Ectoin Lozenges (EHT02) in the Treatment of Oropharyngeal Allergic Symptoms

Application of Ectoin Lozenges (EHT02) in Patients With Oropharyngeal Allergic Symptoms

The goal of this multicentric, prospective, randomised, controlled study (§23b German Act on Medical Devices (MPG)) is to investigate the efficacy of Ectoin Lozenges (EHT02) in treatment and prevention of oropharyngeal allergic symptoms.

Study Overview

• Status: Completed
• Conditions: Allergy
• Intervention / Treatment: Device: Medical Device: Ectoin Lozenge

Detailed Description

The immune system of humans can show an overreaction to proteins from the environment (allergic reaction). Triggers of these allergic reactions may be e.g. pollen, dust mites, mold or animal hair. Common allergic symptoms include itchy, stuffy, runny nose, sneezing, itchy and watery eyes and respiratory complaints. Allergen-specific immunotherapy is the only treatment that eliminates the causes of allergic disease. An example of such immunotherapies is the sublingual immunotherapy (SLIT). During SLIT, side effects may occur such as local oropharyngeal reactions, e.g. manifesting as itching, swelling or irritation.

The current study aims to investigate the efficacy of Ectoin Lozenges (EHT02) in patients suffering from oropharyngeal allergic symptoms. The symptoms are induced by SLIT.

Patients are dedicated to one of three groups: a) preventive application of Ectoin Lozenges before SLIT-initiation, b) therapeutic application of Ectoin Lozenges after SLIT-initiation or c) control: SLIT-initiation without application of Ectoin Lozenges.

The symptoms itching, swelling and irritation of mouth, lips and throat will be documented by the patients once 30 minutes after SLIT-initiation.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany
    • Facharzt f. HNO-Heilkunde
  • Bad Schönborn, Germany
    • Fachärztin für Hals-Nasen-Ohrenheilkunde
  • Bochum, Germany, 44803
    • Facharzt f. Dermatologie ruhrDerm GbR
  • Bonn, Germany, 53119
    • Facharzt für Lungen- und Bronchialheilkunde
  • Gelsenkirchen, Germany
    • Facharzt für Haut und Geschlechtskrankheiten
  • Heidelberg, Germany
    • Arzt für Hals-Nasen-Ohrenheilkunde, Allergologie, Umweltmedizin, Naturheilverfahren, Flugmedizin, Taucherarzt (GTÜM)
  • Jülich, Germany, 52428
    • Fachärztin f. HNO-Heilkunde, Allergologie
  • Schorndorf, Germany
    • Facharzt für Hals-Nasen-Ohrenheilkunde, Allergo GmbH Stuttgart, Klinische Prüfstelle Schorndorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• initiation of a SLIT
• minimum age of 18 years
• written consent of the patient

Exclusion criteria:

• Surgical Procedures in the mouth and throat region prior to the study
• patients with known intolerance to one of the substances used
• pregnant or breast-feeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preventive application of EHT02; application of one Ectoin Lozenge before SLIT-initiation	Device: Medical Device: Ectoin Lozenge; Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use; Other Names: EHT02
Experimental: Therapeutic application of EHT02; application of one Ectoine Lozenge after SLIT-initiation	Device: Medical Device: Ectoin Lozenge; Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use; Other Names: EHT02
No Intervention: No application of EHT02; SLIT-Initiation without Ectoin Lozenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulative score of allergic symptoms of the lips evaluated by the patient	about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the lips (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)	about 30 minutes after SLIT-initiation
cumulative score of allergic symptoms of the mouth evaluated by the patient	about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the mouth (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)	about 30 minutes after SLIT-initiation
cumulative score of allergic symptoms of the throat evaluated by the patient	about 30 minutes after SLIT-initiation patients will assess allergic symptoms of the throat (swelling, itching and irritation) on a 4 point scale (0=none to 3=severe)	about 30 minutes after SLIT-initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events/serious adverse events	All occurring adverse events/serious adverse events will be documented during the study.	through study visit (participation encompasses 1 visit of approx. 60 min duration)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): September 12, 2019
• Study Completion (Actual): September 12, 2019

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

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

More Information

Terms related to this study

• Other Study ID Numbers: btph-021-2018-EHT02

Drug and device information, study documents

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