A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
This research study, called DOMINICA, is looking for children and teenagers aged 6 to 18 who have severe asthma with a special type of inflammation. The main goal is to find out if a medicine called benralizumab can help reduce asthma attacks and how safe it is. Participants will receive either benralizumab or a dummy medicine (placebo) by injection. Doctors will then closely watch how many asthma attacks happen and check for any side effects. The study aims to gather important information to help improve treatment for children with severe asthma. It's a 'double-blind' study, meaning neither the patient nor the doctor knows if they're getting the active medicine or the placebo at first.
At a glance
What is this study about?
This study is called DOMINICA, and it's looking into a new treatment for children and teenagers who have a specific type of severe asthma. We know that severe asthma can be really tough, leading to lots of asthma attacks and hospital visits, even with regular medication. This type of asthma, called 'eosinophilic asthma', involves certain inflammatory cells, and the new medicine, benralizumab, aims to reduce these cells to help control the condition.
The main idea is to see if benralizumab can help stop these severe asthma attacks from happening. The study will also carefully check to make sure the medicine is safe for young people. Finding new and better ways to manage severe asthma in children is really important, as it can greatly improve their quality of life, allowing them to go to school and enjoy activities more freely.
By taking part, your child would be helping doctors understand more about this medicine. This information could eventually lead to new treatment options for many other children with severe asthma in the future. The study is very carefully designed to give us the clearest and most reliable results possible.
Key takeaways
- This study is for children aged 6-18 with severe asthma.
- It tests a new medicine (benralizumab) for preventing asthma attacks.
- Participants will get either the medicine or a dummy injection.
- Your child's asthma will be closely monitored by specialists.
- The study could help develop new treatments for severe childhood asthma.
- You can withdraw from the study at any time.
Who may be eligible?
This study is specifically for children and teenagers aged between 6 and 18 years old. They must have a diagnosis of severe asthma that has been confirmed by a doctor for at least a year. Their asthma should be what doctors call 'eosinophilic', which means they have high levels of certain cells (eosinophils) in their blood or airways.
Participants also need to have a history of severe asthma attacks. This means they would have had at least two severe asthma attacks in the past two years, or one in the last year that needed hospital treatment or strong steroid medications. They must already be taking high-dose inhaled steroids and at least one other regular asthma medicine, but their asthma is still not fully controlled.
Both the child and their parent or guardian need to be willing to take part, understand what the study involves, and be able to answer questions throughout. The doctor running the study will carefully check all these points to make sure the study is right for your child.
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 6 and 18 years old?
- Has a doctor diagnosed your child with severe asthma for at least 12 months?
- Does your child have a history of severe asthma attacks (e.g., needing strong steroids or hospitalisation)?
- Is your child currently taking high-dose inhaled steroids and at least one other asthma medicine?
- Are you and your child willing to attend regular clinic visits and answer questions?
- Does your child have 'eosinophilic' asthma (e.g., high blood eosinophil counts)?
What does participation involve?
If your child joins the study, they'll be in it for a while. First, there's a screening period of about 1 to 3 months to make sure they're a good fit. During this time, they'll have several visits for health checks and tests.
Once accepted, they'll be sorted into one of two groups by chance, like flipping a coin. One group will get the study medicine (benralizumab), and the other will get a dummy medicine (placebo), both given as injections. Neither you, your child, nor the study doctors will know which one they are receiving at first. This part of the study will last at least 16 weeks, and potentially longer, until enough asthma attacks have been seen across the entire study.
If your child has an asthma attack during this time, they will then be offered the opportunity to enter an 'open-label' period, where they will definitely receive benralizumab for at least 48 more weeks. There will be regular visits to the clinic throughout the study to monitor their health, asthma control, and any side effects. After their last dose, there will be one final follow-up visit about 8 weeks later.
Potential risks and benefits
Locations (116)
- Research SiteVerified postcodeMobile, United States· Withdrawn
- Research SiteVerified postcodeMontgomery, United States· Withdrawn
- Research SiteVerified postcodeTucson, United States· Recruiting
- Research SiteVerified postcodeLittle Rock, United States· Withdrawn
- Research SiteVerified postcodeMadera, United States· Withdrawn
- Research SiteVerified postcodeTorrance, United States· Recruiting
- Research SiteVerified postcodeWashington D.C., United States· Recruiting
- Research SiteVerified postcodeMiami, United States· Recruiting
- Research SiteVerified postcodeMiami, United States· Recruiting
- Research SiteVerified postcodeOcala, United States· Completed
- Research SiteVerified postcodeOwensboro, United States· Recruiting
- Research SiteVerified postcodeLafayette, United States· Recruiting
Common questions
What is 'severe eosinophilic asthma'?
It's a type of asthma that doesn't get better with usual treatments and is linked to high levels of certain immune cells called eosinophils.
What is benralizumab?
It's a medicine given by injection that's designed to reduce the number of eosinophils in the body, which can help reduce asthma attacks.
What does 'double-blind' mean?
It means that neither your child nor the doctors will know if they are receiving the actual medicine or a dummy medicine (placebo) until the study is over.
How long will my child be in the study?
The initial part of the study is at least 16 weeks, and then many children will move into an extension period for at least 48 more weeks, plus follow-up visits.
Can my child continue to take their regular asthma medicines?
Yes, children in this study will continue to take their usual high-dose inhaled steroids and other controller medicines for their asthma.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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