Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-03-01 @ 8:56 PM
Study NCT ID:
NCT03975257
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2019-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ectoin Lozenges (EHT02) in the Treatment of Oropharyngeal Allergic Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cumulative score of allergic symptoms of the lips evaluated by the patient', 'timeFrame': 'about 30 minutes after SLIT-initiation', 'description': '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)'}, {'measure': 'cumulative score of allergic symptoms of the mouth evaluated by the patient', 'timeFrame': 'about 30 minutes after SLIT-initiation', 'description': '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)'}, {'measure': 'cumulative score of allergic symptoms of the throat evaluated by the patient', 'timeFrame': 'about 30 minutes after SLIT-initiation', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events/serious adverse events', 'timeFrame': 'through study visit (participation encompasses 1 visit of approx. 60 min duration)', 'description': 'All occurring adverse events/serious adverse events will be documented during the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe current study aims to investigate the efficacy of Ectoin Lozenges (EHT02) in patients suffering from oropharyngeal allergic symptoms. The symptoms are induced by SLIT.\n\nPatients 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.\n\nThe symptoms itching, swelling and irritation of mouth, lips and throat will be documented by the patients once 30 minutes after SLIT-initiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* initiation of a SLIT\n* minimum age of 18 years\n* written consent of the patient\n\nExclusion criteria:\n\n* Surgical Procedures in the mouth and throat region prior to the study\n* patients with known intolerance to one of the substances used\n* pregnant or breast-feeding women'}, 'identificationModule': {'nctId': 'NCT03975257', 'briefTitle': 'Ectoin Lozenges (EHT02) in the Treatment of Oropharyngeal Allergic Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bitop AG'}, 'officialTitle': 'Application of Ectoin Lozenges (EHT02) in Patients With Oropharyngeal Allergic Symptoms', 'orgStudyIdInfo': {'id': 'btph-021-2018-EHT02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preventive application of EHT02', 'description': 'application of one Ectoin Lozenge before SLIT-initiation', 'interventionNames': ['Device: Medical Device: Ectoin Lozenge']}, {'type': 'EXPERIMENTAL', 'label': 'Therapeutic application of EHT02', 'description': 'application of one Ectoine Lozenge after SLIT-initiation', 'interventionNames': ['Device: Medical Device: Ectoin Lozenge']}, {'type': 'NO_INTERVENTION', 'label': 'No application of EHT02', 'description': 'SLIT-Initiation without Ectoin Lozenge'}], 'interventions': [{'name': 'Medical Device: Ectoin Lozenge', 'type': 'DEVICE', 'otherNames': ['EHT02'], 'description': 'Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use', 'armGroupLabels': ['Preventive application of EHT02', 'Therapeutic application of EHT02']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aachen', 'country': 'Germany', 'facility': 'Facharzt f. HNO-Heilkunde', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Bad Schönborn', 'country': 'Germany', 'facility': 'Fachärztin für Hals-Nasen-Ohrenheilkunde', 'geoPoint': {'lat': 49.20122, 'lon': 8.64179}}, {'zip': '44803', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Facharzt f. Dermatologie ruhrDerm GbR', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '53119', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Facharzt für Lungen- und Bronchialheilkunde', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Gelsenkirchen', 'country': 'Germany', 'facility': 'Facharzt für Haut und Geschlechtskrankheiten', 'geoPoint': {'lat': 51.50508, 'lon': 7.09654}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Arzt für Hals-Nasen-Ohrenheilkunde, Allergologie, Umweltmedizin, Naturheilverfahren, Flugmedizin, Taucherarzt (GTÜM)', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '52428', 'city': 'Jülich', 'country': 'Germany', 'facility': 'Fachärztin f. HNO-Heilkunde, Allergologie', 'geoPoint': {'lat': 50.92149, 'lon': 6.36267}}, {'city': 'Schorndorf', 'country': 'Germany', 'facility': 'Facharzt für Hals-Nasen-Ohrenheilkunde, Allergo GmbH Stuttgart, Klinische Prüfstelle Schorndorf', 'geoPoint': {'lat': 48.80537, 'lon': 9.52721}}], 'overallOfficials': [{'name': 'Andreas Bilstein, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bitop AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}