Respiratory Therapy with Digital Inhalers: Insights from Multimodal Experimental and In Vitro Analysis.

Background: The RS01X is a digital dry powder inhaler (DPI) that records inhalation parameters such as technique or adherence. This offers patients and health care providers a way to have a feedback on inhalation treatments. This study used real-life data gained from 28 healthy volunteers for adherence assessment, technique evaluation, and in vitro testing. Methods: The study enrolled 28 healthy volunteers. Participants were shown how to use an inhaler and provided with empty capsules. The inhalers record several inhalation parameters such as peak inspiratory flow (PIF), volume, duration, and orientation. Half of the participants were selected to be in an "intervention" group with access to their inhalation data as well as feedback to improve their inhalation. The other half were a "control" group without access to their data nor any feedback. The data were then used for in vitro testing. Results: Overall, 28 participants were enrolled, and inhalation data were available for 13 interventions and 15 controls. Average adherence was 82.0% and 69.5% for intervention and control, respectively. The technique of inhalation was 65.58% good, 19.89% fair, and 14.53% poor for the intervention group and 36.73% good, 26.99% fair, and 36.28% poor for the control group. The variability of PIF was 9% for intervention and 30% for control. In vitro simulations showed the importance of proper angle orientation in inhalation, which was supported by in vivo data. The fine particle fraction of active pharmaceutical ingredients was similar to the inhalation profile of the intervention in comparison with a theoretical perfect inhalation. Conclusion: This study results showed clear improvement in inhalation technique and adherence for patients using digital DPI. In addition, in vitro testing provided concrete data illustrating the measurable advancements digitalization offers in enhancing patient adherence and inhalation technique.