Subjects n | 383 | 388 | 666 | 671 | 3445 | 3450 |
Age years | 63.9±8.6 | 64.2±8.2 | 65.9±8.2 | 66.2±7.8 | 65.1±7.8 | 65.1±8.0 |
Males | 330 (86%) | 328 (85%) | 607 (91%) | 616 (92%) | 2464 (72%) | 2496 (72%) |
Body mass index kg·m−2 | 22.5±3.2 | 22.6±3.4 | 23.1±3.9 | 23.3±4.1 | 28.9±5.7 | 28.9±5.8 |
Baseline post-bronchodilator FEV1 L | 1.94±0.54 | 1.93±0.52 | 1.43±0.31 | 1.43±0.30 | 1.75±0.39 | 1.76±0.40 |
Post-bronchodilator FEV1 % pred | 78.1±17.1 | 77.9±15.8 | 60.7±6.4 | 60.9±6.3 | 59.5±6.0 | 59.5±6.1 |
Current smokers | 154 (40%) | 160 (41%) | 231 (35%) | 221 (33%) | 1705 (49%) | 1647 (48%) |
Exacerbation rate per year | 0.38 | 0.20 | 0.54 | 0.33 | 0.31 | 0.23 |
Hospitalised exacerbation rate per year | 0.07 | 0.03 | 0.15 | 0.08 | 0.05 | 0.05 |
Post-bronchodilator rate of decline in FEV1 mL per year, mean (se) | 51 (6) | 29 (5) | 56 (7) | 40 (6) | 44 (3) | 37 (3) |
Difference in active versus placebo mL per year (95% CI) | 22 (6 to 37) | 16 (−1 to 34) | 7 (−1 to 14) |
Post-bronchodilator rate of decline in FEV1# % pred per year, mean (se) | 2.1 (0.2) | 1.2 (0.2) | 2.4 (0.3) | 1.7 (0.3) | 1.5 (0.1) | 1.2 (0.1) |
Difference in active versus placebo % pred per year (95% CI) | 0.9 (0.2 to 1.5) | 0.7 (−0.1 to 1.4) | 0.2 (0.0 to 0.5) |