Rhinitis
Conditions
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).
Interventions
OTHERSea 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.
Sponsors
YSLab
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Symptom score | 7 days | The effect of nasal wash on the evolution of symptoms over time |
| Safety of medical device | 7 days | Number of adverse events |
| Likert scale | 7 days | Satisfaction of patient for the medical device |
| Number of concomitant treatment | 7 days | concomitant administration of treatments related to rhinitis |
| Use of medical device | 7 days | Number of daily sprays |
Countries
France
Outcome results
None listed