Understanding how eosinophil depletion affects asthma inflammation
Beyond the Eosinophil: Understanding the Impact of Eosinophil Depletion on T2 Inflammation. (BEUTI)
This study is testing how a new treatment that lowers eosinophils affects asthma symptoms and inflammation in people with severe asthma that isn't well controlled.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Drugs / interventions | benralizumab |
| Locations | 1 site (London) |
| Trial ID | NCT05847452 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of benralizumab, a monoclonal antibody that targets eosinophils, on type-2 inflammation in patients with severe eosinophilic asthma. It aims to clarify whether the clinical benefits of eosinophil depletion are solely due to the reduction of these cells or if they also involve broader impacts on the immune system. Patients eligible for this study must have poorly controlled asthma despite high doses of inhaled corticosteroids and meet specific criteria set by NICE. The study will analyze the relationship between eosinophil levels and asthma exacerbations, particularly in response to respiratory viruses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with a diagnosis of severe eosinophilic asthma that remains poorly controlled despite high-dose inhaled corticosteroids.
Not a fit: Patients with other severe eosinophilic lung diseases or those on maintenance oral corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with severe asthma by enhancing understanding of eosinophil depletion's role in managing inflammation.
How similar studies have performed: Previous studies have shown success with benralizumab in treating severe eosinophilic asthma, indicating a promising approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Informed consent. 2. Patients aged 18 and over with a diagnosis of severe eosinophilic asthma for at least the last 6 months 3. Eligible for benralizumab based on NICE criteria 4. Poorly-controlled (ACQ-6 \>1.5) 5. FeNO ≥50ppb at screening despite high dose inhaled corticosteroids (at least 1000mcg BDP equivalent) +/- maintenance prednisolone 6. Adult-onset (18+) asthma in a minimum of 50% of the study subjects Exclusion Criteria: 1. Other severe eosinophilic lung disease including EGPA, chronic eosinophilic pneumonia and ABPA 2. Maintenance daily oral corticosteroids (prednisolone) 3. Severe bronchiectasis on CT causing daily sputum production 4. Inability to give written informed consent 5. Current smoking or \>20 pack year smoking history 6. Resting oxygen saturations \<94% on air 7. Any severe cardiac or other non-asthma related co-morbidity that would make bronchoscopy and/or sedation high risk 8. Symptoms suggestive of a respiratory viral / bacterial infection within the last 3 weeks 9. Acute exacerbations of asthma requiring high dose prednisolone within the last 3 weeks 10. A change in dose of maintenance inhaled and/or oral corticosteroid dose within the last 3 weeks 11. Positive strongyloides serology following screening 12. Pregnancy or lactation 13. Hypersensitivity to benralizumab or any of the excipients
Where this trial is running
London
- Guy's & St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Prof. David Jackson, PhD — Guy's and St. Thomas NHS Foundation Trust
- Study coordinator: Mathew Clinical Trial Coordinator, MSc
- Email: mathew.furtado@gstt.nhs.uk
- Phone: 0207 188 5075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.