Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
NCT ID: NCT01928771
Last Updated: 2017-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2681 participants
INTERVENTIONAL
2013-09-19
2016-04-05
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 44 inclusive.
Benralizumab 30 mg q.8 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab
Benralizumab subcutaneously on study week 0 until study week 44 inclusive.
Placebo
Placebo administered subcutaneously
Placebo
Placebo subcutaneously on study week 0 until study week 44 inclusive.
Interventions
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Benralizumab
Benralizumab subcutaneously on study week 0 until study week 44 inclusive.
Placebo
Placebo subcutaneously on study week 0 until study week 44 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. 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
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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Eugene R. Bleecker, MD, Professor of Medicine
Role: PRINCIPAL_INVESTIGATOR
Center for Genomics and Personalized Medicine Research, Medical Center Boulevard, Winston-Salem, North Carolina 27157
Locations
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Research Site
Foley, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Scottsboro, Alabama, United States
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Sheffield, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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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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Hartford, Connecticut, United States
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New Haven, Connecticut, United States
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Brandon, Florida, United States
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Clearwater, Florida, United States
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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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Albany, Georgia, United States
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Gainesville, Georgia, United States
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Lawrenceville, Georgia, United States
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Gurnee, Illinois, United States
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Normal, Illinois, United States
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Iowa City, Iowa, United States
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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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Opelousas, Louisiana, United States
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Baltimore, Maryland, United States
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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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Farmington Hills, Michigan, United States
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Rochester, Minnesota, United States
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Saint Paul, Minnesota, United States
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Picayune, Mississippi, United States
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Billings, Montana, United States
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Bellevue, Nebraska, United States
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Las Vegas, Nevada, United States
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Sparks, Nevada, United States
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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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Albuquerque, New Mexico, 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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Staten Island, New York, United States
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The Bronx, New York, United States
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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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Grand Forks, North Dakota, United States
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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 City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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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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Warwick, Rhode Island, United States
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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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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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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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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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Abingdon, Virginia, United States
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Hopewell, Virginia, United States
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Morgantown, West Virginia, United States
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Greenfield, Wisconsin, United States
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Bedford Park, , Australia
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Box Hill, , Australia
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Clayton, , Australia
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Concord, , Australia
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Frankston, , Australia
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Nedlands, , Australia
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New Lambton Heights, , Australia
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Parkville, , Australia
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Prahran, , Australia
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Randwick, , Australia
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Woolloongabba, , Australia
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Santo André, , Brazil
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São Paulo, , Brazil
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Sorocaba, , Brazil
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Dupnitsa, , Bulgaria
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Pernik, , Bulgaria
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Pleven, , Bulgaria
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Rousse, , 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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Brno, , Czechia
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Jindřichův Hradec, , Czechia
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Karlovy Vary, , Czechia
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Ostrava, , Czechia
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Pardubice, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Rokycany, , Czechia
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Strakonice, , Czechia
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Teplice, , Czechia
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Brest, , France
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Clermont-Ferrand, , France
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Dijon, , France
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Le Kremlin-Bicêtre, , France
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Le Mans, , France
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Lyon, , France
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Marseille, , France
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Montpellier, , France
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Paris, , France
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Pau, , France
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Pringy, , France
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Saint-Pierre, , France
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Strasbourg, , France
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Toulouse, , France
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Bari, , Italy
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Bologna, , Italy
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Catania, , Italy
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Cona, , Italy
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Florence, , Italy
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Foggia, , Italy
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Legnago, , Italy
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Milan, , Italy
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Palermo, , Italy
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Perugia, , 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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Guadalajara, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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Cusco, , Peru
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Lima, , Peru
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Surco, , Peru
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Bialystok, , Poland
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Dobre Miasto, , Poland
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Gdansk, , 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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Lodz, , Poland
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Lublin, , Poland
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Poznan, , 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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Wroclaw, , Poland
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Zgierz, , Poland
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Chelyabinsk, , Russia
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Ivanovo, , Russia
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Izhevsk, , Russia
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Kazan', , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Pyatigorsk, , Russia
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Rostov-on-Don, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Smolensk, , Russia
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StPetersburg, , Russia
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Tomsk, , Russia
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Vladikavkaz, , Russia
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Vladimir, , Russia
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Volgograd, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Benoni, , South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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KwaDukuza, , South Africa
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Mowbray, , South Africa
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Anyang-si, , South Korea
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Bucheon-si, , South Korea
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Busan, , South Korea
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Cheongju-si, , South Korea
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Gwangju, , South Korea
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Incheon, , South Korea
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Jeju City, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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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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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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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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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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.
Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, Sproule S, Gilmartin G, Aurivillius M, Werkstrom V, Goldman M; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-2127. doi: 10.1016/S0140-6736(16)31324-1. Epub 2016 Sep 5.
Related Links
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Other Identifiers
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D3250C00017
Identifier Type: -
Identifier Source: org_study_id
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