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

NCT06902129 | Not Yet Recruiting

• 1 other identifier: EDDIS-ENG-03D
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Device Recording Fidelity

  up to 6 hours (during all sessions)

• Subjective Device Comfort Score

  up to 6 hours (after each device use - 3 total sessions)

• Safety Event Detection

  up to 3 hours (during each inhalation session per device)

Study Arms (3)

Healthy Volunteers - VMT First

EXPERIMENTAL

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)

Healthy Volunteers - Atomizer First

EXPERIMENTAL

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)

Healthy Volunteers - Ultrasonic First

EXPERIMENTAL

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)

Interventions

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

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.

Also known as: EDDIS-VMT, EDDIS-ATM, EDDIS-ULT, Breath-actuated Inhaler, Disposable Digital Inhalation Device

Healthy Volunteers - Atomizer First; Healthy Volunteers - Ultrasonic First; Healthy Volunteers - VMT First

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Petrov, Andrey: lead

Study Sites (1)

Central Contact

Lausanne, CH-1005, Switzerland

Location

MeSH Terms

Interventions

Nebulizers and Vaporizers; Ultrasonography

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Andrey Petrov, Dr

CONTACT

+41766165523; apetrov@swissbio.zuerich

Ruslan Lytvin

CONTACT

+64272550534; ruslanlytvyn@swissbio.zuerich

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 30, 2025
• Study Start: November 9, 2025
• Primary Completion: March 10, 2026
• Study Completion: April 12, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CH (1)