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Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
Sponsor: AstraZeneca
Summary
The purpose of the study is to evaluate effect of benralizumab on structural and lung function changes in severe eosinophilic asthmatics. Changes will be assessed over 48 week treatment period in patients with persistent symptoms despite standard therapy of inhaled corticosteroids (ICS) plus long acting B2-agonist (LABA) with or without additional controller medication. Patients who complete treatment will enter 4 weeks follow-up period.
Official title: A Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2019-10-08
Completion Date
2026-10-19
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Benralizumab
Benralizumab: 30 mg/mL solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.
Placebo
Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.
Locations (35)
Research Site
Birmingham, Alabama, United States
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Los Angeles, California, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Snellville, Georgia, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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Ann Arbor, Michigan, United States
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Bloomfield Hills, Michigan, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Maspeth, New York, United States
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New Bern, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Pittsburgh, Pennsylvania, United States
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Galveston, Texas, United States
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Lewisville, Texas, United States
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Mansfield, Texas, United States
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Calgary, Alberta, Canada
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Aalborg, Denmark
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Aarhus N, Denmark
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Copenhagen, Denmark
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Hvidovre, Denmark
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Næstved, Denmark
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Odense C, Denmark
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Vejle, Denmark
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Gothenburg, Sweden
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Lund, Sweden
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Cambridge, United Kingdom
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Headington, United Kingdom
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Leicester, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Wythenshawe, United Kingdom