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Eur Respir J 2008, doi:10.1183/09031936.00111707
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ORIGINAL ARTICLE |
Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE)
1 University of Copenhagen & Hvidovre Hospital, Hvidovre, Denmark, and University of Manchester & Wythenshawe Hospital, Manchester, UK
2 GlaxoSmithKline R&D, Research Triangle Park, NC, USA
3 University of British Columbia, Vancouver, Canada
4 GlaxoSmithKline R&D, Greenford, MIDDX, UK
5 University of Cambridge, Cambridge, UK
6 University of Edinburgh & Royal Infirmary, Edinburgh, UK
7 Brigham & Women's Hospital, Boston, USA
8 GlaxoSmithKline R&D, King of Prussia, PA, USA
* To whom correspondence should be addressed. E-mail: joergen.vestbo{at}hvh.regionh.dk.
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Abstract |
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COPD is a heterogeneous disease and not well understood. Forced expiratory volume in 1 second (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.
ECLIPSE is a 3 year longitudinal study with 4 specific aims: (i) to define clinically relevant COPD subtypes, (ii) to identify parameters that predict disease progression in these subtypes, (iii) to examine biomarkers that correlate with COPD subtypes and may predict disease progression, and (iv) to identify novel genetic factors and/or biomarkers that both correlate with clinically relevant COPD subtypes and predict disease progression.
It is planned to recruit 2180 COPD subjects in GOLD categories II–IV, 343 smoking and 223 non-smoking control subjects. Study procedures will be performed at baseline, 3 months, 6 months, and then every 6 months. Assessments include pulmonary function measurements (spirometry, impulse oscillometry, and plethysmography), computed chest tomography, biomarkers (in blood, sputum, urine and exhaled breath condensate), health outcomes, body impedance, resting oxygen saturation and 6 minute walking distance.
ECLIPSE is the largest study attempting to better describe the subtypes of COPD as well as defining predictive markers of COPD progression.
Keywords: Biomarkers, chronic obstructive lung disease, emphysema, genetics, lung function, natural history
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