This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Sponsor University of Zurich
Start date May 2011
End date April 2017
Trial size 313 participants
Trial identifier NCT01527773, TOPDOCS V1.2


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Cohort of patients with proven COPD

Primary Outcomes

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

Secondary Outcomes

time frame: The number of exacerbations observed within 3 years
Cardiovascular risk score
time frame: The change from baseline in risk score function at 3 years
time frame: The change from baseline in BODE-index at 3 years
Quality of life
time frame: The change from baseline in quality of life scale at 3 years
Blood pressure
time frame: The change from baseline in mean blood pressure at 3 years
time frame: The change from baseline in activity at 3 years
Hear Arterial Stiffness
time frame: The change from baseline in arterial stiffness at 3 years
Endothelial Function
time frame: The change from baseline in endothelial function at 3 years
Exercise capacity
time frame: The change from baseline in exercise capacity at 3 years

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

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

Additional Information

Official title The Obstructive Pulmonary Disease Outcomes Cohort of Switzerland (TOP DOCS): Phenotypes and Vascular Damage in COPD
Principal investigator Malcolm Kohler, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Zurich.