Clinical trial NCT06498843: Efficacy of Two Nasal Products Based on Diluted Seawater in the Treatment of Upper Respiratory Infections/Conditions
Official title: Clinical Evaluation of the Effectiveness of Nasal Pump Spray Medical Devices DM004 and DM020 Based on Diluted Seawater in the Treatment of Colds, Rhinitis, Sinusitis, and Other Upper Respiratory Infections/Conditions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rhinitis
Sinusitis
Upper Respiratory Infections
Colds
Lead sponsor: YSLab
Sponsor class: INDUSTRY
First posted: 2024-07-12
Enrollment: 91
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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) \&amp;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.

Primary outcomes:
measure: Measurement of the severity of Upper Respiratory Tract Symptoms (due to common cold, rhinitis, nasopharyngitis) using the Jackson scale.
timeFrame: on Day 0, immediately after the first use, Day 3, and Day 7.
measure: Clinical global impression using a scale
timeFrame: on Day 0, immediately after the first use, Day 3, and Day 7
measure: Patient global impression using a scale
timeFrame: on Day 0, immediately after the first use, Day 3, and Day 7
measure: Questionnaire on subject's satisfaction and use of devices
timeFrame: Day 7
measure: Concomitant treatments using a questionnaire
timeFrame: Immediately after the first use, Day 3, and Day 7
measure: Collection of Side Effects Using a Questionnaire
timeFrame: Immediately after the first use, Day 3, and Day 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: