- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06026202
Non-Eosinophilic Biological Effects of IL-5
October 26, 2023 updated by: Imperial College London
Non-Eosinophilic Biological Effects of Interleukin 5 (IL-5) - Role of IL-5 in Suppressing Anti-Viral Immunity in Bronchial Epithelial Cells and Dendritic Cells in Asthma
This study aims to investigate the role of IL-5 in suppressing anti-viral immune responses in bronchial epithelial cells (BECs) and in peripheral blood mononuclear cells (PBMCs) from 5 people with asthma.
Study Overview
Status
Recruiting
Conditions
Detailed Description
IL-5 has been shown to be present in higher levels in those with asthma, more so during viral infection.
The investigators know from existing evidence that having increased levels of interferon (IFN) reduces asthma exacerbations and viral load.
The investigators suspect that IL-5 reduces the immune response during viral infection in bronchial epithelial cells (BECs) and peripheral blood mononuclear cells (PBMCs) by reducing levels of IFN.
The aim is to investigate if increased IL-5 in stable eosinophilic asthma and asthma exacerbations suppresses anti-viral immunity in bronchial epithelial cells and in peripheral blood mononuclear cells directly via IL-5 receptor signalling, suppressing rhinovirus induction of IFNs.
The investigators also will evaluate if anti-IL-5 therapies suppress IL-5 concentrations in stable and exacerbated asthma in vivo and whether suppression of IL-5 in vivo restores deficient anti-viral immunity in BECs and PBMCs, thereby protecting against asthma exacerbations.
Study Type
Observational
Enrollment (Estimated)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sebastian L Johnston, MBBS
- Phone Number: +44 20 7594 3764
- Email: s.johnston@imperial.ac.uk
Study Locations
-
-
-
London, United Kingdom, W2 1NY
- Recruiting
- Imperial College London
-
Contact:
- Sebastian L Johnston, MBBS
- Phone Number: +442075943764
- Email: s.johnston@imperial.ac.uk
-
Contact:
- Eva Fiorenzo, BMBS
- Phone Number: +442075943751
- Email: efiorenz@ic.ac.uk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Those with mild asthma on as required salbutamol only.
Description
Must be eligible for the study 'Mechanisms of Adverse Effects of Long-Acting Beta-Agonists in Asthma' (MAELABA) (19SM5101).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IL-5 suppresses anti-viral immunity in BECs and in PBMCs/pDCs directly via IL-5 receptor signalling suppressing RV induction of IFNs.
Time Frame: 1 year
|
Expression of IL-5RA, CSF2RB and IFN mRNA and protein in BECs and PBMCs will be measured at baseline and following rhinovirus infection.Viral load will be measured by PCR(copies/ml) of viral RNA in cell lysates and virus release into supernatants by TCID50 assay to determine whether IL-5 augments virus replication.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2023
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
August 25, 2023
First Submitted That Met QC Criteria
September 1, 2023
First Posted (Actual)
September 7, 2023
Study Record Updates
Last Update Posted (Actual)
October 30, 2023
Last Update Submitted That Met QC Criteria
October 26, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 326910
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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