Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma

The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Biological: Benralizumab; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 2681
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Bedford Park, Australia
    • Research Site
  • Box Hill, Australia
    • Research Site
  • Clayton, Australia
    • Research Site
  • Concord, Australia
    • Research Site
  • Frankston, Australia
    • Research Site
  • Nedlands, Australia
    • Research Site
  • New Lambton Heights, Australia
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  • Parkville, Australia
    • Research Site
  • Prahran, Australia
    • Research Site
  • Randwick, Australia
    • Research Site
  • Woolloongabba, Australia
    • Research Site
• Brazil
  • Porto Alegre, Brazil
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  • Rio de Janeiro, Brazil
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  • Santo André, Brazil
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  • Sao Paulo, Brazil
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  • Sorocaba, Brazil
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  • São Paulo, Brazil
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• Bulgaria
  • Dupnitsa, Bulgaria
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  • Pernik, Bulgaria
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  • Pleven, Bulgaria
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  • Ruse, Bulgaria
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  • Samokov, Bulgaria
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  • Sliven, Bulgaria
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  • Sofia, Bulgaria
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  • Stara Zagora, Bulgaria
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  • Varna, Bulgaria
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  • Velingrad, Bulgaria
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  • Yambol, Bulgaria
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• Czech Republic
  • Brno, Czech Republic
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  • Jindrichuv Hradec, Czech Republic
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  • Karlovy Vary, Czech Republic
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  • Ostrava, Czech Republic
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  • Pardubice, Czech Republic
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  • Plzen, Czech Republic
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  • Praha, Czech Republic
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  • Rokycany, Czech Republic
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  • Strakonice, Czech Republic
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  • Teplice, Czech Republic
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• France
  • Brest Cedex, France
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  • Clermont Ferrand, France
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  • Dijon Cedex, France
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  • Le Kremlin Bicêtre, France
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  • Le Mans Cedex, France
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  • Lyon Cedex 4, France
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  • Marseille, France
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  • Montpellier, France
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  • Paris, France
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  • Pau Cedex, France
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  • Pringy Cedex, France
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  • Saint Pierre, France
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  • Strasbourg Cedex, France
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  • Toulouse, France
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• Italy
  • Bari, Italy
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  • Bologna, Italy
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  • Catania, Italy
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  • Cona, Italy
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  • Firenze, Italy
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  • Foggia, Italy
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  • Legnago, Italy
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  • Milano, Italy
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  • Napoli, Italy
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  • Palermo, Italy
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  • Pavia, Italy
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  • Perugia, Italy
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  • Pisa, Italy
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  • Roma, Italy
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  • San Pietro Vernotico, Italy
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  • Torino, Italy
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  • Verona, Italy
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• Korea, Republic of
  • Anyang-si, Korea, Republic of
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  • Bucheon-si, Korea, Republic of
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  • Busan, Korea, Republic of
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  • Cheongju-si, Korea, Republic of
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  • Gwangju, Korea, Republic of
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  • Incheon, Korea, Republic of
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  • Jeju-si, Korea, Republic of
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  • Seoul, Korea, Republic of
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  • Suwon-si, Korea, Republic of
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• Mexico
  • Guadalajara, Mexico
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  • Monterrey, Mexico
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  • Morelia, Mexico
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• Peru
  • Cusco, Peru
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  • Lima, Peru
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  • Surco, Peru
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• Poland
  • Białystok, Poland
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  • Dobre Miasto, Poland
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  • Gdańsk, Poland
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  • Giżycko, Poland
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  • Grodzisk Mazowiecki, Poland
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  • Kościan, Poland
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  • Legnica, Poland
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  • Lublin, Poland
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  • Poznań, Poland
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  • Proszowice, Poland
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  • Rzeszów, Poland
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  • Sosnowiec, Poland
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  • Wołomin, Poland
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  • Wrocław, Poland
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  • Zgierz, Poland
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  • Łódź, Poland
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• Russian Federation
  • Chelyabinsk, Russian Federation
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  • Ekaterinburg, Russian Federation
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  • Ivanovo, Russian Federation
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  • Izhevsk, Russian Federation
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  • Kazan, Russian Federation
