Lung Health of Early COPD: a Multi-center Cohort Study (LHEC)

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.

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Behavioral: smoking

• Study Type: Observational
• Enrollment (Estimated): 1550

Contacts and Locations

• Study Contact: Name: Ke Huang, M.D.; Phone Number: +86-010-84206276; Email: huangke_zryy@163.com
• Study Contact Backup: Name: Jieping Lei, PhD; Phone Number: +86-010-84206279; Email: jiepinglei@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Ke Huang, MD; Phone Number: +86-15120079197; Email: huangke_zryy@163.com
      • Contact: Ke Huang, MD
      • Contact: Ting Yang, MD
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • Recruiting
      • Affiliated Hospital of Zunyi Medical University
      • Contact: Liang Zhou, MD; Phone Number: 15208628481; Email: syj_1991@163.com
      • Contact: Liang Zhou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Smokers with Pre-COPD; Smoking history ≥ 10 pack-years 0.7≤ FEV1/FVC<0.8 and FEV1%pred ≥ 80% (post-bronchodilator)	Behavioral: smoking; 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)	Behavioral: smoking; 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)
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function decline in Pre-COPD and Mild-COPD patients	FEV1 decline in Pre-COPD and Mild-COPD patients	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function decline in smokers with Pre-COPD and Mild-COPD	FEV1 decline in smokers with Pre-COPD and Mild-COPD	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	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function decline and biomarkers in Pre-COPD and Mild-COPD patients	Association between FEV1 decline and biomarkers in blood, sputum or urine in Pre-COPD and Mild-COPD patients	2 years
Lung function decline and Image markers in Pre-COPD and Mild-COPD patients	Association between FEV1 decline and structural markers form chest CT scan in Pre-COPD and Mild-COPD patients	2 years

Collaborators and Investigators

• Sponsor: Ting YANG
• Collaborators: Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Ting Yang, M.D., China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 17, 2022
• First Submitted That Met QC Criteria: July 17, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: spirometry; early COPD; lung health
• Other Study ID Numbers: LHEC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No