Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-29 @ 1:03 AM
Study NCT ID:
NCT00928668
Status:
COMPLETED
Last Update Posted:
2014-07-01
First Post:
2009-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy (Bronchoprotection) and Safety of Orally Inhaled BI 1744 CL in Patients With Intermittent 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': 'C549647', 'term': 'olodaterol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'description': 'Single dose including washout phase', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.', 'otherNumAtRisk': 29, 'otherNumAffected': 4, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Olo 2 mcg', 'description': 'Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.', 'otherNumAtRisk': 28, 'otherNumAffected': 1, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Olo 5 mcg', 'description': 'Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.', 'otherNumAtRisk': 28, 'otherNumAffected': 1, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Olo 10 mcg', 'description': 'Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.', 'otherNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Olo 20 mcg', 'description': 'Olodaterol 20 mcg qd delivered by the Respimat Inhaler.', 'otherNumAtRisk': 29, 'otherNumAffected': 4, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo delivered by the Respimat Inhaler.'}, {'id': 'OG001', 'title': 'Olodaterol (Olo) 2 mcg qd', 'description': 'Olodaterol 2 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG002', 'title': 'Olodaterol (Olo) 5 mcg qd', 'description': 'Olodaterol 5 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG003', 'title': 'Olodaterol (Olo) 10 mcg qd', 'description': 'Olodaterol 10 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG004', 'title': 'Olodaterol (Olo) 20 mcg qd', 'description': 'Olodaterol 20 mcg qd delivered by the Respimat Inhaler.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.793', 'spread': '0.182', 'groupId': 'OG000'}, {'value': '1.950', 'spread': '0.186', 'groupId': 'OG001'}, {'value': '2.504', 'spread': '0.190', 'groupId': 'OG002'}, {'value': '3.236', 'spread': '0.179', 'groupId': 'OG003'}, {'value': '3.777', 'spread': '0.183', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.157', 'ciLowerLimit': '0.657', 'ciUpperLimit': '1.657', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.252', 'estimateComment': 'Olo 2 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.711', 'ciLowerLimit': '1.205', 'ciUpperLimit': '2.217', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.255', 'estimateComment': 'Olo 5 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.443', 'ciLowerLimit': '1.952', 'ciUpperLimit': '2.935', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.248', 'estimateComment': 'Olo 10 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 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FEV1 (PC20FEV1) at 24 hours', 'unitOfMeasure': 'Log base 2 (mg/ml)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo delivered by the Respimat Inhaler.'}, {'id': 'OG001', 'title': 'Olodaterol (Olo) 2 mcg qd', 'description': 'Olodaterol 2 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG002', 'title': 'Olodaterol (Olo) 5 mcg qd', 'description': 'Olodaterol 5 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG003', 'title': 'Olodaterol (Olo) 10 mcg qd', 'description': 'Olodaterol 10 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG004', 'title': 'Olodaterol (Olo) 20 mcg qd', 'description': 'Olodaterol 20 mcg qd delivered by the Respimat Inhaler.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.393', 'spread': '0.180', 'groupId': 'OG000'}, {'value': '2.532', 'spread': '0.184', 'groupId': 'OG001'}, {'value': '3.029', 'spread': '0.187', 'groupId': 'OG002'}, {'value': '3.953', 'spread': '0.177', 'groupId': 'OG003'}, {'value': '4.617', 'spread': '0.181', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.139', 'ciLowerLimit': '1.645', 'ciUpperLimit': '2.633', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.249', 'estimateComment': 'Olo 2 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.636', 'ciLowerLimit': '2.135', 'ciUpperLimit': '3.136', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.252', 'estimateComment': 'Olo 5 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.560', 'ciLowerLimit': '3.074', 'ciUpperLimit': '4.046', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.245', 'estimateComment': 'Olo 10 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.224', 'ciLowerLimit': '3.731', 'ciUpperLimit': '4.717', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.249', 'estimateComment': 'Form 20 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '30 minutes post dose', 'description': 'Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes', 'unitOfMeasure': 'Log base 2 (mg/ml)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo delivered by the Respimat Inhaler.'