Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo in 1 to 5 Year Old Patients With Persistent Asthma

Inclusion criteria:

1. All patients' parents (or legal guardians) must sign and date an informed consent
consistent with ICH-GCP guidelines and local legislation prior to participation in
the trial. Where appropriate, participants should assent to enroll in the study.

2. Male or female patients between 1 and 5 years of age.

3. By a physician documented history of persistent asthma symptoms, including (but not
limited to) wheezing, cough, and/or shortness of breath.

4. For patients aged 5 years and capable of performing technically acceptable PFTs:
documented impaired lung function (e.g. pre-bronchodilator FEV1 = 90% of predicted
normal).

5. All patients must have been on maintenance treatment with an inhaled corticosteroid
at stable dose for at least 4 weeks before Visit 1.

6. All patients must be symptomatic (partly controlled) as defined by the GINA guideline
for children aged 5 years and younger in the week prior to Visit 1 (screening) and in
the week prior to randomisation (Visit 2).

Exclusion criteria:

1. Patients with a significant disease other than asthma.

2. Patients with clinically relevant abnormal screening haematology or blood chemistry
will be excluded if the abnormality defines a significant disease as defined in
exclusion criterion 1.

3. Patients with a history of congenital or acquired heart disease, or patients who have
been hospitalised for cardiac syncope or failure during the past year.

4. Patients with any unstable or life-threatening cardiac arrhythmia, including cardiac
arrhythmia requiring intervention (e.g. pacemaker implantation) or a change in drug
therapy within the past year.

5. Patients with a malignancy for which the patient has undergone resection, radiation
therapy or chemotherapy.

6. Patients with clinically significant lung diseases other than asthma.

7. Alternative causes (other causes than asthma) that can lead to respiratory symptoms
of wheeze, cough and shortness of breath.

8. Patients with known active tuberculosis.

9. Patients who have undergone thoracotomy with pulmonary resection.

10. Patients who are currently in a pulmonary rehabilitation program or have completed a
pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit
1).