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Recruiting NCT05494346

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"

No phase Interventional Acute Rhinitis Nasal Obstruction Rhinosinusitis Rhinopharyngitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Measurement of peak nasal flow..
Who it may be relevant to
Registry conditions: Acute Rhinitis, Nasal Obstruction, Rhinosinusitis, Rhinopharyngitis. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Multicenter Clinical Investigation Evaluating the Performance and Safety of Gilbert Laboratories' Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils

Overview

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.

Interventions

  • Device 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).

Primary outcome measures

  • Performance of the Gilbert Laboratories pocket valve spray. [Time frame: From Day 0 to Day 3]
Secondary outcome measures (12)
  • Change of nasal obstruction between Day 0 and Day 3 [Time frame: From Day 0 to Day 3]
  • Immediate change of nasale obstruction at D0 on first use (Arm A) [Time frame: At Day 0]
  • Subjective feeling of reduced nasal obstruction on each day of use (arms A+B). [Time frame: From Day 0 to Day 6]
  • Subjective feeling of nasal cavity cleansing (freshness) each day of use (arms A+B). [Time frame: From Day 0 to Day 6]
  • Subjective feeling of nasal secretion thinning on each day of use (arms A+B). [Time frame: From Day 0 to Day 6]
  • Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use (arms A+B). [Time frame: From Day 0 to Day 6]
  • Subjective feeling of relief of nasal itching on each day of use (arms A+B). [Time frame: From Day 0 to Day 6]
  • Speed of action at which the patient feels (subjectively) a decrease in nasal obstruction at D0 and D3 (arms A+B). [Time frame: At Day 0 and Day 3]
  • Speed of action at which the patient feels (subjectively) a purification of his nasal cavities (sensation of freshness) at D0 and D3 (arms A+B). [Time frame: At Day 0 and Day 3]
  • Improvement in the patient's quality of life after 7 days of use (arms A+B). [Time frame: From Day 0 to Day 6]
  • Patient satisfaction with the medical device after 7 days of use (arm A+B). [Time frame: At Day 6]
  • Facility of use of the medical device after 7 days of use (arm A+B) [Time frame: At Day 6]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 5 centers
  • Cabinet Médical — Blainville-sur-Orne
  • Cabinet Médical Caen — Caen
  • MSP du Haut Anjou — Châteauneuf-sur-Sarthe
  • Cabinet Médical Gainneville — Gainneville
  • ALYATEC — Strasbourg

Identifiers

NCT: NCT05494346 · 2021-A01898-33

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