Phase 4 Asthma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 75 years old.
• People who have been diagnosed with severe asthma, meaning their asthma requires high doses of inhaled corticosteroid medication (above 1000 micrograms per day of Beclomethasone or an equivalent) combined with other long-acting medicines to keep it under control, and/or their asthma remains uncontrolled despite these medicines, and/or their asthma worsens when their medicines are reduced.
• People whose breathing test results have previously shown a meaningful improvement (at least 12% and 200 millilitres increase in a measure called FEV1) after taking a reliever medicine.
• People whose asthma control questionnaire score (ACQ-7) is 1.5 or higher at the start of the trial.
• People who have had 3 or more asthma attacks (exacerbations) in the 12 months before the initial screening visit.
• People whose blood test shows a type of immune cell called eosinophils at a level of 0.3 G/L or higher, either at the time of joining or within the previous 12 months. People with a slightly lower eosinophil level (between 0.15 and 0.3 G/L) may still be eligible if they also meet at least one additional marker of an eosinophilic asthma type — either a nitric oxide breath test result above 25 ppm, or eosinophils making up 3% or more of cells in a mucus (sputum) sample (confirm with trial site).
• People who provide written consent to take part before the study begins.

Who may not be able to join:

• People whose asthma is considered difficult-to-treat or whose breathing problems may be caused by another condition (such as vocal cord dysfunction, acid reflux, sleep apnoea, a fungal lung condition, or an overlap between asthma and another lung disease called COPD), as determined by the trial doctor.
• People who have not been consistently taking their prescribed inhaled asthma medicines (inhaled corticosteroids and long-acting bronchodilators).
• People who currently smoke, or former smokers who smoked heavily (more than 20 pack-years — a measure combining the number of cigarettes smoked and the number of years of smoking).
• People who are experiencing an asthma attack at the time of the first main trial visit.
• People who currently have cancer, or who have had cancer that has been in remission for less than 5 years.
• People with a current parasitic infection, or who have had one in the past 24 weeks.
• People who have a known allergy or sensitivity to Benralizumab or any of the ingredients in Fasenra® (the study drug).
• People who require other medicines that suppress or alter the immune system.
• People who need a different type of biologic therapy (a specialised medicine that targets the immune system) other than Benralizumab, whether or not it is approved in France for severe asthma.
• People with a current SARS-CoV-2 (COVID-19) infection.
• People who are pregnant, breastfeeding, or who are capable of becoming pregnant and are not willing to use an effective contraceptive method during the trial.
• People with a psychiatric condition that affects their understanding or their ability to give informed consent.
• People who are already participating in another clinical intervention research study.
• People who do not have French health insurance coverage.
• People who are under legal guardianship or a similar protective legal arrangement.

Important: Always verify eligibility with the trial site directly before applying.