Lung Health of Early COPD: A Multi-center Cohort Study

NCT ID: NCT05466396

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Smokers with Pre-COPD

Smoking history ≥ 10 pack-years 0.7≤ FEV1/FVC\<0.8 and FEV1%pred ≥ 80% (post-bronchodilator)

smoking

Intervention Type BEHAVIORAL

Smoking history and spirometry are used to define groups

Smokers with Mild-COPD

Smoking history ≥ 10 pack-years FEV1/FVC\<0.7 and FEV1%pred ≥ 80% (post-bronchodilator)

smoking

Intervention Type BEHAVIORAL

Smoking history and spirometry are used to define groups

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)

No interventions assigned to this group

Non-Smokers with Mild-COPD

Smoking history \< 10 pack-years or never-smokers FEV1/FVC\<0.7 and FEV1%pred ≥ 80% (post-bronchodilator)

No interventions assigned to this group

Healthy Controls

Healthy volunteers without smoking history FEV1/FVC ≥ 0.8 and FEV1%pred ≥ 80% (post-bronchodilator)

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

smoking

Smoking history and spirometry are used to define groups

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Gender: male or female
2. Age: 35-75 years old
3. post-bronchodilator spirometry: FEV1/FVC \< 0.8 and FEV1%pred ≥80%

Exclusion Criteria

1. Other diseases may affect lung function, like lung cancer, bronchiectasis, interstitial lung disease or chest surgery.
2. BMI \> 35 kg/m2
3. Dementia or other severe neurological disease
4. Pregnancy
5. Conditions that contraindicated lung function test
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Ting YANG

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ting YANG

Vice Director of Respiratory Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ting Yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ke Huang, M.D.

Role: CONTACT

+86-010-84206276

Jieping Lei, PhD

Role: CONTACT

+86-010-84206279

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ke Huang, MD

Role: primary

+86-15120079197

Liang Zhou, MD

Role: primary

15208628481

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40703223 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LHEC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.