Use of the device led to better lung function, the company reported. It published its study in Global Pediatric Health under the title “The Use of Home Spirometry in Pediatric Cystic Fibrosis Patients: Results of a Feasibility Study.”
The U.S. Food and Drug Administration (FDA) approved Spiro PD in 2011. Since then, the personal spirometer has been widely adopted by healthcare institutions. It has also become the standard of care for remote monitoring of lung function in people with CF or those who have had lung transplant surgery.
A spirometer measures how much and how fast someone can move air out of their lungs.
The two-phase Spiro PD study was aimed at understanding the barriers to the device’s use, what motivates people to stick with it, and the feasibility of using it at home.
In the first part of the study, researchers asked 40 CF patients ages 12 to 21 what would prompt them to stick with the Spiro PD. They conducted the survey during visits to pediatric wards or by telephone over four months.
The top considerations patients mentioned were being able to use the device at home, and having a system in place for remembering their medication. The second part of the study evaluated whether the Spiro PD could meet those needs.
This pilot study (NCT02301377) recruited five subjects between the ages of 10 and 14. Three were randomly selected to receive a Spiro PD to measure their lung function at home for three months. Researchers followed the other two to see how well they stuck with their medication without a way to remind them about it.
Spiro PD allows patients to measure pulmonary function test results up once a day, store and track values on the device, and download the results onto a computer as a PDF file.
It generates flow-volume loops and volume-time curves. It also reports forced vital capacity (FVC) and forced expiratory volume in 1 second, or FEV1 — another measure of lung function.
The patients’ health outcomes, body mass index (BMI), and treatment scores were used to compare the group using a Spiro PD with the control group. The study showed that 94.7% of patients using the Spiro PD stuck with their home spirometry.
Feedback from the test results, plus the medication reminders, proved to be strong motivations for sticking with the Spiro PD. Lung function test measurements, BMI and treatment-burden scores all improved in the group using the devices, compared with the control group.
“This study offers further evidence of how remote patient monitoring and supportive adherence reminders can have a positive impact on patient self-management and play a pivotal role in treatment success,” Steve Sullivan, executive vice president at PMD Healthcare, said in a press release.
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