Benralizumab’s impact on severe asthma study

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    What is this study about?

    The study will examine the effects of a drug called benralizumab on people suffering from a severe type of asthma called eosinophilic asthma. Scientists will do this by using special imaging technology called functional airway imaging (FRI) to take pictures of the lungs before and after treatment. It’s an open-label trial, which means everyone knows that the asthma drug under investigation is benralizumab. The study will last from 15 to 23 weeks. Participants in this study must be adults (18 years of age or older), both men and women, who already have severe eosinophilic asthma. Their asthma is not currently well treated with regular inhalers or other asthma medications. One of the goals of the study is to see if benralizumab helps reduce airway resistance and clear mucus in the lungs. Scientists will measure parameters such as lung volume, airway resistance and mucus accumulation.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Liege , Belgium

      Mechelen , Belgium

      Montigny-le-Tilleul , Belgium

      Namur , Belgium

      Roeselare , Belgium

      Cannes , France

      Clermond Ferrand , France

      Libourne Cedex , France

      Montpellier Cedex 5 , France

      Lisboa , Portugal

      Porto , Portugal

      Alzira , Spain

      Barcelona , Spain

      Barcelona , Spain

      Madrid , Spain

      Santander , Spain

      Villarreal (Castellu00f3n) , Spain

      Bradford , United Kingdom

      Nottingham , United Kingdom

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In this clinical trial, patients will need to participate for a minimum of 15 weeks and up to 23 weeks. The following are the steps a patient will take during the trial:

      1. Screening visit (V0)
      2. Visit 1 (V1; week 0; within 1 to 21 days of screening)
      3. Visit 2 (V2; week 4 ± 5 days)
      4. Visit 3 (V3; week 8 ± 5 days)
      5. Visit 4 (V4; week 13 ± 5 days)
      6. Follow-up (2 weeks ± 7 days after V4) is done through a phone call follow-up after which participants will be discharged from the study.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      Based on the eligibility criteria, to join this study you need to have the following diseases:

      • Asthma: You must be diagnosed with asthma with documented reversibility (your airways open up) after using a bronchodilator medication. The asthma needs to be severe, inadequately controlled by inhaled corticosteroids and long-acting beta-agonists.
      • Eosinophilic asthma: Your asthma must be “eosinophilic”, meaning you have high levels of a type of white blood cell called eosinophils. You need a documented eosinophil count of at least 300 cells/μL, or at least 150 cells/μL if you are dependent on oral corticosteroids.

      The study excludes people with any clinically important lung diseases other than asthma. You also cannot have certain other conditions like a current malignancy, hepatitis B or C, or HIV.

      So in summary, the key diseases needed are severe eosinophilic asthma that is not well controlled with standard inhaled medications. Let me know if you have any other questions!


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria for the Clinical Trial with Explanations:

      1. Asthma diagnosis with documented reversibility post-bronchodilator or salbutamol either historical or at Visit 0 (V0): This means participants must have a confirmed diagnosis of asthma and show improved lung function following the use of a bronchodilator (a medication that widens the air passages of the lungs) or salbutamol, a type of bronchodilator.
      2. Documented treatment with ICS and LABA for ≥ 3 months prior to V0 with or without oral corticosteroids and additional asthma controllers: Participants must have been on a stable regimen of inhaled corticosteroids (ICS, anti-inflammatory medication) and long-acting beta agonists (LABA, a type of bronchodilator) for at least three months. They may also have been taking oral corticosteroids and other medications for asthma control.
      3. Documented peripheral blood eosinophil count ≥ 300 cells/μL at V0, or if OCS-dependent, a documented peripheral blood eosinophil count ≥ 150 cells/μL at V0: Eosinophils are a type of white blood cell involved in allergic responses and asthma inflammation. A count of at least 300 cells/microliter is required, or if the participant is dependent on oral corticosteroids, a count of at least 150 cells/microliter.
      4. Minimum of 2 exacerbations in the last 12 months prior to V0: Participants must have experienced at least two episodes of worsening asthma symptoms (exacerbations) in the year before the initial visit.
      5. Pre-bronchodilator FEV1/FVC ≤ 70% at V0: This criterion involves a spirometry test to measure the forced expiratory volume in one second (FEV1) and the forced vital capacity (FVC). FEV1/FVC ratio of 70% or less indicates airflow limitation, common in asthma patients.
      6. Pre-bronchodilator FEV1 < 80% of predicted at V0: This requires a spirometry result showing that the amount of air a person can forcefully exhale in one second is less than 80% of the expected value based on their age, gender, height, and race.
      7. Ability to perform acceptable and repeatable spirometry: Participants must be able to properly perform spirometry tests, which measure lung function by assessing how much and how quickly air can be exhaled.
      8. Capability to withhold asthma maintenance medication for at least 12 hours prior to V0, 1, and 4 where spirometry and/or CT scan procedures will be performed except for once-a-day dosage where 24 hours will be required: This is to ensure that medications do not interfere with the results of tests like spirometry and CT scans.
      9. Female participants with a negative pregnancy test prior to investigational product administration and high-resolution CT scan and must agree to highly effective birth control methods: Women of childbearing potential must not be pregnant when undergoing certain procedures in the trial and must use reliable contraception to prevent pregnancy during the study and for 12 weeks after the last dose of the investigational product.

