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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01527773
Acronym
TOPDOCS
Enrollment
313
Registered
2012-02-07
Start date
2011-05-31
Completion date
2017-01-31
Last updated
2017-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Cardiovascular disease, Phenotypes

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.

Interventions

None listed

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Lung functionThe change from baseline in lung function at 3 yearsFEV1

Secondary

MeasureTime frameDescription
ExacerbationsThe number of exacerbations observed within 3 yearsNumber of COPD exacerbations observed within 3 years of observation
Cardiovascular risk scoreThe change from baseline in risk score function at 3 yearsPocock score
BODE-indexThe change from baseline in BODE-index at 3 yearsBODE-Index
Quality of lifeThe change from baseline in quality of life scale at 3 yearsQuality of life scales
ActivityThe change from baseline in activity at 3 yearsActigraphy
Hear Arterial StiffnessThe change from baseline in arterial stiffness at 3 yearsArterial stiffness by pulse wave analysis
Endothelial FunctionThe change from baseline in endothelial function at 3 yearsEndothelial function assessed by flow-mediated dilatation (FMD)
Exercise capacityThe change from baseline in exercise capacity at 3 years6 minute walking test and sit-to-stand test
Blood pressureThe change from baseline in mean blood pressure at 3 yearsMean blood pressure

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026