Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction

Last updated: December 12, 2023
Sponsor: Laboratoires Gilbert
Overall Status: Active - Recruiting

Phase

N/A

Condition

Common Cold

Sinus Infections

Allergy

Treatment

Measurement of peak nasal flow.

Clinical Study ID

NCT05494346
DEVALPO
  • 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 study specificprocedure. b. Informed minor patient who has given assent and whose legal guardianshave 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 chronic nasal obstruction.
    1. Patients on local and systemic vasoconstrictors, local and systemic corticosteroidsand antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics andlocal antiseptics.
    1. Concomitant use of other nasal sprays, essential oils for local nasal use, nasalcreams or gels.
    1. Patients under guardianship, curatorship or safeguard of justice.

Study Design

Total Participants: 101
Treatment Group(s): 1
Primary Treatment: Measurement of peak nasal flow.
Phase:
Study Start date:
May 31, 2023
Estimated Completion Date:
November 30, 2024

Connect with a study center

  • Cabinet Médical Caen

    Caen, 14000
    France

    Active - Recruiting

  • Cabinet Médical Gainneville

    Gainneville, 76700
    France

    Site Not Available

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