Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-27 @ 4:33 PM
Study NCT ID:
NCT01473758
Status:
TERMINATED
Last Update Posted:
2017-02-14
First Post:
2011-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease
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': 'C424423', 'term': 'Roflumilast'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director, Clinical Science', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Signing of informed consent until Follow-up Visit (Up to 56 days)', 'description': 'AEs were analyzed using an Initial Approach (all patients treated in Cycle 1) and an Extended Approach (all patients treated in Cycle 1 and patients re-randomized and treated in Cycle 2). The data from the 2 approaches are entered in one table. Please note: a result of 0 corresponds to no patients with AEs for the preferred term \\> the 5% threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Roflumilast 500 μg (Initial Approach)', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Initial Approach Arm includes all participants who received treatment in Cycle 1.', 'otherNumAtRisk': 38, 'otherNumAffected': 35, 'seriousNumAtRisk': 38, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo (Initial Approach)', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Initial Approach Arm includes all participants who received treatment in Cycle 1.', 'otherNumAtRisk': 43, 'otherNumAffected': 25, 'seriousNumAtRisk': 43, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Roflumilast 500 µg (Extended Approach)', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Extended Approach Arm includes all participants who received treatment in Cycle 1 and those participants who were re-randomized and received treatment in Cycle 2.', 'otherNumAtRisk': 48, 'otherNumAffected': 44, 'seriousNumAtRisk': 48, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Placebo (Extended Approach)', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Extended Approach Arm includes all participants who received treatment in Cycle 1 and those participants who were re-randomized and received treatment in Cycle 2.', 'otherNumAtRisk': 47, 'otherNumAffected': 28, 'seriousNumAtRisk': 47, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Sputum Neutrophil Counts at Day 14 Post Exacerbation (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.705', 'spread': '2.263', 'groupId': 'OG000'}, {'value': '-20.109', 'spread': '1.995', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6491', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.404', 'ciLowerLimit': '-4.731', 'ciUpperLimit': '7.538', 'pValueComment': 'The model contains neutrophil count at Baseline and treatment as independent variables, fixed effects.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.070', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used with neutrophil count at Baseline and treatment as independent variables, fixed effects.', 'unitOfMeasure': '10^6 cells/gram sputum', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Sputum Neutrophil Counts at Day 14 Post Exacerbation (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.569', 'spread': '1.906', 'groupId': 'OG000'}, {'value': '-19.157', 'spread': '1.855', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8786', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.412', 'ciLowerLimit': '-5.766', 'ciUpperLimit': '4.943', 'pValueComment': 'The model contains neutrophil count at Baseline and treatment as independent variables, fixed effects.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.687', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used with neutrophil count at Baseline and treatment as independent variables, fixed effects.', 'unitOfMeasure': '10^6 cells/gram sputum', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Whose Sputum Neutrophil Counts Returned to Stable State at Day 14 (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '64.6'}, {'value': '55.2', 'groupId': 'OG001', 'lowerLimit': '35.7', 'upperLimit': '73.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) and were determined with a Neubauer hemocytometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Whose Sputum Neutrophil Counts Returned to Stable State at Day 14 (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000', 'lowerLimit': '23.1', 'upperLimit': '68.5'}, {'value': '51.6', 'groupId': 'OG001', 'lowerLimit': '33.1', 'upperLimit': '69.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) and were determined with a Neubauer hemocytometer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Total Cells (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=35, 39)', 'categories': [{'measurements': [{'value': '-25.559', 'spread': '3.529', 'groupId': 'OG000'}, {'value': '-27.563', 'spread': '3.334', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=32, 38)', 'categories': [{'measurements': [{'value': '-21.813', 'spread': '2.706', 'groupId': 'OG000'}, {'value': '-25.111', 'spread': '2.505', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=25, 37)', 'categories': [{'measurements': [{'value': '-29.200', 'spread': '4.022', 'groupId': 'OG000'}, {'value': '-22.218', 'spread': '3.362', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=24, 33)', 'categories': [{'measurements': [{'value': '-24.477', 'spread': '2.708', 'groupId': 'OG000'}, {'value': '-26.474', 'spread': '2.341', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': '10^6 cells/gram sputum', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Total Cells (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=45, 43)', 'categories': [{'measurements': [{'value': '-26.634', 'spread': '3.030', 'groupId': 'OG000'}, {'value': '-26.335', 'spread': '3.124', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=41, 42)', 'categories': [{'measurements': [{'value': '-23.512', 'spread': '2.448', 