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.

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 characterised in other regions. 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; NCT04853225) is a prospective, 2.5-year-long, multi-centre, longitudinal, observational study with three aims: 1) to characterise stable and exacerbation phenotypes/endotypes in terms of clinical characteristics, blood and sputum biomarkers, lung microbiome and lung imaging; 2) to understand the relevance of markers of COPD disease progression identified in Western cohorts to Chinese patients; and 3) to characterise treatment pathways and healthcare resource utilisation. COMPASS will recruit 2000 participants, of which 1700 will be in Global Initiative for Chronic Obstructive Lung Disease (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-characterised cohort of individuals with COPD in China, with a particular focus on milder patients. As the first study of its kind attempting to understand the disease in an Asian setting, it will provide valuable insights into regional and ethnic differences in COPD.

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Déclaration de conflit d'intérêts

Conflict of interest: Z. Liang reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900, 2017YFC1310600). The author reports other financial or nonfinancial interests as follows: key coordinator between GlaxoSmithKline and COMPASS investigators, and clinical expert for the First Affiliated Hospital of Guangzhou Medical University. Conflict of interest: N. Zhong reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900, 2017YFC1310600). The author reports other financial or non-financial interests as follows: member of the COMPASS steering committee for GlaxoSmithKline and a medical expert for the First Affiliated Hospital of Guangzhou Medical University. Conflict of interest: R. Chen reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900 and 2017YFC1310600). The author reports other financial or nonfinancial interests as follows: member of the COMPASS steering committee for GlaxoSmithKline and a medical expert for the First Affiliated Hospital of South University of Science and Technology of China. Conflict of interest: Q. Ma reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900 and 2017YFC1310600). The author reports other financial or nonfinancial interests as follows: member of the COMPASS steering committee for GlaxoSmithKline and a medical expert for the North Kuanren General Hospital. Conflict of interest: Y. Sun reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900 and 2017YFC1310600). The author reports other financial or nonfinancial interests as follows: member of the COMPASS steering committee for GlaxoSmithKline and a medical expert for Peking University Third Hospital. Conflict of interest: F. Wen reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900 and 2017YFC1310600). The author reports other financial or nonfinancial interests as follows: member of COMPASS steering committee for GlaxoSmithKline and medical expert for West China Hospital of Sichuan University. Conflict of interest: R. Tal-Singer reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900 and 2017YFC1310600). The author also reports that they currently hold stock of GlaxoSmithKline and a former employee of GlaxoSmithKline. Conflict of interest: B. Miller reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900 and 2017YFC1310600). The author also reports that they currently hold stock of GlaxoSmithKline and a former employee of GlaxoSmithKline and member of COMPASS steering committee for GlaxoSmithKline. Conflict of interest: J. Yates reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900 and 2017YFC1310600). The author also reports that they currently hold stock of GlaxoSmithKline and a former employee of GlaxoSmithKline and member of COMPASS steering committee for GlaxoSmithKline. Conflict of interest: J. Song reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900 and 2017YFC1310600). The author also reports that they are currently an employee of GlaxoSmithKline and member of the COMPASS steering committee for GlaxoSmithKline. Conflict of interest: C. Compton reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900 and 2017YFC1310600). The author also reports that they currently hold stock of GlaxoSmithKline and a former employee of GlaxoSmithKline and member of COMPASS steering committee for GlaxoSmithKline. Conflict of interest: B. Ji reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900 and 2017YFC1310600). The author also reports that they currently hold stock of GlaxoSmithKline and are an employee of GlaxoSmithKline and member of COMPASS steering committee. Conflict of interest: L. Wu reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900 and 2017YFC1310600). The author also reports that they currently employed by GlaxoSmithKline. Conflict of interest: Y. Yang reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900 and 2017YFC1310600). The author also reports that they are currently an employee of GlaxoSmithKline. Conflict of interest: P. Jones reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900 and 2017YFC1310600). The author also reports that they are currently an employee of GlaxoSmithKline and member of the COMPASS steering committee for GlaxoSmithKline. The author currently holds stock in GlaxoSmithKline. Conflict of interest: Jinping Zheng reports support for the present manuscript from GlaxoSmithKline, which funded the study (Study 208630) and National Key R&D Program of China, which supported the study (2018YFC1311900 and 2017YFC1310600). The author reports other financial or nonfinancial interests as follows: member of COMPASS steering committee for GlaxoSmithKline and medical expert for the First Affiliated Hospital of Guangzhou Medical University.