Trials / Unknown
UnknownNCT03460106
The Development of a Screening Assay by LC-MS/MS to Monitor Adherence to Asthma Treatment
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- Heart of England NHS Trust · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Timeline
- Start date
- 2018-04-03
- Primary completion
- 2020-09-30
- Completion
- 2021-09-30
- First posted
- 2018-03-09
- Last updated
- 2020-02-11
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03460106. Inclusion in this directory is not an endorsement.