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.
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,
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,
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.
Case-only
Prospective
Not listed
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.
Performance of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert after the first use
Proportion of patients who experienced an amelioration of their nasal obstruction after the first use of the spray at Day 0 on patient questionnaire.
Subjective feeling of reduced nasal obstruction on each day of use
Proportion of patients with a reduction in the symptom -nasal obstruction- of at least 1pt, in the SNOT22 Test (item 22), on each day of use (between Day 0 and Day 6). The item is scaled form 0 to 5 and 5 is the worst value.
Subjective feeling of nasal secretion thinning on each day of use
Proportion of patients presenting a change of the symptom -thick nasal discharge- by at least 1 pt, in the SNOT22 Test, and on each day of use (from Day 0 to Day 6)
Subjective feeling of nasal cavity cleansing (freshness) on each day of use
Proportion of patients who experienced nasal cavity cleansing (feeling of freshness), on Patient Questionnaire, and on each day of use (from Day 0 to Day 6).
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Laboratoires Gilbert
Lead sponsor
EVAMED
Collaborator