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

Completed

• Conditions: Acute Laryngitis; Acute Pharyngitis

• Registration Number: NCT02160912
• Lead Sponsor: Bitop AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-11
• Primary Completion: 2014-07
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-08
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Pharyngitis symptom score evaluated by the physician	Visit 1, Visit 2 (after 3 days), Visite 3 (after 7 days)	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

Secondary Outcome Measures

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

Trial Locations

Locations (8)

HNO Praxis Aachen Brand; 🇩🇪 Aachen, Germany

Bey - Facharzt f. HNO Heilkunde; 🇩🇪 Köln, Germany

HNo Praxis Dr. Uta Thieme; 🇩🇪 Duisburg, Germany

Wilhelm Schütz -Facharzt für HNO Heilkunde; 🇩🇪 Jülich, Germany

Taufik Shahab -Facharzt für HNO Heilkunde; 🇩🇪 Köln, Germany

Norbert Pasch-Facharzt für HNO Heilkunde; 🇩🇪 Aachen, Germany

Dr. Lenzenhuber-Fachärztin für HNO Heilkunde; 🇩🇪 Jülich, Germany

HNO-Praxis Peter Hinterkausen & Dr. med. Eva Bottler-Neufert; 🇩🇪 Köln, Germany