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