Back to resultsEfficacy of Two Nasal Products for Decongestion and Mucus Fluidification (DEFI)
Primary Purpose
Rhinitis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sea water solution
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis
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.
Sites / Locations
- Medical office
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Ocean Bio Actif-Fluid+
Ocean Bio Active-Stuffy nose
Ocean Bio Active-Hygiene of the nose
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Symptom score
The effect of nasal wash on the evolution of symptoms over time
Presence or absence of fluid mucus
The effect of nasal wash on the evolution of the mucus fluidification over time
Global Clinical Impression Scale
Global Clinical Impression of the investigator on the evolution of symptoms
Global Patient Impression Scale
Global Impression of the patient on the evolution of symptoms
Use of medical device
Number of daily sprays
Safety of medical device
Number of adverse events
Likert scale
Satisfaction of patient for the medical device
Number of concomitant treatment
concomitant administration of treatments related to rhinitis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04230993
Brief Title
Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
Acronym
DEFI
Official Title
Clinical Evaluation of the Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 24, 2019 (Actual)
Primary Completion Date
June 20, 2020 (Actual)
Study Completion Date
June 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
YSLab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ocean Bio Actif-Fluid+
Arm Type
Experimental
Arm Description
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.
Arm Title
Ocean Bio Active-Stuffy nose
Arm Type
Experimental
Arm Description
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.
Arm Title
Ocean Bio Active-Hygiene of the nose
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sea water solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of nasal washing with a hypertonic seawater solution Nose hygiene).
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Symptom score
Description
The effect of nasal wash on the evolution of symptoms over time
Time Frame
7 days
Title
Presence or absence of fluid mucus
Description
The effect of nasal wash on the evolution of the mucus fluidification over time
Time Frame
7 days
Title
Global Clinical Impression Scale
Description
Global Clinical Impression of the investigator on the evolution of symptoms
Time Frame
between day 3 and day 7
Title
Global Patient Impression Scale
Description
Global Impression of the patient on the evolution of symptoms
Time Frame
between day 3 and day 7
Title
Use of medical device
Description
Number of daily sprays
Time Frame
7 days
Title
Safety of medical device
Description
Number of adverse events
Time Frame
7 days
Title
Likert scale
Description
Satisfaction of patient for the medical device
Time Frame
7 days
Title
Number of concomitant treatment
Description
concomitant administration of treatments related to rhinitis
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain BOYE, MD
Organizational Affiliation
Coordinator of the study
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical office
City
Oignies
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
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