Day 1 | Week 6 | |||||
Change from baseline in normalised FEV1 vs placebo, mL |
Aclidinium 400 µg |
Tiotropium 18 µg | Aclidinium vs tiotropium |
Aclidinium 400 µg |
Tiotropium 18 µg | Aclidinium vs tiotropium |
FEV1 AUC –24/24h | 150* | 87* | 63† | 140** | 106* | 34 |
FEV1 AUC12–24/12h (night-time) | 157** | 67* | 90† | 153** | 90** | 63† |
FEV1 AUC –12 (day time) | 147** | 112** | 35 | 126* | 123* | 3 |
Morning pre-dose (trough) FEV1 | 136** | 68* | 68† | 137* | 70* | 65† |
E-RS Total Score over 6 weeks | - | - | - | -2.15* | -0.98 | -1.17† |
a Early morning symptom severity over 6 weeks (% reduction) | - | - | - | -0.25* (-9.54%) | -0.11 (-4.33%) | -0.14†
(-5.21%) |
b Night-time symptom severity over 6 weeks (% reduction) | - | - | - | -0.23* (-10.31%) | -0.09 (-4.23%) | -0.14
†
(-6.09%) |
↵*p < 0.05 vs placebo; **p ≤ 0.0001 vs placebo; †p < 0.05 vs tiotropium.
↵aLeast squares mean change from baseline in the severity of early morning symptoms over 6 weeks: 1 = No symptoms, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very severe.
↵bChange from baseline in the severity of night-time symptoms over 6 weeks: 1 = No symptoms, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very severe.
AUC, area under the curve; COPD, chronic obstructive pulmonary disease; E-RS, EXAcerbations of Chronic pulmonary disease Tool-Respiratory Symptoms; FEV1, forced expiratory volume in 1 s.