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

Petrov, Andrey

Status: Not yet enrolling

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

Treatments: Device: EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)

Study type: Interventional

Funder types: Other

Identifiers

NCT06902129

EDDIS-ENG-03D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Healthy Volunteers - VMT First

Experimental group

Description:

All participants receive the VMT device first, followed by the Atomizer and Ultrasonic devices in a randomized crossover sequence using a non-active saline aerosol with chitosan nanoparticles. Device performance parameters and user tolerability will be recorded

Treatment:

Device: EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)

Healthy Volunteers - Atomizer First

Experimental group

Description:

All participants receive the Atomizer device first, followed by the VMT and Ultrasonic devices in a randomized crossover sequence using a non-active saline aerosol with chitosan nanoparticles. Device performance parameters and user tolerability will be recorded

Treatment:

Device: EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)

Healthy Volunteers - Ultrasonic First

Experimental group

Description:

All participants receive the Ultrasonic device first, followed by the VMT and Atomizer devices in a randomized crossover sequence using a non-active saline aerosol with chitosan nanoparticles. Device performance parameters and user tolerability will be recorded

Treatment:

Device: EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)