NCT03975257

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

Application of Ectoin Lozenges (EHT02) in Patients With Oropharyngeal Allergic Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Bitop AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergy

Interventions

Type	Name	Description
DEVICE	Medical Device: Ectoin Lozenge	Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use

Timeline

• Start date: 2019-02-04
• Primary completion: 2019-09-12
• Completion: 2019-09-12
• First posted: 2019-06-05
• Last updated: 2019-12-10

Locations

8 sites across 1 country: Germany