Efficacy and Safety Study of Benralizumab to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy
NCT ID: NCT02075255
Last Updated: 2018-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
220 participants
INTERVENTIONAL
2014-04-28
2016-08-08
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 Arm A
Benralizumab administered subcutaneously every 4 weeks
Benralizumab
Benralizumab administered subcutaneously every 4 weeks
Benralizumab Arm B
Benralizumab administered subcutaneously every 4 weeks for the first 3 dose and then every 8 weeks; matching placebo subcutaneously at the 4 week interim to maintain the blind.
Benralizumab
Benralizumab administered subcutaneously every 4 weeks for the first 3 dose and then every 8 weeks; matching placebo subcutaneously at the 4 week interim to maintain the blind.
Placebo
Placebo administered subcutaneously every 4 weeks
Placebo
Placebo subcutaneously on study week 0 until study week 24 inclusive.
Interventions
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Benralizumab
Benralizumab administered subcutaneously every 4 weeks
Placebo
Placebo subcutaneously on study week 0 until study week 24 inclusive.
Benralizumab
Benralizumab administered subcutaneously every 4 weeks for the first 3 dose and then every 8 weeks; matching placebo subcutaneously at the 4 week interim to maintain the blind.
Eligibility Criteria
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Inclusion Criteria
2. Female and male aged from 18 to 75 years, inclusively.
3. History of physician-diagnosed asthma requiring treatment with medium dose ICS and LABA.
4. Elevated level of peripheral blood eosinophil
5. Documented treatment with high-dose ICS and LABA for at least 6 months prior to Visit 1
6. Chronic oral corticosteroid therapy for at least 6 continuous months directly preceding Visit 1. Subjects must be on doses equivalent to 7.5 - 40 mg/day of prednisolone/prednisone at Visit 1 and be on a stable dose for at least 2 weeks prior to randomization. Patients must agree to switch to study required prednisone/prednisolone as their oral corticosteroid for the duration of the study.
7. Patients with documented failures of OCS reduction within 6 months prior to Visit 1 will not be required to proceed through the dose optimization phase during run-in.
8. Morning pre-bronchodilator (Pre-BD) FEV1 of \<80% predicted
9. Evidence of asthma as documented by either:
Airway reversibility (FEV1 ≥12% and 200 mL) demonstrated at Visit 1, Visit 2, or Visit 3 using the Maximum Post-bronchodilator Procedure OR Documented reversibility in the previous 24 months prior to Visit 1 OR Airway hyperresponsiveness (PC20 FEV1 methacholine concentration ≤8mg/mL) documented in the previous 12 months prior to planned date of randomization OR Airflow variability in clinic FEV1 ≥20% between 2 consecutive clinic visits documented in the 12 months prior to the planned date of randomization (FEV1 recorded during an exacerbation should not be considered for this criterion).
All patients must have reversibility testing performed before randomization to establish a baseline characteristic.
If patients do not demonstrate airway reversibility at either Visit 1 or Visit 2 and this is needed to qualify the patient for randomization, the site should reiterate the need to withhold short- and long-acting bronchodilators prior to Visit 3 in an effort to meet this inclusion criterion.
10. At least 1 documented asthma exacerbation in the previous 12 months prior to the date informed consent is obtained
11. Optimized OCS dose reached at least 2 weeks prior to randomization
12. Additional asthma controller medication must not have been initiated during run in/optimization period (not applicable for management of exacerbations during screening/ run in optimization phase)
13. At least 70% compliance with OCS use
14. At least 70% compliance with usual asthma controller ICS-LABA
15. Minimum 70% (i.e. 10 of 14 days) compliance with asthma daily diary (morning and evening diary)
Exclusion Criteria
2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, 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, hematology, clinical chemistry, or urinalysis during run-in/optimization 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
5. History of life-threatening asthma
6. Asthma control reached at an OCS dose of ≤5mg during run-in/OCS optimization phase
7. Qualifies for 3 consecutive dose reductions at Visits 2-4 and continues to meet OCS dose reduction criteria at Visit 5
8. Receipt of oral corticosteroids, other than prednisone or prednisolone, as the maintenance oral steroid controller for asthma symptoms from Visit 1 and throughout the study.
9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.5 times the upper limit of normal (ULN) confirmed during screening period
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Parameswaran Nair, MD,PhD,FRCP,FRCPC
Role: PRINCIPAL_INVESTIGATOR
St Joseph's Healthcare Hamilton Firestone Institute for Respiratory Health 50 Charlton Avenue East Hamilton
Locations
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Research Site
Los Angeles, California, United States
Research Site
Centennial, Colorado, United States
Research Site
Denver, Colorado, United States
Research Site
Hialeah, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Iowa City, Iowa, United States
Research Site
Fort Mitchell, Kentucky, United States
Research Site
Rochester, Minnesota, United States
Research Site
The Bronx, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Middleburg Heights, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Mt. Pleasant, South Carolina, United States
Research Site
Madison, Wisconsin, United States
Research Site
Buenos Aires, , Argentina
Research Site
CABA, , Argentina
Research Site
Florida, , Argentina
Research Site
Mendoza, , Argentina
Research Site
Kozloduy, , Bulgaria
Research Site
Pazardzhik, , Bulgaria
Research Site
Petrich, , Bulgaria
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Rousse, , Bulgaria
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Samokov, , Bulgaria
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Vratsa, , Bulgaria
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
Research Site
Quillota, , Chile
Research Site
Rancagua, , Chile
Research Site
Santiago, , Chile
Research Site
Talca, , Chile
Research Site
Talcahuano, , Chile
Research Site
Valparaíso, , Chile
Research Site
Brest, , France
Research Site
Lyon, , France
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Marseille, , France
Research Site
Montpellier, , France
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Strasbourg, , France
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Toulouse, , France
Research Site
Bamberg, , Germany
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Berlin, , Germany
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Freiburg im Breisgau, , Germany
Research Site
Großhansdorf, , Germany
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Hanover, , Germany
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Leipzig, , Germany
Research Site
Mainz, , Germany
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Bydgoszcz, , Poland
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Karczew, , Poland
Research Site
Koszalin, , Poland
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Krakow, , Poland
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Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Lubin, , Poland
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Szczecin, , Poland
Research Site
Tarnów, , Poland
Research Site
Trzebnica, , Poland
Research Site
Wroclaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
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Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Suwon, , South Korea
Research Site
Málaga, , Spain
Research Site
Valencia, , Spain
Research Site
Adana, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Bursa, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Dnipropetrovsk, , Ukraine
Research Site
Ivano-Frankivsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Vinnytsia, , Ukraine
Countries
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References
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Nair P, Wenzel S, Rabe KF, Bourdin A, Lugogo NL, Kuna P, Barker P, Sproule S, Ponnarambil S, Goldman M; ZONDA Trial Investigators. Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. 2017 Jun 22;376(25):2448-2458. doi: 10.1056/NEJMoa1703501. Epub 2017 May 22.
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.
Menzies-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.
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.
Related Links
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Other Identifiers
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D3250C00020
Identifier Type: -
Identifier Source: org_study_id
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