Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-27 @ 3:11 PM
Study NCT ID:
NCT01127035
Status:
COMPLETED
Last Update Posted:
2010-06-07
First Post:
2010-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sublingual Immunotherapy In Alternaria-Induced Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D063729', 'term': 'Sublingual Immunotherapy'}], 'ancestors': [{'id': 'D003888', 'term': 'Desensitization, Immunologic'}, {'id': 'D007165', 'term': 'Immunosuppression Therapy'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-04', 'studyFirstSubmitDate': '2010-05-19', 'studyFirstSubmitQcDate': '2010-05-19', 'lastUpdatePostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in symptom score active versus placebo'}], 'secondaryOutcomes': [{'measure': 'change in rescue medication intake'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['allergic rhinitis', 'alternaria alternata', 'symptom score'], 'conditions': ['Allergic Rhinitis (w/w Asthma) Due to Alternaria Alternata']}, 'referencesModule': {'references': [{'pmid': '17651380', 'type': 'BACKGROUND', 'citation': 'Tabar AI, Lizaso MT, Garcia BE, Gomez B, Echechipia S, Aldunate MT, Madariaga B, Martinez A. Double-blind, placebo-controlled study of Alternaria alternata immunotherapy: clinical efficacy and safety. Pediatr Allergy Immunol. 2008 Feb;19(1):67-75. doi: 10.1111/j.1399-3038.2007.00589.x. Epub 2007 Jul 25.'}, {'pmid': '21055665', 'type': 'DERIVED', 'citation': 'Cortellini G, Spadolini I, Patella V, Fabbri E, Santucci A, Severino M, Corvetta A, Canonica GW, Passalacqua G. Sublingual immunotherapy for Alternaria-induced allergic rhinitis: a randomized placebo-controlled trial. Ann Allergy Asthma Immunol. 2010 Nov;105(5):382-6. doi: 10.1016/j.anai.2010.08.007. Epub 2010 Sep 26.'}]}, 'descriptionModule': {'briefSummary': 'Respiratory allergy due to Alternaria is a relevant clinical problem, and specific immunotherapy may represent a viable treatment option. Sublingual immunotherapy (SLIT) is safe and effective, but data for Alternaria are lacking. The study is aimed at assessing the efficacy of a standardized SLIT in patients sensitised to Alternaria, in a randomized, double blind, placebo controlled fashion.\n\nPatients with rhinitis with/without intermittent asthma, and ascertained allergy to Alternaria are enrolled. After a baseline season, SLIT or matched placebo are given for 10 months. Symptoms and rescue medication intake are recorded on diary cards from June to October. Skin prick test, specific IgE and IgG4 and precipitins are measured at baseline and at the end of the study. Alternaria spore count is also performed. Primary outcome is the change in symptom score in the active vs placebo group. Secondary outcomes: changes in rescue medication intake, alternaria specific IgE and IgG4, skin prick test reactivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Allergic rhinitis\n* Symptoms May-October\n* Specific IgE to alternaria (skin test/radioallergosorbent \\[RAST\\] test)\n* Age \\>14\n\nExclusion Criteria:\n\n* Sensitization to mites, parietaria, mugwort\n* Pregnancy-lactation\n* Malignancies\n* Chronic systemic steroids\n* Previous immunotherapy to alternaria'}, 'identificationModule': {'nctId': 'NCT01127035', 'briefTitle': 'Sublingual Immunotherapy In Alternaria-Induced Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Genova'}, 'officialTitle': 'STUDIO IN DOPPIO CIECO DISODIOCROMOGLICATO + PLACEBO vs DISODIOCROMOGLICATO + IMMUNOTERAPIA SPECIFICA SUBLINGUALE PER ALTERNARIA IN PAZIENTI CON RINITE ALLERGICA DOVUTA A SENSIBILIZZAZIONE AD ALTERNARIA', 'orgStudyIdInfo': {'id': 'SLITALT2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLIT', 'description': 'sublingual immunotherapy biologically standardized', 'interventionNames': ['Biological: sublingual immunotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'same preparation of SLIT without the allergen', 'interventionNames': ['Biological: placebo']}], 'interventions': [{'name': 'sublingual immunotherapy', 'type': 'BIOLOGICAL', 'armGroupLabels': ['SLIT']}, {'name': 'placebo', 'type': 'BIOLOGICAL', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rimini', 'country': 'Italy', 'facility': 'Rimini Hospital', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Genova', 'class': 'OTHER'}}}}