Table 3.
Symptom and Quality of Life Endpoints (Efficacy Estimand; mITT Population)
| BGF MDI 320/18/9.6 µg | GFF MDI 18/9.6 µg | BFF MDI 320/9.6 µg | BUD/FORM DPI 400/12 µg | |
|---|---|---|---|---|
| TDI focal score over Weeks 12–24 | ||||
| Japan | ||||
| n LSM (SE) |
133 0.42 (0.12) |
126 0.25 (0.12) |
64 0.19 (0.17) |
64 0.07 (0.17) |
| Treatment difference for BGF MDI vs. comparators | ||||
| LSM (95% CI) P-value |
NA | 0.17 (–0.17, 0.50) 0.3279 |
0.22 (–0.18, 0.63) 0.2804 |
0.34 (–0.06, 0.75) 0.0952 |
| Global | ||||
| n LSM (SE) |
585 1.21 (0.10) |
544 1.13 (0.10) |
274 1.06 (0.14) |
280 0.72 (0.14) |
| Treatment difference for BGF MDI vs. comparators | ||||
| LSM (95% CI) P-value |
NA | 0.07 (–0.20, 0.35) 0.5928 |
0.15 (–0.18, 0.48) 0.3729 |
0.49 (0.16, 0.82) 0.0037 |
| Change from baseline in SGRQ total score over Weeks 12–24 | ||||
| Japan | ||||
| n LSM (SE) |
133 –4.1 (0.75) |
126 –2.6 (0.77) |
65 –4.3 (1.06) |
64 –3.4 (1.06) |
| Treatment difference for BGF MDI vs. comparators | ||||
| LSM (95% CI) P-value |
NA | –1.52 (–3.60, 0.55) 0.1495 |
0.20 (–2.33, 2.73) 0.8766 |
–0.73 (–3.26, 1.81) 0.5724 |
| Global | ||||
| n LSM (SE) |
592 –7.9 (0.50) |
553 –6.8 (0.51) |
277 –7.4 (0.67) |
284 –6.5 (0.67) |
| Treatment difference for BGF MDI vs. comparators | ||||
| LSM (95% CI) P-value |
NA | –1.10 (–2.29, 0.10) 0.0717 |
–0.52 (–1.99, 0.95) 0.4893 |
–1.42 (–2.88, 0.04) 0.0570 |
| Change from baseline in E-RS total score over Weeks 12–24 | ||||
| Japan | ||||
| n LSM (SE) |
134 –0.9 (0.35) |
127 0.0 (0.35) |
65 –0.4 (0.49) |
66 –0.3 (0.49) |
| Treatment difference for BGF MDI vs. comparators | ||||
| LSM (95% CI) P-value |
NA | –0.89 (–1.86, 0.07) 0.0701 |
–0.52 (–1.70, 0.66) 0.3899 |
–0.60 (–1.78, 0.58) 0.3204 |
| Global | ||||
| n LSM (SE) |
596 –1.1 (0.16) |
560 –0.8 (0.16) |
278 –1.0 (0.23) |
292 –0.9 (0.22) |
| Treatment difference for BGF MDI vs. comparators | ||||
| LSM (95% CI) P-value |
NA | –0.29 (–0.72, 0.15) 0.1965 |
–0.05 (–0.59, 0.48) 0.8445 |
–0.16 (–0.69, 0.37) 0.5538 |
| Change from baseline in average daily rescue medication use over 24 weeks, puffs/day | ||||
| Japan | ||||
| n LSM (SE) |
139 –0.2 (0.07) |
138 0.0 (0.07) |
70 –0.1 (0.10) |
68 –0.3 (0.10) |
| Treatment difference for BGF MDI vs. comparators | ||||
| LSM (95% CI) P-value |
NA | –0.13 (–0.32, 0.06) 0.1831 |
–0.09 (–0.33, 0.14) 0.4439 |
0.12 (–0.12, 0.35) 0.3358 |
| Global | ||||
| n LSM (SE) |
638 –0.5 (0.06) |
621 –0.4 (0.06) |
313 –0.4 (0.08) |
313 –0.7 (0.08) |
| Treatment difference for BGF MDI vs. comparators | ||||
| LSM (95% CI) P-value |
NA | –0.12 (–0.28, 0.04) 0.1543 |
–0.14 (–0.34, 0.06) 0.1793 |
0.16 (–0.04, 0.36) 0.1198 |
Abbreviations: BFF, budesonide/formoterol fumarate; BGF, budesonide/glycopyrrolate/formoterol fumarate; BUD/FORM DPI, budesonide/formoterol fumarate dry powder inhaler; CI, confidence interval; COPD, chronic obstructive pulmonary disease; E-RS, Evaluating Respiratory Symptoms in COPD Total score; GFF, glycopyrrolate/formoterol fumarate; LSM, least squares mean; MDI, metered dose inhaler; mITT, modified intent-to-treat; NA, not applicable; SE, standard error; SGRQ, St George’s Respiratory Questionnaire; TDI, Transition Dyspnea Index.