      Source of criteria: .

      What Reasons Could Exclude Me from the Study?

      Based on the eligibility criteria, you cannot take part in the study if you meet any of the following:

      Unstable asthma or recent exacerbation:
      – If your asthma is unstable or you had an asthma exacerbation (worsening of symptoms) in the 6 weeks before the screening visit

      Recent airway infection:
      – If you had an acute upper or lower respiratory infection in the 6 weeks before the screening visit

      Other significant lung diseases:
      – If you have been diagnosed with any clinically important lung disease besides asthma
      – If you have a lung or systemic disease (affecting the whole body) that causes high eosinophil counts in the blood, other than asthma

      Recent biologic asthma treatment:
      – If you received any biologic medications for asthma within 4 months or 5 half-lives before screening, whichever is longer

      Immunosuppressive medications:
      – If you have a history of using or currently use chronic immunosuppressive medications (that suppress the immune system) for more than 4 weeks

      Prior lung surgery or rehabilitation:
      – If you had lung volume reduction surgery, lung resection, or bronchial thermoplasty before screening
      – If you are currently in an active pulmonary rehabilitation program

      History of cancer:
      – If you have a current malignancy (cancer) or history of malignancy

      Other clinically significant conditions:
      – If you have a history of any other clinically significant disease or abnormality

      Positive for certain infections:
      – If you test positive for Hepatitis B, Hepatitis C, or HIV

      COVID-19 restrictions:
      – If you have a positive COVID-19 test at screening
      – If you had COVID-19 within 6 weeks before screening
      – If you have a history of severe COVID-19 requiring ICU stay or mechanical ventilation at any time


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drug involved in the study is benralizumab, which is also known by its trade name Fasenra. Participants will receive 3 doses of benralizumab with a strength of 30 mg subcutaneously once every 4 weeks.

      The active substance in benralizumab is an anti-interleukin-5 receptor alpha monoclonal antibody. It targets and reduces eosinophils, a type of white blood cell that plays a central role in the pathophysiology of asthma. By reducing the number of eosinophils, benralizumab helps in reducing airway inflammation and preventing asthma exacerbations in individuals with severe eosinophilic asthma.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substance being investigated in the clinical trial is Benralizumab. Below is a description of this substance:

      1. Benralizumab: This is a monoclonal antibody and is already known in medicine and medical literature, mainly under the trade name Fasenra. It is being used in this clinical trial to assess the effects on airway dynamics in severe eosinophilic asthma, using quantitative computed tomography (CT)-derived measurements of pulmonary structure and function using the Functional Respiratory Imaging (FRI) platform. The trial is a phase IV, interventional, open-label, single-group, multicenter clinical trial. This substance is used to target and decrease eosinophils, a type of white blood cell that plays a key role in the symptoms of eosinophilic asthma.

      Study ID

      CT-EU-00034282

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      IV

      Medicinal Product