BENRAPREDPredictive Signature of Benralizumab Response
Benralizumab Prefilled Syringe
Asthme+12
+ Maladies bronchiques
+ Éosinophilie
Autre étude
Résumé
Date de début de l'étude : 11 octobre 2021
Date à laquelle le premier participant a commencé l'étude.The objective of the study is to establish the predictive value of early blood gene expression signature of Benralizumab response associated with a significant reduction of the number of exacerbations in treated severe asthmatic patients. This trial is a French, multicenter and no-randomized trial. Patients enrolled will be clinically followed for 16 months (the treatment period: 12 months and 1 month follow-up; 6 clinical visit on site and in phone call at 13 months)
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.220 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Autre
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 75 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 ≥ 200 milliliter * ACQ-7 score ≥ 1,5 at M0. * ≥ 3 exacerbations in the 12 months prior to screening visit M-1. * 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: * Fractional Exhaled Nitric Oxide (FeNO) \> 25 ppm at inclusion visit or in the 12 months prior to the inclusion visit. * Sputum eosinophils ≥ 3% at inclusion visit or in the 12 months prior to the inclusion visit. * 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). * 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 * 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, curators or safeguard of justice
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 20 sites
Centre hospitalier Intercommunal Aix-en-Provence
Aix-en-Provence, FranceOuvrir Centre hospitalier Intercommunal Aix-en-Provence dans Google MapsCHU Angers
Angers, FranceCHU Bordeaux
Bordeaux, FranceCHRU Brest
Brest, France