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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00706602
Acronym
ICECOLDERIC
Enrollment
450
Registered
2008-06-27
Start date
2008-05-31
Completion date
2014-08-31
Last updated
2010-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD, prognosis, prediction rule, health-related quality of life, risk factors, derivation, validation, exacerbation, mortality, primary care, treatment, decision making

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.

Interventions

None listed

Sponsors

Swiss National Science Foundation
CollaboratorOTHER
Zurich Lung League
CollaboratorOTHER
The Netherlands Asthma Foundation
CollaboratorOTHER
University of Zurich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Chronic Respiratory QuestionnaireAt least 5 years

Secondary

MeasureTime frame
ExacerbationAt least 5 years

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026