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| Name | Class |
|---|---|
| Asthma UK | OTHER |
| General Practitioners Research Institute | NETWORK |
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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oscillometry with reversibility testing | Diagnostic Test | Oscillometry is a test that uses sound waves to measure the mechanical properties in the lungs during tidal breathing | ||
| Breath volatile testing | Diagnostic Test | 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 | ||
| Nasal eosinophil peroxidase | Diagnostic Test | We will be evaluating the sensitivity and specificity of a novel nasal swab test for eosinophil peroxidase | ||
| Handheld capnometry | Diagnostic Test | We will be evaluating handheld capnometry (carbon dioxide breath testing) to diagnose adult asthma |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | To compare the sensitivity and specificity of pairwise permutations of testing | 6 months |
| To compare the concordance of positive and negative test results for (i) oscillometry±reversibility, (ii) spirometry ±reversibility and (iii) Fractional Exhaled Nitric Oxide (FeNO) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the diagnostic accuracy of the targeted reactive aldehyde species (RASP) panel in breath for asthma diagnosis | As an exploratory endpoint we will be optimising and assessing the diagnostic accuracy of a novel breath volatile organic compound test in asthma | 6 months |
| To evaluate the diagnostic accuracy of nasal biomarker eosinophil peroxidase (EPX) |
Inclusion Criteria:
Exclusion Criteria:
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Participants will be eligible if being referred by their doctor for investigation for possible asthma, or for confirmation of asthma due to absence of objective diagnosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salman Siddiqui, PhD | Contact | 07989594095 | s.siddiqui@imperial.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | W2 1PG | United Kingdom | |||
| Imperial College Healthcare NHS Trust |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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RNA
To assess the degree of agreement between each of the diagnostic tests |
| 6 months |
| To collect data on (i) testing time, (ii) testing burden, (iii) general feasibility of implementation of the asthma diagnostic tests | We will collect data on feasibility on each of the diagnostics (spirometry, FeNO, oscillometry) | 6 months |
As an exploratory endpoint we will be assessing the diagnostic accuracy of a novel nasal swab eosinophil protein biomarker for asthma |
| 6 months |
| To evaluate the diagnostic accuracy of tidal breath CO2 waveforms using the N-Tidal handheld capnometry device | As an exploratory endpoint we will be assessing the diagnostic accuracy of handheld capnometry for asthma | 6 months |
| London |
| W21NY |
| United Kingdom |
|
| Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |