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Completed

NCT Number: NCT04230993

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.

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Key information

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical office

Oignies, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sea water solution

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

YSLab

Industry

Registry information

Official study title

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

Acronym: DEFI

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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