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"
Condition(s) studied
Investigational drug(s) / intervention(s)
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).
Study 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
Primary outcome measure(s)
- Performance of the Gilbert Laboratories pocket valve spray. — From Day 0 to Day 3
Proportion of patient presenting a change of the symptom "nasal obstruction" by at least 1 pt, in the SNOT22 Test (item 22), between Day 0 (at inclusion in the office before use of the spray) and Day 3 (in the evening after last daily use of the spray). This item is scaled from 0 to 5, 5 being the worst value.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Cabinet Médical | Blainville-sur-Orne | France | Recruiting |
| Cabinet Médical Caen | Caen | France | Recruiting |
| MSP du Haut Anjou | Châteauneuf-sur-Sarthe | France | Recruiting |
| Cabinet Médical Gainneville | Gainneville | France | Withdrawn |
| ALYATEC | Strasbourg | France | Completed |
More Laboratoires Gilbert trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05494346 on ClinicalTrials.gov ↗ ← All trials in France