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Study on Tezepelumab for Children Aged 5 to 11 with Severe 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 severe uncontrolled asthma in children aged 5 to under 12 years. Asthma is a condition that makes it difficult to breathe, and in severe cases, it can be hard to control even with existing treatments. The study will test a medication called tezepelumab, which is given as an injection under the skin. Tezepelumab is being compared to a placebo to see how well it works in reducing asthma attacks in these children.

The purpose of the study is to assess the effect of tezepelumab on severe asthma attacks in children with severe uncontrolled asthma. Participants will receive either tezepelumab or a placebo over a period of time. The study will monitor the frequency of asthma attacks and other health indicators to determine the medication's effectiveness and safety. The study will last for a certain period, during which participants will have regular check-ups to track their progress.

Throughout the study, researchers will collect information on how often asthma attacks occur, any changes in breathing ability, and the overall health and well-being of the participants. This information will help determine if tezepelumab can be a beneficial treatment for children with severe uncontrolled asthma. The study aims to provide valuable insights into managing this challenging condition in young patients.

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 participant is required to have a documented diagnosis of severe asthma for at least six months.
The participant must be between 5 and 12 years old and weigh at least 16 kg.
Step 2
Screening and run-in period
During this period, the participant's asthma condition is assessed to confirm it is uncontrolled. This includes checking the frequency of asthma symptoms and the use of reliever medication.
The participant must have a history of severe asthma attacks that required treatment with systemic corticosteroids or hospitalization.
Step 3
Randomization
Participants are randomly assigned to receive either tezepelumab or a matching placebo. This is done to compare the effects of the medication with no active treatment.
The study is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.
Step 4
Treatment period
The treatment involves subcutaneous injections of tezepelumab or placebo. The frequency and dosage are determined by the study protocol.
This phase lasts for 52 weeks, during which the participant's asthma symptoms and overall health are closely monitored.
Step 5
Monitoring and assessments
Throughout the study, various assessments are conducted to measure the participant's response to the treatment. This includes lung function tests and tracking the number of asthma attacks.
The study also evaluates the participant's quality of life and any changes in the use of asthma medications.
Step 6
End of study
At the end of the 52-week treatment period, final assessments are conducted to determine the overall effect of the treatment.
The study aims to understand the impact of tezepelumab on reducing severe asthma attacks and improving asthma control in children.

Who can join the trial?

8 criteria

The child must be between 5 and less than 12 years old at the time of signing the necessary forms.
The child must have a documented diagnosis of severe asthma for at least 6 months before the first visit. Severe asthma is a type of asthma that is difficult to control and causes frequent symptoms.
The child must be on a treatment plan prescribed by a doctor that includes a daily dose of medium or high dose ICS (inhaled corticosteroids) and another asthma medication for at least 3 months, with a stable dose for at least 1 month before the first visit.
There must be evidence of asthma, shown by one of the following: a history of lung function improvement of at least 10% after using a bronchodilator (a medicine that helps open the airways) in the past year, a specific test result from a methacholine challenge (a test to see how sensitive the airways are), or improvement in lung function after using a bronchodilator during the screening period.
The child must have a history of at least 2 severe asthma attacks that required treatment with a systemic corticosteroid (a strong anti-inflammatory medicine) or 1 severe asthma attack that required hospitalization in the past year.
The child must have certain lung function test results, either before using a bronchodilator or based on a specific ratio of lung function measurements, during the screening period.
There must be evidence of uncontrolled asthma, which means the asthma is not well managed, shown by at least one of the following: a specific score on an asthma control questionnaire, frequent use of a reliever medication, waking up at night due to asthma symptoms, or having asthma symptoms on multiple days in a week during the screening period.
The child must weigh at least 16 kg (about 35 pounds) at the first and third visits.

Who cannot join the trial?

7 criteria

Children who do not have severe uncontrolled asthma cannot participate. This means their asthma is not causing frequent breathing problems despite treatment.
Children who are not between the ages of 5 and less than 12 years old cannot participate.
Children who have other serious health conditions that might interfere with the study cannot participate.
Children who are taking certain medications that might affect the study cannot participate.
Children who have had a recent asthma attack that required hospitalization cannot participate.
Children who have a history of severe allergic reactions cannot participate.
Children who are unable to follow the study procedures cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
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Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
Hospices Civils De Lyon
Responsive
Lyon, France

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Investigated drugs

Tezepelumab is a medication being studied for its potential to help children aged 5 to under 12 years old who have severe uncontrolled asthma. The goal of using this medication in the trial is to see if it can reduce the number of severe asthma attacks these children experience.

Tezepelumab

What is already known about the treatment

Tezepelumab – Tezepelumab is administered as an injection under the skin, typically in a healthcare setting. It is currently being studied in clinical trials, particularly for its effectiveness in treating severe uncontrolled asthma in children aged 5 to under 12 years. The medication works by blocking a specific protein involved in the inflammatory process that leads to asthma attacks, helping to reduce the frequency and severity of these episodes. It is classified as a monoclonal antibody, which targets and neutralizes specific molecules in the immune system to prevent inflammation.

Investigated diseases

Severe Uncontrolled Asthma – This is a form of asthma where the condition remains poorly managed despite the use of standard treatments. Individuals with this type of asthma experience frequent asthma attacks, which are episodes of increased symptoms such as wheezing, shortness of breath, chest tightness, and coughing. These attacks can occur unexpectedly and may be triggered by various factors, including allergens, exercise, or respiratory infections. The condition is characterized by persistent inflammation and narrowing of the airways, leading to difficulty in breathing. Patients often require additional medical interventions to manage their symptoms and prevent exacerbations. The disease can significantly impact daily activities and quality of life due to its unpredictable nature.