'groupId': 'OG000'}, {'value': '-25.332', 'spread': '2.471', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=30, 40)', 'categories': [{'measurements': [{'value': '-29.023', 'spread': '3.347', 'groupId': 'OG000'}, {'value': '-22.920', 'spread': '2.947', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=28, 36)', 'categories': [{'measurements': [{'value': '-19.551', 'spread': '3.920', 'groupId': 'OG000'}, {'value': '-26.855', 'spread': '3.536', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': '10^6 cells/gram sputum', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Percentage of Neutrophils (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=30, 35)', 'categories': [{'measurements': [{'value': '-11.325', 'spread': '3.837', 'groupId': 'OG000'}, {'value': '-14.484', 'spread': '3.559', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=31, 37)', 'categories': [{'measurements': [{'value': '-16.770', 'spread': '3.983', 'groupId': 'OG000'}, {'value': '-20.346', 'spread': '3.550', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=24, 34)', 'categories': [{'measurements': [{'value': '-27.760', 'spread': '5.275', 'groupId': 'OG000'}, {'value': '-13.837', 'spread': '4.498', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=16, 30)', 'categories': [{'measurements': [{'value': '-19.663', 'spread': '5.561', 'groupId': 'OG000'}, {'value': '-17.047', 'spread': '4.229', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of neutrophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'percentage of neutrophils', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Percentage of Neutrophils (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 39)', 'categories': [{'measurements': [{'value': '-14.637', 'spread': '3.748', 'groupId': 'OG000'}, {'value': '-16.060', 'spread': '3.713', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=39, 40)', 'categories': [{'measurements': [{'value': '-20.690', 'spread': '3.758', 'groupId': 'OG000'}, {'value': '-21.052', 'spread': '3.678', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=29, 36)', 'categories': [{'measurements': [{'value': '-29.848', 'spread': '4.721', 'groupId': 'OG000'}, {'value': '-14.664', 'spread': '4.371', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=20, 32)', 'categories': [{'measurements': [{'value': '-21.327', 'spread': '5.009', 'groupId': 'OG000'}, {'value': '-17.328', 'spread': '4.188', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of neutrophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percentage of neutrophils', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Percentage of Macrophages (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=30, 35)', 'categories': [{'measurements': [{'value': '11.393', 'spread': '3.837', 'groupId': 'OG000'}, {'value': '15.430', 'spread': '3.559', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=31, 37)', 'categories': [{'measurements': [{'value': '16.062', 'spread': '3.929', 'groupId': 'OG000'}, {'value': '20.774', 'spread': '3.506', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=24, 34)', 'categories': [{'measurements': [{'value': '27.535', 'spread': '5.284', 'groupId': 'OG000'}, {'value': '13.382', 'spread': '4.503', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=16, 30)', 'categories': [{'measurements': [{'value': '16.593', 'spread': '5.539', 'groupId': 'OG000'}, {'value': '15.877', 'spread': '4.171', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of macrophages was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'percentage of macrophages', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Percentage of Macrophages (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 39)', 'categories': [{'measurements': [{'value': '14.679', 'spread': '3.740', 'groupId': 'OG000'}, {'value': '17.228', 'spread': '3.704', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=39, 40)', 'categories': [{'measurements': [{'value': '20.331', 'spread': '3.745', 'groupId': 'OG000'}, {'value': '21.599', 'spread': '3.667', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=29, 36)', 'categories': [{'measurements': [{'value': '29.510', 'spread': '4.717', 'groupId': 'OG000'}, {'value': '14.463', 'spread': '4.367', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=20, 32)', 'categories': [{'measurements': [{'value': '19.075', 'spread': '5.003', 'groupId': 'OG000'}, {'value': '16.322', 'spread': '4.156', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of macrophages was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'percentage of macrophages', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Percentage of Eosinophils (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=30, 35)', 'categories': [{'measurements': [{'value': '-0.259', 'spread': '0.245', 'groupId': 'OG000'}, {'value': '-0.100', 'spread': '0.225', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=31, 37)', 'categories': [{'measurements': [{'value': '-0.110', 'spread': '0.326', 'groupId': 'OG000'}, {'value': '-0.188', 'spread': '0.288', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=24, 34)', 'categories': [{'measurements': [{'value': '0.043', 'spread': '1.209', 'groupId': 'OG000'}, {'value': '1.597', 'spread': '1.020', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=16, 30)', 'categories': [{'measurements': [{'value': '2.187', 'spread': '2.278', 'groupId': 'OG000'}, {'value': '1.086', 'spread': '1.766', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of eosinophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'percentage of eosinophils', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Percentage of Eosinophils (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 39)', 'categories': [{'measurements': [{'value': '-0.341', 'spread': '0.206', 'groupId': 'OG000'}, {'value': '-0.141', 'spread': '0.202', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=39, 