DEFI: Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Other: 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.
|
| Experimental: 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. |
Other: 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.
|
| Active Comparator: 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. |
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Symptom score [7 days]
The effect of nasal wash on the evolution of symptoms over time
- 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
- 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
Eligibility Criteria
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
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical office | Oignies | France |
Sponsors and Collaborators
- YSLab
Investigators
- Principal Investigator: Alain BOYE, MD, Coordinator of the study
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-A01705-52