Benralizumab in Severe Asthma (BISA) version 2.0
Research type
Research Study
Full title
A Pragmatic Proof of Concept Study to Evaluate the Effect of Benralizumab on Mannitol Challenge in Severe Eosinophilic Asthma
IRAS ID
265967
Contact name
Chris RuiWen Kuo
Contact email
Sponsor organisation
Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside
Eudract number
2019-003763-22
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The presence of airway twitchiness, also known as airway hyper-responsiveness, is one of the hallmark features of persistent asthma, reflecting increased sensitivity of the airway to a variety of external stimuli. Studies have found that asthmatic patients with airway twitchiness have significantly higher levels of a particular white blood cells called eosinophils.
Benralizumab also known as Fasenra is a monoclonal antibody. This is a type of protein that recognises and attaches to a specific target protein, called an interleukin-5 receptor, which is found particularly on eosinophils. Benralizumab is approved by The National Institute for Health and Care Excellence (NICE) as a possible additional treatment for severe eosinophilic asthma in adults who are taking high-dose inhaled corticosteroids plus a long-acting beta-agonist. In this study, we aim to assess if benralizumab, after 3 months of treatment, improves airway twitchiness in severe eosinophilic asthma. We believe that benralizumab may result in a rapid and sustained improvement of airway twitchiness in this group of asthma patients.
Eligible patients will be those with a diagnosis of severe asthma who are already taking a medium to high dose of inhaled corticosteroids (ICS), +/- a long-acting beta-agonist (LABA) or other second line asthma therapy, who exhibit a significant degree of airway twitchiness and a raised blood eosinophil level.REC name
East of Scotland Research Ethics Service REC 2
REC reference
19/ES/0134
Date of REC Opinion
9 Dec 2019
REC opinion
Further Information Favourable Opinion