Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
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
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