Allergy
Conditions
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.
Interventions
DEVICEMedical Device: Ectoin Lozenge
Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use
Sponsors
Bitop AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed