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
NCT Number: NCT06580210
Acronym: DEMECA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Rhinitis|Nasal Obstruction|Rhinosinusitis|Rhinopharyngitis|Allergic Rhinitis
Sponsor: Laboratoires Gilbert
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 114
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-10

Summary:
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, 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., From Day 0 to Day 3
Secondary Outcome Measures: 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., At Day 0|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., From Day 0 and Day 6|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), 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)., From Day 0 to Day 6|Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use, Proportion of patients who experienced relief of nasal irritation (mucous membrane), on Patient Questionnaire, on each day of use (from Day 0 to Day 6)., From Day 0 to Day 6|Subjective feeling of relief of nasal itching on each day of use, Proportion of patients who experienced relief of nasal itching, on Patient Questionnaire, on each day of use (from Day 0 to Day 6)., 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, Proportion of patient who experienced nasal cavity cleansing (feeling of freshness) immediately (2 minuts) after the use of the spray, on Patient Questionnaire, at Day 0 and Day 6., At Day 0 and Day 6|Subjective feeling of reduced nasal obstruction immediately (2 minuts) after the use of the spray at Day 6, Proportion of patient who experienced a reduction of nasal obstruction immediately (2 minuts) after the use of the spray, on Patient Questionnaire, at Day 6., At Day 6|Subjective feeling of reduced nasal obstruction immediately (2 minuts) after the use of the spray at Day 0, Proportion of patient who experienced a reduction of nasal obstruction immediately (2 minuts) after the use of the spray, on Patient Questionnaire, at Day 0., At Day 0|Improvement in the patient s quality of life after 7 days of use, Proportion of patients who experienced an improvement in quality of life, on Patient Questionnaire (scale of 0-10 with 10 is the best value), between Day 0 and Day 6., At Day 0 et Day 6|Patient satisfaction with the spray after 7 days of use, Proportion of patients satisfied with the spray on a 4-points scale, at Day 6. The best value is -very satisfied- and the worst value is -very unsatisfied-., At Day 6|Patient s recommendation of the spray after 7 days of use, Proportion of patients who would recommend the spray, on a 4-points scale, at Day 6. The best value is -definitely yes- and the worst value is -definitely no-., At Day 6|Patient s willingness to continue using the spray at Day 6, Proportion of patients who will continue to use the spray and the reason if he does not want to continue, on a 4-points scale, at Day 6. The best value is -definitely yes- and the worst value is -definitely no-., At day 6|Facility of use of the spray after 7 days of use, Proportion of patients who find the spray easy to use, on a 4-points scale, at Day 6. The best value is -very easy- and the worst value is -very difficult-., At Day 6|Evolution of the overall severity of symptoms, Average SNOT22 score each day and comparison of SNOT22 score at Day 3 versus DAy 0 (baseline). \[0 to 220\] with 0 is the best value and 220 is the worst value., At Day 0 and Day 3|Sensations of tingling and transient irritation, Proportion of patients with at least 1 adverse event among :

* tingling sensation
* sensations of transient irritation during the 7 days of use., From Day 0 to Day 6|All device deficiencies reported by patients using the spray during the 7 days of use, Proportion of patients with at least 1 device deficiency during the clinical investigation., From Day 0 to Day 6|All adverse events reported by patients using the spray during the 7 days of use, All adverse events reported by the patient during the clinical investigation., From Day 0 to Day 6