Study identifier:D3250R00107
ClinicalTrials.gov identifier:NCT05552508
EudraCT identifier:2022-000152-11
CTIS identifier:N/A
BURAN: Effects of Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma using Functional Respiratory Imaging Parameters
asthma
Phase 4
No
-
All
45
Interventional
18 Years - 70 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
-
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.
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.
Location
Location
Plantation, FL, United States, 33324
Location
Greenwood, IN, United States, 46143
Location
Barcelona, Spain, 08006
Location
Saint Louis, MO, United States, 63110
Location
Madrid, Spain, 28007
Location
Namur, Belgium, 5101
Location
Villarreal (Castellón), Spain, 12540
Location
Barcelona, Spain, 8003
Arms | Assigned Interventions |
---|---|
Experimental: Benralizumab Participants will receive 3 doses of benralizumab having a strength of 30 mg subcutaneously once every 4 weeks (Week 0, Week 4, and Week 8). | - |
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