Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-25 @ 6:12 PM
Study NCT ID:
NCT01437995
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2011-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-acting Beta Agonist Step Down Study
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': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'area5@jhu.edu', 'phone': '4432878496', 'title': 'Alexis Rea', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'At the time of this release, this data has not undergone peer-review.'}}, 'adverseEventsModule': {'timeFrame': '52 weeks', 'description': 'Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.', 'eventGroups': [{'id': 'EG000', 'title': 'Stable ICS-LABA', 'description': 'Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily', 'otherNumAtRisk': 151, 'otherNumAffected': 110, 'seriousNumAtRisk': 151, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Reduced ICS/LABA', 'description': 'Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily', 'otherNumAtRisk': 149, 'otherNumAffected': 102, 'seriousNumAtRisk': 149, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'LABA Step Off', 'description': 'Fluticasone Diskus alone 250 ug twice daily without Salmeterol\n\nFluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol', 'otherNumAtRisk': 155, 'otherNumAffected': 100, 'seriousNumAtRisk': 155, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Skin bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 48, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 35, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 48, 'numAffected': 46}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 37, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 35, 'numAffected': 34}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hoarseness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 55, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 59, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 61, 'numAffected': 58}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 36, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 27, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 39, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 29, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 40, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased/irregular heartbeat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restlessness or nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Runny nose/congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 60, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 58, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 55, 'numAffected': 52}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma Exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest discomfort, shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute renal failure, resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated blood sugar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': "Graves' Disease, diagnosis", 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Partial small bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee replacement (planned)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized for contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stable ICS-LABA', 'description': 'Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily'}, {'id': 'OG001', 'title': 'Reduced ICS/LABA', 'description': 'Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily'}, {'id': 'OG002', 'title': 'LABA Step Off', 'description': 'Fluticasone Diskus alone 250 ug twice daily without Salmeterol\n\nFluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.3', 'paramValue': '1.07', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.65', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Rate of treatment failures assessed by decline in peak flow or FEV1, increased need for beta agonists, requirement for non-scheduled medical care for asthma symptoms, or prednisone taper.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pulmonary Function- Change in Peak Expiratory Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stable ICS-LABA', 'description': 'Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily'}, {'id': 'OG001', 'title': 'Reduced ICS/LABA', 'description': 'Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily'}, {'id': 'OG002', 'title': 'LABA Step Off', 'description': 'Fluticasone Diskus alone 250 ug twice daily without Salmeterol\n\nFluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.08', 'groupId': 'OG000', 'lowerLimit': '-8.10', 'upperLimit': '7.94'}, {'value': '4.40', 'groupId': 'OG001', 'lowerLimit': '-3.46', 'upperLimit': '12.26'}, {'value': '-14.16', 'groupId': 'OG002', 'lowerLimit': '-23.1', 'upperLimit': '-5.22'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.022', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.002', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 48 weeks', 'description': "Change in morning peak expiratory flow rate from the patients' daily diary cards, calculated at 48 weeks minus baseline (randomization)", 'unitOfMeasure': 'Liters per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Episodes of Poor Asthma Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stable ICS-LABA', 'description': 'Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily'}, {'id': 'OG001', 'title': 'Reduced ICS/LABA', 