Holmes Martin S, Seheult Jansen N, O'Connell Peter, D'Arcy Shona, Ehrhardt Carsten, Healy Anne Marie, Costello Richard W, Reilly Richard B
1 Trinity Centre for Bioengineering, Trinity College Dublin , Ireland .
2 The Department of Medicine Respiratory Research Division, The Royal College of Surgeons in Ireland .
J Aerosol Med Pulm Drug Deliv. 2015 Aug;28(4):247-53. doi: 10.1089/jamp.2014.1169. Epub 2014 Nov 13.
Dry powder inhaler (DPI) users frequently exhale into their inhaler mouthpiece before the inhalation step. This error in technique compromises the integrity of the drug and results in poor bronchodilation. This study investigated the effect of four exhalation factors (exhalation flow rate, distance from mouth to inhaler, exhalation duration, and relative air humidity) on dry powder dose delivery. Given that acoustic energy can be related to the factors associated with exhalation sounds, we then aimed to develop a method of identifying and quantifying this critical inhaler technique error using acoustic based methods.
An in vitro test rig was developed to simulate this critical error. The effect of the four factors on subsequent drug delivery were investigated using multivariate regression models. In a further study we then used an acoustic monitoring device to unobtrusively record the sounds 22 asthmatic patients made whilst using a Diskus(™) DPI. Acoustic energy was employed to automatically detect and analyze exhalation events in the audio files.
All exhalation factors had a statistically significant effect on drug delivery (p<0.05); distance from the inhaler mouthpiece had the largest effect size. Humid air exhalations were found to reduce the fine particle fraction (FPF) compared to dry air. In a dataset of 110 audio files from 22 asthmatic patients, the acoustic method detected exhalations with an accuracy of 89.1%. We were able to classify exhalations occurring 5 cm or less in the direction of the inhaler mouthpiece or recording device with a sensitivity of 72.2% and specificity of 85.7%.
Exhaling into a DPI has a significant detrimental effect. Acoustic based methods can be employed to objectively detect and analyze exhalations during inhaler use, thus providing a method of remotely monitoring inhaler technique and providing personalized inhaler technique feedback.
干粉吸入器（DPI）使用者在吸入步骤之前经常对着吸入器吸嘴呼气。这种技术错误会损害药物的完整性，并导致支气管扩张效果不佳。本研究调查了四个呼气因素（呼气流量、嘴与吸入器的距离、呼气持续时间和相对空气湿度）对干粉剂量递送的影响。鉴于声能可能与呼气声音相关的因素有关，我们的目标是开发一种基于声学方法来识别和量化这种关键吸入器技术错误的方法。
开发了一个体外试验台来模拟这种关键错误。使用多元回归模型研究了这四个因素对后续药物递送的影响。在进一步的研究中，我们使用声学监测设备在22名哮喘患者使用Diskus（™）DPI时悄无声息地记录声音。利用声能自动检测和分析音频文件中的呼气事件。
所有呼气因素对药物递送均有统计学显著影响（p<0.05）；与吸入器吸嘴的距离影响最大。发现与干燥空气相比，呼出潮湿空气会降低细颗粒分数（FPF）。在来自22名哮喘患者的110个音频文件的数据集中，声学方法检测呼气的准确率为89.1%。我们能够以72.2%的灵敏度和85.7%的特异性对在吸入器吸嘴或记录设备方向5厘米或更近处发生的呼气进行分类。
对着DPI呼气有显著的有害影响。基于声学的方法可用于客观地检测和分析吸入器使用过程中的呼气，从而提供一种远程监测吸入器技术并提供个性化吸入器技术反馈的方法。
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