}, {'id': 'OG001', 'title': 'Olodaterol (Olo) 2 mcg qd', 'description': 'Olodaterol 2 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG002', 'title': 'Olodaterol (Olo) 5 mcg qd', 'description': 'Olodaterol 5 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG003', 'title': 'Olodaterol (Olo) 10 mcg qd', 'description': 'Olodaterol 10 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG004', 'title': 'Olodaterol (Olo) 20 mcg qd', 'description': 'Olodaterol 20 mcg qd delivered by the Respimat Inhaler.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.577', 'spread': '0.214', 'groupId': 'OG000'}, {'value': '2.602', 'spread': '0.219', 'groupId': 'OG001'}, {'value': '2.957', 'spread': '0.223', 'groupId': 'OG002'}, {'value': '4.126', 'spread': '0.211', 'groupId': 'OG003'}, {'value': '4.786', 'spread': '0.215', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.025', 'ciLowerLimit': '1.437', 'ciUpperLimit': '2.613', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.296', 'estimateComment': 'Olo 2 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.380', 'ciLowerLimit': '1.785', 'ciUpperLimit': '2.975', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.300', 'estimateComment': 'Olo 5 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.549', 'ciLowerLimit': '2.971', 'ciUpperLimit': '4.127', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.292', 'estimateComment': 'Olo 10 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.208', 'ciLowerLimit': '3.622', 'ciUpperLimit': '4.794', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.296', 'estimateComment': 'Form 20 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 hours post dose', 'description': 'Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours', 'unitOfMeasure': 'Log base 2 (mg/ml)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo delivered by the Respimat Inhaler.'}, {'id': 'OG001', 'title': 'Olodaterol (Olo) 2 mcg qd', 'description': 'Olodaterol 2 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG002', 'title': 'Olodaterol (Olo) 5 mcg qd', 'description': 'Olodaterol 5 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG003', 'title': 'Olodaterol (Olo) 10 mcg qd', 'description': 'Olodaterol 10 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG004', 'title': 'Olodaterol (Olo) 20 mcg qd', 'description': 'Olodaterol 20 mcg qd delivered by the Respimat Inhaler.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.576', 'spread': '0.213', 'groupId': 'OG000'}, {'value': '2.484', 'spread': '0.218', 'groupId': 'OG001'}, {'value': '3.050', 'spread': '0.222', 'groupId': 'OG002'}, {'value': '3.903', 'spread': '0.210', 'groupId': 'OG003'}, {'value': '4.796', 'spread': '0.214', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.907', 'ciLowerLimit': '1.322', 'ciUpperLimit': '2.492', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.295', 'estimateComment': 'Olo 2 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.474', 'ciLowerLimit': '1.822', 'ciUpperLimit': '3.066', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.299', 'estimateComment': 'Olo 5 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.327', 'ciLowerLimit': '2.752', 'ciUpperLimit': '3.902', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.290', 'estimateComment': 'Olo 10 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.220', 'ciLowerLimit': '3.637', 'ciUpperLimit': '4.803', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.294', 'estimateComment': 'Form 20 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 hours post dose', 'description': 'Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours', 'unitOfMeasure': 'Log base 2 (mg/ml)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo delivered by the Respimat Inhaler.'}, {'id': 'OG001', 'title': 'Olodaterol (Olo) 2 mcg qd', 'description': 'Olodaterol 2 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG002', 'title': 'Olodaterol (Olo) 5 mcg qd', 'description': 'Olodaterol 5 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG003', 'title': 'Olodaterol (Olo) 10 mcg qd', 'description': 'Olodaterol 10 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG004', 'title': 'Olodaterol (Olo) 20 mcg qd', 'description': 'Olodaterol 20 mcg qd delivered by the Respimat Inhaler.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.960', 'spread': '0.200', 'groupId': 'OG000'}, {'value': '2.189', 'spread': '0.200', 'groupId': 'OG001'}, {'value': '2.785', 'spread': '0.203', 'groupId': 'OG002'}, {'value': '3.074', 'spread': '0.192', 'groupId': 'OG003'}, {'value': '3.605', 'spread': '0.197', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.229', 'ciLowerLimit': '0.692', 'ciUpperLimit': '1.766', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.271', 'estimateComment': 'Olo 2 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.825', 'ciLowerLimit': '1.281', 'ciUpperLimit': '2.369', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.274', 'estimateComment': 'Olo 5 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.114', 'ciLowerLimit': '1.578', 'ciUpperLimit': '2.650', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.270', 'estimateComment': 'Olo 10 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.645', 'ciLowerLimit': '2.110', 'ciUpperLimit': '3.181', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.270', 'estimateComment': 'Form 20 mcg minus Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '32 hours post dose', 'description': 'Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours', 'unitOfMeasure': 'Log base 2 (mg/ml)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.'}, {'type': 'SECONDARY', 'title': 'Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.'}, {'id': 'OG001', 'title': 'Olo 2 mcg', 'description': 'Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.'}, {'id': 'OG002', 'title': 'Olo 5 mcg', 'description': 'Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.'}, {'id': 'OG003', 'title': 'Olo 10 mcg', 'description': 'Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.'}, {'id': 'OG004', 'title': 'Olo 20 mcg', 'description': 'Olodaterol 20 mcg qd delivered by the Respimat Inhaler.'}], 'classes': [{'title': 'Cardiac disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 days', 'description': 'Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set included all patients who received any study medication.'}, {'type': 'SECONDARY', 'title': 'Laboratory Testing: Average Change From Baseline of Potassium and Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo delivered by the Respimat Inhaler.'}, {'id': 'OG001', 'title': 'Olodaterol (Olo) 2 mcg qd', 'description': 'Olodaterol 2 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG002', 'title': 'Olodaterol (Olo) 5 mcg qd', 'description': 'Olodaterol 5 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG003', 'title': 'Olodaterol (Olo) 10 mcg qd', 'description': 'Olodaterol 10 mcg qd delivered by the Respimat Inhaler.'}, {'id': 'OG004', 'title': 'Olodaterol (Olo) 20 mcg qd', 'description': 'Olodaterol 20 mcg qd delivered by the Respimat Inhaler.'}], 'classes': [{'title': 'Potassium', 'categories': [{'measurements': [{'value': '1.01', 'spread': 'NA', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '1.05'}, {'value': '1.04', 'spread': 'NA', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '1.06'}, {'value': '1.02', 'spread': 'NA', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '1.05'}, {'value': '1.00', 'spread': 'NA', 'groupId': 'OG003', 'lowerLimit': '0.98', 'upperLimit': '1.03'}, {'value': '0.98', 'spread': 'NA', 'groupId': 'OG004', 'lowerLimit': '0.95', 'upperLimit': '1.02'}]}]}, {'title': 'Calcium', 'categories': [{'measurements': [{'value': '1.00', 'spread': 'NA', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '1.03'}, {'value': '1.01', 'spread': 'NA', 'groupId': 'OG001', 'lowerLimit': '0.99', 'upperLimit': '1.02'}, {'value': '1.00', 'spread': 'NA', 'groupId': 'OG002', 'lowerLimit': '0.98', 'upperLimit': '1.03'}, {'value': '1.00', 'spread': 'NA', 'groupId': 'OG003', 'lowerLimit': '0.99', 'upperLimit': '1.02'}, {'value': '1.01', 'spread': 'NA', 'groupId': 'OG004', 'lowerLimit': '0.99', 'upperLimit': '1.03'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline to Visit 6', 'description': 'Laboratory testing: Average change from baseline of potassium and calcium measured on test-days', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the Safety set who have a baseline value and post dose values for each planned time.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg', 'description': 'Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 10 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.'}, {'id': 'FG001', 'title': 'Olo 10mcg / Olo 20mcg / Olo 2mcg / Olo 5mcg / Placebo', 'description': 'Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.'}, {'id': 'FG002', 'title': 'Olo 2mcg / Placebo / Olo 20mcg / Olo 10mcg / Olo 5mcg', 'description': 'Patients were administered Olodaterol 2 mcg qd in the first period, matching Placebo in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.'}, {'id': 'FG003', 'title': 'Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg / Olo 10mcg', 'description': 'Patients were administered Olodaterol 20 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, matching Placebo in the third period, Olodaterol 2 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.'}, {'id': 'FG004', 'title': 'Placebo / Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg', 'description': 'Patients were administered matching Placebo in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and Olodaterol 2 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other reasons not listed above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a randomised, double-blind, placebo-controlled, 5-way crossover trial. The duration of each treatment period was 1 day with a 14 day washout period between treatments.', 'preAssignmentDetails': 'One patient was randomized, but the trial was put on hold so that the patient had to be discontinued and re-randomized. This causes a discrepancy between the 32 patients enrolled and the 31 patients reported for the participant flow.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Total', 'description': 'Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 5-way crossover trial. 31 patients were assigned randomly to one of 5 treatment sequences in which they received each of 5 treatments. The duration of each treatment period was 1 day with a 14 day washout period between treatments.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '9.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-29', 'studyFirstSubmitDate': '2009-06-25', 'resultsFirstSubmitDate': '2014-03-28', 'studyFirstSubmitQcDate': '2009-06-25', 'lastUpdatePostDateStruct': {'date': '2014-07-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-29', 'studyFirstPostDateStruct': {'date': '2009-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours', 'timeFrame': '24 hours post dose', 'description': 'Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours'}], 'secondaryOutcomes': [{'measure': 'Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes', 'timeFrame': '30 minutes post dose', 'description': 'Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes'}, {'measure': 'Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours', 'timeFrame': '4 hours post dose', 'description': 'Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours'}, {'measure': 'Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours', 'timeFrame': '8 hours post dose', 'description': 'Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours'}, {'measure': 'Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours', 'timeFrame': '32 hours post dose', 'description': 'Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours'}, {'measure': 'Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG', 'timeFrame': '5 days', 'description': 'Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).'}, {'measure': 'Laboratory Testing: Average Change From Baseline of Potassium and Calcium', 'timeFrame': 'Baseline to Visit 6', 'description': 'Laboratory testing: Average change from baseline of potassium and calcium measured on test-days'}]}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the efficacy (bronchoprotection) and safety of single doses of BI 1744 CL inhalation solution (2, 5, 10 and 20 mcg) delivered via the Respimat® inhaler, in patients with intermittent asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Diagnosis of intermittent asthma according to Global Initiative for Asthma criteria\n2. Non-smokers or ex-smokers who have not smoked for at least 1 year and have a smoking history of less than 5 pack-years\n3. Forced Expiratory Volume in 1second greater than or equal to 80% predicted normal (Visit 1).\n4. Bronchial hyperresponsiveness to inhaled methacholine with a provocative concentration of a methacholine causing a 20% fall in Forced Expiratory Volume in one second less than or equal to 8 mg/mL (Visit 1).\n5. Be able to perform technically acceptable pulmonary function tests\n6. Be able to inhale medication in a competent manner from the Respimat® inhaler\n7. Must sign and date an informed consent consistent with International Conference on Harmonisation-Good Clinical Practice guidelines prior to participation in the trial, which includes medication washout and restrictions.