Tiotropium in preventing preschool asthma (TIPP)

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. TIPP-Study - TIPP

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000190-81-DE

Enrollment

204

Registered

2021-09-21

Start date

2021-12-29

Completion date

Unknown

Last updated

2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe asthma exacerbations in partial and uncontrolled preschool asthma

Interventions

Product Name: tiotropium bromide inhalation solution Pharmaceutical Form: Inhalation solution INN or Proposed INN: Tiotropium bromide CAS Number: 411207-31-3 Other descriptive name: TIOTROPIUM BROMIDE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female patients with preschool asthma aged between 1 and 5 years (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Number of severe exacerbations, number of hospitalizations (severe exacerbation), (severe) exacerbation-free survival time, number of asthma-related events defined by use of antibiotics, percentage of night-time awakenings due to asthma symptoms as assessed by the electronic patient`s diary/PACD, percentage of days without asthma symptoms assessed by TIPP diary App (PACD), percentage of days and episodes of > 3 days with use of PRN salbutamol rescue medication, health utilization (number of physician visits), number of missed days in daycare, result of TRACK, CGI-C at end of treatment and potential biomarkers for treatment response: Eosinophils, IgE, specific IgE to common allergens (birch, grass, Dermatophagoides pteronyssinus, Dermatophagoides farina, Alternaria, Cladosporium, cat, dog, hen's egg, cow's milk and peanut. Assessment of safety: Safety will be ensured by analysis of symptom scores and rescue medication use by the electronic diary, and adverse events (AEs).;Timepoint(s) of evaluation of this end point: 52 weeks	—

Measure

Time frame

Secondary end point(s): Number of severe exacerbations, number of hospitalizations (severe exacerbation), (severe) exacerbation-free survival time, number of asthma-related events defined by use of antibiotics, percentage of night-time awakenings due to asthma symptoms as assessed by the electronic patient`s diary/PACD, percentage of days without asthma symptoms assessed by TIPP diary App (PACD), percentage of days and episodes of > 3 days with use of PRN salbutamol rescue medication, health utilization (number of physician visits), number of missed days in daycare, result of TRACK, CGI-C at end of treatment and potential biomarkers for treatment response: Eosinophils, IgE, specific IgE to common allergens (birch, grass, Dermatophagoides pteronyssinus, Dermatophagoides farina, Alternaria, Cladosporium, cat, dog, hen's egg, cow's milk and peanut. Assessment of safety: Safety will be ensured by analysis of symptom scores and rescue medication use by the electronic diary, and adverse events (AEs).;Timepoint(s) of evaluation of this end point: 52 weeks

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Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Germany

Contacts

Public ContactProf. Dr. med. Stefan Zielen

Goethe University Frankfurt, Department for Children and Adolescents

Stefan.Zielen@kgu.de+4969630183063

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026