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NCT Number: NCT05466396

Lung Health of Early COPD: 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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

China-Japan Friendship Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

smoking

Behavioral

Smoking history and spirometry are used to define groups

Primary outcomes

  1. Lung function decline in Pre-COPD and Mild-COPD patients

    Time frame: 2 years

    FEV1 decline in Pre-COPD and Mild-COPD patients

Secondary outcomes

  1. Lung function decline in smokers with Pre-COPD and Mild-COPD

    Time frame: 2 years

    FEV1 decline in smokers with Pre-COPD and Mild-COPD

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

    Time frame: 2 years

    FEV1 decline in non-smokers with Pre-COPD and Mild-COPD

Other outcomes

  1. Lung function decline and biomarkers in Pre-COPD and Mild-COPD patients

    Time frame: 2 years

    Association between FEV1 decline and biomarkers in blood, sputum or urine in Pre-COPD and Mild-COPD patients

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

    Time frame: 2 years

    Association between FEV1 decline and structural markers form chest CT scan in Pre-COPD and Mild-COPD patients

Study contacts

Contact information is provided by the study sponsor or research team.

Jieping Lei, PhD

CONTACT

[email protected]

+86-010-84206279

Ke Huang, M.D.

CONTACT

[email protected]

+86-010-84206276

Sponsors and collaborators

Lead sponsor

Ting YANG

Other

Collaborators

  • Chinese Academy of Medical Sciences

Registry information

Official study title

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

Acronym: LHEC

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jul 20, 2022
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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