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

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ClinicalTrials.gov Identifier: NCT00706602
Recruitment Status : Unknown
Verified June 2010 by University of Zurich.
Recruitment status was:  Active, not recruiting
First Posted : June 27, 2008
Last Update Posted : June 28, 2010
Swiss National Science Foundation
Zurich Lung League
The Netherlands Asthma Foundation
Information provided by:
University of Zurich

Brief 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). 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.

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.

Condition or disease

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Collaborative Effort on Chronic Obstructive Lung Disease: Exacerbation Risk Index Cohorts
Study Start Date : May 2008
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Swiss COPD cohort
Dutch COPD cohort

Primary Outcome Measures :
  1. Chronic Respiratory Questionnaire [ Time Frame: At least 5 years ]

Secondary Outcome Measures :
  1. Exacerbation [ Time Frame: At least 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD patients from primary care. Patients are identified through electronic or paper-based patient charts and by participating general practitioners.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706602

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Institute for primary care, University of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
Zurich Lung League
The Netherlands Asthma Foundation
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Principal Investigator: Milo A Puhan, MD PhD University of Zurich, Switzerland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Milo A Puhan/MD PhD, University of Zurich and Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00706602    
Other Study ID Numbers: 3233B0-115216
First Posted: June 27, 2008    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: June 2010
Keywords provided by University of Zurich:
prediction rule
health-related quality of life
risk factors
primary care
decision making