Actively Recruiting
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"
Led by Laboratoires Gilbert · Updated on 2025-09-25
101
Participants Needed
5
Research Sites
157 weeks
Total Duration
On this page
Sponsors
L
Laboratoires Gilbert
Lead Sponsor
E
EVAMED
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 12 years or older.
- Patient has acute rhinitis with nasal obstruction during infectious episodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectious episodes such as allergic rhinitis.
- Informed adult patient with written consent, or informed minor patient with assent and guardian consent before any study procedure.
- Patient able to follow study requirements for monitoring, spray use, and questionnaire completion.
- Patient affiliated with a social security scheme.
You will not qualify if you...
- Pregnant or breastfeeding women.
- Hypersensitivity to seawater or allergies to any spray ingredients.
- Diseases causing airway narrowing (e.g., asthma, COPD) or respiratory insufficiency.
- Patients with uncontrolled asthma (GINA score ≥ 4).
- Patients undergoing allergy desensitization.
- Chronic nasal obstruction from nasal wall deformation or nasal polyps.
- Use of local or systemic vasoconstrictors, corticosteroids, NSAIDs, antibiotics, or local antiseptics.
- Use of other nasal sprays, essential oils, creams, or gels for the nose.
- Patients under guardianship, conservatorship, or legal protection.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Cabinet Médical
Blainville-sur-Orne, France, 14550
Actively Recruiting
2
Cabinet Médical Caen
Caen, France, 14000
Actively Recruiting
3
MSP du Haut Anjou
Châteauneuf-sur-Sarthe, France, 49330
Actively Recruiting
4
Cabinet Médical Gainneville
Gainneville, France, 76700
Withdrawn
5
ALYATEC
Strasbourg, France, 67000
Completed
Research Team
C
Carine BRUNEL
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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