Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist
NCT ID: NCT01914757
Last Updated: 2017-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2508 participants
INTERVENTIONAL
2013-08-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Benralizumab 30 mg q.4 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Benralizumab 30 mg q.8 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Placebo
Placebo administered subcutaneously
Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.
Interventions
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Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.
Eligibility Criteria
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Inclusion Criteria
2. Female and male aged 12 to 75 years, inclusively, at the time of Visit 1
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. 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
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
12 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Fitzgerald, MD, PhD, Professor of Medicine
Role: PRINCIPAL_INVESTIGATOR
The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada
Locations
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Research Site
Andalusia, Alabama, United States
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Birmingham, Alabama, United States
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Flagstaff, Arizona, United States
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Alhambra, California, United States
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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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Westminster, California, United States
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Woodland, California, United States
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Centennial, Colorado, United States
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Colorado Springs, Colorado, United States
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Wheat Ridge, Colorado, United States
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Celebration, Florida, United States
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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
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Virginia Gardens, Florida, United States
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Gainesville, Georgia, United States
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Smyrna, Georgia, United States
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Eagle, Idaho, United States
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Shiloh, Illinois, United States
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Lenexa, Kansas, United States
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Fort Mitchell, Kentucky, United States
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Covington, Louisiana, United States
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Bangor, Maine, United States
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Farmington Hills, Michigan, United States
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Flint, Michigan, United States
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Traverse City, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Las Vagas, Nevada, United States
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Union, New Jersey, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Wilmington, North Carolina, United States
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Cincinnati, Ohio, United States
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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 City, Oklahoma, United States
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Corvallis, Oregon, United States
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Portland, Oregon, United States
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Jefferson Hills, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Old Point Station, South Carolina, United States
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Rapid City, South Dakota, United States
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Knoxville, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Boerne, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Midvale, Utah, United States
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Murray, Utah, United States
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Fairfax, Virginia, United States
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Falls Church, Virginia, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, , Argentina
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Caba, , Argentina
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Ciudad Autónoma de Bs. As., , Argentina
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Ciudad de Buenos Aires, , Argentina
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Concepción del Uruguay, , Argentina
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Corrientes, , Argentina
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Córdoba, , Argentina
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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 Tucumán, , Argentina
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Calgary, Alberta, Canada
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Sherwood Park, Alberta, Canada
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Vancouver, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Burlington, Ontario, Canada
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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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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Concepción, , Chile
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Quillota, , Chile
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Santiago, , Chile
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Talcahuano, , Chile
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Valparaíso, , Chile
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Viña del Mar, , Chile
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Aschaffenburg, , Germany
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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 am Main, , Germany
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Geesthacht, , Germany
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Gelsenkirchen, , Germany
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Hamburg, , Germany
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Hanover, , 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
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Chiyoda-ku, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Himeji-shi, , Japan
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Hiroshima, , Japan
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Itabashi-ku, , Japan
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Kagoshima, , Japan
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Kishiwada-shi, , Japan
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Kobe, , Japan
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Kokubunji-shi, , Japan
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Matsue, , Japan
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Minatoku, , Japan
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Mizunami-shi, , Japan
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Niigata, , Japan
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Obihiro-shi, , Japan
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Ota-shi, , Japan
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Ōita, , Japan
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Sagamihara-shi, , Japan
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Sakaide-shi, , Japan
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Sakaishi, , Japan
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Sapporo, , Japan
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Sendai, , 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, , Japan
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Toshima-ku, , Japan
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Tsukubo-gun, , Japan
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Yokohama, , Japan
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Iloilo City, , Philippines
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Lipa City, , Philippines
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Quezon City, , Philippines
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Aleksandrów Łódzki, , Poland
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Bialystok, , Poland
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Bielsko-Biala, , Poland
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Bydgoszcz, , Poland
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Bystra, , Poland
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Gdansk, , 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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Krakow, , Poland
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Lodz, , Poland
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Lubin, , Poland
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Lublin, , Poland
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Ostrów Wielkopolski, , Poland
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Poznan, , Poland
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Ruda Śląska, , Poland
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Rzeszów, , Poland
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Skierniewice, , Poland
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Szczecin, , Poland
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Tarnów, , Poland
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Torun, , Poland
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Trzebnica, , Poland
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Warsaw, , Poland
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Wieluń, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Żnin, , Poland
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Łęczna, , Poland
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Bragadiru, , Romania
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Brasov, , Romania
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Bucharest, , Romania
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Constanța, , Romania
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Deva, , Romania
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Iași, , Romania
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Timișoara, , Romania
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Gothenburg, , Sweden
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Luleå, , Sweden
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Lund, , Sweden
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Chernivtsi, , Ukraine
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Dnipropetrovsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Mykolayiv, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhia, , Ukraine
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Zaporizhzhya, , Ukraine
Countries
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References
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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.
Chupp G, Lugogo NL, Kline JN, Ferguson GT, Hirsch I, Goldman M, Zangrilli JG, Trudo F. Rapid onset of effect of benralizumab on morning peak expiratory flow in severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2019 May;122(5):478-485. doi: 10.1016/j.anai.2019.02.016. Epub 2019 Feb 23.
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.
DuBuske L, Newbold P, Wu Y, Trudo F. Seasonal variability of exacerbations of severe, uncontrolled eosinophilic asthma and clinical benefits of benralizumab. Allergy Asthma Proc. 2018 Sep 4;39(5):345-349. doi: 10.2500/aap.2018.39.4162. Epub 2018 Aug 4.
Chipps BE, Newbold P, Hirsch I, Trudo F, Goldman M. Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):504-511.e4. doi: 10.1016/j.anai.2018.01.030. Epub 2018 Feb 1.
Ohta K, Adachi M, Tohda Y, Kamei T, Kato M, Mark Fitzgerald J, Takanuma M, Kakuno T, Imai N, Wu Y, Aurivillius M, Goldman M. Efficacy and safety of benralizumab in Japanese patients with severe, uncontrolled eosinophilic asthma. Allergol Int. 2018 Apr;67(2):266-272. doi: 10.1016/j.alit.2017.10.004. Epub 2017 Nov 8.
FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, Lommatzsch M, Ferguson GT, Busse WW, Barker P, Sproule S, Gilmartin G, Werkstrom V, Aurivillius M, Goldman M; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor alpha monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2128-2141. doi: 10.1016/S0140-6736(16)31322-8. Epub 2016 Sep 5.
Related Links
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Other Identifiers
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D3250C00018
Identifier Type: -
Identifier Source: org_study_id
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