NCT07267689

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

Performance and Safety Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children With Upper Respiratory Tract Infection: a Prospective and Multicenter Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Laboratoires Gilbert · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Hypertonic seawater-based solution is a simple and well-known product. The performance of these solutions has been established in paediatric (infants, children), and in adult populations. The mode of action is based on the physical (mechanical) osmotic effect of the solution. Hypertonic saline induces an osmotic flow of water into the mucus layer, rehydrating the airway surface liquid and improving mucus clearance. Hypertonic saline also reduces viscosity and elasticity of mucus. Hypertonic saline solution (seawater based or not) can be used for intranasal wash, or in association with a nebulization system as an aerosol therapy solution for inhalation. Inhalation via nebulization allows the formation of fine particles or liquid droplets in a gas. In this study, 22‰ Hypertonic seawater solution, in unidose container, manufactured by Laboratoires Gilbert will be used as an aerosol therapy solution for inhalation in the treatment of URTIs such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold. The investigational medical device 22‰ Hypertonic seawater solution from Laboratoires Gilbert will be used in association with a nebulization system. 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.

Conditions

• Upper Resp Tract Infection
• Rhinitis Acute
• Rhinopharyngitis
• Cold Symptom
• Rhinitis Viral

Interventions

Type	Name	Description
DEVICE	Treatment (22‰ Hypertonic seawater aerosol therapy solution)	Treatment twice a day for 7 consecutive days with 22‰ Hypertonic seawater aerosol therapy solution used in association with a nebulizer

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

6 sites across 1 country: Poland