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

• Conditions: Asthma

• Registration Number: NCT03460106
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-02-23
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-09
• Study Start: 2018-04-03
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11
• Primary Completion: 2020-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Aged 18-80
2. Able to give valid informed consent
3. Prescribed one or more of the medications to be tested
4. Able to provide a blood and urine sample
5. Able to complete questionnaires in English

Exclusion Criteria

1. Females who are pregnant or lactating.
2. Patients known to have any blood borne virus that would render the sample hazardous. This includes Hepatitis B, Hepatitis C and HIV.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To develop and validate laboratory urine and blood test for the detection of medications commonly used in the treatment of asthma	4 months	5ml biochemistry SST and 2.5ml EDTA blood sample and urine 10ml sample will be collected simultaneously from the patient on the same day and transferred to biochemistry department at Heartlands hospital. These samples will be used to develop and validate the assays

Secondary Outcome Measures

Name	Time	Method
To test the developed assay in the clinic, to determine its practicality to conduct, and its clinical utility in adherence assessment.	6 months	Patients' assessment will be similar to that described in phase I, however in phase II the administration treatment will not be directly observed. Patients will be recruited from the clinic. Patients will be asked to identify the time they took their prescribed medication and asked to provide a 5ml biochemistry SST and 2.5ml EDTA blood sample and urine 10ml sample.

Trial Locations

Locations (1)

Birmingham Heartlands Hospital; 🇬🇧 Birmingham, West Midlands, United Kingdom