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Study on Tiotropium for Preventing Severe Asthma Attacks in Preschool Children with Uncontrolled Asthma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Tiotropium bromide monohydrate in young children with asthma. Asthma is a condition that affects the airways in the lungs, making it difficult to breathe. The study aims to see if adding Tiotropium, delivered through a device called the Respimat Inhaler, can help prevent severe asthma attacks in children whose asthma is not fully controlled.

Participants in the study will either receive Tiotropium or a placebo, which looks like the real medication but does not contain any active ingredients. The study will observe the children over a period to see how often they experience severe asthma attacks, which may require hospitalization or additional medication. The goal is to determine if Tiotropium can reduce the frequency of these severe episodes.

Throughout the study, researchers will also monitor other aspects of the children's health, such as the number of asthma-related events, nighttime awakenings due to asthma symptoms, and overall health care usage. This information will help assess the safety and effectiveness of Tiotropium in managing asthma in young children. The study is expected to provide valuable insights into improving asthma care for preschool-aged children.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be assessed to ensure they meet the eligibility criteria. This includes being between 1 and 5 years old, having a history of asthma symptoms for at least 6 months, and being on a stable dose of inhaled corticosteroids (ICS) for at least 4 weeks prior to the first visit.
The patient must have experienced severe asthma symptoms in the past, such as hospitalization or treatment with systemic steroids, and must be able to use the Respimat® inhaler with a spacer.
Step 2
Initial assessment
The initial assessment involves a detailed review of the patient's asthma history and current symptoms. This is to confirm that the asthma is partly controlled or uncontrolled despite current treatment with ICS.
The patient will be required to provide assent according to local regulations before any study-specific procedures begin.
Step 3
Treatment phase
During the treatment phase, the patient will receive Tiotropium bromide monohydrate via the Respimat® inhaler. This medication is administered through inhalation.
The purpose of this treatment is to evaluate its effectiveness in preventing severe asthma exacerbations when added to the existing ICS treatment.
Step 4
Monitoring and follow-up
Throughout the study, the patient's health and response to the treatment will be closely monitored. This includes tracking the time to the first severe exacerbation, the number of severe exacerbations, and any hospitalizations due to severe asthma.
Additional assessments will include the number of asthma-related events, night-time awakenings due to asthma symptoms, and the use of rescue medication.
Step 5
Safety and efficacy evaluation
The study will also evaluate the safety of the treatment by analyzing symptom scores, rescue medication use, and any adverse events reported.
The effectiveness of the treatment will be assessed through various endpoints, including the percentage of days without asthma symptoms and the number of missed days in daycare.
Step 6
Completion of the study
The study is expected to conclude by February 2025. At the end of the study, a comprehensive evaluation of the treatment's impact on asthma management will be conducted.
The results will include an analysis of potential biomarkers for treatment response and overall health utilization.

Who can join the trial?

6 criteria

The child must be a boy or girl with asthma, aged between 1 and 5 years old.
The child must have a doctor's diagnosis of asthma for at least 6 months, showing symptoms like wheezing, coughing, or shortness of breath.
The child must have been taking a stable dose of an **inhaled corticosteroid (ICS)**, which is a type of medication to help control asthma, for at least 4 weeks before the first visit.
The child must have been hospitalized for severe asthma or treated with at least 2 courses of **systemic steroids** (a type of medication to reduce inflammation) in the last 24 months before the first visit.
The child must still have asthma symptoms that are partly controlled or uncontrolled, as defined by the **GINA guideline** for children aged 5 years and younger, in the four weeks before the first and second visits, even while using ICS.
The child must be able to use the **Respimat® inhaler** with a spacer, which is a device to help them inhale their medication.

Who cannot join the trial?

6 criteria

Children who have other serious health conditions that could affect their safety during the study.
Children who are currently participating in another clinical trial.
Children who have had a severe allergic reaction to any of the study medications in the past.
Children who are unable to use the inhaler device properly.
Children who have a history of non-compliance with medical treatments, meaning they have not followed their doctor's instructions in the past.
Children who have been diagnosed with a condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
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Goethe University Frankfurt
Frankfurt, Germany
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Klinikum der Universitaet Muenchen AöR
Munich, Germany

Trial locations

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Investigated drugs

Tiotropium: This medication is used to help prevent severe asthma attacks in children with asthma that is not fully controlled. It is administered using a device called Respimat, which helps deliver the medication directly to the lungs. Tiotropium works by relaxing the muscles around the airways, making it easier to breathe and reducing the likelihood of asthma attacks.

Tiotropium Bromide Monohydrate

What is already known about the treatment

Tiotropium – Tiotropium is administered through inhalation using a device called Respimat. It is currently being studied in clinical trials to assess its effectiveness and safety in preventing severe asthma attacks in young children with partially controlled or uncontrolled asthma. The main therapeutic use of Tiotropium is to manage asthma symptoms and prevent exacerbations. At the molecular level, Tiotropium works by blocking certain receptors in the lungs, which helps to relax and open the airways, making breathing easier. It is classified as a long-acting anticholinergic bronchodilator.

Investigated diseases

Severe Asthma Exacerbations in Partial and Uncontrolled Preschool Asthma – This condition involves episodes of worsening asthma symptoms in young children whose asthma is not fully controlled. These exacerbations can lead to increased breathing difficulties, coughing, and wheezing. The episodes may require hospitalization or the use of systemic steroids to manage the symptoms. Children with this condition may experience frequent nighttime awakenings and require rescue medication to alleviate symptoms. The condition can also lead to increased healthcare utilization, such as more frequent doctor visits. It is important to monitor symptoms closely to manage and prevent severe episodes effectively.