COPDLHECNCT05466396
Lung Health of Early COPD: A Multi-center Cohort Study
An observational study of COPD, run by Ting YANG at 2 sites in China.
Trial summary
This is a multi-center, prospective, cohort study in early COPD patients. This study aims to elucidate the lung function decline and its association with smoking and other risk factors. Other biomarkers and image markers from chest CT scan are also analyzed to investigate the lung function in early COPD patients. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- smoking
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,550 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers with mild lung function abnormality will be included in this cohort study.
Who may be able to join
- Gender: male or female
- Age: 35-75 years old
- post-bronchodilator spirometry: FEV1/FVC < 0.8 and FEV1%pred ≥80%
Who cannot join
- Other diseases may affect lung function, like lung cancer, bronchiectasis, interstitial lung disease or chest surgery.
- BMI > 35 kg/m2
- Dementia or other severe neurological disease
- Pregnancy
- Conditions that contraindicated lung function test
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Ke Huang, MD, +86-15120079197, huangke_zryy@163.com
Ke Huang, MD
- Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Liang Zhou, MD, 15208628481, syj_1991@163.com
Liang Zhou, MD
About this study
Official title: Lung Health of Early Chronic Obstructive Pulmonary Disease: A Multi-center Cohort Study
This is a multi-center, prospective, cohort study in early COPD patients. This study aims to elucidate the lung function decline and its association with smoking and other risk factors. Other biomarkers and image markers from chest CT scan are also analyzed to investigate the lung function in early COPD patients.
- Conditions
- COPD
- Being tested
- smoking
- Keywords
- early COPD, spirometry, lung health
- 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.
smokingBehavioural
Smoking history and spirometry are used to define groups
| Study group | Role | What they receive |
|---|---|---|
| Smokers with Pre-COPD | Smoking history ≥ 10 pack-years 0.7≤ FEV1/FVC<0.8 and FEV1%pred ≥ 80% (post-bronchodilator) Receives: Behavioral: smoking | |
| Smokers with Mild-COPD | Smoking history ≥ 10 pack-years FEV1/FVC<0.7 and FEV1%pred ≥ 80% (post-bronchodilator) Receives: Behavioral: smoking | |
| Non-Smokers with Pre-COPD | Smoking history < 10 pack-years or never-smokers 0.7≤ FEV1/FVC<0.8 and FEV1%pred ≥ 80% (post-bronchodilator) | |
| Non-Smokers with Mild-COPD | Smoking history < 10 pack-years or never-smokers FEV1/FVC<0.7 and FEV1%pred ≥ 80% (post-bronchodilator) | |
| Healthy Controls | Healthy volunteers without smoking history FEV1/FVC ≥ 0.8 and FEV1%pred ≥ 80% (post-bronchodilator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function decline in Pre-COPD and Mild-COPD patients
FEV1 decline in Pre-COPD and Mild-COPD patients
Measured: 2 years
Secondary outcomes (2)
Lung function decline in smokers with Pre-COPD and Mild-COPD
FEV1 decline in smokers with Pre-COPD and Mild-COPD
Measured: 2 years
Lung function decline in non-smokers with Pre-COPD and Mild-COPD
FEV1 decline in non-smokers with Pre-COPD and Mild-COPD
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Aug 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
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
- 1,550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ting YANG
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Sponsor-investigator, Ting YANG, China-Japan Friendship Hospital
- Investigators
- Ting Yang, M.D., Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466396
- Sponsor's protocol ID
- LHEC
- Acronym
- LHEC
- Status last verified
- Feb 2025
- First submitted
- 17 Jul 2022
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li W, Lei J, Li B, Tang X, Peng Y, Huang K, Yang T. Lung Health of Early COPD (LHEC): A Multi-Center Cohort Study-Rational and Design. Int J Chron Obstruct Pulmon Dis. 2025 Jul 19;20:2561-2568. doi: 10.2147/COPD.S517185. eCollection 2025.
PubMed 40703223
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Health of Early Chronic Obstructive Pulmonary Disease: A Multi-center Cohort Study
- ClinicalTrials.gov ID
- NCT05466396
- Acronym / sponsor ID
- LHEC / LHEC
- Conditions
- COPD
- Keywords
- early COPD, spirometry, lung health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,550 participants (estimated)
- Lead sponsor
- Ting YANGUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jul 2022 (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 multi-center, prospective, cohort study in early COPD patients. This study aims to elucidate the lung function decline and its association with smoking and other risk factors. Other biomarkers and image markers from chest CT scan are also analyzed to investigate the lung function in early COPD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Smokers with Pre-COPD | – | Behavioral: smokingSmoking history ≥ 10 pack-years 0.7≤ FEV1/FVC<0.8 and FEV1%pred ≥ 80% (post-bronchodilator) |
| Smokers with Mild-COPD | – | Behavioral: smokingSmoking history ≥ 10 pack-years FEV1/FVC<0.7 and FEV1%pred ≥ 80% (post-bronchodilator) |
| Non-Smokers with Pre-COPD | – | –Smoking history < 10 pack-years or never-smokers 0.7≤ FEV1/FVC<0.8 and FEV1%pred ≥ 80% (post-bronchodilator) |
| Non-Smokers with Mild-COPD | – | –Smoking history < 10 pack-years or never-smokers FEV1/FVC<0.7 and FEV1%pred ≥ 80% (post-bronchodilator) |
| Healthy Controls | – | –Healthy volunteers without smoking history FEV1/FVC ≥ 0.8 and FEV1%pred ≥ 80% (post-bronchodilator) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers with mild lung function abnormality will be included in this cohort study.
Key inclusion criteria (3 listed)
- Gender: male or female
- Age: 35-75 years old
- post-bronchodilator spirometry: FEV1/FVC < 0.8 and FEV1%pred ≥80%
Key exclusion criteria (5 listed)
- Other diseases may affect lung function, like lung cancer, bronchiectasis, interstitial lung disease or chest surgery.
- BMI > 35 kg/m2
- Dementia or other severe neurological disease
- Pregnancy
- Conditions that contraindicated lung function test
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 |
|---|---|---|
| smokingSmoking history and spirometry are used to define groups | Behavioural | Smokers with Mild-COPD, Smokers with Pre-COPD |
Primary outcome
Lung function decline in Pre-COPD and Mild-COPD patients
Time frame: 2 years
FEV1 decline in Pre-COPD and Mild-COPD patients
2 secondary outcomes
Lung function decline in smokers with Pre-COPD and Mild-COPD
Time frame: 2 years
Lung function decline in non-smokers with Pre-COPD and Mild-COPD
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 40703223Li W, Lei J, Li B, Tang X, Peng Y, Huang K, Yang T. Lung Health of Early COPD (LHEC): A Multi-Center Cohort Study-Rational and Design. Int J Chron Obstruct Pulmon Dis. 2025 Jul 19;20:2561-2568. doi: 10.2147/COPD.S517185. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ting Yang, M.D. principal investigator
China-Japan Friendship Hospital
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 Ting YANG 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke Huang, M.D. (+86-010-84206276, huangke_zryy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function decline in Pre-COPD and Mild-COPD patients (time frame: 2 years). 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 NCT05466396, 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 17 Feb 2025.