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

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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy Volunteers; Drug Delivery Systems; Inhalation of Liquid Air; Administration Site Injury
• Intervention / Treatment: Device: EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, CH-1005
    • Central Contact

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Volunteers - VMT First; 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	Device: EDDIS 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.; Other Names: EDDIS-VMT, EDDIS-ATM, EDDIS-ULT, Breath-actuated Inhaler, Disposable Digital Inhalation Device
Experimental: Healthy Volunteers - Atomizer First; 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	Device: EDDIS 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.; Other Names: EDDIS-VMT, EDDIS-ATM, EDDIS-ULT, Breath-actuated Inhaler, Disposable Digital Inhalation Device
Experimental: Healthy Volunteers - Ultrasonic First; 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	Device: EDDIS 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.; Other Names: EDDIS-VMT, EDDIS-ATM, EDDIS-ULT, Breath-actuated Inhaler, Disposable Digital Inhalation Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airflow Resistance Measurement	change in airflow resistance (cmH₂O/L/s) across three devices (cmH₂O/L/s via digital sensor output)	up to 72 hours
Inspiratory Flow Detection Accuracy	quantitative indicators (%) of detection of valid inhalation efforts compared to reference pneumotachograph	up to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Recording Fidelity	rate of accurate digital logging of breath events ( accuracy vs manually annotated data) %)	up to 6 hours (during all sessions)
Subjective Device Comfort Score	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"	up to 6 hours (after each device use - 3 total sessions)
Safety Event Detection	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	up to 3 hours (during each inhalation session per device)

Collaborators and Investigators

• Sponsor: Petrov, Andrey

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2025
• Primary Completion (Actual): March 30, 2026
• Study Completion (Actual): May 30, 2026

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Bioavailability; Aerosol Delivery; Breath-Activated Inhaler; Drug Delivery Device; Portable Inhaler; Inhalation Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Diagnostic Techniques and Procedures; Diagnosis; Equipment and Supplies; Diagnostic Imaging; Ultrasonography; Nebulizers and Vaporizers
• Other Study ID Numbers: EDDIS-ENG-03D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No