40)', 'categories': [{'measurements': [{'value': '-0.174', 'spread': '0.271', 'groupId': 'OG000'}, {'value': '-0.214', 'spread': '0.263', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=29, 36)', 'categories': [{'measurements': [{'value': '0.031', 'spread': '1.044', 'groupId': 'OG000'}, {'value': '1.518', 'spread': '0.952', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=20, 32)', 'categories': [{'measurements': [{'value': '1.714', 'spread': '1.969', 'groupId': 'OG000'}, {'value': '0.913', 'spread': '1.655', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of eosinophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'percentage of macrophages', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Percentage of Lymphocyte (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=30, 35)', 'categories': [{'measurements': [{'value': '0.229', 'spread': '0.353', 'groupId': 'OG000'}, {'value': '0.182', 'spread': '0.326', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=31, 37)', 'categories': [{'measurements': [{'value': '0.430', 'spread': '0.254', 'groupId': 'OG000'}, {'value': '0.295', 'spread': '0.225', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=24, 34)', 'categories': [{'measurements': [{'value': '0.039', 'spread': '0.183', 'groupId': 'OG000'}, {'value': '-0.325', 'spread': '0.155', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=16, 30)', 'categories': [{'measurements': [{'value': '-0.095', 'spread': '0.187', 'groupId': 'OG000'}, {'value': '-0.051', 'spread': '0.137', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of lymphocytes was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Percentage of Lymphocytes (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 39)', 'categories': [{'measurements': [{'value': '0.109', 'spread': '0.308', 'groupId': 'OG000'}, {'value': '-0.015', 'spread': '0.303', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=39, 40)', 'categories': [{'measurements': [{'value': '0.309', 'spread': '0.250', 'groupId': 'OG000'}, {'value': '0.195', 'spread': '0.243', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=29, 36)', 'categories': [{'measurements': [{'value': '-0.118', 'spread': '0.173', 'groupId': 'OG000'}, {'value': '-0.431', 'spread': '0.158', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=20, 32)', 'categories': [{'measurements': [{'value': '-0.203', 'spread': '0.164', 'groupId': 'OG000'}, {'value': '-0.208', 'spread': '0.132', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of lymphocytes was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-6 (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=31, 38)', 'categories': [{'measurements': [{'value': '-1317.400', 'spread': '143.748', 'groupId': 'OG000'}, {'value': '-934.624', 'spread': '133.217', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=30, 35)', 'categories': [{'measurements': [{'value': '-822.715', 'spread': '221.328', 'groupId': 'OG000'}, {'value': '-695.955', 'spread': '206.201', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=22, 35)', 'categories': [{'measurements': [{'value': '-1232.929', 'spread': '212.663', 'groupId': 'OG000'}, {'value': '-955.365', 'spread': '174.734', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=22, 29)', 'categories': [{'measurements': [{'value': '-1042.097', 'spread': '225.619', 'groupId': 'OG000'}, {'value': '-996.485', 'spread': '196.729', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-6 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-6 (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 42)', 'categories': [{'measurements': [{'value': '-1207.678', 'spread': '133.298', 'groupId': 'OG000'}, {'value': '-923.325', 'spread': '130.533', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=36, 39)', 'categories': [{'measurements': [{'value': '-725.454', 'spread': '195.921', 'groupId': 'OG000'}, {'value': '-705.849', 'spread': '192.890', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=26, 38)', 'categories': [{'measurements': [{'value': '-1115.741', 'spread': '200.367', 'groupId': 'OG000'}, {'value': '-877.871', 'spread': '172.950', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=26, 32)', 'categories': [{'measurements': [{'value': '-860.191', 'spread': '206.289', 'groupId': 'OG000'}, {'value': '-962.342', 'spread': '189.817', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-6 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-8 (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=31, 38)', 'categories': [{'measurements': [{'value': '-174718.396', 'spread': '45481.710', 'groupId': 'OG000'}, {'value': '-227274.816', 'spread': '41821.023', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=30, 35)', 'categories': [{'measurements': [{'value': '-149198.139', 'spread': '47388.834', 'groupId': 'OG000'}, {'value': '-199515.687', 'spread': '43965.789', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=22, 35)', 'categories': [{'measurements': [{'value': '-255317.294', 'spread': '70915.154', 'groupId': 'OG000'}, {'value': '-160587.365', 'spread': '57944.793', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=21, 29)', 'categories': [{'measurements': [{'value': '-204731.356', 'spread': '50404.332', 'groupId': 'OG000'}, {'value': '-223918.341', 'spread': '43039.568', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-8 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-8 (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 42)', 'categories': [{'measurements': [{'value': '-193222.856', 'spread': '39595.196', 'groupId': 'OG000'}, {'value': '-215296.477', 'spread': '38432.424', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=36, 39)', 'categories': [{'measurements': [{'value': '-172069.810', 'spread': '41341.330', 'groupId': 'OG000'}, {'value': '-195751.307', 'spread': '40449.866', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=26, 