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NCT Number: NCT02160912

Non Interventional Study (NIS) 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.

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Key information

Conditions

Acute Pharyngitis Acute Laryngitis Croup Laryngeal Diseases Laryngitis Otorhinolaryngologic Diseases Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HNO Praxis Aachen Brand, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 11, 2014
Registry last updated
Jan 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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