Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

Laboratoires Gilbert

Status

Enrolling

Conditions

Nasal Obstruction

Rhinosinusitis

Acute Rhinitis

Allergic Rhinitis

Rhinopharyngitis

Treatments

Device: Measurement of peak nasal flow.

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05494346

2021-A01898-33

Details and patient eligibility

About

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.

Enrollment

101 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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 uncontrolled asthma (GINA score greater than or equal to 4)
5. Patients undergoing allergy desensitization
6. Patients suffering from chronic nasal obstruction due to a deformation of the nasal wall or nasal polyps. creams or gels.
7. Patients taking local and systemic vasoconstrictors, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotics, and local antiseptics.
8. Concomitant use of other nasal sprays, essential oils for local nasal use, creams, or gels for the nose.
9. Patients under guardianship, conservatorship, or legal protection.