Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-04-23 @ 2:53 PM
Study NCT ID:
NCT02533505
Status:
COMPLETED
Last Update Posted:
2018-07-30
First Post:
2015-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase IV O2 Consumption Study in COPD Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'AstraZeneca Clinical', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively.", 'otherNumAtRisk': 51, 'otherNumAffected': 13, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively.", 'otherNumAtRisk': 51, 'otherNumAffected': 11, 'seriousNumAtRisk': 51, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Oxygen Consumption (VO2; Obtained Via a Metabolic Cart)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}, {'id': 'OG001', 'title': 'Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}], 'classes': [{'categories': [{'measurements': [{'value': '11.366', 'groupId': 'OG000', 'lowerLimit': '5.148', 'upperLimit': '17.584'}, {'value': '1.252', 'groupId': 'OG001', 'lowerLimit': '-4.867', 'upperLimit': '7.371'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.114', 'ciLowerLimit': '2.943', 'ciUpperLimit': '17.286', 'pValueComment': 'All p-values ≤ 0.05 after rounding will be considered statistically significant.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).', 'unitOfMeasure': 'mL/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Oxygen Pulse (Defined as VO2/Heart Rate [HR]; VO2 is Obtained Via a Metabolic Cart; Used as a Surrogate for Stroke Volume)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}, {'id': 'OG001', 'title': 'Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}], 'classes': [{'categories': [{'measurements': [{'value': '0.256', 'groupId': 'OG000', 'lowerLimit': '0.166', 'upperLimit': '0.345'}, {'value': '0.168', 'groupId': 'OG001', 'lowerLimit': '0.081', 'upperLimit': '0.256'}]}]}], 'analyses': [{'pValue': '0.111', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.087', 'ciLowerLimit': '-0.021', 'ciUpperLimit': '0.196', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).', 'unitOfMeasure': 'mL/min/beats/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter HR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}, {'id': 'OG001', 'title': 'Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.481', 'groupId': 'OG000', 'lowerLimit': '-3.709', 'upperLimit': '-1.253'}, {'value': '-2.831', 'groupId': 'OG001', 'lowerLimit': '-4.049', 'upperLimit': '-1.614'}]}]}], 'analyses': [{'pValue': '0.609', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.350', 'ciLowerLimit': '-1.018', 'ciUpperLimit': '1.719', 'groupDescription': 'ΔHR', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).', 'unitOfMeasure': 'ΔHR: beats/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Pre-dose (Visit 2)to Post-dose (Visit 5) Assessment in Spirometry.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}, {'id': 'OG001', 'title': 'Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}], 'classes': [{'title': 'ΔFEV1', 'categories': [{'measurements': [{'value': '0.187', 'groupId': 'OG000', 'lowerLimit': '0.151', 'upperLimit': '0.224'}, {'value': '-0.004', 'groupId': 'OG001', 'lowerLimit': '-0.040', 'upperLimit': '0.033'}]}]}, {'title': 'ΔFVC', 'categories': [{'measurements': [{'value': '0.259', 'groupId': 'OG000', 'lowerLimit': '0.196', 'upperLimit': '0.322'}, {'value': '-0.052', 'groupId': 'OG001', 'lowerLimit': '-0.115', 'upperLimit': '0.011'}]}]}, {'title': 'ΔIC', 'categories': [{'measurements': [{'value': '0.256', 'groupId': 'OG000', 'lowerLimit': '0.210', 'upperLimit': '0.302'}, {'value': '-0.024', 'groupId': 'OG001', 'lowerLimit': '-0.070', 'upperLimit': '0.022'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.191', 'ciLowerLimit': '0.150', 'ciUpperLimit': '0.233', 'groupDescription': 'ΔFEV1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.312', 'ciLowerLimit': '0.236', 'ciUpperLimit': '0.388', 'groupDescription': 'ΔFVC', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.280', 'ciLowerLimit': '0.218', 'ciUpperLimit': '0.342', 'groupDescription': 'ΔIC', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'Forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and IC (using an slow vital capacity \\[SVC\\] maneuver; IC/total lung capacity \\[TLC\\] will be used as a measure of resting hyperinflation). