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

Launched by LABORATOIRES GILBERT · Aug 29, 2024

Keywords

ClinConnect Summary

This clinical trial is examining a seawater nasal spray that contains essential oils to see how well it works and how safe it is for people with acute rhinitis, which is a condition that causes nasal congestion or obstruction. This can happen during infections like colds or allergies. The study will take place over a week and aims to find out if this spray can help relieve symptoms for patients aged 12 and older.

To participate, individuals must have acute rhinitis and be able to complete questionnaires about their experience. However, there are some exclusions; for example, those with certain allergies or respiratory issues, as well as those using specific medications or other nasal sprays, cannot join. Participants will be required to provide informed consent, meaning they will be fully informed about the study and agree to take part. It's important for potential participants to know that the study is not yet recruiting, so they will need to wait for it to start before applying.

Gender

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Eligibility criteria

• 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.