Short summary

The aim of this project is to evaluate determinants of COPD treated in primary care and to analyse if specific protein biomarkers in the blood are useful in predicting the trajectory of the disease. We intend to evaluate:

• If specific protein biomarkers (SP-D and MFAP4) are clinically useful in predicting the course of COPD
• The association between biomarkers (SP-D and MFAP4) and clinical parameters such as lung function and exacerbation rate
• The association between biomarkers and the patient's quality of life and level of activity
• The cost-effectiveness of using SP-D and MFAP4 as COPD biomarkers

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Rationale

Chronic Obstructive Pulmonary Disease (COPD) is the most common severe disease in primary care. The disease is typically diagnosed by GPs at a late stage and displays various clinical courses. Some patients experience rapid decline in lung function and frequent exacerbations while others seems to have a much slower progression. Identifying clinically relevant subtypes of COPD and finding prognostic markers to help predicting the trajectory of the disease is an objective for research. This can help the physician to identify the patients at high risk of early progression and hence to tailor treatment, prevention and rehabilitation.

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Description of the cohort

The PROTECCT-M study is a prospective observational cohort study of COPD patients in a primary care setting. It is the primary care part of the CeKOL collaboration at the University of Southern Denmark comprising researchers also in molecular medicine, lung medicine and health economics.

General Practitioners on Funen, using the Data Capture system, are invited to participate in the study. Participating GPs include patients with a diagnosis of COPD who are aged ? 40 years. The GPs are encouraged to screen for COPD in patients at risk and include those who are diagnosed. Only patients who understand Danish, are able to visit their GP and do not have severe psychiatric or cognitive diseases are included.

Participating COPD patients visit the GP for a baseline consultation. It includes an examination and registration of clinical data and a blood sample. After the consultation the patients fill in a questionnaire. Yearly follow-ups include examination and registration of clinical data.

We intend to include 2.000 patients with COPD in the study from October 2012 and till the end of 2016. Yearly follow-ups continue until 2020.

Data and biological material

Clinical data is registered by the GPs in pop-ups designed for this study, collected by the Data Capture programme and send to Danish General Practice Research Database. The collected data include, among others; lung function, rate of exacerbations, BMI, gender, age, smoking status, comorbidity, MRC level and use of medicine.

A questionnaire is filled in by the patients regarding symptoms (respiratory, fatigue, depression), quality of life and level of activity.

Blood samples are stored in a biobank for later analysis of the protein biomarkers SP-D and MFAP4.

For specific research questions data will be obtained from the following registries: Statistics Denmark, the National Patient Registry (LPR), the Register of Medicinal Products Statistics (LMDB), the Danish Health Insurance Registry and others.

Collaborating researchers and departments

Research Unit of General Practice, Institute of Public Health, Faculty of Health Science, University of Southern Denmark

• Professor Frans Boch Waldorff, MD, PhD
• Professor and Head of Research Unit Jens Søndergaard
• René duPont Christensen, PhD

Publications associated with the project

The PROTECCT-M study: a cohort study investigating associations between novel specific biomarkers, patient-related, healthcare system markers and the trajectory of COPD patients treated in primary care. / Søndergaard, J. Halling, A. BMC Pulmonary Medicine 2014 14:88