LUNG-Tech
Research type
Research Study
Full title
A Trial Evaluating Novel Technologies for the Diagnosis of Asthma
IRAS ID
319664
Contact name
Joe Shoebridge
Contact email
Sponsor organisation
Portsmouth Hospitals University NHS Trust
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Currently, there is no single test to diagnose asthma; instead, it’s based on a combination of clinical history, different investigations, and ‘trial by treatment’, leading to diagnostic uncertainty and over- or under-treatment. We want to try and make the journey to a diagnosis of asthma easier and quicker, and through this study we hope to test new devices that could be used in both GP practices and hospitals to help make the diagnosis of asthma. 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 (currently N-tidal and Inflammacheck). These devices have been used in earlier studies and measure different physical, biological and chemical changes in breath which have been shown to be different in people with asthma.REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0367
Date of REC Opinion
27 Sep 2022
REC opinion
Favourable Opinion