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

Launched by YSLAB · Jul 4, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of two nasal products made from diluted seawater to help treat upper respiratory infections, like colds, rhinitis (inflammation of the nose), and sinusitis (sinus infections). The study will include both adults and children starting from 3 months old, and participants will use the products over a period of 7 days. To join the trial, individuals must have moderate to severe symptoms of nasal congestion and discharge that began within the last 48 hours.

To be eligible, participants need to be capable of following the instructions for using the products, and adults or their guardians must provide consent to participate. However, those who don't have cold symptoms, are currently taking certain medications, or have recently used similar nasal products won't be able to take part. If you join the study, you can expect to use the nasal products daily and keep track of your symptoms in a diary. This research aims to find better ways to relieve the discomfort of upper respiratory infections for everyone involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Autonomous adult, or minor with the consent of their legal representative
• • Adults and children from 3 months old
• • Ability of the patient (for adults) or their legal representative (for children) to follow the instructions for product use
• • Having signed a free and informed consent to participate in the study expressed by the patient (for adults) or by their legal representative (for children) after being informed by the doctor.
• • Person with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis...) with symptoms of nasal congestion and nasal discharge of moderate to severe intensity (Jackson derived score (nasal congestion + nasal discharge) ≥ 4 on Day 0).
• • Persons with symptoms that started no more than 48 hours before the first visit
• Exclusion Criteria:
• • Person not showing cold symptoms, particularly no nasal congestion (chronic dry rhinitis, or Jackson derived score (nasal congestion + nasal discharge) \< 4 on Day 0).
• • Person undergoing treatment with a cortisone derivative, mucolytic, or medication containing pseudoephedrine or a similar product acting on nasal congestion or having used such a product within the 3 days preceding inclusion.
• • Person having used a nasal wash product within the 3 days preceding inclusion.
• • Person whose ability to use the product daily and complete the daily follow-up diary is in doubt.
• • Person refusing to sign the informed consent form prior to the study.
• • Person participating or having participated in any other clinical study within the 30 days preceding the study.
• • Person participating in any other clinical study.