Study on the Effects of Benralizumab on Lung Function in Patients with Severe Eosinophilic 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 eosinophilic asthma. Severe eosinophilic asthma is a type of asthma characterized by high levels of a specific type of white blood cell called eosinophils, which can cause inflammation and breathing difficulties. The medication being tested, benralizumab, is given as an injection and is designed to reduce the number of eosinophils in the body, potentially improving asthma symptoms and lung function.

The purpose of the study is to evaluate how benralizumab affects the structure and function of the lungs in patients with severe asthma. Participants in the study will receive either benralizumab or a placebo, which is a substance with no active medication, to compare the effects. The study will involve regular visits to the clinic for injections and assessments over a period of time. During these visits, doctors will use methods like computed tomography (CT) scans to measure changes in the airways and lung function.

Throughout the study, participants will be monitored closely to ensure their safety and to gather information on how the treatment affects their asthma. The study aims to provide valuable insights into the potential benefits of benralizumab for people with severe eosinophilic asthma, helping to improve treatment options for this challenging condition.

1 initial visit and screening

The initial visit involves a comprehensive screening process to confirm eligibility for the study. This includes a review of medical history and current asthma treatment.

A blood test is conducted to measure eosinophil levels, which are a type of white blood cell associated with asthma.

A lung function test is performed to assess breathing capacity.

2 randomization and baseline assessment

Participants are randomly assigned to receive either the benralizumab treatment or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

Baseline measurements are taken, including lung function tests and possibly imaging studies to assess airway structure.

3 treatment administration

The treatment involves subcutaneous injections of Fasenra (benralizumab) or a placebo. The dosage is 30 mg per injection.

Injections are administered at regular intervals as specified by the study protocol.

4 follow-up visits

Regular follow-up visits are scheduled to monitor health status and response to treatment.

These visits include repeated lung function tests and possibly additional imaging studies to evaluate changes in airway structure.

5 end of treatment assessment

At the end of the treatment period, a final assessment is conducted to evaluate the effects of the treatment.

This includes measuring changes in eosinophil levels and lung function compared to baseline.

6 post-treatment follow-up

Participants may be asked to attend additional follow-up visits after the treatment period to monitor long-term effects and ensure safety.

Who Can Join the Study?

Must be able to understand and sign a written consent form before any study procedures begin.
Women can participate if they are not able to have children, which means they are either permanently sterilized or have gone through menopause. Menopause is when a woman hasn’t had a period for 12 months or more without another medical reason.
Women who can have children must have a negative pregnancy test before starting the study and agree to use a highly effective birth control method during the study and for 12 weeks after the last dose of the study medication.
Must have an acceptable technique for using an inhaler, as judged by the study doctor.
Must have an ACQ-6 score greater than 1.5. ACQ-6 is a questionnaire that measures asthma control.
Must have taken their inhaled asthma medication correctly more than 70% of the time during a specific period before the study.
Must have had fewer than 12 asthma flare-ups in the 6 months before a specific study visit.
Must be between 18 and 70 years old at the time of the first study visit.
Must have a history of asthma diagnosed by a doctor that requires continuous treatment with medium- or high-dose inhaled corticosteroids (ICS) and a long-acting beta-agonist (LABA) for at least 12 months before the first study visit.
Must currently be treated with high-dose ICS and LABA for at least 3 months before the first study visit, with or without additional asthma medication.
Must have a specific lung function measurement called FEV1 between 50% and less than 80% of the predicted normal value, or between 50% and less than 90% if a past measurement was less than 80%.
Must have a certain level of eosinophils in the blood, which are a type of white blood cell. This can be met by different criteria, such as having 300 or more eosinophils per microliter during screening or having a history of high eosinophil counts.
Must weigh at least 40 kilograms.
Female participants who can have children must have a negative blood pregnancy test at the first study visit.
Female participants who can have children must have a negative urine pregnancy test before starting the study medication.

Who Cannot Join the Study?

Patients with other types of asthma that are not severe eosinophilic asthma cannot participate. Eosinophilic asthma is a type of asthma where there are high levels of a certain type of white blood cell called eosinophils.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are not detailed here but are important for ensuring the safety and effectiveness of the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Næstved Hospital	Næstved	Denmark
Aalborg University Hospital	Aalborg	Denmark
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Hxcjxn Hewzvigh	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	26.02.2024
Sweden	Not recruiting	26.02.2024

Trial locations

Investigated drugs:

Benralizumab

Benralizumab is a medication used in this clinical trial to treat severe eosinophilic asthma. It works by targeting and reducing the number of eosinophils, which are a type of white blood cell that can cause inflammation in the airways. The trial aims to see how well benralizumab can improve lung function and reduce structural changes in the lungs of patients with this type of asthma.

Investigated diseases:

Asthma

Severe eosinophilic asthma – This is a type of asthma characterized by high levels of eosinophils, a type of white blood cell, in the lungs. These cells can cause inflammation and swelling in the airways, leading to breathing difficulties. Symptoms often include wheezing, coughing, shortness of breath, and chest tightness. The condition can be persistent and may not respond well to standard asthma treatments. It often requires specialized management to control the inflammation and reduce symptoms. The disease can vary in severity and may worsen over time if not properly managed.

Trial ID:

2023-506614-40-00

Protocol code:

D3250C00059

NCT ID:

NCT03953300

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Benralizumab on Lung Function in Patients with Severe Eosinophilic Asthma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?