Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-08 @ 12:59 AM
Study NCT ID:
NCT02030535
Status:
COMPLETED
Last Update Posted:
2015-07-16
First Post:
2014-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Effect on Lung Function and ECG When a Combination of Tiotropium Plus Olodaterol is Administered to Patients With COPD Either From a Single Inhaler or Each Compound is Administered After Each Other From Two Different Inhalers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549647', 'term': 'olodaterol'}, {'id': 'D000069447', 'term': 'Tiotropium Bromide'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab "Full Text Review", section "More Information".'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) occurring up to the minimum of 21 days after drug stop date or the start of the next treatment period were considered on treatment; Up to 64 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.', 'otherNumAtRisk': 53, 'otherNumAffected': 3, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tio+Olo FDC', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.', 'otherNumAtRisk': 52, 'otherNumAffected': 1, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Tiotropium and Olodaterol FC', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination FC (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing.', 'otherNumAtRisk': 52, 'otherNumAffected': 2, 'seriousNumAtRisk': 52, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}], 'seriousEvents': [{'term': 'Prinzmetal angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Mean (Heart Rate Corrected QT Interval (Using Fredericia Adjustment)) QTcF Interval Change From Patient Baseline Over All Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '6.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Mean QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'Peak QTcF Interval Change From Patient Baseline Over All Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '7.6', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '7.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Peak QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'Mean Heart Rate Change From Patient Baseline Over All Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '4.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Mean heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'Peak Heart Rate Change From Patient Baseline Over All Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations (a.m. dosing) via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations (a.m. dosing) via RESPIMAT® inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '4.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Peak heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'PRIMARY', 'title': 'Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations ante meridiem (a.m.) dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler.'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.014', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '0.233', 'spread': '0.016', 'groupId': 'OG001'}, {'value': '0.266', 'spread': '0.016', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.219', 'ciLowerLimit': '0.187', 'ciUpperLimit': '0.252', 'pValueComment': 'Mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; patient baseline and period baseline as covariates; patient as a random effect', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.016', 'estimateComment': 'Tio+Olo 5/5μg minus Placebo.', 'statisticalMethod': 'Mixed models repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation of denominator degrees of freedom. Compound symmetry covariance structure for within-patient variation', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.252', 'ciLowerLimit': '0.220', 'ciUpperLimit': '0.284', 'pValueComment': 'Mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; patient baseline and period baseline as covariates; patient as a random effect', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.016', 'estimateComment': 'Tiotropium 5μg + Olodaterol 5μg minus Placebo.', 'statisticalMethod': 'Mixed models repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kenward-Roger approximation of denominator degrees of freedom. Compound symmetry covariance structure for within-patient variation.', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.033', 'ciLowerLimit': '-0.065', 'ciUpperLimit': '-0.001', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.016', 'estimateComment': 'Tio+Olo 5/5μg minus Tiotropium 5μg + Olodaterol 5μg.', 'groupDescription': 'Descriptive comparison. Statistical Analyses 1 \\& 2 were included in the hierarchical testing sequence (alpha protected), and analysis 3 was not included in the hierarchical testing sequence (not alpha protected)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 hour (h) and 10 min pre-dose and at 15 min, 30 min, 1 h, 2 h and 3 h post-dose', 'description': 'The response was defined as the change from patient baseline. Patient baseline was the average of the mean pre-dose values (period baseline) on each test day (Visit 2 (Day 1), Visit 3 (Day 22 (±7days)), and Visit 4 (Day 43±7days)).\n\nFor patients who did not complete all periods, patient baseline was the average of the available period baselines.\n\nThe means presented are the adjusted means.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set included all patients in the TS who had at least 1 visit (Visit 2(Day1), Visit 3(Day22), or Visit 4(Day43)) with both the period baseline value plus any evaluable post-dose spirometry measurement from the same visit.'}, {'type': 'SECONDARY', 'title': 'Heart Rate Change From Patient Baseline at Individual Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'title': '5 min', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '4.6', 'groupId': 'OG002'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '4.6', 'groupId': 'OG002'}]}]}, {'title': '25 min', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '5.0', 'groupId': 'OG002'}]}]}, {'title': '50 min', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '-3.9', 'spread': '4.