TABLE 1.
Baseline patient demographics and disease characteristics
| Tiotropium Respimat 5 µg once daily | Tiotropium Respimat 2.5 µg once daily | Placebo Respimat once daily | Total | |
| Patients | 130 | 127 | 135 | 392 |
| Age years | 14.3±1.6 | 14.4±1.8 | 14.1±1.7 | 14.2±1.7 |
| Age | ||||
| 12–14 years | 71 (54.6) | 66 (52.0) | 74 (54.8) | 211 (53.8) |
| 15–17 years | 59 (45.4) | 61 (48.0) | 61 (45.2) | 181 (46.2) |
| Males | 83 (63.8) | 80 (63.0) | 79 (58.5) | 242 (61.7) |
| Body mass index kg·m−2 | 21.4±4.5 | 21.1±4.1 | 21.1±4.8 | 21.2±4.5 |
| Smoking status | ||||
| Never-smokers | 130 (100) | 127 (100) | 135 (100) | 392 (100) |
| Ex-smokers | 0 | 0 | 0 | 0 |
| Exposure to second-hand smoke? | ||||
| No | 120 (92.3) | 119 (93.7) | 128 (94.8) | 367 (93.6) |
| Yes | 10 (7.7) | 8 (6.3) | 6 (4.4) | 24 (6.1) |
| Missing data | 0 | 0 | 1 (0.7) | 1 (0.3) |
| Duration of asthma years | 7.3±4.0 | 8.0±3.9 | 8.0±3.7 | 7.8±3.9 |
| Pre-bronchodilator FEV1 at screening | ||||
| Actual mL | 2479±593 | 2436±609 | 2312±510 | 2408±574 |
| % pred | 76.2±8.3 | 75.9±7.6 | 75.0±8.2 | 75.7±8.0 |
| FEV1 | ||||
| Actual mL | 2580±658 | 2546±593 | 2451±597 | 2525±618 |
| % pred | 79.4±12.3 | 79.8±9.9 | 79.4±12.2 | 79.5±11.5 |
| FVC | ||||
| Actual mL | 3386±841 | 3280±821 | 3280±771 | 3315±811 |
| % pred | 91.5±15.6 | 89.8±13.7 | 93.4±14.6 | 91.6±14.7 |
| FEF25–75% L·s−1 | 2.3±1.1 | 2.3±0.8 | 2.1±0.9 | 2.2±1.0 |
| Pre-dose morning PEF L·min−1 | 331.0±91.8 | 332.8±97.3 | 322.7±90.1 | 328.7±92.9 |
| Pre-dose evening PEF L·min−1 | 347.9±91.3 | 348.1±97.8 | 342.5±87.0 | 346.1±91.8 |
| ACQ-6 score | 2.0±0.4 | 2.1±0.5 | 2.1±0.5 | 2.1±0.5 |
| ACQ-7 score | 2.1±0.4 | 2.2±0.4 | 2.2±0.5 | 2.1±0.4 |
| ICS dose of stable maintenance treatment µg# | 776.7±381.2 | 727.8±343.6 | 736.6±347.9 | 747.0±357.7 |
| Controller therapies | ||||
| 2 controllers | 43 (33.1) | 43 (33.9) | 38 (28.1) | 124 (31.6) |
| 3 controllers | 87 (66.9) | 84 (66.1) | 97 (71.9) | 268 (68.4) |
Data are presented as n, mean±sd or n (%). Treated set. FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; % pred: % predicted; FEF25–75%: forced expiratory flow at 25–75% of FVC; PEF: peak expiratory flow; ACQ: Asthma Control Questionnaire (six- or seven-question); ICS: inhaled corticosteroids. #: budesonide or equivalent dose.