TABLE 1.
Distribution of patients within subgroups in the intent-to-treat (ITT) population (which included the extension (EXT) population up to week 24) and the EXT population (up to week 52)
| Week 24 (ITT population) | Week 52 (EXT population) | |||||
| FF/UMEC/VI | BUD/FOR | Total | FF/UMEC/VI | BUD/FOR | Total | |
| Total patients | 911 | 899 | 1810 | 210 | 220 | 430 |
| COPD medication class at screening# | ||||||
| Patients | 705 | 678 | 1383 | 181 | 171 | 352 |
| ICS+LABA | 268 (29) | 259 (29) | 527 (29) | 72 (34) | 68 (31) | 140 (33) |
| BUD+FOR | 87 (10) | 83 (9) | 170 (9) | 28 (13) | 25 (11) | 53 (12) |
| ICS+LABA+LAMA | 257 (28) | 256 (28) | 513 (28) | 63 (30) | 58 (26) | 121 (28) |
| LAMA alone | 79 (9) | 79 (9) | 158 (9) | 20 (10) | 20 (9) | 40 (9) |
| TIO alone | 65 (7) | 67 (7) | 132 (7) | 15 (7) | 16 (7) | 31 (7) |
| LAMA+LABA | 101 (11) | 84 (9) | 185 (10) | 26 (12) | 25 (11) | 51 (12) |
| Disease severity | ||||||
| Patients | 906 | 894 | 1800 | 208 | 218 | 426 |
| FEV1 % pred <50%, no moderate/severe exacerbations | 311 (34) | 315 (35) | 626 (35) | 62 (30) | 71 (32) | 133 (31) |
| FEV1 % pred <50%, ≥1 moderate/severe exacerbation | 299 (33) | 290 (32) | 589 (33) | 70 (33) | 73 (33) | 143 (33) |
| FEV1 % pred 50– <80%, ≥2 moderate or ≥1 severe exacerbations | 296 (33) | 289 (32) | 585 (33) | 76 (36) | 74 (34) | 150 (35) |
| Exacerbation history | ||||||
| Patients | 911 | 899 | 1810 | 210 | 220 | 430 |
| 0/1 moderate exacerbations | 600 (66) | 613 (68) | 1213 (67) | 148 (70) | 159 (72) | 307 (71) |
| ≥2 moderate exacerbations | 311 (34) | 286 (32) | 597 (33) | 62 (30) | 61 (28) | 123 (29) |
| ≥1 severe exacerbations | 185 (20) | 200 (22) | 385 (21) | 58 (28) | 57 (26) | 115 (27) |
Data are presented as n or n (%). FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg); COPD: chronic obstructive pulmonary disease; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist; TIO: tiotropium; FEV1: forced expiratory volume in 1 s. #: subgroups are not exclusive (the n-values in the “Patients” row represent the number of patients in any of the categories for the subgroup; patients receiving BUD/FOR are included in the ICS+LABA group and patients receiving TIO alone are included in the LAMA alone group).