Title
Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
Clinical Evaluation of the Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
Phase
Phase 4Lead Sponsor
YSLabStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
RhinitisIntervention/Treatment
Sea water solutionStudy Participants
210The main objective is to compare the effect of nasal washing on nasal discharge and nasal congestion during treatment after 3 days of use.
The main endpoint is a symptom score derived from the Jackson scale: sum of 2 items relating to runny nose and nasal congestion (stuffy nose), with ratings of 0 to 3 for each (0: absent ; 1: mild; 2: moderate; 3: severe).
Administration of different sea water solution is performed and the rating of cold symptoms according to the Jackson scale, the fluidity of mucus and the ease of blowing will be evaluated.
Moderate hypertonic seawater solution (15 g / L NaCl) with polysorbate 80. The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products.
Moderate hypertonic seawater solution (15 g / L NaCl) without polysorbate 80. The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products.
Isotonic seawater solution (9 g / L NaCl). The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products.
Inclusion Criteria: Person with an upper respiratory condition (cold, rhinitis, nasopharyngitis ...) with symptoms of nasal congestion and intense runny nose moderate to severe (Jackson derived score ≥ 4) Ability of the patient (for adults) or their legal representative (for children) to follow the guidelines of the medical device have given their written informed consent Exclusion Criteria: Patient with no cold symptoms, including no nasal congestion (chronic dry rhinitis…) Patient under treatment with cortisone derivative, mucolytic, or medication containing pseudoephedrine or related product acting on nasal congestion or having used such a product in the 3 days before inclusion Patient who used a nasal wash product in the 3 days before inclusion Patient allergic to seafood, or to any of the components of the products under study Vulnerable patient whose inclusion is not justified by the research objectives: woman pregnant, parturient, psychiatric patient, or adult subject to legal protection Patient participating or having participated in any other clinical study in the 30 days before the study.
