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Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE)

¹ Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark, ² Wythenshawe Hospital, University of Manchester, Manchester, ⁵ GlaxoSmithKline R&D, Greenford, ⁶ University of Cambridge, Cambridge, and ⁷ Royal Infirmary, University of Edinburgh, Edinburgh, UK. ³ GlaxoSmithKline R&D, Research Triangle Park, NC, ⁸ Brigham and Women’s Hospital, Boston, MA, and ⁹ GlaxoSmithKline R&D, King of Prussia, PA, USA. ⁴ University of British Columbia, Vancouver, BC, Canada.

CORRESPONDENCE: J. Vestbo, Cardiology and Respiratory Medicine 253, Hvidovre Hospital, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark. Fax: 45 36323716. E-mail: joergen.vestbo{at}hvh.regionh.dk

Keywords: Biomarkers, chronic obstructive lung disease, emphysema, genetics, lung function, natural history

Received: August 26, 2007
Accepted December 21, 2007

Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease and not well understood. The forced expiratory volume in one second 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.

Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE) is a 3-yr longitudinal study with four specific aims: 1) definition of clinically relevant COPD subtypes; 2) identification of parameters that predict disease progression in these subtypes; 3) examination of biomarkers that correlate with COPD subtypes and may predict disease progression; and 4) identification of novel genetic factors and/or biomarkers that both correlate with clinically relevant COPD subtypes and predict disease progression.

ECLIPSE plans to recruit 2,180 COPD subjects in Global Initiative for Chronic Obstructive Lung Disease categories II–IV and 343 smoking and 223 nonsmoking control subjects. Study procedures are to be performed at baseline, 3 months, 6 months and every 6 months thereafter. Assessments include pulmonary function measurements (spirometry, impulse oscillometry and plethysmography), chest computed tomography, biomarker measurement (in blood, sputum, urine and exhaled breath condensate), health outcomes, body impedance, resting oxygen saturation and 6-min walking distance.

Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points is the largest study attempting to better describe the subtypes of chronic obstructive pulmonary disease, as well as defining predictive markers of its progression.