Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-03-01 @ 6:12 AM
Study NCT ID:
NCT00569192
Status:
COMPLETED
Last Update Posted:
2014-01-09
First Post:
2007-12-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'dkellerman@mappharma.com', 'phone': '650-386-3100', 'title': 'VP, Scientific Affairs', 'organization': 'MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'All randomized patients who received at least one dose of study drug and who have at least one post dosing safety evaluation were included in the adverse event analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo delivered by nebulization twice daily for 12 weeks', 'otherNumAtRisk': 110, 'otherNumAffected': 33, 'seriousNumAtRisk': 110, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '0.135 mg MAP0010', 'description': '0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks', 'otherNumAtRisk': 123, 'otherNumAffected': 31, 'seriousNumAtRisk': 123, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': '0.25 mg MAP0010', 'description': '0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks', 'otherNumAtRisk': 123, 'otherNumAffected': 42, 'seriousNumAtRisk': 123, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Upper Respiratory Tract Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'Pneumonia Necrotising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Daytime Composite Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo delivered by nebulization twice daily for 12 weeks'}, {'id': 'OG001', 'title': '0.135 mg MAP0010', 'description': '0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}, {'id': 'OG002', 'title': '0.25 mg MAP0010', 'description': '0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.73', 'spread': '1.406', 'groupId': 'OG000'}, {'value': '2.96', 'spread': '1.329', 'groupId': 'OG001'}, {'value': '2.87', 'spread': '1.383', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at week 12', 'categories': [{'measurements': [{'value': '-1.38', 'spread': '1.722', 'groupId': 'OG000'}, {'value': '-1.77', 'spread': '1.618', 'groupId': 'OG001'}, {'value': '-1.56', 'spread': '1.591', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 12', 'description': "The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.\n\nThe individual symptoms were scored using a four point scale:\n\n0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms\n\nDaily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 7 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FEV1% Predicted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo delivered by nebulization twice daily for 12 weeks'}, {'id': 'OG001', 'title': '0.135 mg MAP0010', 'description': '0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}, {'id': 'OG002', 'title': '0.25 mg MAP0010', 'description': '0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '96.96', 'spread': '18.646', 'groupId': 'OG000'}, {'value': '91.20', 'spread': '17.713', 'groupId': 'OG001'}, {'value': '93.00', 'spread': '17.305', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 12', 'categories': [{'measurements': [{'value': '1.51', 'spread': '13.068', 'groupId': 'OG000'}, {'value': '4.14', 'spread': '12.845', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '16.657', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 12', 'description': 'The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer and the largest volume from the 3 maneuvers was selected. An increase indicates an improvement (a greater volume of air expired).', 'unitOfMeasure': 'percentage of predicted FEV1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified-intent-to-treat population includes all randomized patients who were deemed capable of spirometry measurements at baseline and at least at one of the post treatment visits.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Nighttime Composite Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo delivered by nebulization twice daily for 12 weeks'}, {'id': 'OG001', 'title': '0.135 mg MAP0010', 'description': '0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}, {'id': 'OG002', 'title': '0.25 mg MAP0010', 'description': '0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.71', 'spread': '1.393', 'groupId': 'OG000'}, {'value': '2.97', 'spread': '1.466', 'groupId': 'OG001'}, {'value': '2.82', 'spread': '1.349', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at week 12', 'categories': [{'measurements': [{'value': '-1.47', 'spread': '1.572', 'groupId': 'OG000'}, {'value': '-1.82', 'spread': '1.907', 'groupId': 'OG001'}, {'value': '-1.59', 'spread': '1.516', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 12', 'description': "The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.\n\nThe individual symptoms were scored using a four point scale:\n\n0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms\n\nNightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 7 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PEF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo delivered by nebulization twice daily for 12 weeks'}, {'id': 'OG001', 'title': '0.135 mg MAP0010', 'description': '0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}, {'id': 'OG002', 'title': '0.25 mg MAP0010', 'description': '0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '170.94', 'spread': '49.343', 'groupId': 'OG000'}, {'value': '163.39', 'spread': '52.881', 'groupId': 'OG001'}, {'value': '165.34', 'spread': '49.133', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 12', 'categories': [{'measurements': [{'value': '0.71', 'spread': '44.544', 'groupId': 'OG000'}, {'value': '20.10', 'spread': '45.444', 'groupId': 'OG001'}, {'value': '15.02', 'spread': '45.306', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 12', 'description': 'The peak expiratory flow (PEF) is the highest air flow achieved from a maximum forced expiratory maneuver measured in liters of air per minute (L/min). Subjects had to perform at least 3 acceptable maneuvers into a PEF meter. An increase indicates an improvement (a greater volume of air expired).', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified-intent-to-treat population includes all randomized patients who were deemed capable of spirometry measurements at baseline and at least at one of the post treatment visits.