Efficacy and Safety of Benralizumab in Moderate to Very Severe COPD
Research type
Research Study
Full title
A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group,\nPlacebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of\nBenralizumab 100 mg in Patients with Moderate to Very Severe Chronic\nObstructive Pulmonary Disease (COPD) with a History of Frequent COPD\nExacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)
IRAS ID
266822
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2019-001800-39
Duration of Study in the UK
3 years, 11 months, 20 days
Research summary
RESOLUTE is a clinical study being carried out in patients with moderate to very severe\nChronic Obstructive Pulmonary Disease (COPD). It is being conducted to see if a new precision\ndrug called benralizumab can help control COPD better if it is added to available COPD inhaled\nmedications.\nBenralizumab is an antibody and a precision drug that works with the body to lower the\nnumber of eosinophils (a specific type of white blood cells) in the blood and tissue. Benralizumab\ntargets eosinophils and attracts specific cells in the immune system to remove them from the\nbody naturally. Effective removal of eosinophils from the blood and the lungs reduces airway\ninflammation and may help prevent further flare ups (exacerbations).\nThe RESOLUTE study is recruiting patients who:\n Have moderate to very severe COPD that is not well controlled\n Are aged 40–85 years\n Have a history of frequent COPD flare-ups despite taking triple inhaler therapy\n(ICS/LABA/LAMA)\n Have high levels of a type of white blood cell, called eosinophil, in their blood\nParticipants that take part in the study, will enter a period called run-in that may take up to 13\nweeks. During this time, they will undergo a number of tests, used to determine whether they are\nsuitable for the study. If they are suitable to take part in this study, they will enter the treatment\nperiod and be enrolled into one of the two treatment groups where they will receive regular\ninjections of either benralizumab or placebo. The treatment period will be of variable duration.\nThis means that it can last from 56 weeks to approximately 3.5 years, depending on when the\npatient enters the study. The study will end when the last patient enrolled has completed at least\n1 year of the treatment period.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0229
Date of REC Opinion
7 Sep 2019
REC opinion
Further Information Favourable Opinion