Table 2.
Primary and secondary endpoints: LSM treatment difference versus placebo MDI (mITT population)
| LSM treatment difference versus placebo MDI, mL (95% CI) | GP MDI 7.2 μg, n=62 | GP MDI 14.4 μg, n=61 | GP MDI 28.8 μg, n=61 |
|---|---|---|---|
| Primary endpoint | |||
| Change from baseline in morning pre-dose trough FEV1 on Day 8 | 108 (72, 144) | 129 (93, 165) | 131 (95, 168) |
| Secondary endpoints | |||
| FEV1 AUC0–2 on Day 1 | 84 (53, 115) | 97 (66, 128) | 133 (102, 164) |
| FEV1 AUC0–2 on Day 8 | 151 (107, 195) | 181 (137, 225) | 175 (131, 219) |
| Peak change from baseline in FEV1 on Day 1 | 88 (52, 124) | 108 (72, 144) | 150 (114, 186) |
| Peak change from baseline in FEV1 on Day 8 | 155 (108, 203) | 183 (135, 231) | 178 (130, 226) |
| FVC AUC0–2 on Day 8 | 176 (105, 247) | 218 (147, 289) | 227 (155, 298) |
Note: p<0.0001 for all treatments versus placebo MDI (n=62 on Day 1; n=61 on Day 8).
Abbreviations: AUC0–2, area under the curve from 0 to 2 hours; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; GP, glycopyrronium; LSM, least squares mean; MDI, metered dose inhaler; mITT, modified intent-to-treat.