Benralizumab treatment in patients with uncontrolled asthma (SIROCCO)
Research type
Research Study
Full title
A multicentre, randomised, double-blind, parallel group, placebo-controlled, phase III efficacy and safety study of benralizumab (MEDI-563) added to high-dose inhaled corticosteroid plus long-acting B2-agnoist in patients with uncontrolled asthma (SIROCCO)
IRAS ID
135524
Contact name
Hassan Burhan
Contact email
Eudract number
2013-002345-11
Research summary
The purpose of this trial is to investigate the safety and clinical benefit of benralizumab treatment in asthma patients who are otherwise uncontrolled on current standard of care. In addition the trial will also assess whether levels of a type of white blood cell (eosinophil) can be used to predict whether a patient will benefit from treatment with benralizumab.
Patients who are currently treated with high dose inhaled corticosteroid and long-acting B2-agonists and are aged between 18 and 75 may be eligible to take part in the study which will last for approximately 62 weeks.
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. Patients will also be issued with an electronic diary and spirometer for use at home to record lung function, asthma symptoms, use of reliever medication and compliance with investigational product in the morning and evening.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0612
Date of REC Opinion
10 Oct 2013
REC opinion
Further Information Favourable Opinion