Status:
NOT_YET_RECRUITING
Validation of Safety and Performance of Three EDDIS Breath-Activated Portable Inhalation Systems
Lead Sponsor:
Petrov, Andrey
Conditions:
Healthy Volunteers
Drug Delivery Systems
Eligibility:
All Genders
21-75 years
Phase:
NA
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 ...
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 sys...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 12 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06902129
Start Date
November 9 2025
End Date
April 12 2026
Last Update
November 18 2025
Active Locations (1)
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1
Central Contact
Lausanne, Switzerland, CH-1005