38)', 'categories': [{'measurements': [{'value': '-264788.038', 'spread': '62440.420', 'groupId': 'OG000'}, {'value': '-160441.028', 'spread': '53963.528', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=25, 32)', 'categories': [{'measurements': [{'value': '-168204.970', 'spread': '51760.361', 'groupId': 'OG000'}, {'value': '-205822.814', 'spread': '46476.985', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-8 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Concentration of Myeloperoxidase (MPO) (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=31, 38)', 'categories': [{'measurements': [{'value': '-9253.786', 'spread': '1997.077', 'groupId': 'OG000'}, {'value': '-4521.397', 'spread': '1863.867', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=30, 35)', 'categories': [{'measurements': [{'value': '-8072.784', 'spread': '2144.895', 'groupId': 'OG000'}, {'value': '-6318.878', 'spread': '2002.939', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=22, 35)', 'categories': [{'measurements': [{'value': '-13744.824', 'spread': '2476.123', 'groupId': 'OG000'}, {'value': '-5944.184', 'spread': '2041.587', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=22, 29)', 'categories': [{'measurements': [{'value': '-10248.612', 'spread': '2578.146', 'groupId': 'OG000'}, {'value': '-9478.460', 'spread': '2234.238', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker MPO was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Concentration of Myeloperoxidase (MPO) (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 42)', 'categories': [{'measurements': [{'value': '-8606.357', 'spread': '1747.094', 'groupId': 'OG000'}, {'value': '-4380.803', 'spread': '1713.047', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=36, 39)', 'categories': [{'measurements': [{'value': '-8380.855', 'spread': '1871.930', 'groupId': 'OG000'}, {'value': '-5929.775', 'spread': '1843.806', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=26, 38)', 'categories': [{'measurements': [{'value': '-12692.279', 'spread': '2220.374', 'groupId': 'OG000'}, {'value': '-5351.001', 'spread': '1933.964', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=26, 32)', 'categories': [{'measurements': [{'value': '-9424.227', 'spread': '2275.981', 'groupId': 'OG000'}, {'value': '-8527.766', 'spread': '2078.411', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker MPO was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Concentration of Neutrophil Elastase (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=31, 38)', 'categories': [{'measurements': [{'value': '-222995.020', 'spread': '14887.254', 'groupId': 'OG000'}, {'value': '-224606.396', 'spread': '13669.986', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=30, 35)', 'categories': [{'measurements': [{'value': '-149211.318', 'spread': '39523.470', 'groupId': 'OG000'}, {'value': '-125385.276', 'spread': '36629.962', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=22, 35)', 'categories': [{'measurements': [{'value': '-200905.068', 'spread': '25432.984', 'groupId': 'OG000'}, {'value': '-149865.936', 'spread': '20549.567', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=21, 30)', 'categories': [{'measurements': [{'value': '-141985.838', 'spread': '28278.566', 'groupId': 'OG000'}, {'value': '-169389.587', 'spread': '23767.879', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker Neutrophil Elastase was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sputum Marker Concentration of Neutrophil Elastase (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 42)', 'categories': [{'measurements': [{'value': '-202235.344', 'spread': '12993.506', 'groupId': 'OG000'}, {'value': '-206912.465', 'spread': '12543.143', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=36, 39)', 'categories': [{'measurements': [{'value': '-143831.510', 'spread': '34043.871', 'groupId': 'OG000'}, {'value': '-110144.325', 'spread': '33211.578', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=26, 38)', 'categories': [{'measurements': [{'value': '-183452.324', 'spread': '22560.241', 'groupId': 'OG000'}, {'value': '-130613.019', 'spread': '19255.852', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=25, 33)', 'categories': [{'measurements': [{'value': '-118129.436', 'spread': '25397.042', 'groupId': 'OG000'}, {'value': '-156544.533', 'spread': '22550.054', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker Neutrophil Elastase was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Biomarker Interleukin (IL)-6 (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 41)', 'categories': [{'measurements': [{'value': '-12.469', 'spread': '0.782', 'groupId': 'OG000'}, {'value': '-11.904', 'spread': '0.742', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=33, 41)', 'categories': [{'measurements': [{'value': '-1.973', 'spread': '1.918', 'groupId': 'OG000'}, {'value': '-5.728', 'spread': '1.730', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=28, 40)', 'categories': [{'measurements': [{'value': '-8.108', 'spread': '2.360', 'groupId': 'OG000'}, {'value': '-7.243', 'spread': '1.997', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=27, 40)', 'categories': [{'measurements': [{'value': '-11.665', 'spread': '1.129', 'groupId': 'OG000'}, {'value': '-9.431', 'spread': '0.937', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and serum biomarker IL-6 was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Biomarker Interleukin (IL)-6 (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=47, 45)', 'categories': [{'measurements': [{'value': '-12.314', 'spread': '0.652', 'groupId': 'OG000'}, {'value': '-11.802', 'spread': '0.665', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=43, 45)', 'categories': [{'measurements': [{'value': '1.607', 'spread': '2.543', 'groupId': 'OG000'}, {'value': '-6.069', 