Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
220 participants
INTERVENTIONAL
2021-10-11
2026-11-30
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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BENRALIZUMAB
Patients receive BENRALIZUMAB if they meet the criteria for inclusion and non-inclusion at the inclusion visit. Injections take place at the inclusion visit, at 1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months.
Benralizumab Prefilled Syringe
Patients receive BENRALIZUMAB if they meet the criteria for inclusion and non-inclusion at the inclusion visit. Injections take place at the inclusion visit, at 1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months.
Interventions
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Benralizumab Prefilled Syringe
Patients receive BENRALIZUMAB if they meet the criteria for inclusion and non-inclusion at the inclusion visit. Injections take place at the inclusion visit, at 1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Ministère de la Santé - France
UNKNOWN
Nantes University Hospital
OTHER
Responsible Party
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Locations
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Centre hospitalier Intercommunal Aix-en-Provence
Aix-en-Provence, , France
CHU Angers
Angers, , France
CHU Bordeaux
Bordeaux, , France
CHRU Brest
Brest, , France
CHU Dijon
Dijon, , France
CHU Grenoble
Grenoble, , France
Hôpital Bicêtre - AP-HP
Le Kremlin-Bicêtre, , France
CH Mans
Le Mans, , France
CHU Lille
Lille, , France
Hospices Civils de Lyon
Lyon, , France
Assistance Publique des Hôpitaux de Marseille
Marseille, , France
CHU Montpellier
Montpellier, , France
CHU Nantes
Nantes, , France
CHR Orléans
Orléans, , France
Hôpital Bichat - AP-HP
Paris, , France
CHU Rouen
Rouen, , France
CHU Strasbourg
Strasbourg, , France
Hôpital FOCH
Suresnes, , France
CHU Toulouse
Toulouse, , France
Médipôle Hôpital Mutualiste de Villeurbanne
Villeurbanne, , France
Countries
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Central Contacts
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Facility Contacts
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Youssef TRIGUI, MD-PHD
Role: primary
Hakima OUKSEL, MD
Role: primary
Pierre-Olivier GIRODET, MD-PHD
Role: primary
Raphael LE MAO, MD-PHD
Role: primary
Philippe BONNIAUD, MD-PHD
Role: primary
Christel SAINT-RAYMOND, MD-PHD
Role: primary
Marc HUMBERT, MD-PHD
Role: primary
Gilles DEVOUASSOUX, MD-PHD
Role: primary
Pascal CHANEZ, MD-PHD
Role: primary
Sylvie DRUELLE
Role: primary
Camille TAILLE, MD-PHD
Role: primary
Naji KHAYATH, MD
Role: primary
Colas TCHERAKIAN, MD-PHD
Role: primary
Laurent GUILLEMINAULT, PD-PHD
Role: primary
Jean-Marc DOT, MD-PHD
Role: primary
Other Identifiers
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RC19_0292
Identifier Type: -
Identifier Source: org_study_id
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