Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification

Study Overview
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Brief Summary
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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
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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).

Official Title
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Clinical Evaluation of the Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification

Conditions
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Rhinitis

Intervention / Treatment
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* Other: Sea water solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ocean Bio Actif-Fluid+<br>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. | Other: Sea water solution<br>* 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.<br>|
| Experimental: Ocean Bio Active-Stuffy nose<br>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. | Other: Sea water solution<br>* 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.<br>|
| Active Comparator: Ocean Bio Active-Hygiene of the nose<br>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. | Other: Sea water solution<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of nasal washing with a hypertonic seawater solution Nose hygiene). | 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. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom score | The effect of nasal wash on the evolution of symptoms over time | 7 days | 
| Presence or absence of fluid mucus | The effect of nasal wash on the evolution of the mucus fluidification over time | 7 days | 
| Global Clinical Impression Scale | Global Clinical Impression of the investigator on the evolution of symptoms | between day 3 and day 7 | 
| Global Patient Impression Scale | Global Impression of the patient on the evolution of symptoms | between day 3 and day 7 | 
| Use of medical device | Number of daily sprays | 7 days | 
| Safety of medical device | Number of adverse events | 7 days | 
| Likert scale | Satisfaction of patient for the medical device | 7 days | 
| Number of concomitant treatment | concomitant administration of treatments related to rhinitis | 7 days |