Heart of England NHS Trust
Phase I: To develop and validate laboratory urine and blood test for the detection of medications commonly used in the treatment of asthma Phase II: to test the developed assay in the clinic, to determine its practicality to conduct, and its clinical utility in adherence assessment.
Phase I: laboratory based study to develop LC-MS/MS assay of urine / blood to detect presence or lack asthma medication in 50 volunteers with asthma. Phase II: once the test is validated it will be tested in a 100 patients attending the asthma clinics to test its clinical utility. Urine and blood samples will be collected from patients at time of clinic attendance to test for asthma medication panel and outcome will determine adherence or non-adherence. Clinical outcomes of adherent versus non adherent groups will be compared in terms of asthma control, lung function, biomarkers FeNO and blood eosinophils, exacerbation frequency and hospitalisation.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||The Development of a Screening Assay by LC-MS/MS to Monitor Adherence to Asthma Treatment|
|Actual Study Start Date :||April 3, 2018|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2021|
Information not available for Arms and Intervention/treatment
|Ages Eligible for Study:||18 Years to 80 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Birmingham Heartlands Hospital
Birmingham, West Midlands, United Kingdom, B9 5SS