Table 2.
Primary and Secondary Lung Function 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 | |
|---|---|---|---|---|
| Primary Endpoint | ||||
| Change from baseline in morning pre-dose trough FEV1 (Weeks 12–24), mL | ||||
| Japan | ||||
| n LSM (SE) |
134 123 (12.6) |
126 85 (12.8) |
65 56 (17.7) |
65 87 (17.6) |
| Treatment difference for BGF MDI vs. comparators | ||||
| LSM (95% CI) P-value |
NA | 37 (3, 72) 0.0337 |
67 (25, 109) 0.0020 |
35 (–7, 77) 0.0996 |
| Global | ||||
| n LSM (SE) |
592 138 (7.0) |
559 118 (7.1) |
278 61 (9.9) |
288 76 (9.8) |
| Treatment difference for BGF MDI vs. comparators | ||||
| LSM (95% CI) P-value |
NA | 20 (1, 39) 0.0424 |
77 (53, 100) <0.0001 |
62 (38, 85) <0.0001 |
| Secondary Endpoint | ||||
| Change from baseline in morning pre-dose trough FEV1 (over 24 weeks), mL | ||||
| Japan | ||||
| n LSM (SE) |
137 130 (11.7) |
134 96 (11.9) |
68 68 (16.4) |
68 97 (16.4) |
| Treatment difference for BGF MDI vs. comparators | ||||
| LSM (95% CI) P-value |
NA | 34 (2, 66) 0.0368 |
62 (23, 101) 0.0020 |
33 (–6, 72) 0.1014 |
| Globala | ||||
| n LSM (SE) |
622 147 (6.5) |
601 125 (6.6) |
300 73 (9.2) |
301 88 (9.1) |
| Treatment difference for BGF MDI vs. comparators | ||||
| LSM (95% CI) P-value |
NA | 22 (4, 39) 0.0139 |
74 (52, 95) <0.0001 |
59 (38, 80) <0.0001 |
Notes: aData from Ferguson et al.15
Abbreviations: BFF, budesonide/formoterol fumarate; BGF, budesonide/glycopyrrolate/formoterol fumarate; BUD/FORM DPI, budesonide/formoterol fumarate dry powder inhaler; CI, confidence interval; FEV1, forced expiratory volume in 1 s; GFF, glycopyrrolate/formoterol fumarate; LSM, least squares mean; MDI, metered dose inhaler; mITT, modified intent-to-treat; NA, not applicable; SE, standard error.