Skip to main content
OpenTrials
Completed

NCT Number: NCT03975257

Ectoin Lozenges (EHT02) in the Treatment of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facharzt f. HNO-Heilkunde, Aachen, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Device: Ectoin Lozenge

Device

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

Other names: EHT02

Primary outcomes

  1. cumulative score of allergic symptoms of the lips evaluated by the patient

    Time frame: about 30 minutes after SLIT-initiation

    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)

  2. cumulative score of allergic symptoms of the mouth evaluated by the patient

    Time frame: about 30 minutes after SLIT-initiation

    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)

  3. cumulative score of allergic symptoms of the throat evaluated by the patient

    Time frame: about 30 minutes after SLIT-initiation

    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)

Secondary outcomes

  1. Incidence of adverse events/serious adverse events

    Time frame: through study visit (participation encompasses 1 visit of approx. 60 min duration)

    All occurring adverse events/serious adverse events will be documented during the study.

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 5, 2019
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.