Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma
PONENTE
PONENTE: A Multicenter, Open-label, Phase 3b Efficacy and Safety Study of Benralizumab 30 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Patients With Severe Eosinophilic Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy
1 other identifier
interventional
598
17 countries
144
Brief Summary
This is a study designed to evaluate efficacy and safety of Benralizumab in reducing the Oral Corticosteroid (OCS) use in adult patients with severe asthma who are receiving OCS with or without additional asthma controller medications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Aug 2018
Longer than P75 for phase_3 asthma
144 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2018
CompletedFirst Posted
Study publicly available on registry
June 15, 2018
CompletedStudy Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2022
CompletedResults Posted
Study results publicly available
June 28, 2022
CompletedJune 6, 2023
May 1, 2023
2.7 years
May 14, 2018
February 7, 2022
May 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patients Who Achieve 100% Reduction in Daily OCS Dose
Patients who achieve 100% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma
Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)
Patients Who Achieve 100% Reduction or a Daily OCS Dose of <=5mg
Patients who achieve 100% reduction or a daily OCS dose of \<=5mg, if reason for no further OCS reduction is Adrenal Insufficiency, that are sustained over at least 4 weeks without worsening of asthma
Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)
Secondary Outcomes (3)
Patients Who Achieve a Daily OCS of ≤5mg
Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)
Patients Who Achieve a ≥90%, ≥75%, and ≥50% Reduction in Daily OCS Dose
Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)
Change From Baseline in Average Daily OCS Dose (mg)
Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)
Other Outcomes (4)
Patients Who Achieve 100% Reduction in Daily OCS Dose From Main Study Baseline OCS Dose to the End of the Long Term Follow up Substudy
from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days.
Patients Who Achieve a Daily OCS Dose of ≤5 mg at the End of the Long Term Follow up Substudy
from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days.
Patients Who Achieve ≥90%, ≥75%, ≥50% or >0% OCS Reduction From Main Study Baseline OCS Dose to the End of the Long Term Follow up Substudy
from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days.
- +1 more other outcomes
Study Arms (1)
Benralizumab
EXPERIMENTALBenralizumab subcutaneous injection
Interventions
Eligibility Criteria
You may qualify if:
- Peripheral blood eosinophil count of ≥150 cells/μL assessed by central lab at Visit 1 or ≥ 300 cells/μL in the past 12 months
- History of physician diagnosed asthma requiring continuous treatment with high dose ICS (high-dose ICS is budesonide/formoterol HFA ≥640/18 per day or equivalent, fluticasone propionate DPI \> 500/day or equivalent, or authorized generics for these products) plus LABA for at least 6 months prior to Visit 1. The ICS and LABA can be contained within a combination product or given by separate inhalers. The ICS can also be given via nebulized solution for inhalation.
- Chronic oral corticosteroid therapy equivalent to a daily dose of at least 5 mg of prednisone, for at least 3 continuous months directly preceding Visit 1.
- Patient should be on a stable OCS dose for at least 4 weeks prior to Visit 1.
- Non-smokers, current smokers or former smokers with a smoking history of \< or =20 pack-years at Visit 1
You may not qualify if:
- Clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts
- Known history of allergy or reaction to the study drug formulation
- History of anaphylaxis to any biologic therapy
- A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
- Asthma exacerbation requiring use of systemic corticosteroids, or an increase in maintenance dose of OCS, or acute upper/lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to Visit 2 (first benralizumab dose)
- A history of known immunodeficiency disorder including history of a positive human immunodeficiency virus (HIV) test
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3 times the upper limit of normal (ULN) confirmed at Visit 1.
- Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
- Coincident primary adrenal failure (Addison's disease) or irreversible secondary hypoadrenalism due to another independent cause (e.g. pituitary tumour or its treatment)
- Co-existent inflammatory conditions for which chronic OCS doses are part of their maintenance treatment such as Giant Cell Arteritis, Polymyalgia Rheumatica
- Current night-shift workers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (144)
Research Site
Flagstaff, Arizona, 86001, United States
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Los Angeles, California, 90025, United States
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Aurora, Colorado, 80045, United States
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Newark, Delaware, 19713, United States
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Tampa, Florida, 33607, United States
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Winter Park, Florida, 32789-4681, United States
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Albany, Georgia, 31707, United States
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Atlanta, Georgia, 30322, United States
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Savannah, Georgia, 31405, United States
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Normal, Illinois, 61761, United States
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Georgetown, Kentucky, 40324, United States
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Lakeside Park, Kentucky, 41017, United States
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Ann Arbor, Michigan, 48109, United States
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Minneapolis, Minnesota, 55402, United States
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Saint Paul, Minnesota, 55101, United States
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St Louis, Missouri, 63156, United States
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New York, New York, 10016, United States
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Chapel Hill, North Carolina, 27599, United States
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Greenville, North Carolina, 27834, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27104, United States
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DuBois, Pennsylvania, 15801, United States
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North Charleston, South Carolina, 29406, United States
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Buenos Aires, C1121ABE, Argentina
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CABA, C1012AAR, Argentina
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Cap. Fed, 1280, Argentina
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Ciudad Autónoma de Bs. As., 1426, Argentina
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Ciudad Autónoma de Buenos Aire, C1440BRR, Argentina
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Mar del Plata, 7600, Argentina
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Mendoza, M5500GIP, Argentina
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Monte Grande, 1842, Argentina
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Ranelagh, 1886, Argentina
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Rosario, 2000, Argentina
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Rosario, S2000DEJ, Argentina
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San Juan Bautista, 1888, Argentina
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Brussels, 1200, Belgium
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Erpent, 5101, Belgium
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Ghent, 9000, Belgium
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Botucatu, 18618-970, Brazil
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Londrina, 86057-970, Brazil
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Maringá, 87015-000, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Salvador, 40060-330, Brazil
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Santo André, 09060-650, Brazil
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Santo André, 09080-110, Brazil
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Sorocaba, 18040-425, Brazil
