Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-02 @ 12:42 PM
Study NCT ID:
NCT01147159
Status:
COMPLETED
Last Update Posted:
2017-05-02
First Post:
2010-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Standardization of Allergen Extracts of Pollens of Betula Pendula, Phleum Pratense and Mite Extract of Dermatophagoides Pteronyssinus
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Skin prick test of extracts of allergens in 4 tenfold dilutions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-28', 'studyFirstSubmitDate': '2010-05-25', 'studyFirstSubmitQcDate': '2010-06-17', 'lastUpdatePostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wheal size area', 'timeFrame': '15 minutes after skin prick test', 'description': 'The primary efficacy variable will be the wheal size area of the immediate phase reaction in mm2'}]}, 'conditionsModule': {'conditions': ['Allergy']}, 'descriptionModule': {'briefSummary': 'Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. Many factors such as the biovariability, differences in extraction process and subsequent handling of allergens can affect the final composition, potency, and stability of allergen preparations. Genetic diversity of affected people adds another level of complexity. In order to control variability and to achieve consistency and reproducibility for optimal safety and sensitivity/specificity, it is essential to standardize the amount of allergen used in prick tests. Therefore, the system for biological standardization mainly used in Europe still is the biological calibration of in-House Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT) value. The aim of this procedure is to estimate the biological activity of allergen extracts. The activity of an allergen extract is defined as 10,000 Diagnostic Biological Units (DBU) per ml (1 SPT per ml), when the extract provokes a specific skin reaction with a wheal of the same size as a wheal provoked by reference histamine at a concentration of 10 mg/ml, when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are clinically allergic and cutaneously reactive to the allergen concerned.\n\nThe present study aims to standardize the allergen extracts of Betula pendula, Phleum pratense and Dermatophagoides pteronyssinus by using this method.\n\n* Trial with medicinal product'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Positive clinical history with inhalant allergy to at least one of the allergen to be standardized.\n* At least one positive prick test (mean wheal diameter = 3mm) when tested with already standardized extracts of the allergens under investigation.\n* Positive prick test (wheal diameter =3 mm) to Histamine 10 mg/ml\n* Age: 18-60 years\n* Written informed consent\n\nExclusion criteria:\n\n* Diseases or medications, influencing the skin tests or that contradict the correct conduct and evaluation of the study.\n* Pregnancy, skin irritations, drug and alcohol abuse and participation in another clinical trial within the last 30 days'}, 'identificationModule': {'nctId': 'NCT01147159', 'briefTitle': 'Biological Standardization of Allergen Extracts of Pollens of Betula Pendula, Phleum Pratense and Mite Extract of Dermatophagoides Pteronyssinus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Roxall Medicina España S.A'}, 'officialTitle': 'Biological Standardization of Allergen Extracts of Pollens of Betula Pendula, Phleum Pratense and Mite Extract of Dermatophagoides Pteronyssinus in Patients With Rhinoconjunctivitis With/ Without Asthma Sensitized to Betula Pendula, Dermatophagoides Pteronyssinus and Phleum Pratense An Open-label, Single-center Study', 'orgStudyIdInfo': {'id': 'BIA-STD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Skin Prick Test', 'interventionNames': ['Other: Extracts of allergens']}], 'interventions': [{'name': 'Extracts of allergens', 'type': 'OTHER', 'description': 'Skin prick test of extracts of allergens in 4 tenfold dilutions. Assessment wheal size after 15 minutes', 'armGroupLabels': ['Skin Prick Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Zentrum für klinische Forschung Clinical Trials Center, University Hospital and University Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': '01 Studienregister MasterAdmins', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UniversitaetsSpital Zuerich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roxall Medicina España S.A', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University Hospital, Zürich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}