Patient demographic and baseline characteristics of the safety population
| Variable | Placebo (n=1544) | Salmeterol (n =1542) | FP (n =1552) | SFC (n =1546) |
| Age at enrolment, years | 65.1 (8.1) | 65.2 (8.2) | 65.1 (8.4) | 65.0 (8.3) |
| Male gender, n (%) | 1175 (76) | 1176 (76) | 1169 (75) | 1164 (75) |
| Body mass index, kg/m2 | 25.5 (5.2) | 25.4 (5.2) | 25.3 (5.1) | 25.4 (5.3) |
| Postbronchodilator FEV1, % predicted | 44.1 (12.2) | 43.6 (12.6) | 44.1 (12.3) | 44.3 (12.4) |
| <30%, n (%) | 215 (14) | 261 (17) | 223 (14) | 246 (16) |
| 30–< 50%, n (%) | 786 (51) | 750 (49) | 785 (51) | 735 (48) |
| ≥50%, n (%) | 543 (35) | 531 (34) | 544 (35) | 565 (37) |
| Geographical region, n (%) | ||||
| USA | 348 (23) | 351 (23) | 350 (23) | 352 (23) |
| Asia Pacific | 188 (12) | 189 (12) | 193 (12) | 188 (12) |
| Eastern Europe | 297 (19) | 296 (19) | 293 (19) | 293 (19) |
| Western Europe | 478 (31) | 475 (31) | 481 (31) | 477 (31) |
| Other | 234 (15) | 231 (15) | 234 (15) | 236 (15) |
| Current smoker, n (%) | 664 (43) | 657 (43) | 666 (43) | 667 (43) |
| Pack-years smoked | 48.6 (27.0) | 49.3 (27.7) | 49.2 (28.5) | 46.9 (26.5) |
| Previous COPD treatment, n (%)* | ||||
| ICS alone | 346 (22) | 278 (18) | 310 (20) | 295 (19) |
| LABA alone | 118 (8) | 138 (9) | 133 (9) | 137 (9) |
| ICS + LABA | 453 (29) | 417 (27) | 416 (27) | 437 (28) |
| Neither ICS nor LABA | 557 (36) | 634 (41) | 629 (41) | 623 (40) |
| Previous MI, n (%) | n=1543 | n=1541 | n=1552 | n=1545 |
| 0 | 1432 (93) | 1427 (93) | 1460 (94) | 1443 (93) |
| 1 | 91 (6) | 93 (6) | 79 (5) | 83 (5) |
| ≥2 | 29 (1) | 21 (1) | 13 (<1) | 19 (1) |
| Baseline CV treatment, n (%)† | 608 (39%) | 630 (41%) | 630 (41%) | 662 (43%) |
| Baseline short-acting anticholinergics, n (%) | 926 (60%) | 921 (60%) | 943 (61%) | 925 (60%) |
Data are mean (SD) unless otherwise indicated.
CV, cardiovascular; FEV1, forced expiratory volume in 1 s; FP, fluticasone propionate; ICS, inhaled corticosteroid; LABA, long-acting β2 agonist; MI, myocardial infarction; SFC, salmeterol/fluticasone propionate combination.
↵* Self-reported in the 12 months prior to screening.
↵† See list in table 1.