A randomised dose-ranging study of tiotropium Respimat® in children with symptomatic asthma despite inhaled corticosteroids

Table 2 Disease characteristics measured during reversibility testing and at baseline (treated set)

	Reversibility testing
	Pre-bronchodilator ^a		Post-bronchodilator ^b		Baseline pre-dose ^c
	Mean	SD	Mean	SD	Mean	SD
FEV₁
Predicted normal, L	1.928	0.416
Actual, L	1.539	0.385	1.909	0.469	1.640	0.386
Actual, % predicted normal	79.661	8.142	98.908	11.024	85.392	10.711
Reversibility, mL^d			370	171
Reversibility, % of pre-bronchodilator^e			24.578	12.106
Variation, %^f					7.60	12.43
FVC	2.233	0.519
Predicted normal, L	2.059	0.567	2.341	0.611
Actual, L	92.266	13.339	105.080	15.560	2.127	0.545
Actual, % predicted normal	75.830	9.623	82.404	8.817	95.844	15.067
FEV₁/FVC, %					78.109	9.467
PEF, L/min					220	56
ICS maintenance dose, μg (budesonide or equivalent dose)					282.2	85.8

^aMeasured 10 minutes prior to inhalation of two puffs of salbutamol (100 μg per puff) at screening (Visit 1); ^bMeasured 15–30 minutes after inhalation of two puffs of salbutamol (100 μg per puff) at screening (Visit 1); ^cMeasured 10 minutes prior to inhalation of study medication at baseline (Visit 2); ^dCalculated as FEV₁ post-bronchodilator – FEV₁ pre-bronchodilator; ^eCalculated as 100 × (FEV₁ post-bronchodilator/FEV₁ pre-bronchodilator) – 1; ^fCalculated as 100 × (FEV₁ at baseline/pre-bronchodilator FEV₁ at screening) – 1. FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroids; PEF, peak expiratory flow; SD, standard deviation.

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