TABLE 1

Baseline patient demographics and disease characteristics

Tiotropium Respimat 5 µg once dailyTiotropium Respimat 2.5 µg once dailyPlacebo Respimat once dailyTotal
Patients130127135392
Age years14.3±1.614.4±1.814.1±1.714.2±1.7
Age
 12–14 years71 (54.6)66 (52.0)74 (54.8)211 (53.8)
 15–17 years59 (45.4)61 (48.0)61 (45.2)181 (46.2)
Males83 (63.8)80 (63.0)79 (58.5)242 (61.7)
Body mass index kg·m−221.4±4.521.1±4.121.1±4.821.2±4.5
Smoking status
 Never-smokers130 (100)127 (100)135 (100)392 (100)
 Ex-smokers0000
Exposure to second-hand smoke?
 No120 (92.3)119 (93.7)128 (94.8)367 (93.6)
 Yes10 (7.7)8 (6.3)6 (4.4)24 (6.1)
 Missing data001 (0.7)1 (0.3)
Duration of asthma years7.3±4.08.0±3.98.0±3.77.8±3.9
Pre-bronchodilator FEV1 at screening
 Actual mL2479±5932436±6092312±5102408±574
 % pred76.2±8.375.9±7.675.0±8.275.7±8.0
FEV1
 Actual mL2580±6582546±5932451±5972525±618
 % pred79.4±12.379.8±9.979.4±12.279.5±11.5
FVC
 Actual mL3386±8413280±8213280±7713315±811
 % pred91.5±15.689.8±13.793.4±14.691.6±14.7
FEF25–75% L·s−12.3±1.12.3±0.82.1±0.92.2±1.0
Pre-dose morning PEF L·min−1331.0±91.8332.8±97.3322.7±90.1328.7±92.9
Pre-dose evening PEF L·min−1347.9±91.3348.1±97.8342.5±87.0346.1±91.8
ACQ-6 score2.0±0.42.1±0.52.1±0.52.1±0.5
ACQ-7 score2.1±0.42.2±0.42.2±0.52.1±0.4
ICS dose of stable maintenance treatment µg#776.7±381.2727.8±343.6736.6±347.9747.0±357.7
Controller therapies
 2 controllers43 (33.1)43 (33.9)38 (28.1)124 (31.6)
 3 controllers87 (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.