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"
NCT ID: NCT05494346
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
101 participants
INTERVENTIONAL
2023-06-23
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Patients with peak nasal flow performed
This arm is made up of major patients. Nasal flow point measurements will be performed at D0 and D3.
Measurement of peak nasal flow.
Peak nasal flow measurements will be performed before and after the first use of the spray at D0, as well as after the use of the spray at the medical office at D3 (only for arm A).
Arm B: No peak nasal flow
This arm is made up of minor patients. Unlike arm A, nasal flow measurements will not be performed at D0 and D3.
No interventions assigned to this group
Interventions
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Measurement of peak nasal flow.
Peak nasal flow measurements will be performed before and after the first use of the spray at D0, as well as after the use of the spray at the medical office at D3 (only for arm A).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
ALL
No
Sponsors
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EVAMED
OTHER
Laboratoires Gilbert
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Pascal MABIRE, Dr
Role: primary
Other Identifiers
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2021-A01898-33
Identifier Type: -
Identifier Source: org_study_id
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