Investigation of the Clinical, Radiological and Biological factors associated with disease progression, phenotypes and endotypes of COPD in China (COMPASS study): study design, protocol, and rationale
- Zhenyu Liang1,
- Nanshan Zhong1,
- Rongchang Chen2,
- Qianli Ma3,
- Yongchang Sun4,
- Fuqiang Wen5,
- Ruth Tal-Singer6,10,
- Bruce E. Miller6,10,
- Julie Yates7,10,
- Jie Song8,
- Chris Compton9,
- Beulah Ji8,
- Li Wu8,
- Yang Yang8,
- Paul Jones9 and
- Jinping Zheng1
- 1State Key Laboratory of Respiratory Disease & National Clinical Research Center of Respiratory Disease, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, , Guangzhou , China
- 2Pulmonary and Critical Care Dept, Shenzhen Institute of Respiratory Diseases, First Affiliated Hospital of South University of Science and Technology of China (Shenzhen People's Hospital), Shenzhen , Guangdong, China
- 3Chronic Respiratory Disease Care Centre, The North Kuanren General Hospital, , Chongqing , China
- 4Department of Respiratory and Critical Care Medicine, Peking University Third Hospital, Beijing, , China
- 5Division of Pulmonary Diseases, State Key Laboratory of Biotherapy of China, and Department of Respiratory Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan , China
- 6GlaxoSmithKline, Collegeville, PA, USA
- 7GlaxoSmithKline, Research Triangle Park, NC, USA
- 8GlaxoSmithKline, Research and Development, Shanghai, China
- 9GlaxoSmithKline, Brentford, Middlesex, UK
- 10No longer employees of GSK but were during the design of this study.
- Corresponding author: Paul Jones (pjones{at}sgul.ac.uk)
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.
Footnotes
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Conflict of interest: Zhenyu Liang reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who supported the study (2018YFC1311900, 2017YFC1310600). The author reports other financial or non-financial interests as follows: key coordinator between GlaxoSmithKline and COMPASS investigators and is a clinical expert for the First Affiliated Hospital of Guangzhou Medical University.
Conflict of interest: Nanshan Zhong reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who 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 is a medical expert for the First Affiliated Hospital of Guangzhou Medical University.
Conflict of interest: Rongchang Chen reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who 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 is a medical expert for the First Affiliated Hospital of South University of Science and Technology of China.
Conflict of interest: Qianli Ma reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who 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 is a medical expert for the North Kuanren General Hospital.
Conflict of interest: Yongchang Sun reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who 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 is a medical expert for Peking University Third Hospital.
Conflict of interest: Fuqiang Wen reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who supported the study (2018YFC1311900, 2017YFC1310600). The author reports other financial or non-financial interests as follows: member of COMPASS steering committee for GlaxoSmithKline and medical expert for West China Hospital of Sichuan University.
Conflict of interest: Ruth Tal-Singer reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who supported the study (2018YFC1311900, 2017YFC1310600). The author also reports that they currently hold stock of GlaxoSmithKline and is a former employee of GlaxoSmithKline.
Conflict of interest: Bruce Miller reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who supported the study (2018YFC1311900, 2017YFC1310600). The author also reports that they currently hold stock of GlaxoSmithKline and is a former employee of GlaxoSmithKline and member of COMPASS steering committee for GlaxoSmithKline.
Conflict of interest: Julie Yates reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who supported the study (2018YFC1311900, 2017YFC1310600). The author also reports that they currently hold stock of GlaxoSmithKline and is a former employee of GlaxoSmithKline and member of COMPASS steering committee for GlaxoSmithKline.
Conflict of interest: Jie Song reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who supported the study (2018YFC1311900, 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: Chris Compton reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who supported the study (2018YFC1311900, 2017YFC1310600). The author also reports that they currently hold stock of GlaxoSmithKline and is a former employee of GlaxoSmithKline and member of COMPASS steering committee for GlaxoSmithKline.
Conflict of interest: Beulah Ji reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who supported the study (2018YFC1311900, 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: Li Wu reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who supported the study (2018YFC1311900, 2017YFC1310600). The author also reports that they currently employed by GlaxoSmithKline.
Conflict of interest: Yang Yang reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who supported the study (2018YFC1311900, 2017YFC1310600). The author also reports that they currently an employee of GlaxoSmithKline.
Conflict of interest: Paul Jones reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who supported the study (2018YFC1311900, 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 of GlaxoSmithKline.
Conflict of interest: Jinping Zheng reports support for the present manuscript from GlaxoSmithKline, who funded the study (Study 208630) and National Key R&D Program of China, who supported the study (2018YFC1311900, 2017YFC1310600). The author reports other financial or non-financial interests as follows: member of COMPASS steering committee for GlaxoSmithKline and medical expert for the First Affiliated Hospital of Guangzhou Medical University.
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- Received March 18, 2021.
- Accepted June 24, 2021.
- Copyright ©The authors 2021
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