Demographic and clinical characteristics
| Not randomised | Placebo | FSC 250/50 µg | SAL 50 µg | Total | |
|---|---|---|---|---|---|
| N | 52 | 75 | 139 | 152 | 418 |
| Age, year (mean (SD)) | 63.8 (9.6) | 62.8 (9.8) | 60.2 (9.5) | 60.1 (9.6) | 61.1 (9.7) |
| Male, n (%) | 25 (48) | 46 (61) | 79 (57) | 89 (59) | 239 (57) |
| White, n (%) | 44 (85) | 65 (87) | 127 (91) | 140 (92) | 376 (90) |
| Current smoker, n (%) | 29 (57) | 46 (61) | 84 (60) | 99 (65) | 258 (62) |
| Body mass index, mean (SD) | 28.3 (6.9) | 26.6 (6.1) | 29.0 (7.3) | 28.5 (6.2) | 28.3 (6.7) |
| Postbronchodilator FEV1% predicted mean (SD) | 50.3 (15.1) | 49.4 (13.1) | 49.5 (13.7) | 50.2 (13.8) | 49.9 (13.8) |
| FEV1/FVC % (mean (SD)) | 55.7 (35.2) | 51.6 (11.4) | 53.7 (11.4) | 52.2 (10.9) | 53.0 (16.1) |
| Percentage of reversibility (mean (SD)) | 8.6 (14.4) | 16.7 (19.2) | 14.5 (18.5) | 11.7 (13.9) | 13.1 (16.8) |
The ‘not randomised’ column reflects those patients who completed the visit 1 and 2 assessments but were not eligible to be randomised. The ‘total’ column reflects the run-in population, defined as patients who completed visits 1 and 2, including those who were not randomised.
FEV1, forced expiratory volume in 1 s; FSC, fluticasone propionate/salmeterol combination; FVC, forced vital capacity; SAL, salmeterol.