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

Study Overview
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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.

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

Conditions
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Allergy

Intervention / Treatment
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* Device: Medical Device: Ectoin Lozenge


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) |