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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preventive application of EHT02 | Experimental | application of one Ectoin Lozenge before SLIT-initiation |
|
| Therapeutic application of EHT02 | Experimental | application of one Ectoine Lozenge after SLIT-initiation |
|
| No application of EHT02 | No Intervention | SLIT-Initiation without Ectoin Lozenge |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Device: Ectoin Lozenge | Device | Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use |
|
| 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 |
| 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) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Bilstein, Dr. | CSO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facharzt f. HNO-Heilkunde | Aachen | Germany | ||||
| Fachärztin für Hals-Nasen-Ohrenheilkunde |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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|
| Bad Schönborn |
| Germany |
| Facharzt f. Dermatologie ruhrDerm GbR | Bochum | 44803 | Germany |
| Facharzt für Lungen- und Bronchialheilkunde | Bonn | 53119 | 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 | 52428 | Germany |
| Facharzt für Hals-Nasen-Ohrenheilkunde, Allergo GmbH Stuttgart, Klinische Prüfstelle Schorndorf | Schorndorf | Germany |