Chronic Obstructive Pulmonary DiseaseTOPDOCSNCT01527773
Phenotypes and Vascular Damage in Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 313 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2011to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with proven COPD, GOLD stages I-IV
Who may be able to join
- Proven COPD (GOLD stages I-IV)
- Age: 40-75 years
Who cannot join
- Mental or physical disability precluding informed consent or compliance with the protocol
- Acute or recent (within the last 6 weeks) exacerbation of COPD
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Pneumology
Zurich, Canton of Zurich, 8091
About this study
Official title: The Obstructive Pulmonary Disease Outcomes Cohort of Switzerland (TOP DOCS): Phenotypes and Vascular Damage in 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Cardiovascular disease, Phenotypes
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD cohort | Cohort of patients with proven COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
FEV1
Measured: The change from baseline in lung function at 3 years
Secondary outcomes (9)
Exacerbations
Number of COPD exacerbations observed within 3 years of observation
Measured: The number of exacerbations observed within 3 years
Cardiovascular risk score
Pocock score
Measured: The change from baseline in risk score function at 3 years
BODE-index
BODE-Index
Measured: The change from baseline in BODE-index at 3 years
Quality of life
Quality of life scales
Measured: The change from baseline in quality of life scale at 3 years
Blood pressure
Mean blood pressure
Measured: The change from baseline in mean blood pressure at 3 years
Activity
Actigraphy
Measured: The change from baseline in activity at 3 years
Hear Arterial Stiffness
Arterial stiffness by pulse wave analysis
Measured: The change from baseline in arterial stiffness at 3 years
Endothelial Function
Endothelial function assessed by flow-mediated dilatation (FMD)
Measured: The change from baseline in endothelial function at 3 years
Exercise capacity
6 minute walking test and sit-to-stand test
Measured: The change from baseline in exercise capacity at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startMay 2011
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malcolm Kohler, MD, Principal investigator, University Hospital Zurich, Division of Pneumology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527773
- Sponsor's protocol ID
- TOPDOCS V1.2
- Acronym
- TOPDOCS
- Status last verified
- Aug 2017
- First submitted
- 18 Jan 2012
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32158204Sievi 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.
PubMed 31959169Sievi 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.
PubMed 30863043Sievi 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.
PubMed 30053953Clarenbach 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.
PubMed 29229089Sievi 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.
PubMed 26392763Sievi 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.
PubMed 25565363Schonmann 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.
PubMed 25503750
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Obstructive Pulmonary Disease Outcomes Cohort of Switzerland (TOP DOCS): Phenotypes and Vascular Damage in COPD
- ClinicalTrials.gov ID
- NCT01527773
- Acronym / sponsor ID
- TOPDOCS / TOPDOCS V1.2
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Cardiovascular disease, Phenotypes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD cohort | – | –Cohort of patients with proven COPD |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with proven COPD, GOLD stages I-IV
Key inclusion criteria (2 listed)
- Proven COPD (GOLD stages I-IV)
- Age: 40-75 years
Key exclusion criteria (2 listed)
- Mental or physical disability precluding informed consent or compliance with the protocol
- Acute or recent (within the last 6 weeks) exacerbation of COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung function
Time frame: The change from baseline in lung function at 3 years
FEV1
9 secondary outcomes
Exacerbations
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
BODE-index
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
Activity
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Derived from this study: PubMed 32158204Roeder 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.
- Derived from this study: PubMed 31959169Sievi 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.
- Derived from this study: PubMed 30863043Sievi 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.
- Derived from this study: PubMed 30053953Sievi 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.
- Derived from this study: PubMed 29229089Clarenbach 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.
- Derived from this study: PubMed 26392763Sievi 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.
- Derived from this study: PubMed 25565363Sievi 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.
- Derived from this study: PubMed 25503750Schonmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm Kohler, MD principal investigator
University Hospital Zurich, Division of Pneumology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function (time frame: The change from baseline in lung function at 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01527773, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.