EVALUATION OF COPD LONGITUDINALLY TO IDENTIFY PREDICTIVE SURROGATE ENDPOINTS (ECLIPSE)

Jørgen Vestbo1, Harvey Coxson2, Ffyona Dawber3, David Lomas4,  William Macnee5, and Edwin Silverman6 on behalf of the ECLIPSE investigators (study sponsored by GSK).  1Respiratory Medicine, Hvidovre Hospital, Copenhagen, Denmark; 2Radiology, University of British Columbia, Vancouver, Canada 3Respiratory MDC, GSK, London, United Kingdom; 4Respiratory Medicine, University of Cambridge, Cambridge, United Kingdom; 5Respiratory Medicine, Royal Infirmary, Edinburgh, United Kingdom and 6Channing Laboratory, Brigham and Women's Hospital, Boston, United States of America

FEV1 is used for the diagnosis and staging of COPD but there is wide acceptance that it is a crude measure and insensitive to change over shorter periods of time. Thus more sensitive measures of disease progression are needed.

ECLIPSE is a 3 year longitudinal study with 4 specific aims: (i) to define clinically relevant COPD phenotypes, (ii) to define parameters that predict disease progression in these phenotypes, (iii) to examine biomarkers that correlate with COPD phenotypes and may predict disease progression, and (iv) to identify novel genetic factors and/or biomarkers that both correlate with clinically relevant COPD phenotypes and predict disease progression.

2180 COPD subjects in GOLD categories II-IV will be enrolled, plus 566 control subjects. Study procedures will be performed at 8 visits; baseline, 3 months, 6 months, and then every 6 months. Assessments include pulmonary function measurements (plethysmography, spirometry and forced oscillometry), biomarkers (in blood, sputum urine and exhaled breath condensate for proteomic and metabolomic analysis), health outcomes, chest computed tomography scans, body impedance, resting oxygen saturation and 6 minute walk distance.

ECLIPSE is the largest study that attempts to better describe the phenotypes of COPD as well as defining predictive markers of COPD progression.

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