Clinical trial NCT06580210: 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
Official title: Prospective Multicenter Clinical Investigation to Evaluate the Performance and the Safety of the Mechanical Decongestant Seawater Spray Enriched with Essential Oils from Laboratoires Gilbert (DEMECA)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Rhinitis
Nasal Obstruction
Rhinosinusitis
Rhinopharyngitis
Allergic Rhinitis
Lead sponsor: Laboratoires Gilbert
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2024-08-30
Enrollment: 114
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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,
* 4. Patient able to meet the study requirements (questionnaire completion),
* 5. Patient affiliated to a social security scheme.

Exclusion Criteria:

* 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,
* 5. Patient suffering from nasal deformity or nasal polyps leading to chronic nasal obstruction,
* 6. Patient on local ans systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory (NSAIDs), antibiotics and local antiseptics,
* 7. Concomitant use of other nasal sprays, essential oils for local nasal use and nsal cream or gel,
* 8. Patient under guardianship, curatorship of safeguard of justice.

Primary outcomes:
measure: Performance of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert at 3 days
timeFrame: From Day 0 to Day 3
Secondary outcomes:
measure: Performance of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert after the first use
timeFrame: At Day 0
measure: Subjective feeling of reduced nasal obstruction on each day of use
timeFrame: From Day 0 and Day 6
measure: Subjective feeling of nasal secretion thinning on each day of use
timeFrame: From Day 0 to Day 6
measure: Subjective feeling of nasal cavity cleansing (freshness) on each day of use
timeFrame: From Day 0 to Day 6
measure: Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use
timeFrame: From Day 0 to Day 6
measure: Subjective feeling of relief of nasal itching on each day of use
timeFrame: From Day 0 to Day 6
measure: Subjective feeling of nasal cavity cleansing (freshness) immediately (2 minuts) after the use of the spray at Day 0
timeFrame: At Day 0 and Day 6
measure: Subjective feeling of reduced nasal obstruction immediately (2 minuts) after the use of the spray at Day 6
timeFrame: At Day 6
measure: Subjective feeling of reduced nasal obstruction immediately (2 minuts) after the use of the spray at Day 0
timeFrame: At Day 0
measure: Improvement in the patient s quality of life after 7 days of use
timeFrame: At Day 0 et Day 6
measure: Patient satisfaction with the spray after 7 days of use
timeFrame: At Day 6
measure: Patient s recommendation of the spray after 7 days of use
timeFrame: At Day 6
measure: Patient s willingness to continue using the spray at Day 6
timeFrame: At day 6
measure: Facility of use of the spray after 7 days of use
timeFrame: At Day 6
measure: Evolution of the overall severity of symptoms
timeFrame: At Day 0 and Day 3
measure: Sensations of tingling and transient irritation
timeFrame: From Day 0 to Day 6
measure: All device deficiencies reported by patients using the spray during the 7 days of use
timeFrame: From Day 0 to Day 6
measure: All adverse events reported by patients using the spray during the 7 days of use
timeFrame: From Day 0 to Day 6
Other outcomes:
Locations:
city: Caen
country: France
facility: Pharmacie de la Guérinière
Study officials:
References: