Phenotypes and Vascular Damage in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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TOPDOCS is a prospective cohort study including COPD patients from currently six study centers in Switzerland. Patients with COPD GOLD stages I-IV will be enrolled and followed-up annually for at least 3 years. Yearly assessments will include a detailed patient history, quality of life and activity questionnaires, history of exacerbations, lung function, measurements of exercise capacity, measurements of vascular function, exhaled breath analysis and blood sampling. The overall objective of the project is to establish a meticulously characterized cohort of COPD patients living in Switzerland in order to allow high quality research on the pathogenesis, treatment and complications of COPD. The specific aim of the project is to determine clinically relevant COPD phenotypes and biological factors influencing vascular function in COPD patients.

Official Title
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The Obstructive Pulmonary Disease Outcomes Cohort of Switzerland (TOP DOCS): Phenotypes and Vascular Damage in COPD

Conditions
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Chronic Obstructive Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Proven COPD (GOLD stages I-IV) Age: 40-75 years Exclusion criteria: Mental or physical disability precluding informed consent or compliance with the protocol Acute or recent (within the last 6 weeks) exacerbation of COPD

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD cohort<br>Cohort of patients with proven COPD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function | FEV1 | The change from baseline in lung function at 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbations | Number of COPD exacerbations observed within 3 years of observation | The number of exacerbations observed within 3 years | 
| Cardiovascular risk score | Pocock score | The change from baseline in risk score function at 3 years | 
| BODE-index | BODE-Index | The change from baseline in BODE-index at 3 years | 
| Quality of life | Quality of life scales | The change from baseline in quality of life scale at 3 years | 
| Blood pressure | Mean blood pressure | The change from baseline in mean blood pressure at 3 years | 
| Activity | Actigraphy | The change from baseline in activity at 3 years | 
| Hear Arterial Stiffness | Arterial stiffness by pulse wave analysis | The change from baseline in arterial stiffness at 3 years | 
| Endothelial Function | Endothelial function assessed by flow-mediated dilatation (FMD) | The change from baseline in endothelial function at 3 years | 
| Exercise capacity | 6 minute walking test and sit-to-stand test | The change from baseline in exercise capacity at 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Cardiovascular disease, Phenotypes