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NCT03460106 | Recruiting | Asthma

The Development of a Screening Assay by LC-MS/MS to Monitor Adherence to Asthma Treatment

Heart of England NHS Trust

Brief 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.

Condition or disease


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.

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
Inclusion Criteria
  • Aged 18-80
  • Able to give valid informed consent
  • Prescribed one or more of the medications to be tested
  • Able to provide a blood and urine sample
  • Able to complete questionnaires in English
Exclusion Criteria
  • Females who are pregnant or lactating.
  • Patients known to have any blood borne virus that would render the sample hazardous. This includes Hepatitis B, Hepatitis C and HIV.

How to Participate

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United Kingdom, West Midlands

Birmingham Heartlands Hospital

Birmingham, West Midlands, United Kingdom, B9 5SS