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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| administration of an isotonic seawater solution (9g/L) in the nose | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| administration of a hypertonic seawater solution (21g/L) in the nose | Other |
|
|
| 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 |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D012852 | Sinusitis |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010254 | Paranasal Sinus Diseases |
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