Introduction
The ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints) study is a non-interventional, observational, multicentre, three-year study in people with Chronic Obstructive Pulmonary Disease (COPD). COPD is most commonly caused by smoking and is usually diagnosed based on a history of exposure to risk factors and the presence of airflow limitation that is not fully reversible (as measured by spirometry). However, spirometry only measures one aspect of disease – airway obstruction. Therefore in order to expand disease understanding and enable the development of more treatment options to optimise management of all aspects of the disease (e.g. muscle dysfunction, mucus hypersecretion, emphysema, dyspnea and cough), better characterisation of the disease entities that make up COPD is required. In addition, identification of more sensitive measures and/or markers of disease progression are also needed.
The ECLIPSE study was therefore designed to determine the underlying mechanisms of disease progression and identify biomarkers that may serve as surrogate endpoints and therefore measures of disease progression. ECLIPSE is a unique collaborative project between external experts and industry.
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ECLIPSE is the first study to investigate novel endpoints in COPD disease progression.
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ECLIPSE will provide a greater insight into patient needs and expand COPD disease understanding – causes, processes, patterns and progression.
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The ECLIPSE study is leading the advancement of scientific and medical investigation into COPD.
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• Study design
• Study endpoints
Last updated: October 2010
Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease state characterised by airflow limitation that is not fully reversible. COPD is an umbrella term, which is used to describe chronic bronchitis, emphysema or a combination of these. COPD is most commonly caused by smoking and is usually diagnosed based on a history of exposure to risk factors and the presence of airflow limitation that is not fully reversible (as measured by spirometry). It is a fatal lung disease that kills more people each year than lung cancer and breast cancer combined. As there is no cure for COPD, all currently available treatments concentrate on slowing progression of the disease, controlling symptoms and reducing complications.
Spirometry (a relatively simple lung function test) measures forced expiratory volume in one second (FEV1) which is used for the diagnosis and staging of COPD. However there is wide acceptance that it is a crude measure and insensitive to change over shorter periods of time and only measures one clinical manifestation of COPD: airway obstruction. Therefore in order to expand disease understanding and enable the development of more treatment options to optimise management of all aspects of the disease (e.g. muscle dysfunction, mucus hypersecretion, emphysema, dyspnoea and cough), better characterisation of the disease entities that make up COPD is required. In addition, identification of more sensitive measures and/or markers of disease progression are also needed.
Design: ECLIPSE is a non-interventional, longitudinal prospective three-year study in people with COPD and control subjects. In the study, novel COPD biochemical, radiological and physiological biomarker endpoints will be compared with FEV1 in COPD patients and control subjects.
Study procedures performed at 8 visits (baseline, 3 months, 6 months, and then every 6 months for 3 years).
Endpoints
Assessments include:
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Pulmonary function measurements (plethysmography, spirometry and forced oscillometry)
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Biomarkers (in blood, sputum, urine, and exhaled breath condensate for proteomic and metabolomic analysis)
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Health outcomes
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Chest computed tomography scans
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Body impedance
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Resting oxygen saturation
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6 minute walk distance
Note: list above is not in any order of importance.