Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-02-10 @ 10:02 AM
Study NCT ID:
NCT02404103
Status:
COMPLETED
Last Update Posted:
2017-12-14
First Post:
2015-03-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Flunisolide HFA in Children With Small Airway Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C007734', 'term': 'flunisolide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'n.eid@louisville.edu', 'phone': '502-852-3772', 'title': 'Nemr Eid, MD', 'organization': 'University Louisville'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The small numbers of subjects who qualified and completed the study.'}}, 'adverseEventsModule': {'timeFrame': 'up to 6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Flunisolide 160 mcg Per Day', 'description': 'Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period\n\nFlunisolide HFA', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Flunisolide 320 mcg Per Day', 'description': 'Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period\n\nFlunisolide HFA', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Spirometry Forced Expiratory Volume 1 (FEV1) After Flunisolide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Flunisolide 160 mcg Per Day Pretreatment - Baseline', 'description': 'Baseline value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period\n\nFlunisolide HFA'}, {'id': 'OG001', 'title': 'Flunisolide 320 mcg Per Day Pretreatment - Baseline', 'description': 'Baseline for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period\n\nFlunisolide HFA'}, {'id': 'OG002', 'title': 'Flunisolide 160 mcg Per Day Posttreatment - 6 Wks', 'description': 'After 6 weeks treatment value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period'}, {'id': 'OG003', 'title': 'Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks', 'description': 'After 6 week valeus for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period\n\nFlunisolide HFA'}], 'classes': [{'categories': [{'measurements': [{'value': '80.4', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '78.7', 'spread': '9.0', 'groupId': 'OG001'}, {'value': '85.0', 'spread': '10.3', 'groupId': 'OG002'}, {'value': '77.0', 'spread': '7.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.148', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used', 'nonInferiorityComment': 'The primary goal of the current study is to determine the effects of Aerospan on lung function in children with small airway obstruction with two doses.'}, {'pValue': '.740', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.'}, {'pValue': '.921', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used'}], 'paramType': 'MEAN', 'timeFrame': 'Before and after treatment at baseline and six week followup', 'description': 'the most used outcome in respiratory studies', 'unitOfMeasure': '% of predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those subjects that completed the study protocol.'}, {'type': 'PRIMARY', 'title': 'Impulse Oscillometry (IOS) Area of Reactance (AX) After Flunisolide Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Flunisolide 160 mcg Per Day Pretreatment - Baseline', 'description': 'Before Patients received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period\n\nFlunisolide HFA'}, {'id': 'OG001', 'title': 'Flunisolide 320 mcg Per Day Pretreatment - Baseline', 'description': 'Before Patients received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period\n\nFlunisolide HFA'}, {'id': 'OG002', 'title': 'Flunisolide 160 mcg Per Day Posttreatment - 6 Wks', 'description': 'After 6 weeks treatment value forPatients who received inhaled Flunisolide HFA 80 mg twice per day.'}, {'id': 'OG003', 'title': 'Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks', 'description': 'After 6 weeks treatment value for Patients who received inhaled Flunisolide HFA 160 mg twiece a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '16.6', 'groupId': 'OG001'}, {'value': '18.5', 'spread': '9.6', 'groupId': 'OG002'}, {'value': '14.9', 'spread': '13.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.872', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used', 'nonInferiorityComment': 'The primary goal of the current study is to determine the effects of Aerospan on lung function in children with small airway obstruction.'}, {'pValue': '0.820', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used', 'nonInferiorityComment': 'secondary goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.'}, {'pValue': '0.582', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and six week followup', 'description': 'A composite measure of small airway dysfunction. A reduction in IOS scores indicate an improvement.', 'unitOfMeasure': 'cmH2O/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those subjects that completed the study protocol.'}, {'type': 'PRIMARY', 'title': 'Spirometry Forced Expiratory Flow 25-75% (FEF 25-75%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Flunisolide 160 mcg Per Day Pretreatment - Baseline', 'description': 'Baseline in Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period'}, {'id': 'OG001', 'title': 'Flunisolide 320 mcg Per Day Pretreatment - Baseline', 'description': 'Baseline in patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period'}, {'id': 'OG002', 'title': 'Flunisolide 160 mcg Per Day Posttreatment - 6 Wks', 'description': 'Six week followup in Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period'}, {'id': 'OG003', 'title': 'Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks', 'description': 'Six week followup in patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period'}], 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '61.5', 'spread': '13.7', 'groupId': 'OG001'}, {'value': '57.7', 'spread': '12.1', 'groupId': 'OG002'}, {'value': '65.2', 'spread': '18.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.782', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.', 'nonInferiorityComment': 'The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.'}, {'pValue': '.906', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.', 'nonInferiorityComment': 'The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.'}, {'pValue': '.102', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.', 'nonInferiorityComment': 'The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and six week followup', 'description': 'Indirectly assess small airway function.', 'unitOfMeasure': '% of predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those subjects that completed the study protocol.'}, {'type': 'PRIMARY', 'title': 'Impulse Oscillometry (IOS) Resistance 5 (R5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Flunisolide 160 mcg Per Day Pretreatment - Baseline', 'description': 'Baseline value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period\n\nFlunisolide HFA'}, {'id': 'OG001', 'title': 'Flunisolide 320 mcg Per Day Pretreatment - Baseline', 'description': 'Baseline for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period\n\nFlunisolide HFA'}, {'id': 'OG002', 'title': 'Flunisolide 160 mcg Per Day Posttreatment - 6 Wks', 'description': 'After 6 weeks treatment value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period'}, {'id': 'OG003', 'title': 'Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks', 'description': 'After 6 week valeus for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period\n\nFlunisolide HFA'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '6.0', 'spread': '1.