Status and phase
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About
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)
Enrollment
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Inclusion criteria
Patients between 18 and 75 years old.
Patients diagnosed with severe asthma (Chung and al, Eur Respir J 2014), i.e.:
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:
Patients who provide written informed consent prior to participation in the study
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
220 participants in 1 patient group
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Central trial contact
François-Xavier BLANC, MD-PHD
Data sourced from clinicaltrials.gov
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