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

NCT01527773 | Completed

• 1 other identifier: TOPDOCS V1.2
• Study Type: observational
• Target: 313
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Cardiovascular disease; Phenotypes

Outcome Measures

Primary Outcomes (1)

• Lung function

  FEV1

  The change from baseline in lung function at 3 years

Secondary Outcomes (9)

• Exacerbations

  The number of exacerbations observed within 3 years

• Cardiovascular risk score

  The change from baseline in risk score function at 3 years

• BODE-index

  The change from baseline in BODE-index at 3 years

• Quality of life

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

• Blood pressure

  The change from baseline in mean blood pressure at 3 years

Study Arms (1)

COPD cohort

Cohort of patients with proven COPD

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with proven COPD, GOLD stages I-IV

You may qualify if:

• Proven COPD (GOLD stages I-IV)
• Age: 40-75 years

You may not qualify if:

• Mental or physical disability precluding informed consent or compliance with the protocol
• Acute or recent (within the last 6 weeks) exacerbation of COPD

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Pneumology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (8)

• 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.

  PMID: 32158204 DERIVED

• 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.

  PMID: 31959169 DERIVED

• 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.

  PMID: 30863043 DERIVED

• 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.

  PMID: 30053953 DERIVED

• 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.

  PMID: 29229089 DERIVED

• 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.

  PMID: 26392763 DERIVED

• 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.

  PMID: 25565363 DERIVED

• 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.

  PMID: 25503750 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Malcolm Kohler, MD

  University Hospital Zurich, Division of Pneumology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: February 7, 2012
• Study Start: May 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

CH (1)