22‰ hypertonic seawater aerosol to relieve nasal and cold symptoms in children and adults
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
This will try a 22‰ hypertonic seawater aerosol inhaled with a nebulizer to help relieve nasal congestion, thin mucus, and improve sleep in children and adults with upper respiratory infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Laboratoires Gilbert Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 6 sites (Częstochowa and 5 other locations) |
| Trial ID | NCT07267689 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-comparative evaluation of a 22‰ hypertonic seawater solution supplied in unidose containers and used with a nebulizer for inhalation in patients aged 2 years and older with acute upper respiratory infections. Treatment is performed at home with participants completing symptom and function questionnaires for seven consecutive days from treatment start, and attending two on-site visits for baseline and follow-up assessments. The study measures changes from baseline to characterize performance (symptom relief, mucus fluidizing, sleep quality), tolerance, and general safety of the device. The primary focus is on real-world use, device tolerability, and any adverse events when used as an aerosol therapy solution.
Who should consider this trial
Good fit: Ideal candidates are people aged 2 years and older with a recent diagnosis of an upper respiratory infection (rhinopharyngitis, rhinitis, acute rhinosinusitis, or common cold) who can attend two clinic visits and agree to avoid excluded medications during the study period.
Not a fit: Patients with infections requiring antibiotics, those using prohibited nasal or systemic medications, or those with conditions that demand other active respiratory treatments may not receive benefit from this device in the study context.
Why it matters
Potential benefit: If successful, this could offer a simple, drug-free way to reduce nasal congestion, loosen mucus, and improve sleep during colds and other upper respiratory infections.
How similar studies have performed: Hypertonic saline inhalation has previously been shown to improve mucus clearance and some symptoms in pediatric and adult populations, although data specific to a 22‰ seawater aerosol for acute URTIs are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Częstochowa and 5 other locations
- Centrum Medyczne Pratia Częstochowa — Częstochowa, Poland (Not_yet_recruiting)
- Centrum Medyczne PZU Zdrowie — Kielce, Poland (Not_yet_recruiting)
- Centrum Medyczne Zdrowie — Kielce, Poland (Recruiting)
- Centrum Nowoczesnych Terapii "Dobry Lekarz" — Krakow, Poland (Not_yet_recruiting)
- Centrum Medyczne Pratia Poznań — Poznan, Poland (Not_yet_recruiting)
- Krajmed Centrum Medyczne — Warsaw, Poland (Not_yet_recruiting)
Study contacts
- Principal investigator: Sebastian Kędzierski, Dr. — Centrum Medyczne PZU Zdrowie
- Study coordinator: Léa RADDAY
- Email: ARMed@labogilbert.fr
- Phone: +33 231471661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.