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

COPD Clinical Trial

— ICECOLDERIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00706602
• Other study ID #: 3233B0-115216
• Secondary ID: 3.4.07.045
• Status: Active, not recruiting
• Phase: N/A
• First received: June 25, 2008
• Last updated: June 24, 2010
• Start date: May 2008
• Est. completion date: August 2014

Study information

• Verified date: June 2010
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionNetherlands: Independent Ethics Committee
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Switzerland	Institute for primary care, University of Zurich	Zurich

Sponsors (4)

Lead Sponsor	Collaborator
University of Zurich	Swiss National Science Foundation, The Netherlands Asthma Foundation, Zurich Lung League

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic Respiratory Questionnaire		At least 5 years	No
Secondary	Exacerbation		At least 5 years	No