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Recruiting Not applicable

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"

NCT05494346 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-06-23
Last updated
2026-08-26

Condition(s) studied

Acute RhinitisNasal ObstructionRhinosinusitisRhinopharyngitisAllergic Rhinitis

Investigational drug(s) / intervention(s)

Measurement of peak nasal flow.

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).

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Performance of the Gilbert Laboratories pocket valve spray. — From Day 0 to Day 3
    Proportion of patient presenting a change of the symptom "nasal obstruction" by at least 1 pt, in the SNOT22 Test (item 22), between Day 0 (at inclusion in the office before use of the spray) and Day 3 (in the evening after last daily use of the spray). This item is scaled from 0 to 5, 5 being the worst value.

Trial sites (5)

FacilityCityRegionStatus
Cabinet Médical Blainville-sur-Orne France Recruiting
Cabinet Médical Caen Caen France Recruiting
MSP du Haut Anjou Châteauneuf-sur-Sarthe France Recruiting
Cabinet Médical Gainneville Gainneville France Withdrawn
ALYATEC Strasbourg France Completed
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05494346 on ClinicalTrials.gov ↗ ← All trials in France