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

Acute Viral Pharyngitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943186
• Other study ID #: btph-014-2018-EHT02
• Status: Completed
• Start date: December 13, 2018
• Est. completion date: May 13, 2019

Study information

• Verified date: July 2019
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 13, 2019
• Est. primary completion date: May 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Viral Pharyngitis
• Pharyngitis

Intervention

Device:
• Ectoin Lozenges Honey Lemon
application of Ectoin Lozenges (EHT02) in accordance with the instructions for use
• Hyaluronic Acid/Icelandic moss Lozenges
application of the lozenges in accordance with the instructions for use

Locations

Country	Name	City	State
Germany	bitop AG	Dortmund

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pharyngitis symptom score evaluated by the physician	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	day 1 and day 7
Secondary	Change in Pharyngitis Symptoms evaluated in patient's diaries	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	7 days
Secondary	Change of Saliva production evaluated by the physician	Assessment on a continuous numeric scale (0-no, 10-yes)	day 7
Secondary	Evaluation how efficient the treatment is judged by physician	Assessment on a continuous numeric scale (0-bad, 10-very good)	day 7
Secondary	Evaluation how efficient the treatment is judged by patient	Assessment on a continuous numeric scale (0-bad, 10-very good)	7 days
Secondary	Evaluation how treatment is tolerated (judged by physician)	Assessment on a continuous numeric scale (0-bad, 10-very good)	day 7
Secondary	Evaluation how treatment is tolerated (judged by patients)	Assessment on a continuous numeric scale (0-bad, 10-very good)	7 days
Secondary	Evaluation of compliance evaluated by physician	Assessment on a continuous numeric scale (0-bad, 10-very good)	day 7
Secondary	Incidence of adverse events/serious adverse events	All occuring adverse events/serious adverse events will be documented during the entire study period.	7 days