Predictive Signature of Benralizumab Response. BENRAPRED Study.

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

Patients between 18 and 75 years old, Patients diagnosed with severe asthma (Chung and al, Eur Respir J 2014), i.e.: asthma requiring high doses of ICS (>1000 microgram per day of Beclomethasone or equivalent) associated with LABA and/or systemic corticosteroids to be controlled over one year, and/or uncontrolled asthma despite the later medications, and/or a controlled asthma worsening after decreasing medications, Documented historical reversibility of FEV1 =12% and FEV1 gain = 200mL, ACQ-7 score = 1,5 at M0, At least 3 exacerbations in the 12 months prior to inclusion visit M0, Eosinophil blood count = 0,3 G/L at inclusion visit or in the 12 months prior to the inclusion visit. If eosinophil blood count is = 0,15 G/L and < 0,3 G/L, an eosinophilic phenotype defined by at least 1 of the following criteria will be required: FeNO > 25 ppm at inclusion visit or in the 12 months prior to the inclusion visit, or/andSputum eosinophils at leat 3% at inclusion visit or in the 12 months prior to the inclusion visit, Patient who has never received treatment with Benralizumab before prior to participation in the study, Patients who provide written informed consent prior to participation in the study

Exclusion Criteria

Patients diagnosed with difficult-to-treat asthma and/or with uncontrolled asthma differential diagnosis according to the judgment of the investigator (e.g., vocal cord dysfunction, gastroesophageal reflux disease, granulomatous eosinophilic vasculitis, obstructive sleep apnea syndrome, hyperventilation syndrome, allergic broncho-pulmonary aspergillosis, Carrington disease, DIPNECH, asthma/COPD overlap syndrome)., Patients requiring other biotherapy than Benralizumab that affects the immune system, SARS-COV2 infection, Pregnancy, lactation, or patients with childbearing potential refusing efficient contraceptive method., Patients under psychiatric condition altering their comprehension and their ability to give informed consent., Patients already enrolled in a clinical interventional research., Patients not affiliated to a health insurance plan, Patients under guardianship, curatorship or safeguard of justice, Non-adherent patients to inhaled treatment (ICS + LABA)., Active smokers or former smokers exceeding 20 packs year., Exacerbation at inclusion visit M0, Active malignancy or malignancy in remission over less than 5 years., Active parasitic infection or parasitic infection in the past 24 weeks., Hypersensitivity to Benralizumab or to any of the excipients of Fasenra® (histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20), Patients requiring other immunosuppressive and immunomodulator drugs, Patients requiring other biotherapy than Benralizumab, with or without French’s marketing authorisation in severe asthma

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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