Medical office
Oignies, France
NCT Number: NCT04230993
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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Notify Me3 year and older
All sexes
Interventional
Not applicable
Oignies, France
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 7 days
The effect of nasal wash on the evolution of symptoms over time
Time frame: 7 days
The effect of nasal wash on the evolution of the mucus fluidification over time
Time frame: between day 3 and day 7
Global Clinical Impression of the investigator on the evolution of symptoms
Time frame: between day 3 and day 7
Global Impression of the patient on the evolution of symptoms
Time frame: 7 days
Number of daily sprays
Time frame: 7 days
Number of adverse events
Time frame: 7 days
Satisfaction of patient for the medical device
Time frame: 7 days
concomitant administration of treatments related to rhinitis
YSLab
Industry
Clinical Evaluation of the Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
Acronym: DEFI
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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