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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.
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.
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| 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 | 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 |
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adel Dr Mansur | Contact | 0121 424 2000 | 3928 | adel.mansur@heartofengland.nhs.uk |
| Mary Mrs Bellamy | Contact | 0121 424 2000 | 1685 | mary.bellamy@heartofengland.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Robert Mr Williams | Heart of England NHS Foundation Trust | Principal Investigator |
| Alexander Lawson Dr Lawson | Heart of England NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Heartlands Hospital | Recruiting | Birmingham | West Midlands | B9 5SS | United Kingdom |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 6 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |