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ClinicalTrials.gov ID

NCT04565483

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

220Estimated

Last Update Posted

Apr 26, 2024Actual

Start Date

Oct 11, 2021Actual

Primary Completion Date

Oct 2026Estimated

Completion Date

Nov 2026Estimated

Official Title

Predictive Signature of Benralizumab Response

Brief Summary

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)

• Asthma; Eosinophilic
• Severe Asthma

• Benralizumab Prefilled Syringe

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Nantes University HospitalOTHER

Collaborators

AstraZenecaINDUSTRY

Ministère de la Santé - FranceUNKNOWN

xavier.blanc@chu-nantes.fr+33240165545