Investigation of the Clinical, Radiological and Biological Factors Associated with Disease Progression, Phenotypes and Endotypes of COPD in China (COMPASS): study design, protocol and rationale

Abstract

Chronic obstructive pulmonary disease (COPD) is heterogeneous and its presentation varies between countries. The major COPD cohort studies have only been performed in Western populations, the disease is not well characterized in other regions. The COMPASS (Investigation of the Clinical, Radiological and Biological factors, humanistic and healthcare utilization burden associated with disease Progression, phenotypes and endotypes of COPD in China; NCT04853225) is a prospective, 2.5 years, multi-center, longitudinal, observational study with three aims: 1) characterize stable and exacerbation phenotypes/endotypes in terms of clinical characteristics, blood and sputum biomarkers, lung microbiome and lung imaging; 2) understand the relevance of markers of COPD disease progression identified in Western cohorts to Chinese patients; 3) characterize treatment pathways and healthcare resource utilization. COMPASS will recruit 2000 participants, of which 1700 will be in GOLD grades I-IV (n=700, 700, 200, and 100, respectively), 180 participants with chronic bronchitis without airflow limitation, and 120 never-smoker healthy controls. Study visits will be at baseline, 6, 18 and 30 months and at exacerbation. Assessments include lung function, exacerbation frequency, health status, blood biomarkers and, in a sub-cohort of 400 patients, chest high-resolution computed tomography, additional blood and sputum biomarkers, airway micro-, viral- and myco-biome and physical activity. COMPASS will establish a unique clinical and biological dataset in a well-characterized cohort of individuals with COPD in China, with a particular focus on milder patients. As the first disease understanding study of its kind in an Asian setting it will provide valuable insights into regional and ethnic differences in COPD.

Clinical Characteristics and Frequency of Chronic Obstructive Pulmonary Disease Exacerbations in Korean Patients: Findings From the KOCOSS Cohort 2012–2021

“…Additionally, our study results can enhance understanding of COPD in an Asian setting, for which data are currently lacking. 52 …”

Development and application of a deep learning-based comprehensive early diagnostic model for chronic obstructive pulmonary disease

“…The COMPASS (Investigation of the Clinical, Radiological and Biological Factors, Humanistic and Healthcare Utilisation Burden Associated with Disease Progression, Phenotypes and Endotypes of COPD in China) is a Fig. 3 The SHAP values of epidemiological variables in the comprehensive model prospective multi-center study started in 2019, which has marked a recent effort in understanding the relevance of COPD biomarkers identified in Western cohorts to Chinese patients [46]. Our study bears unique significance as it employed an extensive dataset of CT scans from individuals residing in the eastern region of China, presenting a COPD diagnostic model tailored specifically for the Chinese population.…”

The utility of quantitative computed tomography in cohort studies of chronic obstructive pulmonary disease: a narrative review

“…Internationally significant COPD cohort studies, including COPD Genetic Epidemiology (COPDGene) ( 10 ), Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-Points (ECLIPSE) ( 11 ), and Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS) ( 12 ) have been conducted in recent years. In China, Investigation of the Clinical, Radiological and Biological Factors, Humanistic and Healthcare Utilization Burden Associated with Disease Progression, Phenotypes, and Endotypes of COPD (COMPASS) ( 13 ) is one of the largest research projects on COPD. Each cohort study has specific distinct objectives and observation indexes ( Table 2 ).…”