Demographics and baseline characteristics (modified intent-to-treat population)
| BFF MDI 320/10 µg | BFF MDI 160/10 µg | FF MDI 10 µg | All patients | |
| Patients, n | 619 | 617 | 607 | 1843 |
| Age, years | 65.3±8.1 | 64.5±8.4 | 64.8±8.5 | 64.9±8.3 |
| Age ≥65 years | 347 (56.1) | 318 (51.5) | 334 (55.0) | 999 (54.2) |
| Male | 367 (59.3) | 345 (55.9) | 339 (55.8) | 1051 (57.0) |
| White/black/other, % | 83.0/4.8/12.1 | 83.6/3.6/12.8 | 83.0/4.8/12.2 | 83.2/4.4/12.4 |
| Current smoker | 257 (41.5) | 223 (36.1) | 245 (40.4) | 725 (39.3) |
| Number of pack-years smoked | 44.2±26.0 | 45.8±28.0 | 44.9±27.4 | 45.0±27.1 |
| Total CAT score# | 21.7±6.4 | 21.3±6.1 | 21.2±6.3 | 21.4±6.3 |
| SGRQ total score | 51.4±18.2 | 51.1±17.8 | 50.7±17.6 | 51.1±17.8 |
| History of moderate/severe exacerbations | ||||
| 0 exacerbations | 5 (0.8) | 2 (0.3) | 1 (0.2) | 8 (0.4) |
| 1 exacerbation | 378 (61.1) | 374 (60.6) | 374 (61.6) | 1126 (61.1) |
| ≥2 exacerbations | 236 (38.1) | 241 (39.1) | 232 (38.2) | 709 (38.5) |
| History of severe exacerbations | ||||
| 0 exacerbations | 494 (79.8) | 510 (82.7) | 497 (81.9) | 1501 (81.4) |
| 1 exacerbation | 108 (17.4) | 96 (15.6) | 93 (15.3) | 297 (16.1) |
| ≥2 exacerbations | 17 (2.7) | 11 (1.8) | 17 (2.8) | 45 (2.4) |
| COPD severity | ||||
| Mild | 0 (0.0) | 1 (0.2) | 1 (0.2) | 2 (0.1) |
| Moderate | 338 (54.6) | 330 (53.5) | 321 (52.9) | 989 (53.7) |
| Severe | 241 (38.9) | 230 (37.3) | 244 (40.2) | 715 (38.8) |
| Very severe | 37 (6.0) | 56 (9.1) | 36 (5.9) | 129 (7.0) |
| COPD duration, years | 8.1±6.4 | 7.7±5.5 | 7.9±6.2 | 7.9±6.1 |
| Prior COPD treatment¶ | ||||
| SABA and/or SAMA only, PRN | 4 (0.6) | 3 (0.5) | 1 (0.2) | 8 (0.4) |
| MA only | 26 (4.2) | 33 (5.3) | 30 (4.9) | 89 (4.8) |
| BA only | 22 (3.6) | 37 (6.0) | 39 (6.4) | 98 (5.3) |
| ICS only | 12 (1.9) | 14 (2.3) | 13 (2.1) | 39 (2.1) |
| MA/BA only | 83 (13.4) | 81 (13.1) | 71 (11.7) | 235 (12.8) |
| ICS/BA only | 272 (43.9) | 264 (42.8) | 258 (42.5) | 794 (43.1) |
| ICS/MA only | 13 (2.1) | 16 (2.6) | 17 (2.8) | 46 (2.5) |
| ICS/MA/BA | 185 (29.9) | 165 (26.7) | 177 (29.2) | 527 (28.6) |
| ICS use at screening | 482 (77.9) | 459 (74.4) | 465 (76.6) | 1406 (76.3) |
| Baseline blood eosinophil count | ||||
| <150 cells·mm−3 | 197 (31.8) | 213 (34.5) | 193 (31.8) | 603 (32.7) |
| ≥150 cells·mm−3 | 422 (68.2) | 403 (65.3) | 413 (68.0) | 1238 (67.2) |
| Post-bronchodilator FEV1, % predicted | 51.09±13.70 | 50.59±14.27 | 50.97±13.46 | 50.88±13.81 |
| Post-bronchodilator reversibility for FEV1, %+ | 12.1±13.0 | 13.2±14.1 | 12.9±14.3 | 12.7±13.8 |
| Rescue medication use, puffs·day-1 | 3.5±3.2 | 3.7±3.4 | 3.6±3.5 | 3.6±3.4 |
Data are presented as mean±standard deviation or n (%), unless otherwise stated. BFF: budesonide/formoterol fumarate dihydrate; MDI: metered dose inhaler; FF: formoterol fumarate dihydrate; CAT: Chronic Obstructive Pulmonary Disease (COPD) Assessment Test; SGRQ: St George's Respiratory Questionnaire; SABA: short-acting β2-agonist; SAMA: short-acting muscarinic antagonist; PRN: as needed; MA: muscarinic antagonist; BA: β2-agonist; ICS: inhaled corticosteroid; FEV1: forced expiratory volume in 1 s. #: total CAT score was the sum of eight CAT item scores and could range from 0 to 40; ¶: scheduled use of a SAMA and/or SABA was included in all categories except PRN; +: reversibility is defined as (change from pre-bronchodilator to post-bronchodilator for FEV1)×100/pre-bronchodilator FEV1.