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

Recruiting

• Conditions: COPD
• Interventions: Behavioral: smoking

• Registration Number: NCT05466396
• Lead Sponsor: Ting YANG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-17
• Study First Submitted QC: 2022-07-17
• Study First Posted: 2022-07-20
• Study Start: 2022-08-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1550

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Smokers with Pre-COPD	smoking	Smoking history ≥ 10 pack-years 0.7≤ FEV1/FVC\<0.8 and FEV1%pred ≥ 80% (post-bronchodilator)
Smokers with Mild-COPD	smoking	Smoking history ≥ 10 pack-years FEV1/FVC\<0.7 and FEV1%pred ≥ 80% (post-bronchodilator)

Primary Outcome Measures

Name	Time	Method
Lung function decline in Pre-COPD and Mild-COPD patients	2 years	FEV1 decline in Pre-COPD and Mild-COPD patients

Secondary Outcome Measures

Name	Time	Method
Lung function decline in non-smokers with Pre-COPD and Mild-COPD	2 years	FEV1 decline in non-smokers with Pre-COPD and Mild-COPD
Lung function decline in smokers with Pre-COPD and Mild-COPD	2 years	FEV1 decline in smokers with Pre-COPD and Mild-COPD

Trial Locations

Locations (2)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Affiliated Hospital of Zunyi Medical University; 🇨🇳 Zunyi, Guizhou, China