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

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.

Study Overview

• Status: Recruiting
• Conditions: Cold Symptom; Upper Resp Tract Infection; Rhinopharyngitis; Rhinitis Viral; Rhinitis Acute
• Intervention / Treatment: Device: Treatment (22‰ Hypertonic seawater aerosol therapy solution)

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Léa RADDAY; Phone Number: +33 +33 231471661; Email: ARMed@labogilbert.fr
• Study Contact Backup: Name: Carla LIPPENS, PhD; Phone Number: +33 +33 4 28 38 38 10; Email: carla.lippens@complifegroup.com

Study Locations

• Poland
  • Częstochowa, Poland, 42-217
    • Withdrawn
    • Centrum Medyczne Pratia Częstochowa
  • Kielce, Poland, 25-713
    • Recruiting
    • Centrum Medyczne Zdrowie
    • Contact: Michał Bator, Manager; Phone Number: +48 791 532 230; Email: m.bator@zdrowiekielce.com
    • Principal Investigator: Małgorzata Nowalska, Dr.
  • Kielce, Poland, 25-017
    • Recruiting
    • Centrum Medyczne PZU Zdrowie
    • Contact: Dariusz Saletra, Manager; Phone Number: +48 41 367 17 17; Email: artimed@artimed.pl
    • Principal Investigator: Sebastian Kędzierski, Dr.
  • Krakow, Poland, 31-011
    • Recruiting
    • Centrum Nowoczesnych Terapii "Dobry Lekarz"
    • Contact: Katarzyna Gajda, Manager; Phone Number: +48 690 000 367; Email: katarzyna.gajda@dobrylekarz.com.pl
    • Principal Investigator: Anna Chmielewska, Dr.
  • Poznan, Poland, 60-192
    • Withdrawn
    • Centrum Medyczne Pratia Poznań
  • Warsaw, Poland, 02-743
    • Recruiting
    • Krajmed Centrum Medyczne
    • Contact: Krzysztof Bączek, Manager; Phone Number: +48 785 850 444; Email: k.baczek@krajmed.pl
    • Principal Investigator: Damian Okruciński, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult subject voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures.
2. Minor subjects (7-17 years old) given informed assent to investigation participation in writing encompassing consent to data recording and verification procedures
3. Male and female subjects, aged from 2 years old;
4. Subject diagnosed with URTIs such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold based on the medical examination done by the doctor.
5. Subject willing to adhere to the requirements of the protocol, including availability for follow-up visits
6. Subject who agrees to no use decongestants, corticosteroids, antibiotics, allergen-specific immunotherapy, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), local nasal antiseptics, other nasal saline solutions or irrigations, nasal sprays, nasal creams or gels, systemic analgesics or antipyretics (except paracetamol if needed);
7. Subject who is able to comply with the study requirements, at the Investigator's appreciation.
8. For minor (<18) subjects, parents/guardians willing and able to sign written consent
9. Subject able and willing to use an internet-enabled device (computer, tablet, or smartphone) to complete study procedures (online questionnaires) and have regular access to a device with internet connectivity (personal or household device) for the duration of the study.

Exclusion Criteria:

1. Person with hypersensitivity to seawater
2. Subject who previously undergone bronchospasm
3. Children under 2 years of age
4. Pregnant and breastfeeding women
5. Onset of URTI symptoms > 48 hours
6. Subject with COVID or flu
7. Subject presenting alarm symptoms (periorbital oedema/erythema, displaced globe, double vision, ophthalmoplegia, reduced visual acuity, severe headache, frontal swelling, signs of sepsis, sign of meningitis, neurological signs) at the day of inclusion
8. Subject known to have allergy to the components of the masks that is used with the inhalation device;
9. Subject with asthma,
10. Subject presenting infection or pathology of the inferior respiratory tracts;
11. Subject with chronic nasal obstruction (polypes)
12. Subject who used any decongestants, corticosteroids, antibiotics or allergen-specific immunotherapy within 4 weeks prior to inclusion;
13. Subject who used any antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs) or local nasal antiseptics within 7 days prior to inclusion;
14. Subject who used any nasal saline solutions or irrigations, nasal sprays, nasal creams or gels, systemic analgesics or antipyretics within 24 hours prior to inclusion;
15. Subject with drug or alcohol abuse
16. Subjects who is deprived for their freedom by administrative or legal decision
17. Subject living in a social or sanitary establishment.
18. Subject being in an exclusion period for a previous study or with a current or recent (<3 months) participation in another investigational study involving a drug or combined device with drug.
19. Other condition preventing the subject to participate the study in the investigator's opinion: subject deemed unreliable or incapable of understanding and complying with the study assessment or unrealistic expectations of treatment results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient treated with 22‰ Hypertonic seawater solution, used as aerosol therapy for inhalati; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- 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 .	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.	From Day 1 to Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	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).	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	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).	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)	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.	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.	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.	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)	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 .	From Day 1 to Day 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	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.	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	Day 8

Collaborators and Investigators

• Sponsor: Laboratoires Gilbert
• Investigators: Principal Investigator: Sebastian Kędzierski, Dr., Centrum Medyczne PZU Zdrowie; Principal Investigator: Michal Tyrek, Dr., Centrum Medyczne Pratia Częstochowa

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: inhalation; nebulization; hypertonic seawater; upper respiratory tract infection (URTIs)
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Pathologic Processes; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Respiration Disorders; Picornaviridae Infections; Otorhinolaryngologic Diseases; Nasopharyngeal Diseases; Pharyngeal Diseases; Pharyngitis; Pathological Conditions, Signs and Symptoms; Respiratory Aspiration; Respiratory Tract Infections; Common Cold; Nasopharyngitis; Therapeutics
• Other Study ID Numbers: MAR-2022-0832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No