Menu
Recruiting NCT06580210

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

— Observational 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
This is an observational study: the protocol does not assign a study treatment.
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 to Evaluate the Performance and the Safety of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert (DEMECA)

Overview

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.

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Performance of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert after the first use [Time frame: At Day 0]
  • Subjective feeling of reduced nasal obstruction on each day of use [Time frame: From Day 0 and Day 6]
  • Subjective feeling of nasal secretion thinning on each day of use [Time frame: From Day 0 to Day 6]
  • Subjective feeling of nasal cavity cleansing (freshness) on each day of use [Time frame: From Day 0 to Day 6]
  • Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use [Time frame: From Day 0 to Day 6]
  • Subjective feeling of relief of nasal itching on each day of use [Time frame: 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 [Time frame: At Day 0 and Day 6]
  • Subjective feeling of reduced nasal obstruction immediately (2 minuts) after the use of the spray at Day 6 [Time frame: At Day 6]
  • Subjective feeling of reduced nasal obstruction immediately (2 minuts) after the use of the spray at Day 0 [Time frame: At Day 0]
  • Improvement in the patient s quality of life after 7 days of use [Time frame: At Day 0 et Day 6]
  • Patient satisfaction with the spray after 7 days of use [Time frame: At Day 6]
  • Patient s recommendation of the spray after 7 days of use [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 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.

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

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 3 centers
  • Pharmacie du Pont Saint Jean — Bayeux
  • Pharmacie de la Guérinière — Caen
  • Pharmacie de la Force — La Force

Identifiers

NCT: NCT06580210 · 2022-A01585-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