Table 1.
Demographics and baseline characteristics (PFT sub-study mITT population).
| BGF 320/18/9.6 µg n = 747 | BGF 160/18/9.6 µg n = 807 | GFF 18/9.6 µg n = 779 | BFF 320/9.6 µg n = 755 | |
|---|---|---|---|---|
| Age, years, mean (SD) | 64.3 (7.5) | 64.4 (7.6) | 64.8 (7.6) | 64.3 (7.5) |
| Male, n (%) | 397 (53.1) | 441 (54.6) | 386 (49.6) | 407 (53.9) |
| CAT score, mean (SD)a | 20.2 (6.5) | 20.5 (6.6) | 20.3 (6.8) | 20.4 (6.7) |
| Body mass index, kg/m2, mean (SD)b | 28.4 (6.6) | 28.3 (6.9) | 28.6 (6.6) | 27.9 (6.9) |
| Current smoker, n (%) | 331 (44.3) | 351 (43.5) | 336 (43.1) | 339 (44.9) |
| No. pack-years smoked,c median (range) | 44.0 (10.0–150.0) | 44.6 (10.0–187.5) | 43.0 (10.0–168.0) | 44.0 (10.0–250.0) |
| Baseline eosinophil count, n (%) | ||||
| <100 cells/mm3 | 106 (14.2) | 120 (14.9) | 95 (12.2) | 100 (13.2) |
| ⩾100 cells/mm3 | 641 (85.8) | 687 (85.1) | 684 (87.8) | 655 (86.8) |
| <150 cells/mm3 | 255 (34.1) | 303 (37.5) | 266 (34.1) | 247 (32.7) |
| ⩾150 cells/mm3 | 492 (65.9) | 504 (62.5) | 513 (65.9) | 508 (67.3) |
| Exacerbation history, n (%) | ||||
| 1 | 349 (46.7) | 371 (46.0) | 352 (45.2) | 343 (45.4) |
| ⩾2 | 398 (53.3) | 436 (54.0) | 427 (54.8) | 412 (54.6) |
| Post-albuterol FEV1% of predicted normal, mean (SD) | 43.1 (10.4) | 42.5 (10.4) | 43.0 (10.3) | 42.7 (10.5) |
| Reversibility post-albuterol FEV1,%, mean (SD)d | 17.4 (16.6) | 16.3 (16.3) | 17.3 (15.9) | 15.8 (15.4) |
| Reversible, n (%) | 264 (35.3) | 257 (31.8) | 280 (35.9) | 251 (33.2) |
| Use of ICS at screening, n (%) | 562 (75.2) | 628 (77.8) | 598 (76.8) | 573 (75.9) |
a
BGF 320/18/9.6 µg, n = 745; BGF 160/18/9.6 µg, n = 806.
b
BGF 160/18/9.6 µg, n = 806.
c
Number of pack-years smoked = (number of cigarettes per day/20) × number of years smoked.
d
BGF 320/18/9.6 µg, n = 745; BGF 160/18/9.6 µg, n = 806; GFF 18/9.6 µg, n = 778; BFF 320/9.6 µg, n = 753.
BFF, budesonide/formoterol fumarate; BGF, budesonide/glycopyrrolate/formoterol fumarate; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; GFF, glycopyrrolate/formoterol fumarate; ICS, inhaled corticosteroid; mITT, modified intent-to-treat; PFT, pulmonary function test; SD, standard deviation.