Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-31 @ 4:33 AM
Study NCT ID:
NCT01407835
Status:
COMPLETED
Last Update Posted:
2012-08-09
First Post:
2011-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Standardization of Dactylis Glomerata Allergen Extract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-08', 'studyFirstSubmitDate': '2011-08-01', 'studyFirstSubmitQcDate': '2011-08-01', 'lastUpdatePostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.', 'timeFrame': 'Test sites should be inspected and recorded 15-20 min after application'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Immunotherapy', 'Skin prick test', 'Standardization', 'Dactylis glomerata'], 'conditions': ['Allergy to Grass Pollen (Dactylis Glomerata)']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the biologic activity of a Dactylis glomerata allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).', 'detailedDescription': 'This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.\n\nFour concentrations of Dactylis glomerata allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to Dactylis glomerata.\n2. Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).\n3. Subject can be male or female of any race and ethnic group.\n4. Age \\> 18 years and \\< 50 years at the study inclusion day.\n5. Positive skin prick test with a standardized commercially available preparation of Dactylis glomerata allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study\n6. A positive test for specific IgE to Dactylis glomerata(CAP-RAST ≥ 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.\n7. Allergic symptoms during the pollen season of Dactylis glomerata.\n8. Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm.\n\nExclusion Criteria:\n\n1. Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., grass group extracts).\n2. Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1\n3. Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (\\> 10 mg/day of prednisone or equivalent).\n4. Pregnancy.\n5. Dermographism affecting the skin area at the test site at either study visit.\n6. Atopic dermatitis affecting the skin area at the test site at either study visit.\n7. Urticaria affecting the skin area at the test site at either study visit.\n8. Participation in another clinical trial within the last month.\n9. Subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension,..)'}, 'identificationModule': {'nctId': 'NCT01407835', 'briefTitle': 'Biological Standardization of Dactylis Glomerata Allergen Extract', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Leti, S.L.'}, 'officialTitle': 'Biological Standardization of Dactylis Glomerata Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units', 'orgStudyIdInfo': {'id': '6038-PR-PRI-181'}, 'secondaryIdInfos': [{'id': '2010-023948-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '* Dactylis glomerata allergen extract at 4 different concentrations\n* Positive control\n* Negative control', 'interventionNames': ['Biological: Four different concentrations of Dactylis glomerata allergen extract, positive control and negative control']}], 'interventions': [{'name': 'Four different concentrations of Dactylis glomerata allergen extract, positive control and negative control', 'type': 'BIOLOGICAL', 'description': 'Four concentrations of Dactylis glomerata allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28005', 'city': 'Madrid', 'state': 'Madrid / Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41700', 'city': 'Seville', 'state': 'Sevilla / Andalucía', 'country': 'Spain', 'facility': 'Hospital El Tomillar - Area Hospitalaria de Valme', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'María José Gómez', 'role': 'STUDY_CHAIR', 'affiliation': 'Laboratorios LETI, S.L.Unipersonal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Leti, S.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}