Characteristic | Study 1 | Study 2 | |
PBO + TIO | BUD/FORM + TIO | All | |
Subjects n | 331 | 329 | 442 |
Males | 245 (74) | 251 (76) | 316 (71) |
Mean age yrs (range) | 62.5 (41–82) | 62.4 (40–85) | 63.0 (40–86) |
Median time since diagnosis yrs (range) | 5.7 (0.2–52.6) | 5.7 (0.3–43.4) | 6.3 (0–52) |
Previous smokers % | 54 | 58 | 66 |
Median smoking history pack-yrs (IQR) | 38 (11) | 36 (12) | 40 (30) |
Mean FEV1 % pred normal (range) | 37.7 (16–51) | 38.1 (10–58) | 36.1 (13−51) |
GOLD severity stage+ | |||
II ≥50–<80% | 70 (21) | 90 (27) | 98 (22) |
III ≥30–<50% | 217 (66) | 203 (62) | 261 (59) |
IV <30% | 42 (13) | 33 (10) | 82 (19) |
Data are presented as n (%), unless otherwise stated. PBO: placebo; TIO: tiotropium; BUD: budesonide; FORM: formoterol; IQR: interquartile range; FEV1: forced expiratory volume in 1 s; % pred: % predicted; GOLD: Global Initiative for Chronic Obstructive Lung Disease. #: Welte et al. 12; ¶: Partridge et al. 14; +: defined by measuring post-bronchodilator FEV1 as % pred normal. Data from 12, 14.