Clinical Evaluation of the Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rhinitis
- Sponsor
- YSLab
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Effect of nasal washing with a hypertonic seawater solution Nose hygiene).
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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).
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Effect of nasal washing with a hypertonic seawater solution Nose hygiene).
Time Frame: 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 Outcomes
- Likert scale(7 days)
- Symptom score(7 days)
- Number of concomitant treatment(7 days)
- Safety of medical device(7 days)
- Presence or absence of fluid mucus(7 days)
- Global Clinical Impression Scale(between day 3 and day 7)
- Global Patient Impression Scale(between day 3 and day 7)
- Use of medical device(7 days)