Table 1.
Patient demographics and clinical characteristics (ITT population)
| Characteristic | FF/UMEC/VI 100/62.5/25 μg | FF/VI 100/25 μg + UMEC 62.5 μg | Total |
|---|---|---|---|
| (N = 527) | (N = 528) | (N = 1055) | |
| Age (years), mean (SD) | 66.7 (8.5) | 65.9 (8.8) | 66.3 (8.6) |
| Female, n (%) | 136 (26) | 134 (25) | 270 (26) |
| Current smoker at screening, n (%) | 209 (40) | 192 (36) | 401 (38) |
| Smoking pack-years, mean (SD) | 43.4 (23.9) | 44.2 (25.2) | 43.8 (24.6) |
| Current cardiovascular risk factors, n (%) | 379 (72) | 367 (70) | 746 (71) |
| Number of exacerbations in previous 12 months, n (%)a | |||
| 1 moderate/severe | 236 (45) | 227 (43) | 463 (44) |
| ≥ 2 moderate/severe | 291 (55) | 301 (57) | 592 (56) |
| ≥ 2 moderate or ≥1 severe | 352 (67) | 360 (68) | 712 (67) |
| History of pneumonia, n (%) | 86 (16) | 100 (19) | 186 (18) |
| Screening lung function, mean (SD) | n = 515 | n = 512 | n = 1027 |
| Post-bronchodilator FEV1, mL | 1247 (465) | 1297 (471) | 1272 (469) |
| Post-bronchodilator FVC, mL | 2879 (885) | 2896 (849) | 2887 (867) |
| Post-bronchodilator FEV1/FVC ratio | 0.440 (0.116) | 0.455 (0.119) | 0.447 (0.118) |
| Post-bronchodilator percent predicted FEV1 | 44.5 (14.5) | 45.5 (14.1) | 45.0 (14.3) |
| Percent reversibility | 9.02 (11.22) | 8.87 (10.15)b | 8.95 (10.69) |
| Number of long-acting bronchodilators per day during the run-in, n (%) | |||
| 0/1 | 225 (43) | 226 (43) | 451 (43) |
| 2 | 302 (57) | 302 (57) | 604 (57) |
| Concomitant COPD medications taken at screening, n (%) | |||
| Single-inhaler maintenance bronchodilator | 40 (8) | 42 (8) | 82 (8) |
| LAMA | 32 (6) | 35 (7) | 67 (6) |
| LABA | 8 (2) | 7 (1) | 15 (1) |
| Combination therapy | 448 (85) | 443 (84) | 891 (84) |
| ICS + LABA+LAMA | 198 (38) | 193 (37) | 391 (37) |
| ICS + LABA | 144 (27) | 137 (26) | 281 (27) |
| LABA+LAMA | 62 (12) | 76 (14) | 138 (13) |
| ICS + LABA+LAMA+ xanthine | 29 (6) | 25 (5) | 54 (5) |
| ICS + LAMA | 7 (1) | 9 (2) | 16 (2) |
| LABA+LAMA+xanthine | 8 (2) | 3 (< 1) | 11 (1) |
| COPD severity at screening | |||
| GOLD grade, n (%) | n = 515 | n = 512 | n = 1027 |
| 1 (mild) | 0 | 1 (< 1) | 1 (< 1) |
| 2 (moderate) | 174 (34) | 189 (37) | 363 (35) |
| 3 (severe) | 251 (49) | 253 (49) | 504 (49) |
| 4 (very severe) | 90 (17) | 69 (13) | 159 (15) |
| Reversible, n (%)c | n = 515 | n = 511 | n = 1026 |
| Yes | 73 (14) | 74 (14) | 147 (14) |
| GOLD grade/exacerbation history, n (%)a | n = 514 | n = 512 | n = 1026 |
| Grade 1/2 with ≥2 moderate or ≥1 severe | 173 (34) | 190 (37) | 363 (35) |
| Grade 3/4 with < 2 moderate and no severe | 171 (33) | 164 (32) | 335 (33) |
| Grade 3/4 with ≥2 moderate or ≥1 severe | 170 (33) | 158 (31) | 328 (32) |
| CAT score, mean (SD) | 19.6 (5.8) | 20.1 (6.1) | 19.9 (6.0) |
CAT COPD Assessment Test™, COPD chronic obstructive pulmonary disease, FEV1 forced expiratory volume in 1 s, FF fluticasone furoate, FVC forced vital capacity, GOLD Global Initiative for Chronic Obstructive Lung Disease, ICS inhaled corticosteroid, ITT intent-to-treat, LABA long-acting β2-agonist, LAMA long-acting muscarinic antagonist, SD standard deviation, UMEC umeclidinium, VI vilanterol
aModerate exacerbations were defined as exacerbations requiring oral/systemic corticosteroids and/or antibiotics (not involving hospitalization). Severe exacerbations were defined as exacerbations that required in-patient hospitalization
bFF/VI + UMEC, n = 511
cReversible was an increase in FEV1 of ≥12% and ≥200 mL following administration of salbutamol. Not reversible was an increase in FEV1 of < 200 or ≥200 mL increase that is < 12% of the pre-salbutamol FEV1