Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT00791102
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2008-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rnacleri@surgery.bsd.uchicago.edu', 'phone': '773-702-0080', 'title': 'Robert Naclerio, MD', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Topical ASP-1001', 'description': 'Topical ASP-1001\n\nASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo for Topical ASP-1001', 'description': 'Placebo for Topical ASP-1001\n\nPlacebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Sneezing Symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical ASP-1001', 'description': 'Topical ASP-1001\n\nASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.'}, {'id': 'OG001', 'title': 'Placebo for Topical ASP-1001', 'description': 'Placebo for Topical ASP-1001\n\nPlacebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '10 minutes after diluent challenge and 10 minutes after each antigen challenge', 'description': 'Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.', 'unitOfMeasure': 'sneezes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nasal Peak Inspiratory Flow Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical ASP-1001', 'description': 'Topical ASP-1001\n\nASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.'}, {'id': 'OG001', 'title': 'Placebo for Topical ASP-1001', 'description': 'Placebo for Topical ASP-1001\n\nPlacebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.5', 'groupId': 'OG000', 'lowerLimit': '-51.25', 'upperLimit': '3.75'}, {'value': '-30', 'groupId': 'OG001', 'lowerLimit': '-40', 'upperLimit': '-20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '15 minutes after diluent challenge and 15 minutes after each antigen challenge', 'description': 'The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Runny Nose Symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical ASP-1001', 'description': 'Topical ASP-1001\n\nASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.'}, {'id': 'OG001', 'title': 'Placebo for Topical ASP-1001', 'description': 'Placebo for Topical ASP-1001\n\nPlacebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '10 minutes after diluent challenge and 10 minutes after each antigen challenge', 'description': 'The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Stuffy Nose Symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical ASP-1001', 'description': 'Topical ASP-1001\n\nASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.'}, {'id': 'OG001', 'title': 'Placebo for Topical ASP-1001', 'description': 'Placebo for Topical ASP-1001\n\nPlacebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.75'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '10 minutes after diluent challenge and 10 minutes after each antigen challenge', 'description': 'The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Itching Symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical ASP-1001', 'description': 'Topical ASP-1001\n\nASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.'}, {'id': 'OG001', 'title': 'Placebo for Topical ASP-1001', 'description': 'Placebo for Topical ASP-1001\n\nPlacebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.75'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '10 minutes after diluent challenge and 10 minutes after each antigen challenge', 'description': 'The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical ASP-1001', 'description': 'Topical ASP-1001\n\nASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.'}, {'id': 'OG001', 'title': 'Placebo for Topical ASP-1001', 'description': 'Placebo for Topical ASP-1001\n\nPlacebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.5', 'groupId': 'OG000', 'lowerLimit': '-20', 'upperLimit': '0'}, {'value': '-10', 'groupId': 'OG001', 'lowerLimit': '-20', 'upperLimit': '9.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '15 minutes prior to treatment and 15 minutes post antigen challenges', 'unitOfMeasure': 'L/min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topical ASP-1001', 'description': 'Topical ASP-1001\n\nASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.'}, {'id': 'FG001', 'title': 'Placebo for Topical ASP-1001', 'description': 'Placebo for Topical ASP-1001\n\nPlacebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period of 2 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '9.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-08', 'studyFirstSubmitDate': '2008-11-13', 'resultsFirstSubmitDate': '2013-03-06', 'studyFirstSubmitQcDate': '2008-11-13', 'lastUpdatePostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-08', 'studyFirstPostDateStruct': {'date': '2008-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Sneezing Symptom', 'timeFrame': '10 minutes after diluent challenge and 10 minutes after each antigen challenge', 'description': 'Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.'}, {'measure': 'Change in Runny Nose Symptom', 'timeFrame': '10 minutes after diluent challenge and 10 minutes after each antigen challenge', 'description': 'The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.'}, {'measure': 'Change in Stuffy Nose Symptom', 'timeFrame': '10 minutes after diluent challenge and 10 minutes after each antigen challenge', 'description': 'The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.'}, {'measure': 'Change in Itching Symptom', 'timeFrame': '10 minutes after diluent challenge and 10 minutes after each antigen challenge', 'description': 'The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.'}], 'secondaryOutcomes': [{'measure': 'Nasal Peak Inspiratory Flow Measurements', 'timeFrame': '15 minutes after diluent challenge and 15 minutes after each antigen challenge', 'description': 'The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge.'}, {'measure': 'Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment', 'timeFrame': '15 minutes prior to treatment and 15 minutes post antigen challenges'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females between 18 and 55 years of age.\n2. History of grass and/or ragweed allergic rhinitis.\n3. Positive skin test to grass and/or ragweed antigen.\n4. Positive response to screening nasal challenge.\n\nExclusion Criteria:\n\n1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.\n2. Pregnant or lactating women.\n3. Upper respiratory infection or sinusitis within 14 days of study start.\n4. Use of nasal steroids, antihistamines in the last 2 weeks.\n5. FEV1\\<80% of predicted at screening for subjects with history of mild asthma\n6. current smokers or recent ex-smokers\n7. Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.'}, 'identificationModule': {'nctId': 'NCT00791102', 'briefTitle': 'Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical ASP-1001 (Contrast Media Formulation) in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (NAC)', 'orgStudyIdInfo': {'id': '16504B (ASP2002-AR-01)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Topical ASP-1001', 'interventionNames': ['Drug: ASP-1001 nasal spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo for Topical ASP-1001', 'interventionNames': ['Drug: Placebo for ASP-1001']}], 'interventions': [{'name': 'ASP-1001 nasal spray', 'type': 'DRUG', 'description': '2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.', 'armGroupLabels': ['1']}, {'name': 'Placebo for ASP-1001', 'type': 'DRUG', 'description': '2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Robert Naclerio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asphelia Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert Naclerio', 'investigatorAffiliation': 'University of Chicago'}}}}