Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-03 @ 5:43 AM
Study NCT ID:
NCT01760304
Status:
TERMINATED
Last Update Posted:
2017-06-14
First Post:
2012-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Changes in Cardiac Function in COPD Patients After Administration of Budesonide/Formoterol (Symbicort®) Versus Placebo
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': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'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': {'email': 'mdivo@bwh.harvard.edu', 'phone': '8573070311', 'title': 'Dr. Miguel Divo', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Budesonide / Formoterol', 'description': 'This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo\n\nBudesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.\n\nSubject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).\n\nAfter 45 minutes , the above measurements will be repeated.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo\n\nPlacebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).\n\nAfter 45 minutes , the above measurements will be repeated.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cardiac Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide / Formoterol', 'description': 'In this arm patients received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) first then placebo on subsequent visit (cross-over study)\n\nBudesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.\n\nSubject who met inclusion criteria will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).\n\nAfter 45 minutes , the above measurements will be repeated.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In this arm patients received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® ) on subsequent visit (cross-over study).\n\nPlacebo: On visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).\n\nAfter 45 minutes , the above measurements will be repeated.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '0.8'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '2.5'}]}]}], 'analyses': [{'pValue': '0.769', 'groupIds': ['OG000'], 'groupDescription': 'a paired t-test was calculated comparing baseline measures and post intervention', 'statisticalMethod': '2-sided paired t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'a paired t-test was calculated comparing baseline measures and post intervention', 'statisticalMethod': 'paired T-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline and at 45 minutes after administration of study medication or placebo', 'description': 'Impedance cardiography (ICG) (BioZ Dx ICG machine, by CardioDynamics) was used to measure cardiac output without the need for invasive devices. Cardiac output measurement by impedance cardiography (CO-ICG) is a plethysmography technique using sensors to detect the properties of the blood flow in the thorax.\n\nAll subjects had on each visit a baseline measurement at rest and then 45 minutes after intervention (Budesonide/formoterol or Placebo). Measurement were performed at rest for 5 minutes to obtain a steady state and the last 2 minutes were taken for analysis as an averaged value labeled as pre and post intervention. For the analysis we calculated the difference from pre and post intervention at each visit. Paired t-test was used to compare the mean+/- SD of the pre and post difference when taking the study drug vs placebo.', 'unitOfMeasure': 'ml/beat', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lung Hyperinflation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide / Formoterol', 'description': 'In this arm patients received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) first then placebo on subsequent visit (cross-over study)\n\nBudesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.\n\nSubject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).\n\nAfter 45 minutes , the above measurements will be repeated.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In this arm patients will received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® ) on subsequent visit (cross-over study)\n\nPlacebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).\n\nAfter 45 minutes , the above measurements will be repeated.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '0.166', 'upperLimit': '0.514'}, {'value': '-0.058', 'groupId': 'OG001', 'lowerLimit': '-0.234', 'upperLimit': '0.118'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline and after 45 minutes after administration of study medication or placebo', 'description': 'Evaluation of lung hyperinflation as determined by Pulmonary function test where Inspiratory Capacity (IC) before and 45 minutes after the administration of the budesonide/formoterol or placebo.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluation of O2 Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide / Formoterol', 'description': 'This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo\n\nBudesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.\n\nSubject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).\n\nAfter 45 minutes , the above measurements will be repeated.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo\n\nPlacebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).\n\nAfter 45 minutes , the above measurements will be repeated.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '0.03'}, {'value': '0.17', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.26'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline and 45 minutes after administration of study medication or placebo', 'description': 'Evaluation of O2 Pulse is the measurement of oxygen consumption pre and post intervention', 'unitOfMeasure': 'ml/beat', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Budesonide / Formoterol , Then Placebo', 'description': 'This is a crossover study, where every patient signed to this arm received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) 160/4.5 mcg (2 inhalations) then placebo\n\nBudesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.\n\nSubject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).\n\nAfter 45 minutes , the above measurements will be repeated.'}, {'id': 'FG001', 'title': 'Placebo Then Budesonide/Formoterol', 'description': 'Every patient in this arm received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® )\n\nPlacebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).\n\nAfter 45 minutes , the above measurements will be repeated.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'This is a double crossover study design, therefore each patient use intervention and placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Budesonide / Formoterol First , Then Placebo', 'description': 'Subjects received in a blinded fashion Budesonide/Formoterol (Symbicort ® )2 inhalations (160/4.5) then placebo 2 inhalations Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.\n\nSubject will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).\n\nAfter 45 minutes , the above measurements will be repeated.'}, {'id': 'BG001', 'title': 'Placebo First, Then Budesonide/Formoterol', 'description': 'Subjects received in a blinded fashion placebo 2 inhalation then Budesonide/Formoterol (Symbicort ® )2 inhalations (160/4.5)\n\nSubject will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs Placebo on visit 1 then Budesonide/formoterol (B/F) 160/4.5 msg per activation on visit 2 (as per the randomization-crossover schema).\n\nAfter 45 minutes , the above measurements will be repeated.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '7', 'groupId': 'BG000'}, {'value': '70', 'spread': '10', 'groupId': 'BG001'}, {'value': '67', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Sponsor decided to stop the study due to expiration of blinded placebo .', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-18', 'studyFirstSubmitDate': '2012-10-23', 'resultsFirstSubmitDate': '2016-12-09', 'studyFirstSubmitQcDate': '2013-01-03', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-18', 'studyFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Output', 'timeFrame': 'Change from Baseline and at 45 minutes after administration of study medication or placebo', 'description': 'Impedance cardiography (ICG) (BioZ Dx ICG machine, by CardioDynamics) was used to measure cardiac output without the need for invasive devices. Cardiac output measurement by impedance cardiography (CO-ICG) is a plethysmography technique using sensors to detect the properties of the blood flow in the thorax.\n\nAll subjects had on each visit a baseline measurement at rest and then 45 minutes after intervention (Budesonide/formoterol or Placebo). Measurement were performed at rest for 5 minutes to obtain a steady state and the last 2 minutes were taken for analysis as an averaged value labeled as pre and post intervention. For the analysis we calculated the difference from pre and post intervention at each visit. Paired t-test was used to compare the mean+/- SD of the pre and post difference when taking the study drug vs placebo.'}], 'secondaryOutcomes': [{'measure': 'Lung Hyperinflation', 'timeFrame': 'Change from Baseline and after 45 minutes after administration of study medication or placebo', 'description': 'Evaluation of lung hyperinflation as determined by Pulmonary function test where Inspiratory Capacity (IC) before and 45 minutes after the administration of the budesonide/formoterol or placebo.'}, {'measure': 'Evaluation of O2 Pulse', 'timeFrame': 'Change from Baseline and 45 minutes after administration of study medication or placebo', 'description': 'Evaluation of O2 Pulse is the measurement of oxygen consumption pre and post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'To investigate whether Budesonide/Formoterol (Symbicort ®) therapy can improve heart function at rest by decreasing lung hyperinflation in patients with COPD (Chronic Obstructive Pulmonary Disease).', 'detailedDescription': "Patients with moderate to advanced COPD are known to have static hyperinflation (at rest) as a consequence of expiratory flow limitation. Hyperinflation is easily detected by measuring lung volumes during standard pulmonary function testing.