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

TLDR

COPD is heterogeneous and poorly understood, and while FEV1 is used for diagnosis and staging, it is a crude, insensitive measure over short periods. ECLIPSE is a 3‑year longitudinal study designed to define clinically relevant COPD subtypes, identify parameters and biomarkers that predict disease progression, and discover novel genetic factors associated with these subtypes. The study enrolls 2,180 COPD patients and 566 controls, with assessments at baseline, 3 and 6 months and every 6 months thereafter, including spirometry, oscillometry, plethysmography, CT, multiple biomarkers, health outcomes, impedance, oxygen saturation, and 6‑minute walk distance. ECLIPSE is the largest effort to characterize COPD subtypes and establish predictive markers of disease progression.

Abstract

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.