Table 2.
Changes from baseline in lung function and body plethysmography parameters at Week 3 (ITT population)
| Parameter | Placebo (N = 108) | Aclidinium 400 μg BID (N = 109) | Treatment difference vs placebo (95% CI) |
|---|---|---|---|
| Pre-dose (trough) IC (mL) | 20 (25) | 98 (24) | 78 (10, 145)* |
| Pre-dose (trough) FEV1 (mL) | -25 (21) | 108 (21) | 132 (74, 191)**** |
| Pre-dose (trough) FVC (mL) | -46 (31) | 198 (30) | 243 (157, 329)**** |
| FRC (mL) | |||
| Pre-dose (trough) | 15 (39) | -182 (39) | -197 (-321, -72)** |
| Post-dose | -130 (46) | -449 (46) | -318 (-448, -189)**** |
| RV (mL) | |||
| Pre-dose (trough) | 15 (60) | -222 (60) | -238 (-396, -79)** |
| Post-dose | -81 (57) | -523 (57) | -443 (-599, -286)**** |
| TLC (mL) | |||
| Pre-dose (trough) | -6 (41) | -82 (41) | -76 (-201, 49) |
| Post-dose | -49 (41) | -199 (41) | -150 (-262, -37)** |
| sGaw (s-1kPa-1) | |||
| Pre-dose (trough) | 0.002 (0.020) | 0.096 (0.020) | 0.094 (0.038, 0.150)** |
| Post-dose | 0.054 (0.027) | 0.297 (0.026) | 0.243 (0.182, 0.303)**** |
Data reported as least squares means (standard error) change from baseline (analysis of covariance).
*p < 0.05, **p < 0.01, ****p < 0.0001 versus placebo.
BID, twice daily; CI, confidence interval; FEV1, forced expiratory volume in 1 s; FRC, functional residual capacity; FVC, forced vital capacity; IC, inspiratory capacity; ITT, intent-to-treat; RV, residual volume; sGaw, specific airway conductance; TLC, total lung capacity.