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Clinical Trial Summary

This study will assess the effects of benralizumab on airway dynamics in severe eosinophilic asthma in terms of quantitative computed tomography (CT)-derived measurements of pulmonary structure and function using the Functional Respiratory Imaging (FRI) platform.


Clinical Trial Description

This is a phase IV, interventional single group, open-label, uncontrolled, prospective, multicenter clinical trial. This study will be conducted in male and female participants ≥18 years old with established severe eosinophilic asthma as defined by European Respiratory Society (ERS)/American Thoracic Society (ATS) clinical guidelines inadequately controlled by treatment with Inhaled Corticosteroids-Long-acting β2 agonists (ICS-LABA) with or without oral corticosteroids (OCS) or other asthma controller medications. Each participant will participate in the study for a minimum of 15 weeks and up to 23 weeks. This study will comprise of: Screening visit (V0) Visit 1 (V1; week 0; within 1 to 21 days of screening) Visit 2 (V2; week 4 ± 5 days) Visit 3 (V3; week 8 ± 5 days) Visit 4 (V4; week 13 ± 5 days) Follow-up (2 weeks [± 7 days] after V4) - Phone call follow-up. Participants will be discharged from the study after the phone call follow-up is completed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05552508
Study type Interventional
Source AstraZeneca
Contact
Status Active, not recruiting
Phase Phase 4
Start date October 11, 2022
Completion date July 31, 2024

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