Table 1.
Patient demographics and baseline characteristics
| ITT population | MN population | |||
|---|---|---|---|---|
| UMEC/VI 62.5/25 (N = 878) |
TIO (N = 869) |
UMEC/VI 62.5/25 (N = 275) |
TIO (N = 258) |
|
| Age, years, mean (SD) | 63.0 (8.6) | 63.4 (8.7) | 61.7 (8.6) | 62.3 (8.7) |
| Male, n (%) | 596 (68) | 594 (68) | 194 (71) | 165 (64) |
| Current smoker at screeninga, n (%) | 457 (52) | 439 (51) | 180 (65) | 155 (60) |
| Smoking pack-yearsb, n (%) | 45.1 (25.6) | 46.1 (27.0) | 47.1 (25.6) | 49.5 (30.1) |
| Reversible to albuterolc,d, n (%) | 243 (28) | 248 (29) | 94 (34) | 77 (30) |
| Post-albuterol% predicted FEV1 Mean (SD)e | 47.0 (13.1) | 47.0 (12.99) | 50.9 (12.27) | 50.1 (12.84) |
| GOLD stage, n f* (%) | ||||
| II | 393 (45) | 385 (44) | 154 (56) | 141 (55) |
| III | 372 (42) | 375 (43) | 103 (38) | 94 (37) |
| IV | 111 (13) | 106 (12) | 17 (6) | 22 (9) |
| ICS use at screeningg, n (%) | ||||
| Yes | 443 (50) | 445 (51) | 0 | 0 |
| Exacerbation historyh, n (%) | ||||
| Required corticosteroid and/or antibiotic (without hospitalization) | 193 (22) | 215 (25) | 57 (21) | 45 (17) |
| Required hospitalization | 73 (8) | 80 (9) | 18 (7) | 20 (7) |
FEV 1 forced expiratory volume in 1 s, GOLD global initiative for chronic obstructive lung disease, ICS inhaled corticosteroid, ITT intent to treat, MN maintenance-naïve, SD standard deviation, TIO tiotropium, UMEC umeclidinium, VI vilanterol
aPatient reclassified as current smoker if smoked within 6 months
bSmoking pack-years = (number of cigarettes smoked per day/20) × number of years smoked
cReversibility was defined as an increase in FEV1 of ≥12% and ≥200 ml following administration of albuterol
dITT population: UMEC/VI, n = 876; TIO, n = 863
eITT population: UMEC/VI, n = 876; TIO, n = 866, MN population: UMEC/VI, n = 274; TIO n = 257
fUMEC/VI, n = 873; TIO, n = 859
gICS use was defined as those patients who were currently taking ICS medications at the screening visit
hPatients experiencing ≥1 exacerbation during the 12 months prior to screening