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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01527773
First Posted: February 7, 2012
Last Update Posted: August 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose
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.

Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Obstructive Pulmonary Disease Outcomes Cohort of Switzerland (TOP DOCS): Phenotypes and Vascular Damage in COPD

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Lung function [ Time Frame: The change from baseline in lung function at 3 years ]
    FEV1


Secondary Outcome Measures:
  • Exacerbations [ Time Frame: The number of exacerbations observed within 3 years ]
    Number of COPD exacerbations observed within 3 years of observation

  • Cardiovascular risk score [ Time Frame: The change from baseline in risk score function at 3 years ]
    Pocock score

  • BODE-index [ Time Frame: The change from baseline in BODE-index at 3 years ]
    BODE-Index

  • Quality of life [ Time Frame: The change from baseline in quality of life scale at 3 years ]
    Quality of life scales

  • Blood pressure [ Time Frame: The change from baseline in mean blood pressure at 3 years ]
    Mean blood pressure

  • Activity [ Time Frame: The change from baseline in activity at 3 years ]
    Actigraphy

  • Hear Arterial Stiffness [ Time Frame: The change from baseline in arterial stiffness at 3 years ]
    Arterial stiffness by pulse wave analysis

  • Endothelial Function [ Time Frame: The change from baseline in endothelial function at 3 years ]
    Endothelial function assessed by flow-mediated dilatation (FMD)

  • Exercise capacity [ Time Frame: The change from baseline in exercise capacity at 3 years ]
    6 minute walking test and sit-to-stand test


Biospecimen Retention:   Samples Without DNA
Blood samples

Enrollment: 313
Study Start Date: May 2011
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD cohort
Cohort of patients with proven COPD

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with proven COPD, GOLD stages I-IV
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527773


Locations
Switzerland
University Hospital Zurich, Pneumology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Malcolm Kohler, MD University Hospital Zurich, Division of Pneumology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01527773     History of Changes
Other Study ID Numbers: TOPDOCS V1.2
First Submitted: January 18, 2012
First Posted: February 7, 2012
Last Update Posted: August 11, 2017
Last Verified: August 2017

Keywords provided by University of Zurich:
COPD
Cardiovascular disease
Phenotypes

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases