Not recruiting

Study on Asthma Control and Adherence with Mepolizumab in Pre-filled Devices for Patients with Asthma

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of asthma, a condition that affects the airways in the lungs, making it difficult to breathe. The study will use a medication called Mepolizumab, which is designed to help control asthma symptoms. Mepolizumab is administered in two different ways: one group of patients will receive it through a pre-filled syringe given by a nurse, while another group will use an auto-injector pen to self-administer the medication. The purpose of the study is to compare how well patients adhere to their treatment and how effectively their asthma is controlled over a period of six months.

Participants in the study will be monitored for a total of 12 months. During this time, they will receive Mepolizumab injections once a month. The study will assess how well patients follow their treatment plan and how their asthma symptoms are managed. Patients will be asked to keep a diary to track their medication use and asthma symptoms. The study will also compare the proportion of patients who have their asthma under control after six months of treatment.

Throughout the study, various assessments will be conducted to evaluate the effectiveness of the treatment. These assessments include measuring asthma control using a questionnaire called the ACT score, monitoring any asthma exacerbations, and evaluating the need for additional medical consultations. The study will also collect information on any side effects experienced by participants. The goal is to determine which method of administering Mepolizumab is more effective in helping patients manage their asthma symptoms and adhere to their treatment plan.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the clinical trial, you will attend an initial visit. During this visit, a healthcare professional will review your medical history and confirm your eligibility for the study.
You will receive detailed information about the trial, including the schedule of visits and procedures. You will also be asked to provide informed consent, confirming your understanding and willingness to participate.
Step 2
Treatment group assignment
You will be assigned to one of two groups. One group will receive mepolizumab through a pre-filled syringe administered by a nurse, while the other group will use an auto-injector pen for self-administration.
The treatment involves monthly administration of mepolizumab for a period of six months.
Step 3
Monthly treatment
Each month, you will receive your assigned treatment. If you are in the nurse-administered group, a healthcare professional will administer the injection. If you are in the self-administered group, you will use the auto-injector pen to administer the injection yourself.
You will be required to maintain a diary to record your treatment and any symptoms or side effects you experience.
Step 4
Midpoint assessment
After six months of treatment, you will attend a midpoint assessment. This visit will include a review of your treatment diary and an evaluation of your asthma control using the ACT score (Asthma Control Test).
Your compliance with the treatment regimen will be assessed, and any necessary adjustments to your treatment plan will be discussed.
Step 5
Continued treatment
You will continue with your assigned treatment for an additional six months. The method of administration will remain the same as in the first six months.
You will continue to maintain your treatment diary and report any changes in your symptoms or side effects.
Step 6
Final assessment
At the end of the 12-month period, you will attend a final assessment. This visit will include a comprehensive evaluation of your asthma control and overall health.
The study team will review your treatment diary and assess your compliance and response to the treatment. You will also complete questionnaires to evaluate your satisfaction with the treatment and any changes in your quality of life.

Who can join the trial?

8 criteria

Patient must be 18 years or older.
Must have severe asthma diagnosed by a lung specialist and have been followed for at least a year.
Must have had high levels of eosinophils (a type of white blood cell) in the blood, at least 0.15 G/L, in the past 12 months.
Must have had at least 2 asthma attacks in the past 12 months, each treated with oral corticosteroids (a type of medication) for at least 72 hours.
Must be on high dose inhaled corticosteroid therapy (specific amounts of medications like budesonide, fluticasone, or beclometasone) and at least one other asthma treatment with LABA or LAMA (types of medications that help open the airways).
Must be affiliated with a social security scheme.
Must be able to give free, informed, and written consent.
If applicable, must have an effective contraception method.

Who cannot join the trial?

3 criteria

Patients who do not have a diagnosis of asthma.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Paris
Verified
Paris, France
Besancon University Hospital Center
Verified
Besançon, France
CHU Croix Rousse-Lyon
Verified
Lyon, France

Trial locations

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Investigated drugs

Mepolizumab is a medication used in this clinical trial to help control asthma symptoms. It works by targeting and reducing the activity of certain cells in the body that can cause inflammation in the airways, which is a common problem for people with asthma. In this study, patients receive Mepolizumab in two different ways: one group gets it through a pre-filled syringe administered by a nurse, and the other group uses an auto-injector pen to give themselves the medication. The goal is to see how well patients can manage their asthma symptoms and stick to their treatment plan with these different methods of taking the medication.

What is already known about the treatment

Mepolizumab – Mepolizumab is administered as an injection, either by a healthcare professional using a pre-filled syringe or by the patient themselves using an auto-injector pen. It is currently used in the treatment of asthma, specifically to help control symptoms and improve adherence to treatment. Mepolizumab works by targeting and blocking a specific protein in the body that contributes to inflammation, helping to reduce asthma symptoms. It is classified as a monoclonal antibody, a type of medication that is designed to target specific molecules in the body.

Investigated diseases

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The progression of asthma can vary, with some individuals experiencing mild symptoms and others having more severe episodes. Asthma symptoms can be triggered by various factors, including allergens, exercise, cold air, and stress. Over time, repeated inflammation can lead to structural changes in the airways, known as airway remodeling. This condition requires ongoing management to control symptoms and prevent exacerbations.