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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT01527773
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-07
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lung function	The change from baseline in lung function at 3 years	FEV1

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Zurich, Pneumology; 🇨🇭 Zurich, ZH, Switzerland