Beyond the Eosinophil: Understanding the Impact of Eosinophil Depletion on T2 Inflammation. (BEUTI)

Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Benralizumab is a relatively new treatment that is approved by NICE (National Institute for Health and Care Excellence, https://www.nice.org.uk/) for patients with severe asthma who have ongoing eosinophilic inflammation that remains poorly controlled despite high dose inhaled glucocorticosteroid medication. Eosinophils are a type of white blood cell that are linked to allergy and inflammation and are raised in people with severe asthma. Severe asthma is associated with a type-2 (T2) inflammation phenotype characterised by increased T2 cytokines (IL-13, IL-4, IL-5). Increased levels of eosinophils can cause inflammation in the lungs, increasing the risk of asthma attacks. The standard treatment for asthma involves taking inhaled glucocorticosteroid medication which primarily work by suppressing eosinophilic inflammation in the lungs. Benralizumab is a monoclonal antibody that targets a receptor on the surface of eosinophils called interleukin-5 receptor-α (IL-5Rα) leading to the rapid death of these cells and consequently a reduction in airways inflammation. In clinical trials, benralizumab has been shown to reduce both symptoms and the number of asthma attacks suffered by those with severe eosinophilic asthma. However, it remains unclear whether this clinical efficacy relates purely to the removal of the eosinophil, or additionally to the impact of this on other parts of the immune system. The BEUTI study will examine the structure and function of airway cells in patients with severe eosinophilic asthma. Particularly how the immune function of these cells changes with treatment and whether benralizumab leads to a reduction in T2 mediators and/or activation in airway cells. The aim is to take samples of cells from the airways during a bronchoscopy (a camera test looking into the lungs) before starting benralizumab and after 12 weeks of treatment. These investigations will allow us to better understand how benralizumab affects the cells within the airways and the pathways involved.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Informed consent.

• Patients aged 18 and over with a diagnosis of severe eosinophilic asthma for at least the last 6 months

• Eligible for benralizumab based on NICE criteria

• Poorly-controlled (ACQ-6 \>1.5)

• FeNO ≥50ppb at screening despite high dose inhaled corticosteroids (at least 1000mcg BDP equivalent) +/- maintenance prednisolone

• Adult-onset (18+) asthma in a minimum of 50% of the study subjects

Locations
Other Locations
United Kingdom
Guy's & St Thomas' NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Mathew Clinical Trial Coordinator, MSc
mathew.furtado@gstt.nhs.uk
0207 188 5075
Backup
Varsha Clinical Research Scientist, PhD
varsha.kanabar@kcl.ac.uk
0207 188 5075
Time Frame
Start Date: 2023-05-22
Completion Date: 2025-01
Participants
Target number of participants: 12
Treatments
All participants
All eligible participants will be consented and enrolled into the study and given the IMP as follows:~Benzraliziumab 30mcg once a month for 3 months
Related Therapeutic Areas
Sponsors
Leads: Guy's and St Thomas' NHS Foundation Trust
Collaborators: King's College London

This content was sourced from clinicaltrials.gov