Table 3.
Summary of other efficacy endpoints (intent-to-treat population)
| UMEC/VI, N = 482 |
TIO + IND, N = 479 |
||
|---|---|---|---|
| Rescue use | |||
| Days 1–84 | n = 474 | n = 472 | |
| LS mean change in mean puffs per day from baseline (SE) | −1.5 (0.06) | −1.4 (0.06) | |
| Difference (95 % CI) | 0.1 (−0.1 to 0.3) | ||
| TDI focal score | |||
| Day 28 | n = 470 | n = 461 | |
| LS mean change from baseline (SE) | 2.07 (0.12) | 2.02 (0.12) | |
| Difference (95 % CI) | 0.05 (−0.29 to 0.39) | ||
| Day 56 | n = 462 | n = 459 | |
| LS mean change from baseline (SE) | 2.08 (0.12) | 2.14 (0.12) | |
| Difference (95 % CI) | −0.05 (−0.38 to 0.28) | ||
| Day 84 | n = 459 | n = 455 | |
| LS mean change from baseline (SE) | 2.32 (0.13) | 2.62 (0.13) | |
| Difference (95 % CI) | −0.30 (−0.65 to 0.05) | ||
| Proportion of responders according to TDI scorea | |||
| Day 28 | n = 478 | n = 471 | |
| Responders [n (%)] | 302 (63) | 295 (63) | |
| Odds ratio (95 % CI) | 1.01 (0.77 to 1.33) | ||
| Day 56 | n = 477 | n = 474 | |
| Responders [n (%)] | 287 (60) | 289 (61) | |
| Odds ratio (95 % CI) | 0.95 (0.73 to 1.25) | ||
| Day 84 | n = 478 | n = 476 | |
| Responders [n (%)] | 298 (62) | 309 (65) | |
| Odds ratio (95 % CI) | 0.88 (0.67 to 1.16) | ||
| SGRQ total score | |||
| Day 28 | n = 461 | n = 456 | |
| LS mean change from baseline (SE) | −4.41 (0.50) | −3.28 (0.50) | |
| Difference (95 % CI) | −1.12 (−2.50 to 0.26) | ||
| Day 56 | n = 448 | n = 458 | |
| LS mean change from baseline (SE) | −5.26 (0.54) | −4.89 (0.53) | |
| Difference (95 % CI) | −0.37 (−1.86 to 1.12) | ||
| Day 84 | n = 450 | n = 453 | |
| LS mean change from baseline (SE) | −4.93 (0.58) | −5.01 (0.57) | |
| Difference (95 % CI) | 0.08 (−1.52 to 1.67) | ||
| Proportion of responders according to SGRQ total scoreb | |||
| Day 28 | n = 470 | n = 466 | |
| Responders [n (%)] | 210 (45) | 185 (40) | |
| Odds ratio (95 % CI) | 1.19 (0.92 to 1.55) | ||
| Day 56 | n = 464 | n = 472 | |
| Responders [n (%)] | 229 (49) | 224 (47) | |
| Odds ratio (95 % CI) | 1.04 (0.80 to 1.35) | ||
| Day 84 | n = 471 | n = 476 | |
| Responders [n (%)] | 223 (47) | 216 (45) | |
| Odds ratio (95 % CI) | 1.05 (0.81 to 1.37) | ||
CI confidence interval, IND indacaterol, LS least squares, SE standard error, SGRQ St. George’s Respiratory Questionnaire, TDI Transition Dyspnea Index, TIO tiotropium, UMEC umeclidinium, VI vilanterol
aTDI focal score of ≥1 unit
bProportion of responders is defined by a difference of −4 units or lower from the visit score to the baseline score