Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-26 @ 5:11 PM
Study NCT ID:
NCT01272635
Status:
COMPLETED
Last Update Posted:
2016-12-28
First Post:
2011-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Preschool Children With Upper Respiratory Tract Illnesses Using Azythromycin and Lower Respiratory Tract Symptoms Using Oral Corticosteroids.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012135', 'term': 'Respiratory Sounds'}], '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'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dtm5@psu.edu', 'phone': '717-531-7178', 'title': 'David Mauger', 'organization': 'Penn State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Azythromycin', 'description': 'Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day', 'otherNumAtRisk': 307, 'otherNumAffected': 179, 'seriousNumAtRisk': 307, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day', 'otherNumAtRisk': 300, 'otherNumAffected': 180, 'seriousNumAtRisk': 300, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Acute nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 60, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 47, 'numAffected': 43}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Acute Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 93, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 98, 'numAffected': 86}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 62, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 59, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 79, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 85, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'seriousEvents': [{'term': 'Asthma exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Acute bronchitis/wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Viral Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Complex Febrile Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression to Clinically Significant Lower Respiratory Tract Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azythromycin', 'description': 'Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.41', 'ciUpperLimit': '0.98', 'estimateComment': 'Hazard ratio: Numerator is Azithromycin and Denominator is Placebo', 'statisticalMethod': 'Discrete time survival analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '14 days after initiation of APRIL therapy', 'description': 'Progression to clinically significant lower respiratory tract symptoms defined by: (1) having symptoms that were more than mild after 3 albuterol administrations over 1 hour, or (2) requiring albuterol administrations more often than once every 4 hours, or (3) requiring more than 6 albuterol treatments over a 24-hour period, or (4) having moderate to severe cough or wheeze for 5 or more days since study medication was initiated.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated APRIL therapy'}, {'type': 'PRIMARY', 'title': 'OCELOT: Pediatric Respiratory Assessment Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone', 'description': 'Active Prednisone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Prednisone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '0.82', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '1.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36-72 hours after initiation of OCELOT therapy', 'description': 'The Pediatric Respiratory Assessment Measure (PRAM) is a composite outcome with scores ranging from 0-12 with higher numbers representing worse symptoms. The score is calculated as the sum total of the follow five elements: (1) scalene retractions, (2) suprasternal retractions, (3) wheezing, (4) air entry, (5) oxygen saturation. A complete description can be found in: Ducharme FM, Chalut D, Plotnick L, et al. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr 2008;152:476-80.', 'unitOfMeasure': 'PRAM score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who developed severe lower respiratory tract infections and initiate blinded OCELOT therapy.'}, {'type': 'SECONDARY', 'title': 'Asthma Related Symptoms Among RTI Progressing to Severe LRTI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azythromycin', 'description': 'Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '140', 'spread': '74', 'groupId': 'OG000'}, {'value': '195', 'spread': '137', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days after initiation of therapy', 'description': 'Asthma related symptoms as measured by the parent-completed Pre-school Asthma Symptom Diary (PAD). The PAD was completed daily starting on the first day of an illness and continued until the participant was symptom-free for 2 days. It contains questions of frequency of respiratory symptoms, each scored on a scale of 1 through 7, with higher scores representing increasingly frequent symptoms, with daily scores ranging from 0 (asymptomatic) to a maximum of 102. The total PAD score is the sum of the daily individual symptom scores over the duration of the illness, with higher scores representing more frequent symptoms.', 'unitOfMeasure': 'PAD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Respiratory Tract Infections (RTI) progressing to Severe Lower RTI'}, {'type': 'SECONDARY', 'title': 'Absence From School, Daycare, and/or Parental Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azythromycin', 'description': 'Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day'}], 'timeFrame': '14 days after initiation of therapy', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were of insufficient quality to be analyzed.'