Tiotropium in preventing preschool asthma (TIPP)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 204

Inclusion Criteria

1. 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.
2. Physician diagnosed asthma of at least 6 months’ history of asthma symptoms, including (but not limited to) wheezing, cough, and/or shortness of breath.
3. 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.
4. 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.
5. 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).
6. Patients must be able to inhale from the Respimat® inhaler (with a spacer).
Are the trial subjects under 18? yes
Number of subjects for this age range: 204
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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.
2. 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.
3. Patients with known hypersensitivity to anticholinergic drugs, or any other components of the Tiotropium inhalation solution.
4. 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate whether addition of Tiotropium via Respimat® to ICS prevents severe asthma exacerbations.;Secondary Objective: The secondary objective is to evaluate whether addition of Tiotropium via Respimat® to ICS reduces health utilization (hospitalizations, physician visits, antibiotic use) in partial or uncontrolled preschool asthma.;Primary end point(s): Time to first severe exacerbations, defined by hospitalization and/or at least 3 days of systemic steroids or one day of rectal prednisolone (Rectodelt®).;Timepoint(s) of evaluation of this end point: Timepoint to first severe exacerbations

Secondary Outcome Measures

Name	Time	Method

Related Trials