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Completed

NCT Number: NCT01527773

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Cardiovascular Diseases Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich, Pneumology

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Lung function

    Time frame: The change from baseline in lung function at 3 years

    FEV1

Secondary outcomes

  1. Exacerbations

    Time frame: The number of exacerbations observed within 3 years

    Number of COPD exacerbations observed within 3 years of observation

  2. Cardiovascular risk score

    Time frame: The change from baseline in risk score function at 3 years

    Pocock score

  3. BODE-index

    Time frame: The change from baseline in BODE-index at 3 years

    BODE-Index

  4. Quality of life

    Time frame: The change from baseline in quality of life scale at 3 years

    Quality of life scales

  5. Blood pressure

    Time frame: The change from baseline in mean blood pressure at 3 years

    Mean blood pressure

  6. Activity

    Time frame: The change from baseline in activity at 3 years

    Actigraphy

  7. Hear Arterial Stiffness

    Time frame: The change from baseline in arterial stiffness at 3 years

    Arterial stiffness by pulse wave analysis

  8. Endothelial Function

    Time frame: The change from baseline in endothelial function at 3 years

    Endothelial function assessed by flow-mediated dilatation (FMD)

  9. Exercise capacity

    Time frame: The change from baseline in exercise capacity at 3 years

    6 minute walking test and sit-to-stand test

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: TOPDOCS

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Feb 7, 2012
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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