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.