Validation of Safety and Performance of Three EDDIS Breath-Activated Portable Inhalation Systems (NCT06902129) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Validation of Safety and Performance of Three EDDIS Breath-Activated Portable Inhalation Systems
Switzerland10 participantsStarted 2025-11-09
Plain-language 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.
Who can participate
Age range21 Years – 75 Years
SexALL
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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