The study population corresponds to severe eosinophilic asthma patients
Conditions
Interventions
Trade Name: Fasenra (benralizumab)
Pharmaceutical Form: Solution for injection
Sponsors
University Hospital of Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Understanding and acceptance of the protocol •The patient has given his/her informed consent and signed the consent form •Affiliation with or beneficiary of the French national health insurance system •Female and male patients aged 18 to 75 years (inclusively) with a history of physician-diagnosed severe asthma (according to GINA criteria) requiring treatment with inhaled corticosteroid (ICS) plus asthma controller for at least 12 months prior to inclusion Other acceptable asthma controllers include a long acting bronchodilator (LABA or long-acting muscarinic antagonists [LAMA]), a leukotriene inhibitor, theophylline preparations or maintenance oral corticosteroid (OCS) (daily or every other day OCS requirement in order to maintain asthma control; maximum total daily dose 20 mg prednisone or equivalent). •Documented current treatment with high daily doses of ICS (>1000 µg equivalent beclomethasone) plus at least one other asthma controller for at least 6 months prior to inclusion •History of at least 2 asthma exacerbations while on ICS plus another asthma controller that required treatment with systemic corticosteroids (any administration route) in the 12 months prior to inclusion. For patients receiving corticosteroids as a maintenance therapy, the corticosteroid treatment for the exacerbation is defined as a temporary increase in their maintenance dose. •Uncontrolled disease (Asthma Control Questionnaire >1.5) •Pre bronchodilator forced expiratory volume at 1 second (% predicted) between 40% and 85%, established according to the NHANESIII criteria •Blood eosinophilia = 300 cells / µl at least twice during the previous 12 months –OR– blood eosinophilia = 300 cells / µl upon inclusion •Women of childbearing potential must use at least one acceptable and effective form of birth control •Weight = 40 kg 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: •Other respiratory diseases or associated lung infections •Patient treated with a monoclonal antibody in the 5 months preceding inclusion •Patient who participated in a therapeutic study in the month prior to inclusion •Patient deprived of liberty by judicial or administrative decision •Major (adult) protected by the law (under any kind of guardianship) •Patient in an exclusion period determined by another protocol •Patient who participated in another research protocol with X-ray exposure in the past 12 months •Patient who has already participated in the present protocol •Hypersensitivity to benralizumab* or to any of the excipients*: histidine, histidine hydrochloride monohydrate, trehalose dehydrate, polysorbate 20 and water for injections •Exacerbation*, antibiotics, or non-maintenance systemic steroids during the 6 weeks prior to inclusion •Subjects with untreated helminthic parasitic infection* •Lactating or pregnant* females or females who intend to become pregnant •Subjects with a history of anaphylaxis to any biologic therapy •Subjects taking immunosuppressive medications (except oral prednisone and inhaled and topical corticosteroids) •Subjects with intercurrent illnesses (eg, viral illnesses) that may compromise the safety of the subject •Subjects who are febrile (=38°C) •Currently smoking or smoking history = 20 pack years •Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date of informed consent, and assent when applicable was obtained •Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date of informed consent, and assent when applicable, was obtained *Elements mentioned in the Summary of Product Characteristics for benralizumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the prognostic value (sensitivity and specificity) of air-trapping measures (Expiratory/Inspiratory Mean Lung Density) detected via quantitative thoracic computed tomography at baseline for improvement in exacerbation rate (0 to 1 non-severe exacerbation during follow-up versus all others) at 52 weeks among eosinophilic patients with chronic airway disorders treated with Benralizumab.;Secondary Objective: • To describe clinical improvement category sub-groups (non-responders versus strong responders) • To perform exploratory, prognostic-value studies (including prognostic variables derived changes occurring over 24 weeks and from clustering or factor mining at baseline and 24 weeks). These exploratory studies will include estimating the sensitivity/specificity of baseline/early imaging variables for predicting clinical response variables. • To describe the prognostic categories (predicted non-responder versus predicted responder) • To create a centralized image library associated with the study. • To explore the association between bronchial homothety curves and disease severity/progression. • To verify the reproducibility of the relationships found between mean lung density, the fractal dimension of -850 HU segmentations, and clinical variables found during the SCANN’AIR study (NCT03102749). • To monitor patient safety throughout the study.;Primary end point(s): The sensitivity and specificity of the baseline expiratory to inspiratory mean lung density (E/I MLD) for predicting improvement in exacerbation rate (0 to 1 non-severe exacerbation during follow-up versus all others) at week 52.;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of exacerbations occurring during follow-up • FEV1 pre BD • ACQ score • Concomitant medication • Self-questionnaires : ACQ, SNOT22, St-George • Plethysmography variables • Spirometry variables • Blood counts • Thoracic CT scans • Sinus CT scan;Timepoint(s) of evaluation of this end point: Week 52 | — |
Countries
France
Contacts
Public ContactGuillemette TACONNET DECKER
University Hospital of Montpellier
Outcome results
None listed