Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
Study NCT ID:
NCT01115595
Status:
COMPLETED
Last Update Posted:
2019-03-18
First Post:
2010-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-14', 'studyFirstSubmitDate': '2010-05-01', 'studyFirstSubmitQcDate': '2010-05-03', 'lastUpdatePostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total nasal symptoms score', 'timeFrame': 'average within 1 week', 'description': '3 point scale (0,1,2,3) and combination of\n\n* nasal block\n* rhinorrhea\n* itching\n* sneezing'}], 'secondaryOutcomes': [{'measure': 'Combined total symptoms score and medication score', 'timeFrame': 'average within 1 week', 'description': 'Total symptom score (nasal block, rhinorrhea, itching, sneezing, and eye symptoms with chest symptoms = Maximal score --\\> 18 devided by 6 = 3) PLUS medication score ( antihistamine = 1, topical nasal steroid = 2; --\\> Maximal score = 3).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Allergic rhinitis', 'Allergen injection immunotherapy', 'Efficacy'], 'conditions': ['Rhinitis, Allergic, Perennial']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the efficacy of allergen injection immunotherapy for allergic rhinitis by\n\n* symptoms score\n* medication score\n* quality of life\n* immunologic test from blood', 'detailedDescription': 'Compare the efficacy of allergen injection immunotherapy between the treatment group and the placebo group after injection for\n\n* 2 months\n* 6 months\n* 12 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with the symptoms of allergic rhinitis who sensitized to mite (Dermatophagoides pteronyssinus)\n* positive skin prick test to D.p. at 4+ degree\n\nExclusion Criteria:\n\n* steroid dependent asthma\n* force expiratory volume (FEV1) less than 70% of predicted value\n* previous injection immunotherapy within 2 years\n* pregnancy\n* medical conditions such as ischemic heart disease, autoimmune disease, cancer, previous history of anaphylaxis'}, 'identificationModule': {'nctId': 'NCT01115595', 'briefTitle': 'Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Efficacy of Mite Allergen Vaccine Among Thai Patients With Allergic Rhinitis', 'orgStudyIdInfo': {'id': '336/2552'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'injection by Mite extract with standard allergic medication (oral antihistamine and/or topical nasal steroid)', 'interventionNames': ['Biological: Intervention']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Injection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Intervention', 'type': 'BIOLOGICAL', 'otherNames': ['Mite allergen extract (D.p) from ALK company. 10,000 AU/ml'], 'description': 'Dermatophagoides pteronyssinus from ALK company', 'armGroupLabels': ['Intervention']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Injection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid)', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Division of Allergy and Rhinology, Faculty of Medicine Siriraj, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Pongsakorn Tantilipikorn, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of allergy and rhinology, Faculty of Medicine Siriraj, Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pongsakorn Tantilipikorn', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Council of Thailand', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Dr.', 'investigatorFullName': 'Pongsakorn Tantilipikorn', 'investigatorAffiliation': 'Mahidol University'}}}}