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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"

RecruitingNAAges 12 Years - anyAllLaboratoires Gilbert
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In plain words

What the trial is, and whether it could suit you

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 study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 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.
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What it tests

  • Measurement of peak nasal flow.
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Where

5 sites
Cabinet Médical
Blainville-sur-Orne, France
Cabinet Médical Caen
Caen, France
MSP du Haut Anjou
Châteauneuf-sur-Sarthe, France
Cabinet Médical Gainneville
Gainneville, France
ALYATEC
Strasbourg, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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