Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT00791518
Status:
COMPLETED
Last Update Posted:
2014-07-30
First Post:
2008-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Lung Function and Symptoms in Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy
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'}]}}, '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': {'timeFrame': 'Day 1 of a 1-day study', 'eventGroups': [{'id': 'EG000', 'title': 'Participants With Diagnosed COPD', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician', 'otherNumAtRisk': 1084, 'otherNumAffected': 5, 'seriousNumAtRisk': 1084, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1084, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1084, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1084, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1084, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1084, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1072', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Diagnosed COPD', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician'}], 'classes': [{'title': '<80% predicted normal', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': '>=80% predicted normal', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)', 'description': "The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) \\<80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1072', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Diagnosed COPD', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician'}], 'classes': [{'title': '<50% predicted normal', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': '>=50% predicted normal', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)', 'description': "The percentage of participants on long-acting bronchodilator (LABD) monotherapy who met spirometric criteria for chronic obstructive pulmonary disease (COPD) and who had a post-albuterol FEV1 (the amount of air expelled from the lungs in one second after a full inspiration) \\<50% predicted normal was calculated. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1072', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Diagnosed COPD', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician'}], 'classes': [{'title': '<=0.70', 'categories': [{'measurements': [{'value': '689', 'groupId': 'OG000'}]}]}, {'title': '>0.70', 'categories': [{'measurements': [{'value': '383', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 <80%', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 \\<80%'}, {'id': 'OG001', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 \\>=80%'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.4', 'estimateComment': 'Least squares mean differences are calculated as \\<80% group minus \\>=80% group and are adjusted for Investigator.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 \\<80% and \\>=80% percent predicted'}, {'type': 'SECONDARY', 'title': 'Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '819', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 <50%', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 \\<50%'}, {'id': 'OG001', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 \\>=80%'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.2', 'ciUpperLimit': '0.4', 'estimateComment': 'Least squares mean differences are calculated as \\<50% group minus \\>=50% group and was adjusted for Investigator.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 \\<50% and \\>=50% predicted'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 <80%', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 \\<80%'}, {'id': 'OG001', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 \\>=80%'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '828', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 <50%', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician and a post-albuterol FEV1 \\<50%'}, {'id': 'OG001', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician and a post-albuterol FEV1 \\>=50%'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of 1-day study', 'description': 'The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 <80%', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 \\<80%'}, {'id': 'OG001', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 \\>=80%'}], 'classes': [{'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of 1-day study', 'description': 'The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '828', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 <50%', 'description': 'Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 \\<50%'}, {'id': 'OG001', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%', 'description': 'Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 \\>=50%'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of 1-day study', 'description': 'The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure'}, {'type': 'SECONDARY', 'title': 'Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 <80%', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 \\<80%'}, {'id': 'OG001', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%', 'description': 'Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 \\>=80%'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '1.7', 'estimateComment': 'Least squares mean differences are calculated as \\<80% group minus \\>=80% group and was adjusted for Investigator.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.', 'unitOfMeasure': 'puffs', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure'}, {'type': 'SECONDARY', 'title': 'Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '828', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 <50%', 'description': 'Current and previous smokers with at least a 10 pack-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 \\<50%'}, {'id': 'OG001', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%', 'description': 'Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 \\>=50%'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '2.1', 'estimateComment': 'Least squares mean differences are calculated as \\<50% group minus \\>=50% group and was adjusted for Investigator.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.', 'unitOfMeasure': 'puffs', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reports of Diagnosis and/or Treatment for Specific Cardiovascular (Heart), Psychiatric (Anxiety or Depression), and/or Bone Disorders in the <80%, >=80%, <50%, and >=50% FEV1 Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}, {'value': '828', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 <80%', 'description': 'Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and a an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 \\<80%'}, {'id': 'OG001', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%', 'description': 'Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 \\>=80%'}, {'id': 'OG002', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 <50%', 'description': 'Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 \\<50%'}, {'id': 'OG003', 'title': 'Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%', 'description': 'Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 \\>=50%'}], 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '389', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '400', 'groupId': 'OG003'}]}]}, {'title': 'Coronary artery disease', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}]}, {'title': 'Edema', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}]}, {'title': 'Atherosclerosis', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'Arrhythmia', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': 'Heart failure', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'Stable angina', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}, {'title': 'Peripheral vascular disease', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': 'Valvular heart disease', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}, {'title': 'Pulmonary edema', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Ischemic heart disease without cardiomyopathy', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Cardiomyopathy', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Ischemic heart disease with cardiomyopathy', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Cardiomegaly', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Left ventricular dysfunction', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic dysfunction', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Cerebrovascular disease', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Left ventricular hypertrophy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Stroke', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Cardiac arrest', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Myocardial infarction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Transient ischemic attack', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Unstable angina', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Generalized anxiety disorder', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}]}]}, {'title': 'Major depressive disorder, recurrent episode', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}]}, {'title': 'Social anxiety disorder (social phobia)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}]}, {'title': 'Panic disorder', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}]}, {'title': 'Major depressive disorder, single episode', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}, {'title': 'Post-traumatic stress disorder', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Attention deficit/hyperactivity disorder', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Osteoporosis', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}]}, {'title': 'Osteopenia', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'The number of participants with the indicated affected medical conditions were counted.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With Diagnosed COPD', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1084'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '991'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '93'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1084', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With Diagnosed COPD', 'description': 'Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '10.90', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '537', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '547', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '933', 'groupId': 'BG000'}]}]}, {'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Japanese East Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native and White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'One participant chose more than one race category; this participant was counted twice.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1084}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-24', 'studyFirstSubmitDate': '2008-11-13', 'resultsFirstSubmitDate': '2010-03-25', 'studyFirstSubmitQcDate': '2008-11-13', 'lastUpdatePostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-25', 'studyFirstPostDateStruct': {'date': '2008-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal', 'timeFrame': 'Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)', 'description': "The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) \\<80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal', 'timeFrame': 'Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)', 'description': "The percentage of participants on long-acting bronchodilator (LABD) monotherapy who met spirometric criteria for chronic obstructive pulmonary disease (COPD) and who had a post-albuterol FEV1 (the amount of air expelled from the lungs in one second after a full inspiration) \\<50% predicted normal was calculated. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics."}, {'measure': 'Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC).'}, {'measure': 'Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).'}, {'measure': 'Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).'}, {'measure': 'Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.'}, {'measure': 'Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%', 'timeFrame': 'Day 1 of 1-day study', 'description': 'The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.'}, {'measure': 'Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%', 'timeFrame': 'Day 1 of 1-day study', 'description': 'The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.'}, {'measure': 'Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%', 'timeFrame': 'Day 1 of 1-day study', 'description': 'The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.'}, {'measure': 'Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.'}, {'measure': 'Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50%', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.'}, {'measure': 'Number of Participants With Reports of Diagnosis and/or Treatment for Specific Cardiovascular (Heart), Psychiatric (Anxiety or Depression), and/or Bone Disorders in the <80%, >=80%, <50%, and >=50% FEV1 Groups', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'The number of participants with the indicated affected medical conditions were counted.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease (COPD)', 'Spirometry'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '20886200', 'type': 'BACKGROUND', 'citation': "Dransfield MT, Bailey W, Crater G, Emmett A, O'Dell DM, Yawn B. Disease severity and symptoms among patients receiving monotherapy for COPD. Prim Care Respir J. 2011 Mar;20(1):46-53. doi: 10.4104/pcrj.2010.00059."}]}, 'descriptionModule': {'briefSummary': 'A multicenter study to evaluate lung function and symptoms in subjects with COPD who have been on regular use of only one long-acting bronchodilator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diagnosed COPD who are on only one long acting bronchodilator medication to control their COPD symptoms.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cigarette smoking history-Current or ex-smokers (defined as stopped smoking for at least three months prior to the study visit)\n* Established history of COPD as diagnosed by a physician\n* Regular use (prescribed for use every day) of only one long-acting bronchodilator greater than or equal to one month before the study visit\n* Ability to read, comprehend, and record information in the English language\n\nExclusion Criteria:\n\n* Currently active asthma (receiving asthma therapy and or having asthma symptoms)\n* Use of ipratropium/albuterol combination products greater than three times per day, use of inhaled corticosteroids, use of inhaled corticosteroid/long-acting beta-agonist combinations, theophylline preparations, or oral beta agonists within 3 months prior to the study visit\n* Previous lung surgery\n* Other respiratory disorders other than COPD\n* Current alcohol, illegal drug, or solvent abuse\n* Females with a positive urine pregnancy test at the study visit'}, 'identificationModule': {'nctId': 'NCT00791518', 'acronym': 'LABD', 'briefTitle': 'Evaluation of Lung Function and Symptoms in Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Evaluation of Lung Function and Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy', 'orgStudyIdInfo': {'id': '111891'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No group', 'description': 'No group', 'interventionNames': ['Drug: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'DRUG', 'description': 'No intervention', 'armGroupLabels': ['No group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91950', 'city': 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