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

Bitop AG8 sites in 1 country95 target enrollmentFebruary 2014

ConditionsAcute Pharyngitis Acute Laryngitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Pharyngitis
Sponsor: Bitop AG
Enrollment: 95
Locations: 8
Primary Endpoint: Change in Pharyngitis symptom score evaluated by the physician
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

December 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bitop AG

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Pharyngitis symptom score evaluated by the physician

Time Frame: 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 Outcomes

Change in patient's general condition evaluated by the physician(Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
Change in Evaluation of the hoarseness(Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
Change in Dysphagia(Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
Change in efficacy evaluation by the physician(Visit 1, Visit 2 (after 3 days), Visit 3 (after 1 week))
Change in efficacy evaluation by the patient(Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
Change in Evaluation of the tolerability by the physician(Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)))
Change in number and type of adverse events(Visit 2 (after 3 days) Visit 3 (after 7 days))
Change in Evaluation of the tolerability by the patient(Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)))