Tables
- Table 1—
Inclusion criteria for the Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE) study
COPD subjects Controls Smoking Nonsmoking Male/female subjects aged 40–75 yrs Male/female subjects aged 40–75 yrs, who are free from significant disease as determined by history, physical examination and screening investigations Male/female subjects aged 40–75 yrs, who are free from significant disease as determined by history, physical examination and screening investigations Baseline post-bronchodilator FEV1 of <80% pred and FEV1/FVC of ≤0.7 Baseline post-bronchodilator FEV1 of >85% pred and FEV1/FVC of >0.7 Baseline post-bronchodilator FEV1 of >85% pred and FEV1/FVC of >0.7 Current or ex-smokers with a smoking history of ≥10 pack-yrs# Current or ex-smokers with a smoking history ≥10 pack-yrs# Nonsmokers with a smoking history of <1 pack-yr Signed and dated written informed consent obtained prior to participation Signed and dated written informed consent obtained prior to participation Signed and dated written informed consent obtained prior to participation Ability to comply with the requirements of the protocol and be available for study visits over 3 yrs Ability to comply with the requirements of the protocol and be available for study visits over 3 yrs Ability to comply with the requirements of the protocol and be available for study visits over 3 yrs COPD: chronic obstructive pulmonary disease; FEV1: forced expiratory volume in one second; % pred: % predicted; FVC: forced vital capacity. #: equivalent to, for example, 20 cigarettes·day−1 for 10 yrs or 10 cigarettes·day−1 for 20 yrs. 1 pack-yr = 1 pack (20 cigarettes)·day−1 for 1 yr.
- Table 2—
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.
