The Development of a Screening Assay by LC-MS/MS to Monitor Adherence to Asthma Treatment
SALMA
1 other identifier
observational
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2018
CompletedFirst Posted
Study publicly available on registry
March 9, 2018
CompletedStudy Start
First participant enrolled
April 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedFebruary 11, 2020
February 1, 2020
2.5 years
February 23, 2018
February 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To develop and validate laboratory urine and blood test for the detection of medications commonly used in the treatment of asthma
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 Outcomes (1)
To test the developed assay in the clinic, to determine its practicality to conduct, and its clinical utility in adherence assessment.
6 months
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Birmingham Heartlands Hospital
Birmingham, West Midlands, B9 5SS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Mr Williams
Heart of England NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Alexander Lawson Dr Lawson
Heart of England NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2018
First Posted
March 9, 2018
Study Start
April 3, 2018
Primary Completion
September 30, 2020
Study Completion
September 30, 2021
Last Updated
February 11, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share