\n\nDecreased Inspiratory Capacity (IC) secondary to hyperinflation has been described as a predictor of mortality in COPD, and as a limiting factor for the maximal tidal volume attained during exercise. Hyperinflation has been linked to a low cardiac output in part by limiting left ventricular ejection fraction during exercise.\n\nTreatment with inhaled anticholinergic agents or long-acting beta agonists (LABA) and combination of the LABA formoterol and budesonide has been shown to improve IC and decrease lung hyperinflation. Bronchodilators have been shown to improve exercise endurance in COPD when combined with pulmonary rehabilitation, however the exact mechanism: improvement of lung mechanics and /or improvement in cardiac function is not well known.\n\nImpedance cardiography (ICG) has emerged as a method to measure cardiac output without the need for invasive devices. Cardiac output measurement by impedance cardiography (CO-ICG) is a valid and reproducible method. It has been shown to have good correlation with thermodilution and the direct Fick method for the measurement of stroke volume and cardiac output.\n\nIn addition, the oxygen pulse, easily obtained by dividing the measured oxygen uptake by the heart rate (VO2/HR) provides an adequate reflection of cardiac stroke volume when the systemic extraction of oxygen is stable.\n\nThis method has been used to evaluate the effect of static and dynamic hyperinflation on cardiac function.\n\nThis pilot study is designed to be a single center (Brigham and Women's Hospital), randomized, placebo-controlled, double blind, crossover study of 14 patients (male and female 40 to 80 years old) with COPD and static hyperinflation.\n\nThe primary endpoint is the measurement of stroke volume, cardiac output and oxygen pulse at rest before and after the administration of budesonide/formoterol compared to placebo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nOutpatients subjects of either sex between ages 40-80 years, with a diagnosis of COPD. COPD will be characterized as the presence of airflow obstruction with an FEV1/FVC \\< 0.7 (Forced Expiratory Volume at one second / Forced Vital Capacity) and a FEV1 (Forced Expiratory Volume at one second ) 80% of predicted. All patients must have lung hyperinflation as demonstrated by an increase of ≥100 ml after the administration of budesonide/formoterol. All patients must have a cigarette smoking history of more than 10 pack-years, and be able to perform all the specified procedures as required by the protocol.\n\nExclusion Criteria:\n\n1. Patients with other significant diseases (recent \\< 6 weeks COPD exacerbation) that could place the patient at risk because of participation in the study, or which may influence the results of the study or the patients' ability to participate in the study.\n2. All patients with a recent (\\<1 year) history of myocardial infarction, or with a recent history of heart failure (NYHA class III and IV, pulmonary edema, or patients with cardiac arrhythmias.\n3. Patients on daytime oxygen therapy.\n4. Patients with known active tuberculosis.\n5. Patients with a history of active cancer except for non-metastatic skin cancer.\n6. Patients who have undergone thoracotomy, sternotomy, major cardiopulmonary intervention (lung resection, open heart surgery, etc), or other procedure in the 6 months prior to evaluation likely to cause instability of pulmonary status.\n7. Patients with upper respiratory infection in the past six weeks."}, 'identificationModule': {'nctId': 'NCT01760304', 'acronym': 'AZCO', 'briefTitle': 'Changes in Cardiac Function in COPD Patients After Administration of Budesonide/Formoterol (Symbicort®) Versus Placebo', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Evaluation of Changes in Cardiac Function in COPD Patients With Resting Hyperinflation After Administration of Budesonide/Formoterol (Symbicort®) Compared With Placebo', 'orgStudyIdInfo': {'id': '2011-P-001576/1'}, 'secondaryIdInfos': [{'id': 'D589BL00021/ISSSYMB0033', 'type': 'OTHER_GRANT', 'domain': 'AstraZeneca pharmaceuticals'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Budesonide / Formoterol', 'description': 'This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo', 'interventionNames': ['Drug: Budesonide / Formoterol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Budesonide / Formoterol', 'type': 'DRUG', 'otherNames': ['Symbicort ®'], 'description': 'Budesonide/ formoterol (B/F) 160/4.5 mcg per activation. Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).\n\nAfter 45 minutes , the above measurements will be repeated.', 'armGroupLabels': ['Budesonide / Formoterol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).\n\nAfter 45 minutes , the above measurements will be repeated.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Bartolome R Celli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Medicine, Harvard Medical School', 'investigatorFullName': 'Bartolome Celli', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}