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Heart rate change from patient baseline at individual post-dose time points', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'Mean RR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '40.4', 'spread': '57.7', 'groupId': 'OG000'}, {'value': '29.3', 'spread': '57.1', 'groupId': 'OG001'}, {'value': '39.5', 'spread': '51.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Mean RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'Peak RR Change From Patient Baseline Over All Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'spread': '64.3', 'groupId': 'OG000'}, {'value': '55.5', 'spread': '59.5', 'groupId': 'OG001'}, {'value': '68.0', 'spread': '52.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Peak RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'RR Change From Patient Baseline at Individual Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'title': '5 min', 'categories': [{'measurements': [{'value': '29.9', 'spread': '62.5', 'groupId': 'OG000'}, {'value': '29.7', 'spread': '58.5', 'groupId': 'OG001'}, {'value': '31.9', 'spread': '55.5', 'groupId': 'OG002'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '38.8', 'spread': '68.9', 'groupId': 'OG000'}, {'value': '28.1', 'spread': '57.4', 'groupId': 'OG001'}, {'value': '33.5', 'spread': '56.1', 'groupId': 'OG002'}]}]}, {'title': '25 min', 'categories': [{'measurements': [{'value': '40.4', 'spread': '59.4', 'groupId': 'OG000'}, {'value': '33.0', 'spread': '65.7', 'groupId': 'OG001'}, {'value': '50.0', 'spread': '59.9', 'groupId': 'OG002'}]}]}, {'title': '50 min', 'categories': [{'measurements': [{'value': '52.3', 'spread': '62.7', 'groupId': 'OG000'}, {'value': '25.2', 'spread': '64.9', 'groupId': 'OG001'}, {'value': '44.0', 'spread': '57.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'RR change from patient baseline at individual post-dose time points', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'Mean QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '7.9', 'spread': '9.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Mean QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'Peak QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '13.4', 'spread': '10.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Peak QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'QT Change From Patient Baseline at Individual Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'title': '5 min', 'categories': [{'measurements': [{'value': '4.3', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '11.2', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '10.4', 'groupId': 'OG002'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '7.1', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '11.8', 'groupId': 'OG001'}, {'value': '7.9', 'spread': '11.3', 'groupId': 'OG002'}]}]}, {'title': '25 min', 'categories': [{'measurements': [{'value': '7.9', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '12.0', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '11.1', 'groupId': 'OG002'}]}]}, {'title': '50 min', 'categories': [{'measurements': [{'value': '9.4', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '10.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'QT change from patient baseline at individual post-dose time points', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '8.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '9.7', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '8.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'QTcB Change From Patient Baseline at Individual Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'title': '5 min', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '8.8', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '8.7', 'groupId': 'OG002'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '9.0', 'groupId': 'OG002'}]}]}, {'title': '25 min', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '9.3', 'groupId': 'OG002'}]}]}, {'title': '50 min', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '9.8', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '9.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'QTcB change from patient baseline at individual post-dose time points', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'Mean PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '6.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Mean PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'Peak PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination) Olodaterol: 5 μg (2.5 μg per actuation) Tiotropium: 5 μg (2.5 μg per actuation) 2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '7.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Peak PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'PR Change From Patient Baseline at Individual Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'title': '5 min', 'categories': [{'measurements': [{'value': '0.1', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '7.3', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '6.6', 'groupId': 'OG002'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '0.1', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '7.1', 'groupId': 'OG002'}]}]}, {'title': '25 min', 'categories': [{'measurements': [{'value': '0.1', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '7.8', 'groupId': 'OG002'}]}]}, {'title': '50 min', 'categories': [{'measurements': [{'value': '2.2', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '7.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'PR change from patient baseline at individual post-dose time points', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'Mean QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Mean QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'Peak QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Peak QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}, {'type': 'SECONDARY', 'title': 'QRS Change From Patient Baseline at Individual Post-dose Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.\n\n2 inhalations a.m. dosing.'}, {'id': 'OG001', 'title': 'Tio+Olo 5/5μg', 'description': 'Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}, {'id': 'OG002', 'title': 'Tiotropium 5μg + Olodaterol 5μg', 'description': 'Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)\n\nOlodaterol: 5 μg (2.5 μg per actuation)\n\nTiotropium: 5 μg (2.5 μg per actuation)\n\n2 inhalations a.m. dosing via RESPIMAT® inhaler'}], 'classes': [{'title': '5 min', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': '25 min', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': '50 min', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'QRS change from patient baseline at individual post-dose time points', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (observed cases)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study', 'description': 'Total number of patients randomised and treated in the study. (This is a cross-over trial consisting of a minimum two-week screening period. After screening, eligible patients were randomly assigned to one of 12 treatment sequences. Each patient received all three treatments as single doses on the three test days. Between test days with single dose administration there are 3-week washout periods.)'}], 'periods': [{'title': 'Treatment Period 1 (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 1 (21 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Treatment Period 2 (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 2 (21 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 3 (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Total number of patients randomised and treated in the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.4', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set (TS): This patient set included all randomised patients who were administered study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'dispFirstSubmitDate': '2014-06-25', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-19', 'studyFirstSubmitDate': '2014-01-07', 'dispFirstSubmitQcDate': '2014-06-25', 'resultsFirstSubmitDate': '2015-06-19', 'studyFirstSubmitQcDate': '2014-01-07', 'dispFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-19', 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration', 'timeFrame': '1 hour (h) and 10 min pre-dose and at 15 min, 30 min, 1 h, 2 h and 3 h post-dose', 'description': 'The response was defined as the change from patient baseline. Patient baseline was the average of the mean pre-dose values (period baseline) on each test day (Visit 2 (Day 1), Visit 3 (Day 22 (±7days)), and Visit 4 (Day 43±7days)).\n\nFor patients who did not complete all periods, patient baseline was the average of the available period baselines.\n\nThe means presented are the adjusted means.'}], 'secondaryOutcomes': [{'measure': 'Mean (Heart Rate Corrected QT Interval (Using Fredericia Adjustment)) QTcF Interval Change From Patient Baseline Over All Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Mean QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)'}, {'measure': 'Peak QTcF Interval Change From Patient Baseline Over All Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Peak QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)'}, {'measure': 'Mean Heart Rate Change From Patient Baseline Over All Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Mean heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)'}, {'measure': 'Peak Heart Rate Change From Patient Baseline Over All Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Peak heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)'}, {'measure': 'Heart Rate Change From Patient Baseline at Individual Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Heart rate change from patient baseline at individual post-dose time points'}, {'measure': 'Mean RR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Mean RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)'}, {'measure': 'Peak RR Change From Patient Baseline Over All Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Peak RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)'}, {'measure': 'RR Change From Patient Baseline at Individual Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'RR change from patient baseline at individual post-dose time points'}, {'measure': 'Mean QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Mean QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)'}, {'measure': 'Peak QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Peak QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)'}, {'measure': 'QT Change From Patient Baseline at Individual Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'QT change from patient baseline at individual post-dose time points'}, {'measure': 'Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)'}, {'measure': 'Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)'}, {'measure': 'QTcB Change From Patient Baseline at Individual Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'QTcB change from patient baseline at individual post-dose time points'}, {'measure': 'Mean PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Mean PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)'}, {'measure': 'Peak PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Peak PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)'}, {'measure': 'PR Change From Patient Baseline at Individual Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'PR