'spread': '2.490', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=33, 44)', 'categories': [{'measurements': [{'value': '-7.587', 'spread': '2.088', 'groupId': 'OG000'}, {'value': '-7.619', 'spread': '1.838', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=32, 44)', 'categories': [{'measurements': [{'value': '-10.811', 'spread': '1.064', 'groupId': 'OG000'}, {'value': '-9.604', 'spread': '0.918', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and serum biomarker IL-6 was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Biomarker Interleukin-1 Beta (IL-1β) (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 41)', 'categories': [{'measurements': [{'value': '1.274', 'spread': '0.682', 'groupId': 'OG000'}, {'value': '0.378', 'spread': '0.647', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=33, 41)', 'categories': [{'measurements': [{'value': '0.217', 'spread': '0.359', 'groupId': 'OG000'}, {'value': '0.495', 'spread': '0.324', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=28, 40)', 'categories': [{'measurements': [{'value': '0.657', 'spread': '0.431', 'groupId': 'OG000'}, {'value': '0.541', 'spread': '0.366', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=27, 40)', 'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.329', 'groupId': 'OG000'}, {'value': '0.464', 'spread': '0.288', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and serum biomarker IL-1β was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Biomarker IL-1β (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=47, 45)', 'categories': [{'measurements': [{'value': '0.350', 'spread': '0.590', 'groupId': 'OG000'}, {'value': '-1.002', 'spread': '0.602', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=43, 45)', 'categories': [{'measurements': [{'value': '-0.394', 'spread': '0.355', 'groupId': 'OG000'}, {'value': '-0.841', 'spread': '0.349', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=33, 44)', 'categories': [{'measurements': [{'value': '-0.139', 'spread': '0.414', 'groupId': 'OG000'}, {'value': '-0.757', 'spread': '0.368', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=32, 44)', 'categories': [{'measurements': [{'value': '-0.799', 'spread': '0.333', 'groupId': 'OG000'}, {'value': '-0.806', 'spread': '0.312', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and serum biomarker IL-1β was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Biomarker C-reactive Protein (CRP) (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 41)', 'categories': [{'measurements': [{'value': '-15.579', 'spread': '0.485', 'groupId': 'OG000'}, {'value': '-16.518', 'spread': '0.461', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=33, 41)', 'categories': [{'measurements': [{'value': '4.836', 'spread': '4.249', 'groupId': 'OG000'}, {'value': '-4.369', 'spread': '3.812', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=28, 38)', 'categories': [{'measurements': [{'value': '-9.179', 'spread': '4.110', 'groupId': 'OG000'}, {'value': '-8.018', 'spread': '3.533', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=26, 40)', 'categories': [{'measurements': [{'value': '-14.889', 'spread': '1.395', 'groupId': 'OG000'}, {'value': '-13.057', 'spread': '1.133', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and serum biomarker CRP was measured using Roche Modular Analytics E 170 Module. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'mg/liter(L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Biomarker C-reactive Protein (CRP) (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=47, 45)', 'categories': [{'measurements': [{'value': '-16.166', 'spread': '0.410', 'groupId': 'OG000'}, {'value': '-16.901', 'spread': '0.417', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=43, 45)', 'categories': [{'measurements': [{'value': '5.720', 'spread': '3.600', 'groupId': 'OG000'}, {'value': '-5.257', 'spread': '3.518', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=33, 42)', 'categories': [{'measurements': [{'value': '-8.250', 'spread': '3.802', 'groupId': 'OG000'}, {'value': '-9.254', 'spread': '3.375', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=31, 44)', 'categories': [{'measurements': [{'value': '-15.152', 'spread': '1.219', 'groupId': 'OG000'}, {'value': '-13.793', 'spread': '1.034', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and serum biomarker CRP was measured using Roche Modular Analytics E 170 Module. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Biomarker Fibrinogen (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=34, 39)', 'categories': [{'measurements': [{'value': '-3.916', 'spread': '0.286', 'groupId': 'OG000'}, {'value': '-3.976', 'spread': '0.261', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=33, 38)', 'categories': [{'measurements': [{'value': '0.404', 'spread': '0.625', 'groupId': 'OG000'}, {'value': '-0.184', 'spread': '0.571', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=27, 36)', 'categories': [{'measurements': [{'value': '0.210', 'spread': '0.676', 'groupId': 'OG000'}, {'value': '0.014', 'spread': '0.567', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=26, 38)', 'categories': [{'measurements': [{'value': '-2.127', 'spread': '0.625', 'groupId': 'OG000'}, {'value': '-1.144', 'spread': '0.515', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Biomarker Plasma fibrinogen was determined using the method described by Clauss. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Biomarker Fibrinogen (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=44, 43)', 'categories': [{'measurements': [{'value': '-3.971', 'spread': '0.246', 'groupId': 'OG000'}, {'value': '-3.839', 'spread': '0.244', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=43, 42)', 'categories': [{'measurements': [{'value': '0.051', 'spread': '0.521', 'groupId': 'OG000'}, {'value': '-0.148', 'spread': '0.519', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=32, 40)', 'categories': [{'measurements': [{'value': '0.147', 'spread': '0.599', 'groupId': 'OG000'}, {'value': '-0.091', 'spread': '0.524', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=31, 42)', 'categories': [{'measurements': [{'value': '-2.155', 'spread': '0.533', 'groupId': 'OG000'}, {'value': '-1.162', 'spread': '0.462', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Biomarker Plasma fibrinogen was determined using the method described by Clauss. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Biomarker Glucose (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 41)', 'categories': [{'measurements': [{'value': '1.617', 'spread': '0.426', 'groupId': 'OG000'}, {'value': '1.027', 'spread': '0.397', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=33, 41)', 'categories': [{'measurements': [{'value': '1.000', 'spread': '0.300', 'groupId': 'OG000'}, {'value': '0.432', 'spread': '0.270', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=28, 40)', 'categories': [{'measurements': [{'value': '0.067', 'spread': '0.156', 'groupId': 'OG000'}, {'value': '-0.020', 'spread': '0.129', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=27, 40)', 'categories': [{'measurements': [{'value': '0.255', 'spread': '0.272', 'groupId': 'OG000'}, {'value': '0.226', 'spread': '0.230', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and analyzed for serum glucose levels. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Biomarker Glucose (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=46, 45)', 'categories': [{'measurements': [{'value': '1.767', 'spread': '0.408', 'groupId': 'OG000'}, {'value': '0.973', 'spread': '0.408', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=42, 45)', 'categories': [{'measurements': [{'value': '0.942', 'spread': '0.254', 'groupId': 'OG000'}, {'value': '0.364', 'spread': '0.246', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=33, 44)', 'categories': [{'measurements': [{'value': '0.061', 'spread': '0.139', 'groupId': 'OG000'}, {'value': '-0.008', 'spread': '0.119', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=32, 43)', 'categories': [{'measurements': [{'value': '0.189', 'spread': '0.235', 'groupId': 'OG000'}, {'value': '0.215', 'spread': '0.210', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and analyzed for serum glucose levels. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Volume (FEV1) (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 41)', 'categories': [{'measurements': [{'value': '0.051', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '0.010', 'spread': '0.029', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=33, 41)', 'categories': [{'measurements': [{'value': '0.083', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '0.028', 'spread': '0.031', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=28, 40)', 'categories': [{'measurements': [{'value': '0.095', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '0.001', 'spread': '0.031', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=27, 40)', 'categories': [{'measurements': [{'value': '0.064', 'spread': '0.039', 'groupId': 'OG000'}, {'value': '0.010', 'spread': '0.033', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Volume (FEV1) (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=47, 45)', 'categories': [{'measurements': [{'value': '0.063', 'spread': '0.027', 'groupId': 'OG000'}, {'value': '0.012', 'spread': '0.028', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n= 43, 45)', 'categories': [{'measurements': [{'value': '0.062', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.018', 'spread': '0.029', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=33, 44)', 'categories': [{'measurements': [{'value': '0.084', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '0.028', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=32, 44)', 'categories': [{'measurements': [{'value': '0.050', 'spread': '0.034', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.030', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Vital Capacity (FVC) (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 41)', 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.060', 'groupId': 'OG000'}, {'value': '0.057', 'spread': '0.056', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=33, 41)', 'categories': [{'measurements': [{'value': '0.039', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '0.166', 'spread': '0.056', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=28, 40)', 'categories': [{'measurements': [{'value': '0.039', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '0.075', 'spread': '0.062', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=27, 40)', 'categories': [{'measurements': [{'value': '0.044', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '0.086', 'spread': '0.062', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Vital Capacity (FVC) (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=47, 45)', 'categories': [{'measurements': [{'value': '0.048', 'spread': '0.052', 'groupId': 'OG000'}, {'value': '0.062', 'spread': '0.053', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=43, 45)', 'categories': [{'measurements': [{'value': '0.046', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '0.146', 'spread': '0.053', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=33, 44)', 'categories': [{'measurements': [{'value': '0.053', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '0.067', 'spread': '0.057', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=32, 44)', 'categories': [{'measurements': [{'value': '0.034', 'spread': '0.065', 'groupId': 'OG000'}, {'value': '0.084', 'spread': '0.058', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FEV1/FVC (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=37, 41)', 