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

NCT ID: NCT03975257

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-04

Study Completion Date

2019-09-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preventive application of EHT02

application of one Ectoin Lozenge before SLIT-initiation

Group Type EXPERIMENTAL

Medical Device: Ectoin Lozenge

Intervention Type DEVICE

Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use

Therapeutic application of EHT02

application of one Ectoine Lozenge after SLIT-initiation

Group Type EXPERIMENTAL

Medical Device: Ectoin Lozenge

Intervention Type DEVICE

Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use

No application of EHT02

SLIT-Initiation without Ectoin Lozenge

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Medical Device: Ectoin Lozenge

Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use

Intervention Type DEVICE

Other Intervention Names

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EHT02

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bitop AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Bilstein, Dr.

Role: STUDY_DIRECTOR

CSO

Locations

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Facharzt f. HNO-Heilkunde

Aachen, , Germany

Site Status

Fachärztin für Hals-Nasen-Ohrenheilkunde

Bad Schönborn, , Germany

Site Status

Facharzt f. Dermatologie ruhrDerm GbR

Bochum, , Germany

Site Status

Facharzt für Lungen- und Bronchialheilkunde

Bonn, , Germany

Site Status

Facharzt für Haut und Geschlechtskrankheiten

Gelsenkirchen, , Germany

Site Status

Arzt für Hals-Nasen-Ohrenheilkunde, Allergologie, Umweltmedizin, Naturheilverfahren, Flugmedizin, Taucherarzt (GTÜM)

Heidelberg, , Germany

Site Status

Fachärztin f. HNO-Heilkunde, Allergologie

Jülich, , Germany

Site Status

Facharzt für Hals-Nasen-Ohrenheilkunde, Allergo GmbH Stuttgart, Klinische Prüfstelle Schorndorf

Schorndorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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btph-021-2018-EHT02

Identifier Type: -

Identifier Source: org_study_id