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

Acute Pharyngitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160912
• Other study ID #: EctMRS/aLR/2014
• Status: Completed
• Phase: N/A
• First received: June 4, 2014
• Last updated: January 8, 2015
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Laryngitis
• Acute Pharyngitis
• Laryngitis
• Pharyngitis

Locations

Country	Name	City	State
Germany	HNO Praxis Aachen Brand	Aachen
Germany	Norbert Pasch-Facharzt für HNO Heilkunde	Aachen
Germany	HNo Praxis Dr. Uta Thieme	Duisburg
Germany	Dr. Lenzenhuber-Fachärztin für HNO Heilkunde	Jülich
Germany	Wilhelm Schütz -Facharzt für HNO Heilkunde	Jülich
Germany	Bey - Facharzt f. HNO Heilkunde	Köln
Germany	HNO-Praxis Peter Hinterkausen & Dr. med. Eva Bottler-Neufert	Köln
Germany	Taufik Shahab -Facharzt für HNO Heilkunde	Köln

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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))	Yes
Secondary	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))	Yes
Secondary	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)	Yes