Efficacy of Two Nasal Products Based on Diluted Seawater in the Treatment of Upper Respiratory Infections/Conditions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3+
SponsorYSLab
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
administration of an isotonic seawater solution (9g/L) in the nose
Other intervention1. 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 nose
Other intervention1. 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
Treatment groups
91 Participants
are divided into 3 treatment groupsGroup A: DM004-Isotonic nasal pump spray group (9g/L)Experimental treatment 1 intervention
Group B: DM020-Hypertonic nasal pump spray group (21g/L)Experimental treatment 1 intervention
Group C: common practicesNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 7.2
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 73
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 74
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 7Locations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: