Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-31 @ 9:24 PM
Study NCT ID:
NCT00758706
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2008-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers 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': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)', 'otherNumAtRisk': 26, 'otherNumAffected': 7, 'seriousNumAtRisk': 26, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)', 'otherNumAtRisk': 29, 'otherNumAffected': 10, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Exacerbation COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Increased Dyspnoe After Stopping Normal Treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Decompensation Cordis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ratio of TNF Alpha at Week 6 to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.37', 'spread': '0.532', 'groupId': 'OG000', 'lowerLimit': '0.532', 'upperLimit': '18.7'}, {'value': '1.21', 'spread': '0.270', 'groupId': 'OG001', 'lowerLimit': '0.270', 'upperLimit': '20.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set excluded participants without baseline or post-baseline data.'}, {'type': 'PRIMARY', 'title': 'Ratio of Sputum Total Cells at Week 6 to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'spread': '0.209', 'groupId': 'OG000', 'lowerLimit': '0.209', 'upperLimit': '4.03'}, {'value': '0.876', 'spread': '0.002', 'groupId': 'OG001', 'lowerLimit': '0.002', 'upperLimit': '13.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set excluded participants without baseline or post-baseline data.'}, {'type': 'PRIMARY', 'title': 'Ratio of Total Urine Desmosine at Week 6 to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.946', 'spread': '0.240', 'groupId': 'OG000', 'lowerLimit': '0.240', 'upperLimit': '5.44'}, {'value': '1.27', 'spread': '0.387', 'groupId': 'OG001', 'lowerLimit': '0.387', 'upperLimit': '5.73'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set excluded participants without baseline or post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Incidence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'all study visits', 'description': 'Number of patients who had an AE', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.025', 'spread': '-0.510', 'groupId': 'OG000', 'lowerLimit': '-0.510', 'upperLimit': '0.670'}, {'value': '-0.063', 'spread': '-0.670', 'groupId': 'OG001', 'lowerLimit': '-0.670', 'upperLimit': '0.550'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set completed at week 6'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Vital Capacity (FVC) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.103', 'spread': '-0.960', 'groupId': 'OG000', 'lowerLimit': '-0.960', 'upperLimit': '0.740'}, {'value': '-0.104', 'spread': '-0.900', 'groupId': 'OG001', 'lowerLimit': '-0.900', 'upperLimit': '1.23'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set completed at week 6'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Capacity (VC) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.098', 'spread': '-0.680', 'groupId': 'OG000', 'lowerLimit': '-0.680', 'upperLimit': '2.72'}, {'value': '-0.110', 'spread': '-0.840', 'groupId': 'OG001', 'lowerLimit': '-0.840', 'upperLimit': '0.590'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set completed at week 6'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Inspiratory Capacity (IC) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.082', 'spread': '-0.700', 'groupId': 'OG000', 'lowerLimit': '-0.700', 'upperLimit': '0.500'}, {'value': '-0.173', 'spread': '-2.19', 'groupId': 'OG001', 'lowerLimit': '-2.19', 'upperLimit': '0.840'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set completed at week 6'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.007', 'spread': '-0.410', 'groupId': 'OG000', 'lowerLimit': '-0.410', 'upperLimit': '0.260'}, {'value': '-0.067', 'spread': '-0.780', 'groupId': 'OG001', 'lowerLimit': '-0.780', 'upperLimit': '0.230'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.', 'unitOfMeasure': 'L/s', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set completed at week 6'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.81', 'spread': '-61.2', 'groupId': 'OG000', 'lowerLimit': '-61.2', 'upperLimit': '26.2'}, {'value': '-7.73', 'spread': '-73.2', 'groupId': 'OG001', 'lowerLimit': '-73.2', 'upperLimit': '43.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)', 'description': 'Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.6', 'spread': '-80.3', 'groupId': 'OG000', 'lowerLimit': '-80.3', 'upperLimit': '30.1'}, {'value': '-13.5', 'spread': '-102', 'groupId': 'OG001', 'lowerLimit': '-102', 'upperLimit': '27.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)', 'description': 'Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical COPD Questionnaire(CCQ) Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.011', 'spread': '-0.800', 'groupId': 'OG000', 'lowerLimit': '-0.800', 'upperLimit': '1.40'}, {'value': '-0.241', 'spread': '-1.74', 'groupId': 'OG001', 'lowerLimit': '-1.74', 'upperLimit': '1.20'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value. 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', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.191', 'spread': '-1.51', 'groupId': 'OG000', 'lowerLimit': '-1.51', 'upperLimit': '1.00'}, {'value': '-0.338', 'spread': '-1.74', 'groupId': 'OG001', 'lowerLimit': '-1.74', 'upperLimit': '1.42'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)', 'description': 'Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.149', 'spread': '-1.11', 'groupId': 'OG000', 'lowerLimit': '-1.11', 'upperLimit': '1.00'}, {'value': '-0.156', 'spread': '-1.74', 'groupId': 'OG001', 'lowerLimit': '-1.74', 'upperLimit': '1.27'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)', 'description': 'Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.114', 'spread': '-1.81', 'groupId': 'OG000', 'lowerLimit': '-1.81', 'upperLimit': '1.78'}, {'value': '-0.324', 'spread': '-1.94', 'groupId': 'OG001', 'lowerLimit': '-1.94', 