Active not recruitingOBSERVATIONAL

The Influence of Mepolizumab on Structural and Inflammatory Cells in Severe Eosinophilic Asthma

The IRIS study is investigating how a medicine called Mepolizumab works in people with a type of severe asthma linked to immune cells called eosinophils. This medicine is already used to reduce asthma flare-ups, but researchers want to understand exactly how it changes the cells and structure of the airways. To do this, they will take small samples from the airways using a camera tube (bronchoscopy) before and after six months of Mepolizumab treatment. By looking closely at these samples in the lab, the study hopes to learn more about how Mepolizumab improves asthma control and helps repair damaged airways. This knowledge could lead to better treatments in the future.

At a glance

Status

Active not recruiting

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

Start

25 May 2022

Estimated completion

30 Nov 2027

Asthma; Eosinophilic

What is this study about?

The IRIS study is focused on a specific type of severe asthma called eosinophilic asthma. In this condition, special immune cells called eosinophils cause a lot of irritation and damage in the airways, making standard asthma treatments less effective. This can lead to frequent asthma attacks and ongoing breathing difficulties. We know that Mepolizumab, a medicine already approved for severe eosinophilic asthma, can help reduce these asthma attacks and improve overall breathing. However, we don't fully understand exactly how it works at a very detailed level within the airway walls.

This study aims to discover how Mepolizumab affects the cells and structures inside the airways. For example, in severe asthma, the lining of the airways can become damaged, and cells that produce mucus can increase. The researchers want to see if Mepolizumab helps to repair these damaged areas and improve the way airway cells work. By taking tiny samples from the airways before and after treatment, they can study these changes very closely.

Understanding these detailed effects could be very important. If we can see exactly how Mepolizumab helps to heal and protect the airways, it could help doctors choose the best treatments for patients in the future and could even lead to new medicines that target these problems more effectively. This will help us improve the lives of people living with severe eosinophilic asthma.

Key takeaways

This study investigates how Mepolizumab affects airway cells in severe eosinophilic asthma.
It involves two bronchoscopies to take samples, before and after 6 months of treatment.
The research aims to understand how the medicine helps repair damaged airways.
Participation requires you to be an adult with severe eosinophilic asthma, starting Mepolizumab.
The findings could lead to better future treatments for severe asthma.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or over. You must have been diagnosed with severe eosinophilic asthma by a specialist team at Southampton and approved for treatment with Mepolizumab following specific NHS guidelines.

There are also some reasons why you might not be able to take part. For example, if you are currently taking daily steroid tablets for your asthma, or if you are pregnant or planning to become pregnant during the study period. You also can't be a current smoker or have a significant smoking history. Some other health conditions, certain medications, or previous treatments like another biological therapy for asthma would also mean you couldn't join.

Basically, the study is looking for participants who have severe eosinophilic asthma, are about to start Mepolizumab, and meet specific health criteria to ensure the study focuses on how Mepolizumab works without other factors complicating the results. The research team will go through all the criteria with you carefully.

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 eosinophilic asthma, managed by a specialist team?
Are you about to start Mepolizumab treatment?
Are you not currently pregnant or planning to be during the study?
Are you not a current smoker or someone with a heavy smoking history?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a procedure called a bronchoscopy twice: once before you start your Mepolizumab treatment and again after you have completed six months of treatment. A bronchoscopy involves a very thin, flexible tube with a camera being gently guided into your airways to take very small samples. This is usually done with some sedation to make you comfortable. You will also have blood tests and other routine assessments to collect information about your asthma and health during the study period, which will be discussed with you in detail.

The Mepolizumab treatment itself will be given as prescribed by your doctor, not specifically by the study, and you will receive regular doses over six months. The total duration of your active participation, including follow-up assessments, will align with your six months of treatment and the timing of your two bronchoscopies.

Potential risks and benefits

Participating in this study might offer a small benefit by giving you more detailed insights into your asthma and its response to Mepolizumab. The study itself doesn't offer direct medical treatment beyond your usual care, but the information gained could benefit future patients. Taking part does involve some procedures, like bronchoscopies, which carry a small risk of discomfort or complications, similar to any medical procedure. These risks will be fully explained to you before you agree to take part. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

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

NIHR Clinical Research Facility
Verified postcode
Southampton, United Kingdom

Common questions

What is Mepolizumab?

Mepolizumab is a medicine used to treat severe eosinophilic asthma. It helps to reduce the number of certain immune cells called eosinophils, which cause inflammation in the airways.

What is a bronchoscopy?

A bronchoscopy is a procedure where a thin, flexible tube with a camera is used to look inside your airways and collect small tissue samples.

Will I get extra medicine in this study?

No, this study observes how Mepolizumab works when given as part of your usual care. You won't receive extra or different medicines because of the study.

How long will I be in the study?

You'll be actively involved for about six months, which includes two bronchoscopies and your Mepolizumab treatment period.

Who is funding this research?

The study details don't mention the specific funder, but research like this is typically supported by grants from medical research charities, universities, or pharmaceutical companies.