change from patient baseline at individual post-dose time points'}, {'measure': 'Mean QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Mean QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)'}, {'measure': 'Peak QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'Peak QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)'}, {'measure': 'QRS Change From Patient Baseline at Individual Post-dose Time Points', 'timeFrame': '40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose', 'description': 'QRS change from patient baseline at individual post-dose time points'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy and safety of orally inhaled tiotropium and olodaterol as both a fixed dose combination and a free combination with respect to lung function and ECG parameters'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* patients must sign informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.\n* Patients must have a diagnosis of COPD and must meet the following spirometric criteria:\n\nPatients must have relatively stable airway obstruction with a post-bronchodilator (10 to 45 minutes after 400mcg salbutamol) FEV1\\>30% and \\< 80% of predicted normal (ECSC, GOLD II - III) and a post-bronchodilator FEV1/FVC \\<70% at Visit 1\n\n* Male or female patients, 40 years of age or older.\n* Patients must be current or ex-smokers with a smoking history of more than 10 pack years.\n* Patients who have never smoked cigarettes must be excluded.\n* Patients must be able to perform technically acceptable pulmonary function tests according to ATS/ERS guidelines and maintain records in a paper diary\n* Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).\n\nExclusion criteria:\n\n* Significant disease other than COPD\n* Clinically relevant abnormal lab values.\n* History of asthma.\n* Diagnosis of thyrotoxicosis\n* Diagnosis of paroxysmal tachycardia\n* History of myocardial infarction within 1 year of screening visit\n* Unstable or life-threatening cardiac arrhythmia\n* Hospitalization for heart failure within the past year\n* Known active tuberculosis\n* Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years\n* History of life-threatening pulmonary obstruction and patients with chronic respiratory failure\n* History of cystic fibrosis\n* Clinically evident bronchiectasis\n* History of significant alcohol or drug abuse\n* Thoracotomy with pulmonary resection\n* Patients treated with oral or patch ß-adrenergics\n* Patients treated with oral corticosteroid medication at unstable doses or at doses in excess of 10mg prednisolone per day or equivalent\n* Regular use of daytime oxygen therapy for more than one hour per day\n* Pulmonary rehabilitation program in the six weeks prior to the screening visit or patients currently in a pulmonary rehabilitation program\n* Investigational drug within one month or six half lives (whichever is greater) prior to screening visit\n* Known hypersensitivity to ß-adrenergic and/or anticholinergic drugs, BAC, EDTA\n* Pregnant or nursing women\n* Women of childbearing potential not using a highly effective method of birth control\n* Patient who have previously been randomized in this study or are currently participating in another study\n* Patients who are unable to comply with pulmonary medication restrictions prior to randomization'}, 'identificationModule': {'nctId': 'NCT02030535', 'briefTitle': 'Study to Evaluate the Effect on Lung Function and ECG When a Combination of Tiotropium Plus Olodaterol is Administered to Patients With COPD Either From a Single Inhaler or Each Compound is Administered After Each Other From Two Different Inhalers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomised, Placebo-controlled, Double-blind, Single Dose, Cross-over Study to Evaluate the Efficacy and Safety of Orally Inhaled Tiotropium + Olodaterol as Both a Fixed Dose Combination and a Free Combination (Both Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '1237.7'}, 'secondaryIdInfos': [{'id': '2013-002652-32', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tiotropium/Olodaterol FDC', 'description': 'patient will receive tiotropium and olodaterol in a fixed dose combination', 'interventionNames': ['Drug: tiotropium', 'Drug: olodaterol']}, {'type': 'EXPERIMENTAL', 'label': 'Tiotropium and Olodaterol FC', 'description': 'patient will receive tiotropium and olodaterol in a free combination', 'interventionNames': ['Drug: olodaterol', 'Drug: tiotropium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'patient will receive placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'olodaterol', 'type': 'DRUG', 'description': 'free combination with tiotropium', 'armGroupLabels': ['Tiotropium and Olodaterol FC']}, {'name': 'tiotropium', 'type': 'DRUG', 'description': 'free combination with olodaterol', 'armGroupLabels': ['Tiotropium and Olodaterol FC']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}, {'name': 'tiotropium', 'type': 'DRUG', 'description': 'fixed dose combination with olodaterol', 'armGroupLabels': ['Tiotropium/Olodaterol FDC']}, {'name': 'olodaterol', 'type': 'DRUG', 'description': 'fixed dose combination with tiotropium', 'armGroupLabels': ['Tiotropium/Olodaterol FDC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': '1237.7.49004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': '1237.7.49005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': '1237.7.49007 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Großhansdorf', 'country': 'Germany', 'facility': '1237.7.49002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': '1237.7.49003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Weinheim', 'country': 'Germany', 'facility': '1237.7.49001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.54887, 'lon': 8.66697}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}