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
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
The primary objective of this trial is to evaluate the safety and efficacy of two doses of
 tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the
 afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled
 corticosteroid (ICS) treatment.
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 (at least 6 month) history of persistent asthma symptoms,
 including (but not limited to) wheezing, cough, and/or shortness of breath.
 (persistent = need for inhalation corticosteroid maintenance therapy to control asthma
 symptoms)

 4. For patients aged 5 years and capable of performing technically acceptable Pulmonary
 Function tests (PFTs): documented impaired lung function (i.e. pre-bronchodilator
 Forced Expiratory Volume in 1 second (FEV1) is smaller or equal to 90% of predicted
 normal).

 5. All patients must have been on maintenance treatment with an inhaled corticosteroid at
 stable dose, either as mono treatment or in combination with another controller
 medication, for at least 4 weeks before Visit 1.

 6. All patients must be symptomatic (partly controlled) as defined by the Global
 Initiative for Asthma (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).

 Further inclusion criteria apply.

 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).

 Further exclusion criteria apply.