Exhaled Breath Biomarkers in Acute Asthma: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Study feasibility - assessment
研究概览
简要总结
This study aims to assess the feasibility of capturing data on exhaled breath compounds during an acute asthma exacerbation. In addition to assessing the feasibility of such a study the investigators will collect data on exploratory outcomes including the ability of breath biomarkers to distinguish between controlled and exacerbated states and their ability to differentiate between triggers of exacerbation.
详细描述
This will be a longitudinal observational study in which the investigators assess the ability to capture information on volatile organic compounds in exhaled breath during an acute asthma exacerbation using two different approaches:
A) Recruitment and assessment of patients in secondary care during an acute exacerbation of their asthma; patients to be re-assessed once their asthma is stable and controlled.
B) Recruitment of clinically stable outpatients who are at increased risk of exacerbation by virtue of having had an acute exacerbation within the previous 12 months. Participants to be followed for a period of up to 12 months; assessed in the event of an exacerbation; and re-assessed once controlled.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Aged 18 or above
- •Able to provide informed consent
- •A confirmed asthma diagnosis requiring treatment with inhaled bronchodilator therapy +/- inhaled corticosteroids.
- •Non-smoker (or ex-smoker of 6 months or more with a less than 10 pack year history).
- •Current exacerbation or exacerbation within the previous 12 months.
- •Within 24 hours of having presented to acute secondary care (applicable to current exacerbation only)
排除标准
- •Major chronic cardiorespiratory disease other than asthma
- •Significant comorbid condition
- •Receiving maintenance oral corticosteroid therapy or other immunosuppressant or immunomodulatory therapy (including biologics)
- •Participating in a clinical trial of an investigational medicinal product (CTIMP).
- •Unable to speak English.
结局指标
主要结局
Study feasibility - assessment
时间窗: 18 months
Percentage of participants who experience an exacerbation, contact the study team and complete an assessment
Study feasibility - patient acceptability
时间窗: 18 months
Patient acceptability of breath capture devices (assessed by questionnaire)
Study feasibility - recruitment
时间窗: 18 months
Recruitment rate
次要结局
- Breath profile of exhaled volatile organic compounds (VOCs).(12 months)