NCT06498843

Efficacy of Two Nasal Products Based on Diluted Seawater in the Treatment of Upper Respiratory Infections/Conditions

Clinical Evaluation of the Effectiveness of Nasal Pump Spray Medical Devices DM004 and DM020 Based on Diluted Seawater in the Treatment of Colds, Rhinitis, Sinusitis, and Other Upper Respiratory Infections/Conditions

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (estimated)
• Sponsor: YSLab · Industry
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

Summary

The goal of this interventional clinical trial is to test the safety and efficacy of two medical devices in subjects aged from 3 months old for the treatment of colds, rhinitis, sinusitis, and other upper respiratory infections/conditions for 7 days.

Detailed description

The main endpoint is a symptom score evaluation. Severity is evaluated using the Jackson scale, which includes 8 symptoms (nasal discharge, nasal congestion, sneezing, sore throat, cough, headache, discomfort, chills) rated as absent, mild, moderate, or severe by the physician/investigator, on Day 0, immediately after the first use, on Day 3, and on Day 7. The clinical evaluation is also conducted by the ENT specialist using the CGI (Clinical Global Impression - 7-point scale) on Day 0, immediately after the first use, on Day 3, and on Day 7, and by patients using the PGI (Patient Global Impression - 7-point scale) every day. Concomitant treatments, number and timing of daily use, and tolerance (adverse effects) will also be studied.

Conditions

• Rhinitis
• Sinusitis
• Upper Respiratory Infections
• Colds

Interventions

Type	Name	Description
OTHER	administration of an isotonic seawater solution (9g/L) in the nose	1. pump spray group : people with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis, and other upper respiratory infections/conditions). 2. sprays per nostril, at least 2 times a day up to 6 times a day. For 7 days
OTHER	administration of a hypertonic seawater solution (21g/L) in the nose	1. pump spray group : people with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis and other upper respiratory infections/conditions). 2. sprays per nostril, at least 2 times a day up to 6 times a day. For 7 days

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-03-01
• Completion: 2025-06-01
• First posted: 2024-07-12
• Last updated: 2024-08-02