Table 1.
Patient demographics and baseline characteristics (intent-to-treat population)
| UMEC/VI, N = 482 |
TIO + IND, N = 479 |
|
|---|---|---|
| Mean age [years (SD)] | 64 (7.75) | 64 (8.44) |
| Male [n (%)] | 355 (74) | 341 (71) |
| Race [n (%)] | ||
| White | 453 (94) | 450 (94) |
| American Indian or Alaska native | 24 (5) | 27 (6) |
| Asian | 5 (1) | 2 (<1) |
| Current smoker at screening [n (%)] | 198 (41) | 218 (46) |
| Mean smoking pack-years (SD)a | 43.17 (22.71) | 42.30 (23.12) |
| ICS use at screening [n (%)] | 269 (56) | 243 (51) |
| Post-albuterol FEV1 [L; mean (SD)]b | 1.369 (0.46) | 1.357 (0.48) |
| Post-albuterol FEV1/FVC [mean (SD)]b | 45.70 (11.09) | 45.55 (11.12) |
| Reversible with albuterol [n (%)]c,d | 126 (26) | 125 (26) |
| % Reversibility with albuterol [mean (SD)]c,d | 12.2 (13.06) | 12.5 (12.87) |
| GOLD category [n (%)]b | ||
| II | 209 (44) | 200 (42) |
| III | 222 (46) | 220 (46) |
| IV | 48 (10) | 57 (12) |
| GOLD grade according to CAT [n (%)]e | ||
| A: low risk, less symptoms | 26 (5) | 19 (4) |
| B: low risk, more symptoms | 139 (29) | 146 (31) |
| C: high risk, less symptoms | 22 (5) | 25 (5) |
| D: high risk, more symptoms | 293 (61) | 287 (60) |
| Mean BDI focal score (SD) | 5.9 (1.89) | 6.0 (1.67) |
BDI Baseline Dyspnea Index, CAT COPD assessment test, COPD chronic obstructive pulmonary disease, FEV 1 forced expiratory volume in 1 s, FVC forced vital capacity, GOLD Global initiative for chronic Obstructive Lung Disease, ICS inhaled corticosteroid, IND indacaterol, SD standard deviation, TIO tiotropium, UMEC umeclidinium, VI vilanterol
aSmoking pack-years = (number of cigarettes smoked per day/20) × number of years of smoking
bUMEC/VI, n = 479; TIO + IND, n = 477
cReversibility was defined as an increase in the FEV1 of ≥12 % and ≥200 mL following administration of albuterol
dUMEC/VI, n = 477; TIO + IND, n = 477
eUMEC/VI, n = 480; TIO + IND, n = 477