A Trial Evaluating Novel Technologies for the Diagnosis of Asthma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Pathway 1
研究概览
简要总结
This trial aims to evaluate novel diagnostic technologies for asthma in 3 different pathways providing the necessary evidence-base to allow adoption into clinical practice:
- Pathway 1 evaluates whether the technology can distinguish between people with asthma and healthy volunteers, and other respiratory conditions in a well characterised secondary-care population and whether the parameters they measure correlate with the current standard diagnostic tests;
- Pathway 2 assesses whether the technology can accurately diagnose asthma (either independently or alongside current diagnostic tests) in a primary care population of patients where there is a clinical suspicion of asthma;
- Pathway 3 explores the ability of the technology to identify clinically important phenotypic characteristics which are difficult to measure in primary care and/or significantly impact on patient management and treatment
The novel technology and devices will be entered into the pathway most suited to their stage of development, with this study design also allowing information collected for participants with a confirmed diagnosis of asthma in pathways 1 or 2 to be included in pathway 3. Participants will undergo the investigations currently used to diagnose asthma as well as using the novel devices being investigated in the relevant pathway.
详细描述
This trial aims to evaluate novel diagnostic technologies for asthma in 3 different pathways providing the necessary evidence-base to allow adoption into clinical practice.
Pathway 1: Diagnostic case control study undertaken in a secondary care population
This will assess whether the novel technology can differentiate asthma from other respiratory conditions and from healthy volunteers, and whether the parameters they measure correlate with the current standard diagnostic tests (in line with the NICE algorithm) including those methods assessing airway inflammation and disease severity. Assessment of safety and acceptability of the technology will also be undertaken. We will invite patients who have asthma, other respiratory conditions and people who do not have any breathing problems to take part. It will be a single visit and all eligible participants will perform informed consent, and will then have baseline characteristics recorded, along with past medical history and demographical information. Participants will undergo the investigations currently used for the asthma diagnostic work-up in routine care. This will include spirometry, airway inflammation measurements (using FeNO), oscillometry and blood tests (where these have not been taken in the preceding 12 months). Participants will also be asked to use the novel device(s) currently being tested in this pathway. All participants will be asked to answer a questionnaire about how easy they found each test to use.
Pathway 2: Prospective diagnostic study undertaken in a primary care population
This study will assess whether the novel technology can be used to accurately diagnose asthma independently or whether it can be used alongside current diagnostic tests to improve the diagnostic pathway for patients with asthma. Acceptability of the novel device to patients and HCPs will be measured and the feasibility of using the novel device in the clinical pathway will be assessed. Participants with a clinical suspicion of asthma presenting with ≥1 symptom suggestive of asthma identified will be identified either from GP practices or patients presenting to the Portsmouth asthma service with diagnostic uncertainty.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Diagnosis confirmed by a specialist supported by any of the following within the last 5-years: i) Evidence of variable and/or reversible airflow obstruction
- •FEV1/FVC ratio <70% on spirometry with FEV1 ≥12% and 200 ml increase post-BD or
- •FEV1 variability ≥20% between clinic visits within 12-months or
- •R5-R20 ≥0.1kPa/(L/s) with ≥40% improvement post-BD or ii) Evidence of significant peak expiratory flow (PEF) variability
- •≥ 20% PEF variability iii) Evidence of airway hyperresponsiveness (AHR)
- •Positive methacholine challenge test (PD20 ≤8mg/ml) or equivalent iv) Evidence of T2 airway inflammation
- •FeNO ≥40ppb
- •Poor disease control evidenced by an ACQ-6 score ≥1.5
- •Not on a biologic therapy for severe asthma
排除标准
- •• Known clinically significant chest wall, neuromuscular, cardiac or other co-morbidity or abnormality that would affect spirometry and/or other measures of lung function/inflammation (in the opinion of the investigator)
- •Respiratory tract infection/exacerbation of respiratory condition requiring systemic corticosteroids and/or antibiotic treatment within the last 2 weeks
- •Current smokers or Ex-smokers with >20 PYH (other than COPD and asthma with significant smoking history group)
- •The participant is unable to provide informed consent or is unable to complete the study procedures
- •Healthy Volunteers:
- •No current clinical diagnosis of (or treatment for) a respiratory disease and no treatment for a respiratory tract Infection within the last 6 months
- •Never smoker or ex-smoker with ≤10 pack-years smoking history, and stopped smoking at least 6-months prior to enrolment
- •Non-obstructive spirometry
结局指标
主要结局
Pathway 1
时间窗: 3 months
The difference in each of the parameters (and combinations of these parameters), measured using the novel technology in patients with asthma, other respiratory conditions (COPD, BPD, bronchiectasis), and healthy volunteers As this is a pathway trial, it is not possible to define all of the parameters proactively as the novel devices included with the pathway will increase/change. This would be updated via amendments which will include devices and parameters
Pathway 3
时间窗: 6 months
To assess the associations between each of the parameters (and combinations of these parameters) measured by the novel technology and the presence of: * T2 inflammation (defined by FeNO ≥40ppb and/or blood eosinophils ≥0.3x109/L) * SAD (IOS R5-R20 ≥0.1kPa/(L/s) and/or HRCT chest evidence of gas trapping * BPD defined by a BPAT score ≥4 or a specialist diagnosis As this is a pathway trial, it is not possible to define all of the parameters proactively as the novel devices included with the pathway will increase/change. This would be updated via amendments which will include devices and parameters
Pathway 2
时间窗: 6 months
Compare each device-specific parameter measured using the novel technology (and combinations of these parameters) between asthma, other respiratory conditions (COPD, BPD, bronchiectasis), and healthy volunteers Compare levels of device-specific parameters independently or in combination, that optimally discriminate between asthma, other respiratory conditions (COPD, BPD, bronchiectasis), and healthy volunteers. As this is a pathway trial, it is not possible to define all of the parameters proactively as the novel devices included with the pathway will increase/change. This would be updated via amendments which will include devices and parameters
次要结局
未报告次要终点