Stop pulmonary airleaks with a novel inhaled dry powder aerosol

项目摘要摘要 每年有超过30,000名美国人因肺部漏气导致晕倒 肺部有痛苦的侵入性治疗，以及昂贵的住院费用。目前的治疗方法不是 在控制空气泄漏方面足够有效，医疗提供者正在寻找新的治疗方法。那里 是否有强有力的证据表明，局部吸入治疗会产生重大影响 关于通过直接促进闭合漏气来减轻这种疾病的负担。然而，在那里 是否没有批准的治疗方法来实现通过吸入快速解决空气泄漏的目标，以及 有效的治疗仍然是一个重要的未得到满足的需求。 因此，我们正在开发一种微创的吸入性气雾剂，旨在密封 肺部快速有效地漏气，以避免痛苦的手术和昂贵的住院费用。 这个第一阶段项目的目标是开发和测试我们的新技术的可行性和有效性 使用活体肺漏气模型的吸入干粉气雾剂配方。成功 完成这一第一阶段的工作将使我们能够在体内毒理学中证明安全性 研究并准备一项首个人类临床研究。将这项技术转化为临床 有益的医疗产品有可能显著改善患者的生活 肺部漏气。

Project Summary Abstract Over 30,000 Americans suffer each year from pulmonary airleaks leading to collapsed lungs with painful, invasive treatments, and costly hospitalizations. Current treatments are not effective enough in controlling airleaks and medical providers are seeking new therapies. There is strong evidence that a locally delivered therapeutic via inhalation would have a major impact on reducing the burden of this disease by promoting closure of the airleak directly. However, there are no approved therapies to achieve the aim of quickly resolving airleaks via inhalation, and effective treatment remains a significant unmet need. Therefore, we are developing a minimally invasive inhaled aerosol that aims to seal an airleak quickly and efficiently in the lung to prevent painful procedures and costly hospitalizations. The goal of this Phase I project is to develop and test the feasibility and efficacy of our novel inhaled dry powder aerosol formulation using an in-vivo pulmonary airleak model. Successful completion of this Phase I effort will position us to demonstrate safety in an in-vivo toxicology study and prepare for a first-in-human clinical study. Translation of this technology into a clinically beneficial medical product has the potential to significantly improve the lives of patients with pulmonary airleaks.