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COPDICECOLDERICNCT00706602

Predicting the Course of Chronic Obstructive Pulmonary Disease (COPD) in Primary Care

An observational study of COPD, run by University of Zurich at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: COPD is a systemic illness; morbidity and mortality due to this disease are on the increase, and it has great impact on patients' lives. Most COPD patients are managed by general practitioners (GP). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
COPD
How many people
450 participants
Where
1 siteSwitzerland
Study dates
May 2008to Aug 2014
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: COPD patients from primary care. Patients are identified through electronic or paper-based patient charts and by participating general practitioners.

Who may be able to join

  • Patients ≥40 years of age with COPD in GOLD stage II to IV (postbronchodilator FEV1/FVC≤0.70, postbronchodilator FEV1≤80% predicted) are eligible if in- or outpatient treatment of their last exacerbation ended ≥4 weeks ago.

Who cannot join

  • Patients who received mechanical ventilation in the previous 12 months (because of extremely poor prognosis), patients with co-morbidities associated with a life expectancy of ≤12 months, patients diagnosed with dementia, psychosis or other psychiatric illness that invalidate assessment of patient-reported parameters and patients who cannot complete thr baseline assessment due to language difficulties.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Institute for primary care, University of Zurich

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

Official title: International Collaborative Effort on Chronic Obstructive Lung Disease: Exacerbation Risk Index Cohorts

Background: COPD is a systemic illness; morbidity and mortality due to this disease are on the increase, and it has great impact on patients' lives. Most COPD patients are managed by general practitioners (GP). GPs base their initial assessment of patients' disease severity mainly on lung function and then inform patients about adequate treatment. However, lung function correlates poorly with COPD-specific health-related quality of life and exacerbation frequency. Preventive cardiology embraced risk index-guided treatment successfully. COPD disease severity indices that better represent the clinical manifestations of COPD are needed that can be used to guide risk-stratified treatment.

Objectives: (1) The development and validation of a practical COPD disease severity index to predict the course of health-related quality of life over time. (2) The validation of the ADO-Index (Age, Dyspnea, Obstruction) to predict 3-year mortality in COPD patients in primary care. (3) Link evidence on treatment effects to the COPD risk indices to guide COPD treatment selection.

Read more

Methods: We are in the process of conducting two linked prospective cohort studies with 413 COPD patients (GOLD stages 2-4) from GPs in Switzerland and the Netherlands. We performed a sound baseline assessment including detailed patient history, lung function, measurement of exercise capacity and blood sampling. During the follow-up of at least five years, we update the patients' profile by registering health status, exacerbations and health-related quality of life and, after 2 years, lung function and measurement of exercise capacity. For aim 1, we will identify the best combination of variables predicting the course of health-related quality of life over time using multivariable regression analysis. For aim 2, we will assess discrimination and calibration of the ADO index to predict 3-year mortality. For aim 3, we will estimate treatment effects for individual patient profiles using complex statistical models such as Markov models.

Significance of project: After this study, different risk scores will be available for use in primary care so that general practitioners can estimate what impact COPD will have on the patients. By linking these risk scores to evidence form treatment studies, it will be possible to show for an individual patient how COPD and different treatments impacts on mortality, symptoms and exacerbations. Thereby, patients and physicians can make more informed treatment decisions balancing the benefits and downsides of different treatments.

