Study on Tezepelumab for Children Aged 5 to 11 with Severe Asthma

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Centre Hospitalier Intercommunal Creteil	Creteil	France

Other Sites

Site Name	City	Country
Hospital Infantil Universitario Nino Jesus	Madrid	Spain
Centre Hospitalier Universitaire Rouen	Rouen	France
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.	Tarnow	Poland
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Robert Debre University Hospital	Paris	France
Institutul De Pneumoftiziologie Marius Nasta	Bucharest	Romania
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi	Lodz	Poland
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Universitario De La Plana	Villarreal	Spain
Aranyklinika Kft.	Szeged	Hungary
Spiroped Szigetvar Kft.	Szigetvar	Hungary
Hospital Clinico Universitario De Valencia	Valencia	Spain
Assistance Publique Hopitaux De Paris	Paris	France
Hospices Civils De Lyon	Lyon	France
University Of Debrecen	Debrecen	Hungary
Hopital Beaujon	Clichy	France
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
CHRU De Nancy	Vandoeuvre Les Nancy	France
Centermed Sp. z o.o.	Lublin	Poland
Pulz Tieuv Hprhspuv Uooaczsonjps	Sabadell	Spain
Ijdpewiepy Nqoezwxx Pgmdhl Sdpbnuqjl Muwlp Sf Cpqbakexm Alclrauavbsumcawktiiq	Bucharest	Romania
Apnxjzxmj Uey	Amsterdam	The Netherlands
Azilmwxijc Pdnmvmov Hkqbqtvc Dc Mobapftcs	Marseille	France
Extfizo Uxswrgzmmulu Mukttew Ctzjaon Rhwmzrhwg (hxcmxpv Mzt	Rotterdam	The Netherlands
Hspbaryw Uwnjumldieiyx Hoghumpz Tiyrc y Pyddko Icsezovz Chqmqa dtjrpuumkrzfdciia (rghd	Badalona	Spain
Hvilrbsc Vbnh dqvswjvi	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	28.11.2023
Hungary	Recruiting	28.11.2023
Italy	Recruiting	28.11.2023
Poland	Recruiting	28.11.2023
Romania	Recruiting	28.11.2023
Spain	Recruiting	28.11.2023
The Netherlands	Recruiting	28.11.2023

Trial locations

Investigated drugs:

Tezepelumab

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.

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.

Trial ID:

2022-502984-39-00

Protocol code:

D5180C00016

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Tezepelumab for Children Aged 5 to 11 with Severe Asthma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?