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Recruiting NCT05466396

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

Observational COPD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: smoking.
Who it may be relevant to
Registry conditions: COPD. Basic parameters: 35 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Lung function decline in Pre-COPD and Mild-COPD patients [Time frame: 2 years]
Secondary outcome measures (2)
  • Lung function decline in smokers with Pre-COPD and Mild-COPD [Time frame: 2 years]
  • Lung function decline in non-smokers with Pre-COPD and Mild-COPD [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • China-Japan Friendship Hospital — Beijing
  • Affiliated Hospital of Zunyi Medical University — Zunyi

Publications

  • 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 40703223

Identifiers

NCT: NCT05466396 · LHEC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