Table 3.
Change from baseline in morning pre-dose trough FEV1 and FEV1 AUC0–4 at week 24 by post-bronchodilator FEV1% predicted (efficacy estimand; PFT sub-study mITT population).
| % Predicted post-bronchodilator FEV1 | BGF 320/18/9.6 μg versus GFF 18/9.6 μg | BGF 160/18/9.6 μg versus GFF 18/9.6 μg | BGF 320/18/9.6 μg versus BFF 320/9.6 μg | BGF 160/18/9.6 μg versus BFF 320/9.6 μg | |
|---|---|---|---|---|---|
| Morning pre-dose trough FEV1, mL | |||||
| <50% n = 2250 | LSM (95% CI) | 31 (7, 55) | 29 (5, 53) | 71 (47, 95) | 69 (45, 92) |
| p-value | 0.0118 | 0.0180 | <0.0001 | <0.0001 | |
| ⩾50% n = 838 | LSM (95% CI) | 47 (−4, 97) | 47 (−2, 95) | 90 (39, 140) | 89 (40, 138) |
| p-value | 0.0705 | 0.0624 | 0.0006 | 0.0004 | |
| FEV1 AUC0–4, mL | |||||
| <50% n = 2250 | LSM (95% CI) | 48 (22, 75) | 39 (13, 65) | 112 (86, 138) | 103 (77, 129) |
| p-value | 0.0003 | 0.0036 | <0.0001 | <0.0001 | |
| ⩾50% n = 838 | LSM (95% CI) | 67 (16, 118) | 57 (8, 107) | 135 (83, 186) | 125 (75, 175) |
| p-value | 0.0108 | 0.0241 | <0.0001 | <0.0001 | |
AUC0–4, area under the curve from 0 to 4 hours post-dose; BFF, budesonide/formoterol fumarate; BGF, budesonide/glycopyrrolate/formoterol fumarate; CI, confidence interval; FEV1, forced expiratory volume in 1 second; GFF, glycopyrrolate/formoterol fumarate; LSM, least squares mean; mITT, modified intent-to-treat; PFT, pulmonary function test.