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

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ClinicalTrials.gov Identifier: NCT03460106
Recruitment Status : Unknown
Verified February 2020 by Heart of England NHS Trust.
Recruitment status was:  Recruiting
First Posted : March 9, 2018
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Heart of England NHS Trust

Study Description
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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
Asthma

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
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Study Type : Observational
Estimated 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 : April 3, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Groups and Cohorts
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Outcome Measures
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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 [ Time Frame: 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. [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be identified at the BRSAS, general asthma clinics and as inpatients admitted to wards at HEFT. The research team will approach patients in these settings.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460106


Contacts
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Contact: Adel Dr Mansur 0121 424 2000 ext 3928 adel.mansur@heartofengland.nhs.uk
Contact: Mary Mrs Bellamy 0121 424 2000 ext 1685 mary.bellamy@heartofengland.nhs.uk

Locations
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United Kingdom
Birmingham Heartlands Hospital Recruiting
Birmingham, West Midlands, United Kingdom, B9 5SS
Contact: Adel Mansur, PhD    0121 424 3928    adel.mansur@heartofengland.nhs.uk   
Contact: Mary Bellamy, RN    0121 424 1685    mary.bellamy@heartofengland.nhs.uk   
Sponsors and Collaborators
Heart of England NHS Trust
Investigators
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Principal Investigator: Robert Mr Williams Heart of England NHS Foundation Trust
Principal Investigator: Alexander Lawson Dr Lawson Heart of England NHS Foundation Trust
More Information
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Responsible Party: Heart of England NHS Trust
ClinicalTrials.gov Identifier: NCT03460106    
Other Study ID Numbers: 2017097RM
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases