Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 8:10 AM
Study NCT ID:
NCT00784550
Status:
COMPLETED
Last Update Posted:
2016-11-23
First Post:
2008-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
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': 'D000069447', 'term': 'Tiotropium Bromide'}, {'id': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}], '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'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The serious adverse events of finger amputation and shoulder amputation were actually coded to the system organ class of surgical and medical procedures.', 'eventGroups': [{'id': 'EG000', 'title': 'FSC + Tio', 'description': 'Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)', 'otherNumAtRisk': 173, 'otherNumAffected': 34, 'seriousNumAtRisk': 173, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Tiotropium', 'description': 'Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID', 'otherNumAtRisk': 169, 'otherNumAffected': 29, 'seriousNumAtRisk': 169, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder transitional cell carcinoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bone neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Splenic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Finger amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Shoulder operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hemolytic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FSC + Tio', 'description': 'Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)'}, {'id': 'OG001', 'title': 'Tiotropium', 'description': 'Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID'}], 'classes': [{'categories': [{'measurements': [{'value': '101', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '-16', 'spread': '20.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant)', 'description': 'Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.', 'unitOfMeasure': 'milliliters (ml)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants randomized to study drug'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FSC + Tio', 'description': 'Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)'}, {'id': 'OG001', 'title': 'Tiotropium', 'description': 'Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID'}], 'classes': [{'categories': [{'measurements': [{'value': '233', 'spread': '23.1', 'groupId': 'OG000'}, {'value': '77', 'spread': '20.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of 2 hour post-dose FEV1 for each participant)', 'description': 'Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Vital Capacity (FVC) at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FSC + Tio', 'description': 'Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)'}, {'id': 'OG001', 'title': 'Tiotropium', 'description': 'Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'spread': '32.7', 'groupId': 'OG000'}, {'value': '-28', 'spread': '30.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (defined as the last recorded measure [up to Week 24] of AM pre-dose FVC for each participant)', 'description': 'Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FVC fore each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in 2 Hour Post-dose FVC at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FSC + Tio', 'description': 'Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)'}, {'id': 'OG001', 'title': 'Tiotropium', 'description': 'Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID'}], 'classes': [{'categories': [{'measurements': [{'value': '265', 'spread': '35.9', 'groupId': 'OG000'}, {'value': '87', 'spread': '31.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (defined as the last recorded measure of 2 hour post-dose FVC [up to Week 24] for each participant)', 'description': 'Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FVC for each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration (FVC).', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-Dose Inspiratory Capacity (IC) at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FSC + Tio', 'description': 'Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)'}, {'id': 'OG001', 'title': 'Tiotropium', 'description': 'Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'spread': '28.4', 'groupId': 'OG000'}, {'value': '-8', 'spread': '28.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (defined as the last recorded measure of AM pre-dose IC [up to Week 24] for each participant)', 'description': 'Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose IC for each participant) value minus the baseline value. IC is defined as the amount of air that can be inhaled after a normal expiration. IC is a measure of pulmonary function.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FSC + Tio', 'description': 'Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)'}, {'id': 'OG001', 'title': 'Tiotropium', 'description': 'Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID'}], 'classes': [{'title': 'Mastery', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.078', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.090', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.091', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Function', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.073', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnea', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.091', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.091', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.069', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Mastery domain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.470', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Fatigue domain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.394', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Emotional function domain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.879', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Dyspnea domain', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Endpoint (defined as the last recorded score [up to Week 24 or the early withdrawal visit] on each of the questions on this questionnaire)', 'description': 'The CRQ-SAS measures 4 domains of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FSC + Tio', 'description': 'Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)'}, {'id': 'FG001', 'title': 'Tiotropium', 'description': 'Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '169'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '127'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '342', 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'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'dispFirstSubmitDate': '2010-08-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-11', 'studyFirstSubmitDate': '2008-10-31', 'dispFirstSubmitQcDate': '2010-08-12', 'resultsFirstSubmitDate': '2010-11-18', 'studyFirstSubmitQcDate': '2008-11-03', 'dispFirstPostDateStruct': {'date': '2010-08-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-18', 'studyFirstPostDateStruct': {'date': '2008-11-04', 'type': 'ESTIMATED'}, 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FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint', 'timeFrame': 'Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of 2 hour post-dose FEV1 for each participant)', 'description': 'Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.'}, {'measure': 'Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Vital Capacity (FVC) at Endpoint', 'timeFrame': 'Baseline and Endpoint (defined as the last recorded measure [up to Week 24] of AM pre-dose FVC for each participant)', 'description': 'Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FVC fore each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration.'}, {'measure': 'Mean Change From Baseline in 2 Hour Post-dose FVC at Endpoint', 'timeFrame': 'Baseline and Endpoint (defined as the last recorded measure of 2 hour post-dose FVC [up to Week 24] for each participant)', 'description': 'Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FVC for each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration (FVC).'}, {'measure': 'Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-Dose Inspiratory Capacity (IC) at Endpoint', 'timeFrame': 'Baseline and Endpoint (defined as the last recorded measure of AM pre-dose IC [up to Week 24] for each participant)', 'description': 'Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose IC for each participant) value minus the baseline value. IC is defined as the amount of air that can be inhaled after a normal expiration. IC is a measure of pulmonary function.'}, {'measure': 'Mean Change From Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint', 'timeFrame': 'Baseline and Endpoint (defined as the last recorded score [up to Week 24 or the early withdrawal visit] on each of the questions on this questionnaire)', 'description': 'The CRQ-SAS measures 4 domains of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). 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Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD. Respir Med. 2012 Jan;106(1):91-101. doi: 10.1016/j.rmed.2011.09.002. Epub 2011 Oct 29."}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD.\n\nSPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH \\& Co. 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