Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification

Rhinitis Clinical Trial

— DEFI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04230993
• Other study ID #: 2019-A01705-52
• Status: Completed
• Phase: N/A
• Start date: December 24, 2019
• Est. completion date: June 20, 2020

Study information

• Verified date: July 2020
• Source: YSLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 20, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rhinitis

Intervention

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.

Locations

Country	Name	City	State
France	Medical office	Oignies

Sponsors (1)

Lead Sponsor	Collaborator
YSLab

Country where clinical trial is conducted

France, 

Outcome

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