Wednesday, May 14, 2025
5/14/2025
ASTHMA MEDICATION DELIVERY WITH A NEW INCENTIVE SPACER - 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.
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