Characteristic | Placebo (N = 2463) | Tiotropium (N = 2579) |
---|---|---|
Age, yrs, mean (SD) | 64.2 (8.39) | 64.3 (8.39) |
>65 yrs, N (%) | 1158 (47.0%) | 1223 (47.4%) |
≤65 yrs, N (%) | 1305 (53.0%) | 1356 (52.6%) |
Gender, male, N (%) | 1852 (75.2%) | 1965 (76.2%) |
Pre-bronchodilator FEV1, L, mean (SD) | 1.12 (0.40) | 1.11 (0.40) |
Pre-bronchodilator FEV1, % predicted, mean (SD) | 39.9 (11. 8) | 39.8 (11.9) |
Post-bronchodilator FEV1, L, mean (SD) | 1.35 (0.44) | 1.34 (0.43) |
Post-bronchodilator FEV1, % predicted, mean (SD) | 48.2 (12.4) | 48.1 (12.5) |
Pre-bronchodilator FVC, L, mean (SD) | 2.66 (0.83) | 2.64 (0.80) |
Pre-bronchodilator FVC, % predicted, mean (SD) | 75.4 (18.0) | 74.8 (17.9) |
Post-bronchodilator FVC, L, mean (SD) | 3.13 (0.90) | 3.11 (0.86) |
Post-bronchodilator FVC, % predicted, mean (SD) | 88.7 (18.7) | 88.2 (18.5) |
Pre-bronchodilator FEV1/FVC ratio, %, mean (SD) | 42.5 (10.3) | 42.7 (10.4) |
Post-bronchodilator FEV1/FVC ratio, %, mean (SD) | 43.8 (10.5) | 43.9 (10.7) |
Smoking status | ||
Sustained ex-smoker, N (%) | 1471 (59.7%) | 1502 (58.2%) |
Intermittent smoker, N (%) | 679 (27.6%) | 761 (29.5%) |
Continuing smoker, N (%) | 313 (12.7%) | 316 (12.3%) |
Pack-yrs smoking, mean (SD) | 48.0 (27.9) | 49.0 (28.0) |
GOLD grade of airflow obstruction | ||
Grade I/II, N (%) | 1179 (48.6%) | 1226 (48.3%) |
Grade III, N (%) | 1059 (43.6%) | 1118 (44.0%) |
Grade IV, N (%) | 189 (7.79%) | 197 (7.75%) |
Use of Inhaled Corticosteroids at baseline | ||
Yes | 1506 (61.1%) | 1581 (61.3%) |
No | 957 (38.9%) | 998 (38.7%) |
SGRQ total scores, mean (SD) | 45.2 (17.2) | 45.0 (17.0) |