The Development of a Screening Assay by LC-MS/MS to Monitor Adherence to Asthma Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To develop and validate laboratory urine and blood test for the detection of medications commonly used in the treatment of asthma
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
To develop and validate laboratory urine and blood test for the detection of medications commonly used in the treatment of asthma
时间窗: 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
次要结局
- To test the developed assay in the clinic, to determine its practicality to conduct, and its clinical utility in adherence assessment.(6 months)