Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children (AIR)
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
Sponsor: Laboratoires Gilbert
This observational or N/A phase trial investigates Cold Symptom and Rhinitis Acute and is currently actively recruiting participants. Laboratoires Gilbert leads this study, which shows 2 recorded versions since 2026 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.
Study Description(click to expand)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...
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.
Status Flow
Change History
2 versions recorded-
Apr 28, 2026 — Present [daily]
Recruiting
Status: Not Yet Recruiting → Recruiting · Phase: NA → None
-
Jan 2026 — Apr 2026 [monthly]
Not Yet Recruiting NA
First recorded
Eligibility 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.
Contact Information
- Laboratoires Gilbert
For direct contact, visit the study record on ClinicalTrials.gov .