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. 2017 Jan 12;49(1):1601100. doi: 10.1183/13993003.01100-2016

TABLE 2.

Secondary and further efficacy end-point responses at week 12

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.