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Stop pulmonary airleaks with a novel inhaled dry powder aerosol

使用新型吸入干粉气雾剂阻止肺部漏气

基本信息

批准号：
10602342
负责人：
Bryce Beverlin II
金额：
$ 29.98万
依托单位：
QUENCH MEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-02-10 至 2024-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10602342
关键词：
Acceleration Aerosols Air American Animal Model Benchmarking Biopsy Cadaver Caring Characteristics Chest Tubes Clinic Clinical Clinical Research Coughing Data Data Analyses Deposition Devices Disease Dryness Excipients Family suidae Fibrinogen Formulation Future Glues Goals Grant Growth Hospital Costs Hospitalization Human Inhalation Investigational Drugs Lead Lung Lung diseases Medical Modeling Nebulizer Operative Surgical Procedures Oral cavity Pain Particle Size Patient Care Patients Peripheral Personal Behavior Pharmaceutical Preparations Pharmacologic Substance Pharyngeal structure Phase Pleurodesis Pneumothorax Positioning Attribute Powder dose form Procedures Process Production Provider Safety Site Suction System Techniques Technology Testing Therapeutic Therapeutic Agents Thoracic Surgical Procedures Thrombin Time Toxicology Translations United States Work burden of illness comparison control cost drug development effective therapy efficacy study experience experimental study feasibility testing first-in-human healing improved in vivo in vivo evaluation manufacture meetings meter minimally invasive new technology novel novel therapeutics porcine model pre-clinical pressure prevent seal success

项目摘要

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.

项目摘要每年有超过30，000名美国人患有肺漏气，肺部疼痛，侵入性治疗和昂贵的住院治疗。目前的治疗方法不是在控制漏气方面不够有效，医疗提供者正在寻求新的治疗方法。那里强有力的证据表明，通过吸入局部输送的治疗剂将产生重大影响，通过直接促进漏气的关闭来减少这种疾病的负担。但没有获得批准的疗法来实现通过吸入快速解决漏气的目的，以及有效的治疗仍然是一个重大的未满足的需求。因此，我们正在开发一种微创吸入气雾剂，旨在密封快速有效地防止肺部漏气，以避免痛苦的手术和昂贵的住院治疗。这个第一阶段项目的目标是开发和测试我们的小说的可行性和有效性，使用体内肺漏气模型的吸入干粉气溶胶制剂。成功完成这一第一阶段的努力将使我们能够证明在体内毒理学的安全性研究并准备首次人体临床研究。将这项技术转化为临床上有益的医疗产品有可能显着改善患者的生活，肺漏气