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Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment
Sponsor: AstraZeneca
Summary
This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.
Official title: BRISOTE: A Multicentre, Randomised, Double-Blind, Parallel Group, Active-Controlled, Phase 3b Study to Evaluate the Efficacy and Safety of Benralizumab 30 mg SC in Eosinophilic Asthma Patients Uncontrolled on Medium-Dose Inhaled Corticosteroid Plus Long-acting β2-Agonist.
Key Details
Gender
All
Age Range
12 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2025-03-28
Completion Date
2026-09-21
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
ICS-LABA
ICS-LABA inhalation
benralizumab
Benralizumab. SC injection.
Placebo for Benralizumab
Placebo for Benralizumab (aka, "placebo"). SC injection.
Locations (86)
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Sun City, Arizona, United States
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Tucson, Arizona, United States
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Inglewood, California, United States
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Newport Beach, California, United States
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Pasadena, California, United States
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Cape Coral, Florida, United States
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Lauderdale Lakes, Florida, United States
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Leesburg, Florida, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Ann Arbor, Michigan, United States
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Henderson, Nevada, United States
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Northfield, New Jersey, United States
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New Hyde Park, New York, United States
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The Bronx, New York, United States
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DuBois, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Greenville, South Carolina, United States
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San Antonio, Texas, United States
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Kamloops, British Columbia, Canada
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Ajax, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Beijing, China
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Beijing, China
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Changsha, China
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Chongqing, China
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Fuzhou, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Hefei, China
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Huizhou, China
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Jinan, China
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Qinhuangdao, China
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Shanghai, China
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Shanghai, China
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Wuhan, China
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Xuzhou, China
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Yinchuan, China
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Zhengzhou, China
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Créteil, France
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Montpellier, France
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Toulouse, France
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Villeurbanne, France
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Berlin, Germany
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Berlin, Germany
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Cottbus, Germany
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Geesthacht, Germany
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Lübeck, Germany
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Wiesbaden, Germany
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Shatin, Hong Kong
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Cork, Ireland
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Dublin, Ireland
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Moneymore, Ireland
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Bergamo, Italy
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Genoa, Italy
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Milan, Italy
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Naples, Italy
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Roma, Italy
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Roma, Italy
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Rozzano, Italy
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Verona, Italy
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Lørenskog, Norway
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Alcorcón, Spain
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Badalona, Spain
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Barakaldo, Spain
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Jerez de la Frontera, Spain
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Lugo, Spain
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Madrid, Spain
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Marbella, Spain
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Marbella, Spain
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Málaga, Spain
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Palma de Mallorca, Spain
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Santander, Spain
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Aarau, Switzerland
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Birmingham, United Kingdom
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Bradford, United Kingdom
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Bristol, United Kingdom
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Leeds, United Kingdom