Chronic Obstructive Pulmonary DiseaseNCT06096285
Heterogeneity and Development of Early COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This study aims to investigate the clinical characteristics and heterogeneities of early chronic obstructive pulmonary disease (COPD), to determine the disease development of early COPD, and to establish a multidimensional model for predicting the outcomes of early COPD. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 Jan 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study plans to involve the individuals with different early COPD status, as well as comparable controls.
Who may be able to join
- The individuals who meet the defining criteria of PRISm, COPD Stage 0, Pre-COPD, Early COPD, Young COPD, and Mild COPD, according to the latest GOLD documents and publications.
Who cannot join
- Age < 18 years or > 80 years;
- Pregnant or maternal women;
- Having malignant and active tumor(s), and receiving treatment;
- Undergoing a surgical operation;
- Having problems with mental awareness;
- Having difficulties in daily activities;
- Participating in other interventional clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Jieping Lei, Ph.D., +86 010 8420 6408, jiepinglei@126.com
About this study
Official title: Heterogeneity and Disease Development of Early Chronic Obstructive Pulmonary Disease
This study aims to investigate the clinical characteristics and heterogeneities of early chronic obstructive pulmonary disease (COPD), to determine the disease development of early COPD, and to establish a multidimensional model for predicting the outcomes of early COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, Early COPD, Heterogeneity, Disease development
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Preserved ratio impaired spirometry (PRISm) | People with post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ≥ 0.70 and FEV1 and/or FVC < 80% predicted, or FEV1/FVC ≥ lower limit of normal (LLN) and FEV1 < LLN. | |
| COPD Stage 0 | People who had COPD-related risk factor exposure (e.g. cigarette smoke) and/or presented with respiratory symptoms (e.g. chronic cough, and/or sputum production) whereas with normal pulmonary function. | |
| Pre-COPD | People (importantly, of any age) who had respiratory symptoms (e.g. cough, sputum production, dyspnea, and/or exacerbation) with or without detectable structural (e.g. thoracic computed tomography (CT) emphysema, small and/or large airway impairments) and/or functional (e.g. low diffusion capacity for carbon monoxide (DLCO), hyperinflation, small airway obstruction, and/or accelerated FEV1 decline) abnormalities, in the absence of airflow limitation, and who might (or not) develop persistent airflow limitation (i.e. COPD) over time. | |
| Early COPD | People who were younger than 50 years with ten or more pack-years smoking history and any of these abnormalities: i) early airflow limitation (post-bronchodilator FEV1/FVC < LLN), ii) compatible thoracic CT abnormalities, iii) rapid decline in FEV1 (> 60 ml/year) that was accelerated relative to FVC. | |
| Young COPD | COPD patients with post-bronchodilator FEV1/FVC < 0.70 diagnosed in the 20-50 year age range. | |
| Mild COPD | COPD patients with post-bronchodilator FEV1/FVC < 0.70 and FEV1 ≥ 80% predicted. | |
| Controls | People who were not belonged to any of above six early COPD status, and with pre- and post-bronchodilator FEV1/FVC ≥ 0·70, and with post-bronchodilator FEV1/FVC ≥ LLN. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with COPD exacerbation
COPD exacerbation refers to acute deterioration of respiratory symptoms (e.g. cough, sputum, wheeze, dyspnea), especially resulting in hospital visit or admission.
Measured: One year
Secondary outcomes (7)
FEV1
Measured: One year
FVC
Measured: One year
FEV1/FVC ratio
Measured: One year
FEV1% predicted value
Measured: One year
FVC% predicted value
Measured: One year
The COPD Assessment Test scale
The COPD Assessment Test scores range from 0 to 40, with higher scores indicating worse symptoms.
