Comparative Diagnostic Accuracy of First-line Objective Tests for Asthma in Adults With Suspected Disease: Evaluation of Individual and Combined Tests, and the Impact of Normal Spirometry and Obesity.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,176
- 试验地点
- 1
- 主要终点
- Primary outcome measure- Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, and Area Under the ROC Curve of Combined First-Line Objective Testing for Asthma Diagnosis
研究概览
简要总结
Asthma is a common long-term condition that can be difficult to diagnose accurately. Symptoms such as breathlessness, wheeze and cough can vary over time and may be caused by other conditions. Some people with asthma have normal breathing test results when they are assessed, which can make diagnosis challenging and lead to delays in treatment.
This study aims to determine which commonly used tests, either alone or in combination, are most accurate for diagnosing asthma in adults with suspected disease. Participants referred to George Eliot Hospital for investigation of possible asthma will be invited to take part.
Following informed consent, participants will undergo a range of routine diagnostic tests during their first visit. These include spirometry with bronchodilator response testing in patient with both normal airway function and airflow obstruction, fractional exhaled nitric oxide (FeNO), which measures airway inflammation, and oscillometry, which assesses how air moves through the lungs. Participants will then attend a second visit for a bronchial provocation challange test, which helps determine whether the airways are unusually sensitive, a key feature of asthma.
The study will compare the results of these tests with the final diagnosis to assess how accurately each test identifies or excludes asthma. It will also investigate whether combining different tests improves diagnostic accuracy and whether factors such as obesity affect diagnostic measurements of increased asthma prevalence.
The findings will help improve understanding of the most effective ways to diagnose asthma in routine clinical practice. This may lead to faster and more accurate diagnoses, reduce the need for unnecessary investigations, and support better care for people with suspected asthma.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- ••Adults aged 16years and older
- •Referral for objective investigation of suspected asthma
- •Ability to provide written informed consent
排除标准
- •Previous confirmed diagnosis of asthma or other chronic airways disease
- •Respiratory tract infection within six weeks prior to testing
- •Current smoker or ex-smoker with a greater than 10p\pack-year smoking history
- •Inability to perform pulmonary function testing to acceptable technical standards
- •Contraindications to any of the diagnostic investigations as per departmental guidelines
- •Lack of capacity to provide informed consent
结局指标
主要结局
Primary outcome measure- Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, and Area Under the ROC Curve of Combined First-Line Objective Testing for Asthma Diagnosis
时间窗: 6 weeks
Diagnostic performance of combined first-line objective investigations (fractional exhaled nitric oxide \[FeNO\], oscillometry, spirometry, and bronchodilator reversibility testing) compared with the composite reference standard incorporating bronchial provocation testing. Diagnostic performance will be assessed using sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve (AUC).
次要结局
- Secondary out come measure - Number and Proportion of Participants Requiring Bronchial Provocation Testing Following First-Line Assessment(6 weeks)
- Diagnostic Concordance Between First-Line Objective Investigations and the Composite Reference Standard(6 weeks)
- Diagnostic Performance of First-Line Objective Investigations According to Obesity Status(6 weeks)
- Diagnostic Performance of First-Line Objective Investigations in Participants With Preserved Baseline Spirometry(6 weeks)