Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-30 @ 12:29 PM
Study NCT ID:
NCT01048333
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2010-01-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®
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': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'phone': '+44 1509 645895', 'title': 'Gerard Lynch', 'organization': 'Astra Zeneca'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Formoterol', 'description': 'Formoterol Turbuhaler 9 mcg', 'otherNumAtRisk': 108, 'otherNumAffected': 0, 'seriousNumAtRisk': 108, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Salmeterol', 'description': 'Serevent Diskus (salmeterol) 50 mcg', 'otherNumAtRisk': 109, 'otherNumAffected': 0, 'seriousNumAtRisk': 109, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo salmeterol Diskus and Placebo Turbuhaler', 'otherNumAtRisk': 109, 'otherNumAffected': 0, 'seriousNumAtRisk': 109, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Formoterol', 'description': 'Formoterol Turbuhaler 9 mcg'}, {'id': 'OG001', 'title': 'Salmeterol', 'description': 'Serevent Diskus (salmeterol) 50 mcg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo salmeterol Diskus and Placebo Turbuhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '1.072', 'groupId': 'OG000', 'lowerLimit': '1.055', 'upperLimit': '1.088'}, {'value': '1.041', 'groupId': 'OG001', 'lowerLimit': '1.025', 'upperLimit': '1.057'}, {'value': '1.007', 'groupId': 'OG002', 'lowerLimit': '0.992', 'upperLimit': '1.023'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 5 minutes post-dose', 'description': 'FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1', 'unitOfMeasure': 'percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average FEV1 During the First 15 Minutes Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Formoterol', 'description': 'Formoterol Turbuhaler 9 mcg'}, {'id': 'OG001', 'title': 'Salmeterol', 'description': 'Serevent Diskus (salmeterol) 50 mcg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo salmeterol Diskus and Placebo Turbuhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '1.064', 'groupId': 'OG000', 'lowerLimit': '1.052', 'upperLimit': '1.077'}, {'value': '1.041', 'groupId': 'OG001', 'lowerLimit': '1.030', 'upperLimit': '1.053'}, {'value': '1.012', 'groupId': 'OG002', 'lowerLimit': '1.001', 'upperLimit': '1.024'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre dose and 15 minutes post dose', 'description': 'Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1', 'unitOfMeasure': 'percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average FEV1 During 120 Minutes Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Formoterol', 'description': 'Formoterol Turbuhaler 9 mcg'}, {'id': 'OG001', 'title': 'Salmeterol', 'description': 'Serevent Diskus (salmeterol) 50 mcg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo salmeterol Diskus and Placebo Turbuhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '1.096', 'groupId': 'OG000', 'lowerLimit': '1.079', 'upperLimit': '1.112'}, {'value': '1.082', 'groupId': 'OG001', 'lowerLimit': '1.066', 'upperLimit': '1.098'}, {'value': '1.014', 'groupId': 'OG002', 'lowerLimit': '0.999', 'upperLimit': '1.029'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre dose and 120 minutes post dose', 'description': 'Average FEV1 during 120 minutes post dose, change versus pre dose FEV1', 'unitOfMeasure': 'percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Formoterol', 'description': 'Formoterol Turbuhaler 9 mcg'}, {'id': 'OG001', 'title': 'Salmeterol', 'description': 'Serevent Diskus (salmeterol) 50 mcg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo salmeterol Diskus and Placebo Turbuhaler'}], 'classes': [{'title': '5 min', 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}, {'value': '6.4', 'groupId': 'OG002'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}]}]}, {'title': '15 min', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000'}, {'value': '23.9', 'groupId': 'OG001'}, {'value': '9.2', 'groupId': 'OG002'}]}]}, {'title': '20 min', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '27.5', 'groupId': 'OG001'}, {'value': '10.1', 'groupId': 'OG002'}]}]}, {'title': '30 min', 'categories': [{'measurements': [{'value': '45.4', 'groupId': 'OG000'}, {'value': '32.1', 'groupId': 'OG001'}, {'value': '13.8', 'groupId': 'OG002'}]}]}, {'title': '40 min', 'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}, {'value': '15.6', 'groupId': 'OG002'}]}]}, {'title': '50 min', 'categories': [{'measurements': [{'value': '53.7', 'groupId': 'OG000'}, {'value': '40.4', 'groupId': 'OG001'}, {'value': '16.5', 'groupId': 'OG002'}]}]}, {'title': '60 min', 'categories': [{'measurements': [{'value': '54.6', 'groupId': 'OG000'}, {'value': '43.1', 'groupId': 'OG001'}, {'value': '18.3', 'groupId': 'OG002'}]}]}, {'title': '120 min', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}, {'value': '48.6', 'groupId': 'OG001'}, {'value': '20.