Measured: One year
The modified Medical Research Council dyspnea scale
The modified Medical Research Council dyspnea scores range from 0 to 4, with higher scores indicating more severe dyspnea.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Feb 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jieping LEI, Ph.D., China-Japan Friendship Hospital
- Investigators
- Jieping Lei, Ph.D., Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096285
- Sponsor's protocol ID
- 2023-ZF-9
- Status last verified
- Oct 2023
- First submitted
- 15 Oct 2023
- Last updated
- 24 Oct 2023
- 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 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heterogeneity and Disease Development of Early Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06096285
- Acronym / sponsor ID
- 2023-ZF-9
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, Early COPD, Heterogeneity, Disease development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 23 Oct 2023 (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 study aims to investigate the clinical characteristics and heterogeneities of early chronic obstructive pulmonary disease (COPD), to determine the disease development of early COPD, and to establish a multidimensional model for predicting the outcomes of early COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Preserved ratio impaired spirometry (PRISm) | – | –People with post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ≥ 0.70 and FEV1 and/or FVC < 80% predicted, or FEV1/FVC ≥ lower limit of normal (LLN) and FEV1 < LLN. |
| COPD Stage 0 | – | –People who had COPD-related risk factor exposure (e.g. cigarette smoke) and/or presented with respiratory symptoms (e.g. chronic cough, and/or sputum production) whereas with normal pulmonary function. |
| Pre-COPD | – | –People (importantly, of any age) who had respiratory symptoms (e.g. cough, sputum production, dyspnea, and/or exacerbation) with or without detectable structural (e.g. thoracic computed tomography (CT) emphysema, small and/or large airway impairments) and/or functional (e.g. low diffusion capacity for carbon monoxide (DLCO), hyperinflation, small airway obstruction, and/or accelerated FEV1 decline) abnormalities, in the absence of airflow limitation, and who might (or not) develop persistent airflow limitation (i.e. COPD) over time. |
| Early COPD | – | –People who were younger than 50 years with ten or more pack-years smoking history and any of these abnormalities: i) early airflow limitation (post-bronchodilator FEV1/FVC < LLN), ii) compatible thoracic CT abnormalities, iii) rapid decline in FEV1 (> 60 ml/year) that was accelerated relative to FVC. |
| Young COPD | – | –COPD patients with post-bronchodilator FEV1/FVC < 0.70 diagnosed in the 20-50 year age range. |
| Mild COPD | – | –COPD patients with post-bronchodilator FEV1/FVC < 0.70 and FEV1 ≥ 80% predicted. |
| Controls | – | –People who were not belonged to any of above six early COPD status, and with pre- and post-bronchodilator FEV1/FVC ≥ 0·70, and with post-bronchodilator FEV1/FVC ≥ LLN. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study plans to involve the individuals with different early COPD status, as well as comparable controls.
Key inclusion criteria (1 listed)
- The individuals who meet the defining criteria of PRISm, COPD Stage 0, Pre-COPD, Early COPD, Young COPD, and Mild COPD, according to the latest GOLD documents and publications.
Key exclusion criteria (7 listed)
- Age < 18 years or > 80 years;
- Pregnant or maternal women;
- Having malignant and active tumor(s), and receiving treatment;
- Undergoing a surgical operation;
- Having problems with mental awareness;
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
Number of participants with COPD exacerbation
Time frame: One year
COPD exacerbation refers to acute deterioration of respiratory symptoms (e.g. cough, sputum, wheeze, dyspnea), especially resulting in hospital visit or admission.
7 secondary outcomes
FEV1
Time frame: One year
FVC
Time frame: One year
FEV1/FVC ratio
Time frame: One year
FEV1% predicted value
Time frame: One year
FVC% predicted value
Time frame: One year
The COPD Assessment Test scale
Time frame: One year
The modified Medical Research Council dyspnea scale
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- 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.
Jieping Lei, 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?
An observational study of 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 1 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: status not confirmed, as of the sponsor's last update on 24 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jieping Lei, Ph.D. (+86 010 8420 6408, jiepinglei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with COPD exacerbation (time frame: One year). 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 24 Oct 2023.