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

NCT06498843 | Not Yet Recruiting

• 1 other identifier: STUU524AA0972
• Study Type: interventional
• Target: 91
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rhinitis; Sinusitis; Upper Respiratory Infections; Colds

Outcome Measures

Primary Outcomes (6)

• 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.

  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).

  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.

  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.

  Day 7

• Concomitant treatments using a questionnaire

  This measure involves documenting any additional treatments or medications that participants may be receiving alongside the study intervention. It includes recording the types of treatments, their frequencies, durations, and any changes during the study period.

  Immediately after the first use, Day 3, and Day 7

• Collection of Side Effects Using a Questionnaire

  This measure involves the daily recording of side effects experienced by participants. Side effects will be systematically documented each day, providing a comprehensive overview of the frequency and severity of adverse events throughout the study period. The number of patient with side effects will be notified

  Immediately after the first use, Day 3, and Day 7

Study Arms (3)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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.

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

common practices

NO INTERVENTION

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

Interventions

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

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

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

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• YSLab: lead

MeSH Terms

Conditions

Rhinitis; Sinusitis; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 12, 2024
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share