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  • Moscow, Russian Federation
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  • Nizhny Novgorod, Russian Federation
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  • Novosibirsk, Russian Federation
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  • Pyatigorsk, Russian Federation
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  • Rostov-on-Don, Russian Federation
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  • Ryazan, Russian Federation
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  • Saint - Petersburg, Russian Federation
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  • Saint Petersburg, Russian Federation
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  • Saint-Petersburg, Russian Federation
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  • Saratov, Russian Federation
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  • Smolensk, Russian Federation
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  • St. Petersburg, Russian Federation
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  • StPetersburg, Russian Federation
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  • Tomsk, Russian Federation
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  • Vladikavkaz, Russian Federation
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  • Vladimir, Russian Federation
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  • Volgograd, Russian Federation
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  • Yaroslavl, Russian Federation
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  • Yekaterinburg, Russian Federation
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• South Africa
  • Benoni, South Africa
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  • Cape Town, South Africa
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  • Durban, South Africa
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  • Mowbray, South Africa
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  • Stanger, South Africa
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• Spain
  • Barcelona, Spain
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  • Lugo, Spain
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  • Madrid, Spain
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  • Málaga, Spain
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  • Oviedo, Spain
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  • Palma de Mallorca, Spain
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  • Sagunto(Valencia), Spain
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  • Salamanca, Spain
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  • Valencia, Spain
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• Turkey
  • Adana, Turkey
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  • Ankara, Turkey
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  • Antalya, Turkey
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  • Bursa, Turkey
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  • Istanbul, Turkey
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  • Izmir, Turkey
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  • Kocaeli, Turkey
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  • Mersin, Turkey
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• United Kingdom
  • Birmingham, United Kingdom
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  • Bradford, United Kingdom
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  • Cambridge, United Kingdom
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  • Chertsey, United Kingdom
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  • Chester, United Kingdom
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  • Chippenham, United Kingdom
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  • Cottingham, United Kingdom
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  • Darlington, United Kingdom
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  • Glasgow, United Kingdom
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  • High Heaton/Newcastle upon Tyn, United Kingdom
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  • Leeds, United Kingdom
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  • Liverpool, United Kingdom
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  • London, United Kingdom
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  • Maidstone, United Kingdom
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  • Manchester, United Kingdom
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  • Nottingham, United Kingdom
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  • Plymouth, United Kingdom
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  • Portsmouth, United Kingdom
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  • Soham, United Kingdom
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  • Somerset, United Kingdom
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  • Stevenage, United Kingdom
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  • Stockton, United Kingdom
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• United States
  • Alabama
    • Foley, Alabama, United States
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    • Huntsville, Alabama, United States
      • Research Site
    • Mobile, Alabama, United States
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    • Scottsboro, Alabama, United States
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    • Sheffield, Alabama, United States
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  • Arizona
    • Phoenix, Arizona, United States
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    • Tucson, Arizona, United States
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  • California
    • Bakersfield, California, United States
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    • Beverly Hills, California, United States
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    • Costa Mesa, California, United States
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    • Huntington Beach, California, United States
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    • Huntington Park, California, United States
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    • Los Angles, California, United States
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    • Newport Beach, California, United States
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    • Orange, California, United States
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    • Riverside, California, United States
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    • San Jose, California, United States
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    • Santa Ana, California, United States
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  • Connecticut
    • Hartford, Connecticut, United States
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    • New Haven, Connecticut, United States
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  • Florida
    • Brandon, Florida, United States
      • Research Site
    • Clearwater, Florida, United States
      • Research Site
    • Cutler Bay, Florida, United States
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    • DeLand, Florida, United States
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    • Gainesville, Florida, United States
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    • Hialeah, Florida, United States
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    • Hollywood, Florida, United States
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    • Homestead, Florida, United States
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    • Jackonsville, Florida, United States
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    • Lynn Haven, Florida, United States
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    • Miami, Florida, United States
