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NCT07267689

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

Sponsor: Laboratoires Gilbert

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-04

Completion Date

2027-01

Last Updated

2025-12-05

Healthy Volunteers

Conditions

Upper Resp Tract Infection Rhinitis Acute Rhinopharyngitis Cold Symptom Rhinitis Viral

Interventions

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

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 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: 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 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.

Locations (6)

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