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A chronic irritation of the nasal mucosa can be painful and unpleasant for the individual. Dry nasal mucosa with scabs is a common problem but not everyone seeks care. The causes can be several such as staying for long periods in dry and dusty air, hot rooms or hot environments, tobacco smoke, side effects of drugs and mechanical irritation (nasal congestion). The nasal spray contains salic acid (neuraminic acid). This substance is found naturally in humans in the nasal mucosa which keeps it moist. Salic acid is also found, for example, in breast milk and is also found in food production. Previous studies have shown that treatment with salic acid is gentle, relieves symptoms and has a soothing and moisturising effect.
The purpose of the study is to evaluate whether the symptoms of dry nose can be improved with treatment with Viiral®Nasal spray and have a soothing and moisturising effect. The treatment also aims to prevent colds caused by viruses.
As a control product in the study, a nasal spray with isotonic saline solution will be used. In this study, a total of 78 women and men who have been diagnosed with dry nose / rhinitis sicca will be included in the study. After the participants have given their consent to participate in the study, treatment with the study product or control product will begin. The treatment is started by the study participants themselves at home. Two thirds will be treated with the study product and one third will be treated with a control product. Clinic visits will be performed at three occasions after the screening/baseline visit, at day 14, day 28 and on day 56.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viiral® Nasal Spray group | Experimental | The nasal spray to be administrated twice daily for 8 weeks. |
|
| Isotonic Saline Nasal Spray | Active Comparator | The nasal spray to be administrated twice daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sialic acid nasal spray | Device | The nasal spray will be self administered twice daily for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rhinitis Sicca Symptom Score (RSSS) | RSSS score constitutes of the sum of ten (10) individual symptoms. Each symptom assessed on 5-point scale (0 = none, 1 = mild, 2 = moderated, 3 = strong, 4 = very strong).
| Up to 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal spray sensory scale (NSSS) | Tolerability examination, sensory perception of the spray. Parameters to be answered using visual analog scale (VAS 0 = worst grading - 100 = best grading)
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitetssjukhuset, Avdelning för kliniska prövningar | Örebro | Region Örebro | 701 85 | Sweden | ||
| Cordinator Medical Service AB |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 20, 2023 | |
| Reset | Mar 22, 2024 |
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Subjects will be randomised in proportions 2:1, Viiral® Nasal Spray group: Isotonic Saline Nasal Spray group. Block randomisation will be performed with varying block sizes. Numbered randomisation envelopes containing cards with code numbers will be prepared.
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| Isotonic Saline Nasal Spray | Device | The nasal spray will be self administered twice daily for 8 weeks. |
|
| Up to 8 weeks. |
| Short Form 12 (SF-12) | SF-12 is a health-related quality of life questionnaire consisting of twelve questions that measure functional health and well-being form the subject's point of view. | Up to 8 weeks. |
| Endoscopy score of the nasal cavity (ES) | Changes of the nasal mucosa using a 3-point scale (0 = no, 1 = mild, 2 = severe).
| Up to 8 weeks. |
| Episodes of common cold/sick days | The total number of common cold episodes and episodes days. | Up to 8 weeks. |
| Linköping |
| Region Östergötland |
| 58 758 |
| Sweden |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 20, 2023 | Mar 22, 2024 |