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

COPD Clinical Trial

— LHEC  

Official title:

Lung Health of Early Chronic Obstructive Pulmonary Disease: A Multi-center Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05466396
• Other study ID #: LHEC
• Status: Not yet recruiting
• Start date: August 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2022
• Source: China-Japan Friendship Hospital
• Contact: Ke Huang, M.D.
• Phone: +86-010-84206276
• Email: huangke_zryy[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1550
• Est. completion date: December 31, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Behavioral:
• smoking
Smoking history and spirometry are used to define groups

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ting YANG	Chinese Academy of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Lung function decline in Pre-COPD and Mild-COPD patients	FEV1 decline in Pre-COPD and Mild-COPD patients	2 years
Secondary	Lung function decline in smokers with Pre-COPD and Mild-COPD	FEV1 decline in smokers with Pre-COPD and Mild-COPD	2 years
Secondary	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