Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT01392859
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2011-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Characterization of the Role of Histamine in Children With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C472067', 'term': 'levocetirizine'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bljones@cmh.edu', 'phone': '816-302-3811', 'title': 'Dr. Bridgette Jones', 'organization': "Children's Mercy Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Initial Treatment: Levocetirizine First, Then Placebo', 'description': "Only a small sub-set of the overall study participants were included in this analysis.\n\nGroup 1 will begin with active Levocetirizine(LCT) 0.5 mg/ml oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and placebo will be provided for 5-8 days.\n\nLevocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.\n\nThese participants also went through the laser doppler portion prior to the crossover portion of the study.\n\nNote: Adverse Events (AE) were recorded by arm therefore AE's cannot be provided for each intervention separately. This data is no longer available to retrospectively separate AE's out by intervention.", 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 9, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Initial Treatment: Placebo First, Then Levocetirizine', 'description': "Only a small sub-set of the overall study participants were included in this analysis.\n\nGroup 2 will begin with placebo oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and active Levocetirizine(LCT) 0.5 mg/ml will be provided for 5-8 days.\n\nLevocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.\n\nThese participants also went through the laser doppler portion prior to the crossover portion of the study.\n\nNote: Adverse Events (AE) were recorded by arm therefore AE's cannot be provided for each intervention separately. This data is no longer available to retrospectively separate AE's out by intervention.", 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Laser Doppler Portion Only', 'description': 'Participants who completed Only Laser Doppler portion of the study.', 'otherNumAtRisk': 183, 'deathsNumAtRisk': 183, 'otherNumAffected': 0, 'seriousNumAtRisk': 183, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Characterize Contribution of Histamine in Children With Asthma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'Comparison of the microvasculature response to histamine in children with allergic asthma and children with non-allergic asthma, measured by histamine iontophoresis with laser Doppler (HILD) monitoring, to determine potential phenotype-associated differences in the pharmacodynamic response to histamine.'}], 'classes': [{'title': 'Hyper-Reactive-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11253.24', 'spread': '4271.17', 'groupId': 'OG000'}]}]}, {'title': 'Normo-Reactive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6464.20', 'spread': '1048.63', 'groupId': 'OG000'}]}]}, {'title': 'Hypo-Reactive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3539.67', 'spread': '1239.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one year', 'description': 'The investigators will compare the response to histamine via histamine iontophoresis with laser doppler monitoring (measured in flux units on a continuous scale)between subjects with allergic asthma compared to subjects with non-allergic asthma.', 'unitOfMeasure': 'flux units on a continuous scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants have been stratified based on their reactivity (i.e., participants with hyper-, normo-, or hypo-reactivity) and therefore the Number Analyzed for each Row differs from the Overall Number of Participants Analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Initial Treatment: Levocetirizine First, Then Placebo', 'description': 'Only a small sub-set of the overall study participants were included in this analysis.\n\nGroup 1 will begin with active Levocetirizine(LCT) 0.5 mg/ml oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and placebo will be provided for 5-8 days.\n\nThese participants also went through the laser doppler portion prior to the crossover portion of the study.\n\nLevocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.'}, {'id': 'FG001', 'title': 'Initial Treatment: Placebo First, Then Levocetirizine', 'description': 'Only a small sub-set of the overall study participants were included in this analysis.\n\nGroup 2 will begin with placebo oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and active Levocetirizine(LCT) 0.5 mg/ml will be provided for 5-8 days.\n\nThese participants also went through the laser doppler portion prior to the crossover portion of the study.\n\nLevocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.'}, {'id': 'FG002', 'title': 'Laser Doppler Portion Only', 'description': 'Participants who completed Only Laser Doppler portion of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '183'}]}, {'type': 'Wash Out 3-7 Days', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '183'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '211 total participants enrolled in the study including the laser doppler testing. Only a small sub-set (n=28) of these participants were included in the sub-study including Levocetirizine.