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

NCT ID: NCT06498843

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2025-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

common practices

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

YSLab

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

STUU524AA0972

Identifier Type: -

Identifier Source: org_study_id