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.620', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.', 'nonInferiorityComment': 'To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.'}, {'pValue': '.543', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used', 'nonInferiorityComment': 'To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.'}, {'pValue': '.6', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used', 'nonInferiorityComment': 'To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.'}], 'paramType': 'MEAN', 'timeFrame': 'initial visit and six week followup', 'description': 'Resistance of the respiratory system at 5 Hz is a measure of total airway resistance. Elevated value is indicative of respiratory dysfunction.', 'unitOfMeasure': 'cmH2O(L/s)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only data for subjects who completed study are presented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flunisolide 160 mcg Per Day', 'description': 'Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period\n\nFlunisolide HFA'}, {'id': 'FG001', 'title': 'Flunisolide 320 mcg Per Day', 'description': 'Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period\n\nFlunisolide HFA'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Flunisolide 160 mcg Per Day', 'description': 'Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period\n\nFlunisolide HFA'}, {'id': 'BG001', 'title': 'Flunisolide 320 mcg Per Day', 'description': 'Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period\n\nFlunisolide HFA'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '11.1', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '10.5', 'spread': '3.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Those subjects that completed the study protocol.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-26', 'size': 174333, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-08-16T14:18', 'hasProtocol': False}, {'date': '2017-02-26', 'size': 486896, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_003.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-11-13T14:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-13', 'studyFirstSubmitDate': '2015-03-18', 'resultsFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2015-03-25', 'lastUpdatePostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-21', 'studyFirstPostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spirometry Forced Expiratory Volume 1 (FEV1) After Flunisolide', 'timeFrame': 'Before and after treatment at baseline and six week followup', 'description': 'the most used outcome in respiratory studies'}, {'measure': 'Impulse Oscillometry (IOS) Area of Reactance (AX) After Flunisolide Treatment', 'timeFrame': 'Baseline and six week followup', 'description': 'A composite measure of small airway dysfunction. A reduction in IOS scores indicate an improvement.'}, {'measure': 'Spirometry Forced Expiratory Flow 25-75% (FEF 25-75%)', 'timeFrame': 'baseline and six week followup', 'description': 'Indirectly assess small airway function.'}, {'measure': 'Impulse Oscillometry (IOS) Resistance 5 (R5)', 'timeFrame': 'initial visit and six week followup', 'description': 'Resistance of the respiratory system at 5 Hz is a measure of total airway resistance. Elevated value is indicative of respiratory dysfunction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Childhood Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see how two doses of Flunisolide HFA (an FDA approved inhaled medication to treat asthma) affect the small airways in children with asthma.', 'detailedDescription': 'This is a prospective, randomized, parallel, open label study. The primary aim is to compare the average change in spirometric values (Forced expiratory volume 1 (FEV1) and Forced Expiratory Flow 25-75% (FEF 25-75%) and Impulse Oscillometry System (IOS) values (Resistance at 5 Hz (R5), Resistance at 20 Hz (R20), Area of reactance (AX), Resonant frequency (Fres)) from baseline to week 6 from participants randomized flunisolide hydrofluoroalkane (HFA) 1 inhalation BID and to flunisolide HFA 2 inhalations BID. The change in scores from baseline to six week follow up will initially be compared using paired t-tests and Chi-squared tests for trend. Repeated measurements will be analyzed using generalized linear mixed-effects regression modeling (GLMM) techniques. For continuous outcomes (e.g. FEV1, FEF 25-75%, Fres, reactance at 5 Hz (X5), AX, R5-R20). The identity link function and normal distribution will be used. For count data (e.g., use of Beta-agonists, episodes of coughing, episodes of wheezing, etc.) the log link function and the Poisson distribution will be used. If we dichotomize outcomes (e.g., a Beta-agonist was used, coughing occurred, etc.) the logit link function and Bernoulli distribution will be used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of asthma\n* Informed consent by parent or legal guardian\n* 6 years to 18 years of age at screening visit\n* ability to comply with medication use, study visits and study procedures as judged by the site investigator\n* FEF 25-75% \\<65% of predicted as a marker for small airway disease\n\nExclusion Criteria:\n\n* Acute wheezing at screening visit or at Baseline visit\n* Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding screening visit or 3 weeks preceding baseline visit\n* Oxygen saturation \\<95% at screening visit or at Baseline visit\n* Clinically significant upper airway obstruction as determined by the Site Investigator (e.g. severe laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnea.\n* Severe gastroesophageal reflux, defined as persistent frequent emesis despite anti-reflux therapy\n* Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator\n* Inhaled Corticosteroids (ICS) use within 7 days of Baseline visit; systemic steroids within 30 days\n* Cystic Fibrosis, Interstitial lung disease (ILD) history of severe Bronchopulmonary dysplasia (BPD) or other underling significant respiratory disease apart from asthma\n* Potential subjects who are pregnant may not enroll in the study'}, 'identificationModule': {'nctId': 'NCT02404103', 'briefTitle': 'Flunisolide HFA in Children With Small Airway Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Flunisolide HFA in Children With Small Airway Disease', 'orgStudyIdInfo': {'id': '14.1024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Flunisolide 160 mcg per day', 'description': 'Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period', 'interventionNames': ['Drug: Flunisolide HFA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flunisolide 320 mcg per day', 'description': 'Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period', 'interventionNames': ['Drug: Flunisolide HFA']}], 'interventions': [{'name': 'Flunisolide HFA', 'type': 'DRUG', 'armGroupLabels': ['Flunisolide 160 mcg per day', 'Flunisolide 320 mcg per day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Pediatric Pulmonology', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'collaborators': [{'name': 'Meda Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Nemr Eid', 'investigatorAffiliation': 'University of Louisville'}}}}