Peak FEV1(0–3 h), trough FEV1,FEV1 AUC(0–3 h), and Peak FVC(0–3 h) responses at Week 24 (full analysis set); and overall AEs in treated set
| Responses at Week 24 | |||
|---|---|---|---|
| Tiotropium Respimat® 5 µga n = 135 | Tiotropium Respimat® 2.5 µga n = 135 | ||
| Adjusted mean difference versus placebo Respimat®a ± standard error1 | |||
| Background maintenance therapy | Medium-dose ICS (200–400 µg budesonide or equivalent) alone or in combination with another controller medication | ||
| Peak FEV1(0–3h) response, mL | 164 ± 31 P < 0.0001 n = 134 | 170 ± 31 P < 0.0001 n = 131 | |
| Trough FEV1 response, mLb | 118 ± 36 P = 0.0010 n = 134 | 116 ± 36 P = 0.0012 n = 131 | |
| FEV1 AUC(0–3h) response, mL | 157 ± 30 P < 0.0001 n = 134 | 154 ± 30 P < 0.0001 n = 131 | |
| Peak FVC(0–3h) response, mL | 91 ± 37 P = 0.0152 n = 134 | 110 ± 38 P = 0.0036 n = 131 | |
| Adverse Events (AEs)2 | |||
| Placebo Respimat®a n = 131 | Tiotropium Respimat® 5 µga n = 135 | Tiotropium Respimat® 2.5 µga n = 135 | |
| n (%) | |||
| Patients with any AE | 89 (67.9) | 82 (60.7) | 86 (63.7) |
| Patients with investigator-defined drug-related AEs | 2 (1.5) | 0 | 0 |
| Patients with AEs leading to discontinuation | 0 | 0 | 0 |
| Patients with serious AEs | 6 (4.6) | 1 (0.7) | 3 (2.2) |
1Full analysis set. Placebo Respimat®, N = 131; Placebo Respimat®, Week 24, n = 126. Mean baseline values (± standard deviation): ICS dose, 310.0 ± 112.0 µg; ACQ-IA total score, 1.87 ± 0.31; FEV1, 1629 ± 393 mL; FVC, 2121 ± 564 mL.
aAdd-on to background maintenance therapy.
bMeasured 10 minutes before next dose of trial medication.
ACQ-IA, interviewer-administered Asthma Control Questionnaire
2Treated set. Percentages calculated using total number of patients per treatment group as denominator.