Status:
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"
Lead Sponsor:
Laboratoires Gilbert
Collaborating Sponsors:
EVAMED
Conditions:
Acute Rhinitis
Nasal Obstruction
Eligibility:
All Genders
12+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 1\. Patient ≥ 12 years.
- 2\. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectious episodes such as allergic rhinitis.
- 3\. a. Informed adult patient who has given written consent prior to any study specific procedure. b. Informed minor patient who has given assent and whose legal guardians have given written consent prior to any study-specific procedure.
- 4\. Patient able to meet the study requirements for monitoring, spray use, and questionnaire completion.
- 5\. Patient affiliated to a social security scheme.
Exclusion
- 1\. Pregnant and/or breastfeeding woman
- 2\. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray.
- 3\. Diseases causing narrowing of the airways (e.g. asthma, chronic obstructive pulmonary disease (COPD)) and/or respiratory insufficiency.
- 4\. Patients with uncontrolled asthma (GINA score greater than or equal to 4)
- 5\. Patients undergoing allergy desensitization
- 6\. Patients suffering from chronic nasal obstruction due to a deformation of the nasal wall or nasal polyps. creams or gels.
- 7\. Patients taking local and systemic vasoconstrictors, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotics, and local antiseptics.
- 8\. Concomitant use of other nasal sprays, essential oils for local nasal use, creams, or gels for the nose.
- 9\. Patients under guardianship, conservatorship, or legal protection.
Key Trial Info
Start Date :
June 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT05494346
Start Date
June 23 2023
End Date
June 30 2026
Last Update
September 25 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Cabinet Médical
Blainville-sur-Orne, France, 14550
2
Cabinet Médical Caen
Caen, France, 14000
3
MSP du Haut Anjou
Châteauneuf-sur-Sarthe, France, 49330
4
Cabinet Médical Gainneville
Gainneville, France, 76700