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Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.

  • Clinicaltrials.gov identifier

    NCT03943186

  • Recruitment Status

    Completed

  • First Posted

    May 9, 2019

  • Last update posted

    July 10, 2019

Study Description

Brief summary:

The goal of this non-interventional study is to investigate the safety, efficacy and tolerability of Ectoin Lozenges Honey Lemon (EHT02) compared to lozenges containing hyaluronic acid and islandic moss in the treatment of acute viral pharyngitis.

  • Condition or Disease:Acute Viral Pharyngitis
  • Intervention/Treatment: Device: Ectoin Lozenges Honey Lemon
    Device: Hyaluronic Acid/Icelandic moss Lozenges
  • Phase: N/A

Detailed Description

The current non-interventional study aims to investigate the efficacy and tolerability of Ectoin Lozenges Honey Lemon in patients suffering from acute viral pharyngitis. Participants receive treatments as part of routine medical care, and participants can choose one of two treatment options: a) Ectoin Lozenges Honey Lemon or b) lozenges containing hyaluronic acid and icelandic moss. Efficacy will be studied by documentation of the following symptoms: - pain on swallowing - hoarseness - urge to cough - dry mouth and throat - redness of oropharynx and larynx - sore throat - impairment of free breathing - general feeling of illness In parallel, participating patients will document their symptoms over the entire study duration in patient diaries. The observation takes place over a period of seven days.

Study Design

  • Study Type: Observational
  • Actual Enrollment: 102 participants
  • Observational Model: Other
  • Time Perspective: Prospective
  • Official Title: Non-interventional Study to Investigate the Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.
  • Actual Study Start Date: December 2018
  • Actual Primary Completion Date: May 2019
  • Actual Study Completion Date: May 2019

Groups and Cohorts

Groups/Cohorts Intervention/treatment
: Ectoin Lozenges Honey Lemon
application of 1 Lozenge every three hours or as often as required, not more than 10 lozenges per day
Device: Ectoin Lozenges Honey Lemon
application of Ectoin Lozenges (EHT02) in accordance with the instructions for use
: Hyaluronic acid/Icelandic moss Lozenges
application as often as required, not more than 6 lozenges per day
Device: Hyaluronic Acid/Icelandic moss Lozenges
application of the lozenges in accordance with the instructions for use

Outcome Measures

  • Primary Outcome Measures: 1. Change in Pharyngitis symptom score evaluated by the physician [ Time Frame: day 1 and day 7 ]
    The intensity of the symptoms will be graded on a continuous numeric scale, i.e. absent-0, severe-10. The following signs and symptoms will be documented: pain on swallowing hoarseness urge to cough dry mouth and throat reddening of oropharynx reddening of larynx sore throat impairment of free breathing patient's general condition
  • Secondary Outcome Measures: 1. Change in Pharyngitis Symptoms evaluated in patient's diaries [ Time Frame: 7 days ]
    The intensity of the symptoms and signs will be graded on a continuous numeric scale, i.e. absent-0, severe-10. The following signs and symptoms will be documented: pain on swallowing hoarseness urge to cough dry mouth and throat sore throat impairment of free breathing patient's general condition
  • 2. Change of Saliva production evaluated by the physician [ Time Frame: day 7 ]
    Assessment on a continuous numeric scale (0-no, 10-yes)
  • 3. Evaluation how efficient the treatment is judged by physician [ Time Frame: day 7 ]
    Assessment on a continuous numeric scale (0-bad, 10-very good)
  • 4. Evaluation how efficient the treatment is judged by patient [ Time Frame: 7 days ]
    Assessment on a continuous numeric scale (0-bad, 10-very good)
  • 5. Evaluation how treatment is tolerated (judged by physician) [ Time Frame: day 7 ]
    Assessment on a continuous numeric scale (0-bad, 10-very good)
  • 6. Evaluation how treatment is tolerated (judged by patients) [ Time Frame: 7 days ]
    Assessment on a continuous numeric scale (0-bad, 10-very good)
  • 7. Evaluation of compliance evaluated by physician [ Time Frame: day 7 ]
    Assessment on a continuous numeric scale (0-bad, 10-very good)
  • 8. Incidence of adverse events/serious adverse events [ Time Frame: 7 days ]
    All occuring adverse events/serious adverse events will be documented during the entire study period.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: patients diagnosed with acute viral pharyngitis

Criteria

Inclusion Criteria:

- patients with acute viral pharyngitis

Exclusion Criteria:

- patients with known intolerance to one of the substances used

- Pregnancy

- Surgical Procedures in the mouth and throat region prior to the study

- Bacterial Pharyngitis

- symptoms in the throat since more than 5 days

- Contraindications according to the instructions for use

Contacts and Locations

Contacts

Locations

Germany
bitop AG
Dortmund

Sponsors and Collaborators

Bitop AG

Investigators

Study Director: Andreas Bilstein, Dr CSO

More Information

  • Responsible Party: Bitop AG
  • ClinicalTrials.gov Identifier: NCT03943186 History of Changes
  • Other Study ID Numbers: btph-014-2018-EHT02
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: July 10, 2019
  • Last Verified: July 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bitop AG: Pharyngitis
    non-interventional study
    Lozenges
    Ectoin
  • Additional relevant MeSH terms: Pharyngitis