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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02160912
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
Bitop AG

Study Description
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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.


Condition or disease
Acute Pharyngitis Acute Laryngitis

Study Design
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Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Non Interventional Study Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis
Study Start Date : February 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Croup Sore Throat

Groups and Cohorts
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Group/Cohort
Ectoin Mund- & Rachenspray
treatment with Ectoin Mund- & Rachenspray 1%
Emser Pastillen
treatment with Emser Pastillen


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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


Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160912


Locations
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Germany
Norbert Pasch-Facharzt für HNO Heilkunde
Aachen, Germany, 52074
HNO Praxis Aachen Brand
Aachen, Germany, 52078
HNo Praxis Dr. Uta Thieme
Duisburg, Germany, 47051
Dr. Lenzenhuber-Fachärztin für HNO Heilkunde
Jülich, Germany, 52428
Wilhelm Schütz -Facharzt für HNO Heilkunde
Jülich, Germany, 52428
Taufik Shahab -Facharzt für HNO Heilkunde
Köln, Germany, 50667
Bey - Facharzt f. HNO Heilkunde
Köln, Germany, 50933
HNO-Praxis Peter Hinterkausen & Dr. med. Eva Bottler-Neufert
Köln, Germany, 50935
Sponsors and Collaborators
Bitop AG
Investigators
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Principal Investigator: Ralph Mösges, MD Klinikum der Universität zu Köln
More Information
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Responsible Party: Bitop AG
ClinicalTrials.gov Identifier: NCT02160912    
Other Study ID Numbers: EctMRS/aLR/2014
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Pharyngitis
Laryngitis
Croup
Respiratory Tract Infections
Infections
 Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Laryngeal Diseases