Table 2.
Summary of lung function endpoints
| UMEC/VI, PP population, N = 463 |
TIO + IND, PP population, N = 455 |
||
|---|---|---|---|
| Trough FEV1 [mL; PP population] | |||
| Day 85 | n = 392 | n = 392 | |
| LS mean change from baseline (SE) | 172 (11) | 171 (11) | |
| Difference (95 % CI) | 1 (−29 to 30) | ||
| 0- to 6-h WM FEV1 [L; ITT population] | |||
| Day 1 | n = 478 | n = 471 | |
| LS mean change from baseline (SE) | 184 (7) | 185 (7) | |
| Difference (95 % CI) | −1 (−20 to 18) | ||
| Day 84 | n = 455 | n = 452 | |
| LS mean change from baseline (SE) | 235 (11) | 258 (11) | |
| Difference (95 % CI) | −23 (−54 to 8) | ||
| Trough FVC [mL; ITT population] | |||
| Day 85 | n = 455 | n = 455 | |
| LS mean change from baseline (SE) | 239 (18) | 220 (18) | |
| Difference (95 % CI) | 20 (−29 to 68) | ||
CI confidence interval, FEV 1 forced expiratory volume in 1 s, FVC forced vital capacity, IND indacaterol, ITT intent-to-treat, LS least squares, PP per-protocol, SE standard error, TIO tiotropium, UMEC umeclidinium, VI vilanterol, WM weighted mean