In vitro and in vivo assessment of the Funhaler -an innovative therapeutic device for children

气雾剂疗法是治疗儿童呼吸道疾病如哮喘的最有效的方法。虽然优化气雾剂递送系统在提高哮喘治疗的疗效方面具有重要作用，但确保患者依从性通常是临床医生角色中最困难的部分，特别是在儿科年龄组中。一家西澳大利亚公司（InfaMed，Ltd）开发的一种创新的小体积间隔装置（Funhaler）可能有助于克服这一问题。Funhaler包含一个旋转玩具，连接到隔离器的外部。当患者通过垫片呼吸时，玩具被激活。该设备旨在鼓励儿童在接受哮喘治疗时进行合作。Funhaler目前处于后期开发阶段。我们建议，首先，进行体外评估的药物输送从Funhaler相比，两个最广泛使用的小体积间隔：Aerochamber加（Trudell，加拿大）和呼吸-A-技术（斯科特-迪本，澳大利亚）。这些评估将符合全球监管机构（包括FDA）的标准。其次，我们建议进行广泛的体内研究：过滤器研究，以评估药物输送到患者;沉积研究，以测量药物在肺部的沉积;以及一项试点临床试验，以评估该设备在2-8岁儿童中长期使用期间的有效性。

Aerosol therapy is the most effective form of treatment for children with respiratory diseases such as asthma. While optimising aerosol delivery systems has an important role in increasing the efficacy of asthma therapy, ensuring patient compliance is often the most difficult part of the clinician's role, particularly in the paediatric age group. An innovative small volume spacer device (Funhaler) developed by a West Australian company (InfaMed, Ltd) may help overcome this problem. The Funhaler incorporates a spinning toy attached to the outside of the spacer. The toy is activated when the patient breathes through the spacer. The device has been designed to encourage children to co-operate when their asthma therapy is being delivered. The Funhaler is currently in the late development stage. We propose, firstly, to carry out in vitro assessments of drug delivery from the Funhaler compared to the two most widely available small volume spacers: the Aerochamber Plus (Trudell, Canada) and the Breath-A-Tech (Scott-Dibben, Australia). These assessments will be carried out to meet the standards of regulatory bodies worldwide (including the FDA). Secondly, we propose to perform extensive in vivo studie: filter studies to assess drug delivery to the patient; deposition studies to measure drug deposition in the lungs; and a pilot clinical trial to assess the efficacy of the device during medium to long-term use in children aged 2-8 years.