'description': 'Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily'}, {'id': 'OG002', 'title': 'LABA Step Off', 'description': 'Fluticasone Diskus alone 250 ug twice daily without Salmeterol\n\nFluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol'}], 'classes': [{'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.41', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.73', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.81', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Rate of episodes of poor asthma control (EPAC) defined by unscheduled medical care, hospitalization, use of oral corticosteroids and/or increased use of rescue medications and/or decrease of 30% or more in morning peak expiratory flow rate', 'unitOfMeasure': 'Episodes of poor asthma control', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Pulmonary Function: FEV1 and FVC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stable ICS-LABA', 'description': 'Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily'}, {'id': 'OG001', 'title': 'Reduced ICS/LABA', 'description': 'Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily'}, {'id': 'OG002', 'title': 'LABA Step Off', 'description': 'Fluticasone Diskus alone 250 ug twice daily without Salmeterol\n\nFluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol'}], 'classes': [{'title': 'Pre-bronchodilator FEV1', 'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.03'}, {'value': '-0.07', 'groupId': 'OG001', 'lowerLimit': '-0.12', 'upperLimit': '-0.01'}, {'value': '-0.13', 'groupId': 'OG002', 'lowerLimit': '-0.18', 'upperLimit': '-0.09'}]}]}, {'title': 'Pre-bronchodilator FVC', 'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.04'}, {'value': '-0.04', 'groupId': 'OG001', 'lowerLimit': '-0.10', 'upperLimit': '0.01'}, {'value': '-0.09', 'groupId': 'OG002', 'lowerLimit': '-0.14', 'upperLimit': '-0.03'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparing change in pre-bronchodilator FEV1', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Comparing change in pre-bronchodilator FEV1', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.027', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Comparing change in pre-bronchodilator FEV1', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of change in pre-bronchodilator FVC', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.032', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Comparison of change in pre-bronchodilator FVC', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.21', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Comparison of change in pre-bronchodilator FVC', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 48 weeks', 'description': "Change in participant's pre-bronchodilator pulmonary function tests (FEV1 and FVC) calculated as 48 weeks minus baseline.", 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pulmonary Function: Change in FEV1/FVC Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stable ICS-LABA', 'description': 'Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily'}, {'id': 'OG001', 'title': 'Reduced ICS/LABA', 'description': 'Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily'}, {'id': 'OG002', 'title': 'LABA Step Off', 'description': 'Fluticasone Diskus alone 250 ug twice daily without Salmeterol\n\nFluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.002', 'groupId': 'OG000', 'lowerLimit': '-0.009', 'upperLimit': '0.005'}, {'value': '-0.009', 'groupId': 'OG001', 'lowerLimit': '-0.016', 'upperLimit': '-0.002'}, {'value': '-0.02', 'groupId': 'OG002', 'lowerLimit': '-0.028', 'upperLimit': '-0.012'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of change in FEV1/FVC ratio', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Comparison of change in FEV1/FVC ratio', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.031', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Comparison of change in FEV1/FVC ratio', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 48 weeks', 'description': "Change in participant's FEV1/FVC ratio calculated as 48 weeks minus baseline.", 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stable ICS-LABA', 'description': 'Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily'}, {'id': 'FG001', 'title': 'Reduced ICS/LABA', 'description': 'Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily'}, {'id': 'FG002', 'title': 'LABA Step Off', 'description': 'Fluticasone Diskus alone 250 ug twice daily without Salmeterol\n\nFluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '149'}, {'groupId': 'FG002', 'numSubjects': '155'}]}, {'type': 'Included in Treatment Failure Analysis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '146'}, {'groupId': 'FG002', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '131'}, {'groupId': 'FG002', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '20'}]}]}], 'preAssignmentDetails': 'Enrolled participants were enrolled in an 8-week open label treatment run-in and were subsequently randomized only if their asthma remained stable (i.e. an ACT score ≥ 20 at weeks 4 \\& 8, no unscheduled healthcare encounters, no change in asthma medication, pre-bronchodilator FEV1 ≥ 70% predicted, and limited use of rescue beta-agonist).