RecruitingOBSERVATIONAL

A Non-interventional, Prospective Study With Benralizumab

This study is for adults in Germany with severe asthma who are already taking the medicine benralizumab. It's a non-interventional study, meaning doctors aren't deciding who gets the medicine; participants are already prescribed it as part of their usual care. Researchers want to see how benralizumab affects asthma control, overall health, and lung function. They will also track how much other asthma medication people take over 52 weeks. Participants will fill out questionnaires about their asthma and keep a log of their medication. The study aims to understand how this treatment works in everyday life, confirming its benefits outside of strict trial conditions.

At a glance

Status

Recruiting

Sponsor

AstraZeneca

Enrolment target

300

Start

25 Jul 2024

Estimated completion

31 Dec 2027

Asthma, Bronchial

What is this study about?

Imagine you have severe asthma, and your doctor prescribes a specific medicine called benralizumab. This study wants to understand how well that medicine works for people like you in their day-to-day lives. It's not a typical trial where doctors decide if you get the medicine or not. Instead, you're already taking benralizumab as part of your standard treatment.

The main goal is to see if benralizumab helps you breathe better, control your asthma symptoms, and improve your overall quality of life. This means looking at things like how often you have asthma attacks, if you feel better day-to-day, and if your lungs are working more efficiently. Researchers will also keep an eye on how much other asthma medication you need to take alongside benralizumab.

Understanding how benralizumab works in a 'real-world setting' is really important. Clinical trials often have strict rules, but this study wants to see what happens when people use the medicine in their normal routine. The results will help doctors and patients in Germany understand more about the benefits of this treatment for severe asthma.

Key takeaways

This study is for adults with severe asthma already taking benralizumab.
It aims to see how the medicine works in people's real lives over a year.
You'll share information about your asthma control and medication use.
Participation helps doctors understand benralizumab's benefits better.
It does not involve new treatments or changing your current care.

Who may be eligible?

This study is looking for adult men and women, aged 18 or older, who have been diagnosed with severe asthma that's caused by higher levels of certain immune cells (called eosinophils). You must already be on a treatment plan that includes high-dose inhaled steroids and another type of asthma medication called a LABA, and you must have been prescribed benralizumab by your doctor according to standard guidelines.

It's important that your doctor decided you needed benralizumab independently of this study – the study isn't influencing your treatment choice. You also need to be able to understand and follow instructions, and be willing to fill out questionnaires about your asthma symptoms and keep a weekly record of your medication. Signing a consent form means you understand what the study involves and agree to take part.

There are also some reasons you wouldn't be able to join. For example, if you're already in another study that might affect the results of this one, or if you've recently been part of a strict clinical trial. If you've had a severe allergic reaction to similar biologic therapies, or have certain other medical conditions (like some parasitic infections or other lung diseases that aren't asthma), you wouldn't be eligible. Also, if you've taken other similar asthma biologic therapies in the last few months, you likely won't 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.

Are you 18 years old or older?
Do you have severe asthma (eosinophilic type)?
Are you currently prescribed and taking benralizumab as part of your usual care?
Are you able and willing to fill out questionnaires and keep a medication diary?
Do you live in Germany?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your participation will last for about 52 weeks (roughly one year). During this time, you won't be given any new treatments or asked to change your current benralizumab treatment – you’ll continue with your usual care as prescribed by your doctor.

You will be asked to fill out questionnaires about your asthma control (how well your asthma is managed) every four weeks. You'll also complete questionnaires about your quality of life (how your asthma affects your daily activities and feelings) at the beginning and during your regular doctor's visits. Additionally, you will need to keep a daily record of all the asthma medications you take each week, either on paper or electronically. The study will mainly use information gathered from these questionnaires and your medication logs.

Potential risks and benefits

Since you will be continuing your already prescribed treatment, there aren’t direct medical risks from the study itself, beyond those already associated with your benralizumab treatment and usual care. The main benefit is that your participation helps researchers better understand how benralizumab works for people with severe asthma in everyday life, which can help other patients in the future. The main inconvenience would be the time and effort required to complete the weekly medication logs and regular questionnaires. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (41)

Research Site
Verified postcode
Ahrensburg, Germany· Recruiting
Research Site
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Ansbach, Germany· Recruiting
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Aschaffenburg, Germany· Recruiting
Research Site
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Auerbach, Germany· Recruiting
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Augsburg, Germany· Recruiting
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Bad Homburg, Germany· Recruiting
Research Site
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Berlin, Germany· Recruiting
Research Site
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Cottbus, Germany· Recruiting
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Darmstadt, Germany· Recruiting
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Dresden, Germany· Recruiting
Research Site
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Düsseldorf, Germany· Recruiting
Research Site
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Ehringshausen, Germany· Recruiting

Common questions

What is benralizumab?

It's a specific type of medicine used to treat severe asthma, often when other treatments haven't been enough.

Will I get free medicine if I join?

No, you must already be prescribed benralizumab as part of your normal care. The study doesn't provide the medicine.

How long will I be in the study?

Your participation will last for about 52 weeks, which is roughly one year.

Do I need to visit a special clinic?

You'll attend your regular follow-up visits with your own doctor. The study mainly involves filling out forms and keeping a record at home.

What kind of information will I need to share?

You'll fill out questionnaires about your asthma control and quality of life, and keep a weekly diary of the asthma medicines you take.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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