Conditions
COPD
Keywords
COPD, prognosis, prediction rule, health-related quality of life, risk factors, derivation, validation, exacerbation, mortality, primary care, treatment, decision making
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00706602
Study groupRoleWhat they receive
1Swiss COPD cohort
2Dutch COPD cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chronic Respiratory Questionnaire

    Measured: At least 5 years

Secondary outcomes (1)

  1. Exacerbation

    Measured: At least 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionAug 2014 (estimated)
  4. Study completionAug 2014 (estimated)

Resources

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
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00706602
Sponsor's protocol ID
3233B0-115216
Other IDs
3.4.07.045
Acronym
ICECOLDERIC
Status last verified
Jun 2010
First submitted
25 Jun 2008
Last updated
28 Jun 2010
Results posted
No
Data monitoring committee
No

Publications

  • Siebeling L, ter Riet G, van der Wal WM, Geskus RB, Zoller M, Muggensturm P, Joleska I, Puhan MA. ICE COLD ERIC--International collaborative effort on chronic obstructive lung disease: exacerbation risk index cohorts--study protocol for an international COPD cohort study. BMC Pulm Med. 2009 May 6;9:15. doi: 10.1186/1471-2466-9-15.

    PubMed 19419546

  • Tai AS, Liao LH, Lin SH. On the Conventional Definition of Path-specific Effects: Fully Mediated Interaction With Multiple Ordered Mediators. Epidemiology. 2022 Nov 1;33(6):817-827. doi: 10.1097/EDE.0000000000001520. Epub 2022 Jun 24.

    PubMed 36220579

  • Steurer-Stey C, Dalla Lana K, Braun J, Ter Riet G, Puhan MA. Effects of the "Living well with COPD" intervention in primary care: a comparative study. Eur Respir J. 2018 Jan 4;51(1):1701375. doi: 10.1183/13993003.01375-2017. Print 2018 Jan.

    PubMed 29301921

  • Strassmann A, Frei A, Haile SR, Ter Riet G, Puhan MA. Commonly Used Patient-Reported Outcomes Do Not Improve Prediction of COPD Exacerbations: A Multicenter 4(1/2) Year Prospective Cohort Study. Chest. 2017 Dec;152(6):1179-1187. doi: 10.1016/j.chest.2017.09.003. Epub 2017 Sep 18.

    PubMed 28923760

  • Crook S, Frei A, Ter Riet G, Puhan MA. Prediction of long-term clinical outcomes using simple functional exercise performance tests in patients with COPD: a 5-year prospective cohort study. Respir Res. 2017 Jun 2;18(1):112. doi: 10.1186/s12931-017-0598-6.

    PubMed 28578705

  • Frei A, Siebeling L, Wolters C, Held L, Muggensturm P, Strassmann A, Zoller M, Ter Riet G, Puhan MA. The Inaccuracy of Patient Recall for COPD Exacerbation Rate Estimation and Its Implications: Results from Central Adjudication. Chest. 2016 Oct;150(4):860-868. doi: 10.1016/j.chest.2016.06.031. Epub 2016 Aug 26.

    PubMed 27400907

  • Frei A, Muggensturm P, Putcha N, Siebeling L, Zoller M, Boyd CM, ter Riet G, Puhan MA. Five comorbidities reflected the health status in patients with chronic obstructive pulmonary disease: the newly developed COMCOLD index. J Clin Epidemiol. 2014 Aug;67(8):904-11. doi: 10.1016/j.jclinepi.2014.03.005. Epub 2014 Apr 29.

    PubMed 24786594

  • Puhan MA, Siebeling L, Frei A, Zoller M, Bischoff-Ferrari H, Ter Riet G. No association of 25-hydroxyvitamin D with exacerbations in primary care patients with COPD. Chest. 2014 Jan;145(1):37-43. doi: 10.1378/chest.13-1296.

    PubMed 24008868

  • Puhan MA, Siebeling L, Zoller M, Muggensturm P, ter Riet G. Simple functional performance tests and mortality in COPD. Eur Respir J. 2013 Oct;42(4):956-63. doi: 10.1183/09031936.00131612. Epub 2013 Mar 21.

    PubMed 23520321

Questions about this trial

What is this clinical trial studying?

An observational study of COPD, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Jun 2010. 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?

Results are not available in the source record.

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?

Chronic Respiratory Questionnaire (time frame: At least 5 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 NCT00706602, which also lists 9 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 28 Jun 2010.

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