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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04230993
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
YSLab

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
Rhinitis Other: Sea water solution Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
Actual Study Start Date : December 24, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Symptom score [ Time Frame: 7 days ]
    The effect of nasal wash on the evolution of symptoms over time

  2. Presence or absence of fluid mucus [ Time Frame: 7 days ]
    The effect of nasal wash on the evolution of the mucus fluidification over time

  3. Global Clinical Impression Scale [ Time Frame: between day 3 and day 7 ]
    Global Clinical Impression of the investigator on the evolution of symptoms

  4. Global Patient Impression Scale [ Time Frame: between day 3 and day 7 ]
    Global Impression of the patient on the evolution of symptoms

  5. Use of medical device [ Time Frame: 7 days ]
    Number of daily sprays

  6. Safety of medical device [ Time Frame: 7 days ]
    Number of adverse events

  7. Likert scale [ Time Frame: 7 days ]
    Satisfaction of patient for the medical device

  8. Number of concomitant treatment [ Time Frame: 7 days ]
    concomitant administration of treatments related to rhinitis



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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230993


Contacts
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Contact: Roxane FAGON +33 (0)2.98.53.30.03 roxane.fagon@yslab.fr

Locations
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France
Medical office Recruiting
Oignies, France
Contact: Claude BORTOLOTTI, MD         
Sponsors and Collaborators
YSLab
Investigators
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Principal Investigator: Alain BOYE, MD Coordinator of the study

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Responsible Party: YSLab
ClinicalTrials.gov Identifier: NCT04230993    
Other Study ID Numbers: 2019-A01705-52
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pharmaceutical Solutions