The Food and Drug Administration has given clearance to a digital health device and app for patients using an inhaler made by AstraZeneca.
Madison, Wisconsin-based Propeller Health said Tuesday that it had received a 510(k) clearance for its product, Propeller, for use with London-based AstraZeneca’s Symbicort (budesonide, formoterol) inhaler for patients with asthma and chronic obstructive pulmonary disease. Propeller is also used with inhalers made by Boehringer Ingelheim, GlaxoSmithKline, Novartis, Orion and generic drugmakers.
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“Our partnership with AstraZeneca will give respiratory patients a tool to help manage their condition and increase their medication adherence, a critical factor in keeping people out of the hospital,” Propeller Health CEO David Van Sickle said in a statement. “This is an important step in transforming the way people receive preventive care, enabling self-management from home and ensuring that providers have the bandwidth to focus on high-risk patients.”
Propeller consists of sensors attached to inhalers, which then deliver data on medication use to the app, which patients in turn can share with their doctors.
The company has published several clinical studies of its product over the years. A randomized 2016 study of 495 patients to measure its efficacy in reducing inhaler use found a statistically significant decrease in inhaler use among those receiving data from the senors compared with those who did not, while the proportion of days without inhaler use saw a statistically significant increase. Scores on the Asthma Control Test were not significantly different between the two arms overall, but did show a statistically significant difference among those with initially uncontrolled ACT scores.
Another study, published last year, examined the system’s effect on 39 COPD patients considered to show high use of healthcare utilization, defined as at least one hospitalization or emergency room visit during the year before they entered the trial. If data from the sensors showed suboptimal adherence or increased use of rescue inhalers – thus indicating an impending exacerbation of disease – they would receive alerts. Results of the study showed a statistically significant reduction in COPD-related healthcare utilization per year, though the reduction in all-cause healthcare utilization did not reach statistical significance.
The company also cited studies showing that use of Propeller resulted in a 58% increase in medication adherence and a 57% reduction in asthma-related emergency department visits.
Photo: Hiraman, Getty Images
