Efficacy of Two Nasal Products Based on Diluted Seawater in the Treatment of Upper Respiratory Infections/Conditions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3+
SponsorYSLab
About this trial
The goal of this interventional clinical trial is to test the safety and efficacy of two medical devices in subjects aged from 3 months old for the treatment of colds, rhinitis, sinusitis, and other upper respiratory infections/conditions for 7 days.
Eligibility criteria
Qualifiers
Autonomous adult, or minor with the consent of their legal representative
Adults and children from 3 months old
Ability of the patient (for adults) or their legal representative (for children) to follow the instructions for product use
Having signed a free and informed consent to participate in the study expressed by the patient (for adults) or by their legal representative (for children) after being informed by the doctor.
Disqualifiers
Person not showing cold symptoms, particularly no nasal congestion (chronic dry rhinitis, or Jackson derived score (nasal congestion + nasal discharge) < 4 on Day 0).
Person undergoing treatment with a cortisone derivative, mucolytic, or medication containing pseudoephedrine or a similar product acting on nasal congestion or having used such a product within the 3 days preceding inclusion.
Person having used a nasal wash product within the 3 days preceding inclusion.
Person whose ability to use the product daily and complete the daily follow-up diary is in doubt.
Trial design
Treatments tested in this trial
- administration of an isotonic seawater solution (9g/L) in the nose
- administration of a hypertonic seawater solution (21g/L) in the nose
Treatment groups
91 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov