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RECRUITING
NCT05494346
NA

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"

Sponsor: 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.

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

101

Start Date

2023-06-23

Completion Date

2026-06-30

Last Updated

2025-09-25

Healthy Volunteers

No

Interventions

DEVICE

Measurement 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).

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