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Stable ICS-LABA', 'description': 'Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily'}, {'id': 'BG001', 'title': 'Reduced ICS/LABA', 'description': 'Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily\n\nFluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily'}, {'id': 'BG002', 'title': 'LABA Step Off', 'description': 'Fluticasone Diskus alone 250 ug twice daily without Salmeterol\n\nFluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '51'}, {'value': '33', 'groupId': 'BG001', 'lowerLimit': '17', 'upperLimit': '49'}, {'value': '35', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '50'}, {'value': '35', 'groupId': 'BG003', 'lowerLimit': '20', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '<18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}, {'title': '>=18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '355', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '287', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '221', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoke exposure', 'classes': [{'title': 'Former smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}, {'title': 'Secondhand smoke home/work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'History of cigarette smoking and current exposure to secondhand smoke. Individuals with no history of cigarette smoking and no current exposure to second hand smoke are not counted.', 'unitOfMeasure': 'participants'}, {'title': 'Asthma characteristics', 'classes': [{'title': 'Hospitalized for asthma in past year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Oral steroids in past year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}]}, {'title': 'Daily short-acting beta agonist use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'Daily anti-leukotriene use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Description of characteristics of recent asthma treatment. Individuals who did not have a history of the treatment were not counted.', 'unitOfMeasure': 'participants'}, {'title': 'Age of Asthma Onset', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '21'}, {'value': '7', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '18'}, {'value': '7', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '20'}, {'value': '7', 'groupId': 'BG003', 'lowerLimit': '2', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'eNO (exhaled nitric oxide)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'BG000', 'lowerLimit': '12.5', 'upperLimit': '26.5'}, {'value': '17.5', 'groupId': 'BG001', 'lowerLimit': '13.8', 'upperLimit': '25.3'}, {'value': '16.5', 'groupId': 'BG002', 'lowerLimit': '11.5', 'upperLimit': '26.5'}, {'value': '17.5', 'groupId': 'BG003', 'lowerLimit': '12.5', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'parts per billion', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Atopy (phadiatop ≥ 0.35 kUA/l)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '352', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Asthma Symptom Utility Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.95', 'groupId': 'BG000', 'lowerLimit': '0.90', 'upperLimit': '1.00'}, {'value': '0.94', 'groupId': 'BG001', 'lowerLimit': '0.89', 'upperLimit': '1.00'}, {'value': '0.98', 'groupId': 'BG002', 'lowerLimit': '0.92', 'upperLimit': '1.00'}, {'value': '0.95', 'groupId': 'BG003', 'lowerLimit': '0.89', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Asthma Symptom Utility Index asks about asthma symptoms within the past 2 weeks. The scale ranges from 0 to 1 with higher scores indicating better health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Pulmonary function measures', 'classes': [{'title': 'Pre-bronchodilator FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.82', 'groupId': 'BG000', 'lowerLimit': '2.24', 'upperLimit': '3.31'}, {'value': '2.86', 'groupId': 'BG001', 'lowerLimit': '2.35', 'upperLimit': '3.44'}, {'value': '2.82', 'groupId': 'BG002', 'lowerLimit': '2.38', 'upperLimit': '3.49'}, {'value': '2.83', 'groupId': 'BG003', 'lowerLimit': '2.30', 'upperLimit': '3.43'}]}]}, {'title': 'Pre-bronchodilator FVC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3.54', 'groupId': 'BG000', 'lowerLimit': '2.99', 'upperLimit': '4.30'}, {'value': '3.62', 'groupId': 'BG001', 'lowerLimit': '2.97', 'upperLimit': '4.54'}, {'value': '3.65', 'groupId': 'BG002', 'lowerLimit': '3.03', 'upperLimit': '4.56'}, {'value': '3.62', 'groupId': 'BG003', 'lowerLimit': '3.00', 'upperLimit': '4.44'}]}]}, {'title': 'Post-bronchodilator FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.88', 'groupId': 'BG000', 'lowerLimit': '2.34', 'upperLimit': '3.36'}, {'value': '2.96', 'groupId': 'BG001', 'lowerLimit': '2.39', 'upperLimit': '3.50'}, {'value': '2.93', 'groupId': 'BG002', 'lowerLimit': '2.44', 'upperLimit': '3.60'}, {'value': '2.92', 'groupId': 'BG003', 'lowerLimit': '2.39', 'upperLimit': '3.49'}]}]}, {'title': 'Post-bronchodilator FVC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3.59', 'groupId': 'BG000', 'lowerLimit': '3.09', 'upperLimit': '4.28'}, {'value': '3.72', 'groupId': 'BG001', 'lowerLimit': '3.11', 'upperLimit': '4.63'}, {'value': '3.65', 'groupId': 'BG002', 'lowerLimit': '3.06', 'upperLimit': '4.52'}, {'value': '3.62', 'groupId': 'BG003', 'lowerLimit': '3.09', 'upperLimit': '4.50'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Liters', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Pulmonary function measures, percent predicted', 'classes': [{'title': 'Pre-bronchodilator FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000', 'lowerLimit': '82', 