\n\nExclusion criteria\n\n1. Patients with a significant disease other than asthma\n2. Patients with seasonal asthma or allergies whose participation in the trial will occur during the season for which they are allergic.\n3. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with a serum glutamic oxaloacetic transaminase \\> 80 IU/L, serum glutamic pyruvic transaminase \\> 80 IU/L, bilirubin \\>2.0 mg/dL or creatinine \\> 2.0 mg/dL will be excluded regardless of clinical condition\n4. Patients with any of the following conditions: a diagnosis of hyperthyrosis or paroxysmal tachycardia (\\>100 beats per minute), a marked baseline prolongation of QT/QTc interval, a history of additional risk factors for Torsade de Pointes, a history of myocardial infarction, a diagnosis of clinically relevant cardiac arrhythmia, a history of cor pulmonale, known active tuberculosis, a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years (patients with treated basal cell carcinoma are allowed), a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, or a history of significant alcohol or drug abuse.\n5. Patients who have undergone thoracotomy with pulmonary resection\n6. Patients who are being treated with any of the following concomitant medications: medications that prolong the QT/QTc interval, oral beta-adrenergics, beta-blockers or monoamine oxidase inhibitors or tricyclic antidepressants.\n7. Patients who have been treated with any respiratory medications (excluding short-acting beta-agonists) for control of their asthma symptoms within 3 months of the Screening Visit (Visit 1).\n8. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1).\n9. Pregnant or nursing women, or women of childbearing potential not using a highly effective method of birth control.'}, 'identificationModule': {'nctId': 'NCT00928668', 'briefTitle': 'Efficacy (Bronchoprotection) and Safety of Orally Inhaled BI 1744 CL in Patients With Intermittent Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Randomised, Double-Blind, Placebo-Controlled, 5-Way Cross-Over Study to Assess the Efficacy (Bronchoprotection) and Safety of a Single Dose of Orally Inhaled BI 1744 CL (2, 5, 10 and 20ug) in Patients With Intermittent Asthma', 'orgStudyIdInfo': {'id': '1222.4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olodaterol (BI1744) Low', 'description': 'Single dosing of low dose Olodaterol inhaled orally from Respimat Device', 'interventionNames': ['Drug: Olodaterol (BI1744CL)']}, {'type': 'EXPERIMENTAL', 'label': 'Olodaterol (BI1744) Medium Low', 'description': 'Single dosing of medium low dose Olodaterol inhaled orally from Respimat Device', 'interventionNames': ['Drug: Olodaterol (BI1744CL)']}, {'type': 'EXPERIMENTAL', 'label': 'Olodaterol (BI1744) Medium High', 'description': 'Single dosing of medium high dose Olodaterol inhaled orally from Respimat Device', 'interventionNames': ['Drug: Olodaterol (BI1744CL)']}, {'type': 'EXPERIMENTAL', 'label': 'Olodaterol (BI 1744) High', 'description': 'Single dosing of high dose Olodaterol inhaled orally from Respimat Device', 'interventionNames': ['Drug: Olodaterol (BI1744CL)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single dosing of Olodaterol placebo inhaled orally from Respimat Device', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo device for comparison', 'armGroupLabels': ['Placebo']}, {'name': 'Olodaterol (BI1744CL)', 'type': 'DRUG', 'description': 'Olodaterol comparison of low, medium low, medium high and high doses', 'armGroupLabels': ['Olodaterol (BI1744) Medium High']}, {'name': 'Olodaterol (BI1744CL)', 'type': 'DRUG', 'description': 'Olodaterol comparison of low, medium low, medium high and high doses', 'armGroupLabels': ['Olodaterol (BI1744) Low']}, {'name': 'Olodaterol (BI1744CL)', 'type': 'DRUG', 'description': 'Olodaterol comparison of low, medium low, medium high and high doses', 'armGroupLabels': ['Olodaterol (BI1744) Medium Low']}, {'name': 'Olodaterol (BI1744CL)', 'type': 'DRUG', 'description': 'Olodaterol comparison of low, medium low, medium high and high doses', 'armGroupLabels': ['Olodaterol (BI 1744) High']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': '1222.4.103 UBC - Respiratory Medicine', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': '1222.4.104 Department of Medicine, Health Sciences Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Sainte-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': '1222.4.101 2725 Chemin Ste Foy', 'geoPoint': {'lat': 46.78139, 'lon': -71.29217}}, {'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': '1222.4.102', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Boehringer Ingelheim, Study Chair', 'oldOrganization': 'Boehringer Ingelheim'}}}}