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    • Orlando, Florida, United States
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    • Pembroke Pines, Florida, United States
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    • Port Charlotte, Florida, United States
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    • Sebring, Florida, United States
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    • St Petersburg, Florida, United States
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    • Tampa, Florida, United States
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    • Vero Beach, Florida, United States
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    • Winter Park, Florida, United States
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  • Georgia
    • Albany, Georgia, United States
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    • Gainesville, Georgia, United States
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    • Lawrenceville, Georgia, United States
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  • Illinois
    • Gurnee, Illinois, United States
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    • Normal, Illinois, United States
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  • Iowa
    • Iowa City, Iowa, United States
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  • Kentucky
    • Fort Mitchell, Kentucky, United States
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    • Hazard, Kentucky, United States
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    • Louisville, Kentucky, United States
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  • Louisiana
    • Opelousas, Louisiana, United States
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  • Maryland
    • Baltimore, Maryland, United States
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  • Massachusetts
    • Gardner, Massachusetts, United States
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    • North Dartmouth, Massachusetts, United States
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    • Quincy, Massachusetts, United States
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  • Michigan
    • Farmington Hills, Michigan, United States
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  • Minnesota
    • Rochester, Minnesota, United States
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    • St. Paul, Minnesota, United States
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  • Mississippi
    • Picayune, Mississippi, United States
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  • Montana
    • Billings, Montana, United States
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  • Nebraska
    • Bellevue, Nebraska, United States
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  • Nevada
    • Las Vegas, Nevada, United States
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    • Sparks, Nevada, United States
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  • New Jersey
    • Marlton, New Jersey, United States
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    • Northfield, New Jersey, United States
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    • Union, New Jersey, United States
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  • New Mexico
    • Albuquerque, New Mexico, United States
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  • New York
    • Bronx, New York, United States
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    • Hopewell Jct, New York, United States
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    • New York, New York, United States
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    • New York City, New York, United States
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    • Staten Island, New York, United States
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  • North Carolina
    • Huntersville, North Carolina, United States
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    • Shelby, North Carolina, United States
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    • Winston-Salem, North Carolina, United States
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  • North Dakota
    • Grand Forks, North Dakota, United States
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  • Ohio
    • Oregon, Ohio, United States
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    • Toledo, Ohio, United States
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    • Wooster, Ohio, United States
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States
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    • Tulsa, Oklahoma, United States
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  • Pennsylvania
    • Erie, Pennsylvania, United States
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    • Feasterville, Pennsylvania, United States
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    • Philadelphia, Pennsylvania, United States
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    • Phoenixville, Pennsylvania, United States
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    • Pittsburgh, Pennsylvania, United States
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  • Rhode Island
    • Warwick, Rhode Island, United States
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  • South Carolina
    • Charleston, South Carolina, United States
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    • Easley, South Carolina, United States
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    • Hodges, South Carolina, United States
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    • Mt Pleasant, South Carolina, United States
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    • Rock Hill, South Carolina, United States
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  • Tennessee
    • Chattanooga, Tennessee, United States
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    • Germantown, Tennessee, United States
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  • Texas
    • Allen, Texas, United States
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    • Dallas, Texas, United States
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    • Dickinson, Texas, United States
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    • Duncanville, Texas, United States
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    • Georgetown, Texas, United States
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    • Houston, Texas, United States
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    • McAllen, Texas, United States
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    • McKinney, Texas, United States
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    • Pharr, Texas, United States
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    • Plano, Texas, United States
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    • Sealy, Texas, United States
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    • Splendora, Texas, United States
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  • Utah
    • Orem, Utah, United States
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    • Provo, Utah, United States
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    • Salt Lake City, Utah, United States
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  • Virginia
    • Abingdon, Virginia, United States
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    • Hopewell, Virginia, United States
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  • West Virginia
    • Morgantown, West Virginia, United States
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  • Wisconsin
    • Greenfield, Wisconsin, United States
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• Vietnam
  • Hanoi, Vietnam
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  • Ho Chi Minh, Vietnam
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Participation Criteria

