Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2025-12-25 @ 5:57 PM
Study NCT ID:
NCT00758459
Status:
COMPLETED
Last Update Posted:
2011-08-19
First Post:
2008-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients
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': 'C000713527', 'term': '4-((5-chloro-2-pyridinyl)oxy)-1-((((4S)-4-methyl-2,5-dioxo-4-imidazolidinyl)methyl)sulfonyl)-piperidine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AZD1236', 'description': 'AZD1236', 'otherNumAtRisk': 35, 'otherNumAffected': 8, 'seriousNumAtRisk': 35, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 39, 'otherNumAffected': 8, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VIRAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Pharyngeal Cancer Stage Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'all study visits', 'description': 'Number of patients who had an Adverse Event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.006', 'spread': '-0.410', 'groupId': 'OG000', 'lowerLimit': '-0.410', 'upperLimit': '0.450'}, {'value': '0.003', 'spread': '-0.450', 'groupId': 'OG001', 'lowerLimit': '-0.450', 'upperLimit': '0.990'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before treatment and after 1, 2, 4 and 6 weeks of treatment', 'description': 'Change in FEV1 from baseline to end of treatment', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.048', 'spread': '-0.760', 'groupId': 'OG000', 'lowerLimit': '-0.760', 'upperLimit': '0.660'}, {'value': '-0.028', 'spread': '-0.730', 'groupId': 'OG001', 'lowerLimit': '-0.730', 'upperLimit': '0.940'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before treatment and after 1, 2, 4 and 6 weeks of treatment', 'description': 'Change in FVC from baseline to end of treatment', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vital Capacity (VC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.025', 'spread': '-0.840', 'groupId': 'OG000', 'lowerLimit': '-0.840', 'upperLimit': '0.660'}, {'value': '-0.043', 'spread': '-1.03', 'groupId': 'OG001', 'lowerLimit': '-1.03', 'upperLimit': '1.09'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before treatment and after 1, 2, 4 and 6 weeks of treatment', 'description': 'Change in VC from baseline to end of treatment', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Inspiratory Capacity (IC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.083', 'spread': '-0.730', 'groupId': 'OG000', 'lowerLimit': '-0.730', 'upperLimit': '0.720'}, {'value': '0.053', 'spread': '-0.620', 'groupId': 'OG001', 'lowerLimit': '-0.620', 'upperLimit': '1.55'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before treatment and after 1, 2, 4 and 6 weeks of treatment', 'description': 'Change in IC from baseline to end of treatment', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Flow (FEF)25-75%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.073', 'spread': '-1.45', 'groupId': 'OG000', 'lowerLimit': '-1.45', 'upperLimit': '0.250'}, {'value': '0.010', 'spread': '-0.280', 'groupId': 'OG001', 'lowerLimit': '-0.280', 'upperLimit': '1.06'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before treatment and after 1, 2, 4 and 6 weeks of treatment', 'description': 'Change in FEF from baseline to end of treatment', 'unitOfMeasure': 'L/s', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Expiratory Flow (PEF) Morning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'spread': '-78.4', 'groupId': 'OG000', 'lowerLimit': '-78.4', 'upperLimit': '71.5'}, {'value': '7.47', 'spread': '-57.0', 'groupId': 'OG001', 'lowerLimit': '-57.0', 'upperLimit': '138'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily during run-in and treatment', 'description': 'Change in PEF from average during run-in to average during the last 4 w of treatment', 'unitOfMeasure': 'L/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Expiratory Flow (PEF) Evening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '7.48', 'spread': '-70.4', 'groupId': 'OG000', 'lowerLimit': '-70.4', 'upperLimit': '79.6'}, {'value': '6.69', 'spread': '-48.1', 'groupId': 'OG001', 'lowerLimit': '-48.1', 'upperLimit': '139'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily during run-in and treatment', 'description': 'Change in PEF from average during run-in to average during the last 4 w of treatment', 'unitOfMeasure': 'L/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.373', 'spread': '0.270', 'groupId': 'OG000', 'lowerLimit': '0.270', 'upperLimit': '0.900'}, {'value': '-0.374', 'spread': '-4.80', 'groupId': 'OG001', 'lowerLimit': '-4.80', 'upperLimit': '1.30'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before treatment and after 1, 2, 4 and 6 weeks of treatment', 'description': 'Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.173', 'spread': '-1.22', 'groupId': 'OG000', 'lowerLimit': '-1.22', 'upperLimit': '0.885'}, {'value': '-0.390', 'spread': '-2.15', 'groupId': 'OG001', 'lowerLimit': '-2.15', 'upperLimit': '0.567'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily during run-in and treatment', 'description': 'Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.073', 'spread': '-1.10', 'groupId': 'OG000', 'lowerLimit': '-1.10', 'upperLimit': '1.28'}, {'value': '-0.212', 'spread': '-1.89', 