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).', 'unitOfMeasure': 'FEV1: L; ΔFVC: L; ΔIC: L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Vt/Ti', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}, {'id': 'OG001', 'title': 'Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}], 'classes': [{'categories': [{'measurements': [{'value': '26.533', 'groupId': 'OG000', 'lowerLimit': '6.730', 'upperLimit': '46.335'}, {'value': '3.217', 'groupId': 'OG001', 'lowerLimit': '-16.349', 'upperLimit': '22.784'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.315', 'ciLowerLimit': '3.723', 'ciUpperLimit': '42.907', 'groupDescription': 'ΔVT/Ti', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in mean inspiratory flow (tidal volume \\[Vt\\]/inspiratory time \\[Ti\\]). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).', 'unitOfMeasure': 'mL/sec', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Units of measure: Vt/Ti: mL/sec'}, {'type': 'SECONDARY', 'title': 'Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in the Modified Borg Scale for Dyspnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}, {'id': 'OG001', 'title': 'Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.452', 'groupId': 'OG000', 'lowerLimit': '-0.703', 'upperLimit': '-0.202'}, {'value': '-0.248', 'groupId': 'OG001', 'lowerLimit': '-0.499', 'upperLimit': '0.003'}]}]}], 'analyses': [{'pValue': '0.106', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.204', 'ciLowerLimit': '-0.454', 'ciUpperLimit': '0.045', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). Modified Borg scale for dyspnea was self-administered at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21). The Borg scale is a 1-item instrument through which a subject reports dyspnea symptoms on a scale of 0-10 to quantify the intensity of dyspnea (where 10 is most intense).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter VCO2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}, {'id': 'OG001', 'title': 'Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}], 'classes': [{'categories': [{'measurements': [{'value': '5.994', 'groupId': 'OG000', 'lowerLimit': '-1.277', 'upperLimit': '13.264'}, {'value': '-4.251', 'groupId': 'OG001', 'lowerLimit': '-11.417', 'upperLimit': '2.915'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.245', 'ciLowerLimit': '2.469', 'ciUpperLimit': '18.021', 'groupDescription': 'ΔVCO2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).', 'unitOfMeasure': 'ΔVCO2: mL/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter SaO2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}, {'id': 'OG001', 'title': 'Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}], 'classes': [{'categories': [{'measurements': [{'value': '0.422', 'groupId': 'OG000', 'lowerLimit': '0.034', 'upperLimit': '0.810'}, {'value': '0.181', 'groupId': 'OG001', 'lowerLimit': '-0.206', 'upperLimit': '0.568'}]}]}], 'analyses': [{'pValue': '0.333', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.242', 'ciLowerLimit': '-0.255', 'ciUpperLimit': '0.738', 'groupDescription': 'ΔSaO2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).', 'unitOfMeasure': 'SaO2: %', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in RR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}, {'id': 'OG001', 'title': 'Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.193', 'groupId': 'OG000', 'lowerLimit': '-0.691', 'upperLimit': '0.305'}, {'value': '-0.430', 'groupId': 'OG001', 'lowerLimit': '-0.920', 'upperLimit': '0.060'}]}]}], 'analyses': [{'pValue': '0.484', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.237', 'ciLowerLimit': '-0.439', 'ciUpperLimit': '0.913', 'groupDescription': 'ΔRR', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).', 'unitOfMeasure': 'breaths/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ΔRR: breaths/min'}, {'type': 'SECONDARY', 'title': 'Change in Ti/Ttot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}, {'id': 'OG001', 'title': 'Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}], 'classes': [{'categories': [{'measurements': [{'value': '0.012', 'groupId': 'OG000', 'lowerLimit': '-0.003', 'upperLimit': '0.027'}, {'value': '-0.004', 'groupId': 'OG001', 'lowerLimit': '-0.019', 'upperLimit': '0.011'}]}]}], 'analyses': [{'pValue': '0.113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.016', 'ciLowerLimit': '-0.004', 'ciUpperLimit': '0.036', 'groupDescription': 'ΔTi/Ttot', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in fractional inspiratory time (Ti/total cycle time \\[Ttot\\]). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ΔTi/Ttot is measured as a ratio.'}, {'type': 'SECONDARY', 'title': 'Change in Vt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}, {'id': 'OG001', 'title': 'Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}], 'classes': [{'categories': [{'measurements': [{'value': '71.904', 'groupId': 'OG000', 'lowerLimit': '47.804', 'upperLimit': '96.005'}, {'value': '14.281', 'groupId': 'OG001', 'lowerLimit': '-9.475', 'upperLimit': '38.036'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '57.624', 'ciLowerLimit': '29.701', 'ciUpperLimit': '85.546', 'groupDescription': 'ΔVt', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in tidal volume (Vt). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).', 'unitOfMeasure': 'mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Units of measure: ΔVt: mL'}, {'type': 'SECONDARY', 'title': 'Change in Ve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}, {'id': 'OG001', 'title': 'Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}], 'classes': [{'categories': [{'measurements': [{'value': '838.232', 'groupId': 'OG000', 'lowerLimit': '449.034', 'upperLimit': '1227.431'}, {'value': '-23.924', 'groupId': 'OG001', 'lowerLimit': '-410.389', 'upperLimit': '362.541'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '862.157', 'ciLowerLimit': '439.817', 'ciUpperLimit': '1284.496', 'groupDescription': 'ΔVe', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in minute ventilation (Ve). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).', 'unitOfMeasure': 'mL/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Units of measure: ΔVe: mL/min.'}, {'type': 'SECONDARY', 'title': 'Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Spirometry.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}, {'id': 'OG001', 'title': 'Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}], 'classes': [{'categories': [{'measurements': [{'value': '0.017', 'groupId': 'OG000', 'lowerLimit': '0.008', 'upperLimit': '0.026'}, {'value': '-0.002', 'groupId': 'OG001', 'lowerLimit': '-0.011', 'upperLimit': '0.007'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.019', 'ciLowerLimit': '0.005', 'ciUpperLimit': '0.033', 'groupDescription': 'ΔFEV1/FVC', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'FEV1/FVC. For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ΔFEV1/FVC calculated as ratio.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Symbicort pMDI/Placebo/Symbicort pMDI/Placebo', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}, {'id': 'FG001', 'title': 'Placebo/Symbicort pMDI/Placebo/Symbicort pMDI', 'description': "The study utilized a 2-treatment, 4-period, cross-over design with 2 sequences. Each patient was randomized to 1 of 2 sequences (ABAB or BABA), where 'A', 'B' denote the active treatment or placebo treatment, respectively. Patients randomized to sequence ABAB received treatment A, B, A, and B at Visit 2 to Visit 5, respectively. Patients randomized to sequence BABA received B, A, B, and A at Visit 2 to Visit 5, respectively."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 5 sites in the United States (US) between 25 August 2015 and 12 August 2016.', 'preAssignmentDetails': 'This was a Phase 4, randomized, double-blind, multi-center, placebo-controlled, 2 way cross over study to evaluate changes in oxygen consumption and cardiac function in COPD patients with resting hyperinflation after administration of Symbicort pMDI. The study consisted of 5 site visits and 1 phone visit for a total study duration of 6 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Over All'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'spread': '8.32', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<50', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '>=50 - <65', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': '>=65', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black Or African American', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-27', 'studyFirstSubmitDate': '2015-07-30', 'resultsFirstSubmitDate': '2017-08-11', 'studyFirstSubmitQcDate': '2015-08-25', 'lastUpdatePostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-27', 'studyFirstPostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Oxygen Consumption (VO2; Obtained Via a Metabolic Cart)', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).'}], 'secondaryOutcomes': [{'measure': 'Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Oxygen Pulse (Defined as VO2/Heart Rate [HR]; VO2 is Obtained Via a Metabolic Cart; Used as a Surrogate for Stroke Volume)', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).'}, {'measure': 'Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter HR', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).'}, {'measure': 'Change From Pre-dose (Visit 2)to Post-dose (Visit 5) Assessment in Spirometry.', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'Forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and IC (using an slow vital capacity \\[SVC\\] maneuver; IC/total lung capacity \\[TLC\\] will be used as a measure of resting hyperinflation). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).'}, {'measure': 'Change in Vt/Ti', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in mean inspiratory flow (tidal volume \\[Vt\\]/inspiratory time \\[Ti\\]). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).'}, {'measure': 'Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in the Modified Borg Scale for Dyspnea', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). Modified Borg scale for dyspnea was self-administered at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21). The Borg scale is a 1-item instrument through which a subject reports dyspnea symptoms on a scale of 0-10 to quantify the intensity of dyspnea (where 10 is most intense).'}, {'measure': 'Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter VCO2', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).'}, {'measure': 'Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter SaO2', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).'}, {'measure': 'Change in RR', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).'}, {'measure': 'Change in Ti/Ttot', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in fractional inspiratory time (Ti/total cycle time \\[Ttot\\]). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).'}, {'measure': 'Change in Vt', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in tidal volume (Vt). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).'}, {'measure': 'Change in Ve', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in minute ventilation (Ve). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).'}, {'measure': 'Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Spirometry.', 'timeFrame': 'Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.', 'description': 'FEV1/FVC. For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiratory', 'COPD', 'O2 Consumption'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '15764761', 'type': 'RESULT', 'citation': 'Casaburi R, Kukafka D, Cooper CB, Witek TJ Jr, Kesten S. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest. 2005 Mar;127(3):809-17. doi: 10.1378/chest.127.3.809.'}, {'pmid': '15591470', 'type': 'RESULT', 'citation': 'Casanova C, Cote C, de Torres JP, Aguirre-Jaime A, Marin JM, Pinto-Plata V, Celli BR. Inspiratory-to-total lung capacity ratio predicts mortality in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 Mar 15;171(6):591-7. doi: 10.1164/rccm.200407-867OC. Epub 2004 Dec 10.'}, {'pmid': '11491153', 'type': 'RESULT', 'citation': 'Diaz O, Villafranca C, Ghezzo H, Borzone G, Leiva A, Milic-Emili J, Lisboa C. Breathing pattern and gas exchange at peak exercise in COPD patients with and without tidal flow limitation at rest. Eur Respir J. 2001 Jun;17(6):1120-7. doi: 10.1183/09031936.01.00057801.'}, {'pmid': '12570114', 'type': 'RESULT', 'citation': 'Di Marco F, Milic-Emili J, Boveri B, Carlucci P, Santus P, Casanova F, Cazzola M, Centanni S. Effect of inhaled bronchodilators on inspiratory capacity and dyspnoea at rest in COPD. Eur Respir J. 2003 Jan;21(1):86-94. doi: 10.1183/09031936.03.00020102.'}, {'pmid': '16055882', 'type': 'RESULT', 'citation': 'Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.'}, {'pmid': '9817708', 'type': 'RESULT', 'citation': "O'Donnell DE, Lam M, Webb KA. Measurement of symptoms, lung hyperinflation, and endurance during exercise in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1557-65. doi: 10.1164/ajrccm.158.5.9804004."}, {'pmid': '10430726', 'type': 'RESULT', 'citation': "O'Donnell DE, Lam M, Webb KA. Spirometric correlates of improvement in exercise performance after anticholinergic therapy in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Aug;160(2):542-9. doi: 10.1164/ajrccm.160.2.9901038."}, {'pmid': '11549531', 'type': 'RESULT', 'citation': "O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):770-7. doi: 10.1164/ajrccm.164.5.2012122."}, {'pmid': '12204862', 'type': 'RESULT', 'citation': "O'Donnell DE, D'Arsigny C, Fitzpatrick M, Webb KA. Exercise hypercapnia in advanced chronic obstructive pulmonary disease: the role of lung hyperinflation. Am J Respir Crit Care Med. 2002 Sep 1;166(5):663-8. doi: 10.1164/rccm.2201003."}, {'pmid': '3713112', 'type': 'RESULT', 'citation': 'Seibold H, Roth U, Lippert R, Kohler J, Wieshammer S, Henze E, Stauch M. Left heart function in chronic obstructive lung disease. Klin Wochenschr. 1986 May 2;64(9):433-41. doi: 10.1007/BF01727529.'}, {'pmid': '9480959', 'type': 'RESULT', 'citation': 'Sexton WL, Poole DC. Effects of emphysema on diaphragm blood flow during exercise. J Appl Physiol (1985). 1998 Mar;84(3):971-9. doi: 10.1152/jappl.1998.84.3.971.'}, {'pmid': '11401887', 'type': 'RESULT', 'citation': 'Sinderby C, Spahija J, Beck J, Kaminski D, Yan S, Comtois N, Sliwinski P. Diaphragm activation during exercise in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Jun;163(7):1637-41. doi: 10.1164/ajrccm.163.7.2007033.'}, {'pmid': '3943379', 'type': 'RESULT', 'citation': 'Stewart RI, Lewis CM. Cardiac output during exercise in patients with COPD. Chest. 1986 Feb;89(2):199-205. doi: 10.1378/chest.89.2.199.'}, {'type': 'RESULT', 'citation': 'Synn A, Pinto-Plata V, Perham C, Celli B, Divo M. Improvement in cost of breathing after use of budesonide/formoterol in COPD patients with static hyperinflation. Presented at The American Thoracic Society International Conference, May 16-21, 2014.'}, {'pmid': '18550609', 'type': 'RESULT', 'citation': 'Vassaux C, Torre-Bouscoulet L, Zeineldine S, Cortopassi F, Paz-Diaz H, Celli BR, Pinto-Plata VM. Effects of hyperinflation on the oxygen pulse as a marker of cardiac performance in COPD. Eur Respir J. 2008 Nov;32(5):1275-82. doi: 10.1183/09031936.00151707. Epub 2008 Jun 11.'}, {'pmid': '16135736', 'type': 'RESULT', 'citation': 'Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.'}, {'pmid': '9230726', 'type': 'RESULT', 'citation': 'Yan S, Kaminski D, Sliwinski P. Reliability of inspiratory capacity for estimating end-expiratory lung volume changes during exercise in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997 Jul;156(1):55-9. doi: 10.1164/ajrccm.156.1.9608113.'}, {'pmid': '31959167', 'type': 'DERIVED', 'citation': 'Divo MJ, DePietro MR, Horton JR, Maguire CA, Celli BR. Metabolic and cardiorespiratory effects of decreasing lung hyperinflation with budesonide/formoterol in COPD: a randomized, double-crossover, placebo-controlled, multicenter trial. Respir Res. 2020 Jan 20;21(1):26. doi: 10.1186/s12931-020-1288-3.'}]}, 'descriptionModule': {'briefSummary': 'A Phase IV study evaluating changes in oxygen consumption and cardiac function in Subjects with Chronic obstructive pulmonary disease (COPD) with resting hyperinflation after administration of Symbicort pMDI 160/4.5 μg.', 'detailedDescription': 'Patients with moderate/severe COPD are known to have static hyperinflation and to develop dynamic hyperinflation during exercise. Treatment with inhaled long-acting beta agonists and combination of the long-acting beta agonist (LABA), formoterol and the inhaled corticosteroid, budesonide has been shown to improve IC and decrease lung hyperinflation. In a similar previous pilot single centre study with budesonide/formoterol (Symbicort®) the analysis of cardiac outcomes demonstrated a decrease in maximum volume of oxygen (VO2) compared to placebo. Findings suggested that the use of Symbicort can decrease the cost of breathing and therefore reduce the cardiac demand experienced by COPD patients with hyperinflation at rest. The aim of this study is to investigate whether Symbicort therapy can decrease resting VO2 by decreasing static lung hyperinflation in subjects with COPD and to evaluate changes in cardiac function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signing of the informed consent form (ICF) prior to any study specific procedures, including withholding of medications.\n2. Male or female, aged 40 to 80 years, inclusive, at Screening (Visit 1).\n3. Has a clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines with a post bronchodilator FEV1/FVC \\<0.7 at Screening (Visit 1).\n4. Has a post-bronchodilator FEV1 ≤65% of predicted value at Screening (Visit 1). National Health and Nutrition Examination Survey (NHANES) predicted normal standards will be used for all subjects.\n5. Has an increase in IC of \\>10% after the administration of 1 inhalation of open-label Symbicort pMDI administered with a spacer at Screening (Visit 1).