Study on Omalizumab and Mepolizumab for Patients with Severe Allergic and Eosinophilic Asthma

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What is this study about?

This clinical trial is focused on studying treatments for severe allergic and eosinophilic asthma, a type of asthma characterized by high levels of certain white blood cells called eosinophils and allergic reactions. The study will compare two medications: omalizumab and mepolizumab. Omalizumab, also known by its code name IGE-025A, is a medication that helps reduce allergic reactions by targeting a specific protein in the body. Mepolizumab, also known as SB240563, works by reducing the number of eosinophils, which are involved in causing inflammation in asthma.

The purpose of the study is to compare how well patients with severe allergic and eosinophilic asthma respond to these two treatments. Participants will receive either omalizumab or mepolizumab through a subcutaneous injection, which means the medication is injected under the skin. The study will last for a period of 22 weeks, during which the response to the treatments will be monitored. This includes observing the rate of severe asthma attacks and other asthma-related outcomes, such as disease control and quality of life.

Throughout the study, researchers will also look at various factors that might predict a better response to either omalizumab or mepolizumab. These factors include age at the onset of severe asthma, the presence of nasal polyps, and certain blood markers. The goal is to understand which treatment might work best for different patients based on these characteristics. This information could help tailor asthma treatments more effectively in the future.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will review and sign the informed consent form, confirming your understanding and agreement to participate in the trial.

Your eligibility will be confirmed based on criteria such as age, asthma diagnosis, and previous treatments. You must be between 18 and 90 years old and have a documented diagnosis of severe allergic and eosinophilic asthma.

2 randomization

After confirming eligibility, you will be randomly assigned to receive either omalizumab or mepolizumab. This process is random to ensure unbiased results.

3 treatment administration

You will receive your assigned medication through a subcutaneous injection, which means the medication is injected under the skin.

The dosage and frequency of administration will be determined by the study protocol and your healthcare provider. This will continue for the duration of the trial, which is estimated to last up to one year.

4 regular follow-up visits

Throughout the trial, you will attend regular follow-up visits. These visits are important for monitoring your health and the effectiveness of the treatment.

During these visits, various assessments will be conducted, including blood tests and questionnaires about your asthma symptoms and quality of life.

5 end of treatment evaluation

At the end of the treatment period, a final evaluation will be conducted. This will include a comprehensive assessment of your response to the medication.

The primary focus will be on the rate of severe asthma exacerbations and other asthma-related outcomes.

Who Can Join the Study?

Signed informed consent form (ICF): You must agree to participate in the study by signing a form that explains the study details.
Age: You must be between 18 and 90 years old.
Able to comply with the study protocol: You must be able to follow the study instructions and procedures, as judged by the study doctor.
Documented physician-diagnosed asthma: You must have a diagnosis of asthma confirmed by a doctor.
Eligible to receive omalizumab and mepolizumab: These are specific treatments for asthma. You must be suitable to receive these treatments and have not yet started them.

Who Cannot Join the Study?

Patients who do not have severe allergic and eosinophilic asthma cannot participate. This means the study is only for those with a specific type of asthma that involves severe allergies and a high number of a type of white blood cell called eosinophils.
Patients who are not within the specified age range cannot participate. The study is for certain age groups, so if you are outside this range, you cannot join.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care are not included in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hospital Foch	Suresnes	France
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Centre Hospitalier Regional De La Citadelle	Liege	Belgium
CHU Saint Pierre	Brussels	Belgium
HUmani	Charleroi	Belgium
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
CHU Helora	La Louviere	Belgium
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann	Brussels	Belgium
Clfscoamf Uxwbrpfxlqnxil Syzxebtqp	Woluwe-Saint-Lambert	Belgium
Cwqngd Hxfyffefjpb Udoeauvuntnyo Ryajz	Reims	France
Cmyogb Hunhaeyioqr Uehbminfrkkte Dv Dtcme	Dijon	France
Ajlwbhhpyp Punlqzdm Hqzenrop Dt Mgdlkobki	Marseille	France
Besevrkw Upquttlqfx Hxarpyjg Cgcfce	Besançon	France
Chgasn Hnifknxjwlq Uyxwinkywwqdn dw lj Gqzfoxcxuo	Pointe A Pitre	France
Hsuafuxc Ulekyyjftxzsdn Skdjimnoxn &pqyvbw Hcpffqn dz Hnclzqjnwjy	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	10.05.2019
France	Not recruiting	10.05.2019

Trial locations

Investigated drugs:

Omalizumab is a medication used to treat severe allergic asthma. It works by blocking a substance in the body called immunoglobulin E (IgE), which plays a key role in causing allergic reactions. By reducing the effects of IgE, omalizumab helps to decrease the number of asthma attacks and improve breathing in people with severe asthma that is not well controlled with other treatments.

Mepolizumab is a medication used for treating severe eosinophilic asthma. It targets and blocks a protein in the body called interleukin-5 (IL-5), which is involved in the growth and activity of eosinophils, a type of white blood cell that can cause inflammation in the lungs. By reducing the number of eosinophils, mepolizumab helps to lower the frequency of asthma attacks and improve overall asthma control in patients with this specific type of asthma.

Investigated diseases:

Asthma

Severe allergic and eosinophilic asthma – This is a chronic respiratory condition characterized by inflammation and narrowing of the airways, often triggered by allergens and marked by high levels of eosinophils, a type of white blood cell. The disease progresses with episodes of wheezing, shortness of breath, chest tightness, and coughing, which can vary in frequency and intensity. Over time, these symptoms can become more persistent and severe, leading to frequent asthma attacks or exacerbations. The inflammation in the airways can cause long-term damage if not managed, resulting in decreased lung function. The condition is often associated with other allergic disorders, such as nasal polyps or aspirin sensitivity. Management focuses on controlling symptoms and preventing exacerbations to maintain quality of life.

Trial ID:

2024-516783-29-00

Protocol code:

2017/19JUI/325

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Omalizumab and Mepolizumab for Patients with Severe Allergic and Eosinophilic Asthma

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