An observational study in Asthma, sponsored by Imperial College London. Not yet recruiting at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-25.
Sponsored by Imperial College London · Observational
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:
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
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 225 is above the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Oscillometry is a test that uses sound waves to measure the mechanical properties in the lungs during tidal breathing
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
We will be evaluating the sensitivity and specificity of a novel nasal swab test for eosinophil peroxidase
We will be evaluating handheld capnometry (carbon dioxide breath testing) to diagnose adult asthma
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.
Time frame: 6 months
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
Time frame: 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)
To assess the degree of agreement between each of the diagnostic tests
Time frame: 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)
Time frame: 6 months
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
Time frame: 6 months
To evaluate the diagnostic accuracy of nasal biomarker eosinophil peroxidase (EPX)
As an exploratory endpoint we will be assessing the diagnostic accuracy of a novel nasal swab eosinophil protein biomarker for asthma
Time frame: 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
Time frame: 6 months
Plan to share: No
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This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Imperial College London