Validation of an AI-Powered Smart Dry Powder Inhaler (RS01X) for Asthma and COPD in a Clinical Setting

Introduction: The main treatment for patients with chronic obstructive pulmonary disease (COPD) or asthma is inhalation medication. Treatment efficacy is often suboptimal due to poor therapy adherence and errors in inhalation technique. The RS01X™ (RS01X) is a smart, single dose dry powder inhaler (smart DPI) that monitors therapy adherence and inhalation technique via inhalation profiles, consisting of duration, volume and peak inspiratory flow (PIF). The objective was to validate the smart DPI compared to an external inhalation profile recorder (IPR). Methods: This monocenter cross-sectional study with 97 participants comprises patients with COPD, asthma and healthy participants. Participants performed three inhalations with the smart DPI. The inhalations differed in duration, volume and PIF, and orientation of the inhaler (horizontal (correct) and at a 45-degree angle (incorrect)). A paired sample t-test was performed to test for differences in the mean values between the smart DPI and the IPR. Also, the intraclass correlation coefficient (ICC) was calculated. Results: The correlation between the smart DPI and the IPR shows for all the inhalation parameters an ICC > 0.95 (all p < 0.001). Analyses for healthy subjects, and patients with COPD and asthma show no relevant differences between the groups (all ICC > 0.93, all P < 0.001). Inhalations with the inhaler in an incorrect 45-degree angle show negligible but statistically significant differences on the parameters volume (0.44 milliliters) and PIF (1.5L/min) between IPR and smart DPI (P < 0.05). Discussion: The smart DPI is a valid instrument for measuring inhalation parameters to improve therapy adherence and inhalation techniques in patients with asthma and COPD.