Study to Assess Functionality, Reliability, and Performance of a Single-Use Auto-Injector With Benralizumab Administered at Home
NCT ID: NCT02918071
Last Updated: 2018-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
121 participants
INTERVENTIONAL
2016-11-10
2017-08-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm Benralizumab
Benralizumab administered subcutaneously every 4 weeks
Benralizumab
Benralizumab administered subcutaneously every 4 weeks
Interventions
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Benralizumab
Benralizumab administered subcutaneously every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Male and female patients aged 18 to 75 years of age at the time of Visit 1
* Patient or caregiver must be willing and able to self-administer the Investigational product (IP). Caregiver must be age of consent or older at the time of Visit 1, if applicable
* Weight of ≥40 kg
* Evidence of asthma as documented by airway reversibility (FEV1 ≥12% and 200 ml) demonstrated at Visit 1 or 1A or Visit 2
* Documented history of current treatment with Inhaled corticosteroids (ICS) and Long-acting β2 agonists (LABA). 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, both the mid- and high-strength maintenance doses approved in the local country will meet this ICS criterion. Additional asthma controller medications (e.g., Leukotriene receptor antagonists (LTRAs), tiotropium, theophylline, oral corticosteroids) are allowed
* Pre-bronchodilator (pre-BD) FEV1 of \>50% predicted normal at Visit 1 or 1A or Visit 2
* Not well controlled asthma as documented by either: An Asthma Control Questionnaire 6 (ACQ6 ) ≥1.5 OR; A peak flow of 60-80% predicted OR; One or more exacerbation that required oral or systemic corticosteroids in the previous year
Exclusion Criteria
* 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
* Known history of allergy or reaction to the IP formulation
* History of anaphylaxis to any biologic therapy
* History of Guillain-Barré syndrome
* 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
* 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
* Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening 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
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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Gary T. Ferguson, MD, PC
Role: PRINCIPAL_INVESTIGATOR
Pulmonary Research Institute of Southeast Michigan
Locations
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Research Site
Northridge, California, United States
Research Site
Riverside, California, United States
Research Site
Westminster, California, United States
Research Site
Miami, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Albany, Georgia, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Canton, Ohio, United States
Research Site
Edmond, Oklahoma, United States
Research Site
Boerne, Texas, United States
Research Site
McKinney, Texas, United States
Research Site
Plano, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Sherwood Park, Alberta, Canada
Research Site
Ajax, Ontario, Canada
Research Site
Burlington, Ontario, Canada
Research Site
Kanata, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Trois-Rivières, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D3250C00031
Identifier Type: -
Identifier Source: org_study_id
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