NCT06104332

PMCF to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays

Post-marketing Clinical Investigation to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 534 (actual)
• Sponsor: Laboratoire de la Mer · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

The brief of this observational study is to evaluate usage, efficacy, safety and patient satisfaction of a range of hypertonic seawater-based decongestant nasal sprays in general population. The main questions it aims to answer are: * Usage, * Efficacy, * Safety, * Satisfaction, in real-life usage with children, adults and pregnant or breastfeeding women. Participants will use the nasal spray as usual habits and complete daily questionnaires.

Conditions

• Allergic Rhinitis
• URTI

Interventions

Type	Name	Description
DEVICE	ProRhinel Naturel spray nasal/ Allergic rhinitis	ProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day
DEVICE	ProRhinel EXTRA Eucalyptus spray nasal	ProRhinel EXTRA Eucalyptus spray nasal: until resolution of symptoms (period of 14 days maximum) ; 2 to 3 sprays per nostril; 6 times per day maximum
DEVICE	RESPIMER Enfant	RESPIMER Enfant: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 4 times per day maximum
DEVICE	Phytosun Aroms spray nasal MAX	Phytosun Aroms spray nasal MAX: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; up to 4-6 times per day
DEVICE	PHYSIOMER RHUME TRIPLE ACTION	PHYSIOMER RHUME TRIPLE ACTION: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; up to 4-6 times per day
DEVICE	Phytosun Aroms spray nasal decongestionnant	Phytosun Aroms spray nasal decongestionnant : until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 6 times per day maximum
DEVICE	ProRhinel Naturel spray nasal/ URTI	ProRhinel Naturel spray nasal: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 3 to 6 times per day

Timeline

• Start date: 2023-11-04
• Primary completion: 2025-02-13
• Completion: 2025-02-25
• First posted: 2023-10-27
• Last updated: 2025-03-11

Locations

2 sites across 1 country: France