Status:
RECRUITING
Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction
Lead Sponsor:
Laboratoires Gilbert
Collaborating Sponsors:
EVAMED
Conditions:
Acute Rhinitis
Nasal Obstruction
Eligibility:
All Genders
12+ years
Brief Summary
The purpose of this post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert....
Eligibility Criteria
Inclusion
- 1\. Patient ≥ 12 years,
- 2\. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhynopharyngitis (cold), rhinosinusitis, or during non-infectious episodes as allergic rhinitis,
- 3\. a. Informed adult patient who has given written consent prior to any study specific procedure,
- b. Informed minor patients 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 (questionnaire completion),
- 5\. Patient affiliated to a social security scheme.
Exclusion
- 1\. Patient who does not want to participate to the clinical investigation,
- 2\. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray,
- 3\. A child with a history of febrile convulsions,
- 4\. Diseases leading to respiratory insufficiency,
- 5\. Patient suffering from nasal deformity or nasal polyps leading to chronic nasal obstruction,
- 6\. Patient on local ans systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory (NSAIDs), antibiotics and local antiseptics,
- 7\. Concomitant use of other nasal sprays, essential oils for local nasal use and nsal cream or gel,
- 8\. Patient under guardianship, curatorship of safeguard of justice.
Key Trial Info
Start Date :
October 22 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 7 2026
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT06580210
Start Date
October 22 2024
End Date
June 7 2026
Last Update
November 21 2025
Active Locations (3)
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1
Pharmacie du Pont Saint Jean
Bayeux, France, 14400
2
Pharmacie de la Guérinière
Caen, France, 14000
3
Pharmacie de la Force
La Force, France, 24130