Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children

The purpose of this study is to evaluate the tolerance, the performance and safety of this device, 22‰ Hypertonic seawater aerosol therapy solution in unidose container, to treat adult and peadiatric patients with of upper respiratory tract infection such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold. The main questions it aims to answer are to assess if the 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation: * improve nasal symptoms relief; * improve sleep quality; * improve mucus fluidizing; * is safe and well tolerated. The study is none comparative and will assess prospectively the symptomatic and functional benefits, the tolerance and the general safety of the medical device when used as an aerosol therapy solution, measured by change from baseline. Treatments will be done at home and participants will be required to perform two on sites visits and to complete questionnaires and scales for 7 consecutive days from the treatment starting.

NCT Number	NCT07267689
Lead Sponsor	Laboratoires Gilbert
Conditions	Upper Resp Tract Infection, Rhinitis Acute, Rhinopharyngitis, Cold Symptom, Rhinitis Viral
Enrollment	110 participants
Start Date	2026-04-21
Primary Completion	2026-05-18 (estimated)
Study Completion	2026-05-18 (estimated)
Updated on ClinicalTrials.gov	2026-07-23