Study on the Effects and Safety of Dupilumab for Children Aged 2 to Under 6 with Uncontrolled Asthma or Severe Asthmatic Wheeze

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What is this study about?

This clinical trial is focused on studying the effects of a medication called dupilumab in young children aged 2 to less than 6 years who have asthma or experience frequent severe wheezing. Asthma is a condition that affects the airways in the lungs, making it difficult to breathe. The study aims to understand how well dupilumab works in reducing severe asthma attacks and to assess its safety over a long period. Participants in the study will receive either dupilumab or a placebo, which is a substance with no active medication, to compare the effects.

The study will be conducted over a period of 52 weeks, during which the children will receive regular injections of dupilumab in a pre-filled syringe. The study will monitor the frequency of severe asthma attacks and any side effects that may occur. The goal is to see if dupilumab can help reduce the number of asthma attacks and improve the overall health and quality of life for these young children.

In addition to dupilumab, the study will also consider other medications that the children might be using, such as ipratropium bromide, salbutamol, beclometasone, fluticasone, montelukast, and salmeterol. These medications are commonly used to manage asthma symptoms and will help provide a comprehensive understanding of how dupilumab fits into the treatment plan for children with asthma. The study will help determine the best ways to manage asthma in young children and improve their breathing and overall well-being.

1 joining the study

Upon joining the study, the participant is confirmed to be between 2 to less than 6 years old with a diagnosis of asthma or severe wheezing that is not controlled with regular medication.

The participant’s parent or guardian must provide consent and agree to comply with study procedures.

2 initial assessment

An initial assessment is conducted to evaluate the participant’s current health status and asthma control.

This includes a review of medical history and current medications.

3 treatment phase part A

The participant receives either dupilumab or a placebo through a solution for injection in a pre-filled syringe.

The treatment is administered over a 52-week period to assess the reduction in severe asthma attacks.

4 monitoring and follow-up

Regular monitoring is conducted to track the participant’s response to the treatment.

This includes checking for any adverse effects and measuring the concentration of dupilumab in the blood.

5 treatment phase part B

The safety and tolerability of dupilumab are assessed in children with uncontrolled asthma or severe wheezing.

The participant continues to receive the treatment for another 52 weeks.

6 final evaluation

A final evaluation is conducted to assess the overall effectiveness and safety of the treatment.

The participant’s asthma control and quality of life are measured and compared to the baseline.

Who Can Join the Study?

  • The child must be between 2 and less than 6 years old.
  • The child must have a diagnosis of asthma or severe wheezing that is not controlled with regular use of inhaled medications for at least 3 months.
  • The child must meet at least one major criterion from the modified asthma predictive index, such as having a doctor-diagnosed skin condition called Atopic Dermatitis or being allergic to something in the air, shown by a specific blood test result. Alternatively, the child can meet two minor criteria, such as wheezing not related to colds, having a certain type of white blood cell called eosinophils at a level of 4% or more, or being allergic to milk, eggs, or peanuts, shown by a specific blood test result.
  • The parent(s), caregiver(s), or legal guardian(s) must be willing and able to attend clinic visits and follow study procedures.
  • The parent(s), caregiver(s), or legal guardian(s) must be able to understand what the study involves.
  • The child and their parent(s), caregiver(s), or legal guardian(s) must be able to understand and complete study-related questionnaires.
  • The child’s body weight must be more than 5 kg and less than 30 kg at the time of screening and randomization.
  • The parent(s), caregiver(s), or legal guardian(s) must be able to give signed informed consent, which means they agree to let the child participate in the study after understanding what it involves.

Who Cannot Join the Study?

  • Children who are not between the ages of 2 and less than 6 years old.
  • Children who do not have uncontrolled asthma or do not experience frequent severe asthma attacks.
  • Children who have other serious health conditions that might interfere with the study.
  • Children who are taking medications that could affect the study results.
  • Children who have had a recent illness or infection that could impact their participation.
  • Children who have a history of severe allergic reactions to medications.
  • Children who are participating in another clinical trial at the same time.
  • Children whose parents or guardians do not agree to follow the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Prvni plicni ambulance s.r.o. Prague Czechia
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Robert Debre University Hospital Paris France
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi Lodz Poland
ASST Fatebenefratelli Sacco Milan Italy
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou Athens Greece
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o. Tarnow Poland
Semmelweis University Budapest Hungary
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Azienda Ospedaliera di Padova Padua Italy
University Of Debrecen Debrecen Hungary
Universidade De Santiago De Compostela Santiago De Compostela Spain
Assistance Publique Hopitaux De Paris Paris France
Evangelisches Krankenhaus Duesseldorf Duesseldorf Germany
Vita Verum Medical Bt. Szekesfehervar Hungary
Fondation Lenval Nice Nice France
Spiroped Szigetvar Kft. Szigetvar Hungary
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Hopital Jeanne De Flandre Lille France
Poiw Trmkl Hzcddaor Uxubmmiqzmis Sabadell Spain
Ppkkrho Cutzqhytq Gcpnjtz Hnvvprrd Penteli Greece
Eizlfuj Ucbkgqhhkdvr Mepaybw Cfakygs Rrxbuesoa (lvzhqee Mga Rotterdam The Netherlands
Ggkdmx Uwxrazhgtz Fyennpwif Frankfurt Germany
Hiulyiab Vjtz dijmhmbl Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
03.01.2024
France France
Not recruiting
03.01.2024
Germany Germany
Not recruiting
03.01.2024
Greece Greece
Not recruiting
03.01.2024
Hungary Hungary
Not recruiting
03.01.2024
Italy Italy
Not recruiting
03.01.2024
Poland Poland
Not recruiting
03.01.2024
Spain Spain
Not recruiting
03.01.2024
The Netherlands The Netherlands
Not recruiting
03.01.2024

Trial locations

Dupilumab is a medication being studied for its ability to help children aged 2 to under 6 years old who have uncontrolled asthma or experience frequent severe asthma attacks. The trial aims to see if this medication can reduce the number of severe asthma episodes over a year and to ensure it is safe and well-tolerated by young children.

Investigated diseases:

Wheezing – Wheezing is a high-pitched whistling sound made while breathing, often associated with difficulty in breathing. It occurs when air flows through narrowed breathing tubes, typically during exhalation. This condition is commonly seen in respiratory infections, asthma, or allergic reactions. Wheezing can vary in intensity and may be accompanied by other symptoms like coughing or shortness of breath. It can be a temporary condition or a sign of a chronic respiratory issue. The frequency and severity of wheezing episodes can change over time.

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. Symptoms include wheezing, coughing, chest tightness, and shortness of breath, which can vary in severity and frequency. Asthma attacks can be triggered by allergens, exercise, cold air, or stress. The condition often begins in childhood but can occur at any age. Asthma is a long-term condition that can fluctuate, with periods of exacerbation and remission. The progression of asthma can be influenced by environmental factors and individual health conditions.

Trial ID:
2023-504331-41-00
Protocol code:
EFC14771
NCT ID:
NCT06191315
Trial Phase:
Therapeutic confirmatory (Phase III)

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