RecruitingNCT05819944

A Trial Evaluating Novel Technologies for the Diagnosis of Asthma The LUNG-TECH Trial

A Trial Evaluating Novel Technologies for the Diagnosis of Asthma

Sponsor

Portsmouth Hospitals NHS Trust

Enrollment

356 participants

Start Date

Jan 9, 2023

Study Type

OBSERVATIONAL

Conditions

Asthma

Summary

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.

Eligibility

Min Age: 17 Years

Inclusion Criteria9

• 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 Criteria8

• 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