Clinical trial NCT03975257: Ectoin Lozenges (EHT02) in the Treatment of Oropharyngeal Allergic Symptoms
Official title: Application of Ectoin Lozenges (EHT02) in Patients With Oropharyngeal Allergic Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2019-06-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: cumulative score of allergic symptoms of the lips evaluated by the patient
timeFrame: about 30 minutes after SLIT-initiation
measure: cumulative score of allergic symptoms of the mouth evaluated by the patient
timeFrame: about 30 minutes after SLIT-initiation
measure: cumulative score of allergic symptoms of the throat evaluated by the patient
timeFrame: about 30 minutes after SLIT-initiation
Secondary outcomes:
measure: Incidence of adverse events/serious adverse events
timeFrame: through study visit (participation encompasses 1 visit of approx. 60 min duration)
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Facharzt f. HNO-Heilkunde
city: Bad Schönborn
country: Germany
facility: Fachärztin für Hals-Nasen-Ohrenheilkunde
city: Bochum
country: Germany
facility: Facharzt f. Dermatologie ruhrDerm GbR
city: Bonn
country: Germany
facility: Facharzt für Lungen- und Bronchialheilkunde
city: Gelsenkirchen
country: Germany
facility: Facharzt für Haut und Geschlechtskrankheiten
city: Heidelberg
country: Germany
facility: Arzt für Hals-Nasen-Ohrenheilkunde, Allergologie, Umweltmedizin, Naturheilverfahren, Flugmedizin, Taucherarzt (GTÜM)
city: Jülich
country: Germany
facility: Fachärztin f. HNO-Heilkunde, Allergologie
city: Schorndorf
country: Germany
facility: Facharzt für Hals-Nasen-Ohrenheilkunde, Allergo GmbH Stuttgart, Klinische Prüfstelle Schorndorf
Study officials:
affiliation: CSO
name: Andreas Bilstein, Dr.
role: STUDY_DIRECTOR
References: