Table 1.
Patient demographics (integrated ITT population)
| Total (N = 3021) |
UMEC/VI (n = 816) |
UMEC (n = 825) |
VI (n = 825) |
PBO (n = 555) |
|
|---|---|---|---|---|---|
| Age, years, mean (SD) | 63.0 (8.7) | 63.3 (8.4) | 63.5 (8.8) | 62.7 (8.7) | 62.2 (8.8) |
| Male, n (%) | 2057 (68) | 569 (70) | 568 (69) | 550 (67) | 370 (67) |
| BMI, kg/m2, mean (SD) | 26.7 (5.8) | 26.9 (5.6) | 26.4 (5.7) | 26.9 (6.0) | 26.7 (6.0) |
| Current smoker, n (%) | 1528 (51) | 403 (49) | 423 (51) | 409 (50) | 293 (53) |
| Smoking pack yearsa, mean (SD) | 45.1 (24.8) | 45.9 (25.7) | 45.4 (25.3) | 43.8 (23.2) | 45.4 (25.3) |
| Pre-bronchodilator FEV1, mL, mean (SD)b | 1258 (486) | 1272 (503) | 1254 (484) | 1264 (490) | 1234 (460) |
| Post-bronchodilator % predicted FEV1, mean (SD)c | 47.8 (12.9) | 47.8 (12.9) | 47.8 (12.9) | 48.4 (13.0) | 47.1 (12.6) |
| GOLD stage III-IV, FEV1 < 50% predicted, n (%)c | 1605 (53) | 435 (54) | 438 (53) | 418 (51) | 314 (57) |
| Exacerbation history, n (%)d | |||||
| ≥ 1 moderate exacerbatione | 780 (26) | 210 (26) | 211 (26) | 214 (26) | 145 (26) |
| ≥ 1 severe exacerbationf | 302 (10) | 72 (9) | 82 (10) | 93 (11) | 55 (10) |
| Baseline mMRC dyspnea score, mean (SD) | 2.4 (0.5) | 2.4 (0.5) | 2.4 (0.6) | 2.3 (0.6) | 2.4 (0.5) |
| Baseline albuterol use puffs/day, mean (SD)g,h | 5.1 (5.4) | 4.8 (5.1) | 5.1 (5.4) | 5.2 (5.4) | 5.3 (5.9) |
| Maintenance-naïve, n (%)i | |||||
| Yes | 984 (33) | 285 (35) | 245 (30) | 272 (33) | 182 (33) |
| No | 2037 (67) | 531 (65) | 580 (70) | 553 (67) | 373 (67) |
| ICS-free, n (%) | |||||
| Yes | 1543 (51) | 428 (52) | 413 (50) | 422 (51) | 280 (50) |
| No | 1478 (49) | 388 (48) | 412 (50) | 403 (49) | 275 (50) |
| Baseline albuterol use, n (%)g,j | |||||
| High | 1490 (50) | 386 (48) | 405 (50) | 411 (51) | 288 (53) |
| Low | 1488 (50) | 420 (52) | 408 (50) | 401 (49) | 259 (47) |
aSmoking pack years = (number of cigarettes smoked per day/20) x number of years smoked. bTotal: n = 3015; UMEC/VI: n = 815; UMEC: n = 824; VI: n = 822; PBO: n = 554. cTotal: n = 3012; UMEC/VI: n = 813; UMEC: n = 823; VI: n = 822; PBO: n = 554. dNumber of COPD exacerbations reported in the 12-months prior to screening. eRequired oral/systemic corticosteroids and/or antibiotics. fRequired hospitalization. gTotal: n = 2978; UMEC/VI: n = 806; UMEC: n = 813; VI: n = 812; PBO: n = 547. hBaseline rescue medication use was calculated for patients with non-missing values for at least half the days within the baseline period. iPrior to run-in. jMean puffs/day at baseline ≥ 3.60 (high) or < 3.60 (low); 3.60 is the median value of puffs of rescue medication per day at baseline across all treatment groups
BMI body mass index, COPD chronic obstructive pulmonary disease, FEV1 forced expiratory volume in 1 s, GOLD Global initiative for chronic Obstructive Lung Disease, ICS inhaled corticosteroid, ITT intent-to-treat, mMRC modified medical research council, PBO placebo, SD standard deviation, UMEC umeclidinium, VI vilanterol