third HospitalWeining Xiong, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028985
- Sponsor's protocol ID
- 82090011
- Acronym
- EC-CPHS
- Status last verified
- Aug 2021
- First submitted
- 3 Jun 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Early Chronic Obstructive Pulmonary Disease for China Pulmonary Health Study Stage II
- ClinicalTrials.gov ID
- NCT05028985
- Acronym / sponsor ID
- EC-CPHS / 82090011
- Conditions
- Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Second Affiliated Hospital, Zhejiang University, School of Medicine, Capital Medical University, Peking University Third Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Aug 2021 (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.
Discovery of the pathogenesis and targets in the progression of early chronic obstructive pulmonary disease
Detailed description
This project is aimed to investigate and explore the heterogeneity during the progression of Chronic Obstructive Pulmonary Disease (COPD) in the early stage, utilizing the large-scale population cohort databases (including "China Pulmonary Health study", "The Cohort Study for Chronic Obstructive Pulmonary Disease in China" and "Acute Exacerbation of COPD Patient Registry in China" ), biological sample libraries(including blood, sputum, expiratory air, bronchoalveolar lavage fluid(BALF), and lung tissue from COPD patients with different stages and phenotypes), and multi-omics sequencing (including scRNA-seq, metabolomics, proteomics, and metagenome). We propose to establish a new standard for COPD stages and subtypes. By analyzing and mining the multi-omics data, it is expected to illustrate the association between clinical phenotype and molecular, cellular and tissue heterogeneities, thus reveal biomarkers related to the progression, clinical phenotypes, and prognosis of early-stage COPD disease.In addition, we will construct different types and stages of COPD animal models for further mechanism studies, such as the different pathogenic factors, innate and adaptive immunity, and the airway microbial ecosystem, so that we can discovered more potential therapeutic target for early-stage COPD. This project can bring a new insight and scientific evidence for COPD treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early COPD patients | – | –younger than 50 years with 10 or more pack-years smoking history and any of these abnormalities: 1) early airflow limitation (post-bronchodilator forced expiratory volume in the first second(FEV1)/forced vital capacity(FVC) < lower limit of normal), 2) compatible CT abnormalities, 3) rapid decline in FEV1 (≥60 ml/yr). |
| Healthy people | – | –healthy without any disabling, physical, neurological, or mental disease and were excluded living in a nursing home. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- early COPD patients and healthy controls
Key inclusion criteria (3 listed)
- younger than 50 years
- smoking more than 10 pack-years
- early airflow limitation(post-bronchodilator FEV1/FVC< lower limit of normal)
Key exclusion criteria (3 listed)
- cancer
- other respiratory diseases
- mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FEV1 annual decline in clinical practice
Time frame: 2021.1-2024.12
FEV1 measured by portable spirometry can reflect the progression of early COPD.
4 secondary outcomes
dyspnea symptoms
Time frame: 2021.1-2024.12
frequency of COPD acute exacerbation
Time frame: 2021.1-2024.12
chest imaging changes
Time frame: 2021.1-2024.12
systemic complications
Time frame: 2021.1-2024.12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- 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.
Chen Wang study chair
Institue of Basic Medical Sciences Chinese Academy of Medical Sciences
Ting Yang principal investigator
China-Japan Friendship Hospital
Jing Wang principal investigator
Institue of Basic Medical Sciences Chinese Academy of Medical Sciences
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 Obstructive Pulmonary Disease, run by China-Japan Friendship 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 3 inclusion and 3 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 31 Aug 2021. 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 Chen Wang (+86 010 69156477, cyh-birm@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 annual decline in clinical practice (time frame: 2021.1-2024.12). 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 31 Aug 2021.