London Asthma Diagnostics Study
Research type
Research Study
Full title
A pragmatic diagnostic accuracy study of a triple diagnostic approach and exploratory biomarkers in adult asthma diagnosis
IRAS ID
339075
Contact name
Salman Siddiqui
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Asthma is the most common respiratory disease affecting adults and children. It presents with symptoms of cough, wheeze and breathlessness, and results from inflammation of the airways, narrowing and hyper-reactivity to triggers. Despite its prevalence, establishing a firm diagnosis can be difficult as there is no single gold-standard test.
Spirometry, the first-line investigation, requires specialist staff, is time-consuming, challenging for patients as it requires forced blowing and is not very sensitive at picking up asthma. The second most common test, Fractional Exhaled Nitric Oxide (FeNO), a breath test which detects airway inflammation, only detects allergic asthma. It can also be suppressed by factors such as inhaled corticosteroids and smoking.
As a result, there are significant rates of under and over diagnosis. Oscillometry is a test that uses sound waves to measure how much resistance there is in the lungs when breathing normally. Increasing evidence is suggestive that it is more sensitive than spirometry at detecting narrowing of the small airways.
The aim of this study is to evaluate the diagnostic accuracy of a triple diagnostic approach with oscillometry, spirometry and FeNO using portable devices in adults referred with possible asthma.
We will be recruiting patients referred by GPs for suspected asthma across three centres: two secondary care respiratory clinics in St Mary's Hospital (SMH) at Imperial Health Care Trust (ICHT) and Nottingham University Hospitals NHS Trust (NUH), and a primary care diagnostic hub (Willesden Community Diagnostics Centre, WCDC). In addition to routine care (spirometry+/-reversibility and FeNO), patients will have oscillometry+/-reversibility testing, handheld capnography (carbon dioxide breath test), breath and nasal swab testing for novel asthma biomarkers.
The primary outcome will be evaluating the diagnostic accuracy of the triple diagnostic approach compared to the reference standard, which will be an adjudicated asthma diagnosis by two respiratory clinicians based on history and investigations.
REC name
Wales REC 7
REC reference
24/WA/0119
Date of REC Opinion
29 Apr 2024
REC opinion
Favourable Opinion