RecruitingNot ApplicableNCT05494346

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

Prospective Multicenter Clinical Investigation Evaluating the Performance and Safety of Gilbert Laboratories' Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils

Sponsor

Laboratoires Gilbert

Enrollment

101 participants

Start Date

Jun 23, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Rhinitis nasal obstruction Allergic Rhinitis Rhinosinusitis Rhinopharyngitis

Summary

The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Measurement of peak nasal flow. for people with acute rhinitis, allergic rhinitis, and other related conditions. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMeasurement of peak nasal flow.

Peak nasal flow measurements will be performed before and after the first use of the spray at D0, as well as after the use of the spray at the medical office at D3 (only for arm A).