Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-24

Study Completion Date

2020-06-20

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.

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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).

Conditions

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Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ocean Bio Actif-Fluid+

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.

Group Type EXPERIMENTAL

Sea water solution

Intervention Type OTHER

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.

Ocean Bio Active-Stuffy nose

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.

Group Type EXPERIMENTAL

Sea water solution

Intervention Type OTHER

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.

Ocean Bio Active-Hygiene of the nose

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.

Group Type ACTIVE_COMPARATOR

Sea water solution

Intervention Type OTHER

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.

Interventions

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Sea water solution

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.

Intervention Type OTHER

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.

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No