- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01914757
Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist
November 30, 2016 updated by: AstraZeneca
A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)
The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2508
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina
- Research Site
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Caba, Argentina
- Research Site
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Ciudad Autónoma de Bs. As., Argentina
- Research Site
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Ciudad de Buenos Aires, Argentina
- Research Site
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Concepción del Uruguay, Argentina
- Research Site
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Corrientes, Argentina
- Research Site
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Córdoba, Argentina
- Research Site
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Florida, Argentina
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Godoy Cruz, Argentina
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La Plata, Argentina
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Mar del Plata, Argentina
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Mendoza, Argentina
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Ranelagh, Argentina
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Rosario, Argentina
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San Miguel de Tucuman, Argentina
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Quebec, Canada
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Alberta
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Calgary, Alberta, Canada
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Sherwood Park, Alberta, Canada
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British Columbia
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Vancouver, British Columbia, Canada
- Research Site
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New Brunswick
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Moncton, New Brunswick, Canada
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Ontario
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Burlington, Ontario, Canada
- Research Site
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Hamilton, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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St Charles Borromee, Quebec, Canada
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Concepcion, Chile
- Research Site
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Quillota, Chile
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Santiago, Chile
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Talcahuano, Chile
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Valparaiso, Chile
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Viña del Mar, Chile
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Aschaffenburg, Germany
- Research Site
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Bamberg, Germany
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Berlin, Germany
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Bonn, Germany
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Frankfurt, Germany
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Frankfurt/Main, Germany
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Geesthacht, Germany
- Research Site
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Gelsenkirchen, Germany
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Hamburg, Germany
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Hannover, Germany
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Herford, Germany
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Leipzig, Germany
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Mainz, Germany
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München, Germany
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Neu-Isenburg, Germany
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Rostock, Germany
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Rüdersdorf, Germany
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Witten, Germany
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Asahi-shi, Japan
- Research Site
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Chiyoda-ku, Japan
- Research Site
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Chuo-ku, Japan
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Fukuoka-shi, Japan
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Himeji-shi, Japan
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Hiroshima-shi, Japan
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Itabashi-ku, Japan
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Kagoshima-shi, Japan
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Kishiwada-shi, Japan
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Kobe-shi, Japan
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Kokubunji-shi, Japan
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Matsue-shi, Japan
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Minato-ku, Japan
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Mizunami-shi, Japan
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Niigata-shi, Japan
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Obihiro-shi, Japan
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Oita-shi, Japan
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Ota-shi, Japan
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Sagamihara-shi, Japan
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Sakai-shi, Japan
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Sakaide-shi, Japan
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Sapporo-shi, Japan
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Sendai-shi, Japan
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Setagaya-ku, Japan
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Shibuya-ku, Japan
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Shinagawa-ku, Japan
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Sumida-ku, Japan
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Takamatsu-shi, Japan
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Toshima-ku, Japan
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Tsukubo-gun, Japan
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Yokohama-shi, Japan
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Iloilo City, Philippines
- Research Site
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Lipa City, Philippines
- Research Site
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Quezon City, Philippines
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Aleksandrów Łódzki, Poland
- Research Site
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Białystok, Poland
- Research Site
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Bielsko Biala, Poland
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Bydgoszcz, Poland
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Bystra Śląska, Poland
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Gdańsk, Poland
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Gorzów Wlkp, Poland
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Karczew, Poland
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Katowice, Poland
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Koszalin, Poland
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Kraków, Poland
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Lubin, Poland
- Research Site
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Lublin, Poland
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Ostrów Wielkopolski, Poland
- Research Site
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Poznań, Poland
- Research Site
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Ruda Slaska, Poland
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Rzeszów, Poland
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Skierniewice, Poland
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Szczecin, Poland
- Research Site
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Tarnów, Poland
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Toruń, Poland
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Trzebnica, Poland
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Warszawa, Poland
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Wieluń, Poland
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Wroclaw, Poland
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Wrocław, Poland
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Zabrze, Poland
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Łódź, Poland
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Łęczna, Poland
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Żnin, Poland
- Research Site
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Bragadiru, Romania
- Research Site
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Brasov, Romania
- Research Site
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Bucharest, Romania
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Constanta, Romania
- Research Site
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Deva, Romania
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Iasi, Romania
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Timisoara, Romania
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Goteborg, Sweden
- Research Site
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Luleå, Sweden
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Lund, Sweden
- Research Site
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Chernivtsi, Ukraine
- Research Site
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Dnipropetrovsk, Ukraine
