TABLE 2.
Patients | Adjusted response | Active versus placebo Respimat | ||
Adjusted difference (95% CI) mL | p-value | |||
FEV1 AUC(0–3h) mL | ||||
Tiotropium Respimat 5 µg once daily | 130 | 423±43 | 87±53 (−17–191) | 0.100 |
Tiotropium Respimat 2.5 µg once daily | 126 | 449±43 | 113±53 (9–217) | 0.034 |
Placebo Respimat once daily | 132 | 336±43 | ||
Peak FVC(0–3h) mL | ||||
Tiotropium Respimat 5 µg once daily | 130 | 342±48 | 63±59 (−53–179) | 0.285 |
Tiotropium Respimat 2.5 µg once daily | 126 | 370±49 | 91±59 (−26–207) | 0.126 |
Placebo Respimat once daily | 132 | 279±48 | ||
Trough FVC mL | ||||
Tiotropium Respimat 5 µg once daily | 130 | 200±51 | 55±62 (−67–177) | 0.376 |
Tiotropium Respimat 2.5 µg once daily | 126 | 249±52 | 103±62 (−19–226) | 0.098 |
Placebo Respimat once daily | 132 | 145±50 | ||
FVC AUC(0–3h) mL | ||||
Tiotropium Respimat 5 µg once daily | 130 | 227±46 | 52±56 (−58–163) | 0.355 |
Tiotropium Respimat 2.5 µg once daily | 126 | 262±47 | 87±57 (−24–198) | 0.125 |
Placebo Respimat once daily | 132 | 175±45 | ||
Pre-dose morning PEF L·min−1 | ||||
Tiotropium Respimat 5 µg once daily | 129 | 28.05±4.91 | 17.36±6.23 (5.14–29.58) | 0.005 |
Tiotropium Respimat 2.5 µg once daily | 124 | 21.17±5.00 | 10.49±6.29 (−1.86–22.83) | 0.096 |
Placebo Respimat once daily | 131 | 10.69±4.87 | ||
Pre-dose evening PEF L·min−1 | ||||
Tiotropium Respimat 5 µg once daily | 130 | 21.94±4.84 | 17.57±6.12 (5.57–29.57) | 0.004 |
Tiotropium Respimat 2.5 µg once daily | 124 | 15.43±4.93 | 11.06±6.18 (−1.07–23.19) | 0.074 |
Placebo Respimat once daily | 131 | 4.37±4.80 |
Data are presented as n or mean±se, unless otherwise stated. Full analysis set. Adjusted for treatment, country, week, baseline, treatment-by-week interaction and baseline-by-week interaction. Common baseline mean±sd: forced expiratory volume in 1 s (FEV1) 2525±618 mL; forced vital capacity (FVC) 3315±811 mL; pre-dose morning peak expiratory flow (PEF) 328.73±92.93 mL; pre-dose evening PEF 346.11±91.82 mL. AUC(0–3h): area under the curve within 3 h post-dosing; FVC(0–3h): FVC within 3 h post-dosing.