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

YSLab

Status: Not yet enrolling

Conditions: Upper Respiratory Infections; Colds; Rhinitis; Sinusitis

Treatments: Other: administration of a hypertonic seawater solution (21g/L) in the nose; Other: administration of an isotonic seawater solution (9g/L) in the nose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06498843

STUU524AA0972

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 estimated patients

Sex: All

Ages: 3+ months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 3 patient groups

DM004-Isotonic nasal pump spray group (9g/L)

Experimental group

Description:

Isotonic concentration. This solution has a concentration of mineral salts (concentration of halides expressed as NaCl: 9 g/L) similar to the human cells.

Treatment:

Other: administration of an isotonic seawater solution (9g/L) in the nose

DM020-Hypertonic nasal pump spray group (21g/L)

Experimental group

Description:

Hypertonic concentration. This solution has a concentration of mineral salts (concentration of halides expressed as NaCl: 21 g/L) higher than that of human cells.

Treatment:

Other: administration of a hypertonic seawater solution (21g/L) in the nose

common practices

No Intervention group

Description:

1 control group with common practices people with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis...), not using nasal sprays nor nasal drops (in single-dose form, for example) but standard practices: hydration, rest, paracetamol if necessary