Administration Site Injury, Drug Delivery Systems, Healthy Volunteers, Inhalation of Liquid Air
Conditions
Keywords
Breath-Activated Inhaler, Aerosol Delivery, Drug Delivery Device, Portable Inhaler, Inhalation Therapy, Bioavailability
Brief 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.
Detailed description
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.
Interventions
DEVICEEDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)
A set of three single-use, disposable, closely matched and uniform in size, breath-actuated, digitally monitored portable inhalation devices designed for precision aerosol delivery. Devices include a vibrating mesh (VMT), an atomizer-based unit (ATM), and an ultrasonic micro-vibration unit (ULT). Each system records inhalation parameters and connects via Bluetooth to a mobile application for real-time feedback and logging. Used to assess technical performance, gas dynamics, and digital control functions using a non-active NaCl-based aerosol with chitosan nanoparticles.
Sponsors
Petrov, Andrey
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Masking description
None (Open Label)
Intervention model description
Crossover Assignment
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Airflow Resistance Measurement | up to 72 hours | change in airflow resistance (cmH₂O/L/s) across three devices (cmH₂O/L/s via digital sensor output) |
| Inspiratory Flow Detection Accuracy | up to 72 hours | quantitative indicators (%) of detection of valid inhalation efforts compared to reference pneumotachograph |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Recording Fidelity | up to 6 hours (during all sessions) | rate of accurate digital logging of breath events ( accuracy vs manually annotated data) %) |
| Subjective Device Comfort Score | up to 6 hours (after each device use - 3 total sessions) | self-reported comfort level assessed immediately after using each device, using a standardized 10-point Visual Analog Scale (VAS), where 0 represents "very uncomfortable" and 10 represents "extremely comfortable" |
| Safety Event Detection | up to 3 hours (during each inhalation session per device) | The number of abnormal inspiratory events detected per device, including simulated coughs, breath holding, or irregular inspiratory flow patterns. Events are automatically logged by the digital security system and manually reviewed |
Countries
Switzerland
Outcome results
None listed