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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01527773
First received: January 18, 2012
Last updated: February 6, 2012
Last verified: February 2012
  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 ] [ Designated as safety issue: No ]
    FEV1


Secondary Outcome Measures:
  • Exacerbations [ Time Frame: The number of exacerbations observed within 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Pocock score

  • BODE-index [ Time Frame: The change from baseline in BODE-index at 3 years ] [ Designated as safety issue: No ]
    BODE-Index

  • Quality of life [ Time Frame: The change from baseline in quality of life scale at 3 years ] [ Designated as safety issue: No ]
    Quality of life scales

  • Blood pressure [ Time Frame: The change from baseline in mean blood pressure at 3 years ] [ Designated as safety issue: No ]
    Mean blood pressure

  • Activity [ Time Frame: The change from baseline in activity at 3 years ] [ Designated as safety issue: No ]
    Actigraphy

  • Hear Arterial Stiffness [ Time Frame: The change from baseline in arterial stiffness at 3 years ] [ Designated as safety issue: No ]
    Arterial stiffness by pulse wave analysis

  • Endothelial Function [ Time Frame: The change from baseline in endothelial function at 3 years ] [ Designated as safety issue: No ]
    Endothelial function assessed by flow-mediated dilatation (FMD)

  • Exercise capacity [ Time Frame: The change from baseline in exercise capacity at 3 years ] [ Designated as safety issue: No ]
    6 minute walking test and sit-to-stand test


Biospecimen Retention:   Samples Without DNA

Blood samples


Estimated Enrollment: 300
Study Start Date: May 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD cohort
Cohort of patients with proven COPD

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527773

Contacts
Contact: Malcolm Kohler, MD malcolm.kohler@usz.ch

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

Additional Information:
No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01527773     History of Changes
Other Study ID Numbers: TOPDOCS V1.2
Study First Received: January 18, 2012
Last Updated: February 6, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
COPD
Cardiovascular disease
Phenotypes

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

ClinicalTrials.gov processed this record on July 23, 2014