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

Laboratoires Gilbert5 sites in 1 country101 target enrollmentJune 23, 2023

ConditionsAcute Rhinitis Nasal Obstruction Rhinosinusitis Rhinopharyngitis Allergic Rhinitis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Acute Rhinitis
Sponsor: Laboratoires Gilbert
Enrollment: 101
Locations: 5
Primary Endpoint: Performance of the Gilbert Laboratories pocket valve spray.
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 23, 2023

End Date

June 30, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Laboratoires Gilbert

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Performance of the Gilbert Laboratories pocket valve spray.

Time Frame: 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.

Secondary Outcomes

Immediate change of nasale obstruction at D0 on first use (Arm A)(At Day 0)
Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use (arms A+B).(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).(At Day 0 and Day 3)
Subjective feeling of nasal cavity cleansing (freshness) each day of use (arms A+B).(From Day 0 to Day 6)
Sensations of tingling and transient irritation (arms A+B).(From Day 0 to Day 6)
Facility of use of the medical device after 7 days of use (arm A+B)(At Day 6)
All adverse events reported by patients using the pocket valve spray after 7 days of use (arm A+B).(From Day 0 to Day 7)
Change of nasal obstruction between Day 0 and Day 3(From Day 0 to Day 3)
Subjective feeling of reduced nasal obstruction on 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)
Subjective feeling of relief of nasal itching on each day of use (arms A+B).(From Day 0 to Day 6)
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).(At Day 0 and Day 3)
Evolution of the overall severity of symptoms (arm A+B).(At Day 0 and Day 3)
Improvement in the patient's quality of life after 7 days of use (arms A+B).(From Day 0 to Day 6)
Patient satisfaction with the medical device after 7 days of use (arm A+B).(At Day 6)