Benralizumab and the lung microbiome (BALM)
Research type
Research Study
Full title
A single-centre study of the relationship between eosinophil activation and the lung microbiome in severe eosinophilic asthma (SEA) and the effect of benralizumab on these factors
IRAS ID
228723
Contact name
Andrew Menzies-Gow
Contact email
Sponsor organisation
Royal Brompton and Harefield NHS Foundation Trust
Eudract number
2017-003665-10
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary
This is a single-centre study which aims to describe in detail several effects of a newly-approved asthma treatment (benralizumab) on a group of patients with severe asthma who have been approved to commence benralizumab as part of their NHS care.
A patient with asthma who requires high-dose treatments to maintain disease control, or whose symptoms remain uncontrolled despite such treatment has 'Severe Asthma'. If there is evidence of eosinophilic inflammation (e.g. blood eosinophil count of >300 cells per microlitre), the condition is called 'Severe Eosinophilic Asthma' (SEA).
We plan to recruit 20 patients with SEA who fulfil National Institute for Health and Care Excellence (NICE) criteria to commence benralizumab. Patients who satisfy the inclusion and exclusion criteria and provide informed consent to take part in the study will undergo a detailed initial assessment, including a medical history, symptom questionnaires, blood tests, a heart tracing, breathing tests and a magnetic resonance imaging (MRI) scan of their lungs and sinuses. An initial bronchoscopy (camera test into the lungs) will also be performed. At the bronchoscopy appointment, nose and throat swabs will be taken and various lung samples will be obtained.
Patients will attend the Royal Brompton Hospital for benralizumab doses (administered subcutaneously at four-week intervals, as part of their NHS treatment). At their dosing appointments, they will have breathing tests and vital signs checked (as per routine NHS care). In addition, they will perform one extra breathing test, provide information about any adverse events they may have experienced and answer two symptom questionnaires.
Shortly after each patient’s third dose of benralizumab, they will undergo a repeat assessment and repeat bronchoscopy, which will follow the same format as the initial assessment and initial bronchoscopy respectively. We will analyse the changes in lung eosinophil counts and several other factors pre- and post- treatment initiation.
Summary of Results
The study was cancelled due to the first wave of the Covid pandemic (recruitment was due to start in March 2020). Bronchoscopy was identified as an aerosol generating procedure so all research bronchoscopy was paused.
REC name
London - Chelsea Research Ethics Committee
REC reference
19/LO/1955
Date of REC Opinion
25 Feb 2020
REC opinion
Further Information Favourable Opinion