Asthma medication delivery with a new incentive spacer

描述（由申请人提供）： 本研究将讨论两个主要假设：首先，FunhalerR（InfaMed，澳大利亚）设备的当前原型或为该设备设计的新玩具模块是否会影响定量吸入器（MDI）中气雾剂的容纳和输送。其次，先前观察到的Funhaler装置对儿科依从性的影响是否足以改善哮喘儿童气道中的沉积。众所周知，市场上可用的哮喘药物输送装置难以使用且效率低下。许多小孩子发现这个过程非常痛苦，进一步加剧了哮喘症状，在某些情况下导致死亡。为了解决给年轻哮喘患者用药的依从性问题，已经开发了一种与定量吸入器（pMDI）一起使用的新的吸入器连接装置（FunhalerTM; InfaMed Australia），其结合了激励玩具模块（包括旋转盘和哨子），该激励玩具模块由儿童的呼吸模式激活，以允许更少的压力和更有效地使用吸入器治疗。根据Funhaler初步研究的初步数据，该设备有可能对儿科哮喘患者的管理产生重大影响。需要确定的是，观察到的使用Funhaler的依从性显著增加是否转化为儿童更好的结果。然而，有证据表明哮喘儿童的发病率与依从性差有关，数据显示，坚持推荐的药物治疗方案可减少哮喘的非计划性入院。这意味着，即使Funhaler设备将依从性提高10%，它也会对儿童的整体健康产生显著影响，并将减少可预防的住院治疗的国家负担，以及增加吸入药物的消费，这对制药行业来说是一个有吸引力的目标。在Funhaler可以在美国销售之前，其性能必须通过体外和体内试验严格确定，以达到FDA设定的标准。拟议的研究根据这些监管标准进行此类测试。此外，目前从吸入器装置递送药物的测量通常反映在最佳条件下递送的药物量。在这里，我们将试点一个新的视频为基础的protocof测试药物交付给儿童在更现实的条件下。Funhaler的最终目标是通过帮助他们利用有效的药物来改善全球哮喘儿童的健康。

DESCRIPTION (provided by applicant): Two main hypotheses will be addressed in this study: Firstly whether the current prototype of the FunhalerR (InfaMed, Australia) device or a new toy module designed for the device compromises in the containment and delivery of aerosols from Metered Dose Inhalers (MDIs). Secondly, whether the previously observed effect of the Funhaler device on paediatric adherence is sufficient to result in an improved deposition in the airways of asthmatic children. The available asthma medication delivery devices in the market are notoriously difficult to use and inefficient. Many small children find the process exceedingly traumatic, further exacerbating the asthma symptoms, which has led to fatalities in some instances. To address the compliance problem in medicating young asthmatics, a new inhaler attachment device (FunhalerTM; InfaMed Australia) for use with Metered Dose Inhalers (pMDIs) has been developed which incorporates an incentive toy module (including a spinning disk and whistle), which is activated by the child's breathing pattern, to allow for less stressful and more effective use of inhaler therapy. Based on preliminary data from pilot studies with the Funhaler, the device has the potential to have a significant impact on the management of pediatric asthmatics. It needs to be established if the observed striking increase in compliance using the Funhaler is translated into better outcomes for children. However, there is evidence linking poor compliance to morbidity in asthrmatic children, and data showing that adherence to recommended medication regimes is translated into reduced unscheduled asthma admissions into hospital. This means that even if the Funhaler device were to improve compliance by as little as 10% it would have a marked effect on health of children overall and would decrease the national burden of preventable hospitalisation as well as increasing the consumption of inhaled drugs, an attractive goal for the pharmaceutical industry. Before the Funhaler can be available for sale in the US, its perfomance must be rigorously determined by both in vitro and in vivo assays to standards set by the FDA. The proposed study performs such tests to these regulatory standards. In addition current measures of drug delivery from inhaler devices usually reflect the amount of drug delivered under optimal conditions. Here we will pilot a new video based protocof for testing the delivery of drug to children under more realistic conditions. The ultimate goal of the Funhaler is to improve the health of asthmatic children worldwide by helping them take advantage of effective medication available to them.