An interventional study of Treatment (22‰ Hypertonic seawater aerosol therapy solution) in Upper Resp Tract Infection, Rhinitis Acute and Rhinopharyngitis, sponsored by Laboratoires Gilbert. Completed at 4 sites in Poland. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Laboratoires Gilbert · Not applicable, Interventional, and Treatment
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:
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.
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:
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.
751 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.
This study's enrollment of 110 is below the median of 200 across 540 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →Laboratoires Gilbert is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5mL of 22‰ Hypertonic seawater per treatments, 14 treatments on 7 consecutive days
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
- Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-21 questionnaire in minor patients from 14 years old and adults.
Change in global WURSS-21 score as measured in the morning before treatment on Day 1 and Day 3 .
Time frame: From Day 1 to Day 3
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-K questionnaire in minor patients from 4 to 13 years old.
Change in global WURSS-K score as measured in the morning before treatment on Day 1 and Day 3.
Time frame: From Day 1 to Day 3
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-21 questionnaire in minor patients from 14 years old and adults.
Change in global WURSS-21 score as measured in the morning before treatment at Day2, at Day 4, at Day 5, at Day 6, at Day 7 and at Day 8 compared to Day 1 (before treatment) as baseline.
Time frame: Day 1, Day 2, Day 4, Day 5, Day 6, Day 7 and Day 8
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-K questionnaire in minor patients from 4 to 13 years old.
Change in global WURSS-K score as measured in the morning before treatment at Day 2, at Day 4, at Day 5, at Day 6, at Day 7 and at Day 8 compared to Day 1 (before treatment) as baseline.
Time frame: Day 1, Day 2, Day 4, Day 5, Day 6, Day 7 and Day 8
Assess the immediate benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.
Change in VAS (Visual Analog Scale) score before and immediately after treatment (nasal symptom relief).
Time frame: Day 1, Day 3, Day 5 and Day 7
Assess the proportion of patients that note an immediate benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.
Proportion of patients reporting improvement in nasal symptom relief (defined as a VAS increase of more than 3 points on a 10-point scale) immediately after treatment.
Time frame: Day 1, Day 3, Day 5 and Day 7
Assess the sustained benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.
Change in VAS (Visual Analog Scale) score before treatment and 3 hours post-treatment (nasal symptom relief).
Time frame: Day 1, Day 3, Day 5 and Day 7
Assess the proportion of patients that note a sustained benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief during the day.
Proportion of patients reporting improvement in nasal symptom relief (defined as a VAS increase of more than 3 points on a 10-point scale) 3 hours post- treatment
Time frame: Day 1, Day 3, Day 5 and Day 7
Assess the benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation in improving sleep quality.
Improvement in sleep quality defined as a VAS score increase of more than 3 points on a 10-point scale, in the morning following evening treatment compared to baseline (assessment at Day 1 before treatment regarding the sleep quality during the night between Day 0 and Day 1).
Time frame: Day 1 before treatment, Day 2, Day 3, Day 5 and Day 7
Assess the proportion of patients reporting an improvement of sleep quality following evening treatment with the of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation.
Proportion of patients reporting improvement in sleep quality (defined as a VAS increase of more than 3 points on a 10-point scale), in the morning following evening treatment with the device compared to baseline (assessment at Day 1 before treatment regarding the sleep quality during the night between Day 0 and Day 1)
Time frame: Day 1 before treatment, Day 2, Day 3, Day 5 and Day 7
Evaluate the performance of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on the improvement of mucus fluidizing
Assess performance to improve mucus fluidizing (6-point Likert scale) 6-point-Likert scale: 0 (None) - 1 (Very mild) - 2 (Mild) - 3 (Moderate) - 4 (Strong) - 5 (Very strong). Lower score means a worse outcome.
Time frame: Day 1, Day 3, Day 5, Day 7
Evaluate the overall patient's satisfaction.
Assessment by the patient of the overall satisfaction through 5-point Likert scale ((1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied)) at Day 8.
Time frame: Day 8
Evaluate the overall tolerance of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation.
Assessment by the investigator of the occurrence of adverse device effect related to the use of 22‰ Hypertonic seawater solution when used as aerosol therapy solution for inhalation.
Time frame: From Day 1 to Day 7
Evaluate the overall safety of 22‰ Hypertonic seawater solution throughout the study.
Assessment by the investigators of the occurrence and severity of adverse events (AE)
Time frame: From Day 0 to Day 8
Evaluate the device related complications rates throughout the study.
Assessment of the proportion of patients with at least one adverse device effect related to the use of 22‰ Hypertonic seawater solution as an aerosol therapy solution for inhalation .
Time frame: From Day 1 to Day 7
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-K questionnaire completed by parents for the minor patients of 2 to 3 years old.
Change in global WURSS-K score as measured in the morning before treatment on Day 1 and Day 3 .
Time frame: At Day 1 and Day 3
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-K questionnaire completed by parents for the minor patients of 2 to 3 years old
Change in global WURSS-K score as measured in the morning before treatment at Day 2, at Day 4, at Day5, at Day 6, at Day 7 and at Day 8 compared to Day 1 (before treatment) as baseline.
Time frame: Day 1, Day 2, Day 4, Day 5, Day 6, Day 7 and Day 8
Evaluate the satisfaction of use of the device.
Assessment by the user (patient or patient's parent for minors) of the overall satisfaction of use with a satisfaction questionnaire
Time frame: Day 8
Plan to share: Undecided
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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