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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Zurich.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Swiss National Science Foundation
Zurich Lung League
The Netherlands Asthma Foundation
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00706602
First received: June 25, 2008
Last updated: June 24, 2010
Last verified: June 2010
  Purpose

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
COPD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Collaborative Effort on Chronic Obstructive Lung Disease: Exacerbation Risk Index Cohorts

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Chronic Respiratory Questionnaire [ Time Frame: At least 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exacerbation [ Time Frame: At least 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: May 2008
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Swiss COPD cohort
2
Dutch COPD cohort

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706602

Locations
Switzerland
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
Investigators
Principal Investigator: Milo A Puhan, MD PhD University of Zurich, Switzerland
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Milo A Puhan/MD PhD, University of Zurich and Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00706602     History of Changes
Other Study ID Numbers: 3233B0-115216, 3.4.07.045
Study First Received: June 25, 2008
Last Updated: June 24, 2010
Health Authority: Switzerland: Ethikkommission
Netherlands: Independent Ethics Committee

Keywords provided by University of Zurich:
COPD
prognosis
prediction rule
health-related quality of life
risk factors
derivation
validation
exacerbation
mortality
primary care
treatment
decision making

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 29, 2014