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
Sponsors and collaborators
Laboratoires Gilbert
Lead sponsor
EVAMED
Collaborator