validation of safety and performance of three eddis breath-activated portable inhalation systems

Conditions: Healthy Volunteers; Drug Delivery Systems; Inhalation of Liquid Air; Administration Site Injury

Summary: this is a crossover study to evaluate real-time performance, airflow control, user-device interaction, and safety systems of three portable inhalation systems from the eddis platform. the formulation is non-pharmacological and inert. each volunteer will use all three devices in random order. primary endpoints focus on gas dynamics, inhalation recording accuracy, device integrity, and user tolerability.

this is a device-only evaluation of three portable inhalation delivery systems from the eddis platform (vmt, atomizer, ultrasonic). the study focuses on technical performance, gas dynamics, safety system integrity, and user-device interaction under controlled conditions in healthy adult volunteers. each device is breath-actuated, disposable, and digitally integrated with a smartphone application. the inhaled formulation consists of sterile 0.9% sodium chloride containing suspended chitosan nanoparticles (\<200 nm), designed to simulate complex aerosol behavior without delivering any active pharmaceutical ingredients. the study employs a crossover design, allowing each subject to evaluate all three devices in a randomized sequence. performance characteristics such as airflow resistance, aerosol output, inspiratory detection sensitivity, power consumption, and digital logging accuracy will be assessed. special emphasis is placed on safety-related engineering features, including detection of abnormal inhalation patterns (e.g., cough-like events), child-lock functionality, and plume behavior under variable user conditions. this study does not involve any drug or therapeutic intervention, is not classified as a clinical investigation under eu mdr or swissmedic regulations, and does not require ethics committee oversight. the primary objective is to validate the eddis platform as a modular, scalable, and precisely controlled aerosol delivery system suitable for further development in both clinical and non-clinical applications.

Eligibility criteria:
inclusion criteria: age between 21 and 75 years * generally healthy adult (no known systemic or chr * normal pulmonary function (fev1 ≥ 80% predicted at screening) * body mass index (bmi) between 18.5 and 30 kg/m² * able and willing to provide written informed consent form * current or prior use of tabac exclusion criteria: * body temperature ≥ 38.0°c on the day of screening or inhalation * acute respiratory infection, cough, cold, or any inflammatory disease of the head and neck within the last 2 weeks * history of asthma, copd, or other chronic pulmonary disease * history of thoracic or lung surgery * known cardiovascular pathology, including uncontrolled or progressive hypertension * pulmonary bleeding, hemoptysis, or blood in saliva * diagnosed emphysema * known bleeding disorders or use of anticoagulants * known allergy or hypersensitivity to chitosan or related compounds * any inhalation-induced adverse reactions during baseline assessment (e.g., cough reflex not resolving within 30 seconds) * use of investigational drugs or participation in another clinical study within 30 days prior to enrollment * unwillingness or inability to follow the study plan or to comply with the requirements of the informed consent agreement * any condition which, in the opinion of the investigator, may interfere with study participation or result interpretation

Keywords: breath-activated inhaler aerosol delivery drug delivery device portable inhaler inhalation therapy bioavailability