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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ectoin Mund- & Rachenspray | treatment with Ectoin Mund- & Rachenspray 1% | ||
| Emser Pastillen | treatment with Emser Pastillen |
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| 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):
| Visit 1, Visit 2 (after 3 days), Visite 3 (after 7 days) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care unit In this non interventional study the therapy process of a total of 90 patients with acute pharyngitis and/or laryngitis for which the physician has planned a therapy with Ectoin Mund- & Rachenspray 1% (60 Patients) or Emser Pastillen (30 patients) shall be observed in 8 clinical centers
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Mösges, MD | Klinikum der Universität zu Köln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norbert Pasch-Facharzt für HNO Heilkunde | Aachen | 52074 | Germany | |||
| HNO Praxis Aachen Brand |
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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) |
| Aachen |
| 52078 |
| Germany |
| Taufik Shahab -Facharzt für HNO Heilkunde | Cologne | 50667 | Germany |
| Bey - Facharzt f. HNO Heilkunde | Cologne | 50933 | Germany |
| HNO-Praxis Peter Hinterkausen & Dr. med. Eva Bottler-Neufert | Cologne | 50935 | Germany |
| HNo Praxis Dr. Uta Thieme | Duisburg | 47051 | Germany |
| Dr. Lenzenhuber-Fachärztin für HNO Heilkunde | Jülich | 52428 | Germany |
| Wilhelm Schütz -Facharzt für HNO Heilkunde | Jülich | 52428 | Germany |
| ID | Term |
|---|---|
| D003440 | Croup |
| ID | Term |
|---|---|
| D007827 | Laryngitis |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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