Skip to main content
OpenTrials
Completed

NCT Number: NCT03943186

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Viral Pharyngitis Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

bitop AG

Dortmund, 44263, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ectoin Lozenges Honey Lemon

Device

application of Ectoin Lozenges (EHT02) in accordance with the instructions for use

Other names: EHT02

Hyaluronic Acid/Icelandic moss Lozenges

Device

application of the lozenges in accordance with the instructions for use

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study title

Non-interventional Study to Investigate the Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 9, 2019
Registry last updated
Jul 10, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.