'upperLimit': '99'}, {'value': '91', 'groupId': 'BG001', 'lowerLimit': '83', 'upperLimit': '101'}, {'value': '92', 'groupId': 'BG002', 'lowerLimit': '83', 'upperLimit': '101'}, {'value': '91', 'groupId': 'BG003', 'lowerLimit': '83', 'upperLimit': '101'}]}]}, {'title': 'Pre-bronchodilator FVC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000', 'lowerLimit': '89', 'upperLimit': '107'}, {'value': '100', 'groupId': 'BG001', 'lowerLimit': '91', 'upperLimit': '107'}, {'value': '98', 'groupId': 'BG002', 'lowerLimit': '90', 'upperLimit': '108'}, {'value': '99', 'groupId': 'BG003', 'lowerLimit': '90', 'upperLimit': '107'}]}]}, {'title': 'Pre-bronchodilator peak flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000', 'lowerLimit': '84', 'upperLimit': '110'}, {'value': '100', 'groupId': 'BG001', 'lowerLimit': '90', 'upperLimit': '110'}, {'value': '98', 'groupId': 'BG002', 'lowerLimit': '89', 'upperLimit': '113'}, {'value': '98', 'groupId': 'BG003', 'lowerLimit': '88', 'upperLimit': '110'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percent predicted', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Other conditions, based upon self-report', 'classes': [{'title': 'Eczema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}, {'title': 'Sinusitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}]}, {'title': 'Allergic rhinitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '246', 'groupId': 'BG003'}]}]}, {'title': 'Food allergies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}]}, {'title': 'Allergies worsen asthma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '358', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pre-bronchodilator peak flow', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '420', 'groupId': 'BG000', 'lowerLimit': '350', 'upperLimit': '500'}, {'value': '430', 'groupId': 'BG001', 'lowerLimit': '350', 'upperLimit': '500'}, {'value': '430', 'groupId': 'BG002', 'lowerLimit': '360', 'upperLimit': '500'}, {'value': '430', 'groupId': 'BG003', 'lowerLimit': '350', 'upperLimit': '500'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Liters per minute', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Asthma Control Test Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '25'}, {'value': '23', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '24'}, {'value': '23', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '24'}, {'value': '23', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '25'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Asthma Control Test is a validated self-administered survey utilizing 5 questions to assess asthma control on a scale from 1 (poor control) to 5 (total control) in individuals 12 years and older. By answering all 5 questions a patient with asthma can obtain a score that may range between 5 and 25. Asthma control is considered a good characteristic for a person with asthma and therefore a higher score is considered a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Marks AQLQ', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '355', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'BG000', 'lowerLimit': '1.5', 'upperLimit': '8.0'}, {'value': '5.0', 'groupId': 'BG001', 'lowerLimit': '2.0', 'upperLimit': '9.0'}, {'value': '4.0', 'groupId': 'BG002', 'lowerLimit': '2.0', 'upperLimit': '7.0'}, {'value': '4.0', 'groupId': 'BG003', 'lowerLimit': '2.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Marks Asthma Quality of Life Questionnaire (AQLQ) measures physical and emotional asthma specific quality of life during the past four weeks. The minimum score is 0 and the maximum score is 80, with lower scores indicating better quality of life. The scale is for use in adults only (individuals aged 18 or older).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The Marks AQLQ is for adults only and was only administered to adult participants (individuals age 18 or older).'}, {'title': "Children's Health Survey for Asthma - Child Version", 'classes': [{'title': 'Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000', 'lowerLimit': '93', 'upperLimit': '100'}, {'value': '93', 'groupId': 'BG001', 'lowerLimit': '89', 'upperLimit': '100'}, {'value': '96', 'groupId': 'BG002', 'lowerLimit': '93', 'upperLimit': '100'}, {'value': '93', 'groupId': 'BG003', 'lowerLimit': '91', 'upperLimit': '100'}]}]}, {'title': 'Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000', 'lowerLimit': '92', 'upperLimit': '100'}, {'value': '100', 'groupId': 'BG001', 'lowerLimit': '92', 'upperLimit': '100'}, {'value': '100', 'groupId': 'BG002', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '100', 'groupId': 'BG003', 'lowerLimit': '92', 'upperLimit': '100'}]}]}, {'title': 'Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000', 'lowerLimit': '86', 'upperLimit': '98'}, {'value': '95', 'groupId': 'BG001', 'lowerLimit': '91', 'upperLimit': '100'}, {'value': '93', 'groupId': 'BG002', 'lowerLimit': '88', 'upperLimit': '100'}, {'value': '93', 'groupId': 'BG003', 'lowerLimit': '89', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'description': "The Children's Health Survey for Asthma - Child Version (CHSA-C) is a self-reported measure of functional impairments that are most troublesome to children 12 to 17 years of age as a results of their asthma over the past three weeks. Results are reported in Physical, Activity, and Emotion domains. For all domains, the minimum value is 0 and the maximum value is 100, with higher values indicating better health or more positive outcomes.