'groupId': 'OG001', 'lowerLimit': '-1.89', 'upperLimit': '1.41'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily during run-in and treatment', 'description': 'Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.200', 'spread': '-1.36', 'groupId': 'OG000', 'lowerLimit': '-1.36', 'upperLimit': '1.53'}, {'value': '-0.470', 'spread': '-1.73', 'groupId': 'OG001', 'lowerLimit': '-1.73', 'upperLimit': '0.752'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily during run-in and treatment', 'description': 'Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.128', 'spread': '-1.11', 'groupId': 'OG000', 'lowerLimit': '-1.11', 'upperLimit': '1.03'}, {'value': '-0.262', 'spread': '-2.00', 'groupId': 'OG001', 'lowerLimit': '-2.00', 'upperLimit': '0.852'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily during run-in and treatment', 'description': 'Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '6-minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'spread': '-117', 'groupId': 'OG000', 'lowerLimit': '-117', 'upperLimit': '200'}, {'value': '9.68', 'spread': '-111', 'groupId': 'OG001', 'lowerLimit': '-111', 'upperLimit': '150'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before treatment and after 6 weeks of treatment', 'description': 'Change from baseline to end of treatment', 'unitOfMeasure': 'm', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD1236', 'description': 'AZD1236'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '76'}, {'value': '61.7', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '77'}, {'value': '61.7', 'groupId': 'BG002', 'lowerLimit': '46', 'upperLimit': '77'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Year', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-25', 'studyFirstSubmitDate': '2008-09-23', 'resultsFirstSubmitDate': '2011-07-25', 'studyFirstSubmitQcDate': '2008-09-23', 'lastUpdatePostDateStruct': {'date': '2011-08-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-25', 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'all study visits', 'description': 'Number of patients who had an Adverse Event'}], 'secondaryOutcomes': [{'measure': 'Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Before treatment and after 1, 2, 4 and 6 weeks of treatment', 'description': 'Change in FEV1 from baseline to end of treatment'}, {'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': 'Before treatment and after 1, 2, 4 and 6 weeks of treatment', 'description': 'Change in FVC from baseline to end of treatment'}, {'measure': 'Vital Capacity (VC)', 'timeFrame': 'Before treatment and after 1, 2, 4 and 6 weeks of treatment', 'description': 'Change in VC from baseline to end of treatment'}, {'measure': 'Inspiratory Capacity (IC)', 'timeFrame': 'Before treatment and after 1, 2, 4 and 6 weeks of treatment', 'description': 'Change in IC from baseline to end of treatment'}, {'measure': 'Forced Expiratory Flow (FEF)25-75%', 'timeFrame': 'Before treatment and after 1, 2, 4 and 6 weeks of treatment', 'description': 'Change in FEF from baseline to end of treatment'}, {'measure': 'Peak Expiratory Flow (PEF) Morning', 'timeFrame': 'Daily during run-in and treatment', 'description': 'Change in PEF from average during run-in to average during the last 4 w of treatment'}, {'measure': 'Peak Expiratory Flow (PEF) Evening', 'timeFrame': 'Daily during run-in and treatment', 'description': 'Change in PEF from average during run-in to average during the last 4 w of treatment'}, {'measure': 'Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total', 'timeFrame': 'Before treatment and after 1, 2, 4 and 6 weeks of treatment', 'description': 'Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)'}, {'measure': 'Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness', 'timeFrame': 'Daily during run-in and treatment', 'description': 'Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)'}, {'measure': 'Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness', 'timeFrame': 'Daily during run-in and treatment', 'description': 'Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)'}, {'measure': 'Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score', 'timeFrame': 'Daily during run-in and treatment', 'description': 'Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)'}, {'measure': 'Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings', 'timeFrame': 'Daily during run-in and treatment', 'description': 'Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)'}, {'measure': '6-minute Walk Test', 'timeFrame': 'Before treatment and after 6 weeks of treatment', 'description': 'Change from baseline to end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of COPD for 1 month\n* Men or postmenopausal women\n* Spirometry values indicating reduced lung function\n* Smoking history equivalent to using 20 cigarettes a day for 10 years\n\nExclusion Criteria:\n\n* Any current respiratory tract disorders other than COPD\n* Requirement for regular oxygen therapy\n* Use of oral or parenteral glucocorticosteroids within 30 days prior to the study'}, 'identificationModule': {'nctId': 'NCT00758459', 'acronym': 'CERA', 'briefTitle': 'Safety/Tolerability Study With AZD1236 in Chronic Obstructive 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