Predictive Signature of Benralizumab Response

Recruitment & Eligibility

Status: ot 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.:
o asthma requiring high doses of ICS (>1000 ?g per day of Beclomethasone or equivalent) associated with LABA and/or systemic corticosteroids to be controlled over one year,
o and/or uncontrolled asthma despite the later medications,
o and/or a controlled asthma worsening after decreasing medications,
- Pre-BD FEV1 <80% of the predicted value at M-1.
- Documented historical reversibility of FEV1 =12% and FEV1 gain = 200mL.
- ACQ-7 score = 1,5 at M-1 and M0.
- Superior or equal 3 exacerbations in the 12 months prior to screening visit M-1.
- Eosinophil blood count = 0,3 G/L at screening visit or in the 12 months prior to the screening 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:
o FeNO > 25 ppm at screening visit or in the 12 months prior to the screening visit.
o Sputum eosinophils ? 3% at screening visit or in the 12 months prior to the screening visit.
- Patients who provide written informed consent prior to participation in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 165
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

- Patients diagnosed with difficult-to-treat asthma and/or with asthma differential diagnosis that have not yet been excluded (vocal cord dysfunction, gastroesophageal reflux disease, granulomatous eosinophilic vasculitis, obstructive sleep apnea syndrome, hyperventilation syndrome, allergic broncho-pulmonary aspergillosis, Carrington disease, DIPNEC, asthma/COPD overlap syndrome).
- Non-adherent patients to inhaled treatment (ICS + LABA).
- Active smokers or former smokers exceeding 20 packs year.
- Exacerbation at screening visit M-1.
- Exacerbation within the past 4 weeks prior to M0, to avoid confounding effects of a short course of systemic corticosteroids that could bias basal molecular signature.
- 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
- 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

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

Related Trials