Respiri unveils promising wheezo clinical study results

Preliminary results of a clinical study involving the wheezo asthma management platform made by eHealth technology developer Respiri (ASX: RSH) has shown the device is capable of accurately detecting the presence or absence of wheeze in patients with chronic respiratory ailments.

Conducted at Victoria’s Box Hill and Maroondah hospitals, the study compared wheezo to the gold standard clinician-based stethoscope measurement of wheeze in asthma and chronic obstructive pulmonary disease (COPD) patients in a stable condition in the emergency department or admitted to hospital with exacerbated symptoms.

A total of 11 physicians used the electronic hand-held device to assess wheeze severity in 56 patients admitted with pronounced airway disease and a clinically-detectable wheeze, calculated in 30-second-long breath sound recordings.

The findings were correlated with an assessment of wheeze severity using a stethoscope, with each physician scoring the severity of wheeze on a scale of 0 to 10.

Preliminary study results showed the wheeze rate measured by wheezo at the trachea had a true positive (sensitivity) of 74% and correctly detected no wheeze (a true negative) of 83% (specificity).

When compared to the physician assessment of the chest and trachea, the wheezo device was able to correctly detect a true positive (sensitivity) in 81% of cases and correctly detect no wheeze (a true negative) in 79% of cases (specificity).

Respiri said the study recognised that physician assessment of wheeze is subjective and – when adjusted for two physicians which showed significant disagreement to retrospective breathing recordings wheeze assessment – the sensitivity of the device increased to 89%.

Accurate, real-time measurement

Respiri chief executive officer Marjan Mikel said the study showed the important role wheezo could play in the management of severe respiratory disease.

“The detection of wheeze at such high levels of sensitivity and specificity when benchmarked against a physical assessment by a trained clinician using a stethoscope, 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,” he said.

“For clinicians, this study represents an important step in the ongoing validation of our device as it is the first time we have shown a high degree of accuracy to the gold standard measurement of wheeze,” Mr Mikel added.

He said patient self-assessment using wheezo and the real-time data it provides will confer a “high degree of confidence” in wheeze measurement and monitoring for treating doctors outside of the clinic.

Uncontrolled asthma in Australia

A recent Australian survey reported the incidence of uncontrolled asthma in the community is as high as 45%, characterised by frequent hospital admissions and unscheduled medical visits.

Despite the prevalence, only 50% of patients have been seen by a general practitioner within the previous year, and only 10% have been reviewed by a specialist.

In one multinational survey, 90% of patients self-rate their asthma as well-controlled, but only 18% of them actually meet the definition of “controlled” as it appears in the Global Initiative for Asthma guidelines.

Mr Mikel said there exists a high market need for a device that effectively monitors wheeze in an ambulatory setting and correlates with physician-based measures.