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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:
Sponsor: Bitop AG

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in patient's general condition evaluated by the physician [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Visit 2 (after 3 days) Visit 3 (after 7 days) ]
    incidence of adverse events and correlation with the therapy


Original Secondary Outcome: Same as current

Information By: Bitop AG

Dates:
Date Received: June 4, 2014
Date Started: February 2014
Date Completion:
Last Updated: January 8, 2015
Last Verified: January 2015