Prospective Multicenter Clinical Investigation to Evaluate the Performance and the Safety of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert (DEMECA)

Laboratoires Gilbert3 sites in 1 country114 target enrollmentOctober 22, 2024

ConditionsAcute Rhinitis Nasal Obstruction Rhinosinusitis Rhinopharyngitis Allergic Rhinitis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Acute Rhinitis
Sponsor: Laboratoires Gilbert
Enrollment: 114
Locations: 3
Primary Endpoint: Performance of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert at 3 days
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert. The study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period.

Registry

clinicaltrials.gov

Start Date

October 22, 2024

End Date

June 7, 2026

Last Updated

5 months ago

Study Type

Observational

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 rhynopharyngitis (cold), rhinosinusitis, or during non-infectious episodes as allergic rhinitis,
•3\. a. Informed adult patient who has given written consent prior to any study specific procedure,
•b. Informed minor patients 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 (questionnaire completion),
•5\. Patient affiliated to a social security scheme.

Exclusion Criteria

•1\. Patient who does not want to participate to the clinical investigation,
•2\. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray,
•3\. A child with a history of febrile convulsions,
•4\. Diseases leading to respiratory insufficiency,
•5\. Patient suffering from nasal deformity or nasal polyps leading to chronic nasal obstruction,
•6\. Patient on local ans systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory (NSAIDs), antibiotics and local antiseptics,
•7\. Concomitant use of other nasal sprays, essential oils for local nasal use and nsal cream or gel,
•8\. Patient under guardianship, curatorship of safeguard of justice.

Outcomes

Primary Outcomes

Performance of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert at 3 days

Time Frame: From Day 0 to Day 3

Proportion of patients 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 pharmacy before using the spray) and Day 3 (in the evening after the last daily use of the spray). This item is scaled form 0 to 5 and 5 is the worst value.

Secondary Outcomes

Performance of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert after the first use(At Day 0)
Subjective feeling of reduced nasal obstruction on each day of use(From Day 0 and Day 6)
Subjective feeling of nasal secretion thinning on each day of use(From Day 0 to Day 6)
Subjective feeling of nasal cavity cleansing (freshness) on each day of use(From Day 0 to Day 6)
Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use(From Day 0 to Day 6)
Subjective feeling of relief of nasal itching on each day of use(From Day 0 to Day 6)
Subjective feeling of nasal cavity cleansing (freshness) immediately (2 minuts) after the use of the spray at Day 0(At Day 0 and Day 6)
Subjective feeling of reduced nasal obstruction immediately (2 minuts) after the use of the spray at Day 6(At Day 6)
Subjective feeling of reduced nasal obstruction immediately (2 minuts) after the use of the spray at Day 0(At Day 0)
Improvement in the patient s quality of life after 7 days of use(At Day 0 et Day 6)
Patient satisfaction with the spray after 7 days of use(At Day 6)
Patient s recommendation of the spray after 7 days of use(At Day 6)
Patient s willingness to continue using the spray at Day 6(At day 6)
Facility of use of the spray after 7 days of use(At Day 6)
Evolution of the overall severity of symptoms(At Day 0 and Day 3)
Sensations of tingling and transient irritation(From Day 0 to Day 6)
All device deficiencies reported by patients using the spray during the 7 days of use(From Day 0 to Day 6)
All adverse events reported by patients using the spray during the 7 days of use(From Day 0 to Day 6)