}, {'type': 'SECONDARY', 'title': 'Urgent Care Visits, ED Visits and Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azythromycin', 'description': 'Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days after initiation of therapy', 'description': 'Number of participants who had urgent care visits, ED visits, and/or hospitalizations for respiratory symptoms.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who initiated APRIL therapy'}, {'type': 'SECONDARY', 'title': 'Drug Related Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azythromycin', 'description': 'Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days after initiation of therapy', 'description': 'Parent-reported gastrointestinal symptoms during treated RTI.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azithromycin/Prednisolone', 'description': 'Active Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day\n\nActive Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day'}, {'id': 'FG001', 'title': 'Azithromycin/Placebo', 'description': 'Active Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day\n\nPlacebo Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day'}, {'id': 'FG002', 'title': 'Placebo/Prednisolone', 'description': 'Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day\n\nActive Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day'}, {'id': 'FG003', 'title': 'Placebo/Placebo', 'description': 'Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day\n\nPlacebo Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '154'}, {'groupId': 'FG002', 'numSubjects': '148'}, {'groupId': 'FG003', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '117'}, {'groupId': 'FG003', 'numSubjects': '129'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '23'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '607', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Azythromycin', 'description': 'Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'spread': '16.5', 'groupId': 'BG000'}, {'value': '41.1', 'spread': '16.4', 'groupId': 'BG001'}, {'value': '41.5', 'spread': '16.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '307', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '607', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Urgent care or ED visits in prior year', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '2.5', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'visits', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Wheezing episodes in prior year', 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '4.4', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '4.5', 'spread': '3.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'episodes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hospitalizations for respiratory symptoms in prior year', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Hospitalizations', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 607}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-01-07', 'resultsFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2011-01-07', 'lastUpdatePostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-01', 'studyFirstPostDateStruct': {'date': '2011-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression to Clinically Significant Lower Respiratory Tract Symptoms', 'timeFrame': '14 days after initiation of APRIL therapy', 'description': 'Progression to clinically significant lower respiratory tract symptoms defined by: (1) having symptoms that were more than mild after 3 albuterol administrations over 1 hour, or (2) requiring albuterol administrations more often than once every 4 hours, or (3) requiring more than 6 albuterol treatments over a 24-hour period, or (4) having moderate to severe cough or wheeze for 5 or more days since study medication was initiated.'}, {'measure': 'OCELOT: Pediatric Respiratory Assessment Measure', 'timeFrame': '36-72 hours after initiation of OCELOT therapy', 'description': 'The Pediatric Respiratory Assessment Measure (PRAM) is a composite outcome with scores ranging from 0-12 with higher numbers representing worse symptoms. The score is calculated as the sum total of the follow five elements: (1) scalene retractions, (2) suprasternal retractions, (3) wheezing, (4) air entry, (5) oxygen saturation. A complete description can be found in: Ducharme FM, Chalut D, Plotnick L, et al. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr 2008;152:476-80.'}], 'secondaryOutcomes': [{'measure': 'Asthma Related Symptoms Among RTI Progressing to Severe LRTI', 'timeFrame': '14 days after initiation of therapy', 'description': 'Asthma related symptoms as measured by the parent-completed Pre-school Asthma Symptom Diary (PAD). The PAD was completed daily starting on the first day of an illness and continued until the participant was symptom-free for 2 days. It contains questions of frequency of respiratory symptoms, each scored on a scale of 1 through 7, with higher scores representing increasingly frequent symptoms, with daily scores ranging from 0 (asymptomatic) to a maximum of 102. The total PAD score is the sum of the daily individual symptom scores over the duration of the illness, with higher scores representing more frequent symptoms.'}, {'measure': 'Absence From School, Daycare, and/or Parental Work', 'timeFrame': '14 days after initiation of therapy'}, {'measure': 'Urgent Care Visits, ED Visits and Hospitalizations', 'timeFrame': '14 days after initiation of therapy', 'description': 'Number of participants who had urgent care visits, ED visits, and/or hospitalizations for respiratory symptoms.'}, {'measure': 'Drug Related Side Effects', 'timeFrame': '14 days after initiation of therapy', 'description': 'Parent-reported gastrointestinal symptoms during treated RTI.