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daytime Individual Symptom Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo delivered by nebulization twice daily for 12 weeks'}, {'id': 'OG001', 'title': '0.135 mg MAP0010', 'description': '0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}, {'id': 'OG002', 'title': '0.25 mg MAP0010', 'description': '0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}], 'classes': [{'title': 'Cough: Baseline', 'categories': [{'measurements': [{'value': '1.16', 'spread': '0.544', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.490', 'groupId': 'OG001'}, {'value': '1.18', 'spread': '0.582', 'groupId': 'OG002'}]}]}, {'title': 'Cough: Change from Baseline at week 12', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.734', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.705', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '0.664', 'groupId': 'OG002'}]}]}, {'title': 'Wheeze: Baseline', 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.591', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.546', 'groupId': 'OG001'}, {'value': '0.88', 'spread': '0.550', 'groupId': 'OG002'}]}]}, {'title': 'Wheeze: Change from Baseline at week 12', 'categories': [{'measurements': [{'value': '-0.45', 'spread': '0.615', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.563', 'groupId': 'OG001'}, {'value': '-0.49', 'spread': '0.589', 'groupId': 'OG002'}]}]}, {'title': 'Shortness of Breath: Baseline', 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.557', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.612', 'groupId': 'OG001'}, {'value': '0.81', 'spread': '0.602', 'groupId': 'OG002'}]}]}, {'title': 'Shortness of Breath: Change from Baseline at Wk 12', 'categories': [{'measurements': [{'value': '-0.37', 'spread': '0.635', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.632', 'groupId': 'OG001'}, {'value': '-0.49', 'spread': '0.626', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 12', 'description': "The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.\n\nThe individual symptoms were scored using a four point scale:\n\n0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms\n\nIndividual Daytime symptom score is defined as an average of the last 5 days' individual symptom scores within the last 7 days immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Nighttime Individual Symptom Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo delivered by nebulization twice daily for 12 weeks'}, {'id': 'OG001', 'title': '0.135 mg MAP0010', 'description': '0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}, {'id': 'OG002', 'title': '0.25 mg MAP0010', 'description': '0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}], 'classes': [{'title': 'Cough: Baseline', 'categories': [{'measurements': [{'value': '1.16', 'spread': '0.528', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '0.495', 'groupId': 'OG001'}, {'value': '1.17', 'spread': '0.565', 'groupId': 'OG002'}]}]}, {'title': 'Cough: Change from Baseline at week 12', 'categories': [{'measurements': [{'value': '-0.59', 'spread': '0.663', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '0.720', 'groupId': 'OG001'}, {'value': '-0.61', 'spread': '0.638', 'groupId': 'OG002'}]}]}, {'title': 'Wheeze: Baseline', 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.563', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '0.592', 'groupId': 'OG001'}, {'value': '0.90', 'spread': '0.548', 'groupId': 'OG002'}]}]}, {'title': 'Wheeze: Change from Baseline at week 12', 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.594', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.704', 'groupId': 'OG001'}, {'value': '-0.51', 'spread': '0.603', 'groupId': 'OG002'}]}]}, {'title': 'Shortness of Breath: Baseline', 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.543', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.622', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '0.569', 'groupId': 'OG002'}]}]}, {'title': 'Shortness of Breath: Change from Baseline at Wk 12', 'categories': [{'measurements': [{'value': '-0.39', 'spread': '0.549', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.690', 'groupId': 'OG001'}, {'value': '-0.47', 'spread': '0.566', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, week 12', 'description': "The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.\n\nThe individual symptoms were scored using a four point scale:\n\n0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms\n\nIndividual nighttime symptom score is defined as an average of the last 5 nights' individual symptom scores within the last 7 nights immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo delivered by nebulization twice daily for 12 weeks'}, {'id': 'FG001', 'title': '0.135 mg MAP0010', 'description': '0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}, {'id': 'FG002', 'title': '0.25 mg MAP0010', 'description': '0.125mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '125'}, {'groupId': 'FG002', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '105'}, {'groupId': 'FG002', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '25'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '360', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo delivered by nebulization twice daily for 12 weeks'}, {'id': 'BG001', 'title': '0.135 mg MAP0010', 'description': '0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}, {'id': 'BG002', 'title': '0.25 mg MAP0010', 'description': '0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '2.17', 'groupId': 'BG000'}, {'value': '4.4', 'spread': '2.33', 'groupId': 'BG001'}, {'value': '4.2', 'spread': '2.27', 'groupId': 'BG002'}, {'value': '4.4', 'spread': '2.26', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '4.0', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '4.0', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '4.0', 'groupId': 'BG003', 'lowerLimit': '1', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '216', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-09', 'studyFirstSubmitDate': '2007-12-05', 'resultsFirstSubmitDate': '2013-08-19', 'studyFirstSubmitQcDate': '2007-12-05', 'lastUpdatePostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-08-19', 'studyFirstPostDateStruct': {'date': '2007-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Daytime Composite Symptom Score', 'timeFrame': 'baseline, week 12', 'description': "The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.\n\nThe individual symptoms were scored using a four point scale:\n\n0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms\n\nDaily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 7 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."}, {'measure': 'Change From Baseline in Nighttime Composite Symptom Score', 'timeFrame': 'baseline, week 12', 'description': "The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.\n\nThe individual symptoms were scored using a four point scale:\n\n0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms\n\nNightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 7 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in FEV1% Predicted', 'timeFrame': 'baseline, week 12', 'description': 'The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer and the largest volume from the 3 maneuvers was selected. An increase indicates an improvement (a greater volume of air expired).'}, {'measure': 'Change From Baseline in PEF', 'timeFrame': 'baseline, week 12', 'description': 'The peak expiratory flow (PEF) is the highest air flow achieved from a maximum forced expiratory maneuver measured in liters of air per minute (L/min). Subjects had to perform at least 3 acceptable maneuvers into a PEF meter. An increase indicates an improvement (a greater volume of air expired).'}, {'measure': 'Change From Baseline in Daytime Individual Symptom Scores', 'timeFrame': 'baseline, week 12', 'description': "The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.\n\nThe individual symptoms were scored using a four point scale:\n\n0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms\n\nIndividual Daytime symptom score is defined as an average of the last 5 days' individual symptom scores within the last 7 days immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."}, {'measure': 'Change From Baseline in Nighttime Individual Symptom Scores', 'timeFrame': 'baseline, week 12', 'description': "The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.\n\nThe individual symptoms were scored using a four point scale:\n\n0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms\n\nIndividual nighttime symptom score is defined as an average of the last 5 nights' individual symptom scores within the last 7 nights immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['asthmatic children'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female asthmatic children with mild to moderate persistent asthma.\n* 12 months to 8 years of age.\n* For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.\n* For infants age 12 to \\<48 months old: 2 or more wheezing episodes in past 12 months which lasted \\> 1 day and affected sleep.\n* AND with at least one major or two minor risk factors.\n\nExclusion Criteria:\n\n* Any other significant childhood illness/abnormality or chronic lung disease\n* Any history of upper or lower respiratory tract infection, within 2 weeks of screening.\n* Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.\n* Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.\n* Any use of oral corticosteroids within 30 days of screening or prolonged use (\\>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.'}, 'identificationModule': {'nctId': 'NCT00569192', 'briefTitle': 'A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controlled, Parallel Group, Study Investigating the Safety and Efficacy Over 12 Weeks Treatment Period of MAP0010 in Asthmatic Infants and Children 12 Months to 8 Years of Age', 'orgStudyIdInfo': {'id': 'MAP0010-CL-P301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.25mg MAP0010', 'description': '0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks', 'interventionNames': ['Drug: 0.25mg MAP0010']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo delivered by nebulization twice daily for 12 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '0.135mg MAP0010', 'description': '0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks', 'interventionNames': ['Drug: 0.135mg MAP0010']}], 'interventions': [{'name': '0.135mg MAP0010', 'type': 'DRUG', 'description': '0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks', 'armGroupLabels': ['0.135mg MAP0010']}, {'name': '0.25mg MAP0010', 'type': 'DRUG', 'description': '0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks', 'armGroupLabels': ['0.25mg MAP0010']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo delivered by nebulization twice daily for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MAP Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}