Characteristic | ITT population 24 weeks | EXT population 52 weeks | ||
FF/UMEC/VI 100/62.5/25 µg | BUD/FOR 400/12 µg | FF/UMEC/VI 100/62.5/25 µg | BUD/FOR 400/12 µg | |
Subjects n | 911 | 899 | 210 | 220 |
Age years | 64.2±8.6 | 63.7±8.7 | 63.7±7.8 | 63.3±8.4 |
Female | 233 (26) | 236 (26) | 53 (25) | 58 (26) |
Current smokers | 400 (44) | 394 (44) | 95 (45) | 97 (44) |
Smoking pack-years | 39.5±21.9 | 39.2±22.2 | 39.8±19.9 | 39.6±23.1 |
Cardiovascular risk factors# | 599 (66) | 602 (67) | 144 (69) | 152 (69) |
Moderate/severe COPD exacerbation in previous 12 months | ||||
0 | 313 (34) | 317 (35) | 62 (30) | 72 (33) |
1 | 252 (28) | 253 (28) | 77 (37) | 79 (36) |
≥2 | 346 (38) | 329 (37) | 71 (34) | 69 (31) |
History of pneumonia | 87 (10) | 99 (11) | 18 (9) | 20 (9) |
Absolute FEV1 mL | 1349±460 | 1339±480 | 1425±500 | 1368±510 |
FEV1 % pred | 45.5±13.0 | 45.1±13.6 | 47.1±13.3 | 45.4±14.9 |
SGRQ total score | 51.8±16.3 | 50.8±16.7 | 53.0±16.1 | 50.8±15.5 |
E-RS:COPD | 13.20±5.83 | 12.97±5.93 | 13.54±5.44 | 13.00±5.58 |
Data are presented as mean±sd or n (%), unless otherwise stated. ITT: intent-to-treat; EXT: extension; FF: fluticasone furoate; UMEC: umeclidinium; VI: vilanterol; BUD: budesonide; FOR: formoterol; COPD: chronic obstructive pulmonary disease; FEV1: forced expiratory volume in 1 s; SGRQ: St George's Respiratory Questionnaire; E-RS:COPD: Evaluating Respiratory Symptoms in COPD. #: cardiovascular risk factors included, but were not limited to, hypertension, hypercholesterolemia, coronary heart disease and diabetes mellitus.