Asthma; Eosinophilic Clinical Trial
— IRISOfficial title:
The Influence of Mepolizumab on Structural and Inflammatory Cells in Severe Eosinophilic Asthma
The IRIS study aims to investigate the way Mepolizumab affects the structure of the airway cells in patients with Severe Eosinophilic Asthma and how the immune function of these cells changes with treatment. The aim is to take samples of cells from the airways before starting Mepolizumab and after 6 months of treatment. These samples will be taken during a bronchoscopy (a camera test looking into the lungs) and we will analyse these cells in the laboratory. These investigations will allow us to better understand how Mepolizumab affects the cells within the airways.
Status | Not yet recruiting |
Enrollment | 18 |
Est. completion date | October 2024 |
Est. primary completion date | April 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: 1. Diagnosis of Severe Eosinophilic Asthma (as per Southampton Severe Asthma MDT and based on ATS/ERS consensus criteria) 2. Approved for treatment with Mepolizumab by Southampton Severe Asthma MDT (in accordance with NICE TA 431) - Blood eosinophil count is =0.3 x109cells/L in preceding 12 months - =4 asthma exacerbations needing systemic steroids in the preceding 12 months 3. Age =18 years 4. Able to provide written informed consent Exclusion Criteria: 1. On maintenance daily oral steroids, asthma immune modulators 2. On long-term systemic antibiotics or antifungal treatment 3. Current smoker or ex-smoker with >10 pack year smoking history 4. Known clinically significant respiratory disorder such as bronchiectasis, interstitial lung disease, allergic bronchopulmonary aspergillosis 5. Currently pregnant or planning pregnancy within the treatment period or breast-feeding 6. History of psychiatric, medical or surgical disorders that in the opinion of the chief investigator may interfere with undergoing a bronchoscopy or may compromise study completion or data collection 7. Current malignancy 8. Alcohol or recreational drug abuse 9. Diagnosis of immunodeficiency requiring treatment 10. Previous bronchial thermoplasty 11. Previous treatment with biological therapy 12. Previously unable to tolerate a bronchoscopy 13. Current or recent (within the last 12 weeks) infection with SARS-CoV-2 14. Unable to provide written informed consent |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University Hospital Southampton NHS Foundation Trust | King's College London, University of Southampton |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Evaluation of neural structural changes using immunostaining on biopsy specimens | Immunostaining will be reported as mean fluorescence intensity and percentage of cells stained | 36 months | |
Primary | To investigate molecular changes in the bronchial epithelium that occurs with mepolizumab treatment using RNA sequencing | Changes at the level of single cell RNA sequencing will be reported as:
Changes in the percentage of cell populations present in the airways Normalised gene counts |
36 months | |
Secondary | Changes in epithelial barrier integrity using transepithelial resistance | Transepithelial resistance measures changes in voltage across the epithelial cells | 36 months | |
Secondary | Changes in epithelial antiviral responses using interferon and other antiviral gene measurements | Gene expression will be measured using RNA sequencing and reported as gene counts | 36 months | |
Secondary | Changes in airway remodelling by assessing fibroblasts isolated from bronchial biopsies using RNA sequencing | RNA sequencing will be reported as gene counts | 36 months | |
Secondary | Changes in airway remodelling by assessing fibroblasts isolated from bronchial biopsies using immunostaining | Immunostaining will be reported as mean fluorescence intensity and percentage of cells stained | 36 months | |
Secondary | Evaluate the impact of Mepolizumab on peripheral airways by obtaining bronchoalveolar lavage for RNA sequencing | RNA sequencing will be reported as gene counts | 36 months | |
Secondary | Evaluate the impact on peripheral airways by obtaining peripheral airway brushings for RNA sequencing | RNA sequencing will be reported as gene counts | 36 months | |
Secondary | Peripheral airway dysfunction using impulse oscillometry | Impulse oscillometry will be measured as resistance and impedance | 36 months |
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