Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children
NCT ID: NCT07267689
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
110 participants
INTERVENTIONAL
2026-04-30
2027-01-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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 with URTIs such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold.
5. Subject willing to adhere to the requirements of the protocol, including availability for follow-up visits
6. Subject who is able to comply with the study requirements, at the Investigator's appreciation.
7. For minor (\<18) subjects, parents/guardians willing and able to sign written consent
Exclusion Criteria
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 known to have allergy to the components of the masks that is used with the inhalation device;
7. Subject with asthma;
8. Subject presenting infection or pathology of the inferior respiratory tracts;
9. Subject with chronic nasal obstruction (polypes)
10. Subject agrees to not used other saline solutions (irrigation), nasal spray, antihistamines, steroids, antipyretics, analgesic, antibiotics, decongestants, local antispectic, essential oil for nasal use and gel or nasal cream during study participation
11. Subject with drug or alcohol abuse
12. Subjects who is deprived for their freedom by administrative or legal decision
13. Subject living in a social or sanitary establishment.
14. 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.
15. 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.
2 Years
ALL
No
Sponsors
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Laboratoires Gilbert
INDUSTRY
Responsible Party
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Principal Investigators
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Sebastian Kędzierski, Dr.
Role: PRINCIPAL_INVESTIGATOR
Centrum Medyczne PZU Zdrowie
Michal Tyrek, Dr.
Role: PRINCIPAL_INVESTIGATOR
Centrum Medyczne Pratia Częstochowa
Locations
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Centrum Medyczne Pratia Częstochowa
Częstochowa, , Poland
Centrum Medyczne PZU Zdrowie
Kielce, , Poland
Centrum Medyczne Zdrowie
Kielce, , Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz"
Krakow, , Poland
Centrum Medyczne Pratia Poznań
Poznan, , Poland
Krajmed Centrum Medyczne
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MAR-2022-0832
Identifier Type: -
Identifier Source: org_study_id
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