Asthma medication delivery with a new incentive spacer

描述(由申请人提供)： 这项研究将提出两个主要假设：第一，FunhalerR(InfaMed，澳大利亚)装置的当前原型或为该装置设计的新玩具模块是否会影响计量吸入器(MDIs)的气雾剂的遏制和输送。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的呼吸道沉积。众所周知，市场上现有的哮喘药物输送设备难以使用，效率低下。许多小孩子发现这个过程极其痛苦，进一步加剧了哮喘症状，在某些情况下导致了死亡。为了解决给年轻哮喘患者用药的依从性问题，开发了一种新的吸入器附件(FunhalerTM；InfaMed Australia)，用于计量吸入器(PMDI)，其中包括一个激励玩具模块(包括旋转盘和哨子)，该模块由儿童的呼吸模式激活，以减少压力和更有效地使用吸入器治疗。根据Funhaler试点研究的初步数据，该设备有可能对儿童哮喘患者的管理产生重大影响。如果观察到使用Funhaler的遵从性显着增加，并将其转化为对儿童更好的结果，则需要确定这一点。然而，有证据表明，服药依从性差与无痉挛儿童的发病率有关，数据显示，遵守推荐的药物治疗方案会减少非计划哮喘入院人数。这意味着，即使Funhaler设备能够将遵从性提高10%，它也将对儿童的整体健康产生显著影响，并将减轻全国可预防住院的负担，以及增加吸入性药物的消费，这对制药业来说是一个有吸引力的目标。在Funhaler可以在美国销售之前，它的性能必须通过体外和体内测试严格测定，以达到FDA设定的标准。拟议的研究对这些监管标准进行了这样的测试。此外，目前对吸入器输送药物的衡量标准通常反映了在最佳条件下输送的药量。在这里，我们将试验一种新的基于视频的协议，用于在更现实的条件下测试向儿童递送药物的情况。Funhaler的最终目标是通过帮助全球哮喘儿童利用他们可获得的有效药物来改善他们的健康。

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.