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

Completed

• Conditions: Acute Viral Pharyngitis
• Interventions: Device: Ectoin Lozenges Honey Lemon; Device: Hyaluronic Acid/Icelandic moss Lozenges

• Registration Number: NCT03943186
• Lead Sponsor: Bitop AG

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.

Study Timeline

• Study Start: 2018-12-13
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Primary Completion: 2019-05-13
• Study Completion: 2019-05-13
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ectoin Lozenges Honey Lemon	Ectoin Lozenges Honey Lemon	application of 1 Lozenge every three hours or as often as required, not more than 10 lozenges per day
Hyaluronic acid/Icelandic moss Lozenges	Hyaluronic Acid/Icelandic moss Lozenges	application as often as required, not more than 6 lozenges per day

Primary Outcome Measures

Name	Time	Method
Change in Pharyngitis symptom score evaluated by the physician	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

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

Trial Locations

Locations (1)

bitop AG; 🇩🇪 Dortmund, Germany