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

Asthma Clinical Trial

— GRECO  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918071
• Other study ID #: D3250C00031
• Status: Completed
• Phase: Phase 3
• Start date: November 10, 2016
• Est. completion date: August 21, 2017

Study information

• Verified date: October 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 21, 2017
• Est. primary completion date: August 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß2 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

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• Benralizumab
Benralizumab administered subcutaneously every 4 weeks

Locations

Country	Name	City	State
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	Quebec
Canada	Research Site	Quebec City	Quebec
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	Sherwood Park	Alberta
Canada	Research Site	Trois-Rivières	Quebec
United States	Research Site	Albany	Georgia
United States	Research Site	Boerne	Texas
United States	Research Site	Canton	Ohio
United States	Research Site	Edmond	Oklahoma
United States	Research Site	McKinney	Texas
United States	Research Site	Miami	Florida
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Northridge	California
United States	Research Site	Plano	Texas
United States	Research Site	Riverside	California
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Antonio	Texas
United States	Research Site	Westminster	California
United States	Research Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an AI Device at Home	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.	Week 12, Week 16, Week 12 and 16
Primary	Number of Returned AI Devices Used to Administer Benralizumab at Home That Have Been Evaluated as Functional	AI evaluated as functional is defined as the device having adequately passed the visual inspection and function tests.	Week 12, Week 16
Primary	Number of AI Devices Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)	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.	Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16
Secondary	Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score	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.	Week 0 (baseline) and weeks 4, 8, 12, 16, 20
Secondary	The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab	Mean PK Concentration at each visit	Baseline, Week 8, Week 20, and Week 28
Secondary	The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels	Blood eosinophil counts by timepoint	Baseline, Week 20, and Week 28
Secondary	The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA)	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	Baseline until Week 28

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