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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" | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT05494346•Laboratoires Gilbert

View on ClinicalTrials.gov

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

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Patient ≥ 12 years.
•2\. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectious episodes such as allergic rhinitis.
•3\. a. Informed adult patient who has given written consent prior to any study specific procedure. b. Informed minor patient who has given assent and whose legal guardians have given written consent prior to any study-specific procedure.
•4\. Patient able to meet the study requirements for monitoring, spray use, and questionnaire completion.
•5\. Patient affiliated to a social security scheme.

Exclusion Criteria

•1\. Pregnant and/or breastfeeding woman
•2\. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray.
•3\. Diseases causing narrowing of the airways (e.g. asthma, chronic obstructive pulmonary disease (COPD)) and/or respiratory insufficiency.
•4\. Patients with uncontrolled asthma (GINA score greater than or equal to 4)
•5\. Patients undergoing allergy desensitization
•6\. Patients suffering from chronic nasal obstruction due to a deformation of the nasal wall or nasal polyps. creams or gels.
•7\. Patients taking local and systemic vasoconstrictors, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotics, and local antiseptics.
•8\. Concomitant use of other nasal sprays, essential oils for local nasal use, creams, or gels for the nose.
•9\. Patients under guardianship, conservatorship, or legal protection.

Locations (5)

Cabinet Médical

Blainville-sur-Orne, France

Cabinet Médical Caen

Caen, France

MSP du Haut Anjou

Châteauneuf-sur-Sarthe, France

Cabinet Médical Gainneville

Gainneville, France

ALYATEC

Strasbourg, France

Key Dates

Start Date

June 23, 2023

Primary Completion Date

April 18, 2026

Completion Date

June 30, 2026

Last Updated

September 25, 2025

Enrollment

101

ESTIMATED participants

Conditions

Acute RhinitisNasal ObstructionRhinosinusitisRhinopharyngitisAllergic Rhinitis

Interventions

Measurement of peak nasal flow.

DEVICE

Contacts

Carine BRUNEL

CONTACT

+33 (0)1 45 39 50 21 cbrunel@labogilbert.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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"

Inclusion Criteria

Exclusion Criteria

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