NCT05494346

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (estimated)
• Sponsor: Laboratoires Gilbert · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Rhinitis
• Nasal Obstruction
• Rhinosinusitis
• Rhinopharyngitis
• Allergic Rhinitis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-06-23
• Primary completion: 2026-04-18
• Completion: 2026-06-30
• First posted: 2022-08-09
• Last updated: 2025-09-25

Locations

5 sites across 1 country: France