Benralizumab treatment in moderate to very severe COPD (GALATHEA)
Research type
Research Study
Full title
A randomised, double-blind, chronic dosing (56-week), placebo-controlled, parallel group, multicentre, phase III study to evaluate the efficacy and safety of 2 doses of benralizumab )MEDI-563) in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) with a history of COPD exacerbations (GALATHEA)
IRAS ID
150960
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2013-004590-27
Research summary
The purpose of the study is to determine if benralizumab reduces Chronic Obstructive Pulmonary Disease (COPD) exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.
Patients with moderate to very severe COPD who are currently treated with approved COPD standard of care double or triple therapy and have at least 2 moderate COPD exacerbations (treated with systemic corticosteroids and/or antibiotics) or 1 severe COPD exacerbation (hospitalisation) in the previous year, aged between 40 and 85, may be eligible to take part in the study which will last for approximately 64 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 for use at home to record COPD symptoms, use of reliever medication and compliance with maintenance medication on a daily basis.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
14/NE/1018
Date of REC Opinion
15 Jul 2014
REC opinion
Further Information Favourable Opinion