The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.
1. Patient ≥ 12 years.
2. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectious episodes such as allergic rhinitis.
3. a. Informed adult patient who has given written consent prior to any study specific procedure. b. Informed minor patient 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 for monitoring, spray use, and questionnaire completion.
1. Pregnant and/or breastfeeding woman
2. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray.
3. Diseases causing narrowing of the airways (e.g. asthma, chronic obstructive pulmonary disease (COPD)) and/or respiratory insufficiency.
4. Patients with uncontrolled asthma (GINA score greater than or equal to 4)
Parallel
Measurement of peak nasal flow.
DevicePeak nasal flow measurements will be performed before and after the first use of the spray at D0, as well as after the use of the spray at the medical office at D3 (only for arm A).
Performance of the Gilbert Laboratories pocket valve spray.
Proportion of patient 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 office before use of the spray) and Day 3 (in the evening after last daily use of the spray). This item is scaled from 0 to 5, 5 being the worst value.
Change of nasal obstruction between Day 0 and Day 3
Proportion of patients with a change in Peak Inspiratory Nasal Flow value of at least 30 L/min between Day 0 (before use of the spray) and Day 3 (after use of the spray) (arm A). \[0 - 350 L/min\] 350 L/min means a better outcome.
Immediate change of nasale obstruction at D0 on first use (Arm A)
Proportion of patients with a change in Peak Inspiratory Nasal Flow value of at least 30 L/min from pre- to post-spray measurements at Day 0 (arm A). \[ 0 - 350 L/min\] 350 L/min means a better outcome.
Subjective feeling of reduced nasal obstruction on each day of use (arms A+B).
Proportion of patients with a reduction in the symptom "nasal obstruction" of at least 1pt, on SNOT22 (Sino-Nasal Outcome Test 22), and on each day of use (from Day 0 to Day 6) (arms A+B). This item is scaled from 0 to 5, 5 being the worst value.
Subjective feeling of nasal cavity cleansing (freshness) each day of use (arms A+B).
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) (arms A+B).
Click on the lead sponsor to view all of their trials.
Laboratoires Gilbert
Lead sponsor
EVAMED
Collaborator
