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

ConditionCOPD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35-75
SponsorTing YANG

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Gender: male or female

Age: 35-75 years old

post-bronchodilator spirometry: FEV1/FVC < 0.8 and FEV1%pred ≥80%

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • smoking

    Behavioral

    Smoking history and spirometry are used to define groups

Treatment groups

1,550 Participants
are divided into 5 treatment groups
Group A: Smokers with Pre-COPD1 intervention
Group B: Smokers with Mild-COPD1 intervention
Group C: Non-Smokers with Pre-COPD0 interventions
Group D: Non-Smokers with Mild-COPD0 interventions
Group E: Healthy Controls0 interventions

Trial outcomes

Primary outcomes

1

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

FEV1 decline in Pre-COPD and Mild-COPD patients

Time frame
2 years

Secondary outcomes

1

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

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

Time frame
2 years
2

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

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

Time frame
2 years

Other outcomes

1

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

Time frame
2 years
2

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

Time frame
2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ting YANG

Lead sponsor

China-Japan Friendship Hospital

Sponsor institution

Chinese Academy of Medical Sciences

Collaborator

Source ClinicalTrials.gov
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