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

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ClinicalTrials.gov Identifier: NCT03975257
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Bitop AG

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.

Condition or disease Intervention/treatment Phase
Allergy Device: Medical Device: Ectoin Lozenge Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Application of Ectoin Lozenges (EHT02) in Patients With Oropharyngeal Allergic Symptoms
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Preventive application of EHT02
application of one Ectoin Lozenge before SLIT-initiation
Device: Medical Device: Ectoin Lozenge
Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use
Other Name: EHT02

Experimental: Therapeutic application of EHT02
application of one Ectoine Lozenge after SLIT-initiation
Device: Medical Device: Ectoin Lozenge
Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use
Other Name: EHT02

No Intervention: No application of EHT02
SLIT-Initiation without Ectoin Lozenge



Primary Outcome Measures :
  1. cumulative score of allergic symptoms of the lips evaluated by the patient [ Time Frame: 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)

  2. cumulative score of allergic symptoms of the mouth evaluated by the patient [ Time Frame: 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)

  3. cumulative score of allergic symptoms of the throat evaluated by the patient [ Time Frame: 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 Outcome Measures :
  1. Incidence of adverse events/serious adverse events [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975257


Contacts
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Contact: Carina Kolot +49-(0)231-98774418 kolot@bitop.de
Contact: Andreas Bilstein, Dr. +49-(0)231-98774440 bilstein@bitop.de

Locations
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Germany
Facharzt f. HNO-Heilkunde Recruiting
Aachen, Germany
Contact: Niklas Sondermann         
Fachärztin für Hals-Nasen-Ohrenheilkunde Recruiting
Bad Schönborn, Germany
Contact: Andrea Kienle-Gogolok         
Facharzt f. Dermatologie ruhrDerm GbR Recruiting
Bochum, Germany, 44803
Contact: Michael Ardabili         
Facharzt für Lungen- und Bronchialheilkunde Recruiting
Bonn, Germany, 53119
Contact: Thomas Ginko         
Facharzt für Haut und Geschlechtskrankheiten Recruiting
Gelsenkirchen, Germany
Contact: Sebastian Rotterdam         
Arzt für Hals-Nasen-Ohrenheilkunde, Allergologie, Umweltmedizin, Naturheilverfahren, Flugmedizin, Taucherarzt (GTÜM) Recruiting
Heidelberg, Germany
Contact: Andreas Horn         
Fachärztin f. HNO-Heilkunde, Allergologie Recruiting
Jülich, Germany, 52428
Contact: Martina Lenzenhuber         
Facharzt für Hals-Nasen-Ohrenheilkunde, Allergo GmbH Stuttgart, Klinische Prüfstelle Schorndorf Recruiting
Schorndorf, Germany
Contact: Rainer Reiber         
Sponsors and Collaborators
Bitop AG
Investigators
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Study Director: Andreas Bilstein, Dr. CSO

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Responsible Party: Bitop AG
ClinicalTrials.gov Identifier: NCT03975257     History of Changes
Other Study ID Numbers: btph-021-2018-EHT02
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No