A Trial Evaluating Novel Technologies for the Diagnosis of Asthma The LUNG-TECH Trial
Recruiting · NCT05819944 · Observational (researchers observe without assigning treatment) · Lead sponsor: Portsmouth Hospitals NHS Trust
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- • 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
Exclusion criteria
- • 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
Where it is running
1 location listed.
- Portsmouth Hospitals University NHS Trust - Portsmouth, Hampshire, United Kingdom