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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use
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
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)
Time frame: 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)
Time frame: 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)
Time frame: about 30 minutes after SLIT-initiation
Incidence of adverse events/serious adverse events
All occurring adverse events/serious adverse events will be documented during the study.
Time frame: through study visit (participation encompasses 1 visit of approx. 60 min duration)
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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, Germany