Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-25 @ 11:39 PM
Study NCT ID:
NCT00419757
Status:
COMPLETED
Last Update Posted:
2012-08-27
First Post:
2007-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily', 'otherNumAtRisk': 127, 'otherNumAffected': 69, 'seriousNumAtRisk': 127, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Budesonide', 'description': 'budesonide HFA pMDI 160 μg x 2 actuations twice daily', 'otherNumAtRisk': 123, 'otherNumAffected': 48, 'seriousNumAtRisk': 123, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngitis Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Gastrointestinal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Status Asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Morning Peak Expiratory Flow (AM PEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '25.40', 'spread': '6.0', 'groupId': 'OG000', 'lowerLimit': '+/-6.0'}, {'value': '19.90', 'spread': '6.5', 'groupId': 'OG001', 'lowerLimit': '+/-6.5'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.', 'unitOfMeasure': 'Liters/minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pre-defined Asthma Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '25.20', 'groupId': 'OG000'}, {'value': '31.70', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Asthma Events, defined as any of: decrease in lung function (FEV1 or AM PEF), use of rescue medication over maximum allowed per day, night awakening requiring use of rescue medication, exacerbation of asthma requiring medical assistance, use of not allowed asthma medication', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.10', 'groupId': 'OG000'}, {'value': '6.50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Percentage of participants with "Withdrawals Due to Pre-defined Asthma Events" as recorded in CRF. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '0.03', 'groupId': 'OG000', 'lowerLimit': '+/-0.03'}, {'value': '0.11', 'spread': '0.03', 'groupId': 'OG001', 'lowerLimit': '+/-0.03'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 2, 6 and 12 weeks', 'description': 'Changes in pre-dose FEV1 from baseline to the average value over the treatment period, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '20.60', 'spread': '6.2', 'groupId': 'OG000', 'lowerLimit': '+/-6.2'}, {'value': '15.80', 'spread': '6.7', 'groupId': 'OG001', 'lowerLimit': '+/-6.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks with baseline as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.', 'unitOfMeasure': 'Liters/minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.01', 'groupId': 'OG000', 'lowerLimit': '+/-0.01'}, {'value': '-0.30', 'spread': '0.01', 'groupId': 'OG001', 'lowerLimit': '+/-0.01'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline in average of daily scores for nighttime asthma over 12 weeks of treatment, with baseline value as covariate.\n\nDaily scale:\n\n* 0 = No symptoms\n* 1 = Mild symptoms\n* 2 = Moderate symptoms\n* 3 = Severe symptoms', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.01', 'groupId': 'OG000', 'lowerLimit': '+/-0.01'}, {'value': '-0.30', 'spread': '0.01', 'groupId': 'OG001', 'lowerLimit': '+/-0.01'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline in average of daily scores for daytime asthma over 12 weeks of treatment, with baseline value as covariate.\n\nDaily scale:\n\n* 0 = No symptoms\n* 1 = Mild symptoms\n* 2 = Moderate symptoms\n* 3 = Severe symptoms', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '5.40', 'spread': '1.7', 'groupId': 'OG000', 'lowerLimit': '+/-1.7'}, {'value': '5.50', 'spread': '1.9', 'groupId': 'OG001', 'lowerLimit': '+/-1.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.', 'unitOfMeasure': 'Percentage of nights', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.20', 'groupId': 'OG000', 'lowerLimit': '+/-0.20'}, {'value': '-0.60', 'spread': '0.20', 'groupId': 'OG001', 'lowerLimit': '+/-0.20'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline in rescue medication use over 12 weeks of treatment with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.', 'unitOfMeasure': 'puffs/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '19.70', 'spread': '3.30', 'groupId': 'OG000', 'lowerLimit': '+/-3.30'}, {'value': '17.70', 'spread': '3.50', 'groupId': 'OG001', 'lowerLimit': '+/-3.50'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline in percentage of rescue-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.', 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '24.40', 'spread': '3.30', 'groupId': 'OG000', 'lowerLimit': '+/-3.30'}, {'value': '21.00', 'spread': '3.50', 'groupId': 'OG001', 'lowerLimit': '+/-3.50'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline in percentage of symptom-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.', 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Subject Global Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '88.70', 'groupId': 'OG000'}, {'value': '86.30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 12', 'description': 'The assessment was made using a 5-point Likert scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1 and 2 combined as "Yes" and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Physician Global Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '92.00', 'groupId': 'OG000'}, {'value': '84.60', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 12', 'description': 'The assessment was made using a 5-point scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1and 2 combined as "Yes" and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.', 'unitOfMeasure': 'Perscentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '87.20', 'spread': '1.97', 'groupId': 'OG000', 'lowerLimit': '+/-1.97'}, {'value': '82.50', 'spread': '2.08', 'groupId': 'OG001', 'lowerLimit': '+/-2.08'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'Mean scores (6-points scale, where 1-means the most positive opinion and 6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'budesonide HFA pMDI 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '90.67', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '86.66', 'spread': '1.89', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'Mean scores (6 or 5-points scale, where 1-means the most positive opinion and 5/6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily'}, {'id': 'OG001', 'title': 'Budesonide', 'description': 'budesonide HFA pMDI 160 μg x 2 actuations twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '88.45', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '80.60', 'spread': '2.47', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'Mean scores (5-points scale, where 1-means the most positive opinion and 5-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'FG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized patients', 'groupId': 'FG000', 'numSubjects': '127'}, {'comment': 'Randomized patients', 'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Randomized patients', 'groupId': 'FG000', 'numSubjects': '109'}, {'comment': 'Randomized patients', 'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Study specific discontinuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Multiple reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '39 centres in United States enrolled 558 patients with asthma into this study. 308 patients were excluded: 279 for incorrect enrollment/eligibility criteria not fulfilled, 14 for voluntary discontinuations, 2 for development of study specific discontinuation criteria, 2 for adverse events, 10 were lost to follow-up', 'preAssignmentDetails': 'Male or female, Hispanic (self-reported), ≥12 years'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Symbicort', 'description': 'SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily'}, {'id': 'BG001', 'title': 'Budesonide', 'description': 'Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'spread': '39.8', 'groupId': 'BG000'}, {'value': '14.9', 'spread': '37.0', 'groupId': 'BG001'}, {'value': '15.6', 'spread': '38.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': 558}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-24', 'studyFirstSubmitDate': '2007-01-05', 'resultsFirstSubmitDate': '2009-05-20', 'studyFirstSubmitQcDate': '2007-01-05', 'lastUpdatePostDateStruct': {'date': '2012-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-24', 'studyFirstPostDateStruct': {'date': '2007-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morning Peak Expiratory Flow (AM PEF)', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Pre-defined Asthma Events', 'timeFrame': '12 weeks', 'description': 'Asthma Events, defined as any of: decrease in lung function (FEV1 or AM PEF), use of rescue medication over maximum allowed per day, night awakening requiring use of rescue medication, exacerbation of asthma requiring medical assistance, use of not allowed asthma medication'}, {'measure': 'Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events"', 'timeFrame': '12 weeks', 'description': 'Percentage of participants with "Withdrawals Due to Pre-defined Asthma Events" as recorded in CRF. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'measure': 'Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Baseline, 2, 6 and 12 weeks', 'description': 'Changes in pre-dose FEV1 from baseline to the average value over the treatment period, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'measure': 'Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks with baseline as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'measure': 'Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline in average of daily scores for nighttime asthma over 12 weeks of treatment, with baseline value as covariate.\n\nDaily scale:\n\n* 0 = No symptoms\n* 1 = Mild symptoms\n* 2 = Moderate symptoms\n* 3 = Severe symptoms'}, {'measure': 'Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline in average of daily scores for daytime asthma over 12 weeks of treatment, with baseline value as covariate.\n\nDaily scale:\n\n* 0 = No symptoms\n* 1 = Mild symptoms\n* 2 = Moderate symptoms\n* 3 = Severe symptoms'}, {'measure': 'Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.'}, {'measure': 'Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline in rescue medication use over 12 weeks of treatment with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'measure': 'Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline in percentage of rescue-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'measure': 'Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment', 'timeFrame': 'Baseline (run-in) and throughout 12 weeks', 'description': 'Change from baseline in percentage of symptom-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.'}, {'measure': 'Subject Global Assessment', 'timeFrame': 'Baseline and week 12', 'description': 'The assessment was made using a 5-point Likert scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1 and 2 combined as "Yes" and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.'}, {'measure': 'Physician Global Assessment', 'timeFrame': 'Baseline and week 12', 'description': 'The assessment was made using a 5-point scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1and 2 combined as "Yes" and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.'}, {'measure': 'Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index', 'timeFrame': 'Week 12', 'description': 'Mean scores (6-points scale, where 1-means the most positive opinion and 6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.'}, {'measure': 'Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication', 'timeFrame': 'Week 12', 'description': 'Mean scores (6 or 5-points scale, where 1-means the most positive opinion and 5/6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.'}, {'measure': 'Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications', 'timeFrame': 'Week 12', 'description': 'Mean scores (5-points scale, where 1-means the most positive opinion and 5-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.'}]}, 'conditionsModule': {'keywords': ['Moderate asthma', 'Severe asthma'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '22329608', 'type': 'DERIVED', 'citation': 'Murphy KR, Uryniak T, Martin UJ, Zangrilli J. The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma. Drugs R D. 2012 Mar 1;12(1):9-14. doi: 10.2165/11630600-000000000-00000.'}, {'pmid': '21875546', 'type': 'DERIVED', 'citation': "Zangrilli J, Mansfield LE, Uryniak T, O'Brien CD. Efficacy of budesonide/formoterol pressurized metered-dose inhaler versus budesonide pressurized metered-dose inhaler alone in Hispanic adults and adolescents with asthma: a randomized, controlled trial. Ann Allergy Asthma Immunol. 2011 Sep;107(3):258-65.e2. doi: 10.1016/j.anai.2011.05.024. Epub 2011 Jul 14."}], 'seeAlsoLinks': [{'url': 'http://www.asthmaclinicaltrials.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or Female, Hispanic (self-reported), \\> 12 years of age\n* Moderate to severe asthma requiring treatment with an inhaled corticosteroid\n* Diagnosis of asthma for at least 6 months\n\nExclusion Criteria:\n\n* Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)\n* Any significant disease or disorder that may jeopardize a subject's safety"}, 'identificationModule': {'nctId': 'NCT00419757', 'briefTitle': 'An Efficacy Study 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