Non-interventional Study to Investigate the Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Viral Pharyngitis
- Sponsor
- Bitop AG
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Change in Pharyngitis symptom score evaluated by the physician
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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
- Evaluation how efficient the treatment is judged by physician(day 7)
- Change of Saliva production evaluated by the physician(day 7)
- Evaluation how treatment is tolerated (judged by patients)(7 days)
- Evaluation of compliance evaluated by physician(day 7)
- Change in Pharyngitis Symptoms evaluated in patient's diaries(7 days)
- Evaluation how treatment is tolerated (judged by physician)(day 7)
- Incidence of adverse events/serious adverse events(7 days)
- Evaluation how efficient the treatment is judged by patient(7 days)