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Study to Assess Functionality, Reliability, and Performance of a Single-Use Auto-Injector With Benralizumab Administered at Home (GRECO)

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ClinicalTrials.gov Identifier: NCT02918071
Recruitment Status : Completed
First Posted : September 28, 2016
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The purpose of the study is to assess functionality, performance, and reliability of an single-use auto-injector (AI) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or caregiver, and to confirm the safety and clinical benefit of benralizumab administration in asthma patients with severe asthma

Condition or disease Intervention/treatment Phase
Asthma Biological: Benralizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Functionality, Reliability and Performance Study of a Single-Use Auto-Injector With Home-administered Subcutaneous Benralizumab in Adult Patients With Severe Asthma (GRECO)
Actual Study Start Date : November 10, 2016
Actual Primary Completion Date : August 21, 2017
Actual Study Completion Date : August 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Arm Benralizumab
Benralizumab administered subcutaneously every 4 weeks
Biological: Benralizumab
Benralizumab administered subcutaneously every 4 weeks




Primary Outcome Measures :
  1. Number of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an AI Device at Home [ Time Frame: Week 12, Week 16, Week 12 and 16 ]
    Patients who are still in the study is defined as patients who had been treated for the specified timepoint. A successful administration is defined as an injection completed, an answer of "Yes" to all 5 questions in the Questionnaire, and adequately passed the visual inspection and function tests.

  2. Number of Returned AI Devices Used to Administer Benralizumab at Home That Have Been Evaluated as Functional [ Time Frame: Week 12, Week 16 ]
    AI evaluated as functional is defined as the device having adequately passed the visual inspection and function tests.

  3. Number of AI Devices Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints) [ Time Frame: Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16 ]
    Number (%) of AI used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on AI dispensed for patients who were treated for the specific time point. This excludes AIs dispensed but never used for the treatment or the device not returned for evaluation.


Secondary Outcome Measures :
  1. Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score [ Time Frame: Week 0 (baseline) and weeks 4, 8, 12, 16, 20 ]
    The effect of benralizumab on asthma control metrics in terms of change from baseline in mean Asthma Control Questionnaire-6 (ACQ-6) score. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations, and rescue medication. Baseline is defined as the last non-missing observation prior to the first dose of study treatment. ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Smaller score indicates better controlled asthma.

  2. The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab [ Time Frame: Baseline, Week 8, Week 20, and Week 28 ]
    Mean PK Concentration at each visit

  3. The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels [ Time Frame: Baseline, Week 20, and Week 28 ]
    Blood eosinophil counts by timepoint

  4. The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA) [ Time Frame: Baseline until Week 28 ]
    Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union (EU) guidelines
  • 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:

  • Clinically important pulmonary disease other than asthma (eg, active lung infection, COPD (Chronic obstructive pulmonary disease), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918071


Locations
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United States, California
Research Site
Northridge, California, United States, 91324
Research Site
Riverside, California, United States, 92506
Research Site
Westminster, California, United States, 92683
United States, Florida
Research Site
Miami, Florida, United States, 33126
Research Site
Winter Park, Florida, United States, 32789-4681
United States, Georgia
Research Site
Albany, Georgia, United States, 31707
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Research Site
Saint Louis, Missouri, United States, 63141
United States, Ohio
Research Site
Canton, Ohio, United States, 44718
United States, Oklahoma
Research Site
Edmond, Oklahoma, United States, 73034
United States, Texas
Research Site
Boerne, Texas, United States, 78006
Research Site
McKinney, Texas, United States, 75071
Research Site
Plano, Texas, United States, 75093
Research Site
San Antonio, Texas, United States, 78229
Canada, Alberta
Research Site
Sherwood Park, Alberta, Canada, T8L 0N2
Canada, Ontario
Research Site
Ajax, Ontario, Canada, L1S 2J5
Research Site
Burlington, Ontario, Canada, L7N 3V2
Research Site
Kanata, Ontario, Canada, K2L 3C8
Research Site
Mississauga, Ontario, Canada, L5A 3V4
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H3G 1L5
Research Site
Montreal, Quebec, Canada, H4J 1C5
Research Site
Quebec City, Quebec, Canada, G1V 4W2
Research Site
Sherbrooke, Quebec, Canada, J1H 5N4
Research Site
Trois-Rivières, Quebec, Canada, G8T 7A1
Canada
Research Site
Quebec, Canada, G1G 3Y8
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Gary T. Ferguson, MD, PC Pulmonary Research Institute of Southeast Michigan
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] August 23, 2016
Statistical Analysis Plan  [PDF] September 25, 2017


Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02918071     History of Changes
Other Study ID Numbers: D3250C00031
First Posted: September 28, 2016    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: October 2018

Keywords provided by AstraZeneca:
Asthma,
Bronchial Diseases,
Respiratory Tract Diseases,
Lung Diseases,
Obstructive Lung Diseases,
Benralizumab

Additional relevant MeSH terms:
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Benralizumab
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents