NCT06383130

London Asthma Diagnostics Study

A Pragmatic Diagnostic Accuracy Study of a Triple Diagnostic Approach and Exploratory Biomarkers in Adult Asthma Diagnosis

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 225 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this trial is to learn if the addition of oscillometry with reversibility testing increases diagnostic accuracy in adult asthma diagnosis, when added to current standard of care tests: spirometry with reversibility testing and Fractional Exhaled Nitric Oxide (FeNO). The main question it aims to answer is: \- Does oscillometry with reversibility testing increase diagnostic accuracy in detection of asthma in adults when added to spirometry with reversibility and FeNO? Researchers will evaluate the diagnostic accuracy of this approach with the reference standard, which is a clinically adjudicated diagnosis of asthma by two respiratory clinicians based on history and investigation results. Participants will * Undergo oscillometry testing alongside their routine asthma investigations within their scheduled clinic visit * Optionally participate in our sub-studies on new breath and nasal swab tests for asthma * Optionally participate in our qualitative substudy on patients views and attitudes to asthma testing and oscillometry

Conditions

• Asthma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Oscillometry with reversibility testing	Oscillometry is a test that uses sound waves to measure the mechanical properties in the lungs during tidal breathing
DIAGNOSTIC_TEST	Breath volatile testing	We will be optimising and evaluating the sensitivity and specificity of a novel breath volatile organic compound test of a combination of reactive aldehydes using a gas chromatography-ion mobility spectrometry device
DIAGNOSTIC_TEST	Nasal eosinophil peroxidase	We will be evaluating the sensitivity and specificity of a novel nasal swab test for eosinophil peroxidase
DIAGNOSTIC_TEST	Handheld capnometry	We will be evaluating handheld capnometry (carbon dioxide breath testing) to diagnose adult asthma

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-12-01
• Completion: 2026-07-01
• First posted: 2024-04-25
• Last updated: 2024-04-25

Locations

3 sites across 1 country: United Kingdom