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:

1. Written informed consent for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent[s]/guardian[s]) and according to international guidelines and/or applicable European Union guidelines.
2. Female and Male aged 12 to 75 years inclusively, at the time of visit 1. For those patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial.
3. 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

4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers.

   • For subjects 18 years of age and older, the ICS dose must be >500 mcg/day fluticasone propionate dry powder formulation or equivalent daily.
   • For subjects ages 12-17, the ICS dose must be ≥500 mcg /day fluticasone propionate dry powder formulation or equivalent daily.

Exclusion criteria:

1. 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)

2. 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
3. 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
4. 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Benralizumab 30 mg q.4 weeks; Benralizumab administered subcutaneously every 4 weeks	Biological: Benralizumab; Benralizumab subcutaneously on study week 0 until study week 44 inclusive.
Experimental: Benralizumab 30 mg q.8 weeks; Benralizumab administered subcutaneously every 8 weeks	Biological: Benralizumab; Benralizumab subcutaneously on study week 0 until study week 44 inclusive.
Placebo Comparator: Placebo; Placebo administered subcutaneously	Biological: Placebo; Placebo subcutaneously on study week 0 until study week 44 inclusive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL	The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF	Immediately following the first administration of study drug through Study Week 48.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL	The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF	Immediately following the first administration of study drug through Study Week 48.
Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations	The annual exacerbation rate associated with an emergency room visit or a hospitalization (adjudicated)	Immediately following the first administration of study drug through Study Week 48.
Number of Patients With >=1 Asthma Exacerbations		Immediately following the first administration of study drug through Study Week 48.
Time to First Asthma Exacerbation		Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL		Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL		Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL	Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point 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.	Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL	Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point 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.	Immediately following the first administration of study drug through Study Week 48.
Change in Asthma Rescue Medication	Change from baseline to week 48 in number of rescue medication use (puffs/day)	Immediately following the first administration of study drug through Study Week 48.
Home Lung Function Assessment Based on Morning PEF	Change from baseline to week 48 in home lung function morning peak expiratory flow [PEF]	Immediately following the first administration of study drug through Study Week 48.
Home Lung Function Assessment Based on Evening PEF	Change from baseline to week 48 in home lung function evening peak expiratory flow [PEF]	Immediately following the first administration of study drug through Study Week 48.
Proportion of Night Awakening Due to Asthma	Change from baseline to Week 48 on proportion of night awakening due to asthma	Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL	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.	Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL	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.	Immediately following the first administration of study drug through Study Week 48.
Pharmacokinetics of Benralizumab	Mean PK concentrations at each visit	Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56
Immunogenicity of Benralizumab	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 the first and the 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.	Pre-treatment until end of follow-up
Extend of Exposure	Extend of exposure is defined as duration of treatment in days	Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in AQLQ(S)+12	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.	Immediately following the first administration of study drug through Study Week 48.
Mean Change From Baseline to Week 48 in EQ-5D-5L VAS	EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.	Immediately following the first administration of study drug through Study Week 48.
Mean Work Productivity Loss Due to Asthma	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. The work productivity loss is only applicable to patients who employed, which is only subset of the study population.	Immediately following the first administration of study drug through Study Week 48.
Mean Productivity Loss Due to Asthma in Classroom	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 to patients who attending classes	Immediately following the first administration of study drug through Study Week 48.
Number of Participants That Utilized Health Care Resources		Immediately following the first administration of study drug through Study Week 48.
Patient and Clinician's Responder Assessment to Treatment	CGIC (Clinical 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 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse). This is additional measures collected after second Amendment, thus not all patients had data to be analyzed.	Immediately following the first administration of study drug through Study Week 48

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Eugene R. Bleecker, MD, Professor of Medicine, Center for Genomics and Personalized Medicine Research, Medical Center Boulevard, Winston-Salem, North Carolina 27157

Publications and helpful links

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

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Study record dates

Study Major Dates

• Study Start: September 19, 2013
• Primary Completion (Actual): April 5, 2016
• Study Completion (Actual): April 5, 2016

Study Registration Dates

• First Submitted: August 16, 2013
• First Submitted That Met QC Criteria: August 22, 2013
• First Posted (Estimate): August 27, 2013

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Asthma,; Bronchial Diseases,; Respiratory Tract Diseases,; Lung Diseases,; Obstructive Lung Diseases
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Anti-Asthmatic Agents; Respiratory System Agents; Benralizumab
• Other Study ID Numbers: D3250C00017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No