NCT05466396

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,550

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Aug 2022Dec 2027

First Submitted

Initial submission to the registry

July 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

4.4 years

First QC Date

July 17, 2022

Last Update Submit

February 13, 2025

Conditions

COPD

Keywords

early COPDspirometrylung health

Outcome Measures

Primary Outcomes (1)

  • Lung function decline in Pre-COPD and Mild-COPD patients

    FEV1 decline in Pre-COPD and Mild-COPD patients

    2 years

Secondary Outcomes (2)

  • Lung function decline in smokers with Pre-COPD and Mild-COPD

    2 years

  • Lung function decline in non-smokers with Pre-COPD and Mild-COPD

    2 years

Other Outcomes (2)

  • Lung function decline and biomarkers in Pre-COPD and Mild-COPD patients

    2 years

  • Lung function decline and Image markers in Pre-COPD and Mild-COPD patients

    2 years

Study Arms (5)

Smokers with Pre-COPD

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

Behavioral: smoking

Smokers with Mild-COPD

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

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)

Interventions

smokingBEHAVIORAL

Smoking history and spirometry are used to define groups

Smokers with Mild-COPDSmokers with Pre-COPD

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Volunteers with mild lung function abnormality will be included in this cohort study.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40703223DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and sputum simple will be collected

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Smoking Devices

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Ting Yang, M.D.

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke Huang, M.D.

CONTACT

+86-010-84206276huangke_zryy@163.com

Jieping Lei, PhD

CONTACT

+86-010-84206279jiepinglei@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice Director of Respiratory Center

Study Record Dates

First Submitted

July 17, 2022

First Posted

July 20, 2022

Study Start

August 1, 2022

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

February 17, 2025

Record last verified: 2025-02

Locations

CN(2)