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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pharyngitis; Acute Laryngitis

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Norbert Pasch-Facharzt für HNO Heilkunde
  • Aachen, Germany, 52078
    • HNO Praxis Aachen Brand
  • Duisburg, Germany, 47051
    • HNO Praxis Dr. Uta Thieme
  • Jülich, Germany, 52428
    • Dr. Lenzenhuber-Fachärztin für HNO Heilkunde
  • Jülich, Germany, 52428
    • Wilhelm Schütz -Facharzt für HNO Heilkunde
  • Köln, Germany, 50667
    • Taufik Shahab -Facharzt für HNO Heilkunde
  • Köln, Germany, 50933
    • Bey - Facharzt f. HNO Heilkunde
  • Köln, Germany, 50935
    • HNO-Praxis Peter Hinterkausen & Dr. med. Eva Bottler-Neufert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ectoin Mund- & Rachenspray; treatment with Ectoin Mund- & Rachenspray 1%
Emser Pastillen; treatment with Emser Pastillen

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Bitop AG
• Investigators: Principal Investigator: Ralph Mösges, MD, Klinikum der Universität zu Köln

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 4, 2014
• First Submitted That Met QC Criteria: June 10, 2014
• First Posted (Estimate): June 11, 2014

Study Record Updates

• Last Update Posted (Estimate): January 9, 2015
• Last Update Submitted That Met QC Criteria: January 8, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Pharyngitis; Laryngitis; Croup
• Other Study ID Numbers: EctMRS/aLR/2014