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 | Recruiting DMC

• 1 other identifier: 2021-A01898-33
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Acute Rhinitis; Nasal Obstruction; Rhinosinusitis; Rhinopharyngitis; Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Performance of the Gilbert Laboratories pocket valve spray.

  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.

  From Day 0 to Day 3

Secondary Outcomes (15)

• Change of nasal obstruction between Day 0 and Day 3

  From Day 0 to Day 3

• Immediate change of nasale obstruction at D0 on first use (Arm A)

  At Day 0

• Subjective feeling of reduced nasal obstruction on each day of use (arms A+B).

  From Day 0 to Day 6

• Subjective feeling of nasal cavity cleansing (freshness) each day of use (arms A+B).

  From Day 0 to Day 6

• Subjective feeling of nasal secretion thinning on each day of use (arms A+B).

  From Day 0 to Day 6

Study Arms (2)

Arm A: Patients with peak nasal flow performed

OTHER

This arm is made up of major patients. Nasal flow point measurements will be performed at D0 and D3.

Device: Measurement of peak nasal flow.

Arm B: No peak nasal flow

NO INTERVENTION

This arm is made up of minor patients. Unlike arm A, nasal flow measurements will not be performed at D0 and D3.

Interventions

Measurement of peak nasal flow. DEVICE

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).

Arm A: Patients with peak nasal flow performed

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patient ≥ 12 years.
• \. 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.
• \. 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.
• \. Patient able to meet the study requirements for monitoring, spray use, and questionnaire completion.
• \. Patient affiliated to a social security scheme.

You may not qualify if:

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

Sponsors & Collaborators

• Laboratoires Gilbert: lead
• EVAMED: collaborator

Study Sites (5)

Cabinet Médical

Blainville-sur-Orne, 14550, France

RECRUITING

Cabinet Médical Caen

Caen, 14000, France

RECRUITING

MSP du Haut Anjou

Châteauneuf-sur-Sarthe, 49330, France

RECRUITING

Cabinet Médical Gainneville

Gainneville, 76700, France

WITHDRAWN

ALYATEC

Strasbourg, 67000, France

COMPLETED

MeSH Terms

Conditions

Common Cold; Nasal Obstruction; Rhinosinusitis; Nasopharyngitis; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Rhinitis; Sinusitis; Paranasal Sinus Diseases; Pharyngitis; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Carine BRUNEL

CONTACT

+33 (0)1 45 39 50 21; cbrunel@labogilbert.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: June 23, 2023
• Primary Completion: April 18, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)