- Research Site
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Ivano-Frankivsk, Ukraine
- Research Site
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Kharkiv, Ukraine
- Research Site
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Kyiv, Ukraine
- Research Site
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Lutsk, Ukraine
- Research Site
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Mykolayiv, Ukraine
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Uzhgorod, Ukraine
- Research Site
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Vinnytsia, Ukraine
- Research Site
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Vinnytsya, Ukraine
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Zaporizhzhia, Ukraine
- Research Site
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Zaporozhye, Ukraine
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Alabama
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Andalusia, Alabama, United States
- Research Site
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Birmingham, Alabama, United States
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Arizona
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Flagstaff, Arizona, United States
- Research Site
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Glendale, Arizona, United States
- Research Site
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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California
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Alhambra, California, United States
- Research Site
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Anaheim, California, United States
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Beverly Hills, California, United States
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Garden Grove, California, United States
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Lakewood, California, United States
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North Hollywood, California, United States
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Northridge, California, United States
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Palmdale, California, United States
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Rancho Mirage, California, United States
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Redondo Beach, California, United States
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Rolling Hills Estate, California, United States
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Sacramento, California, United States
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Stockton, California, United States
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Thousand Oaks, California, United States
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Upland, California, United States
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Ventura, California, United States
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Walnut Creek, California, United States
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Westminister, California, United States
- Research Site
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Woodland, California, United States
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Colorado
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Centennial, Colorado, United States
- Research Site
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Colorado Springs, Colorado, United States
- Research Site
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Wheat Ridge, Colorado, United States
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Florida
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Celebration, Florida, United States
- Research Site
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Homestead, Florida, United States
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Jacksonville, Florida, United States
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Lehigh Acres, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
- Research Site
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Orlando, Florida, United States
- Research Site
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Ormond Beach, Florida, United States
- Research Site
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Virginia Gardens, Florida, United States
- Research Site
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Georgia
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Gainesville, Georgia, United States
- Research Site
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Smyrna, Georgia, United States
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Idaho
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Eagle, Idaho, United States
- Research Site
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Illinois
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Shiloh, Illinois, United States
- Research Site
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Kansas
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Lenexa, Kansas, United States
- Research Site
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Kentucky
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Fort Mitchell, Kentucky, United States
- Research Site
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Louisiana
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Covington, Louisiana, United States
- Research Site
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Maine
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Bangor, Maine, United States
- Research Site
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Michigan
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Farmington Hills, Michigan, United States
- Research Site
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Flint, Michigan, United States
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Traverse City, Michigan, United States
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Minnesota
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Minneapolis, Minnesota, United States
- Research Site
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Missouri
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St Louis, Missouri, United States
- Research Site
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Nevada
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Las Vagas, Nevada, United States
- Research Site
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New Jersey
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Union, New Jersey, United States
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New York
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Bronx, New York, United States
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North Carolina
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Durham, North Carolina, United States
- Research Site
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Wilmington, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
- Research Site
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Middleburg Heights, Ohio, United States
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Oklahoma
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Oklahoma City, Oklahoma, United States
- Research Site
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Oregon
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Corvallis, Oregon, United States
- Research Site
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Portland, Oregon, United States
- Research Site
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Pennsylvania
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Jefferson Hills, Pennsylvania, United States
- Research Site
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Pittsburgh, Pennsylvania, United States
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South Carolina
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Indian Land, South Carolina, United States
- Research Site
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South Dakota
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Rapid City, South Dakota, United States
- Research Site
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Tennessee
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Knoxville, Tennessee, United States
- Research Site
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Texas
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Arlington, Texas, United States
- Research Site
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Austin, Texas, United States
- Research Site
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Boerne, Texas, United States
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Dallas, Texas, United States
- Research Site
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Houston, Texas, United States
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San Antonio, Texas, United States
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Utah
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Midvale, Utah, United States
- Research Site
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Murray, Utah, United States
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Virginia
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Fairfax, Virginia, United States
- Research Site
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Falls Church, Virginia, United States
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Wisconsin
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Madison, Wisconsin, United States
- Research Site
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Milwaukee, Wisconsin, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- Female and male aged 12 to 75 years, inclusively, at the time of Visit 1
- History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1.
- Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.
Exclusion criteria:
- Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
- Affect the safety of the patient throughout the study
- Influence the findings of the studies or their interpretations
- Impede the patient's ability to complete the entire duration of study
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
- Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Benralizumab 30 mg q.4 weeks
Benralizumab administered subcutaneously every 4 weeks
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Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
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Experimental: Benralizumab 30 mg q.8 weeks
Benralizumab administered subcutaneously every 8 weeks
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Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
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Placebo Comparator: Placebo
Placebo administered subcutaneously
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Placebo subcutaneously on study week 0 until study week 52 inclusive.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
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The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
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Immediately following the first administration of study drug through Study Week 56.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
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The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
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Immediately following the first administration of study drug through Study Week 56.
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Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
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Immediately following the first administration of study drug through Study Week 56.
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Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
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Immediately following the first administration of study drug through Study Week 56.
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Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
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Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary.
Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma).
Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1.
Each timepoint is calculated as bi-weekly means based on daily diary data.
If more than 50% of scores are missing in a 14 day period then this is considered as missing.
Symptom score lower is better.
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Immediately following the first administration of study drug through Study Week 56.
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Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
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Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary.
Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma).
Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1.
Each timepoint is calculated as bi-weekly means based on daily diary data.
If more than 50% of scores are missing in a 14 day period then this is considered as missing.
Symptom score lower is better.
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Immediately following the first administration of study drug through Study Week 56.
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Change in Asthma Rescue Medication Use
Time Frame: Immediately following the first administration of study drug through Study Week 56.
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Change from Baseline to Week 56 in number of Rescue medication use (puffs/day)
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Immediately following the first administration of study drug through Study Week 56.
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Home Lung Function Assessments Based on PEF
Time Frame: Immediately following the first administration of study drug through Study Week 56.
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Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow [PEF])
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Immediately following the first administration of study drug through Study Week 56.
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Proportion of Nights With Awakening Due to Asthma
Time Frame: Immediately following the first administration of study drug through Study Week 56.
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Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma
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Immediately following the first administration of study drug through Study Week 56.
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Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
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ACQ-6 contains one bronchodilator question and 5 symptom questions.
Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled).
Mean ACQ-6 score is the average of the responses.
Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
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Immediately following the first administration of study drug through Study Week 56.
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Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
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ACQ-6 contains one bronchodilator question and 5 symptom questions.
Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled).
Mean ACQ-6 score is the average of the responses.
Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
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Immediately following the first administration of study drug through Study Week 56.
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Number of Patients With >=1 Asthma Exacerbation
Time Frame: Immediately following the first administration of study drug through Study Week 56
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Immediately following the first administration of study drug through Study Week 56
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Time to First Asthma Exacerbation
Time Frame: Immediately following the first administration of study drug through Study Week 56
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Immediately following the first administration of study drug through Study Week 56
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Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations
Time Frame: Immediately following the first administration of study drug through Study Week 56.
