Rationale and design of the Early Chronic Obstructive Pulmonary Disease (ECOPD) study in Guangdong, China: a prospective observational cohort study

Abstract

Background

Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease and its clinically relevant subtypes are not well understood. Which clinical characteristics are more likely to be present among individuals who develop COPD remains to be studied in depth. Therefore, we designed a prospective observational cohort study, entitled the Early Chronic Obstructive Pulmonary Disease (ECOPD) study, to fill this evidence gap. The ECOPD study has four specific aims: (I) identification of characteristics, parameters, and biomarkers that may predict the development of airflow obstruction and annual decline in lung function with normal spirometry; (II) identification of clinically relevant early COPD subtypes; (III) identification of characteristics, parameters, and biomarkers that may predict disease progression in these early COPD subtypes; (IV) development and validation of machine learning models to predict development of airflow obstruction and disease progression.

Methods

We will recruit approximately 2,000 participants aged 40–80 years, including approximately 1,000 with COPD [post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) <0.7] and approximately 1,000 without COPD, using a population-based survey for COPD. We will assess all participants using standard respiratory epidemiological questionnaires, pulmonary function tests [pre-bronchodilator and post-bronchodilator spirometry, and impulse oscillometry (IOS)], health outcomes [modified British Medical Research Council (mMRC) dyspnea scale, COPD assessment test (CAT), COPD clinical questionnaire (CCQ)], inspiratory and expiratory chest computed tomography (CT), and biomarker measurements (blood and urine), as well as satellite remote sensing pollutant exposure measures. Subgroup will additionally complete induced sputum, exercise capacity tests [6-minute walk test (6MWT) and cardiopulmonary exercise testing (CPET)] and home monitoring/personal sampling as pollutant exposure measures. Study procedures will be performed at baseline and every 1 year thereafter.

Discussion

The ECOPD study will provide insight into many aspects of early COPD and improve our understanding of COPD development, which may facilitate therapeutic interventions with the potential to modify the course of disease.

Trial Registration

Chinese Clinical Trial Registry, ChiCTR1900024643. Registered on 19 July, 2019.