BRISOTE: A Multicentre, Randomised, Double-blind, Parallel Group, Active-Controlled, Phase 3b Study to Evaluate the Efficacy and Safety of Benralizumab 30 mg SC in Eosinophilic Asthma Patients Uncontrolled on Medium-Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist
Asthma can cause swelling and narrowing in the airways, making it hard to breathe. In eosinophilic asthma, a specific type of white blood cell called an eosinophil causes this inflammation. For many people, everyday preventer inhalers do not fully control their symptoms. This study, named BRISOTE, is looking at a targeted medicine called benralizumab (also known as Fasenra). Benralizumab is given as an injection under the skin and works by lowering the number of eosinophils in the body. Researchers are testing whether benralizumab helps prevent asthma flare-ups and improves overall quality of life over 48 weeks. Half the participants will receive benralizumab alongside their inhalers, while others will receive standard inhaler treatment or a dummy injection (placebo). This helps doctors learn if this medicine is safe and effective for people whose asthma remains difficult to manage.
At a glance
What is this study about?
Asthma is a common long-term lung condition, but it affects people in different ways. Some people have a type called eosinophilic asthma. In this condition, the body makes too many eosinophils, which are white blood cells that normally fight infections. When too many collect in the lungs, they cause swelling, mucus build-up, and sudden flare-ups or asthma attacks.
Many patients take daily combination inhalers containing steroids to keep their airways open and calm swelling. However, for some adults, standard medium-dose inhalers are not enough to keep symptoms under control. The BRISOTE clinical trial is investigating whether adding a specialist biologic medicine called benralizumab can help these patients lead easier, healthier lives.
Benralizumab works differently from standard inhalers. Instead of opening the airways temporarily, it attaches to eosinophils so the body can remove them, directly reducing the root cause of the swelling. In this study, doctors are measuring how often participants have asthma attacks over a 48-week period. They will also measure how much patients' day-to-day quality of life improves, such as being able to walk, sleep, and work without chest tightness or coughing.
Key takeaways
- The BRISOTE study is testing benralizumab for adults with uncontrolled eosinophilic asthma.
- The main goal is to see if the injection reduces asthma attacks over 48 weeks.
- Participants continue using daily inhalers alongside the study treatment.
- Regular health checks and lung breathing tests will be carried out at clinic visits.
- Taking part is voluntary and does not impact your normal NHS rights.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with eosinophilic asthma. To take part, your asthma must still be causing problems or flare-ups even though you regularly take a medium-dose combination inhaler.
You will need to have medical tests showing higher-than-normal levels of eosinophils in your blood. The study team will review your recent medical history to see how many asthma flare-ups you have experienced over the past year.
You may not be able to take part if you have other significant lung conditions, such as chronic obstructive pulmonary disease (COPD), or if you are currently being treated for a severe infection. Women who are pregnant or breastfeeding are usually not eligible to join.
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.
- Are you aged 18 or older?
- Do you have a diagnosis of asthma?
- Do you still experience asthma symptoms or attacks despite using your daily preventer inhaler?
- Have you been told your asthma involves high eosinophil levels?
- Are you willing to attend regular hospital clinic visits over 48 weeks?
What does participation involve?
Taking part in this study lasts for about 48 weeks. During this time, you will visit a specialist hospital clinic roughly once a month. At these appointments, doctors and nurses will check your lung function with breathing tests, take blood samples, and ask questions about your symptoms and daily activities. You will receive an injection under the skin every few weeks (either benralizumab or a dummy placebo injection), and you will continue to use prescribed inhalers. You will also be asked to track any changes in your breathing or asthma attacks between visits. All study visits, tests, and trial medicines are provided free of charge.
Potential risks and benefits
Locations (7)
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedIreland
- —UnverifiedSpain
- —UnverifiedNorway
- —UnverifiedGermany
- —UnverifiedBulgaria
Common questions
What is benralizumab?
Benralizumab is an injection that targets and removes excess eosinophils (inflammatory white blood cells) to calm swelling in the airways.
What is a placebo?
A placebo looks just like the real medicine but contains no active drug. It helps researchers prove whether the real medicine genuinely works.
Will I have to stop taking my regular asthma inhaler?
No. You will continue to use your regular inhalers to keep your airways open and safe throughout the study.
How is the study medicine given?
It is given as a quick injection just under the skin, usually in the upper arm, thigh, or tummy, by a trained study nurse or doctor.
Can I leave the study if I change my mind?
Yes. You can leave the trial at any point without giving a reason, and your normal NHS treatment will continue as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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