Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis

Non Interventional Clinical Investigation of Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis

This a comparative, open label, parallel group, non interventional study which compares the tolerability and influence of Ectoin containing Lozenges to saline solution and lozenges containing hyaluronic acid for the treatment of acute viral Pharyngitis. The observation takes place over a period of 7 days. Response to treatment is recorded at day 1 and day 7 by the physician and by the patient in a dairy.

Study Overview

• Status: Completed
• Conditions: Acute Viral Pharyngitis
• Intervention / Treatment: Device: Medical devices; Device: traditional household remedy

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10452
    • HNO-Praxis Mahlstedt
  • Elmshorn, Germany, 25337
    • HNO-Praxis Elmshorn
  • Lüneburg, Germany, 21335
    • HNO-Praxis Möller
  • Norderstedt, Germany, 22846
    • HNO-Praxis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with viral pharyngitis

Description

Inclusion Criteria:

• Patients with acute Pharyngitis according to instruction for use
• Female or male individuals ≥ 18 years
• Agreement to abide by the routinely provided doctor's appointment for follow- up (reflected in the planned visits of observation plan resist)

Exclusion Criteria:

• Contraindications according to instructions for use
• Male or female person under 18 years
• Sore throat for more than 5 days
• Any disease that can, in the opinion of the treating physician to affect the outcome of the study.
• Patients with known intolerance to one of the substances used
• Surgical procedures to the mouth and throat in the last 6 weeks before inclusion in the NIS
• Bacterial Pharyngitis
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ectoin containing Lozenges; treatment with Ectoin containing lozenges	Device: Medical devices
Hyaluronic acid containing lozenges; treatment with hyaluronic acid containing lozenges	Device: Medical devices
Saline solution for gargling; Subjects in were requested to gargle with salt water	Device: traditional household remedy

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 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; tickle in the throat; hoarseness; dry mouth and throat; burning of throat; patient´s General condition; reddening of the oropharynx; reddening of the larynx	day 1 and day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pharyngitis symptoms evaluated on 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; tickle in the throat; hoarseness; dry mouth and throat; burning of throat; patient´s General condition	7 days
Change in patient´s General condition evaluated by the physician		day 1 and day 7
Patient´s Evaluation of tolerability	Assessment of tolerability on a numeric scale (bad-0; very good-10)	7 days
physician´s Evaluation of tolerability	Assessment of tolerability on a numeric scale (bad-0; very good-10)	day 7
Change in number and type of adverse Events	Incidence of adverse Events and correlations with the therapy	7 days

Collaborators and Investigators

• Sponsor: Bitop AG
• Investigators: Principal Investigator: Uwe Sonnemann, MD, HNO-Praxis

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: January 27, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Estimate): June 21, 2016
• Last Update Submitted That Met QC Criteria: June 20, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: pharyngitis; Ectoin; Non interventional study; Lozenges
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis
• Other Study ID Numbers: 2016/EHT/NIS