Respiri clinical trial shows ‘substantial agreement’ with doctor stethoscope test for asthma detection
Health & Biotech
Health & Biotech
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Special Report: Respiri remains on track to commercialise its wheezo™ asthma detection device before the end of the year.
eHealth company Respiri (ASX:RSH) has continued its run of positive news flow, with the release of new clinical trial data this morning.
The results showed that Respiri’s proprietary wheezo™ device has a statistically significant correlation for the detection of wheeze, when compared with a physician’s assessment using a stethoscope.
CEO Marjan Mikel said the trial “highlights the potential of our device to provide accurate, real-time measurements of wheeze in patients outside of the clinical setting, where monitoring of the disease is paramount”.
Importantly, the work carried out by Respiri will also form a key building block in the development of a standardised formula for measuring wheeze severity – a crucial preventative step for which the medical community is still building consensus.
To conduct the trial, Respiri ran tests on 56 patients, with 114 recordings taken. A total of 11 physicians participated in the study, which was run by two leading researchers – Monash University Professor Frank Thien (also the director of the Department of Respiratory Medicine at Box Hill Hospital), and Professor Bruce Thompson of Swinburne University.
The preliminary results showed the wheezo™ device returned a true positive (sensitivity) reading of 74 per cent for detecting wheeze rates on patients experiencing breathing difficulties. It also detected no wheezing (a true negative) in 83 per cent of cases.
Armed with the preliminary data, the Respiri team developed and updated the proprietary algorithm behind the wheezo™ device.
With modifications, true positive readings improved to 81 per cent (with a 79 per cent reading for no-wheeze detection).
The true positive figure rose to 89 per cent when adjusted for two of the 11 physicians who showed “significant disagreement” to retrospective breathing recordings.
In other words, the company has now developed intellectual property that closely correlates with the “gold standard” of wheeze detection.
“Further, Cohen’s kappa coefficient also improved from 0.51 (moderate agreement) to 0.64 in the latter population of physicians demonstrating substantial agreement,” the company said.
“This new algorithm will be used to test the device performance in a new clinical study.”
The promising trial results mark yet another strong market update from Respiri, which have seen shares in the company rise by almost 200 per cent since the start of May.
After flagging strong FY21 revenues in late-July, Respiri also landed a distribution deal with the Australian Patients Association (APA), which serves 1.1 million members across the country.
Having made material advances in the accuracy of the wheezo™ device’s underlying algorithm, Mikel said the company was now in the process of filing a Patent Cooperation Treaty (PCT) to protect its intellectual property.
The participation of multiple physicians also marks a key step in building clinical validation for Respiri’s end-goal – to build a device that asthma sufferers can use to accurate and reliably self-assess any symptoms and breathing problems.
While noting there’s more work to do yet in the field, the company highlighted that a “clinical development road map is already in development to accelerate the refinement of wheeze scoring”.
Respiri cited a recent survey which showed rates of uncontrolled asthma in the Australian community could be as high as 45 per cent.
And while most asthma sufferers deemed their breathing issues to be well-controlled, only 18 per cent of respondents actually met that definition in accordance with the Global Initiative for Asthma guidelines.
Mikel said one of the goals of the clinical trial was to give doctors a high degree of confidence their patients could accurately self-assess symptoms when away from the clinic.
And that will be an “important consideration as Respiri moves forward with its commercial launch in the fourth quarter of calendar year 2020”, Mikel said.
This article was developed in collaboration with Respiri, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.