Faculty of Biology, Medicine and Health, School of Biological Sciences, Division of Immunology, Immunity to Infection & Respiratory Medicine, The University of Manchester, Manchester, UK
Manchester Academic Health science Centre, Manchester University NHS Foundation Trust, Manchester, UK.
BMJ Open. 2024 Oct 26;14(10):e083908. doi: 10.1136/bmjopen-2024-083908.
The diagnosis of asthma is often based on characteristic patterns of symptoms in the absence of an alternative explanation, resulting in over and under diagnosis. Therefore, diagnostic guidelines usually recommend including confirmation of variable airflow obstruction. Some recommend using a sequence of objective tests; however the tests used, the specific cut-off values and the specified order are yet to be validated. We aimed to determine the optimal cut-off values and series of investigations to diagnose asthma. We also explore the potential for novel tests of small airways function and biomarkers, which could be incorporated into future diagnostic pathways.
The Rapid Access Diagnostics for Asthma study is an observational study of 300 symptomatic patients with 'clinician-suspected asthma' and healthy controls (aged ≥3 to <70 years), recruited from primary and secondary care in Greater Manchester, UK. Symptomatic participants will undergo four core visits and one optional visit. Participants will complete two baseline visits and undergo a series of established (spirometry, bronchodilator reversibility, exhaled nitric oxide, home peak flow monitoring and bronchial challenge testing) and novel tests. Following visit 2, participants will receive monitored medium-dose inhaled corticosteroid therapy for 6-8 weeks, after which they will return for repeat testing. Patients will be diagnosed with asthma by 'expert panel' opinion (minimum two respiratory specialists) on review of all data (excluding novel tests) pre and post treatment. Healthy controls will attend two visits to establish reference intervals and calculate repeatability coefficients for novel tests where there is a lack of evidence on what threshold constitutes a 'normal' set of values. The primary end point is to determine the optimum diagnostic pathway for diagnosing asthma.
The study was approved by Greater Manchester East Research Ethics Committee (18/NW/0777). All participants or parents/guardians are required to provide written informed consent and children to provide written assent. The results will be published in peer-review journals and disseminated widely at conferences and with the help of Asthma and Lung UK (www.asthmaandlung.org.uk).
ISRCTN11676160.
哮喘的诊断通常基于症状的特征模式，而没有其他解释，导致诊断过度和不足。因此，诊断指南通常建议包括可变气流阻塞的确认。一些人建议使用一系列客观测试；然而，所使用的测试、特定的截止值和指定的顺序尚未得到验证。我们旨在确定诊断哮喘的最佳截止值和一系列研究。我们还探讨了小气道功能和生物标志物的新型测试的潜力，这些测试可能被纳入未来的诊断途径。
快速获得哮喘诊断研究是一项观察性研究，纳入了 300 名来自英国大曼彻斯特地区初级和二级保健的有“临床怀疑哮喘”的症状患者和健康对照者（年龄≥3 至<70 岁）。有症状的参与者将进行四次核心访问和一次可选访问。参与者将完成两次基线访问，并进行一系列已建立的（肺量测定、支气管扩张剂可逆性、呼气一氧化氮、家庭峰流速监测和支气管激发试验）和新型测试。在第 2 次就诊后，参与者将接受监测的中剂量吸入皮质类固醇治疗 6-8 周，之后他们将返回进行重复测试。通过回顾所有治疗前后的数据（不包括新型测试），由专家小组（至少两名呼吸专家）发表意见诊断哮喘。健康对照者将参加两次就诊，以确定新型测试的参考区间并计算重复性系数，对于缺乏什么阈值构成“正常”值集的证据的新型测试。主要终点是确定诊断哮喘的最佳诊断途径。
该研究获得了大曼彻斯特东研究伦理委员会（18/NW/0777）的批准。所有参与者或其父母/监护人都需要提供书面知情同意书，而儿童需要提供书面同意书。研究结果将发表在同行评议期刊上，并在会议上广泛传播，并在英国哮喘和肺部协会（www.asthmaandlung.org.uk）的帮助下传播。
ISRCTN81622054。
