Table 2

Patient demographic and baseline characteristics of the safety population

VariablePlacebo (n=1544)Salmeterol (n =1542)FP (n =1552)SFC (n =1546)
Age at enrolment, years65.1 (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/m225.5 (5.2)25.4 (5.2)25.3 (5.1)25.4 (5.3)
Postbronchodilator FEV1, % predicted44.1 (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 (%)
 USA348 (23)351 (23)350 (23)352 (23)
 Asia Pacific188 (12)189 (12)193 (12)188 (12)
 Eastern Europe297 (19)296 (19)293 (19)293 (19)
 Western Europe478 (31)475 (31)481 (31)477 (31)
 Other234 (15)231 (15)234 (15)236 (15)
Current smoker, n (%)664 (43)657 (43)666 (43)667 (43)
Pack-years smoked48.6 (27.0)49.3 (27.7)49.2 (28.5)46.9 (26.5)
Previous COPD treatment, n (%)*
 ICS alone346 (22)278 (18)310 (20)295 (19)
 LABA alone118 (8)138 (9)133 (9)137 (9)
 ICS + LABA453 (29)417 (27)416 (27)437 (28)
 Neither ICS nor LABA557 (36)634 (41)629 (41)623 (40)
Previous MI, n (%)n=1543n=1541n=1552n=1545
 01432 (93)1427 (93)1460 (94)1443 (93)
 191 (6)93 (6)79 (5)83 (5)
 ≥229 (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.