Asthma
Conditions
Brief 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
Interventions
DIAGNOSTIC_TESTNasal eosinophil peroxidase
We will be evaluating the sensitivity and specificity of a novel nasal swab test for eosinophil peroxidase
DIAGNOSTIC_TESTOscillometry with reversibility testing
Oscillometry is a test that uses sound waves to measure the mechanical properties in the lungs during tidal breathing
DIAGNOSTIC_TESTBreath 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_TESTHandheld capnometry
We will be evaluating handheld capnometry (carbon dioxide breath testing) to diagnose adult asthma
Sponsors
Asthma UK
General Practitioners Research Institute
Imperial College London
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients referred by GP with either (a) possible incident asthma or (b) a diagnostic label of asthma without prior confirmatory objective diagnosis * Age≥18 years * Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study * Able to give informed consent
Exclusion criteria
* Age \<18 years * A chest infection or exacerbation requiring antibiotics or steroids within 4 weeks of testing * Contraindications to spirometry testing * Established or coded diagnosis of COPD * Pregnancy or lactating * Other medical condition that in the opinion of the investigator would preclude compliance with the study protocoll * Inability to understand English * Involvement in Clinical Trial of an Investigational Medicinal Product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO | 6 months | To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO for adult asthma diagnosis compared to the diagnostic reference standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To conduct an analysis comparing the diagnostic accuracy of (i) oscillometry ± reversibility with spirometry ± reversibility, (ii) spirometry±reversibility with FeNO and (iii) oscillometry ±reversibility and FeNO | 6 months | To compare the sensitivity and specificity of pairwise permutations of testing |
| To compare the concordance of positive and negative test results for (i) oscillometry±reversibility, (ii) spirometry ±reversibility and (iii) Fractional Exhaled Nitric Oxide (FeNO) | 6 months | To assess the degree of agreement between each of the diagnostic tests |
| To collect data on (i) testing time, (ii) testing burden, (iii) general feasibility of implementation of the asthma diagnostic tests | 6 months | We will collect data on feasibility on each of the diagnostics (spirometry, FeNO, oscillometry) |
Other
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the diagnostic accuracy of nasal biomarker eosinophil peroxidase (EPX) | 6 months | As an exploratory endpoint we will be assessing the diagnostic accuracy of a novel nasal swab eosinophil protein biomarker for asthma |
| To evaluate the diagnostic accuracy of tidal breath CO2 waveforms using the N-Tidal handheld capnometry device | 6 months | As an exploratory endpoint we will be assessing the diagnostic accuracy of handheld capnometry for asthma |
| To evaluate the diagnostic accuracy of the targeted reactive aldehyde species (RASP) panel in breath for asthma diagnosis | 6 months | As an exploratory endpoint we will be optimising and assessing the diagnostic accuracy of a novel breath volatile organic compound test in asthma |
Countries
United Kingdom
Contacts
Primary ContactSalman Siddiqui, PhD
Outcome results
None listed