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Study on the Effectiveness and Safety of Benralizumab with Budesonide and Formoterol in Patients with Eosinophilic Asthma Uncontrolled by Standard Treatment

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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 effects of a medication called benralizumab in people with a type of asthma known as eosinophilic asthma. Eosinophilic asthma is a form of asthma characterized by high levels of a type of white blood cell called eosinophils, which can lead to inflammation and breathing difficulties. The study aims to evaluate how well benralizumab works and how safe it is when added to standard asthma treatments for patients whose asthma is not well controlled with their current medication.

Participants in the study will receive either benralizumab or a different treatment approach involving higher doses of their current asthma medication, which includes inhaled corticosteroids and long-acting beta2 agonists. The study will compare the effectiveness of adding benralizumab to the existing treatment versus increasing the dose of the current medication. The trial will last for a period of 48 weeks, during which the participants' asthma symptoms and overall health will be closely monitored.

The goal of the study is to determine if benralizumab can help reduce asthma symptoms and improve the quality of life for people with eosinophilic asthma. By participating in this trial, researchers hope to gather valuable information that could lead to better treatment options for individuals with this specific type of asthma. The study will also assess any potential side effects of benralizumab to ensure its safety for patients.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
Begin treatment with Symbicort Turbuhaler at a dose of 160 micrograms/4.5 micrograms per inhalation. This medication is an inhalation powder used for managing asthma symptoms.
Use the inhaler as prescribed, typically twice daily, to maintain control over asthma symptoms.
Step 2
Randomization and treatment adjustment
After the initial treatment phase, randomization occurs to determine the next step in treatment.
Participants may continue with Symbicort forte Turbuhaler at a higher dose of 320 micrograms/9 micrograms per inhalation, or receive an additional treatment with Fasenra (benralizumab) 30 mg solution for injection.
Fasenra is administered via subcutaneous injection, typically once every four weeks.
Step 3
Treatment monitoring
Regular monitoring of asthma symptoms and overall health is conducted throughout the trial.
Participants are required to maintain a daily asthma diary to track symptoms and medication use.
Step 4
End of treatment evaluation
At the end of the 48-week treatment period, an evaluation is conducted to assess the effectiveness and safety of the treatment.
This includes measuring changes in asthma symptoms and overall health status.

Who can join the trial?

11 criteria

Provide written informed consent, which means you agree to participate in the study after understanding all the details.
Have a peripheral blood eosinophil count of at least 150 cells per microliter. Eosinophils are a type of white blood cell involved in asthma.
Show at least 70% compliance with your usual asthma controller medication, which includes ICS-LABA (inhaled corticosteroids and long-acting beta-agonists), during the initial study period.
Be between 18 and 75 years old.
Have a documented history of asthma diagnosed by a doctor, requiring treatment with at least a medium dose of ICS (inhaled corticosteroids) and a LABA (long-acting beta-agonist) for at least 12 months before the study starts.
Have been treated with medium-dose ICS and LABA for at least 3 months before the study starts, with or without other asthma medications, but not including oral corticosteroids.
Weigh at least 35 kilograms.
Have a pre-BD FEV1 (a measure of lung function) of 90% or less of what is predicted for your age and size. FEV1 stands for forced expiratory volume in one second, which is how much air you can forcefully exhale in one second.
Have had at least 2 asthma attacks in the 12 months before giving informed consent.
Have an ACQ-6 score of 1.5 or higher at the start of the study and at least once during the initial study period. ACQ-6 is a questionnaire that measures asthma control.
Show evidence of asthma through excessive variability in lung function, as defined in the study protocol.

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Verified sites

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

Verified
Akershus University Hospital
Lorenskog, Norway
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

Trial locations

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Investigated drugs

Benralizumab
is a medication used in this study to help patients with eosinophilic asthma. It is given as an injection under the skin. The purpose of using benralizumab is to see if it can improve asthma symptoms in patients who are not well-controlled with their current asthma medications. It works by targeting and reducing the number of eosinophils, which are a type of white blood cell that can cause inflammation in the lungs and worsen asthma symptoms.
Inhaled Corticosteroid Plus Long-acting Beta2 Agonist (ICS-LABA)
is a combination of two types of medications used to manage asthma. The inhaled corticosteroid helps to reduce inflammation in the airways, making it easier to breathe. The long-acting beta2 agonist helps to relax the muscles around the airways, keeping them open for a longer period. In this study, patients who are not well-controlled on a medium dose of this combination may have their treatment adjusted to a higher dose to see if it improves their asthma symptoms.

What is already known about the treatment

Benralizumab – This medication is administered as a subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating eosinophilic asthma. It is an approved medication in the medical literature, primarily used for patients whose asthma is not well-controlled with medium-dose inhaled corticosteroids and long-acting beta-2 agonists. Benralizumab works by targeting and reducing eosinophils, a type of white blood cell involved in the inflammation process of asthma, thereby helping to control symptoms. It is classified as a monoclonal antibody, specifically designed to bind to the interleukin-5 receptor on eosinophils, leading to their destruction.

Investigated diseases

Eosinophilic Asthma – Eosinophilic asthma is a type of asthma characterized by high levels of eosinophils, a type of white blood cell, in the airways. This condition often leads to inflammation and swelling, causing symptoms such as wheezing, coughing, shortness of breath, and chest tightness. Unlike other forms of asthma, eosinophilic asthma may not respond well to standard asthma treatments. The disease can vary in severity, with some individuals experiencing frequent asthma attacks. It is often associated with other allergic conditions, such as rhinitis or sinusitis. The progression of symptoms can be influenced by environmental factors and allergens.