A Pragmatic Diagnostic Accuracy Study of a Triple Diagnostic Approach and Exploratory Biomarkers in Adult Asthma Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO
研究概览
简要总结
The goal of this trial is to learn if the addition of oscillometry with reversibility testing increases diagnostic accuracy in adult asthma diagnosis, when added to current standard of care tests: spirometry with reversibility testing and Fractional Exhaled Nitric Oxide (FeNO). The main question it aims to answer is:
- Does oscillometry with reversibility testing increase diagnostic accuracy in detection of asthma in adults when added to spirometry with reversibility and FeNO?
Researchers will evaluate the diagnostic accuracy of this approach with the reference standard, which is a clinically adjudicated diagnosis of asthma by two respiratory clinicians based on history and investigation results.
Participants will
- Undergo oscillometry testing alongside their routine asthma investigations within their scheduled clinic visit
- Optionally participate in our sub-studies on new breath and nasal swab tests for asthma
- Optionally participate in our qualitative substudy on patients views and attitudes to asthma testing and oscillometry
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients referred by GP with either (a) possible incident asthma or (b) a diagnostic label of asthma without prior confirmatory objective diagnosis
- •Age≥18 years
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
- •Able to give informed consent
排除标准
- •Age <18 years
- •A chest infection or exacerbation requiring antibiotics or steroids within 4 weeks of testing
- •Contraindications to spirometry testing
- •Established or coded diagnosis of COPD
- •Pregnancy or lactating
- •Other medical condition that in the opinion of the investigator would preclude compliance with the study protocoll
- •Inability to understand English
- •Involvement in Clinical Trial of an Investigational Medicinal Product
结局指标
主要结局
To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO
时间窗: 6 months
To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO for adult asthma diagnosis compared to the diagnostic reference standard.
次要结局
- To conduct an analysis comparing the diagnostic accuracy of (i) oscillometry ± reversibility with spirometry ± reversibility, (ii) spirometry±reversibility with FeNO and (iii) oscillometry ±reversibility and FeNO(6 months)
- To compare the concordance of positive and negative test results for (i) oscillometry±reversibility, (ii) spirometry ±reversibility and (iii) Fractional Exhaled Nitric Oxide (FeNO)(6 months)
- To collect data on (i) testing time, (ii) testing burden, (iii) general feasibility of implementation of the asthma diagnostic tests(6 months)