Clinical trial NCT06902129: Validation of Safety and Performance of Three EDDIS Breath-Activated Portable Inhalation Systems
Official title: Engineering Evaluation of Aerosol Flow, Inhalation Pattern Control, and Digital Accuracy in Three Breath-Activated EDDIS Systems (VMT, Atomizer, Ultrasonic) Using Inert NaCl-Based Formulation With Chitosan Nanoparticles
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Drug Delivery Systems
Inhalation of Liquid Air
Administration Site Injury
Keywords: Breath-Activated Inhaler
Aerosol Delivery
Drug Delivery Device
Portable Inhaler
Inhalation Therapy
Bioavailability
Lead sponsor: Petrov, Andrey
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Airflow Resistance Measurement
timeFrame: up to 72 hours
measure: Inspiratory Flow Detection Accuracy
timeFrame: up to 72 hours
Secondary outcomes:
measure: Device Recording Fidelity
timeFrame: up to 6 hours (during all sessions)
measure: Subjective Device Comfort Score
timeFrame: up to 6 hours (after each device use - 3 total sessions)
measure: Safety Event Detection
timeFrame: up to 3 hours (during each inhalation session per device)
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Central Contact
Study officials:
References: