Table 2– Patient demographics of Studies 1# and 2
CharacteristicStudy 1Study 2
PBO + TIOBUD/FORM + TIOAll
Subjects n331329442
Males245 (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 %545866
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.