Healthy VolunteersEDDIS-ENGNCT06902129
Validation of Safety and Performance of Three EDDIS Breath-Activated Portable Inhalation Systems
A study testing EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic) in people with Healthy Volunteers and Drug Delivery Systems, run by Petrov, Andrey at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Drug Delivery Systems, Inhalation of Liquid Air
- What is being tested?
- EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Feb 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Volunteers, Drug Delivery Systems, Inhalation of Liquid Air, Administration Site Injury
- Being tested
- EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)
- Keywords
- Breath-Activated Inhaler, Aerosol Delivery, Drug Delivery Device, Portable Inhaler, Inhalation Therapy, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)Device
Also called EDDIS-VMT, EDDIS-ATM, EDDIS-ULT, Breath-actuated Inhaler, Disposable Digital Inhalation 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airflow Resistance Measurement
change in airflow resistance (cmH₂O/L/s) across three devices (cmH₂O/L/s via digital sensor output)
Measured: up to 72 hours
Inspiratory Flow Detection Accuracy
quantitative indicators (%) of detection of valid inhalation efforts compared to reference pneumotachograph
Measured: up to 72 hours
Secondary outcomes (3)
Device Recording Fidelity
rate of accurate digital logging of breath events ( accuracy vs manually annotated data) %)
Measured: 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"
Measured: 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
Measured: up to 3 hours (during each inhalation session per device)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start15 Feb 2025
- Primary completion30 Mar 2026
- Study completion30 May 2026
Why it stopped: significant changes to the design of the inhaler
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petrov, Andrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902129
- Sponsor's protocol ID
- EDDIS-ENG-03D
- Acronym
- EDDIS-ENG
- Status last verified
- May 2026
- First submitted
- 21 Mar 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06902129
- Acronym / sponsor ID
- EDDIS-ENG / EDDIS-ENG-03D
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: significant changes to the design of the inhaler
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Petrov, AndreyUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers - VMT First | Experimental | Device: EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)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 |
| Healthy Volunteers - Atomizer First | Experimental | Device: EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)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 |
| Healthy Volunteers - Ultrasonic First | Experimental | Device: EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)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 |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)Also: EDDIS-VMT, EDDIS-ATM, EDDIS-ULT, Breath-actuated Inhaler, Disposable Digital Inhalation DeviceA 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. | Device | Healthy Volunteers - Atomizer First, Healthy Volunteers - Ultrasonic First, Healthy Volunteers - VMT First |
Primary outcome
Airflow Resistance Measurement
Time frame: 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
Time frame: up to 72 hours
quantitative indicators (%) of detection of valid inhalation efforts compared to reference pneumotachograph
3 secondary outcomes
Device Recording Fidelity
Time frame: up to 6 hours (during all sessions)
Subjective Device Comfort Score
Time frame: up to 6 hours (after each device use - 3 total sessions)
Safety Event Detection
Time frame: up to 3 hours (during each inhalation session per device)
Results and safety
The study was stopped early (reason given: significant changes to the design of the inhaler). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic) in people with Healthy Volunteers and Drug Delivery Systems, run by Petrov, Andrey at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: significant changes to the design of the inhaler). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airflow Resistance Measurement (time frame: up to 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.