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.090', 'ciLowerLimit': '1.31', 'ciUpperLimit': '3.35', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.534', 'ciLowerLimit': '3.55', 'ciUpperLimit': '12.02', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.127', 'ciLowerLimit': '1.77', 'ciUpperLimit': '5.52', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose', 'description': 'Percentage of patients who has achieved at least 12 % increase in FEV1 at each time point between 5 to 120 minutes post dose, change versus pre dose FEV1', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Formoterol', 'description': 'Formoterol Turbuhaler 9 mcg'}, {'id': 'OG001', 'title': 'Salmeterol', 'description': 'Serevent Diskus (salmeterol) 50 mcg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo salmeterol Diskus and Placebo Turbuhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline and at each day of treatment', 'description': 'Number of participants with at least 1 AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Formoterol, Then Salmeterol, Then Placebo', 'description': 'Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler'}, {'id': 'FG001', 'title': 'Salmeterol, Then Palcebo, Then Formoterol', 'description': 'Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus'}, {'id': 'FG002', 'title': 'Placebo, Then Formoterol, Then Salmeterol', 'description': 'Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler'}, {'id': 'FG003', 'title': 'Formoterol, Then Placebo, Then Salmeterol', 'description': 'Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler'}, {'id': 'FG004', 'title': 'Salmeterol, Then Formoterol, Then Placebo', 'description': 'Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler'}, {'id': 'FG005', 'title': 'Placebo, Then Salmeterol, Then Formoterol', 'description': 'Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Wash-Out Period 1 of 2 - 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Wash-Out Period 2 of 2 - 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients recruited at 14 clinics in 3 countries: Sweden (4 clinics); Italy (6 clinics); Spain (6 clinics)between January and May 2010', 'preAssignmentDetails': '141 patients enrolled; 32 excluded: 28 due to eligibility criteria not fulfilled and 4 for subject decision'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes all 3 arms : Formoterol, Salmeterol and Placebo.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.5', 'groupId': 'BG000', 'lowerLimit': '41.0', 'upperLimit': '84.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-25', 'studyFirstSubmitDate': '2010-01-12', 'resultsFirstSubmitDate': '2011-09-09', 'studyFirstSubmitQcDate': '2010-01-12', 'lastUpdatePostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-25', 'studyFirstPostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose', 'timeFrame': 'Pre-dose and 5 minutes post-dose', 'description': 'FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1'}], 'secondaryOutcomes': [{'measure': 'Average FEV1 During the First 15 Minutes Post Dose', 'timeFrame': 'Pre dose and 15 minutes post dose', 'description': 'Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1'}, {'measure': 'Average FEV1 During 120 Minutes Post Dose', 'timeFrame': 'Pre dose and 120 minutes post dose', 'description': 'Average FEV1 during 120 minutes post dose, change versus pre dose FEV1'}, {'measure': 'Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1', 'timeFrame': 'Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose', 'description': 'Percentage of patients who has achieved at least 12 % increase in FEV1 at each time point between 5 to 120 minutes post dose, change versus pre dose FEV1'}, {'measure': 'Adverse Events', 'timeFrame': 'At baseline and at each day of treatment', 'description': 'Number of participants with at least 1 AE.