Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction

NCT06580210 | Recruiting

• 1 other identifier: 2022-A01585-38
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  From Day 0 to Day 3

Secondary Outcomes (18)

• 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

Eligibility Criteria

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

Study Population

Participation in the study is open to patients who buy the mechanical decongestant seawater spray on request or on the advice of their pharmacist. Patients are offered the opportunity to take part in the clinical investigation at the time of payment and after the eligibility critera have been checked by the pharmacist.

You may qualify if:

• \. Patient ≥ 12 years,
• \. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhynopharyngitis (cold), rhinosinusitis, or during non-infectious episodes as allergic rhinitis,
• \. 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,
• \. Patient able to meet the study requirements (questionnaire completion),
• \. Patient affiliated to a social security scheme.

You may not qualify if:

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

Sponsors & Collaborators

• Laboratoires Gilbert: lead
• EVAMED: collaborator

Study Sites (3)

Pharmacie du Pont Saint Jean

Bayeux, 14400, France

NOT YET RECRUITING

Pharmacie de la Guérinière

Caen, 14000, France

RECRUITING

Pharmacie de la Force

La Force, 24130, France

NOT YET RECRUITING

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

Léa RADDAY

CONTACT

+33 (0)2 31 47 16 61; lradday@labogilbert.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: August 30, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 7, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)