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': '211 participants enrolled in overall study including laser doppler testing. Only 28 participants continued to subgroups below:\n\nGroup 1: Initial Treatment: Levocetirizine(LCT) will begin with active Levocetirizine(LCT) 0.5 mg/ml oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and placebo will be provided for 5-8 days.\n\nLevocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.\n\nGroup 2: Initial Treatment: Placebo will begin with placebo oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and active Levocetirizine(LCT) 0.5 mg/ml will be provided for 5-8 days.\n\nLevocetirizine 0.5 Mg/mL Oral Solution: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'spread': '3.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '121', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '115', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '211', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2015-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-26', 'studyFirstSubmitDate': '2011-07-06', 'resultsFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2011-07-12', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-26', 'studyFirstPostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterize Contribution of Histamine in Children With Asthma', 'timeFrame': 'one year', 'description': 'The investigators will compare the response to histamine via histamine iontophoresis with laser doppler monitoring (measured in flux units on a continuous scale)between subjects with allergic asthma compared to subjects with non-allergic asthma.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma', 'Allergic Asthma', 'Non-allergic Asthma']}, 'descriptionModule': {'briefSummary': 'Asthma, a chronic disease which produces significant morbidity and mortality in children, is a significant health problem to a large segment of society. Despite considerable advances in the diagnosis and treatment of asthma over the past several years, a sizeable portion of patients do not respond to the "core" treatments. The investigators are now learning that the underlying pathophysiology of disease is different among patients with asthma therefore; treatments which are beneficial in some patient groups may be not achieve affect in other groups.\n\nAntihistamines have been studied in the past for the treatment of asthma. These studies have shown that there may be a beneficial effect of antihistamines in patients with allergic asthma where histamine likely plays a large role in disease and treatment response. However, there is not enough evidence to include these drugs in the standard treatment of asthma.\n\nThe investigators hypothesize that histamine plays a definable, significant role in disease pathogenesis and treatment response in children with allergic asthma. The investigators plan to test this overall hypothesis through two specific aims. The first aim will characterize the relative contribution of histamine in allergic vs. non-allergic asthma. This aim will be accomplished by comparison of the microvasculature response to histamine in children with allergic asthma and children with non-allergic asthma, measured by histamine iontophoresis with laser Doppler (HILD) monitoring, to determine potential phenotype-associated differences in the pharmacodynamic response to histamine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children age 7-17 years old\n* with the diagnosis of allergic asthma or non-allergic asthma (n=102\n\nExclusion Criteria:\n\n* history of immunodeficiency, mastocytosis\n* chronic abnormal conditions of the skin, liver or kidney\n* neoplastic disease\n* movement or neurologic disorders\n* active eczema on the forearms at the time of study\n* history of a previous anaphylactic episode\n* evidence of pregnancy (by urinary hCG) or lactation at the time of the study'}, 'identificationModule': {'nctId': 'NCT01392859', 'briefTitle': 'Characterization of the Role of Histamine in Children With Asthma', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Characterization of the Role of Histamine in Children With Asthma', 'orgStudyIdInfo': {'id': '105783-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Initial Treatment: Levocetirizine(LCT)', 'description': 'Group 1 will begin with active Levocetirizine(LCT) 0.5 mg/ml oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and placebo will be provided for 5-8 days.', 'interventionNames': ['Drug: Levocetirizine 0.5 Mg/mL Oral Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Initial Treatment: Placebo', 'description': 'Group 2 will begin with placebo oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and active Levocetirizine(LCT) 0.5 mg/ml will be provided for 5-8 days.', 'interventionNames': ['Drug: Levocetirizine 0.5 Mg/mL Oral Solution']}], 'interventions': [{'name': 'Levocetirizine 0.5 Mg/mL Oral Solution', 'type': 'DRUG', 'description': 'Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.', 'armGroupLabels': ['Initial Treatment: Levocetirizine(LCT)', 'Initial Treatment: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital and Clinics", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Bridgette L. Jones, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital and Clinics"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}