MDI COMMERCIAL ACTUATOR CHRONOLOG

MDI 商用执行器计时表

• 批准号: 2232001
• 负责人: JAMES L WOLF
• 金额: $ 10万
• 依托单位: MEDTRAC TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-03-15 至 1995-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2232001
• 关键词: biomedical equipment development; computer program /software; computer system design /evaluation; human subject; information retrieval; inhalation drug administration; patient monitoring device; personal computers; telemetry

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.

定量吸入器是哮喘治疗不可或缺的。 贫困 对治疗方案的依从性和PM药物的不适当使用， 在文献中被记录为严重的问题。 提交给大会的数据 制药公司的FDA是值得怀疑的，没有合规数据。 以前的MDI计时装置具有成本或药物输送问题 性问题 我们建议开发一个系统，远程监控所有 MDI药物无干扰。 MDICAC的显著特点将是：（1）附加到任何商业广告 未对药物输送进行修改的MDI执行器，（2）记录时间 从任何商业致动器分配，（3）感测患者 吸入，（4）可听地提醒患者进行分配，（5）提供 视觉信息给病人，（6）存储至少六百 致动，（7）提供罐剂量计数，（7）双向转移 从远程位置与个人的指令和信息 计算机数据库系统;（8）低成本。 为制药业带来显著、可衡量的效益 从事临床试验以证明安全性和有效性的公司， 从事管理治疗的初级保健医生 将通过I期研究确定慢性病患者 二是这个项目。 拟议的商业应用：引入计时装置 适于记录雾化药物分配和患者 吸入提供了建立远程患者监测的手段， 治疗方案依从性管理。 这个研究项目有 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。