Long-Term Safety Extension Study to Sirocco (BORA)
Research type
Research Study
Full title
A Multicentre, Randomised, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-Acting B2-Agonist (BORA)
IRAS ID
163452
Contact name
Hassan Burhan
Contact email
Sponsor organisation
AstraZeneca UK Ltd
Eudract number
2014-001086-27
Clinicaltrials.gov Identifier
U1111-1162-2422, WHO ICTRP; , ; , ; ,
Duration of Study in the UK
2 years, 4 months, 2 days
Research summary
The purpose of this trial is to continue to investigate the safety and tolerability of benralizumab treatment in asthma patients who are otherwise uncontrolled on current standard of care. Additional information about the risks and benefits of the study drug (benralizumab) will be collected with regard to the impact of benralizumab on asthma worsenings, lung function changes, asthma control, adverse effects, and laboratory data.
Patients who complete the study D3250C00017 are eligible to enrol into this study which will last for approximately 68 weeks. This will allow for the collection of information about how well the drug works and how safe it is in patients for up to 2 continuous years in adults.
Regular visits to the clinic are required for the whole duration of the study, to assess the health of the patient, determine the effect of the drug on lung function tests and to measure levels of benralizumab in the blood, as well as determining how well the treatment is tolerated by patients
REC name
North West - Haydock Research Ethics Committee
REC reference
14/NW/1337
Date of REC Opinion
20 Oct 2014
REC opinion
Favourable Opinion