Table 1 Patient demographics and baseline characteristics by baseline SABA use
Characteristic | High baseline SABA (≥1.5 puffs/day) | Low baseline SABA (< 1.5 puffs/day) | ||||||
|---|---|---|---|---|---|---|---|---|
UMEC/VI (n = 415) | UMEC (n = 401) | SAL (n = 396) | Total (N = 1212) | UMEC/VI (n = 395) | UMEC (n = 399) | SAL (n = 412) | Total (N = 1206) | |
Age, years, mean (SD) | 63.8 (8.6) | 63.8 (8.4) | 63.1 (8.5) | 63.5 (8.5) | 65.6 (8.1) | 66.0 (8.4) | 65.6 (8.4) | 65.7 (8.3) |
Female, n (%) | 168 (40) | 179 (45) | 182 (46) | 529 (44) | 149 (38) | 146 (37) | 159 (39) | 454 (38) |
Current smoker at screening, n (%) | 205 (49) | 222 (55) | 233 (59) | 660 (54) | 187 (47) | 171 (43) | 180 (44) | 538 (45) |
Smoking pack-years, mean (SD) | 49.6 (28.1) | 48.1 (26.8) | 46.8 (24.7) | 48.2 (26.6) | 49.3 (27.4) | 47.4 (25.1) | 49.4 (26.8) | 48.7 (26.4) |
Moderate COPD exacerbation history in prior yeara, n (%) | 63 (15) | 59 (15) | 66 (17) | 188 (16) | 60 (15) | 63 (16) | 79 (19) | 202 (17) |
Duration of COPD, years, mean (SD) | 9.0 (6.6) | 8.1 (5.9) | 9.0 (6.2) | 8.7 (6.3) | 8.5 (7.2) | 7.6 (6.0) | 7.6 (7.1) | 7.9 (6.8) |
No maintenance treatment during run-in, % | 147 (35) | 144 (36) | 148 (37) | 439 (36) | 103 (26) | 105 (26) | 101 (25) | 309 (26) |
Post-salbutamol % predicted FEV1, mean (SD) | 53.1 (13.1) | 53.2 (12.6) | 53.0 (12.9) | 53.1 (12.8) | 56.8 (12.2) | 58.6 (12.2) | 58.1 (12.2) | 57.8 (12.2) |
GOLD spirometric gradeb, n (%) | ||||||||
2 | 240 (58) | 233 (58) | 221 (56) | 694 (57) | 277 (70) | 294 (74) | 300 (73) | 871 (72) |
3 | 175 (42) | 166 (42) | 175 (44) | 516 (43) | 118 (30) | 103 (26) | 111 (27) | 332 (28) |
BDI score, mean (SD) | 6.8 (1.9) | 6.7 (2.0) | 6.8 (1.9) | 6.7 (1.9) | 7.2 (1.8) | 7.3 (1.8) | 7.3 (1.7) | 7.3 (1.8) |
Baseline E-RS total score, mean (SD) | 12.4 (5.5) | 12.7 (5.8) | 12.4 (5.6) | 12.5 (5.6) | 8.9 (5.1) | 8.8 (5.2) | 8.5 (5.2) | 8.7 (5.2) |
Baseline rescue salbutamol, puffs/day, mean (SD) | 3.90 (2.5) | 3.87 (2.2) | 3.98 (2.4) | 3.91 (2.39) | 0.37 (0.4) | 0.37 (0.4) | 0.43 (0.5) | 0.39 (0.45) |
Baseline CAT score, mean (SD) | 20.8 (5.9) | 20.7 (6.3) | 21.0 (6.7) | 20.8 (6.3) | 17.3 (5.4) | 17.8 (5.7) | 17.6 (5.5) | 17.6 (5.5) |
Baseline SGRQ total score, mean (SD) | 48.9 (15.8) | 49.1 (15.7) | 49.9 (16.3) | 49.3 (15.9) | 39.8 (15.1) | 40.9 (15.4) | 39.5 (14.6) | 40.1 (15.0) |
Any vascular comorbidity, n (%) | 233 (56) | 217 (54) | 218 (55) | 668 (55) | 209 (53) | 215 (54) | 230 (56) | 654 (54) |
Any cardiac comorbidity, n (%) | 60 (14) | 71 (18) | 58 (15) | 189 (16) | 50 (13) | 64 (16) | 59 (14) | 173 (14) |
Coronary artery disease | 47 (11) | 53 (13) | 35 (9) | 135 (11) | 33 (8) | 46 (12) | 45 (11) | 124 (10) |
Arrhythmia | 17 (4) | 23 (6) | 19 (5) | 59 (5) | 18 (5) | 21 (5) | 17 (4) | 56 (5) |
Congestive heart failure | 6 (1) | 8 (2) | 11 (3) | 25 (2) | 6 (2) | 9 (2) | 8 (2) | 23 (2) |