MDI COMMERCIAL ACTUATOR CHRONOLOG

计量吸入器是治疗哮喘不可或缺的一部分。穷 对方案的依从性和PM药物的不当使用一直是 在文献中被记录为一个严重的问题。提交给 制药公司的FDA在没有合规数据的情况下是值得怀疑的。 以前的MDI计时装置成本高或药物输送有问题 担忧。我们建议开发一个系统来远程监控所有 不受干扰的MDI药物。 廉政公署的主要特点是：(1)附加于任何商业广告 未对药物输送进行修改的MDI执行器，(2)记录时间 从任何商业执行器分配，(3)感觉病人 吸气，(4)声音提醒病人配药，(5)提供 向患者提供视觉信息，(6)最少存储600个 驱动，(7)提供罐剂量计数，(7)双向转移 来自远程位置的指令和信息 计算机数据库系统，(8)成本低。 给制药制造带来显著的、可衡量的好处 从事临床试验以证明安全性和有效性的公司和 从事管理治疗的初级保健医生 将通过在第一阶段进行的研究确定患有慢性病 和这个项目的第二部分。 拟议的商业应用：引入计时装置 适用于记录雾化配药和患者 吸入法提供了建立远程患者监控的手段 治疗方案依从性管理。这项研究项目有 制药公司的商业适用性，健康维护 组织、医院、诊所和初级保健医生。

Metered dose inhalers are integral to the treatment of Asthma. Poor compliance to regimens and inappropriate usage of pm medications has been documented in the literature as a serious problem. Data submitted to the FDA by pharmaceutical companies are questionable without compliance data. Previous MDI chronolog devices have cost or questionable drug delivery concerns. We propose to develop a system to remotely monitor usage of all MDI medications without interference. Significant features of the MDICAC will be: (1) attach to any commercial MDI actuator with not modification to drug delivery, (2) record the time of dispensing from any commercial actuator, (3) sense the patient inhalation, (4) audibly remind the patient for dispensings, (5) provide visual information to the patient, (6) store minimally six hundred actuations, (7) provide canister dosage count, (7) bi-directional transfer of instructions and information from a remote location with a personal computer database system, (8) low cost. Significant, measurable benefits to the pharmaceutical manufacturing companies engaged in clinical trials for proof of safety and efficacy and the primary care physician engaged in the managed treatment of the chronically ill will be established through studies performed in Phase I and II of this project. PROPOSED COMMERCIAL APPLICATION: The introduction of a chronolog device adaptable to record aerosolized medication dispensing and patient inhalation provides the means to establish remote patient monitoring for therapeutic regimen compliance management. This research project has commercial applicability for pharmaceutical companies, Health Maintenance Organizations, hospitals, clinics, and primary care physicians.