MDI COMMERCIAL ACTUATOR CHRONOLOG

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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.