A pilot study on the first wireless nebulizer for use by people with chronic obstructive pulmonary disease (COPD) has been cleared by a review board of the U.S. Food and Drug Administration (FDA), Wellinks, the nebulizer’s developer, announced.
“Getting into the field with our first digital health offering and welcoming patients on the platform is an exciting milestone for us,” Geoff Matous, Wellinks’ president, said in a press release.
It is estimated that about 25 million people in the U.S. have COPD. The most commonly used treatment for the chronic inflammatory disease is inhalation therapy, based on inhalers and nebulizers.
A nebulizer can significantly improve the quality of life of COPD patients as it allows a fast and effective relief of symptoms. However, while such devices come in a portable size patients can carry with them, there previously had not been a wireless version.
Treatment adherence and symptom management play a key role in patients’ engagement in their condition and therefore in the improvement of medical outcomes, researchers say.
“The company [Wellinks] is on a mission to reinvent respiratory care around the people who need it,” Matous said.
“The journey to improving outcomes and patient engagement in COPD includes generating objective data — this study is the first of many,” he said.
The study — cleared by the FDA’s Institutional Review Board (IRB), which is tasked with reviewing and monitoring biomedical research — will be conducted by a team of researchers from the Weill Cornell Medical College and New York Presbyterian Hospital, both in New York. It will use a Bluetooth version of the company’s Flyp Nebulizer.
Users are able to download a mobile Wellinks app to communicate wirelessly with the device. Once inserted, data is then driven to a cloud environment protected by the Health Insurance Portability and Accountability Act. This rule prevents confidential health information from being revealed without the patient’s consent or knowledge. Data is then available to be shown in dashboards and medical reports.
The device also is suitable to connect with some diagnostic tools, such as spirometry and pulse-oximetry, which measures oxygen saturation in the blood.
The goal of the pilot study is to demonstrate the feasibility of collecting and monitoring data that is important for the management of COPD patients. Adherence to treatment, lung function, and symptoms onset are some of the parameters measured by this digital tool.
“The Flyp Nebulizer has always been popular with my patients with its cutting-edge design,” said Brian D. Gelbman, MD, associate clinical professor of medicine at Weill Cornell and the study’s lead investigator.
“Now that Wellinks has made Flyp Nebulizer a smart device and developed the Wellinks software, I am eager to test the ability of this solution to offer comprehensive monitoring of COPD patients,” Gelbman said.
“Our hope is that with better home monitoring, we can detect exacerbations, understand medication compliance and usage, and adjust therapy to prevent clinical worsening,” he added.
According to Wellinks, the features of this new wireless nebulizer will facilitate patients’ lives, especially during the current COVID-19 pandemic, as about 71% of COPD patients have reported emotional stress.
“This could be immensely useful in the care of COPD patients, many of whom are homebound and have difficulty travelling to office visits, especially during the COVID-19 pandemic,” Gelbman said.
The study also will evaluate the commitment and satisfaction of patients with this new wireless nebulizer. According to the developer, prior data showed that while 80% of COPD patients would be willing to use digital health tools, only 10% already use them.
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