Heterogeneity and Development of Early COPD

Sponsor

China-Japan Friendship Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06096285

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

84 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Heterogeneity and Disease Development of Early Chronic Obstructive Pulmonary Disease

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Jan 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Preserved ratio impaired spirometry (PRISm) 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 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 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 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 COPD patients with post-bronchodilator FEV1/FVC < 0.70 diagnosed in the 20-50 year age range.
Mild COPD COPD patients with post-bronchodilator FEV1/FVC < 0.70 and FEV1 ≥ 80% predicted.
Controls 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.

Outcome Measures

Primary Outcome Measures

Number of participants with COPD exacerbation [One year]
COPD exacerbation refers to acute deterioration of respiratory symptoms (e.g. cough, sputum, wheeze, dyspnea), especially resulting in hospital visit or admission.

Secondary Outcome Measures

FEV1 [One year]
FVC [One year]
FEV1/FVC ratio [One year]
FEV1% predicted value [One year]
FVC% predicted value [One year]
The COPD Assessment Test scale [One year]
The COPD Assessment Test scores range from 0 to 40, with higher scores indicating worse symptoms.
The modified Medical Research Council dyspnea scale [One year]
The modified Medical Research Council dyspnea scores range from 0 to 4, with higher scores indicating more severe dyspnea.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.