Home administration of benralizumab in patients with severe asthma
Research type
Research Study
Full title
A Multicentre, open-label, functionality, reliability, and performance study of an accessorised pre-filled syringe with home-administered subcutaneous benralizumab in adult patients with severe asthma (GREGALE)
IRAS ID
174836
Contact name
Fred Reid
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2015-000521-36
Duration of Study in the UK
0 years, 11 months, 19 days
Research summary
This study is being done to investigate if benralizumab can be given at home by a patient or a caregiver (spouse, partner or other family member). The study will determine if the device (a prefilled syringe with benralizumab) is reliable, functions well, and performs well. In addition the trial will also investigate the safety and clinical effect of benralizumab.
Patients with severe asthma, currently treated with inhaled corticosteroid and long-acting B2-agonists, who are aged between 18 and 75 may be eligible to take part in the study.
The study involves at least 8 visits to the clinic over approximately 30 weeks. During the study patients will receive 5 subcutaneous injections of benralizumab, the first 3 doses will be administered at the study centre and the final 2 doses will be administered by the patient or caregiver at home. After each at home administration the patient will visit the study centre and bring the used syringe back along with a short questionnaire completed by the person administering the injection.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0226
Date of REC Opinion
24 Apr 2015
REC opinion
Further Information Favourable Opinion