Table 1.
Baseline patient demographics, lung function and clinical characteristics (ITT population)
| UMEC/VI 62.5/25 mcg (N = 358) | FP/SAL 500/50 mcg (N = 358) | Total (N = 716) | |
|---|---|---|---|
| Age, mean ± SD, years | 61.8 ± 7.94 | 61.4 ± 8.06 | 61.6 ± 8.00 |
| Sex: male, n (%) | 261 (73) | 254 (71) | 515 (72) |
| BMI, mean ± SD (range), kg/m2 | 27.69 ± 5.085 | 27.26 ± 5.018 | 27.47 ± 5.052 |
| (16.9–45.8) | (15.6–44.4) | (15.6–45.8) | |
| Race, n (%) | |||
| White | 358 (100) | 358 (100) | 716 (100) |
| Smoking history and status | |||
| Current smoker, n (%) | 204 (57) | 217 (61) | 421 (59) |
| Years smoked, mean ± SD (range) | 37.8 ± 10.15 | 37.7 ± 10.27 | 37.8 ± 10.20 |
| (7–67) | (10–70) | (7–70) | |
| No. cigarettes/day, mean ± SD (range) | 21.6 ± 8.18 | 20.8 ± 7.72 | 21.2 ± 7.96 |
| (5–60) | (7–80) | (5–80) | |
| Smoking pack years, mean ± SD (range) | 40.7 ± 19.26 | 39.4 ± 19.09 | 40.1 ± 19.17 |
| (10–125) | (10–140) | (10–140) | |
| COPD history | |||
| Duration of COPD, n (%), years | |||
| < 1 | 10 (3) | 15 (4) | 25 (3) |
| ≥ 1 to <5 | 141 (39) | 140 (39) | 281 (39) |
| ≥ 5 to <10 | 128 (36) | 122 (34) | 250 (35) |
| ≥ 10 | 79 (22) | 81 (23) | 160 (22) |
| COPD type, n (%) a | |||
| Chronic bronchitis | 279 (78) | 287 (80) | 566 (79) |
| Emphysema | 189 (53) | 180 (50) | 369 (52) |
| Screening lung function, mean (SD) | |||
| Pre-salbutamol FEV1, L | 1.423 (0.4573) | 1.457 (0.4555) | 1.440 (0.4564) |
| Post-salbutamol FEV1, L | 1.550 (0.4488) | 1.595 (0.4614) | 1.572 (0.4554) |
| Pre-bronchodilator FEV1/FVC | 47.7 (10.70) | 48.2 (10.08) | 47.9 (10.39) |
| Post-salbutamol FEV1/FVC | 49.0 (10.69) | 49.8 (10.19) | 49.4 (10.45) |
| Post-salbutamol percent predicted FEV1, (%) | 50.2 (10.85) | 51.1 (10.50) | 50.6 (10.68) |
| Percent reversibility to salbutamol, (%) | 10.7 (12.64) | 10.9 (12.63) | 10.8 (12.63) |
| Reversibility to salbutamol, L | 0.127 (0.159) | 0.138 (0.154) | 0.133 (0.157) |
| Reversible to salbutamol, n (%) | 100 (28) | 108 (30) | 208 (29) |
| GOLD stage (percent predicted FEV1), n (%) | |||
| Stage B | 193 (54) | 201 (56) | 394 (55) |
| Stage D | 165 (46) | 157 (44) | 322 (45) |
| mMRC dyspnoea scale, mean (SD) | 2.2 (0.41) | 2.2 (0.42) | 2.2 (0.41) |
| Rescue salbutamol use | |||
| Puffs per day | 2.9 (3.30)b | 2.4 (2.38) | - |
| Rescue-free days (%) | 24.4 (35.01)b | 28.3 (37.40) | - |
| BDI focal score on Day 1 | 6.2 (1.78) | 6.4 (1.58)c | - |
| SGRQ Total score, mean (SD) | 46.57 (16.523)d | 44.02 (15.756)b | - |
| EQ-5D utility score, mean (SD) | 0.70 (0.213) | 0.75 (0.191) | - |
| CAT score, mean (SD) | 18.48 (6.698) | 17.20 (7.031) | - |
BDI baseline Dyspnoea Index, BMI body mass index, CAT COPD Assessment Test, COPD chronic obstructive pulmonary disease, EQ-5D EuroQol-5D questionnaire, FP/SAL fluticasone propionate/salmeterol, FEV 1 forced expiratory volume in 1 s, FVC forced vital capacity, GOLD Global initiative for chronic Obstructive Lung Disease, ITT intent-to-treat, mMRC modified Medical Research Council, SD standard deviation, SGRQ St. George’s Respiratory Questionnaire, UMEC umeclidinium, VI vilanterol
aPatients could select chronic bronchitis, emphysema or both; b n = 354; c n = 356; d n = 353