Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04924478
Status:
UNKNOWN
Last Update Posted:
2021-06-14
First Post:
2021-05-14
Brief Title:
Evaluation of Volatile Organic Compounds in Mepolizumab Therapy
Sponsor:
University Hospital Southampton NHS Foundation Trust
Organization:
University Hospital Southampton NHS Foundation Trust
Study Overview
Official Title:
Evaluation of Volatile Organic Compound Signatures as a Predictive and Therapeutic Response Biomarker for Mepolizumab Therapy in Severe Eosinophilic Asthma
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVOC4M
Brief Summary:
This study will recruit patients who are being prescribed Mepolizumab as part of their standard clinical care for the treatment of severe eosinophilic asthma Over the course of their treatment research data questionnaires and research samples blood breath and urine will be collected in parallel to standard clinical measurements
The data and samples will be investigated to help better understand how Mepolizumab works why it doesnt work in certain patients and why it works very well in others This will help prescribers better identify patients that will benefit from Mepolizumab
The data and samples will be investigated to help better understand how Mepolizumab works why it doesnt work in certain patients and why it works very well in others This will help prescribers better identify patients that will benefit from Mepolizumab
Detailed Description:
EVOC4M is a prospective observational study investigating Mepolizumab in the treatment of severe eosinophilic asthma
This study will recruit patients receiving Mepolizumab as part of their standard clinical care in an NHS commissioned Specialised Adult Severe Asthma Service Over the course of their treatment research data questionnaires and research samples blood breath and urine will be collected in parallel to standard clinical measurements
Clinical studies have demonstrated blood eosinophil levels to be predictive of the magnitude of the impact of Mepolizumab in reducing severe disease exacerbations but it is appreciated that there are still treatment failures despite this selection criteria Clinical decision and policymaking are increasingly concerned by the health economic implications of these high-cost therapies and so clinical biomarkers are now being sought for theragnostics prediction of treatment response
The study will try to identify biomarkers that will can discriminate between those that respond to Mepolizumab responders and those that do not non-responders This will improve our understanding of how Mepolizumab works
In particular the investigators are interested in exhaled volatile organic compounds VOCs which are measured in exhaled breath samples Exhaled breath is safe and easy to collect and has direct contact with the organ of interest the airways A VOC biomarker that predicts Mepolizumab success may translate to clinical practice
This study will recruit patients receiving Mepolizumab as part of their standard clinical care in an NHS commissioned Specialised Adult Severe Asthma Service Over the course of their treatment research data questionnaires and research samples blood breath and urine will be collected in parallel to standard clinical measurements
Clinical studies have demonstrated blood eosinophil levels to be predictive of the magnitude of the impact of Mepolizumab in reducing severe disease exacerbations but it is appreciated that there are still treatment failures despite this selection criteria Clinical decision and policymaking are increasingly concerned by the health economic implications of these high-cost therapies and so clinical biomarkers are now being sought for theragnostics prediction of treatment response
The study will try to identify biomarkers that will can discriminate between those that respond to Mepolizumab responders and those that do not non-responders This will improve our understanding of how Mepolizumab works
In particular the investigators are interested in exhaled volatile organic compounds VOCs which are measured in exhaled breath samples Exhaled breath is safe and easy to collect and has direct contact with the organ of interest the airways A VOC biomarker that predicts Mepolizumab success may translate to clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None