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"
Recruiting now · Not applicable
Conditions studied: Acute Rhinitis, Nasal Obstruction, Rhinosinusitis, Rhinopharyngitis, Allergic Rhinitis
In brief
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.
Key facts
- Study ID
- NCT05494346
- Run by
- Laboratoires Gilbert
- People needed
- 101
- Starts
- 2023-06-23
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2025-09-25
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Cabinet Médical — Blainville-sur-Orne, France (enrolling)
- Cabinet Médical Caen — Caen, France (enrolling)
- MSP du Haut Anjou — Châteauneuf-sur-Sarthe, France (enrolling)
- Cabinet Médical Gainneville — Gainneville, France
- ALYATEC — Strasbourg, France
Full record on ClinicalTrials.gov
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