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 (DEMECA)

Laboratoires Gilbert

Status: Enrolling

Conditions: Nasal Obstruction; Rhinosinusitis; Acute Rhinitis; Allergic Rhinitis; Rhinopharyngitis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06580210

2022-A01585-38

Details and patient eligibility

About

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. The study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period.

Enrollment: 114 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.