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

Non-interventional Study to Investigate the 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.

Study Overview

• Status: Completed
• Conditions: Acute Viral Pharyngitis
• Intervention / Treatment: Device: Ectoin Lozenges Honey Lemon; Device: Hyaluronic Acid/Icelandic moss Lozenges

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 Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Germany
  • Dortmund, Germany, 44263
    • bitop AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with acute viral pharyngitis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ectoin Lozenges Honey Lemon; application of 1 Lozenge every three hours or as often as required, not more than 10 lozenges per day	Device: Ectoin Lozenges Honey Lemon; application of Ectoin Lozenges (EHT02) in accordance with the instructions for use; Other Names: EHT02
Hyaluronic acid/Icelandic moss Lozenges; application as often as required, not more than 6 lozenges per day	Device: Hyaluronic Acid/Icelandic moss Lozenges; application of the lozenges in accordance with the instructions for use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bitop AG
• Investigators: Study Director: Andreas Bilstein, Dr, CSO

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Actual): May 13, 2019
• Study Completion (Actual): May 13, 2019

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: non-interventional study; Ectoin; Pharyngitis; Lozenges
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: btph-014-2018-EHT02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No