Raw JSON
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Higher scores indicate a worse quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mometasone Furoate', 'description': '2 weeks of treatment\n\nmometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': '2 weeks of treatment\n\nplacebo : 2 puffs in each nostril once a day for 2 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mometasone Furoate', 'description': '2 weeks of treatment\n\nmometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': '2 weeks of treatment\n\nplacebo : 2 puffs in each nostril once a day for 2 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'spread': '9.36', 'groupId': 'BG000'}, {'value': '35', 'spread': '12', 'groupId': 'BG001'}, {'value': '33.8', 'spread': '10.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-21', 'studyFirstSubmitDate': '2008-02-06', 'resultsFirstSubmitDate': '2013-11-21', 'studyFirstSubmitQcDate': '2008-02-19', 'lastUpdatePostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-21', 'studyFirstPostDateStruct': {'date': '2008-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Assessment', 'timeFrame': 'at week 2', 'description': 'Global Assessment: 3=significantly improved, 2=moderately improved,\n\n1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse'}], 'secondaryOutcomes': [{'measure': 'Changes in RQLQ: Overall', 'timeFrame': 'Baseline and 2 weeks', 'description': "The RQLQ is a disease-specific measure of a patient's quality of life. It includes domains that measure nasal and eye symptoms as well as those of activity, sleep, non-nasal/eye symptoms, practical and emotional measures. A scale of 0-6 is used to record the patient responses, with lower scores reflecting a better quality of life. The average score of each domain is calculated as well as an overall domain score reflecting the average of all scores."}, {'measure': 'Changes in RQLQ: Activity', 'timeFrame': 'Baseline and 2 weeks', 'description': 'The RQLQ activity range: 0-6. Higher scores indicate a worse quality of life.'}, {'measure': 'Changes in RQLQ: Sleep', 'timeFrame': 'Baseline and 2 weeks', 'description': 'The RQLQ sleep range: 0-6. Higher scores indicate a worse quality of life.'}, {'measure': 'Changes in RQLQ: Non-Nasal/Eye', 'timeFrame': 'Baseline and 2 weeks', 'description': 'The RQLQ non-nasal/eye range: 0-6. Higher scores indicate a worse quality of life.'}, {'measure': 'Changes in RQLQ: Practical', 'timeFrame': 'Baseline and 2 weeks', 'description': 'The RQLQ practical range: 0-6. Higher scores indicate a worse quality of life.'}, {'measure': 'Changes in RQLQ: Nasal', 'timeFrame': 'Baseline and 2 weeks', 'description': 'The RQLQ nasal range: 0-6. Higher scores indicate a worse quality of life.'}, {'measure': 'Changes in RQLQ: Emotional', 'timeFrame': 'Baseline and 2 weeks', 'description': 'The RQLQ emotional range: 0-6. Higher scores indicate a worse quality of life.'}, {'measure': 'Changes in RQLQ: Eye', 'timeFrame': 'Baseline and 2 weeks', 'description': 'The RQLQ eye range: 0-6. Higher scores indicate a worse quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Seasonal Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '21262099', 'type': 'DERIVED', 'citation': 'Sharma S, Vasnani R, De Tineo M, Du G, Pinto JM, Baroody FM, Naclerio RM. Recruitment factors which affect the outcome of a seasonal allergic rhinitis trial. Allergy Asthma Proc. 2011 Jan-Feb;32(1):55-63. doi: 10.2500/aap.2011.32.3414.'}]}, 'descriptionModule': {'briefSummary': 'We hypothesize that those patients with purely seasonal allergic rhinitis will decongest better than those subjects with another cause contributing to their symptoms. These latter patients will not improve as well on an intranasal steroid as those who decongest well, potentially explaining the 60% response rate in prior studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Males and females between 18 and 60 years of age.\n2. History of grass and/or ragweed allergic rhinitis.\n3. Positive skin or RAST test to grass, trees and/or ragweed antigen.\n4. Symptomatic at time of entry into study.\n\nExclusion Criteria\n\n1. Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are pregnant or breastfeeding.\n2. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).\n3. Use of any other investigational agent in the last 30 days.\n4. Absence of nasal symptoms.\n5. Smoking.\n6. URI at the time of screening.'}, 'identificationModule': {'nctId': 'NCT00618332', 'briefTitle': 'Can a Nasal Decongestant Test Predict Treatment Outcomes in Seasonal Allergic Rhinitis?', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Does the Response to a Nasal Decongestant Test Predict the Outcome to Treatment of Seasonal Allergic Rhinitis With Nasonex?', 'orgStudyIdInfo': {'id': '15624B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '2 weeks of treatment', 'interventionNames': ['Drug: mometasone furoate nasal spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': '2 weeks of treatment', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'mometasone furoate nasal spray', 'type': 'DRUG', 'otherNames': ['Nasonex'], 'description': '2 puffs in each nostril once a day for 2 weeks', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['placebo comparator for Nasonex'], 'description': '2 puffs in each nostril once a day for 2 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Robert M Naclerio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Schering-Plough', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}