Heterogeneity and Development of Early COPD

China-Japan Friendship Hospital

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Study type: Observational

Funder types: Other

Identifiers

NCT06096285

2023-ZF-9

Details and patient eligibility

About

This study aims to investigate the clinical characteristics and heterogeneities of early chronic obstructive pulmonary disease (COPD), to determine the disease development of early COPD, and to establish a multidimensional model for predicting the outcomes of early COPD.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The individuals who meet the defining criteria of PRISm, COPD Stage 0, Pre-COPD, Early COPD, Young COPD, and Mild COPD, according to the latest GOLD documents and publications.

Exclusion criteria

• Age < 18 years or > 80 years;
• Pregnant or maternal women;
• Having malignant and active tumor(s), and receiving treatment;
• Undergoing a surgical operation;
• Having problems with mental awareness;
• Having difficulties in daily activities;
• Participating in other interventional clinical trials.

Trial design

84 participants in 7 patient groups

Preserved ratio impaired spirometry (PRISm)

Description:

People with post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ≥ 0.70 and FEV1 and/or FVC \< 80% predicted, or FEV1/FVC ≥ lower limit of normal (LLN) and FEV1 \< LLN.

COPD Stage 0

Description:

People who had COPD-related risk factor exposure (e.g. cigarette smoke) and/or presented with respiratory symptoms (e.g. chronic cough, and/or sputum production) whereas with normal pulmonary function.

Pre-COPD

Description:

People (importantly, of any age) who had respiratory symptoms (e.g. cough, sputum production, dyspnea, and/or exacerbation) with or without detectable structural (e.g. thoracic computed tomography (CT) emphysema, small and/or large airway impairments) and/or functional (e.g. low diffusion capacity for carbon monoxide (DLCO), hyperinflation, small airway obstruction, and/or accelerated FEV1 decline) abnormalities, in the absence of airflow limitation, and who might (or not) develop persistent airflow limitation (i.e. COPD) over time.

Early COPD

Description:

People who were younger than 50 years with ten or more pack-years smoking history and any of these abnormalities: i) early airflow limitation (post-bronchodilator FEV1/FVC \< LLN), ii) compatible thoracic CT abnormalities, iii) rapid decline in FEV1 (\> 60 ml/year) that was accelerated relative to FVC.

Young COPD

Description:

COPD patients with post-bronchodilator FEV1/FVC \< 0.70 diagnosed in the 20-50 year age range.

Mild COPD

Description:

COPD patients with post-bronchodilator FEV1/FVC \< 0.70 and FEV1 ≥ 80% predicted.

Controls

Description:

People who were not belonged to any of above six early COPD status, and with pre- and post-bronchodilator FEV1/FVC ≥ 0·70, and with post-bronchodilator FEV1/FVC ≥ LLN.