'upperLimit': '1.13'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)', 'description': 'Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.072', 'spread': '-0.556', 'groupId': 'OG000', 'lowerLimit': '-0.556', 'upperLimit': '1.38'}, {'value': '-0.150', 'spread': '-2.22', 'groupId': 'OG001', 'lowerLimit': '-2.22', 'upperLimit': '0.976'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)', 'description': 'Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD1236', 'description': 'AZD1236 75mg oral tablet twice daily(bid)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo to AZD1236 twice daily(bid)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '80'}, {'value': '65.7', 'groupId': 'BG001', 'lowerLimit': '49', 'upperLimit': '79'}, {'value': '64.1', 'groupId': 'BG002', 'lowerLimit': '47', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Year', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', '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': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2008-09-23', 'resultsFirstSubmitDate': '2011-07-25', 'studyFirstSubmitQcDate': '2008-09-23', 'lastUpdatePostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-14', 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of TNF Alpha at Week 6 to Baseline', 'timeFrame': 'Baseline and Week 6', 'description': 'Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).'}, {'measure': 'Ratio of Sputum Total Cells at Week 6 to Baseline', 'timeFrame': 'Baseline and Week 6', 'description': 'Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).'}, {'measure': 'Ratio of Total Urine Desmosine at Week 6 to Baseline', 'timeFrame': 'Baseline and Week 6', 'description': 'Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'all study visits', 'description': 'Number of patients who had an AE'}, {'measure': 'Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.'}, {'measure': 'Change From Baseline in Forced Vital Capacity (FVC) at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.'}, {'measure': 'Change From Baseline in Vital Capacity (VC) at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.'}, {'measure': 'Change From Baseline in Inspiratory Capacity (IC) at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.'}, {'measure': 'Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.'}, {'measure': 'Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment', 'timeFrame': 'Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)', 'description': 'Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.'}, {'measure': 'Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment', 'timeFrame': 'Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)', 'description': 'Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.'}, {'measure': 'Change From Baseline in Clinical COPD Questionnaire(CCQ) Total', 'timeFrame': 'Baseline and Week 6', 'description': 'Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)'}, {'measure': 'Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment', 'timeFrame': 'Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)', 'description': 'Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).'}, {'measure': 'Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment', 'timeFrame': 'Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)', 'description': 'Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).'}, {'measure': 'Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment', 'timeFrame': 'Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)', 'description': 'Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).'}, {'measure': 'Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment', 'timeFrame': 'Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)', 'description': 'Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=360&filename=CSR-D4260C00007.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=360&filename=CSR-D4260C00007.pdf', 'label': 'D4260C00007'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum.'}, '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 symptomatic patients\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* Acute worsening of COPD (exacerbation) 1,5 month prior to study drug administration\n* Use of oral or parenteral glucocorticosteroids within 30 days and use of inhaled steroids 14 days prior to the study'}, 'identificationModule': {'nctId': 'NCT00758706', 'acronym': 'BICO', 'briefTitle': 'A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Double-blind, Randomised, Placebo-controlled, Parallel Group Multi-centre Phase IIa Study to Assess the Effects on Biomarkers in Induced Sputum, Bood and Uine of AZD1236 Administered as Oral Tablet in Moderate to Severe COPD Patients During a 6 Week Period.', 'orgStudyIdInfo': {'id': 'D4260C00007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD1236', 'description': 'oral tablet, 75 mg, twice daily during 6 weeks', 'interventionNames': ['Drug: AZD1236']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Dosing to match AZD1236', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD1236', 'type': 'DRUG', 'description': 'oral tablet, 75 mg, twice daily during 6 weeks', 'armGroupLabels': ['AZD1236']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dosing to match AZD1236', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Arhus C', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'København NV', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.71258, 'lon': 12.52343}}, {'city': 'Odense C', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'Research Site', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'Research Site', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Research Site', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'Research Site', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Ronald Dahl, MD, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arhus Kommune HospitalMedicinsk'}, {'name': 'Andrew Lockton, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D Charnwood'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}