CT Air-trapping for the Early Identification of Benralizumab Responders Among Eosinophilic Asthma Patients
Condition: Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Study type: Interventional

Summary: 
      BenraliScan aims to obtain thoracic computed tomography imaging data to predict the future
      level of patient response to a monoclonal antibody. Because the clinical responses under
      study can take many months to manifest, early identification of patients most-likely to
      benefit from treatment and treatment rule-out for others will save considerable time for
      everybody involved.

      The primary objective of BenraliScan is to determine the prognostic value (sensitivity,
      specificity, positive predictive value, negative predictive value) of air-trapping measures
      (Expiratory/Inspiratory ratios for Mean Lung Density (MLDe/i)) detected via quantitative
      thoracic computed tomography at baseline for improvement in exacerbation rate (the presence
      of a ≥50% reduction in baseline exacerbation rate versus the absence of a ≥50% reduction in
      baseline exacerbation rate) at 52 weeks among eosinophilic asthma patients treated with
      Benralizumab.
    

Detailed description: 
      Secondary, exploratory objectives include:

        -  To describe clinical improvement category sub-groups (e.g. non-responders versus strong
           responders) in terms of: target concomitant medication usage, symptomology, quality of
           life (questionnaires), exacerbation rates (and other adverse events) and lung function
           parameters, differential blood counts, serum club cell secretory protein (CCSP) levels,
           other quantitative thoracic computed tomography (QTCT) variables, sinus mucosal
           thickness.

        -  To perform exploratory, prognostic-value studies (including but not limited to
           prognostic variables derived from changes occurring over 24 weeks and from clustering or
           factor mining at baseline and 24 weeks). These exploratory studies will include (but are
           not necessarily limited to) estimating the sensitivity/specificity of baseline/early
           imaging variables (or combination thereof) for predicting clinical response variables.

        -  To describe the prognostic categories (e.g. predicted non-responder versus predicted
           responder) found in terms of: clinical improvement, target concomitant medication usage,
           symptomology, quality of life (questionnaires), exacerbation rates (and other adverse
           events) and lung function parameters, differential blood counts, serum CCSP levels,
           other QTCT variables, sinus mucosal thickness.

        -  To create a centralised image library associated with the study.

        -  To verify the reproducibility of the relationships found between mean lung density
           (upper and lower lung, inspiratory and expiratory), the fractal dimension of -850 HU
           segmentations, and clinical variables found during the SCANN'AIR study (NCT03102749).

        -  To explore the association between bronchial homothety curves (the homothety of two
           consecutive bronchial measurements as a function of bronchial generation) and disease
           severity/progression.

        -  To monitor patient safety throughout the study.
    

Intervention name(s): 48 weeks of Benralizumab; Computed tomography
Intervention type(s): Drug; Other
Intervention description(s): Benralizumab is administered for 48 weeks (week 0 to week 48) every 4 weeks for the first 3 injections (30 mg sc per injection), and then every 8 weeks for the following 5 injections.; Computed tomography of the thorax is performed at the beginning (week 0), middle (week 24) and towards the end (week 48) of Benralizumab therapy. A sinus scan is also added on weeks 0 and 48.
Intervention MeSH terms: Benralizumab
Intervention model: Single Group Assignment
Intervention model description: This single arm protocol will study individual patient responses to 12 months of benralizumab treatment and early means of detecting them. The model is a prognostic study that will use information detected via baseline quantitative thoracic computed tomography for predicting improvement in exacerbation rate 52 weeks after the start of treatment.
Masking: None (Open Label)
Primary purpose: Diagnostic