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Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated)
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Immediately following the first administration of study drug through Study Week 56.
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Pharmacokinetics of Benralizumab
Time Frame: Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60
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Mean PK Concentration at each visit
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Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60
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Immunogenicity of Benralizumab
Time Frame: Pre-treatment until end of follow-up
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Anti-drug antibodies (ADA) responses at baseline and post baseline.
Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment.
Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.
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Pre-treatment until end of follow-up
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Extent of Exposure
Time Frame: Immediately following the first administration of study drug through Study Week 56
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Extent of exposure is defined as the duration of treatment in days
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Immediately following the first administration of study drug through Study Week 56
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Mean Change From Baseline to Week 56 in AQLQ(S)+12
Time Frame: Immediately following the first administration of study drug through Study Week 56
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AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire.
AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).
Total or domain score change of >=0.5 are considered clinically meaningful.
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Immediately following the first administration of study drug through Study Week 56
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Change From Baseline to Week 56 in EQ-5D-5L VAS
Time Frame: Immediately following the first administration of study drug through Study Week 56
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EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.
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Immediately following the first administration of study drug through Study Week 56
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Mean Work Productivity Loss Due to Asthma
Time Frame: Immediately following the first administration of study drug through Study Week 56
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WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions.
Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working.
Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked.
This is only applicable to patients who were employed.
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Immediately following the first administration of study drug through Study Week 56
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Mean Productivity Loss Due to Asthma in Classroom
Time Frame: Immediately following the first administration of study drug through Study Week 56
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WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions.
Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity.
Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes.
This is only applicable for patients who took classes.
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Immediately following the first administration of study drug through Study Week 56
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Number of Participants That Utilized Health Care Resources
Time Frame: Immediately following the first administration of study drug through Study Week 56
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Immediately following the first administration of study drug through Study Week 56
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Patient and Clinician Assessment of Response to Treatment
Time Frame: Immediately following the first administration of study drug through Study Week 56
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CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse).
This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed.
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Immediately following the first administration of study drug through Study Week 56
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark Fitzgerald, MD, PhD, Professor of Medicine, The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Menzies-Gow A, Hoyte FL, Price DB, Cohen D, Barker P, Kreindler J, Jison M, Brooks CL, Papeleu P, Katial R. Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab. Adv Ther. 2022 May;39(5):2065-2084. doi: 10.1007/s12325-022-02098-1. Epub 2022 Mar 14.
- Lugogo NL, Kreindler JL, Martin UJ, Cook B, Hirsch I, Trudo FJ. Blood eosinophil count group shifts and kinetics in severe eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Aug;125(2):171-176. doi: 10.1016/j.anai.2020.04.011. Epub 2020 Apr 22.
- Jackson DJ, Humbert M, Hirsch I, Newbold P, Garcia Gil E. Ability of Serum IgE Concentration to Predict Exacerbation Risk and Benralizumab Efficacy for Patients with Severe Eosinophilic Asthma. Adv Ther. 2020 Feb;37(2):718-729. doi: 10.1007/s12325-019-01191-2. Epub 2019 Dec 14.
- Chipps BE, Hirsch I, Trudo F, Alacqua M, Zangrilli JG. Benralizumab efficacy for patients with fixed airflow obstruction and severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Jan;124(1):79-86. doi: 10.1016/j.anai.2019.10.006. Epub 2019 Oct 15.
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- Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, Goldman M, Newbold P, Zangrilli JG. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018 Oct 18;52(4):1800936. doi: 10.1183/13993003.00936-2018. Print 2018 Oct.
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Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
July 31, 2013
First Submitted That Met QC Criteria
July 31, 2013
First Posted (Estimate)
August 2, 2013
Study Record Updates
Last Update Posted (Estimate)
January 25, 2017
Last Update Submitted That Met QC Criteria
November 30, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D3250C00018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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