Table 2.
Proportion of responders at week 52
| FF/UMEC/VI | FF/VI | UMEC/VI | |
|---|---|---|---|
| SGRQ* | (n = 4108) | (n = 4092) | (n = 2050) |
| Responder, n (%) | 1723 (42) | 1390 (34) | 696 (34) |
| Non-responder, n (%) | 2385 (58) | 2702 (66) | 1354 (66) |
| FF/UMEC/VI vs. column | |||
| OR | – | 1.41 | 1.41 |
| 95% CI | – | 1.29–1.55 | 1.26–1.57 |
| p value | – | < 0.001 | < 0.001 |
| Major/moderate responder, n (%) | 1298 (32) | 1034 (25) | 495 (24) |
| Major responder, n (%) | 749 (18) | 609 (15) | 291 (14) |
| Moderate responder, n (%) | 549 (13) | 425 (10) | 204 (10) |
| Less than moderate responder, n (%) | 2810 (68) | 3058 (75) | 1555 (76) |
| FF/UMEC/VI: major/moderate responder vs. less than major/moderate responder vs. column | |||
| OR | – | 1.38 | 1.45 |
| 95% CI | – | 1.25–1.52 | 1.29–1.64 |
| p value | – | < 0.001 | < 0.001 |
| FF/UMEC/VI: major responder vs. less than major responder vs. column | |||
| OR | – | 1.29 | 1.35 |
| 95% CI | – | 1.15–1.45 | 1.16–1.56 |
| p value | – | < 0.001 | < 0.001 |
| CAT score† | (n = 4076) | (n = 4047) | (n = 2034) |
| Responder, n (%) | 1698 (42) | 1491 (37) | 730 (36) |
| Non-responder, n (%) | 2378 (58) | 2556 (63) | 1304 (64) |
| FF/UMEC/VI vs. column | |||
| OR | – | 1.24 | 1.28 |
| 95% CI | – | 1.14–1.36 | 1.15–1.43 |
| p value | – | < 0.001 | < 0.001 |
| TDI focal score‡ | (n = 2029) | (n = 2014) | (n = 1015) |
| Responder, n (%) | 730 (36) | 591 (29) | 302 (30) |
| Non-responder, n (%) | 1299 (64) | 1423 (71) | 713 (70) |
| FF/UMEC/VI vs. column | |||
| OR | – | 1.36 | 1.33 |
| 95% CI | – | 1.19–1.55 | 1.13–1.57 |
| p value | – | < 0.001 | < 0.001 |
CAT COPD (chronic obstructive pulmonary disease) Assessment Test, CI confidence interval, FF fluticasone furoate, ITT intent to treat, OR odds ratio, SGRQ St George’s Respiratory Questionnaire, TDI Transitional Dyspnea Index, UMEC umeclidinium, VI vilanterol
*ITT population with analyzable data at week 52; major response defined as an SGRQ total score ≥ 14-unit decrease below baseline; moderate response defined as < 14-unit, but ≥ 8-unit decrease below baseline; less than moderate response defined as < 8-unit decrease below baseline or a missing SGRQ total score with no subsequent on-treatment scores
†ITT population with analyzable data at week 52; response defined as a CAT score decrease ≥ 2 units below baseline; non-response defined as < 2-unit decrease below baseline
‡TDI population with analyzable data at week 52; response defined as a TDI focal score of ≥ 1 unit; non-response defined as TDI focal score of < 1 unit