Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Symptoms control and adhErenCe assessment during treatment with mepolizUmab new pREfilled devices. SECURE

This study, called SECURE, is for people with asthma and focuses on a treatment called Mepolizumab. Researchers want to understand how consistently patients use this medication and how well it helps manage their asthma symptoms over a six-month period. They will be looking at information from patient diaries and pharmacy records to see if people are taking their medication as prescribed. The study also explores how different ways of using Mepolizumab (such as pre-filled syringes or auto-injectors, and whether it's administered by a nurse or self-administered) affect how well people stick to their treatment plan and how much their asthma improves. It's a 'Phase IV' study, meaning the treatment is already approved, and researchers are gathering more information on its real-world use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Hospices Civils De Lyon

Enrolment target

130

Start

03 Oct 2022

Asthma

What is this study about?

This study is called SECURE, and it's looking into a specific asthma treatment called Mepolizumab. If you have asthma, you'll know how important it is to take your medication regularly to keep your symptoms under control. This research aims to understand two main things: first, how well people with asthma stick to their Mepolizumab treatment plan, and second, how much this medication helps them manage their asthma symptoms.

The study will follow participants for six months, checking their treatment use through their own diaries and pharmacy records. The researchers want to see if using Mepolizumab regularly leads to better asthma control. They're also interested in whether the way Mepolizumab is given (for example, using a pre-filled syringe or an auto-injector, or if a nurse gives the first doses) makes a difference to how easily people use their medication and how much it helps them.

Because this is a 'Phase IV' study, it means Mepolizumab is already approved and available. These types of studies are important because they gather more information about how treatments work in everyday life, helping doctors and patients make the best choices about care. The goal is to improve how we use Mepolizumab so that more people with asthma can experience better symptom control.

Key takeaways

Study focuses on severe asthma treatment with Mepolizumab.
Aims to understand how well people use their medication and how much it helps.
Compares different ways of taking Mepolizumab (e.g., syringe vs. pen).
Uses patient diaries and pharmacy records to track medication use.
Monitors asthma control using a special questionnaire (ACT score).
Participation could last up to 12 months with regular check-ups.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. The study is open to both men and women.

Medical conditions covered are limited to asthma. More details about health conditions or specific asthma types might be discussed with your doctor to make sure this study is right for you. Make sure to talk to your healthcare team if you're interested.

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?
Have you been diagnosed with asthma?
Are you able to use either a pre-filled syringe or an auto-injector for medication?
Are you willing to keep a monthly diary about your medication?
Are you able to attend regular check-ups and assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main focus will be on your use of the asthma medication, Mepolizumab, and how it helps your symptoms. You will be asked to use Mepolizumab for a period of 6 months, and you might receive it using either a pre-filled syringe or a special pen (auto-injector). Some participants might have their first doses given by a nurse, while others will learn to give it to themselves from the beginning.

You'll be asked to keep a monthly diary to record your medication use, and the study team will also check pharmacy records to see how consistently you've been taking your treatment. Your asthma control will be regularly checked using a questionnaire called the ACT score. The study also aims to compare different ways the medication is given and its effectiveness over a longer period, up to 12 months. This will involve regular assessments to track your asthma control and any flare-ups you might have. The total duration of your participation could be up to 12 months.

Potential risks and benefits

Participating in this study might offer the benefit of receiving regular monitoring for your asthma and close support from a medical team. By tracking your medication use and asthma control, you could gain a better understanding of your condition. However, as with any medication, there can be side effects from Mepolizumab, which your doctor will discuss with you. There might also be a time commitment involved with appointments and keeping a diary. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is Mepolizumab?

Mepolizumab is a medicine used to treat severe asthma. It helps reduce asthma attacks and improve breathing.

What does 'Phase IV' study mean?

A Phase IV study means the treatment is already approved by regulatory bodies, and researchers are gathering more information about its use in everyday patients.

How will my asthma control be measured?

Your asthma control will be measured using a special questionnaire called the ACT score, which helps see how well your symptoms are managed.

Will I have to pay for the medication?

Medications provided as part of a clinical trial are typically covered by the study. You should confirm this with the study team.

Can I leave the study at any time?

Yes, you are completely free to leave the study at any point without it affecting your standard medical care.