'categories': [{'measurements': [{'value': '1.575', 'spread': '0.933', 'groupId': 'OG000'}, {'value': '-1.064', 'spread': '0.870', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=33, 41)', 'categories': [{'measurements': [{'value': '1.874', 'spread': '1.012', 'groupId': 'OG000'}, {'value': '-1.796', 'spread': '0.914', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=28, 40)', 'categories': [{'measurements': [{'value': '2.350', 'spread': '1.138', 'groupId': 'OG000'}, {'value': '-1.029', 'spread': '0.982', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=27, 40)', 'categories': [{'measurements': [{'value': '1.636', 'spread': '0.951', 'groupId': 'OG000'}, {'value': '-1.669', 'spread': '0.828', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'FEV1/FVC is the percentage of the vital capacity which is expired in the first second of maximal expiration. In healthy patients the FEV1/FVC is usually around 70%. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FEV1/FVC (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 7 (n=47, 45)', 'categories': [{'measurements': [{'value': '1.282', 'spread': '0.795', 'groupId': 'OG000'}, {'value': '-1.128', 'spread': '0.799', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=43, 45)', 'categories': [{'measurements': [{'value': '1.394', 'spread': '0.850', 'groupId': 'OG000'}, {'value': '-1.830', 'spread': '0.834', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=33, 44)', 'categories': [{'measurements': [{'value': '2.045', 'spread': '0.974', 'groupId': 'OG000'}, {'value': '-1.198', 'spread': '0.888', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=32, 44)', 'categories': [{'measurements': [{'value': '1.393', 'spread': '0.827', 'groupId': 'OG000'}, {'value': '-1.881', 'spread': '0.765', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'FEV1/FVC is the percentage of the vital capacity which is expired in the first second of maximal expiration. In healthy patients the FEV1/FVC is usually around 70%. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Week 1 (n=27, 34)', 'categories': [{'measurements': [{'value': '19.4', 'spread': '6.65', 'groupId': 'OG000'}, {'value': '19.2', 'spread': '7.20', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=28, 36)', 'categories': [{'measurements': [{'value': '17.1', 'spread': '7.86', 'groupId': 'OG000'}, {'value': '17.1', 'spread': '7.48', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=24, 37)', 'categories': [{'measurements': [{'value': '15.9', 'spread': '7.84', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '7.90', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=23, 38)', 'categories': [{'measurements': [{'value': '15.1', 'spread': '7.85', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '8.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=21, 37)', 'categories': [{'measurements': [{'value': '14.2', 'spread': '7.41', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '8.04', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=19, 37)', 'categories': [{'measurements': [{'value': '12.9', 'spread': '6.85', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '8.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=20, 33)', 'categories': [{'measurements': [{'value': '13.9', 'spread': '8.93', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '8.48', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=18, 30)', 'categories': [{'measurements': [{'value': '12.8', 'spread': '7.85', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '8.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': "The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Week 1 (n=37, 38)', 'categories': [{'measurements': [{'value': '20.4', 'spread': '7.26', 'groupId': 'OG000'}, {'value': '19.3', 'spread': '7.03', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=37, 40)', 'categories': [{'measurements': [{'value': '18.2', 'spread': '8.54', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '7.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=29, 41)', 'categories': [{'measurements': [{'value': '16.2', 'spread': '8.08', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '7.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=27, 42)', 'categories': [{'measurements': [{'value': '16.0', 'spread': '8.21', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '8.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=25, 41)', 'categories': [{'measurements': [{'value': '14.0', 'spread': '7.28', 'groupId': 'OG000'}, {'value': '15.1', 'spread': '7.93', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=23, 41)', 'categories': [{'measurements': [{'value': '12.9', 'spread': '6.58', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '8.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=24, 37)', 'categories': [{'measurements': [{'value': '13.5', 'spread': '8.38', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '8.44', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=19, 30)', 'categories': [{'measurements': [{'value': '13.0', 'spread': '7.68', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '8.