Active not recruitingPHASE4INTERVENTIONAL

Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics

This study is investigating a medicine called benralizumab for people in the UK who have severe asthma. These are individuals whose asthma isn't well-controlled even with their regular inhalers (steroid inhalers and long-acting bronchodilators). The main goal is to find out if benralizumab can help to change and improve the structure of the airways in the lungs, and if it can make breathing easier over a 48-week period. Participants will be carefully monitored throughout the study, which also includes a 4-week follow-up period after the treatment finishes. This research hopes to offer new insights into managing severe asthma.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

AstraZeneca

Enrolment target

Start

08 Oct 2019

Estimated completion

19 Oct 2026

Asthma

What is this study about?

Imagine your lungs are like a tree with many branches, and in people with asthma, these branches (airways) can become inflamed and scarred over time, making it hard to breathe. This study, called the Benralizumab Airway Remodeling Study, is looking into a specific medicine, benralizumab, to see if it can help improve these airways in people who have severe asthma. For many people, their asthma is well-controlled with standard inhalers. However, for some, even with these treatments, their asthma can remain very troublesome and impacts their daily life.

This study specifically focuses on people with 'eosinophilic asthma', which is a type of asthma where a particular type of white blood cell, called eosinophils, are found in higher numbers in the airways and blood. These cells are thought to play a big part in causing the inflammation and changes seen in the lungs of people with severe asthma. Benralizumab is designed to reduce these eosinophils.

The main purpose of this research is to check if benralizumab can actually change the structure of the airways and improve how well the lungs work over nearly a year of treatment. By participating, you could help doctors understand better how to treat severe asthma and potentially improve the lives of many others living with the condition in the future.

Key takeaways

This study is for adults with severe asthma not controlled by usual inhalers.
It aims to see if a drug called benralizumab can improve lung structure and function.
Participation involves receiving either benralizumab or a dummy medicine for nearly a year.
Regular checks and tests will monitor your health and asthma progress.
Your contribution could help improve future treatments for severe asthma.

Who may be eligible?

To join this study, we are looking for adults between 18 and 70 years old who have been diagnosed with asthma by a doctor. Your asthma needs to be severe, meaning it's not well-controlled even though you've been using strong inhalers (like a steroid inhaler and a long-acting bronchodilator) for at least three months. We'll also check your lung function, which shows how well your lungs are working.

We would also check your blood for a specific type of white blood cell called eosinophils. To be eligible, you'd need to have a certain number of these cells, or have had a high count in the past. Other checks include ensuring you don't have certain other health conditions, haven't had specific treatments recently, and are not currently smoking.

It's important that you haven't received benralizumab before, or other similar study drugs or certain vaccines recently. Also, if you've had a procedure called bronchial thermoplasty in the last two years, you wouldn't be able to take part. There are very specific criteria, and the study team will go through all of these in detail with you to see if the study is suitable.

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 to 70 years old?
Do you have asthma that hasn't been well-controlled even with steroid and long-acting inhalers?
Have you not smoked recently?
Have you never received benralizumab before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be visiting the study clinic over a period of about a year, which includes a 48-week treatment period and then a 4-week follow-up. During your visits, you will receive either benralizumab or a placebo (a dummy medicine) through an injection. You will not know which you are receiving, but your doctor will.

Regular assessments will be carried out to monitor your health and how your asthma is responding. These will include breathing tests (to measure your lung function), blood tests (to check things like your eosinophil levels), and questionnaires about your asthma symptoms. The study team will make sure you understand everything involved and will be there to support you throughout.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from this study, but your participation could help researchers learn more about severe asthma, which could help future patients. There is a chance that benralizumab could improve your asthma symptoms or lung function, but it's also possible you could receive the placebo and not experience any direct benefits from the study treatment. Like all medications, benralizumab can have side effects, and some people might experience discomfort from injections or blood tests. The study team will explain all known side effects. Remember, joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (35)

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

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Birmingham, United States
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Los Angeles, United States
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Jacksonville, United States
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Miami, United States
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Snellville, United States
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Indianapolis, United States
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Iowa City, United States
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Kansas City, United States
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Ann Arbor, United States
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Bloomfield Hills, United States
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Rochester, United States
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St Louis, United States

Common questions

What is benralizumab?

Benralizumab is a medicine that targets a specific type of white blood cell, called eosinophils, which are involved in severe asthma. It's hoped to reduce inflammation in the airways.

What is a placebo?

A placebo is a substance that looks exactly like the study medicine but contains no active drug. It helps researchers compare the real medicine's effects.

How long will the study last?

The treatment part of the study lasts for 48 weeks (about 11 months), followed by a 4-week follow-up period. So, in total, it's about a year.

Will I know if I'm getting the study drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving benralizumab or the placebo until the study is over. This helps ensure fair results.

Can I continue my regular asthma medicines?

Yes, you will continue your usual asthma medicines in addition to the study treatment, unless the study doctor advises otherwise. This is important for your safety and to accurately assess the study drug.