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NCT Number: NCT06498843

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

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.

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Key information

Conditions

Rhinitis Colds Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Sinusitis Upper Respiratory Infections

Age range

3 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other
  • pump spray group : people with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis, and other upper respiratory infections/conditions).
  • 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
  • pump spray group : people with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis and other upper respiratory infections/conditions).
  • sprays per nostril, at least 2 times a day up to 6 times a day. For 7 days

Primary outcomes

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

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

    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.

  2. Clinical global impression using a scale

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

    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).

  3. Patient global impression using a scale

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

    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.

  4. Questionnaire on subject's satisfaction and use of devices

    Time frame: Day 7

    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.

  5. Concomitant treatments using a questionnaire

    Time frame: Immediately after the first use, Day 3, and Day 7

    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.

  6. Collection of Side Effects Using a Questionnaire

    Time frame: Immediately after the first use, Day 3, and Day 7

    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

Sponsors and collaborators

Lead sponsor

YSLab

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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