Table 1. .
Demographics and baseline characteristics of the study population (safety population)
| Placebo (N = 85) | Aclidinium 400 μg BID (N = 171) | Tiotropium 18 μg QD (N = 158) | |
|---|---|---|---|
| Gender (male), n (%) | 48 (56.5) | 114 (66.7) | 116 (73.4) |
| Age (years), mean (SD) | 62.2 (8.2) | 61.8 (8.2) | 62.8 (7.9) |
| Race, n (%) | |||
| White | 84 (98.8) | 171 (100) | 158 (100) |
| Asian | 1 (1.2) | 0 (0) | 0 (0) |
| BMI (kg/m2), mean (SD) | 26.7 (4.9) | 27.5 (4.9) | 27.6 (4.8) |
| Current smoker, n (%) | 47 (53.3) | 93 (54.4) | 84 (53.2) |
| Smoking consumption (pack‑years), mean (SD) | 39.6 (15.4) | 41.5 (22.4) | 45.0 (21.8) |
| COPD duration (years), mean (SD) | 9.6 (6.7) | 8.8 (5.9) | 8.2 (6.0) |
| Post-bronchodilator FEV1 (L) | |||
| Mean (SD) | 1.57 (0.52) | 1.61 (0.50) | 1.67 (0.54) |
| % predicted, mean (SD) | 55.5 (11.8) | 55.8 (13.3) | 56.0 (13.2) |
| COPD severity,a,b n (%) | |||
| Moderate | 58 (68.2) | 108 (63.2) | 104 (66.2) |
| Severe | 27 (31.8) | 63 (36.8) | 53 (33.8) |
aGOLD Stage II (moderate): FEV1/FVC < 0.70, and post-bronchodilator FEV1 ≥ 50% and < 80% predicted; GOLD Stage III (severe): FEV1/FVC < 0.70, and post-bronchodilator FEV1 ≥ 30% and < 50% predicted.
bCOPD severity was missing for one patient in the tiotropium treatment group at screening (pre- and post-salbutamol values determined to be unacceptable following review).
BID, twice daily; BMI, body mass index; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; GOLD, Global initiative for chronic Obstructive Lung Disease; QD, once daily; SD, standard deviation.