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

Launched by PETROV, ANDREY · Mar 28, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to test three different portable inhalation devices from the EDDIS platform. The main goal is to see how well these devices work in delivering a non-drug solution safely and effectively. Healthy volunteers will use all three devices in a random order, and researchers will look at how well the devices control airflow, how accurately they record inhalation, and how comfortable they are for users.

To participate in this study, you need to be between 21 and 75 years old and generally healthy, with good lung function. You should also have a body mass index (BMI) between 18.5 and 30. Before starting, you’ll provide written consent and may need to meet certain health criteria. While this study is not yet recruiting participants, it will help gather important information on how these inhalation systems perform and ensure they are safe for use.

Gender

ALL

Eligibility criteria

• 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