Table 1. Baseline patient and disease characteristics.
| Tiotropium Respimat 5 μg (n = 114) a | Tiotropium Respimat 2.5 μg (n = 114) a | Placebo Respimat (n = 57) a | |
|---|---|---|---|
| Sex, n (%) | |||
| Male | 48 (42.1) | 42 (36.8) | 19 (33.3) |
| Female | 66 (57.9) | 72 (63.2) | 38 (66.7) |
| Age, years | 42.6 (12.8) | 44.7 (12.1) | 47.8 (13.0) |
| Weight, kg | 64.1 (12.8) | 64.6 (17.1) | 61.5 (13.6) |
| Height, cm | 162.6 (8.4) | 161.0 (8.8) | 159.6 (8.6) |
| Body mass index, kg/m2 | 24.2 (4.1) | 24.8 (5.6) | 24.0 (4.1) |
| Smoking status | |||
| Never smoked, n (%) | 87 (76.3) | 88 (77.2) | 39 (68.4) |
| Ex-smoker, n (%) | 27 (23.7) | 26 (22.8) | 17 (29.8) |
| Current smoker, n (%) | 0 | 0 | 1 (1.8) |
| Smoking history, pack-years b | 4.51 (2.71) | 4.25 (2.31) | 5.33 (4.69) |
| Concomitant treatment, n (%) | |||
| ICS | 114 (100) | 114 (100) | 57 (100) |
| Long-acting β2-agonists | 65 (57.0) | 62 (54.4) | 35 (61.4) |
| Short-acting β-agonists | 1 (0.9) | 7 (6.1) | 2 (3.5) |
| Leukotriene modifiers | 29 (25.4) | 36 (31.6) | 14 (24.6) |
| Theophyllines | 19 (16.7) | 26 (22.8) | 10 (17.5) |
| Systemic antihistamines | 20 (17.5) | 23 (20.2) | 7 (12.3) |
| Omalizumab | 0 | 0 | 0 |
| ICS maintenance dose, μg c | 658.9 (220.5) | 673.2 (247.4) | 644.2 (220.9) |
| Median (range) age at asthma onset, years | 23.9 (1–39) | 25.0 (1–40) | 25.7 (1–40) |
| Median (range) duration of asthma, years | 21.0 (0.3–54.0) | 21.0 (0.8–57.8) | 26.8 (0.8–63.0) |
| ACQ-7 total score | 1.97 (0.38) | 1.94 (0.43) | 1.90 (0.32) |
| FEV1 reversibility at screening, % of pre-bronchodilator | 23.5 (12.5) | 22.4 (10.8) | 23.0 (10.6) |
Values are mean (standard deviation) unless otherwise stated.
aPatients were randomised 2:2:1 to the tiotropium Respimat 5 μg, tiotropium Respimat 2.5 μg and placebo Respimat groups, respectively.
bCalculated in smokers and ex-smokers.
cBudesonide equipotent dose.
ACQ-7, seven-question Asthma Control Questionnaire; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroids.