Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent Asthma

Inclusion criteria:

Inclusion criteria are:

1. All patients' parent(s) (or legal guardian) must sign and date an informed consent
prior to participation in the trial. In addition, an informed assent suitable for
this age group has to be obtained from patients. A separate informed consent/assent
is required for pharmacogenomic sampling.

2. Male or female patients between 6 and 11 years of age.

3. All patients must have at least a 6-month history of asthma.

4. All patients must have been on maintenance treatment with an inhaled corticosteroid
at a stable medium dose, either as mono treatment or in combination with another
controller medication, for at least 4 weeks before Visit 1. While the LTRA is
permitted throughout the trial, the LABA has to be stopped at least 24 hours prior to
Visit 1, as no LABAs are permitted during screening and treatment period of this
trial.

5. All patients must be symptomatic (partly controlled) at Visit 1 and prior to
randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ-IA) mean
score >= 1.5.

6. All patients must have a pre-bronchodilator forced expiratory volume in one second
(FEV1) >= 60% and =< 90% of predicted normal at Visit 1.

7. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator, considered as 100%)
as compared to Visit 2 (pre-dose) must be within ± 30%.

8. All patients must confirm the diagnosis of asthma by bronchodilator reversibility at
Visit 1, resulting in an increase in FEV1 of >= 12%, 15 to 30 minutes after 200 mcg
salbutamol/albuterol.

9. Patients must be able to use the Respimat inhaler correctly.

10. Patients must be able to perform all trial related procedures including technically
acceptable pulmonary function tests and use of electronic diary/peak flow meter
(diary compliance of at least 80% is required).

Exclusion criteria:

Exclusion criteria are:

1. Patients with a significant disease other than asthma.

2. Patients with a clinically relevant abnormal haematology or blood chemistry at
screening.

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

4. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac
arrhythmia requiring intervention 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 within the last five years.

6. Patients with known active tuberculosis.

7. Patients who have undergone thoracotomy with pulmonary resection.

8. Patients who are currently in a pulmonary rehabilitation program or have completed a
pulmonary rehabilitation program in the six weeks prior to Visit 1.

9. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other
components of the inhalation solution used with the Respimat inhaler.

10. Pregnant or nursing female patients, including postmenarchal girl with a positive
urine pregnancy test at Visit 1.

11. Postmenarchal girl of child-bearing potential not using a highly effective method of
birth control.

12. Patients who have been treated with anti-IgE treatment within the last six months
prior to Visit 1 and/or during the screening period.

13. Patients who have been treated with systemic corticosteroids within four weeks prior
to Visit 1.

14. Patients who have been treated with systemic beta-adrenergics within four weeks prior
to Visit 1.

15. Patients who have been treated with oral beta-blocker medication within four weeks
prior to Visit 1 and/or during the screening period.

16. Patients who have been treated with inhaled long-acting anticholinergics or systemic
anticholinergic treatment within four weeks prior to Visit 1 and/or during the
screening period or who have been treated with inhaled short-acting anticholinergics
within two weeks prior to Visit 1.

17. Patients who have been treated with long-acting theophylline preparations within four
weeks prior to Visit 1 and/or during the screening period or who have been treated
with short-acting theophylline preparations within two weeks prior to Visit 1.

18. Patients who have been treated with non-approved and according to international
guidelines not recommended experimental drugs for routine asthma therapy within four
weeks prior to Visit 1 and/or during the screening period.

19. Patients who have taken an investigational drug within six half lives according to
the investigator's information, or four weeks (whichever is greater) prior to Visit 1
and/or during the screening period.

20. Patients who have previously been randomised in this trial or are currently
participating in another trial.

21. Patients with any acute asthma exacerbation or respiratory tract infection in the
four weeks prior to Visit 1 and /or in four weeks prior to Visit 2. In case of an
asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four
weeks prior to Visit 2, the visit must be postponed.

22. Patients requiring six or more puffs of rescue medication per day on more than two
consecutive days in the four weeks prior to Visit 1 and/or in the four weeks prior to
Visit 2. In case of an asthma deterioration occurring in the four weeks prior to
Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed.

23. Patients who are unable to comply with medication restrictions prior to Visit 1 and
or Visit 2.

24. Patients with a known narrow-angle glaucoma, or any other disease where
anticholinergic treatment is contraindicated.

25. Patients with moderate to severe renal impairment, as defined by a creatinine
clearance <50 mL/min/1.73 m2 BSA, as tiotropium is a predominantly renally excreted
drug.