Clincosm LogoSign in Get a demo

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

Sponsor
Heart of England NHS Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT03460106
Collaborator
(none)
150
Enrollment
1
Location
41.9
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Development of a Screening Assay by LC-MS/MS to Monitor Adherence to Asthma Treatment
    Actual Study Start Date :
    Apr 3, 2018
    Anticipated Primary Completion Date :
    Sep 30, 2020
    Anticipated Study Completion Date :
    Sep 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Heartlands Hospital Birmingham West Midlands United Kingdom B9 5SS

    Sponsors and Collaborators

    • Heart of England NHS Trust

    Investigators

    • Principal Investigator: Robert Mr Williams, Heart of England NHS Foundation Trust
    • Principal Investigator: Alexander Lawson Dr Lawson, Heart of England NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heart of England NHS Trust
    ClinicalTrials.gov Identifier:
    NCT03460106
    Other Study ID Numbers:
    • 2017097RM
    First Posted:
    Mar 9, 2018
    Last Update Posted:
    Feb 11, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Heart of England NHS Trust
    Asthma Medical Adherence
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Feb 11, 2020