Active not recruitingPHASE4INTERVENTIONAL

Symptoms Control and adhErenCe Assessment During Treatment With MepolizUmab New pREfilled Devices

This study focuses on people with severe asthma in France who use a medicine called Mepolizumab. Mepolizumab is now available in two new forms: a pre-filled syringe (given by a nurse) and an auto-injector pen (which you can use yourself at home). The study wants to understand if giving yourself the medicine with the auto-injector pen affects how well people take their treatment compared to having a nurse do it. Often, people don't take their asthma medicine exactly as prescribed, which can make their asthma harder to control. By comparing these two ways of getting Mepolizumab, researchers hope to find out if self-injecting impacts how regularly people take their medicine and if this affects their asthma control. This could help make severe asthma treatment easier and more effective for patients in the future.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

09 Mar 2023

Estimated completion

01 Jul 2026

Asthma

What is this study about?

Asthma is a common long-term condition that affects many people in the UK. For some, asthma is very severe and can be hard to manage, even with standard treatments. One important medicine for severe asthma, particularly a type called 'eosinophilic asthma', is Mepolizumab. This medicine helps to reduce flare-ups and can mean you need fewer steroid tablets.

Now, Mepolizumab is available in new, easier-to-use forms like a pre-filled syringe (given by a nurse) and an auto-injector pen (which you can use yourself at home). This offers more freedom and convenience, as you might not need to rely on a healthcare professional to give you your regular injections. However, the study organisers want to check if this new way of giving yourself the medicine impacts whether people remember to take their treatment as prescribed.

It's very common for people with long-term conditions like asthma to sometimes miss doses or not follow their treatment plan exactly – this is called 'non-adherence'. This study aims to compare what happens when a nurse gives monthly Mepolizumab injections with what happens when patients give themselves the injections using the auto-injector pen. By doing this, researchers hope to learn if self-injecting affects how consistently people take their medicine and, in turn, how well their asthma is controlled. The goal is to make sure that new, convenient ways of taking medicine truly help people manage their asthma better.

Key takeaways

This study compares two ways of getting Mepolizumab for severe asthma.
It aims to see if self-injecting affects how regularly people take their medicine.
The new self-injection pen could offer more freedom and convenience.
Your asthma control will be monitored closely throughout the study.
The results could help improve severe asthma treatment in the future.

Who may be eligible?

To join this study, you need to be at least 18 years old and have severe asthma that a lung specialist has been treating for at least a year. You also need to have a certain level of a type of white blood cell called 'eosinophils' in your blood and have had at least two severe asthma flare-ups recently that needed steroid tablets. You should also be using a high dose of inhaled steroids along with another asthma controller medicine.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you still smoke or have only recently stopped. You also can't join if you've had an asthma flare-up in the last four weeks or if you've already had Mepolizumab or similar treatments. If you have other serious lung conditions or other uncontrolled health problems, you might not be able to take part either. The study also cannot include anyone who is currently in another research trial that might affect the results of this one.

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 diagnosed by a lung specialist?
Have you had at least two severe asthma flare-ups requiring steroid tablets in the last year?
Are you currently on high-dose inhaled steroids plus another asthma controller medicine?
Are you not pregnant or breastfeeding?
Have you stopped smoking for at least 6 months?

Answer every question to see your result.

What does participation involve?

If you join this study, you will either receive your monthly Mepolizumab injection from a nurse using a pre-filled syringe, or you will give yourself the injection using an auto-injector pen. Throughout the study, your asthma symptoms will be checked regularly, and you'll likely complete questionnaires, such as the Asthma Control Test, to help researchers understand how well your asthma is being managed. Researchers will also keep track of your medicine use. The total duration of your participation in the study would be discussed with you by the research team.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving close medical attention for your severe asthma and access to Mepolizumab treatment. However, there could also be potential risks, such as side effects from the medication or the act of injecting yourself. The researchers will explain all known risks to you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Service de Pneumologie CHU Besançon
Verified postcode
Besançon, France
Service de Pneumologie CHU Dijon
Verified postcode
Dijon, France
Service de Pneumologie et ImmunoAllergologie CHU Lille
Verified postcode
Lille, France
Departement of Pulmonology, Croix-Rousse Hospital, Hospices Civils de Lyon
Verified postcode
Lyon, France
Service des Maladies Respiratoires CHU Montpellier
Verified postcode
Montpellier, France
Service de Pneumologie A APHP Bichat
Verified postcode
Paris, France
Service des Maladies Respiratoires CHU Reims
Verified postcode
Reims, France
Service de Pneumologie CHU Toulouse
Verified postcode
Toulouse, France

Common questions

What is Mepolizumab?

Mepolizumab is a medicine used to treat severe asthma, especially a type called 'eosinophilic asthma', to help reduce flare-ups.

What is an auto-injector pen?

It's a device that makes it easier for you to give yourself an injection at home, usually with a simple push of a button.

Why is 'adherence' important?

Adherence means taking your medicine as prescribed. If you don't take your medicine regularly, it might not work as well, and your asthma could be harder to control.

Will I have to pay to be in this study?

No, participation in clinical trials doesn't typically involve personal payment for the study treatment or related visits.

What is the Asthma Control Test (ACT)?

It's a short questionnaire that helps doctors and patients understand how well asthma symptoms are currently controlled.