Outcomes measured in the Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE) study
| Description | Frequency of assessment# | |
| Pulmonary function | ||
| Lung function: post-bronchodilator FEV1, rate of decline in FEV1, FVC, FEV1/FVC, FEV6, SVC and reversibility | Each visit | |
| Pulmonary plethysmography: RV, TLC, FRC, airway resistance and specific conductance¶ | Annually | |
| Impulse oscillometry: frequency-dependent resistance and reactance parameters | Measurement of peripheral airways function during tidal breathing | Each visit |
| Exhaled carbon monoxide | Confirmation of smoking status | Each visit |
| Whole body impedance/fat-free mass | ||
| Body composition | Estimated using single-frequency (50 kHz) bioelectrical impedance analysis | Annually |
| Fat-free mass | Calculated from height squared/impedance, age, sex and body weight | Annually |
| Chest computed tomography | Measurement of airway dimensions and quantification of emphysema; to be used for patients stratification during data analysis | Years 1 and 3§ |
| Exercise capacity+ | Supervised standardised 6-min walking test | Annually |
| Resting oxygen saturation | Measured after 10-min rest | Each visit |
| Biomarkers | Evaluation 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 D | Measured 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 mRNA | Total and differential cell count, supernatant proteomics and cell extract transcriptomics | Annually |
| Exhaled breath condensate¶ | Collected by the cooling and freezing of spontaneously exhaled air | Year 3 |
| Blood and urine metabolomics¶ | Taken after 3-h fast following completion of food intake diary | Each visit |
| Health outcomes | ||
| Exacerbation assessment | Details of doctor/hospital visits and use of oral corticosteroids/antibiotics recorded | Each visit plus monthly phone calls |
| ATS respiratory questionnaire | Standardised ATS epidemiology questionnaire | Baseline alone |
| Depression questionnaire | CES-D scale | Year 3 |
| Fatigue questionnaire | FACIT fatigue scale | Year 3 |
| Health status and MRC dyspnoea assessment | SGRQ-C, modified MRC dyspnoea scale, BODE index and Prognostic Index | Annually |
| Blood samples for genetic markers DNA | Identification and/or confirmation of genes believed to be associated with COPD-related phenotypes and COPD subtypes | Ongoing |
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.