BURAN
Research type
Research Study
Full title
BURAN: Effects of Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma using Functional Respiratory Imaging Parameters
IRAS ID
1005902
Contact name
Ginette Hampshire
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-000152-11
Clinicaltrials.gov Identifier
Research summary
Asthma is a disease of the airways that makes breathing difficult. With asthma, there is inflammation (swelling) of the air passages that results in a temporary narrowing of the airways that carry oxygen to the lungs. In eosinophilic asthma, the swelling of the airways is caused by the presence of a larger than usual number of certain blood cells (eosinophils) in your airways and in your lungs.
Approved treatment for severe eosinophilic asthma in the UK includes use of biologics such as mepolizumab, reslizumab and benralizumab (Fasenra®) which work by reducing eosinophils.
Benralizumab is currently approved for clinical use by the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) as add-on maintenance treatment of patients with severe asthma and with an eosinophilic observable characteristics.
Benralizumab significantly decreased the rate of annual worsening and improved forced expiratory volume in 1 second, compared with placebo, in patients with severe uncontrolled asthma who were receiving medium or high dose inhaled corticosteroids and long-acting bronchodilators
The aim of this study is to find out how well Fasenra® works in reducing the narrowing of the participants airways that occurs with asthma, how it improves the participants breathing and the participants quality of life in the short-term, and to know more about its safety.
The sponsor of this study is AstraZeneca, currently 7 counties and 47 sites are expected to take part.REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0571
Date of REC Opinion
4 Oct 2022
REC opinion
Further Information Favourable Opinion