Tiotropium in preventing preschool asthma (TIPP)

Prior treatment

• Patients with any severe acute asthma exacerbation or severe respiratory tract infection defined by systemic steroid intake or hospitalization in the four weeks prior to visit 1.

Other illness

• Patients with a significant disease other than asthma such as, but not limited to, the following diagnoses: cystic fibrosis, bronchopulmonary dysplasia, primary immunodeficiency, congenital heart disease, parasitic disease, and foreign body aspiration.
• Patients with clinically relevant abnormal screening hematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion.
• Patients with known hypersensitivity to anticholinergic drugs, or any other components of the Tiotropium inhalation solution.

• Male or female patients with preschool asthma aged between 1 and 5 years (< 6 at visit 1). In addition, age-appropriate assent in accordance with local regulations or guidelines or both before enrolment in the study and prior to the beginning of any study-specific procedures will be obtained from the child.
• Physician diagnosed asthma of at least 6 months' history of asthma symptoms, including (but not limited to) wheezing, cough, and/or shortness of breath.
• All patients must have been on maintenance treatment with an ICS at a stable dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before visit 1.
• Patient was hospitalized due to acute severe asthma and/or was treated with at least 2 courses of systemic steroids (three days of oral steroids or one day of rectal prednisolone 100mg (Rectodelt®)) in the last 24 months before visit 1.
• All patients must be symptomatic (partly controlled or uncontrolled) as defined by the GINA guideline for children aged 5 years and younger in the four weeks prior to screening (visit 1) and randomization (visit 2) despite treatment with ICS (visit 1 and visit 2).
• Patients must be able to inhale from the Respimat® inhaler (with a spacer).