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

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03975257
• Other study ID #: btph-021-2018-EHT02
• Status: Completed
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: September 12, 2019

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 12, 2019
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergy

Intervention

Device:
• Medical Device: Ectoin Lozenge
Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)