Clinical trial NCT01527773: Phenotypes and Vascular Damage in Chronic Obstructive Pulmonary Disease (COPD)
Official title: The Obstructive Pulmonary Disease Outcomes Cohort of Switzerland (TOP DOCS): Phenotypes and Vascular Damage in COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Cardiovascular disease
Phenotypes
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-02-07
Enrollment: 313
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with proven COPD, GOLD stages I-IV

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.


Eligibility 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

Primary outcomes:
measure: Lung function
timeFrame: The change from baseline in lung function at 3 years
Secondary outcomes:
measure: Exacerbations
timeFrame: The number of exacerbations observed within 3 years
measure: Cardiovascular risk score
timeFrame: The change from baseline in risk score function at 3 years
measure: BODE-index
timeFrame: The change from baseline in BODE-index at 3 years
measure: Quality of life
timeFrame: The change from baseline in quality of life scale at 3 years
measure: Blood pressure
timeFrame: The change from baseline in mean blood pressure at 3 years
measure: Activity
timeFrame: The change from baseline in activity at 3 years
measure: Hear Arterial Stiffness
timeFrame: The change from baseline in arterial stiffness at 3 years
measure: Endothelial Function
timeFrame: The change from baseline in endothelial function at 3 years
measure: Exercise capacity
timeFrame: The change from baseline in exercise capacity at 3 years
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Pneumology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Pneumology
name: Malcolm Kohler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roeder M, Sievi NA, Kohlbrenner D, Clarenbach CF, Kohler M. Arterial Stiffness Increases Over Time in Relation to Lung Diffusion Capacity: A Longitudinal Observation Study in COPD. Int J Chron Obstruct Pulmon Dis. 2020 Jan 23;15:177-187. doi: 10.2147/COPD.S234882. eCollection 2020.
citation: Sievi NA, Brack T, Brutsche MH, Frey M, Irani S, Leuppi JD, Thurnheer R, Kohler M, Clarenbach CF. "Can do, don't do" are not the lazy ones: a longitudinal study on physical functioning in patients with COPD. Respir Res. 2020 Jan 20;21(1):27. doi: 10.1186/s12931-020-1290-9.
citation: Sievi NA, Kohler M, Thurnheer R, Leuppi JD, Irani S, Frey M, Brutsche M, Brack T, Clarenbach CF. No impact of exacerbation frequency and severity on the physical activity decline in COPD: a long-term observation. Int J Chron Obstruct Pulmon Dis. 2019 Feb 15;14:431-437. doi: 10.2147/COPD.S188710. eCollection 2019.
citation: Sievi NA, Brack T, Brutsche MH, Frey M, Irani S, Leuppi JD, Thurnheer R, Kohler M, Clarenbach CF. Physical activity declines in COPD while exercise capacity remains stable: A longitudinal study over 5 years. Respir Med. 2018 Aug;141:1-6. doi: 10.1016/j.rmed.2018.06.013. Epub 2018 Jun 18.
citation: Clarenbach CF, Sievi NA, Kohler M. Annual progression of endothelial dysfunction in patients with COPD. Respir Med. 2017 Nov;132:15-20. doi: 10.1016/j.rmed.2017.09.005. Epub 2017 Sep 18.
citation: Sievi NA, Franzen D, Kohler M, Clarenbach CF. Physical inactivity and arterial stiffness in COPD. Int J Chron Obstruct Pulmon Dis. 2015 Sep 10;10:1891-7. doi: 10.2147/COPD.S90943. eCollection 2015.
citation: Sievi NA, Senn O, Brack T, Brutsche MH, Frey M, Irani S, Leuppi JD, Thurnheer R, Franzen D, Kohler M, Clarenbach CF. Impact of comorbidities on physical activity in COPD. Respirology. 2015 Apr;20(3):413-8. doi: 10.1111/resp.12456. Epub 2015 Jan 6.
citation: Schonmann M, Sievi NA, Clarenbach CF, Brack T, Brutsche M, Frey M, Irani S, Leuppi JD, Ruediger J, Senn O, Thurnheer R, Kohler M. Physical activity and the frequency of acute exacerbations in patients with chronic obstructive pulmonary disease. Lung. 2015 Feb;193(1):63-70. doi: 10.1007/s00408-014-9673-7. Epub 2014 Dec 13.