Benjamin Heine1, Uwe Schuschnig1, Andreas Liebl1, Lea Botermann1, Daniel Wehner1 & Gesa Bräunlich1
1PARI Pharma GmbH, Moosstr. 3, 82319 Starnberg, Germany
Summary
The investigation evaluates a novel breath-guiding concept implemented into the eFlow Integrated Nebulizer, aiming at optimised drug delivery efficiency by improving patients’ breathing patterns. Vibrating mesh nebulizers, especially when breath-triggered, are favoured for maximizing dose delivery— an essential attribute for costly biopharmaceuticals. However, their prolonged nebulization times can hinder patient adherence. Among other means, the breath-guiding approach, incorporating both, device-based and app-based feedback, aims to resolve this contradiction by promoting deeper and slower breathing. In an investigation involving 64 participants (healthy, obstructive, and restrictive lung disease patients), three nebulizer variants were evaluated. Flow metrics were recorded over ~4 minutes per variant and analysed using median-averaged breathing curves. Multifactorial analysis of variance (ANOVA) revealed a significant effect of the device on key breathing pattern parameters. Compared to the eFlow OS, the eFlow Integrated with breath-guiding consistently ensured maximum inspiratory flow rates to be below 30 L/min, which reduces drug deposition in the upper airways. It also resulted in prolonged breath duration and increased I/E ratios enhancing drug delivery efficiency and shortening overall treatment time. The use of the breath guide app increased tidal volume, prolonged inspiration time and could work as an educational tool, promoting adherence and correct inhalation technique. The investigation also illustrates that breathing patterns across participant groups differ substantially from standard US Pharmacopeia (USP) patterns, demonstrating deficiencies in using those for realistic nebulizer performance testing and reference for breath-guiding evaluations.