Validation of Safety and Performance of Three EDDIS Breath-Activated Portable Inhalation Systems

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