Clinical trial NCT05494346: Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction
Official title: Prospective Multicenter Clinical Investigation Evaluating the Performance and Safety of Gilbert Laboratories' Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Rhinitis
Nasal Obstruction
Rhinosinusitis
Rhinopharyngitis
Allergic Rhinitis
Lead sponsor: Laboratoires Gilbert
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2022-08-09
Enrollment: 101
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 5. Patient affiliated to a social security scheme.

Exclusion Criteria:

* 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 chronic nasal obstruction.
* 5. Patients on local and systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics and local antiseptics.
* 6. Concomitant use of other nasal sprays, essential oils for local nasal use, nasal creams or gels.
* 7. Patients under guardianship, curatorship or safeguard of justice.

Primary outcomes:
measure: Performance of the Gilbert Laboratories pocket valve spray.
timeFrame: From Day 0 to Day 3
Secondary outcomes:
measure: Change of nasal obstruction between Day 0 and Day 3
timeFrame: From Day 0 to Day 3
measure: Immediate change of nasale obstruction at D0 on first use (Arm A)
timeFrame: At Day 0
measure: Subjective feeling of reduced nasal obstruction on each day of use (arms A+B).
timeFrame: From Day 0 to Day 6
measure: Subjective feeling of nasal cavity cleansing (freshness) each day of use (arms A+B).
timeFrame: From Day 0 to Day 6
measure: Subjective feeling of nasal secretion thinning on each day of use (arms A+B).
timeFrame: From Day 0 to Day 6
measure: Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use (arms A+B).
timeFrame: From Day 0 to Day 6
measure: Subjective feeling of relief of nasal itching on each day of use (arms A+B).
timeFrame: From Day 0 to Day 6
measure: Speed of action at which the patient feels (subjectively) a decrease in nasal obstruction at D0 and D3 (arms A+B).
timeFrame: At Day 0 and Day 3
measure: Speed of action at which the patient feels (subjectively) a purification of his nasal cavities (sensation of freshness) at D0 and D3 (arms A+B).
timeFrame: At Day 0 and Day 3
measure: Improvement in the patient's quality of life after 7 days of use (arms A+B).
timeFrame: From Day 0 to Day 6
measure: Patient satisfaction with the medical device after 7 days of use (arm A+B).
timeFrame: At Day 6
measure: Facility of use of the medical device after 7 days of use (arm A+B)
timeFrame: At Day 6
measure: Evolution of the overall severity of symptoms (arm A+B).
timeFrame: At Day 0 and Day 3
measure: All adverse events reported by patients using the pocket valve spray after 7 days of use (arm A+B).
timeFrame: From Day 0 to Day 7
measure: Sensations of tingling and transient irritation (arms A+B).
timeFrame: From Day 0 to Day 6
Other outcomes:
Locations:
city: Caen
country: France
facility: Cabinet Médical Caen
city: Gainneville
country: France
facility: Cabinet Médical Gainneville
Study officials:
References: