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

雾化疗法是治疗患有哮喘等呼吸道疾病的儿童最有效的形式。虽然优化气雾剂输送系统在提高哮喘治疗效果方面具有重要作用，但确保患者依从性往往是临床医生职责中最困难的部分，尤其是在儿科年龄组。西澳大利亚州一家公司(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集成了一个安装在间隔器外部的旋转玩具。当患者通过隔板呼吸时，玩具就会被激活。该设备的设计是为了鼓励儿童在进行哮喘治疗时进行合作。Funhaler目前处于后期开发阶段。首先，我们建议对Funhaler的药物释放进行体外评估，将其与两种最广泛使用的小容量间隔器进行比较：Aerochamber Plus(加拿大特鲁德尔)和Breath-A-Tech(Scott-Dibben，澳大利亚)。这些评估将进行，以满足世界各地监管机构(包括FDA)的标准。其次，我们建议进行广泛的体内研究：筛选研究以评估药物在患者体内的传递；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疗效。

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.