Ectoin Lozenges (EHT02) in the Treatment of Oropharyngeal Allergic Symptoms

Bitop

Status: Completed

Conditions: Allergy

Treatments: Device: Medical Device: Ectoin Lozenge

Study type: Interventional

Funder types: Industry

Identifiers

NCT03975257

btph-021-2018-EHT02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Preventive application of EHT02

Experimental group

Description:

application of one Ectoin Lozenge before SLIT-initiation

Treatment:

Device: Medical Device: Ectoin Lozenge

Therapeutic application of EHT02

Experimental group

Description:

application of one Ectoine Lozenge after SLIT-initiation

Treatment:

Device: Medical Device: Ectoin Lozenge

No application of EHT02

No Intervention group

Description:

SLIT-Initiation without Ectoin Lozenge