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RecruitingTherapeutic use (Phase IV)Interventional

Predictive Signature of Benralizumab Response. BENRAPRED Study.

Severe asthma can be difficult to manage, and treatments do not work the same way for everyone. Benralizumab (also known as Fasenra) is an approved injection used to help prevent severe asthma attacks. In this study, called the BENRAPRED study, researchers want to see if blood tests can predict who will benefit most from this medicine. Doctors will take blood samples before and during treatment to look at how certain genes behave. They will follow participants for 12 months to see how their symptoms and attack rates change over time. The goal is to help doctors choose the right treatment sooner. In the future, a simple blood test could show whether benralizumab is the best choice for a patient before they start taking it, saving valuable time and avoiding treatments that might not help.

At a glance

Status
Recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Centre Hospitalier Universitaire De Nantes
Enrolment target
220
Start
24 Jun 2024

What is this study about?

Severe asthma is a long-term lung condition where standard inhalers are not enough to keep symptoms under control. People living with severe asthma often experience sudden breathlessness, wheezing, and frightening flare-ups that may require hospital care. Benralizumab (brand name Fasenra) is a targeted treatment given by regular injection under the skin. It works by lowering the number of specific white blood cells that cause swelling and irritation in the airways.

Although benralizumab helps many people, it does not work equally well for everyone. At the moment, doctors have to wait several months to see if a patient gets better. The BENRAPRED study aims to change this. Researchers are studying gene patterns in the blood to see if they can find clear clues showing whether someone will be a strong responder, an average responder, or someone who needs a different treatment entirely.

If researchers can identify these blood markers, doctors will be able to match people with severe asthma to the best treatment straight away. This personalised approach could prevent unnecessary delays, reduce the risk of serious asthma attacks, and help patients feel better much faster.

Key takeaways

  • The BENRAPRED study investigates whether blood tests can predict how well benralizumab works for severe asthma.
  • The study follows adults with severe asthma over a 12-month period.
  • Researchers will look at gene patterns in blood samples taken before and during treatment.
  • The findings could help doctors tailor asthma treatments to individual patients in the future.
  • Taking part involves routine injections, breathing tests, and regular blood samples.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with severe asthma. Participants are generally people whose asthma remains difficult to control despite using regular inhalers, and who are eligible to receive benralizumab as part of their care.

Both men and women can take part. However, you may not be able to join if you have other major lung conditions that could make it hard to measure how well the medicine is working.

Your hospital respiratory team will look closely at your medical history, current treatments, and general health to confirm whether this study is safe and suitable for you.

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.

  1. You are aged 18 or older.
  2. You have a confirmed diagnosis of severe asthma.
  3. Your asthma is not fully controlled by standard inhalers.
  4. You are eligible to start treatment with benralizumab (Fasenra).
  5. You are able to attend regular hospital appointments over 12 months.
Answer every question to see your result.

What does participation involve?

Taking part in the study lasts for about 12 months. During this time, you will receive standard benralizumab (Fasenra) injections under the skin at your regular hospital clinic visits. You will have blood samples taken at the start of the study and at planned check-ups throughout the year. Doctors will also check your breathing using routine lung function tests, ask you to fill in short questionnaires about your daily symptoms, and keep track of any asthma flare-ups you experience.

Potential risks and benefits

Taking part will not change the standard medicine you receive, but you will benefit from close, regular monitoring by asthma specialists. As with any injection, benralizumab can cause mild side effects, such as headache, a sore throat, or redness and tenderness where the needle entered the skin. Giving blood samples may cause brief discomfort or slight bruising. Your participation is completely voluntary, and you can leave the study at any time without giving a reason and without it affecting your normal NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    France

Common questions

Is benralizumab a new or experimental drug?

No. Benralizumab (Fasenra) is already an approved and widely used treatment for severe asthma in the UK.

Will taking part cure my asthma?

No. There is currently no cure for asthma, but treatments like benralizumab can help control symptoms and prevent severe attacks.

Will I have to pay for the study treatment?

No. All study-related medicines, tests, and hospital check-ups are provided free of charge.

What happens if the treatment does not help me?

Your doctors will monitor your breathing closely. If the medicine is not working well, your specialist team will discuss other treatment options with you.

Can I leave the study if I change my mind?

Yes. You are free to withdraw from the study at any point. Your decision will not affect the quality of your regular NHS medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Predictive Signature of Benralizumab Response. BENRAPRED Stu…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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