- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03460106
The Development of a Screening Assay by LC-MS/MS to Monitor Adherence to Asthma Treatment (SALMA)
February 10, 2020 updated by: Heart of England NHS Trust
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.
Study Overview
Status
Unknown
Conditions
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
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Adel Dr Mansur
- Phone Number: 3928 0121 424 2000
- Email: adel.mansur@heartofengland.nhs.uk
Study Contact Backup
- Name: Mary Mrs Bellamy
- Phone Number: 1685 0121 424 2000
- Email: mary.bellamy@heartofengland.nhs.uk
Study Locations
-
-
West Midlands
-
Birmingham, West Midlands, United Kingdom, B9 5SS
- Recruiting
- Birmingham Heartlands Hospital
-
Contact:
- Adel Mansur, PhD
- Phone Number: 0121 424 3928
- Email: adel.mansur@heartofengland.nhs.uk
-
Contact:
- Mary Bellamy, RN
- Phone Number: 0121 424 1685
- Email: mary.bellamy@heartofengland.nhs.uk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2018
Primary Completion (Anticipated)
September 30, 2020
Study Completion (Anticipated)
September 30, 2021
Study Registration Dates
First Submitted
February 23, 2018
First Submitted That Met QC Criteria
March 2, 2018
First Posted (Actual)
March 9, 2018
Study Record Updates
Last Update Posted (Actual)
February 11, 2020
Last Update Submitted That Met QC Criteria
February 10, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017097RM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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