Heterogeneity and Development of Early COPD

Study Overview
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Brief Summary
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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.

Official Title
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Heterogeneity and Disease Development of Early Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with COPD exacerbation | COPD exacerbation refers to acute deterioration of respiratory symptoms (e.g. cough, sputum, wheeze, dyspnea), especially resulting in hospital visit or admission. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The COPD Assessment Test scores range from 0 to 40, with higher scores indicating worse symptoms. | One year | 
| The modified Medical Research Council dyspnea scale | The modified Medical Research Council dyspnea scores range from 0 to 4, with higher scores indicating more severe dyspnea. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive pulmonary disease, Early COPD, Heterogeneity, Disease development