Ectoin Lozenges (EHT02) in the Treatment of Oropharyngeal Allergic Symptoms
- Conditions
- Allergy
- Registration Number
- NCT03975257
- Lead Sponsor
- Bitop AG
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method cumulative score of allergic symptoms of the lips evaluated by the patient 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)
cumulative score of allergic symptoms of the mouth evaluated by the patient 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)
cumulative score of allergic symptoms of the throat evaluated by the patient 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 Outcome Measures
Name Time Method Incidence of adverse events/serious adverse events 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.
Trial Locations
- Locations (8)
Fachärztin für Hals-Nasen-Ohrenheilkunde
🇩🇪Bad Schönborn, Germany
Facharzt f. HNO-Heilkunde
🇩🇪Aachen, Germany
Facharzt f. Dermatologie ruhrDerm GbR
🇩🇪Bochum, Germany
Facharzt für Lungen- und Bronchialheilkunde
🇩🇪Bonn, Germany
Facharzt für Haut und Geschlechtskrankheiten
🇩🇪Gelsenkirchen, Germany
Arzt für Hals-Nasen-Ohrenheilkunde, Allergologie, Umweltmedizin, Naturheilverfahren, Flugmedizin, Taucherarzt (GTÜM)
🇩🇪Heidelberg, Germany
Facharzt für Hals-Nasen-Ohrenheilkunde, Allergo GmbH Stuttgart, Klinische Prüfstelle Schorndorf
🇩🇪Schorndorf, Germany
Fachärztin f. HNO-Heilkunde, Allergologie
🇩🇪Jülich, Germany