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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorLaboratoires Gilbert

About this trial

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.

Eligibility criteria

Qualifiers

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,

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators