Non Interventional Study (NIS) Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis

Study Overview
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Brief Summary
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In this observational study insights regarding the tolerability and influence on the quality of life of the topical treatment Ectoin Mund- and Rachenspray compared to Emser Pastillen in patients with acute Pharyngitis/ Laryngitis under real life conditions shall be gained. Patients are treated with Ectoin Mund- & Rachenspray 1% or Emser Pastillen according to the demands of the physician and the instructions for use.

Official Title
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Non Interventional Study Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis

Conditions
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Acute Pharyngitis, Acute Laryngitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute Laryngitis and/or Pharyngitis which are already treated with Ectoin Mund- & Rachenspray 1% or Emser Pastillen Exclusion Criteria: contraindications according to instructions for use

Ages Eligible for Study
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Minimum Age: 6 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 Mund- & Rachenspray<br>treatment with Ectoin Mund- & Rachenspray 1% | |
| Emser Pastillen<br>treatment with Emser Pastillen | |

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 | Assessment of the symptoms of pharyngitis on a 4 point scale (none, mild, moderate strong): swollen palatine tonsils swollen lymph nodes in the throat fever cough | Visit 1, Visit 2 (after 3 days), Visite 3 (after 7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient's general condition evaluated by the physician | Physician's assessment of the general conditions on a 4 point scale (good condition, slightly reduced condition, bad condition, very bad condition) | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days) | 
| Change in Evaluation of the hoarseness | physician's assessment of the hoarseness of the patient on a 4 point scale (none, mild, moderate, strong) | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days) | 
| Change in Dysphagia | physician's assessment of dysphagia of the patient on a 4 point scale (none, mild, moderate, strong) | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days) | 
| Change in efficacy evaluation by the physician | Assessment of the efficacy on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good) | Visit 1, Visit 2 (after 3 days), Visit 3 (after 1 week) | 
| Change in efficacy evaluation by the patient | Assessment of the efficacy on a 4 point scale (0_bad, 1=sufficient, 2=good, 3=very good) | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days) | 
| Change in Evaluation of the tolerability by the physician | Assessment of the tolerability by the physician on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good) | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)) | 
| Change in Evaluation of the tolerability by the patient | Assessment of the tolerability by the patient on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good) | Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)) | 
| Change in number and type of adverse events | incidence of adverse events and correlation with the therapy | Visit 2 (after 3 days) Visit 3 (after 7 days) |