Tiotropium in preventing preschool asthma (TIPP)
Key facts
- Where
- Augsburg, Berlin, Bielefeld, Dresden, Duesseldorf, Frankfurt Am Main, Goettingen, Hanover, Jena, Leipzig, Mannheim és Munich, NémetországSee the 12 sites
- Phase
- 3. fázis
Where in Németország
- Universitaetsklinikum AugsburgAugsburg, NémetországNo longer taking part
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországNo longer taking part
- Evangelisches Klinikum Bethel gGmbHBielefeld, NémetországNo longer taking part
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, NémetországNo longer taking part
- Evangelisches Krankenhaus DuesseldorfDuesseldorf, NémetországNo longer taking part
- Universitaetsklinikum Frankfurt AöRFrankfurt Am Main, NémetországNo longer taking part
- Universitaetsmedizin GoettingenGoettingen, NémetországNo longer taking part
- Medizinische Hochschule HannoverHanover, NémetországNo longer taking part
- Universitaetsklinikum Jena KöRJena, NémetországNo longer taking part
- Universitaet LeipzigLeipzig, NémetországNo longer taking part
- Praxis für Kinderpneumologie und AllergologieMannheim, NémetországNo longer taking part
- Klinikum der Universitaet Muenchen AöRMunich, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Goethe University Frankfurt
- Trial code
- EU 2024-513916-84-00
- Record updated
- 2024. június 5.
- Original description
The primary objective is to evaluate whether addition of Tiotropium via Respimat® to ICS prevents severe asthma exacerbations.Read full original descriptionShow less
A prospective multicenter placebo-controlled trial to study the efficacy and safety of Tiotropium in preventing severe asthma exacerbations in partial and uncontrolled preschool asthma.
The primary objective is to evaluate whether addition of Tiotropium via Respimat® to ICS prevents severe asthma exacerbations.
Inclusion: 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).
Exclusion: 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; 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.