Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification (DEFI)

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

The main objective is to compare the effect of nasal washing on nasal discharge and nasal congestion during treatment after 3 days of use.

Study Overview

• Status: Completed
• Conditions: Rhinitis
• Intervention / Treatment: Other: Sea water solution

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 Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Oignies, France
    • Medical Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: YSLab
• Investigators: Principal Investigator: Alain BOYE, MD, Coordinator of the study

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2019
• Primary Completion (Actual): June 20, 2020
• Study Completion (Actual): June 20, 2020

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis
• Other Study ID Numbers: 2019-A01705-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No