Sweden-based Atos Medical has announced positive results from a Phase I/II clinical trial evaluating its Provox Life heat and moisture exchanger (HME) in people with a laryngectomy. The device is designed to improve pulmonary health and quality of life for patients who have had a total laryngectomy (the removal of the larynx and airway separation from the mouth, nose, and oesophagus).
The data analysis showed that during the first stage of the trial the transition to Provox Life significantly improved overall pulmonary health. In the second stage, using the highest humidification HMEs optimally during the day and night further improved pulmonary health.
In addition, Provox Life HMEs improved the quality of sleep significantly for patients when used throughout the day and night. It also improved adherence to HMEs and facilitated the use of an optical day and night regimen.
The results confirm that using better-performing HMEs can potentially improve pulmonary health and related symptoms for laryngectomized patients. There is also a possibility to increase the number of hours that HMEs are used per day when utilising a range of devices with various breathing resistance levels.
Lead investigator Elizabeth Ward said: “Using the Provox Life range improved cough and sputum symptoms and led to associated benefits including improved sleep. These changes can be attributed to both the enhanced humidification properties of the devices and an increased duration of HME use supported by using devices with different breathing resistance for situational use.”
Phase I/II trial design
The objective of the two-part trial (NCT04943731) was to examine the changes in pulmonary and other related symptoms using the new generation of Provox Life HMEs. According to the ClinicalTrials.gov listing, the trial enrolled 48 patients.
The primary endpoints of the trial measured changes in cough symptoms and cough impact that were assessed with the Coughing and Sputum Assessment Questionnaire (CASA-Q). The assessments occurred from week six to week 12.
The trial explored various secondary endpoints, such as changes in sputum symptoms and impact, number of forced mucus expectorations and involuntary coughs, as well as the quality of life, sleep evaluation and skin integrity.
The first part of the trial investigated the transition from currently used HMEs to the new Provox Life HME. In the second part of the trial, participants used the new devices following an optimal day and night regimen with the aim to achieve the best possible humidification throughout the day.