Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis

Study Overview
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Brief Summary
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This a comparative, open label, parallel group, non interventional study which compares the tolerability and influence of Ectoin containing Lozenges to saline solution and lozenges containing hyaluronic acid for the treatment of acute viral Pharyngitis. The observation takes place over a period of 7 days. Response to treatment is recorded at day 1 and day 7 by the physician and by the patient in a dairy.

Official Title
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Non Interventional Clinical Investigation of Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis

Conditions
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Acute Viral Pharyngitis

Intervention / Treatment
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* Device: Medical devices
* Device: traditional household remedy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute Pharyngitis according to instruction for use Female or male individuals ≥ 18 years Agreement to abide by the routinely provided doctor's appointment for follow- up (reflected in the planned visits of observation plan resist) Exclusion Criteria: Contraindications according to instructions for use Male or female person under 18 years Sore throat for more than 5 days Any disease that can, in the opinion of the treating physician to affect the outcome of the study. Patients with known intolerance to one of the substances used Surgical procedures to the mouth and throat in the last 6 weeks before inclusion in the NIS Bacterial Pharyngitis Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ectoin containing Lozenges<br>treatment with Ectoin containing lozenges | Device: Medical devices<br> <br> |
| Hyaluronic acid containing lozenges<br>treatment with hyaluronic acid containing lozenges | Device: Medical devices<br> <br> |
| Saline solution for gargling<br>Subjects in were requested to gargle with salt water | Device: traditional household remedy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pharyngitis symptom score evaluated by the physician | The intensity of the symptoms and signs will be graded on a continuous numeric scale, i.e. absent-0, severe-10. The following signs and symptoms will be documented: pain on swallowing tickle in the throat hoarseness dry mouth and throat burning of throat patient´s General condition reddening of the oropharynx reddening of the larynx | day 1 and day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pharyngitis symptoms evaluated on patient´s diaries | The intensity of the symptoms and signs will be graded on a continuous numeric scale, i.e. absent-0, severe-10. The following signs and symptoms will be documented: pain on swallowing tickle in the throat hoarseness dry mouth and throat burning of throat patient´s General condition | 7 days | 
| Change in patient´s General condition evaluated by the physician |  | day 1 and day 7 | 
| Patient´s Evaluation of tolerability | Assessment of tolerability on a numeric scale (bad-0; very good-10) | 7 days | 
| physician´s Evaluation of tolerability | Assessment of tolerability on a numeric scale (bad-0; very good-10) | day 7 | 
| Change in number and type of adverse Events | Incidence of adverse Events and correlations with the therapy | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharyngitis, Non interventional study, Ectoin, Lozenges