Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
- Conditions
- Rhinitis
- Interventions
- Other: Sea water solution
- Registration Number
- NCT04230993
- Lead Sponsor
- YSLab
- Brief Summary
The main objective is to compare the effect of nasal washing on nasal discharge and nasal congestion during treatment after 3 days of use.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ocean Bio Active-Stuffy nose Sea water solution 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. Ocean Bio Active-Hygiene of the nose Sea water solution 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. Ocean Bio Actif-Fluid+ Sea water solution 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.
- Primary Outcome Measures
Name Time Method Effect of nasal washing with a hypertonic seawater solution Nose hygiene). 3 days Effect of nasal washing with a hypertonic seawater solution (Ocean Bio Actif-Fluid + or Ocean Bio Actif-Stuffy nose) on runny nose and nasal congestion during treatment after 3 days of use, compared to an isotonic solution (Ocean Bio Actif- Nose hygiene). symptom score (runny nose and nasal congestion) derived from the Jackson scale with a score of 0 to 3 for each (0: absent; 1: mild; 2: moderate; 3: severe) between Day 0 and Day 3.
- Secondary Outcome Measures
Name Time Method Symptom score 7 days The effect of nasal wash on the evolution of symptoms over time
Number of concomitant treatment 7 days concomitant administration of treatments related to rhinitis
Safety of medical device 7 days Number of adverse events
Presence or absence of fluid mucus 7 days The effect of nasal wash on the evolution of the mucus fluidification over time
Global Clinical Impression Scale between day 3 and day 7 Global Clinical Impression of the investigator on the evolution of symptoms
Global Patient Impression Scale between day 3 and day 7 Global Impression of the patient on the evolution of symptoms
Use of medical device 7 days Number of daily sprays
Likert scale 7 days Satisfaction of patient for the medical device
Trial Locations
- Locations (1)
Medical office
🇫🇷Oignies, France