Table 2—

Outcomes measured in the Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE) study

DescriptionFrequency of assessment#
Pulmonary function
 Lung function: post-bronchodilator FEV1, rate of decline in FEV1, FVC, FEV1/FVC, FEV6, SVC and reversibilityEach visit
 Pulmonary plethysmography: RV, TLC, FRC, airway resistance and specific conductanceAnnually
 Impulse oscillometry: frequency-dependent resistance and reactance parametersMeasurement of peripheral airways function during tidal breathingEach visit
 Exhaled carbon monoxideConfirmation of smoking statusEach visit
Whole body impedance/fat-free mass
 Body compositionEstimated using single-frequency (50 kHz) bioelectrical impedance analysisAnnually
 Fat-free massCalculated from height squared/impedance, age, sex and body weightAnnually
Chest computed tomographyMeasurement of airway dimensions and quantification of emphysema; to be used for patients stratification during data analysisYears 1 and 3§
Exercise capacity+Supervised standardised 6-min walking testAnnually
Resting oxygen saturationMeasured after 10-min restEach visit
BiomarkersEvaluation of association with disease subtypes and their relationship with disease progression
 Blood samples (for protein or mRNA): CRP, TNF-α, IL-6, Clara cell protein, IL-8 and surfactant protein DMeasured using open-platform technologies (transcriptomics and proteomics) or specific validated assays (ELISA, multiplex and quantitative reverse transcriptase PCR)Each visit
 Induced sputum: inflammatory cell content, soluble markers (e.g. myeloperoxidase) and cellular expression of mRNATotal and differential cell count, supernatant proteomics and cell extract transcriptomicsAnnually
 Exhaled breath condensateCollected by the cooling and freezing of spontaneously exhaled airYear 3
 Blood and urine metabolomicsTaken after 3-h fast following completion of food intake diaryEach visit
Health outcomes
 Exacerbation assessmentDetails of doctor/hospital visits and use of oral corticosteroids/antibiotics recordedEach visit plus monthly phone calls
 ATS respiratory questionnaireStandardised ATS epidemiology questionnaireBaseline alone
 Depression questionnaireCES-D scaleYear 3
 Fatigue questionnaireFACIT fatigue scaleYear 3
 Health status and MRC dyspnoea assessmentSGRQ-C, modified MRC dyspnoea scale, BODE index and Prognostic IndexAnnually
Blood samples for genetic markers DNAIdentification and/or confirmation of genes believed to be associated with COPD-related phenotypes and COPD subtypesOngoing
  • COPD: chronic obstructive pulmonary disease; FEV1: forced expiratory volume in one second; FVC: forced vital capacity; FEV6: forced expiratory volume in six seconds; SVC: slow vital capacity; RV: residual volume; TLC: total lung capacity; FRC: functional residual capacity; CRP: C-reactive protein; TNF: tumour necrosis factor; IL: interleukin; ATS: American Thoracic Society; MRC: UK Medical Research Council; CES-D: Centre for Epidemiological Studies of Depression; FACIT: Functional Assessment of Chronic Illness Therapy; SGRQ-C: COPD-specific version of the St George’s Respiratory Questionnaire; BODE: body mass index, airflow obstruction, dyspnoea and exercise capacity. #: in addition to baseline; : at selected sites, involving 500–510 individuals; +: COPD patients alone; §: baseline alone in nonsmoking controls.