Endpoint | Study 207608 | Study 207609 | Pooled analysis | |||
---|---|---|---|---|---|---|
FF/UMEC/VI N = 363 | BUD/FOR+TIO N = 365 | FF/UMEC/VI N = 366 | BUD/FOR+TIO N = 366 | FF/UMEC/VI N = 729 | BUD/FOR+TIO N = 731 | |
SGRQ total score | ||||||
n | 344 | 342 | 343 | 342 | 687 | 684 |
LS mean (95% CI) | 48.8 (47.8, 49.8) | 48.7 (47.7, 49.7) | 51.8 (50.7, 52.8) | 51.7 (50.7, 52.8) | 50.3 (49.5, 51.0) | 50.2 (49.5, 51.0) |
LS mean (95% CI) change from baseline | −1.2 (−2.2, −0.2) | − 1.3 (− 2.3, −0.3) | −1.5 (− 2.6, −0.4) | −1.5 (− 2.6, − 0.4) | −1.4 (− 2.1, − 0.6) | −1.4 (− 2.1, − 0.6) |
Treatment difference (95% CI) p-value | 0.1 (− 1.3, 1.5) 0.926 | 0.0 (− 1.5, 1.6) 0.974 | 0.0 (− 1.0, 1.1) 0.956 | |||
n | 345 | 343 | 343 | 344 | 688 | 687 |
Responders, n (%) | 117 (34) | 117 (34) | 124 (36) | 119 (35) | 241 (35) | 236 (34) |
Odds ratio (95% CI) p-value | 1.01 (0.74, 1.40) 0.928 | 1.09 (0.79, 1.50) 0.609 | 1.05 (0.84, 1.31) 0.671 | |||
CAT score | ||||||
n | 348 | 344 | 344 | 347 | 692 | 691 |
LS mean (95% CI) | 19.8 (19.3, 20.3) | 20.4 (19.8, 20.9) | 21.1 (20.6, 21.6) | 21.2 (20.7, 21.7) | 20.4 (20.1, 20.8) | 20.8 (20.4, 21.1) |
LS mean (95% CI) change from baseline | −0.8 (−1.4, −0.3) | −0.2 (−0.8, 0.3) | − 0.2 (− 0.7, 0.3) | −0.1 (− 0.6, 0.4) | −0.5 (− 0.9, − 0.2) | −0.2 (− 0.6, 0.2) |
Treatment difference (95% CI) p-value | − 0.6 (− 1.4, 0.2) 0.141 | −0.1 (− 0.8, 0.6) 0.746 | −0.3 (− 0.9, 0.2) 0.201 | |||
n | 349 | 344 | 344 | 348 | 693 | 692 |
Responders, n (%) | 137 (39) | 130 (38) | 126 (37) | 126 (36) | 263 (38) | 256 (37) |
Odds ratio (95% CI) p-value | 1.07 (0.78, 1.47) 0.655 | 1.02 (0.74, 1.40) 0.895 | 1.04 (0.83, 1.30) 0.732 |