Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT00590005
Status:
COMPLETED
Last Update Posted:
2014-02-10
First Post:
2007-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Redox Determinants of Severe Asthma (a Substudy of the Severe Asthma Research Program)
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anne.fitzpatrick@emory.edu', 'phone': '404-727-9112', 'title': 'Dr. Anne Fitzpatrick, Director, Emory Asthma Clinical Research Program', 'organization': 'Emory University Department of Pediatrics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'adverse event data were collected for 3 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Children With Severe Asthma', 'description': 'This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)', 'otherNumAtRisk': 106, 'otherNumAffected': 0, 'seriousNumAtRisk': 106, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Children With Non-severe Asthma', 'description': 'This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.', 'otherNumAtRisk': 119, 'otherNumAffected': 0, 'seriousNumAtRisk': 119, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Exhaled Nitric Oxide at Baseline and Over the Observational Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children With Severe Asthma', 'description': 'This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)'}, {'id': 'OG001', 'title': 'Children With Non-severe Asthma', 'description': 'This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.'}], 'classes': [{'title': 'Exhaled nitric oxide value at 21 days', 'categories': [{'measurements': [{'value': '15.1', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '5.8', 'groupId': 'OG001'}]}]}, {'title': 'Exhaled nitric oxide baseline value', 'categories': [{'measurements': [{'value': '13.7', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and after 21 days', 'description': 'Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag', 'unitOfMeasure': 'parts per billion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '225 children were enrolled into the study and completed baseline assessments. Only 40 children were followed longitudinally. The results from only those 40 children are shown here.'}, {'type': 'SECONDARY', 'title': 'Reduction in Breath pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children With Severe Asthma', 'description': 'This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)'}, {'id': 'OG001', 'title': 'Children With Non-severe Asthma', 'description': 'This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.'}], 'classes': [{'title': 'Breath pH at 21 days', 'categories': [{'measurements': [{'value': '7.08', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '7.58', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Breath pH at baseline', 'categories': [{'measurements': [{'value': '7.68', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '7.63', 'spread': '0.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 21 days', 'description': 'Breath condensate pH was measured by the RTube (trademark) device. This device is a plastic tube with a one-way exhalation valve and a chilled aluminum sleeve. pH (the log of hydrogen ion concentration) was measured using an Orion pH meter and probe calibrated in 4.0, 7.0, and 10.0 pH solutions.', 'unitOfMeasure': 'log of hydrogen ion concentration (pH)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '225 children with asthma were enrolled in the study and completed baseline assessments. Only 40 children were followed longitudinally. The data from those 40 children are shown here.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Children With Severe Asthma', 'description': 'This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)'}, {'id': 'FG001', 'title': 'Children With Non-severe Asthma', 'description': 'This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Children were recruited from January 2003 to June 2011 from the Emory Children's Center asthma clinic.", 'preAssignmentDetails': 'Children with physician diagnosed asthma were enrolled and underwent comprehensive phenotypic characterization consisting of pulmonary function measures, biomarker assessment, and allergy assessment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Children With Asthma', 'description': 'The cohort consists of children with physician-diagnosed asthma across a wide range of severity (mild, moderate, severe)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '225', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'spread': '3.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '123', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '225', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-14', 'studyFirstSubmitDate': '2007-12-27', 'resultsFirstSubmitDate': '2013-07-10', 'studyFirstSubmitQcDate': '2008-01-09', 'lastUpdatePostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-22', 'studyFirstPostDateStruct': {'date': '2008-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exhaled Nitric Oxide at Baseline and Over the Observational Period', 'timeFrame': 'baseline and after 21 days', 'description': 'Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag'}], 'secondaryOutcomes': [{'measure': 'Reduction in Breath pH', 'timeFrame': 'baseline and 21 days', 'description': 'Breath condensate pH was measured by the RTube (trademark) device. This device is a plastic tube with a one-way exhalation valve and a chilled aluminum sleeve. pH (the log of hydrogen ion concentration) was measured using an Orion pH meter and probe calibrated in 4.0, 7.0, and 10.0 pH solutions.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['severe asthma', 'poorly controlled asthma'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Hypotheses: 1) Airway pH regulation is abnormal in severe asthma; 2) In severe asthma, there is formation of cytotoxic nitrogen oxides and loss of beneficial nitrogen oxides in the airways', 'detailedDescription': 'Specific Aim 1:Test hypothesis that airway pH regulation is abnormal in severe asthma.\n\n1a) Determine the effects of systemic corticosteroids on breath pH in children with severe and mild to moderate asthma.\n\n1b) Examine whether breath condensate pH and other biomarkers of oxidant stress can predict clinical outcomes in children with severe and mild to moderate asthma.\n\n1c) Identify whether increased Th1/Th2 cytokine ratio, and abnormalities in airway glutaminase, G-SNO-reductase, VATPase, and carbonic anhydrase are associated with airway pH disturbance in children with severe asthma.\n\n1d) Test whether rhinovirus infections, which reduce airway pH, persist longer or are more frequent in children with severe asthma than in children with mild to moderate asthma.\n\n1e) Examine the relationship between gastroesophageal reflux and proximal airway pH in children with severe asthma and mild to moderate asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of children with physician-diagnosed asthma in the Atlanta, Georgia area across a wide range of asthma severities (mild, moderate, severe)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 6 years old\n* Asthma diagnosis by physician\n* Current treatment with an inhaled corticosteroid medication\n\nExclusion criteria:\n\n* Bronchiectasis\n* Cystic Fibrosis\n* Chronic Obstructive Pulmonary Disease'}, 'identificationModule': {'nctId': 'NCT00590005', 'acronym': 'SARP', 'briefTitle': 'Redox Determinants of Severe Asthma (a Substudy of the Severe Asthma Research Program)', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Redox Determinants of Severe Asthma: A Substudy of the NHLBI Severe Asthma Research Program', 'orgStudyIdInfo': {'id': 'IRB00024906'}, 'secondaryIdInfos': [{'id': '2R01HL069170-07', 'link': 'https://reporter.nih.gov/quickSearch/2R01HL069170-07', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with severe asthma', 'description': 'This group consists of children with severe asthma as defined per ATS workshop criteria (published in 2000).'}, {'label': 'Children with non-severe asthma', 'description': 'This group includes children with asthma who do not meet the ATS criteria for severe asthma as outlined in the 2000 workshop report.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Childrens Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'W G Teague, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Cleveland Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Anne M Fitzpatrick PhD', 'investigatorAffiliation': 'Emory University'}}}}