\n6. Has a cigarette smoking history of more than 10 pack-years (number of cigarettes smoked per day × number of years smoked)/20).\n7. Be able to understand and comply with study requirements, as judged by the Investigator.\n\nExclusion Criteria:\n\n1. Subject is an employee or relative of an employee involved in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).\n2. Previous enrollment or randomization in this study.\n3. Participation in another clinical study with an investigational product (IP) during the last 30 days prior to Screening (Visit 1).\n4. Subjects who are unable to discontinue their regular chronic COPD medications (including LAMAs and/or LABA/ICS) and/or who are unable or unwilling to comply with study requirements.\n5. Subjects who are taking uLABAs (indacaterol, vilanterol) or uLABA-containing products.\n6. Subjects who are taking PDE-4 inhibitors (roflumilast).\n7. Subjects who are taking oral corticosteroids on a chronic, regular basis.\n8. Subjects using daytime oxygen therapy.\n9. Subjects who are currently pregnant (confirmed with positive pregnancy test) or breast feeding.\n10. History of respiratory tract infection (including the upper respiratory tract) and/or pulmonary exacerbation within 6 weeks prior to Screening (Visit 1).\n11. Pulmonary resection or lung volume reduction surgery within 12 months prior to Screening (Visit 1), or history of lung transplantation, or, in the Investigator's opinion, the subject may need thoracotomy or other lung surgery during the study.\n12. History or current diagnosis of asthma and/or alpha 1 anti-trypsin deficiency.\n13. Known active tuberculosis.\n14. History of interstitial lung or massive pulmonary thromboembolic disease.\n15. History of bronchiectasis secondary to respiratory diseases other than COPD (eg, cystic fibrosis, Kartagener's syndrome, etc).\n16. Any clinically significant disease or disorder (eg, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, psychiatric, major physical impairment) which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, may influence the results of the study, or may affect the subject's ability to participate in the study.\n17. Recent (within 12 months prior to Screening \\[Visit 1\\]) history of myocardial infarction, recent history of heart failure (New York Heart Association \\[NYHA\\] class III and IV, pulmonary edema, and/or cardiac arrhythmia.\n18. Previous or current history of lung cancer.\n19. History of cancer (within 5 years prior to Visit 1), except for non-metastatic, non melanoma skin cancer.\n20. Subjects who cannot perform spirometry manuevers or tolerate body plethysmography.\n21. Subjects with known hypersensitivity to Symbicort, its monocomponents (budesonide or formoterol), or its excipients."}, 'identificationModule': {'nctId': 'NCT02533505', 'briefTitle': 'Phase IV O2 Consumption Study in COPD Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 4, Randomized, Double-blind, Multicenter, Placebo-Controlled Two Way Cross-Over Study to Evaluate Changes in Oxygen Consumption and Cardiac Function in COPD Patients With Resting Hyperinflation After Administration of Symbicort pMDI 160/4.5 μg.', 'orgStudyIdInfo': {'id': 'D589CC00014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Symbicort pressurized Metered Dose Inhaler (pMDI)', 'description': 'Symbicort pressurized Metered Dose Inhaler (pMDI)', 'interventionNames': ['Drug: Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of reference drug', 'description': 'Placebo of reference drug', 'interventionNames': ['Drug: Matching Placebo pMDI 160/4.5 μg']}], 'interventions': [{'name': 'Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol', 'type': 'DRUG', 'description': 'Subjects will receive a single dose (2 inhalations) of Symbicort pMDI 160/4.5 μg (2 inhalations; total dosage 320/9.0 μg) or placebo (with a spacer) in a cross-over design (a total of 2 doses of Symbicort and 2 doses of placebo over the duration of the study), and assessments will be made before and after dosing at specified timepoints', 'armGroupLabels': ['Symbicort pressurized Metered Dose Inhaler (pMDI)']}, {'name': 'Matching Placebo pMDI 160/4.5 μg', 'type': 'DRUG', 'description': 'Placebo will be given according at the same dose and schedule as the active comparator - cross-over design.', 'armGroupLabels': ['Placebo of reference drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06105', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}