Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
This research study is looking at a new medicine called dupilumab for children aged 2 to 5 years old. These children have asthma or severe wheezing that isn't well controlled by their usual medicines. The study wants to find out if dupilumab can help reduce their asthma symptoms and improve their wheezing, and if it's safe for them to use for a longer period. Half the children will receive dupilumab, and the other half will get a dummy medicine (placebo) first, so researchers can compare the effects. If the first part of the study goes well, there's an option for all participants to continue on dupilumab in a second part.
At a glance
What is this study about?
This study is called LIBERTY ASTHMA TREKIDS, and it's trying to find a better treatment for young children with asthma or severe wheezing. Asthma in young children can be challenging, especially when their symptoms aren't well managed with standard treatments like inhaled steroids. This can lead to frequent wheezing, coughing, and difficulty breathing, impacting their daily lives.
The medicine being tested is called dupilumab. It's given as an injection under the skin. Researchers believe dupilumab might help by targeting specific parts of the body's immune system that play a role in asthma and allergic reactions. By calming down these overactive responses, dupilumab could potentially reduce asthma attacks and severe wheezing episodes.
The main goal of this study is to see if dupilumab is effective and safe for children aged 2 to 5 years. If it proves to be a good option, it could offer a new way to help these young children breathe easier and have a better quality of life.
Key takeaways
- The study tests a new asthma medicine, dupilumab, for children aged 2-5.
- It aims to see if dupilumab reduces uncontrolled asthma/wheezing and is safe.
- Participation involves regular clinic visits for up to two and a half years.
- Some children will receive the real medicine, others a dummy medicine initially.
- You can withdraw your child from the study at any time.
Who may be eligible?
To join this study, children need to be between 2 and 5 years old. They must have asthma or severe wheezing that isn't well controlled, even with regular use of their current asthma medicines, like inhaled steroids.
They also need to have certain other signs that suggest their asthma might be linked to allergies or certain immune responses. This could include having eczema (atopic dermatitis), allergies to things like pollen or dust mites, or certain levels of immune cells (eosinophils) in their blood. Or, they might have wheezing not caused by colds, or allergies to milk, eggs, or peanuts.
There are also reasons why a child might not be able to join. For example, if they have very severe asthma needing long-term steroid tablets, have had a serious allergic reaction to similar medicines before, or were born very prematurely. Children with other serious lung conditions or who needed a lot of oxygen as a baby would also not be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is your child aged between 2 and 5 years old?
- Does your child have asthma or severe wheezing that isn't well controlled by their current medicines?
- Does your child have certain allergic conditions (like eczema) or allergies to pollens/dust mites, or wheezing not caused by colds?
- Is your child generally healthy apart from their asthma, and not needing long-term steroid tablets for it?
- Are you able to bring your child to regular clinic visits and understand what's involved in the study?
What does participation involve?
If your child takes part in this study, it will involve several visits to the clinic over a period of up to 120 weeks (about two and a half years). The first part of the study lasts 68 weeks. This includes an initial check-up period (4 weeks), a main treatment phase where your child will receive either the study medicine (dupilumab) or a dummy medicine (placebo) by injection (52 weeks), and then a follow-up period after treatment stops (12 weeks).
During clinic visits, your child will have various assessments, which might include health checks, blood tests, and questionnaires for you to fill out. You'll also need to make sure your child receives their study medication as instructed. If your child completes the first part of the study, you'll have the option for them to continue into a second, optional part, where all eligible children will receive dupilumab for an additional 52 weeks, followed by another 12-week follow-up.
Potential risks and benefits
Locations (74)
- Phoenix Children's Hospital- Site Number : 8400001Verified postcodePhoenix, United States· Recruiting
- Allervie Clinical Research - Destin- Site Number : 8400016Verified postcodeDestin, United States· Recruiting
- EMDA Clinical Research- Site Number : 8400026Verified postcodeMiami, United States· Recruiting
- Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400011Verified postcodeChicago, United States· Recruiting
- Allergy and Asthma Specialist- Site Number : 8400002Verified postcodeOwensboro, United States· Recruiting
- Mayo Clinic in Rochester - Minnesota- Site Number : 8400008Verified postcodeRochester, United States· Recruiting
- UBMD Pediatrics- Site Number : 8400013Verified postcodeBuffalo, United States· Recruiting
- Boston Children's Health Physicians - Hawthorne- Site Number : 8400010Verified postcodeHawthorne, United States· Recruiting
- UNC Children's Hospital- Site Number : 8400005Verified postcodeChapel Hill, United States· Recruiting
- Cincinnati Children's Hospital Medical Center- Site Number : 8400004Verified postcodeCincinnati, United States· Recruiting
- University Hospitals Cleveland Medical Center- Site Number : 8400015Verified postcodeCleveland, United States· Recruiting
- Vanderbilt University Medical Center- Site Number : 8400024Verified postcodeNashville, United States· Recruiting
Common questions
What is dupilumab?
Dupilumab is a medicine given by injection that works on the immune system to help reduce inflammation often seen in conditions like asthma and allergies.
Will my child definitely receive the new medicine?
In the first part of the study, your child will either receive dupilumab or a dummy medicine (placebo). In the optional second part, all eligible children will receive dupilumab.
How long will the study last for my child?
The first part of the study will last about 68 weeks, and if you choose to continue into the second part, the total time could be up to 120 weeks (around two and a half years).
Who is paying for this study?
This study is sponsored by a pharmaceutical company, but the research is conducted by medical professionals following strict ethical and scientific guidelines.
What happens if my child's asthma gets worse during the study?
Your child will be closely monitored by the study team, and you should always report any worsening of symptoms immediately. They will ensure your child receives appropriate care.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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