Clinical trial NCT03943186: Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.
Official title: Non-interventional Study to Investigate the Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Viral Pharyngitis
Keywords: non-interventional study
Ectoin
Lozenges
Pharyngitis
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2019-05-09
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with acute viral pharyngitis

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.

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

Primary outcomes:
measure: Change in Pharyngitis symptom score evaluated by the physician
timeFrame: day 1 and day 7
Secondary outcomes:
measure: Change in Pharyngitis Symptoms evaluated in patient's diaries
timeFrame: 7 days
measure: Change of Saliva production evaluated by the physician
timeFrame: day 7
measure: Evaluation how efficient the treatment is judged by physician
timeFrame: day 7
measure: Evaluation how efficient the treatment is judged by patient
timeFrame: 7 days
measure: Evaluation how treatment is tolerated (judged by physician)
timeFrame: day 7
measure: Evaluation how treatment is tolerated (judged by patients)
timeFrame: 7 days
measure: Evaluation of compliance evaluated by physician
timeFrame: day 7
measure: Incidence of adverse events/serious adverse events
timeFrame: 7 days
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: bitop AG
Study officials:
affiliation: CSO
name: Andreas Bilstein, Dr
role: STUDY_DIRECTOR
References: