Last updated: September 19, 2025
Sponsor: Laboratoires Gilbert
Overall Status: Active - Recruiting
Phase
N/A
Condition
Allergy
Allergy (Pediatric)
Allergies & Asthma
Treatment
Measurement of peak nasal flow.
Clinical Study ID
NCT05494346
2021-A01898-33
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient ≥ 12 years.
- Patient with acute rhinitis associated with nasal obstruction during infectiousepisodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectiousepisodes such as allergic rhinitis.
- a. Informed adult patient who has given written consent prior to any studyspecific procedure. b. Informed minor patient who has given assent and whose legalguardians have given written consent prior to any study-specific procedure.
- Patient able to meet the study requirements for monitoring, spray use, andquestionnaire completion.
- Patient affiliated to a social security scheme.
Exclusion
Exclusion Criteria:
- Pregnant and/or breastfeeding woman
- Hypersensitivity to seawater and/or known allergies to any of the ingredients ofthe spray.
- Diseases causing narrowing of the airways (e.g. asthma, chronic obstructivepulmonary disease (COPD)) and/or respiratory insufficiency.
- Patients with uncontrolled asthma (GINA score greater than or equal to 4)
- Patients undergoing allergy desensitization
- Patients suffering from chronic nasal obstruction due to a deformation of thenasal wall or nasal polyps. creams or gels.
- Patients taking local and systemic vasoconstrictors, corticosteroids,nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotics, and local antiseptics.
- Concomitant use of other nasal sprays, essential oils for local nasal use,creams, or gels for the nose.
- Patients under guardianship, conservatorship, or legal protection.
Study Design
Total Participants: 101
Treatment Group(s): 1
Primary Treatment: Measurement of peak nasal flow.
Phase:
Study Start date:
June 23, 2023
Estimated Completion Date:
June 30, 2026
Connect with a study center
Cabinet Médical
Blainville-sur-Orne 3032452, 14550
FranceActive - Recruiting
Cabinet Médical Caen
Caen, 14000
FranceSite Not Available
Cabinet Médical Caen
Caen 3029241, 14000
FranceActive - Recruiting
MSP du Haut Anjou
Châteauneuf-sur-Sarthe 3026221, 49330
FranceActive - Recruiting
Cabinet Médical Gainneville
Gainneville, 76700
FranceSite Not Available
Cabinet Médical Gainneville
Gainneville 3016800, 76700
FranceSite Not Available
ALYATEC
Strasbourg 2973783, 67000
FranceCompleted

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