GP MDI | Placebo | Open-label tiotropium | ||||||
---|---|---|---|---|---|---|---|---|
18 μg | 9 μg | 4.6 μg | 2.4 μg | 1.2 μg | 0.6 μg | |||
Primary endpoint: change from baseline in FEV1 AUC0–12, mL: Day 14 | ||||||||
n | 58 | 58 | 59 | 60 | 53 | 54 | 52 | 55 |
LSM | 159† | 127† | 143† | 127† | 97*** | 64* | 1 | 225† |
95 % CI | 116, 202 | 84, 170 | 100, 185 | 85, 169 | 52, 141 | 20, 108 | −43, 46 | 182, 269 |
Change from baseline in morning pre-dose trough FEV1, mL: Day 14 | ||||||||
n | 58 | 59 | 60 | 59 | 55 | 55 | 56 | 57 |
LSM | 89*** | 80*** | 67** | 77** | 68** | 29 | −8 | 126† |
95 % CI | 47, 132 | 38, 122 | 26, 109 | 35, 118 | 25, 111 | −14, 72 | −50, 35 | 84, 168 |
Change from baseline in evening 12-h post-dose trough FEV1, mL: Day 14 | ||||||||
n | 58 | 58 | 59 | 60 | 53 | 55 | 54 | 56 |
LSM | 116† | 69* | 99*** | 112† | 66* | 55 | 1 | 164† |
95 % CI | 69, 163 | 22, 117 | 52, 145 | 65, 158 | 17, 115 | 7, 104 | −48, 49 | 116, 211 |
Change from baseline in morning pre-dose trough inspiratory capacity, mL: Day 14 | ||||||||
n | 58 | 59 | 60 | 60 | 55 | 54 | 56 | 56 |
LSM | 94* | 45 | 64 | 104* | 69 | 34 | 9 | 138** |
95 % CI | 32, 156 | −16, 106 | 3, 124 | 43, 165 | 6, 132 | −30, 97 | −54, 71 | 76, 201 |
Peak change from baseline in FEV1, mL: Day 1 | ||||||||
n | 59 | 59 | 60 | 59 | 55 | 55 | 60 | 57 |
LSM | 231† | 226† | 165† | 170† | 136** | 107 | 57 | 270† |
95 % CI | 191, 272 | 186, 267 | 125, 205 | 130, 211 | 95, 177 | 65, 149 | 17, 97 | 229, 311 |
Peak change from baseline in FEV1, mL: Day 14 | ||||||||
n | 58 | 59 | 60 | 60 | 54 | 54 | 54 | 57 |
LSM | 288† | 288† | 287† | 261† | 246*** | 188 | 130 | 361† |
95 % CI | 236, 339 | 237, 340 | 236, 338 | 210, 312 | 193, 299 | 135, 241 | 77, 183 | 309, 413 |
Peak change from baseline in inspiratory capacity, mL: Day 1 | ||||||||
n | 59 | 59 | 61 | 60 | 55 | 54 | 60 | 56 |
LSM | 234*** | 263† | 151 | 183* | 126 | 82 | 80 | 343† |
95 % CI | 163, 304 | 193, 333 | 82, 219 | 113, 252 | 54, 198 | 9, 155 | 10, 150 | 271, 414 |
Peak change from baseline in inspiratory capacity, mL: Day 14 | ||||||||
n | 58 | 59 | 60 | 60 | 54 | 54 | 56 | 56 |
LSM | 280† | 259*** | 288† | 226** | 261*** | 172 | 77 | 284† |
95 % CI | 197, 363 | 177, 341 | 206, 370 | 145, 308 | 176, 346 | 87, 256 | −6, 161 | 200, 368 |