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

NCT07267689 | Recruiting

• 1 other identifier: MAR-2022-0832
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

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

Keywords

hypertonic seawater; upper respiratory tract infection (URTIs); inhalation; nebulization

Outcome Measures

Primary Outcomes (2)

• - 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 Outcomes (13)

• 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.

  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.

  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.

  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.

  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.

  Day 1, Day 3, Day 5 and Day 7

Other Outcomes (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.

  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

  Day 1, Day 2, Day 4, Day 5, Day 6, Day 7 and Day 8

• Evaluate the satisfaction of use of the device.

  Day 8

Study Arms (1)

Patient treated with 22‰ Hypertonic seawater solution, used as aerosol therapy for inhalati

EXPERIMENTAL

5mL of 22‰ Hypertonic seawater per treatments, 14 treatments on 7 consecutive days

Device: Treatment (22‰ Hypertonic seawater aerosol therapy solution)

Interventions

Treatment (22‰ Hypertonic seawater aerosol therapy solution) DEVICE

Treatment twice a day for 7 consecutive days with 22‰ Hypertonic seawater aerosol therapy solution used in association with a nebulizer

Patient treated with 22‰ Hypertonic seawater solution, used as aerosol therapy for inhalati

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subject voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures.
• Minor subjects (7-17 years old) given informed assent to investigation participation in writing encompassing consent to data recording and verification procedures
• Male and female subjects, aged from 2 years old;
• Subject diagnosed with URTIs such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold based on the medical examination done by the doctor.
• Subject willing to adhere to the requirements of the protocol, including availability for follow-up visits
• 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);
• Subject who is able to comply with the study requirements, at the Investigator's appreciation.
• For minor (\<18) subjects, parents/guardians willing and able to sign written consent
• 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.

You may not qualify if:

• Person with hypersensitivity to seawater
• Subject who previously undergone bronchospasm
• Children under 2 years of age
• Pregnant and breastfeeding women
• Onset of URTI symptoms \> 48 hours
• Subject with COVID or flu
• Subject known to have allergy to the components of the masks that is used with the inhalation device;
• Subject with asthma,
• Subject presenting infection or pathology of the inferior respiratory tracts;
• Subject with chronic nasal obstruction (polypes)
• Subject with drug or alcohol abuse
• Subjects who is deprived for their freedom by administrative or legal decision
• Subject living in a social or sanitary establishment.
• 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

Sponsors & Collaborators

• Laboratoires Gilbert: lead

Study Sites (6)

Centrum Medyczne Pratia Częstochowa

Częstochowa, 42-217, Poland

NOT YET RECRUITING

Centrum Medyczne PZU Zdrowie

Kielce, 25-017, Poland

NOT YET RECRUITING

Centrum Medyczne Zdrowie

Kielce, 25-713, Poland

RECRUITING

Centrum Nowoczesnych Terapii "Dobry Lekarz"

Krakow, 31-011, Poland

NOT YET RECRUITING

Centrum Medyczne Pratia Poznań

Poznan, 60-192, Poland

NOT YET RECRUITING

Krajmed Centrum Medyczne

Warsaw, 02-743, Poland

NOT YET RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections; Common Cold; Nasopharyngitis; Respiratory Aspiration

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Pharyngitis; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sebastian Kędzierski, Dr.

  Centrum Medyczne PZU Zdrowie

  PRINCIPAL INVESTIGATOR

• Michal Tyrek, Dr.

  Centrum Medyczne Pratia Częstochowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Léa RADDAY

CONTACT

+33 231471661; ARMed@labogilbert.fr

Carla LIPPENS, PhD

CONTACT

+33 4 28 38 38 10; carla.lippens@complifegroup.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pivotal clinical investigation Interventional, prospective, non-comparative, open, multicentric

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 5, 2025
• Study Start: April 21, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

PL (6)