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"

Last updated: September 19, 2025
Sponsor: Laboratoires Gilbert
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy

Allergy (Pediatric)

Allergies & Asthma

Treatment

Measurement of peak nasal flow.

Clinical Study ID

NCT05494346
2021-A01898-33
  • Ages > 12
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

    1. Patient ≥ 12 years.
    1. Patient with acute rhinitis associated with nasal obstruction during infectiousepisodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectiousepisodes such as allergic rhinitis.
    1. a. Informed adult patient who has given written consent prior to any studyspecific procedure. b. Informed minor patient who has given assent and whose legalguardians have given written consent prior to any study-specific procedure.
    1. Patient able to meet the study requirements for monitoring, spray use, andquestionnaire completion.
    1. Patient affiliated to a social security scheme.

Exclusion

Exclusion Criteria:

    1. Pregnant and/or breastfeeding woman
    1. Hypersensitivity to seawater and/or known allergies to any of the ingredients ofthe spray.
    1. Diseases causing narrowing of the airways (e.g. asthma, chronic obstructivepulmonary disease (COPD)) and/or respiratory insufficiency.
    1. Patients with uncontrolled asthma (GINA score greater than or equal to 4)
    1. Patients undergoing allergy desensitization
    1. Patients suffering from chronic nasal obstruction due to a deformation of thenasal wall or nasal polyps. creams or gels.
    1. Patients taking local and systemic vasoconstrictors, corticosteroids,nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotics, and local antiseptics.
    1. Concomitant use of other nasal sprays, essential oils for local nasal use,creams, or gels for the nose.
    1. Patients under guardianship, conservatorship, or legal protection.

Study Design

Total Participants: 101
Treatment Group(s): 1
Primary Treatment: Measurement of peak nasal flow.
Phase:
Study Start date:
June 23, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Cabinet Médical

    Blainville-sur-Orne 3032452, 14550
    France

    Active - Recruiting

  • Cabinet Médical Caen

    Caen, 14000
    France

    Site Not Available

  • Cabinet Médical Caen

    Caen 3029241, 14000
    France

    Active - Recruiting

  • MSP du Haut Anjou

    Châteauneuf-sur-Sarthe 3026221, 49330
    France

    Active - Recruiting

  • Cabinet Médical Gainneville

    Gainneville, 76700
    France

    Site Not Available

  • Cabinet Médical Gainneville

    Gainneville 3016800, 76700
    France

    Site Not Available

  • ALYATEC

    Strasbourg 2973783, 67000
    France

    Completed

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