Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 1:48 PM
Study NCT ID:
NCT01699659
Status:
COMPLETED
Last Update Posted:
2012-10-04
First Post:
2012-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy & Safety of the UAS Immunotherapy Protocol
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': 'D003888', 'term': 'Desensitization, Immunologic'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-03', 'studyFirstSubmitDate': '2012-09-10', 'studyFirstSubmitQcDate': '2012-10-03', 'lastUpdatePostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life (QOL) scores', 'timeFrame': 'Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy', 'description': 'QOL scores will be calculated after one to 2 years of therapy and contrasted with QOL reflecting status 12 months prior to initiation of therapy.'}], 'primaryOutcomes': [{'measure': 'change in symptom scores from 12 months before therapy initiation in contrast to determination during 1 to 2 years of therapy (retrospective).', 'timeFrame': 'Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.', 'description': 'Enrolled patients completed surveys pertinent to symptom scores, contrasting current status on immunotherapy compared (by recall) to a 12 month time point prior to initiation of therapy.'}], 'secondaryOutcomes': [{'measure': 'Changes in medication plus symptom aggregate score.', 'timeFrame': 'Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy.', 'description': 'Aggregate Medication and Symptom surveys were compared to determine changes from a 12 month time point prior to inception of therapy to current time point of 1 to 2 years of therapy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Allergic Rhinitis', 'Allergen Immunotherapy'], 'conditions': ['Perennial Allergic Rhinitis With Seasonal Variation']}, 'descriptionModule': {'briefSummary': 'Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as protocols described in the Allergy literature.', 'detailedDescription': 'Patients will be assessed for efficacy of the immunotherapy protocol by completing Consented-IRB approved clinical, medication, quality of life survey questions comparing current status while on therapy in contrast to 12 months before the inception of therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with allergic rhinitis pre and post immunotherapy (1 to 2 years).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Allergic rhinitis between 18 and 65 years old who have chosen to undergo immunotherapy.\n\nExclusion Criteria:\n\n* No beta blocker use,\n* no pregnancy,\n* no systemic steroids,\n* no severe asthma/copd,\n* no severe collagen vascular disorders,\n* no neoplastic or uncontrolled seizure activity,\n* no previous anaphylaxis, no significant cardiovsacular disease.'}, 'identificationModule': {'nctId': 'NCT01699659', 'briefTitle': 'The Efficacy & Safety of the UAS Immunotherapy Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'United Allergy Services'}, 'officialTitle': 'The Efficacy and Safety of the United Allergy Service (UAS) Immunotherapy Protocol', 'orgStudyIdInfo': {'id': 'UAS protocol #1'}, 'secondaryIdInfos': [{'id': 'UAS protocol #1', 'type': 'OTHER_GRANT', 'domain': 'United Allergy Services'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'allergen immunotherapy', 'type': 'OTHER', 'otherNames': ['allergy shots'], 'description': 'allergy shots'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78216', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'UAS', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Frederick M Schaffer, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'United Allergy Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United Allergy Services', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Medical Officer', 'investigatorFullName': 'Frederick M. Schaffer, MD', 'investigatorAffiliation': 'United Allergy Services'}}}}