Allergy Clinical Trial
Official title:
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.
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.
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