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'Onset of effect', 'COPD', 'Oxis Turbuhaler'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '22235841', 'type': 'DERIVED', 'citation': 'Cazzola M, Paggiaro P, Palange P, Bjermer L, Ausin P, Carlsson LG, Ekelund J, Lotvall J. Onset of action of formoterol versus salmeterol via dry powder inhalers in moderate chronic obstructive pulmonary disease: a randomized, placebo-controlled, double-blind, crossover study. Clin Drug Investig. 2012 Mar 1;32(3):147-55. doi: 10.2165/11630880-000000000-00000.'}]}, 'descriptionModule': {'briefSummary': '* Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose.\n* Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1 curve from 0 to 120 minutes)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A clinical diagnosis of COPD according to GOLD guidelines, and current COPD symptoms\n* A current or previous smoking history equivalent to 10 or more packs per year (1 pack year = 20 cigarettes smoked per day for one year).\n* Documented use of a short-acting inhaled bronchodilator (β2-agonist or anticholinergics) as reliever medication.\n\nExclusion Criteria:\n\n* A history and/or current diagnosis of asthma.\n* Patients who have experienced COPD exacerbation requiring hospitalisation and/or a course of antibiotics and/or a course of systemic steroid within 30 days (from end of exacerbation treatment) prior to Visit 1 and/or during the run-in period.\n* A history and/or current diagnosis of atopic diseases such as allergic rhinitis or eczema before the age of 40.'}, 'identificationModule': {'nctId': 'NCT01048333', 'briefTitle': 'Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Placebo-controlled, Double-blind (Double-dummy Technique),Crossover, Multi-centre Study, to Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler® 9 μg, Compared With Serevent® Diskus® 50 μg.', 'orgStudyIdInfo': {'id': 'D5127C00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Formoterol, then Salmeterol, then Placebo', 'description': 'Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler', 'interventionNames': ['Drug: Formoterol', 'Drug: Salmeterol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Salmeterol, then Palcebo, then Formoterol', 'description': 'Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus', 'interventionNames': ['Drug: Formoterol', 'Drug: Salmeterol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo, then Formoterol, then Salmeterol', 'description': 'Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler', 'interventionNames': ['Drug: Formoterol', 'Drug: Salmeterol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Formoterol, then Placebo, then Salmeterol', 'description': 'Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler', 'interventionNames': ['Drug: Formoterol', 'Drug: Salmeterol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Salmeterol, then Formoterol, then Placebo', 'description': 'Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler', 'interventionNames': ['Drug: Formoterol', 'Drug: Salmeterol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo, then Salmeterol, then Formoterol', 'description': 'Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus', 'interventionNames': ['Drug: Formoterol', 'Drug: Salmeterol', 'Drug: Placebo']}], 'interventions': [{'name': 'Formoterol', 'type': 'DRUG', 'description': 'Formoterol Turbuhaler 9 μg and Placebo Diskus', 'armGroupLabels': ['Formoterol, then Placebo, then Salmeterol', 'Formoterol, then Salmeterol, then Placebo', 'Placebo, then Formoterol, then Salmeterol', 'Placebo, then Salmeterol, then Formoterol', 'Salmeterol, then Formoterol, then Placebo', 'Salmeterol, then Palcebo, then Formoterol']}, {'name': 'Salmeterol', 'type': 'DRUG', 'description': 'Salmeterol Diskus 50 μg and Placebo Turbuhaler', 'armGroupLabels': ['Formoterol, then Placebo, then Salmeterol', 'Formoterol, then Salmeterol, then Placebo', 'Placebo, then Formoterol, then Salmeterol', 'Placebo, then Salmeterol, then Formoterol', 'Salmeterol, then Formoterol, then Placebo', 'Salmeterol, then Palcebo, then Formoterol']}, {'name': 'Placebo', 'type': 'DRUG', 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'Research Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Linköping', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Luleå', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 65.58415, 'lon': 22.15465}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Mario Cazzola, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Italy'}, {'name': 'Georgios Stratelis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca MC Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}