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

N/ANot Yet RecruitingNCT06498843

YSLab91 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rhinitis Sinusitis Upper Respiratory Infections Colds

Interventions

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

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

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

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

Eligibility

Sex: ALLMin age: 3 Months

Medical Language ↔ Plain English

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) \&lt; 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.

Outcomes

Primary Outcomes

Measurement of the severity of Upper Respiratory Tract Symptoms (due to common cold, rhinitis, nasopharyngitis) using the Jackson scale.

The severity of 8 symptoms (nasal discharge, nasal congestion, sneezing, sore throat, cough, headache, discomfort, chills) will be measured by an ENT specialist using the Jackson scale, which ranges from 0 to 3 (0 : none, 1 : mild, 2 : moderate, 3 : severe). The results will be reported as overall scores in comparison to Day 0 (baseline) and relative to the control group.

Time frame: on Day 0, immediately after the first use, Day 3, and Day 7.

Clinical global impression using a scale

This measure involves the clinical evaluation of the patient's condition by an ENT specialist using the Clinical Global Impression (CGI) scale, which utilizes a 7-point scale ((1: greatly improved; 2: moderately improved; 3: slightly improved; 4: unchanged; 5: slightly worsened; 6: moderately worsened; 7: greatly worsened).

Time frame: on Day 0, immediately after the first use, Day 3, and Day 7

Patient global impression using a scale

This measure captures the patient's overall impression of their condition as perceived by the patient themselves. This subjective assessment will be recorded using a standardized 7-point scale ((1: greatly improved; 2: moderately improved; 3: slightly improved; 4: unchanged; 5: slightly worsened; 6: moderately worsened; 7: greatly worsened)), allowing comparison of their current state to the beginning of treatment. This provides insights into the patient's personal perception of their health status and treatment efficacy throughout the study period.

Time frame: on Day 0, immediately after the first use, Day 3, and Day 7

Questionnaire on subject's satisfaction and use of devices

This measure involves the subject's daily self-assessment using a questionnaire. The questionnaire is designed to capture the subject's perceptions and expériences during the study period. Moreover, this questionnaire will allow us to record the number and time of daily use of the devices under study.

Time frame: Day 7

Data from ClinicalTrials.gov

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