Triple Therapy Aerosol Delivery from an Integrated Inhaler Technique Training Device
Mark Sanders1 & Cuong Tran2
1Clement Clarke International Limited, Edinburgh Way, Harlow, CM20 2TT, UK
2i2c Pharma Services, Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJ, UK
The main barrier to asthma control is correct inhaler use and treatment adherence. Training can be variable in quality and occasional in delivery, but can be augmented by whistle training tools which also provide the opportunity for detection by smartphone app. A new actuator-integrated whistle Clip-ToneâM (M for multi-therapy pMDIs) is app-detectable. This device modifies the upright portion of the pMDI actuator body via either a co-manufactured or retro-fit ridging element that whistles at the appropriate flowrate. Proof of concept studies have shown aerosol characteristics and particle size distributions equivalent to use of the pMDI alone. The present Next Generator Impactor research studied aerosol performance of the triple therapy pMDI, Trimbowâ (100 µg beclometasone dipropionate [BDP], 6µg formoterol fumarate, 10 µg glycopyrronium bromide, n=5). The dose, aerosol characteristics and particle size distribution of BDP, as representative of the combination solution, were consistent between control pMDI and pMDI plus Clip-Tone M: mean emitted dose 83.75 µg and 80.64 µg; fine particle fraction 41.87% and 41.27%, and fine particle dose 35.17 µg and 33.42 µg, respectively. These in vitro data support previous Clip-Tone research carried out with single and dual API pMDIs, demonstrating that a retro-fit device that forms part of the actuator has little effect on aerosol performance. Fundamental to this new device approach is that guidance/self-training need not cease once the patient has learnt correct technique. If linked to app technology, this low-cost modification to existing pMDIs is suitable to be extended into adherence monitoring and reinforcement of technique.