Predictive Signature of Benralizumab Response
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNantes University Hospital
About this trial
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)
Eligibility criteria
Qualifiers
Patients between 18 and 75 years old.
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,
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Benralizumab Prefilled Syringe
Treatment groups
220 Participants
are divided into 1 treatment groupSponsors and collaborators
Nantes University Hospital
Lead sponsor
AstraZeneca
Collaborator
Ministère de la Santé - France
Collaborator
Source ClinicalTrials.gov