Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-30 @ 12:23 AM
Study NCT ID:
NCT04872868
Status:
COMPLETED
Last Update Posted:
2022-04-22
First Post:
2021-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Effect of a 3-month Supplementation With Holo-BLG on House Dust Mite Induced Allergic Rhinoconjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092542', 'term': 'Dust Mite Allergy'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2021-04-23', 'studyFirstSubmitQcDate': '2021-04-29', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TNSS', 'timeFrame': 'After 120 minutes of allergen challenge', 'description': 'Total Nasal Symptom Score (TNSS) in response to HDM exposure in an AEC at V1 (baseline AEC exposure) versus V5 (follow-up AEC exposure). The TNSS is the sum of 4 nose symptoms (runny nose, sneezing, itchy nose, and blocked nose) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TNSS of 12.'}], 'secondaryOutcomes': [{'measure': 'TSS', 'timeFrame': 'Up to 120 minutes following allergen challenge', 'description': 'Total Symptom Score in response to HDM exposure in an AEC at V1 (baseline AEC exposure) versus V5 (follow-up AEC exposure). The TSS is the sum of 4 nose symptoms (runny nose, sneezing, itchy nose, and blocked nose), 3 eye symptoms (itchy eyes, watery eyes, and gritty feeling), 4 bronchial symptoms (wheezing, cough, breathlessness, and asthma), and 2 other symptoms (itchy palate, and itchy skin) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TSS of 39.'}, {'measure': 'TESS', 'timeFrame': 'Up to 120 minutes following allergen challenge', 'description': 'The Total Eye Symptom Score (TESS) is the sum of 3 eye symptoms (itchy eyes, watery eyes, and gritty feeling) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TESS of 9.'}, {'measure': 'TBSS', 'timeFrame': 'Up to 120 minutes following allergen challenge', 'description': 'The Total Bronchial Symptom Score (TBSS) is the sum of 4 bronchial symptoms (wheezing, cough, breathlessness, and asthma) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TBSS of 12.'}, {'measure': 'VAS', 'timeFrame': 'Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes', 'description': 'Visual Analogue Scale: Before, every 30 minutes during and after the exposure patients grade the question on their well-being by putting a vertical line on a 10 cm line representing severity from 0 cm "very good" to 10 cm "very bad".'}, {'measure': 'PNIF', 'timeFrame': 'Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes', 'description': 'PNIF (peak nasal inspiration flow) liter/minute.'}, {'measure': 'PEF', 'timeFrame': 'Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes', 'description': 'PEF (peak expiratory flow) liter/minute.'}, {'measure': 'FEV1', 'timeFrame': 'Recorded at time zero (0) and 120 minutes', 'description': 'Forced expiratory volume in 1 second, before and after the exposure.'}, {'measure': 'FEV1/FVC', 'timeFrame': 'Recorded at time zero (0) and 120 minutes', 'description': 'Forced expiratory volume in 1 second/forced vital capacity ratio, before and after the exposure.'}, {'measure': 'rescue medication and/or emergency treatment', 'timeFrame': 'during and up to 24 hours after AEC exposure', 'description': 'Need for rescue medication and/or emergency treatment'}, {'measure': 'Adverse events with regards to the allergen exposure', 'timeFrame': 'up to 24 hours after AEC exposure', 'description': 'Number of events and number of patients recording late-phase reactions and/or adverse events with regards to the allergen exposure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dust Mite Allergy', 'Allergic Rhinitis']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Bergmann, KC., Raab, J., Krause, L. et al. Long-term benefits of targeted micronutrition with the holoBLG lozenge in house dust mite allergic patients. Allergo J Int (2022). https://doi.org/10.1007/s40629-021-00197-z'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the long-term effect of a lozenge containing beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols (holo-BLG) in people with allergic rhinoconjunctivitis caused by house dust mites and the associated symptoms (symptom type and severity) during exposure to house dust mites in an Allergen Exposure Chamber (AEC).\n\nIn particular, the study aims to evaluate whether the improvements in symptoms of house dust mite-induced rhinoconjunctivitis observed after 3 months of supplementation with holo-BLG can still be detected 7 to 8 months after the last intake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'study participants must have been participated in the in the predecessor study (supplementation phase with holo-BLG) including complete intake of the holo-BLG lozenge for 3 months and must have been included in the final analysis set of the predecessor study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in the predecessor study including complete intake of the holo-BLG lozenge for 3 months; inclusion in the final analysis set of the predecessor study\n* patients with allergic rhinoconjunctivitis caused by house dust mites of any gender, aged 18-65 years\n* Verbal and written informed consent\n\nExclusion Criteria:\n\n* Persons \\<18 years\n* lack of verbal and written consent\n* persons who do not speak German\n* seriously ill persons\n* Persons with immunosuppressive medication such as systemic corticosteroids, cyclosporine\n* Pregnancy and breastfeeding\n* psychiatric illness\n* Persons who have received or have started sublingual or subcutaneous immunotherapy (SLIT/SCIT) against house dust mites in the last 2 years before screening\n* Contraindications and/or history of adrenaline intolerance and/or emergency medication.\n* Concurrent use of anti-allergic medications and/or inadequate washout period of these anti-allergic medications prior to the selection process and exposure in the exposure chamber\n* Use of an investigational drug 30 days/5 half-lives of the drug (whichever is longer) prior to screening\n* Use of certain drugs prior to V5: Systemic corticosteroids within 3 weeks; Topical nasal corticosteroids within 2 weeks; Chromones within 7 days; Antihistamines within 72h; Antibiotics within 3 months; Pro-, Pre- and Synbiotics 1 month'}, 'identificationModule': {'nctId': 'NCT04872868', 'briefTitle': 'Long-term Effect of a 3-month Supplementation With Holo-BLG on House Dust Mite Induced Allergic Rhinoconjunctivitis', 'organization': {'class': 'OTHER', 'fullName': 'Ecarf Institute GmbH'}, 'officialTitle': 'Evaluation of the Long-term Effect of a 3-month Supplementation With Holo-BLG (Food for Special Medical Purposes) in People With Allergic Rhinoconjunctivitis Caused by House Dust Mites During Inhalation Exposure to Mite Allergen in an Exposure Chamber.', 'orgStudyIdInfo': {'id': '014-P-21'}}, 'contactsLocationsModule': {'locations': [{'zip': '10115', 'city': 'Berlin', 'country': 'Germany', 'facility': 'ECARF Institute GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Sylvia Becker', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ecarf Institute GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ecarf Institute GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bencard Allergie GmbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}