Study on Benralizumab for Patients with Severe Asthma

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Benralizumab on patients with severe asthma. Severe asthma is a type of asthma that is difficult to control and often requires high doses of medication to manage symptoms. The medication being tested, Benralizumab, is given as an injection under the skin using a pre-filled syringe.

The purpose of the study is to understand how Benralizumab affects the body at a genetic level and to see if it can significantly reduce the number of asthma attacks in patients with severe asthma. Participants in the study will receive Benralizumab and will be monitored over a period of time to observe changes in their condition. The study will look at how the medication influences certain genes in the blood and how these changes relate to the patient’s response to the treatment.

Throughout the study, participants will be grouped based on their response to the medication, and researchers will analyze blood samples to identify patterns in gene expression. This information will help determine if Benralizumab is effective in reducing asthma attacks and improving overall lung function. The study aims to provide insights into the potential benefits of using genetic information to predict how well patients with severe asthma will respond to Benralizumab treatment.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of severe asthma and ensuring the patient meets specific criteria such as age, asthma history, and previous treatments.

Blood tests are performed to check eosinophil levels, which are a type of white blood cell. This helps determine the suitability for the study.

2 treatment initiation

The treatment involves the administration of Fasenra (benralizumab) 30 mg, which is a solution for injection. The medication is given through a subcutaneous injection, meaning it is injected under the skin.

The first dose is administered at the start of the study.

3 follow-up visits

Regular follow-up visits are scheduled to monitor the patient’s response to the treatment. These visits occur at specific intervals: at the start (M0), then at 3 months (M3), 6 months (M6), 9 months (M9), and 12 months (M12).

During these visits, blood samples are taken to analyze gene expression and assess the response to the medication.

4 evaluation of response

The primary goal is to evaluate the reduction in asthma exacerbations, which are episodes of worsening symptoms. This is assessed by analyzing blood samples for gene expression changes.

Patients are categorized into three groups based on their response: responders, intermediate responders, and non-responders.

5 final assessment

At the end of the 12-month period, a final assessment is conducted to evaluate the overall effectiveness of the treatment.

The study aims to identify a predictive blood signature that can indicate the likelihood of a positive response to benralizumab in severe asthma patients.

Who Can Join the Study?

Patients must be between 18 and 75 years old.
Patients must have been diagnosed with severe asthma. This means asthma that needs high doses of inhaled medicines (more than 1000 micrograms per day of Beclomethasone or similar) along with other medications to be controlled for over a year, or asthma that is not controlled even with these medications, or asthma that gets worse when medications are reduced.
Patients must have a documented history showing that their lung function, measured by a test called FEV1, can improve by at least 12% and gain at least 200 mL.
Patients must have an ACQ-7 score of 1.5 or higher at the start of the study. This score is a way to measure asthma control.
Patients must have had at least 3 asthma attacks, known as exacerbations, in the 12 months before joining the study.
Patients must have a certain level of eosinophils in their blood, which are a type of white blood cell. The count should be 0.3 G/L or higher at the start of the study or in the 12 months before. If the count is between 0.15 G/L and less than 0.3 G/L, they must meet additional criteria, such as having a FeNO level greater than 25 ppm or having at least 3% eosinophils in their sputum.
Patients must not have received treatment with Benralizumab before joining the study.
Patients must provide written consent to participate in the study.

Who Cannot Join the Study?

Patients who do not have severe asthma cannot participate. Severe asthma is a type of asthma that is difficult to control and requires high doses of medication.
Patients who are not within the specified age range cannot participate. The age range for this study is from 4 to 3 years old.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Reseau De Sante Mutualiste	Villeurbanne	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hospital Foch	Suresnes	France
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis	Aix En Provence	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Czuteh Hnkuqdyvhda Udswrdwfrbywm Do Dmfyx	Dijon	France
Cuivkm Hxrpalkwlzo Rgmmtxly Dghebukiwelarz	Angers	France
Hljuxxnj Ugiasaafdqyrrb Skkexdpzwr &kflwfi Hleyiiw db Hitmblbjxdf	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	11.10.2021

Trial locations

Investigated drugs:

Benralizumab

Benralizumab is a medication used in this clinical trial to help people with severe asthma. It works by targeting and reducing certain cells in the blood that can cause inflammation and worsen asthma symptoms. The goal of using Benralizumab in this study is to see if it can significantly reduce the number of asthma attacks in patients who have severe asthma.

Investigated diseases:

Asthma

Severe asthma – Severe asthma is a chronic respiratory condition characterized by frequent and intense symptoms such as wheezing, shortness of breath, chest tightness, and coughing. Unlike mild or moderate asthma, severe asthma does not respond well to standard treatments and often requires higher doses of medication or additional therapies. The disease progresses with persistent inflammation and narrowing of the airways, leading to frequent exacerbations or asthma attacks. These exacerbations can significantly impact daily activities and quality of life. Over time, severe asthma may cause structural changes in the airways, known as airway remodeling, which can further complicate management of the condition. Environmental factors, allergens, and respiratory infections can trigger or worsen symptoms in individuals with severe asthma.

Trial ID:

2024-514843-27-00

Protocol code:

RC19_0292

NCT ID:

NCT04565483

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Benralizumab for Patients with Severe Asthma

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