Table 1 Patient demographics and characteristics (ITT/safety population)
Parameter | GP MDI | Placebo n = 62 | Open-label tiotropium n = 62 | |||||
|---|---|---|---|---|---|---|---|---|
18 μg n = 64 | 9 μg n = 64 | 4.6 μg n = 62 | 2.4 μg n = 64 | 1.2 μg n = 57 | 0.6 μg n = 59 | |||
Age, years | ||||||||
Mean (SD) | 61.6 (8.1) | 60.6 (8.6) | 60.8 (8.5) | 60.2 (9.0) | 61.6 (7.9) | 60.3 (8.9) | 61.3 (8.3) | 60.7 (7.1) |
Gender, n (%) | ||||||||
Male | 30 (46.9) | 33 (51.6) | 29 (46.8) | 34 (53.1) | 34 (59.6) | 33 (55.9) | 33 (53.2) | 33 (53.2) |
Race, n (%) | ||||||||
White | 58 (90.6) | 58 (90.6) | 57 (91.9) | 58 (90.6) | 53 (93.0) | 55 (93.2) | 56 (90.3) | 57 (91.9) |
Smoking status, n (%) | ||||||||
Current | 37 (57.8) | 35 (54.7) | 42 (67.7) | 37 (57.8) | 34 (59.6) | 40 (67.8) | 40 (64.5) | 40 (64.5) |
Duration of COPD, years | ||||||||
Mean (SD) | 7.2 (7.3) | 6.0 (6.1) | 8.0 (7.7) | 6.6 (6.0) | 6.7 (7.5) | 7.5 (5.9) | 8.3 (7.7) | 7.2 (5.3) |
Total CAT score | ||||||||
Mean (SD) | 20.0 (6.7) | 20.7 (6.4) | 19.5 (6.0) | 19.8 (6.7) | 20.5 (7.3) | 19.9 (6.3) | 20.3 (6.4) | 20.5 (6.5) |
n a | 59 | 59 | 61 | 60 | 55 | 56 | 60 | 57 |
Mean FEV1, % predicted (SD)a | ||||||||
Pre-bronchodilator | 47.0 (11.9) | 46.6 (13.0) | 47.0 (11.3) | 46.4 (11.7) | 46.2 (10.6) | 45.8 (11.9) | 45.6 (11.6) | 43.4 (10.9) |
Post-bronchodilator | 55.2 (12.6) | 53.7 (12.7) | 54.2 (11.7) | 55.1 (11.5) | 54.5 (12.1) | 52.9 (11.9) | 53.1 (12.7) | 52.5 (11.7) |
Change from pre- to post-bronchodilator | 19.2 (16.9) | 17.9 (17.2) | 16.8 (14.4) | 21.0 (15.8) | 18.9 (15.3) | 17.5 (16.4) | 18.0 (16.6) | 22.5 (15.2)b |
Mean FEV1, L (SD)a | ||||||||
Pre-bronchodilator | 1.363 (0.392) | 1.395 (0.490) | 1.409 (0.432) | 1.408 (0.466) | 1.369 (0.366) | 1.384 (0.456) | 1.358 (0.417) | 1.313 (0.416) |
Post-bronchodilator | 1.603 (0.432) | 1.601 (0.472) | 1.632 (0.493) | 1.670 (0.484) | 1.609 (0.400) | 1.602 (0.478) | 1.587 (0.486) | 1.585 (0.450) |
Change from pre- to post-bronchodilator | 0.239 (0.199) | 0.206 (0.203) | 0.224 (0.183) | 0.261 (0.170) | 0.240 (0.181) | 0.218 (0.225) | 0.229 (0.216) | 0.272 (0.162)b |