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': "The Children's Health Survey for Asthma - Child Version (CHSA-C) is for use in individuals under the age of 18 only. The CHSA-C was administered only to those participants under the age of 18 in our study."}, {'title': 'Euroqual EQ-5D-5L', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'BG000', 'lowerLimit': '0.86', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'BG001', 'lowerLimit': '0.86', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'BG002', 'lowerLimit': '0.86', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'BG003', 'lowerLimit': '0.86', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Euroqual EQ-5D-5L is a self-completed generic instrument for measuring quality of life over five dimensions - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The minimum score is 0 and the maximum score is 1, with higher scores indicating better quality of life or better health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 459}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-14', 'studyFirstSubmitDate': '2011-09-05', 'resultsFirstSubmitDate': '2016-10-07', 'studyFirstSubmitQcDate': '2011-09-20', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-14', 'studyFirstPostDateStruct': {'date': '2011-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Failure', 'timeFrame': '48 weeks', 'description': 'Rate of treatment failures assessed by decline in peak flow or FEV1, increased need for beta agonists, requirement for non-scheduled medical care for asthma symptoms, or prednisone taper.'}], 'secondaryOutcomes': [{'measure': 'Pulmonary Function- Change in Peak Expiratory Flow', 'timeFrame': 'Baseline and 48 weeks', 'description': "Change in morning peak expiratory flow rate from the patients' daily diary cards, calculated at 48 weeks minus baseline (randomization)"}, {'measure': 'Rate of Episodes of Poor Asthma Control', 'timeFrame': '48 weeks', 'description': 'Rate of episodes of poor asthma control (EPAC) defined by unscheduled medical care, hospitalization, use of oral corticosteroids and/or increased use of rescue medications and/or decrease of 30% or more in morning peak expiratory flow rate'}, {'measure': 'Change in Pulmonary Function: FEV1 and FVC', 'timeFrame': 'Baseline and 48 weeks', 'description': "Change in participant's pre-bronchodilator pulmonary function tests (FEV1 and FVC) calculated as 48 weeks minus baseline."}, {'measure': 'Pulmonary Function: Change in FEV1/FVC Ratio', 'timeFrame': 'Baseline and 48 weeks', 'description': "Change in participant's FEV1/FVC ratio calculated as 48 weeks minus baseline."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Asthma', 'Step down therapy', 'Inhaled corticosteroids', 'Long-acting beta agonists', 'Fluticasone Salmeterol'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '37347518', 'type': 'DERIVED', 'citation': 'Blake KV, Antal H, Bunnell HT, He J, Henderson R, Holbrook JT, McCahan SM, Pennington C, Rogers L, Shade D, Sugar EA, Taylor A, Wise RA, Wysocki T. Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial. JMIR Pediatr Parent. 2023 Jun 22;6:e44252. doi: 10.2196/44252.'}, {'pmid': '29863899', 'type': 'DERIVED', 'citation': 'DiMango E, Rogers L, Reibman J, Gerald LB, Brown M, Sugar EA, Henderson R, Holbrook JT. Risk Factors for Asthma Exacerbation and Treatment Failure in Adults and Adolescents with Well-controlled Asthma during Continuation and Step-Down Therapy. Ann Am Thorac Soc. 2018 Aug;15(8):955-961. doi: 10.1513/AnnalsATS.201711-886OC.'}], 'seeAlsoLinks': [{'url': 'http://www.lungusa.org/', 'label': 'American Lung Association'}]}, 'descriptionModule': {'briefSummary': 'This study is a 56-week, multi-center, blinded, randomized, double-masked parallel group comparative effectiveness study of approaches to stepping down therapy for patients with well-controlled asthma treated with combination ICS and LABA.', 'detailedDescription': 'Current asthma guidelines recommend stepping down therapy once asthma is controlled for at least 3 months. For patients treated with inhaled corticosteroids (ICS) alone, a dose reduction of 25-50% to a minimal dose that controls disease is recommended. The optimal approach to reducing treatment in patients with asthma treated with combination inhaled corticosteroids and long-acting beta agonists (ICS/LABA) is not clear. The American Lung Association Asthma Clinical Research Center (ALAACRC) is a network of 18 asthma research centers with the goal of performing clinical trials directly relevant to clinical practice. The question of the optimal way to de-escalate therapy in patients with asthma that is well controlled on fixed dose combination ICS/LABA is a key question for practitioners caring for patients with moderate to severe persistent asthma. We propose a 56 week multi-center, prospective, randomized, three-arm parallel group comparative effectiveness study comparing three approaches to care of patients with asthma well-controlled for three months on combination ICS/LABA: reduction of ICS dose and maintenance of LABA, initial discontinuation of LABA with continuation of ICS, and continuation of stable dose ICS/LABA. Our primary goal is to perform a pragmatic study that resembles clinical practice and determine the optimal treatment strategy that results in the lowest rate of