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Uberlândia, 38411-186, Brazil
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Vancouver, British Columbia, V6Z 1Y6, Canada
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Vancouver, CA, V5Z 4E1, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Mississauga, Ontario, L5A 3V4, Canada
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Ottawa, Ontario, K1H 1E4, Canada
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Toronto, Ontario, M4V 1R2, Canada
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Québec, Quebec, G1V 4W2, Canada
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Barranquilla, 080020, Colombia
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Bogotá, 110221, Colombia
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Cali, 76001000, Colombia
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Cartagena, 130013, Colombia
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Floridablanca, 681004, Colombia
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Manizales, 17001, Colombia
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Medellín, 5001000, Colombia
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Aalborg, 9000, Denmark
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Herlev, 2730, Denmark
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Hvidovre, 2650, Denmark
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Vejle, 7100, Denmark
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Angers, 49933, France
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Besançon, 25030, France
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Colmar, 68024, France
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Marseille, 13300, France
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Nice, 06001, France
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Orléans, 45067, France
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Reims, 51092, France
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Suresnes, 92151, France
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Tours, 37000, France
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Bamberg, 96049, Germany
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Berlin, 12203, Germany
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Berlin, 13187, Germany
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Cologne, 51069, Germany
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Darmstadt, 64283, Germany
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Frankfurt, 60596, Germany
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Großhansdorf, 22927, Germany
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Heidelberg, 69126, Germany
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Leipzig, 04207, Germany
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Lübeck, 23552, Germany
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Magdeburg, 39120, Germany
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München, 81675, Germany
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Florence, 50134, Italy
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Milan, 20162, Italy
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Napoli, 80131, Italy
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Palermo, 90129, Italy
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Pisa, 56100, Italy
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Roma, 00185, Italy
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Sassari, 07100, Italy
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Tradate, 21049, Italy
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Del. Cuauhtemoc, 06700, Mexico
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Durango, 43080, Mexico
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Guadalajara, 44100, Mexico
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Guadalajara, 44130, Mexico
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Mérida, 97070, Mexico
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Veracruz, 91910, Mexico
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Villahermosa, 86035, Mexico
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Bialystok, 15-044, Poland
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Bialystok, 15-430, Poland
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Gdansk, 80-214, Poland
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Krakow, 31-011, Poland
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Lubin, 59-300, Poland
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Ostrowiec Świętokrzyski, 27-400, Poland
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Poznan, 60-693, Poland
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Poznan, 60-823, Poland
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Rzeszów, 35-051, Poland
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Sosnowiec, 41-200, Poland
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Tarnów, 33-100, Poland
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Wieluń, 98-300, Poland
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Wroclaw, 50-449, Poland
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Izhevsk, 426061, Russia
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Kirov, 610014, Russia
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Moscow, 115478, Russia
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Omsk, 644043, Russia
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Omsk, 644112, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 195257, Russia
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Ulyanovsk, 432009, Russia
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Cadiz, 11009, Spain
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Marbella (Málaga), 29603, Spain
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Mérida, 06800, Spain
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Ourense, 32005, Spain
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Sant Joan Despí (Barcelona), 08970, Spain
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Santiago de Compostela-Coruña, 15706, Spain
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Zaragoza, 50009, Spain
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Lund, 221 85, Sweden
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Kaohsiung City, 80756, Taiwan
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Kaohsiung Hsien, 83301, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 110, Taiwan
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Taipei, 235, Taiwan
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Yunlin, 640, Taiwan
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Bradford, BND9 6RJ, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SW3 6HP, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
Related Publications (3)
Menzies-Gow A, Gurnell M, Heaney LG, Corren J, Bel EH, Maspero J, Harrison T, Jackson DJ, Price D, Lugogo N, Kreindler J, Burden A, de Giorgio-Miller A, Faison S, Padilla K, Martin UJ, Garcia Gil E; PONENTE Study Group. Adrenal function recovery after durable oral corticosteroid sparing with benralizumab in the PONENTE study. Eur Respir J. 2022 Dec 22;60(6):2103226. doi: 10.1183/13993003.03226-2021. Print 2022 Dec.
PMID: 35896216DERIVEDMenzies-Gow A, Gurnell M, Heaney LG, Corren J, Bel EH, Maspero J, Harrison T, Jackson DJ, Price D, Lugogo N, Kreindler J, Burden A, de Giorgio-Miller A, Padilla K, Martin UJ, Garcia Gil E. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med. 2022 Jan;10(1):47-58. doi: 10.1016/S2213-2600(21)00352-0. Epub 2021 Oct 4.
PMID: 34619104DERIVEDMenzies-Gow A, Corren J, Bel EH, Maspero J, Heaney LG, Gurnell M, Wessman P, Martin UJ, Siddiqui S, Garcia Gil E. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial. ERJ Open Res. 2019 Sep 25;5(3):00009-2019. doi: 10.1183/23120541.00009-2019. eCollection 2019 Jul.
PMID: 31579676DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
During COVID-19 pandemic, for ongoing patients, patient dosing, and scheduled visits are inevitably impacted, but the primary endpoint was not impacted.
Results Point of Contact
- Title
- Maria Jison, MD Global Clinical Head, FASENRA, Late-stage R&I
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2018
First Posted
June 15, 2018
Study Start
August 1, 2018
Primary Completion
April 16, 2021
Study Completion
March 24, 2022
Last Updated
June 6, 2023
Results First Posted
June 28, 2022
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.