NCT07262450

Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

Real-word Study to Assess Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,065 (estimated)
• Sponsor: Laboratoire de la Mer · Industry
• Sex: All
• Age: 15 Days
• Healthy volunteers: Not accepted

Summary

The purpose of this post-market clinical investigation is to assess in a real-life setting, the effectiveness, usage, tolerance, safety and satisfaction of 4 isotonic and hypertonic seawater-based CE-marked nasal sprays. The main questions it aims to answer are: * Efficacy, * Safety, * Usage, * Satisfaction, in real-life usage among infants, children, adults and pregnant or breastfeeding women suffering from acute and chronic sinonasal pathologies. The 4 medical devices under investigation will be used in accordance with their intended use, target populations and medical indications.

Conditions

• URTI
• Bronchiolitis
• COVID - 19
• Allergic Rhinitis
• Chronic Rhinosinusitis (CRS)
• Post-surgery

Interventions

Type	Name	Description
DEVICE	Respimer® Hygiene-Prevention -Baby, kids, adults	1-3 seconds spray in each nostril, * 4 to 6 times a day, in treatment of nasal symptoms. * 1 to 2 times a day, in hygiene and prevention
DEVICE	Respimer® Hygiene-Prevention Kids, adults	1-2 seconds spray in each nostril, * 4 to 6 times a day, in treatment of nasal symptoms * 1 to 2 times a day, in hygiene and prevention
DEVICE	Respimer® Decongestion Baby, kids, adults	Baby (2 months+): 1-3 seconds spray in each nostril, up to 3 times a day Children (2 y+) and adults: 1-3 seconds spray in each nostril, up to 6 times a day
DEVICE	Phytosun arôms® Hypertonic nasal wash	1 second spray in each nostril, 2-3 times a day.

Timeline

• Start date: 2025-08-27
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-12-03
• Last updated: 2025-12-03

Locations

32 sites across 1 country: France