treatment failure over 48 weeks of follow-up. Additional exploratory analyses include assessing risk factors for step-down failure, and to assess the duration of time that asthma control is maintained when therapy is de-escalated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 12-80 years\n* physician diagnosed asthma that is well-controlled on moderate dose ICS/LABA based on an Asthma Control Test (ACT) score more than or equal to 20, and the absence of unscheduled visits or use of rescue prednisone for 4 weeks prior to enrollment\n* pre-bronchodilator FEV1 (forced expiratory volume in 1 second) more than or equal to 70% predicted\n\nExclusion Criteria:\n\n* chronic oral steroid therapy\n* hospitalization or urgent care visit within 4 weeks of the screening visit\n* lung disease other than asthma including COPD, bronchiectasis, sarcoidosis or other lung disease\n* less than 10 pack/yr of tobacco use and abstinence for at least 1 yr\n* history of extensive environmental tobacco exposure or occupational exposure suggestive of possible COPD (chronic obstructive pulmonary disease) per judgment of investigator\n* post bronchodilator FEV1 less than 70% predicted\n* near fatal asthma (intubation or ICU admission for asthma) within 2 yrs of enrollment\n* high risk of near fatal or fatal asthma\n* history of known premature birth less than 33 weeks or any significant level of respiratory care including prolonged oxygen administration or mechanical ventilation during the neonatal period\n* unstable cardiac disease (decompensated congestive heart failure, unstable angina, recent myocardial infarction, atrial fibrillation, supraventricular or ventricular tachycardia, congenital heart disease, or severe uncontrolled hypertension)\n* other major chronic illnesses which in the judgment of the study physician would interfere with participation in the study e.g. including but not limited to uncontrolled diabetes, uncontrolled HIV infection or other immune system disorder\n* drug allergies to any component of study drug or history of adverse reaction to short or long acting beta agonists\n* for women of child bearing potential; not pregnant, not lactating and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study'}, 'identificationModule': {'nctId': 'NCT01437995', 'acronym': 'LASST', 'briefTitle': 'Long-acting Beta Agonist Step Down Study', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Long-acting Beta Agonist Step Down Study', 'orgStudyIdInfo': {'id': 'ADV115922'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fluticasone/Salmeterol Diskus 250/50 ug', 'description': 'Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily', 'interventionNames': ['Drug: Fluticasone/Salmeterol Diskus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluticasone/Salmeterol Diskus 100/50 ug', 'description': 'Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily', 'interventionNames': ['Drug: Fluticasone/Salmeterol Diskus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluticasone Diskus alone 250 ug', 'description': 'Fluticasone Diskus alone 250 ug twice daily without Salmeterol', 'interventionNames': ['Drug: Fluticasone Diskus']}], 'interventions': [{'name': 'Fluticasone/Salmeterol Diskus', 'type': 'DRUG', 'otherNames': ['Fluticasone', 'Salmeterol'], 'description': 'Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily', 'armGroupLabels': ['Fluticasone/Salmeterol Diskus 250/50 ug']}, {'name': 'Fluticasone/Salmeterol Diskus', 'type': 'DRUG', 'otherNames': ['Fluticasone', 'Salmeterol'], 'description': 'Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily', 'armGroupLabels': ['Fluticasone/Salmeterol Diskus 100/50 ug']}, {'name': 'Fluticasone Diskus', 'type': 'DRUG', 'otherNames': ['Fluticasone'], 'description': 'Fluticasone Diskus alone 250 ug twice daily without Salmeterol', 'armGroupLabels': ['Fluticasone Diskus alone 250 ug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona, Arizona Respiratory Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami/University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The Illinois Consortium', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Vincent Healthcare', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46290', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Vincent Hospital and Health Care Center, Inc', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Sciences Center, The Ernest N. Morial Asthma, Allergy and Respiratory Disease Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri, Kansas City School of Medicine', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University/St. Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Hofstra North Shore-LIJ School of Medicine', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': "Maria Fareri Children's Hospital at Westchester Medical Center and New York Medical College", 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '05446', 'city': 'Colchester', 'state': 'Vermont', 'country': 'United States', 'facility': 'Northern New England Consortium', 'geoPoint': {'lat': 44.54394, 'lon': -73.14791}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Robert A Wise, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Linda Rogers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Lung Association', 'class': 'OTHER'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Robert A. Wise', 'investigatorAffiliation': 'Johns Hopkins University'}}}}