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Asthma', 'Wheezing', 'Respiratory Tract Illness', 'Azythromycin', 'Prednisolone', 'Preschool-age'], 'conditions': ['Asthma', 'Wheezing']}, 'referencesModule': {'references': [{'pmid': '36738927', 'type': 'DERIVED', 'citation': 'Fitzpatrick AM, Grunwell JR, Cottrill KA, Mutic AD, Mauger DT. Blood Eosinophils for Prediction of Exacerbation in Preschool Children With Recurrent Wheezing. J Allergy Clin Immunol Pract. 2023 May;11(5):1485-1493.e8. doi: 10.1016/j.jaip.2023.01.037. Epub 2023 Feb 3.'}, {'pmid': '26575060', 'type': 'DERIVED', 'citation': 'Bacharier LB, Guilbert TW, Mauger DT, Boehmer S, Beigelman A, Fitzpatrick AM, Jackson DJ, Baxi SN, Benson M, Burnham CD, Cabana M, Castro M, Chmiel JF, Covar R, Daines M, Gaffin JM, Gentile DA, Holguin F, Israel E, Kelly HW, Lazarus SC, Lemanske RF Jr, Ly N, Meade K, Morgan W, Moy J, Olin T, Peters SP, Phipatanakul W, Pongracic JA, Raissy HH, Ross K, Sheehan WJ, Sorkness C, Szefler SJ, Teague WG, Thyne S, Martinez FD. Early Administration of Azithromycin and Prevention of Severe Lower Respiratory Tract Illnesses in Preschool Children With a History of Such Illnesses: A Randomized Clinical Trial. JAMA. 2015 Nov 17;314(19):2034-2044. doi: 10.1001/jama.2015.13896.'}]}, 'descriptionModule': {'briefSummary': 'This protocol is comprised of two separate, but linked, clinical trials for treating preschool-aged children with recurrent severe episodes of wheezing. The first study (APRIL) will try to prevent wheezing illness from developing using azithromycin. If a wheezing illness does occur, the second trial (OCELOT) will try to decrease the severity of symptoms using oral corticosteroids.', 'detailedDescription': "Preschool aged children often have severe bouts of coughing and/or wheezing that lead to visits to the doctor's office, urgent care, emergency room and often hospitalization. APRIL-OCELOT is a randomized, double-blind, placebo controlled study in 600 preschool children with a history of significant wheezing episodes in the year prior to enrollment. All children enter the APRIL portion of the study, which will compare azithromycin to placebo, given for 5 days during the early signs of an upper respiratory tract illness, for preventing the development of lower respiratory tract symptoms. APRIL is a 78 week study, but participation will end earlier if the child requires a fourth course of APRIL treatment or develops significant lower respiratory tract symptoms. Only those children who develop significant lower respiratory tract symptoms during APRIL will enter the OCELOT portion of the study, which will compare oral corticosteroid to placebo for treating lower respiratory tract symptoms as measured by the Pediatric Respiratory Assessment Measure (PRAM). OCELOT participation will be complete after 14 days. Children may not reenter APRIL after completing OCELOT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '71 Months', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 12-71 months of age.\n* Recurrent significant wheezing in the past year (any of the following):\n\n * \\>3 episodes, ≥1 of which was clinically significant\\*; OR\n * \\>2 clinically significant\\* episodes; OR\n * \\>4 months of daily controller therapy AND \\>1 clinically significant\\* episode.\n * \\* Clinically significant episode: requiring any of the following: (1) systemic corticosteroids (oral or injectable), (2) unscheduled physician office visit, (3) ED visit, (4) urgent care visit, or (5) hospitalization.\n* Up to date with immunizations, including varicella (unless the subject has already had clinical varicella). If the subject needs varicella vaccine, this will be arranged with the primary care physician and must be received prior to randomization.\n* Willingness to provide informed consent by the child's parent or guardian.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria are NOT eligible for enrollment, but may be re-enrolled if these exclusion criteria are resolved:\n\n* \\>4 courses of systemic corticosteroids in past 12 months.\n* More than 1 hospitalization for wheezing illnesses within the preceding 12 months.\n* Use of long-term controller medications for asthma, including inhaled corticosteroids, leukotriene modifiers, cromolyn/nedocromil, or theophylline for more than 8 months (cumulative use) in the past 12 months.\n* Current use of higher than step 2 NAEPP asthma guideline therapy (e.g. medium-high dose ICS alone or combination therapy of low-medium-high dose ICS + LABA, montelukast, theophylline or cromolyn). NOTE: children who have evidence of well-controlled symptoms immediately preceding study entry while receiving Step 2 controller therapy (presence of self-reported symptoms on average no more than 2 times per week and less than 2 nights per month of nocturnal awakenings, requiring albuterol, during the 4 weeks preceding visit 1) may be enrolled and will have their controller therapy discontinued upon study entry.\n* Use of OCS in the past 2 weeks.\n* Daily symptoms or \\>2 nocturnal awakenings, requiring albuterol, on average in the last 2 weeks.\n* Use of antibiotics in the past month.\n* Current treatment with antibiotics for diagnosed sinus disease.\n* Participation presently or in the past month in another investigational drug trial.\n* Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before trial completion.\n* Contraindication of use of systemic corticosteroids or azithromycin.\n* Clinically relevant gastroesophageal reflux.\n* Concurrent medical conditions other than asthma that are likely to require oral or injectable corticosteroids during the study.