Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction

Launched by LABORATOIRES GILBERT · Aug 8, 2022

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ClinConnect Summary

This clinical trial is looking at a new type of nasal spray that combines seawater with essential oils to help people who are experiencing nasal congestion due to conditions like colds, allergies, or sinus issues. The main goal is to see if this spray is safe and effective in relieving symptoms over an 8-day period. If you are at least 12 years old and have nasal blockage due to these types of conditions, you might be eligible to participate.

Participants will need to agree to take part in the study and complete some questionnaires about their experience with the spray. It's important to note that certain people cannot join, including those who are pregnant, have allergies to seawater or the spray’s ingredients, or have serious breathing problems. This study is currently recruiting participants, and taking part could help researchers learn more about this new treatment for nasal congestion.

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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 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 Criteria:
• • 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 chronic nasal obstruction.
• • 5. Patients on local and systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics and local antiseptics.
• • 6. Concomitant use of other nasal sprays, essential oils for local nasal use, nasal creams or gels.
• • 7. Patients under guardianship, curatorship or safeguard of justice.