Table 2.
Baseline Characteristics of the ITT Population by Recent Exacerbation Subgroup
| Characteristic | Recent Exacerbationa | No Recent Exacerbationa | ||||
|---|---|---|---|---|---|---|
| FF/UMEC/VI (n=598) | BUD/FOR (n=582) | Total (n=1180) | FF/UMEC/VI (n=313) | BUD/FOR (n=317) | Total (n=630) | |
| Age, years, mean (SD) | 64.0 (8.9) | 63.2 (9.3) | 63.6 (9.1) | 64.7 (7.9) | 64.5 (7.6) | 64.6 (7.7) |
| Female, n (%) | 170 (28) | 162 (28) | 332 (28) | 63 (20) | 74 (23) | 137 (22) |
| BMI, kg/m2, mean (SD)b,c | 27.3 (5.1) | 27.0 (4.9) | 27.2 (5.0) | 26.0 (5.2) | 26.9 (5.5) | 26.5 (5.4) |
| CAT score, mean (SD)b | 19.1 (5.1) | 19.2 (5.3) | 19.2 (5.2) | 19.3 (5.4) | 18.8 (5.1) | 19.0 (5.3) |
| Pre-bronchodilator FEV1, mL, mean (SD)d | 1373 (477) | 1353 (498) | 1364 (487) | 1044 (313) | 1032 (294) | 1038 (303) |
| Post-bronchodilator FEV1, % predicted, mean (SD)e | 49.5 (13.2) | 48.9 (14.6) | 49.2 (13.9) | 37.7 (8.2) | 38.1 (7.9) | 37.9 (8.0) |
| Eosinophil count, 109 cells/L, mean (SD)b,f | 0.212 (0.184) | 0.220 (0.333) | 0.216 (0.267) | 0.216 (0.202) | 0.199 (0.151) | 0.207 (0.178) |
Notes: aIn the year prior to study entry. bAt screening. cRecent exacerbation FF/UMEC/VI n=595, BUD/FOR n=580; total n=1175; no recent exacerbation FF/UMEC/VI n=313, BUD/FOR n=317, total n=630. dRecent exacerbation FF/UMEC/VI n=597, BUD/FOR n=582; total n=1179; no recent exacerbation FF/UMEC/VI n=312, BUD/FOR n=317, total n=629. eRecent exacerbation FF/UMEC/VI n=596, BUD/FOR n=581; total n=1177; no recent exacerbation FF/UMEC/VI n=312, BUD/FOR n=316, total n=628. fRecent exacerbation FF/UMEC/VI n=582, BUD/FOR n=560; total n=1142; no recent exacerbation FF/UMEC/VI n=305, BUD/FOR n=313, total n=618.
Abbreviations: BMI, body mass index; BUD, budesonide; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; FF, fluticasone furoate; FOR, formoterol; SD, standard deviation; UMEC, umeclidinium; VI, vilanterol.