Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home

Completed · Phase 3

Conditions studied: Asthma

In brief

The purpose of the study is to assess functionality, performance, and reliability of an accessorized pre-filled syringe (APFS) 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.

Key facts

Study ID: NCT02417961
Run by: AstraZeneca
People needed: 162
Starts: 2015-04-27
Expected to finish: 2016-03-14
Last updated by the study team: 2018-05-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 IP (Investigational product). 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 either: Airway reversibility (FEV1 ≥12% and 200 ml) demonstrated at Visit 1 or 2 OR documented in the previous 12 months OR; Airflow variability in FEV1 ≥20% between pulmonary function testing documented in the 12 months prior to V2 OR; Airflow variability shown by >20% diurnal variability in peak flow observed in the patient's asthma action plan
Documented history of current treatment with ICS (Inhaled corticosteroids) and LABA (Long-acting β2 agonists). 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., LTRAs (Leukotriene receptor antagonists), tiotropium, theophylline, oral corticosteroids) are allowed
Morning pre-bronchodilator (pre-BD) FEV1 of >50% predicted at Visit 1 or Visit 2
Not well controlled asthma as documented by either: An ACQ6 (Asthma Control Questionnaire 6) ≥1.5 OR; A peak flow of 60-80% predicted OR; An exacerbation, one or more, that required oral or systemic corticosteroids in the previous year OR; Any one of the following assessed by patient recall over the previous 2-4 weeks: Asthma symptoms >2 days/week; OR / Nighttime awakenings 1 or more/week; OR / Short acting beta2-agonist use for symptom control (not for prevention of exercise induced asthma) >2 days/week

You may not qualify if…

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 period
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

Where it is running

Research Site — Fountain Valley, California, United States
Research Site — Walnut Creek, California, United States
Research Site — Celebration, Florida, United States
Research Site — Ocala, Florida, United States
Research Site — Orlando, 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 — Bellevue, Nebraska, United States
Research Site — Oklahoma City, Oklahoma, United States
Research Site — San Antonio, Texas, United States
Research Site — Calgary, Alberta, Canada
Research Site — Vancouver, British Columbia, Canada
Research Site — Ajax, Ontario, Canada
Research Site — Burlington, Ontario, Canada
Research Site — Mississauga, Ontario, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Pointe-Claire, Quebec, Canada
Research Site — Québec, Quebec, Canada
Research Site — Saint-Charles-Borromée, Quebec, Canada
Research Site — Trois-Rivières, Quebec, Canada

Full record on ClinicalTrials.gov

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