Actively Recruiting
Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children
Led by Laboratoires Gilbert · Updated on 2026-04-27
110
Participants Needed
6
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults who voluntarily provide written informed consent
- Minors aged 7 to 17 years who provide written assent
- Male and female subjects aged 2 years and older
- Diagnosis of upper respiratory tract infections such as rhinopharyngitis, rhinitis, acute rhinosinusitis, or cold confirmed by a doctor
- Willingness to follow study protocol and attend follow-up visits
- Agreement to avoid use of decongestants, corticosteroids, antibiotics, allergen-specific immunotherapy, antihistamines, NSAIDs, local nasal antiseptics, other nasal saline solutions or irrigations, nasal sprays, nasal creams or gels, systemic analgesics or antipyretics (except paracetamol if needed)
- Ability to comply with study requirements
- Parents or guardians of minors under 18 willing to provide written consent
- Ability and willingness to use an internet-enabled device to complete study procedures and have regular internet access
You will not qualify if you...
- Hypersensitivity to seawater
- History of bronchospasm
- Children under 2 years of age
- Pregnant or breastfeeding women
- Onset of upper respiratory tract infection symptoms more than 48 hours before inclusion
- Current COVID-19 or flu infection
- Presence of alarm symptoms such as periorbital edema, displaced globe, double vision, ophthalmoplegia, reduced visual acuity, severe headache, frontal swelling, signs of sepsis or meningitis, or neurological signs at inclusion
- Allergy to components of the mask used with the inhalation device
- Asthma
- Infection or disease of the lower respiratory tract
- Chronic nasal obstruction such as polyps
- Use of decongestants, corticosteroids, antibiotics, or allergen-specific immunotherapy within 4 weeks prior to inclusion
- Use of antihistamines, NSAIDs, or local nasal antiseptics within 7 days prior to inclusion
- Use of nasal saline solutions, nasal sprays, nasal creams or gels, systemic analgesics or antipyretics within 24 hours prior to inclusion
- Drug or alcohol abuse
- Legal or administrative deprivation of freedom
- Living in social or sanitary establishments
- Current or recent participation in another investigational study within 3 months
- Any condition preventing participation as judged by the investigator, including unreliability or inability to understand and comply with study assessments or unrealistic expectations
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Trial Site Locations
Total: 6 locations
1
Centrum Medyczne Pratia Częstochowa
Częstochowa, Poland, 42-217
Not Yet Recruiting
2
Centrum Medyczne PZU Zdrowie
Kielce, Poland, 25-017
Not Yet Recruiting
3
Centrum Medyczne Zdrowie
Kielce, Poland, 25-713
Actively Recruiting
4
Centrum Nowoczesnych Terapii "Dobry Lekarz"
Krakow, Poland, 31-011
Not Yet Recruiting
5
Centrum Medyczne Pratia Poznań
Poznan, Poland, 60-192
Not Yet Recruiting
6
Krajmed Centrum Medyczne
Warsaw, Poland, 02-743
Not Yet Recruiting
Research Team
L
Léa RADDAY
CONTACT
C
Carla LIPPENS, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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