\n* If receiving allergy shots, change in dose within the past 3 months.\n\nParticipants who meet any of the following criteria are NOT eligible for enrollment, and may not be re-enrolled:\n\n* Gestation less than late preterm as defined as birth before 34 weeks gestational age.\n* Presence of lung disease other than asthma, such as cystic fibrosis and BPD. Evaluation during the screening process will assure that an adequate evaluation of other lung diseases has been performed.\n* Presence of other significant medical illnesses (cardiac, liver, gastrointestinal, endocrine) that would place the study subject at increased risk of participating in the study.\n* Immunodeficiency disorders.\n* History of respiratory failure requiring mechanical ventilation.\n* History of hypoxic seizure.\n* History of significant adverse reaction to any study medication ingredient.\n* The child has significant developmental delay/failure to thrive, defined as crossing of two major percentile lines during the last year for age and gender. If a child plots less than the 10th percentile for age and gender, a growth chart for the previous year will be obtained from the child's primary care provider."}, 'identificationModule': {'nctId': 'NCT01272635', 'acronym': 'APRIL - OCELOT', 'briefTitle': 'Treatment of Preschool Children With Upper Respiratory Tract Illnesses Using Azythromycin and Lower Respiratory Tract Symptoms Using Oral Corticosteroids.', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Azithromycin for Preventing the Development of Upper Respiratory Tract Illness Into Lower Respiratory Tract Symptoms in Children and Oral Corticosteroids for Treating Episodes of Significant Lower Respiratory Tract Symptoms in Children', 'orgStudyIdInfo': {'id': 'AsthmaNet 002'}, 'secondaryIdInfos': [{'id': '1U10HL098115', 'link': 'https://reporter.nih.gov/quickSearch/1U10HL098115', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azythromycin (APRIL) and Prednisolone (OCELOT)', 'interventionNames': ['Drug: Azithromycin', 'Drug: Prednisolone']}, {'type': 'EXPERIMENTAL', 'label': 'Azythromycin (APRIL) and Placebo (OCELOT)', 'interventionNames': ['Drug: Azithromycin', 'Drug: Placebo Prednisolone']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo (APRIL) and Prednisolone (OCELOT)', 'interventionNames': ['Drug: Prednisolone', 'Other: Placebo Azithromycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (APRIL) and Placebo (OCELOT)', 'interventionNames': ['Other: Placebo Azithromycin', 'Drug: Placebo Prednisolone']}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'description': 'Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day', 'armGroupLabels': ['Azythromycin (APRIL) and Placebo (OCELOT)', 'Azythromycin (APRIL) and Prednisolone (OCELOT)']}, {'name': 'Prednisolone', 'type': 'DRUG', 'description': 'Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day', 'armGroupLabels': ['Azythromycin (APRIL) and Prednisolone (OCELOT)', 'Placebo (APRIL) and Prednisolone (OCELOT)']}, {'name': 'Placebo Azithromycin', 'type': 'OTHER', 'description': 'Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day', 'armGroupLabels': ['Placebo (APRIL) and Placebo (OCELOT)', 'Placebo (APRIL) and Prednisolone (OCELOT)']}, {'name': 'Placebo Prednisolone', 'type': 'DRUG', 'description': 'Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day', 'armGroupLabels': ['Azythromycin (APRIL) and Placebo (OCELOT)', 'Placebo (APRIL) and Placebo (OCELOT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona College of Medicine', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital & Research Center Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Memorial Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '53972', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53223', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Center for Urban Population Health', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'William B Busse, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Wisconsin, Madison'}, {'name': 'Leonard B Bacharier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}, {'name': 'Fernando D Martinez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}, {'name': 'David T Mauger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State University'}, {'name': 'Robert F Lemanske, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}, {'name': 'Wanda Phipatanakul, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}, {'name': 'Jacqueline Pongracic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}, {'name': 'David Gozal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Comer Children's Hospital"}, {'name': 'James Moy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}, {'name': 'Stanley Szefler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Jewish Health'}, {'name': 'Hengameh Raissy, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}, {'name': 'Elizabeth Bade, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aurora Sinai Medical Center'}, {'name': 'Fernando Holguin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'James Chmiel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University School of Medicine'}, {'name': 'Michael Cabana, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Mindy Benson, PNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "UCSF Benioff Children's Hospital Oakland"}, {'name': 'W. Gerald Teague, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia Health System'}, {'name': 'Anne Fitzpatrick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, AsthmaNet Data Coordinating Center', 'investigatorFullName': 'dave mauger', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}