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': "The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Stable State in Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Week 1 (n=27, 34)', 'categories': [{'measurements': [{'value': '6.448', 'spread': '1.503', 'groupId': 'OG000'}, {'value': '2.695', 'spread': '1.096', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=28, 36)', 'categories': [{'measurements': [{'value': '3.778', 'spread': '1.239', 'groupId': 'OG000'}, {'value': '0.804', 'spread': '0.911', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3 (n=24, 37)', 'categories': [{'measurements': [{'value': '2.002', 'spread': '0.915', 'groupId': 'OG000'}, {'value': '0.278', 'spread': '0.669', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=23, 38)', 'categories': [{'measurements': [{'value': '0.559', 'spread': '0.739', 'groupId': 'OG000'}, {'value': '0.277', 'spread': '0.536', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 5 (n=21, 37)', 'categories': [{'measurements': [{'value': '-0.412', 'spread': '0.613', 'groupId': 'OG000'}, {'value': '-0.392', 'spread': '0.448', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6 (n=19, 37)', 'categories': [{'measurements': [{'value': '-0.924', 'spread': '0.411', 'groupId': 'OG000'}, {'value': '-0.062', 'spread': '0.297', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 7 (n=20, 33)', 'categories': [{'measurements': [{'value': '-0.228', 'spread': '0.342', 'groupId': 'OG000'}, {'value': '0.048', 'spread': '0.253', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=18, 30)', 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.059', 'groupId': 'OG000'}, {'value': '-0.048', 'spread': '0.044', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': "The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst). A negative change from Baseline indicates improvement. Covariates for MMRM are stable state value, treatment, time point, and treatment by time point interaction.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Stable State in Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Week 1 (n=37, 38)', 'categories': [{'measurements': [{'value': '6.232', 'spread': '1.424', 'groupId': 'OG000'}, {'value': '3.009', 'spread': '1.052', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=37, 40)', 'categories': [{'measurements': [{'value': '3.558', 'spread': '1.178', 'groupId': 'OG000'}, {'value': '1.074', 'spread': '0.876', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=29, 41)', 'categories': [{'measurements': [{'value': '2.044', 'spread': '0.847', 'groupId': 'OG000'}, {'value': '0.458', 'spread': '0.627', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=27, 42)', 'categories': [{'measurements': [{'value': '0.545', 'spread': '0.732', 'groupId': 'OG000'}, {'value': '0.429', 'spread': '0.534', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=25, 41)', 'categories': [{'measurements': [{'value': '-0.347', 'spread': '0.621', 'groupId': 'OG000'}, {'value': '-0.170', 'spread': '0.459', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=23, 41)', 'categories': [{'measurements': [{'value': '-0.668', 'spread': '0.402', 'groupId': 'OG000'}, {'value': '-0.043', 'spread': '0.295', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=24, 37)', 'categories': [{'measurements': [{'value': '-0.121', 'spread': '0.310', 'groupId': 'OG000'}, {'value': '0.014', 'spread': '0.232', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=19, 30)', 'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.061', 'groupId': 'OG000'}, {'value': '-0.031', 'spread': '0.045', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': "The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst). A negative change from Baseline indicates improvement. Covariates for MMRM are stable state value, treatment, time point, and treatment by time point interaction.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Week 1 (n=25, 35)', 'categories': [{'measurements': [{'value': '45.2', 'spread': '8.54', 'groupId': 'OG000'}, {'value': '45.1', 'spread': '8.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=28, 36)', 'categories': [{'measurements': [{'value': '41.2', 'spread': '11.39', 'groupId': 'OG000'}, {'value': '42.4', 'spread': '9.07', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=24, 38)', 'categories': [{'measurements': [{'value': '38.8', 'spread': '11.22', 'groupId': 'OG000'}, {'value': '40.0', 'spread': '10.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=23, 38)', 'categories': [{'measurements': [{'value': '38.3', 'spread': '11.00', 'groupId': 'OG000'}, {'value': '40.2', 'spread': '11.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=21, 37)', 'categories': [{'measurements': [{'value': '35.9', 'spread': '11.11', 'groupId': 'OG000'}, {'value': '39.1', 'spread': '10.55', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=19, 37)', 'categories': [{'measurements': [{'value': '35.1', 'spread': '9.75', 'groupId': 'OG000'}, {'value': '39.4', 'spread': '11.05', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=20, 34)', 'categories': [{'measurements': [{'value': '35.6', 'spread': '13.69', 'groupId': 'OG000'}, {'value': '38.7', 'spread': '12.05', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=18, 32)', 'categories': [{'measurements': [{'value': '34.4', 'spread': '11.50', 'groupId': 'OG000'}, {'value': '39.4', 'spread': '11.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Week 1 (n=35, 39)', 'categories': [{'measurements': [{'value': '45.6', 'spread': '9.19', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '8.39', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=37, 40)', 'categories': [{'measurements': [{'value': '42.0', 'spread': '11.07', 'groupId': 'OG000'}, {'value': '42.3', 'spread': '8.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=29, 42)', 'categories': [{'measurements': [{'value': '39.0', 'spread': '11.27', 'groupId': 'OG000'}, {'value': '39.9', 'spread': '9.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=27, 42)', 'categories': [{'measurements': [{'value': '38.8', 'spread': '11.37', 'groupId': 'OG000'}, {'value': '40.3', 'spread': '10.90', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=25, 41)', 'categories': [{'measurements': [{'value': '35.3', 'spread': '11.03', 'groupId': 'OG000'}, {'value': '39.1', 'spread': '10.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=23, 41)', 'categories': [{'measurements': [{'value': '33.9', 'spread': '10.45', 'groupId': 'OG000'}, {'value': '39.4', 'spread': '10.62', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=24, 38)', 'categories': [{'measurements': [{'value': '34.3', 'spread': '13.09', 'groupId': 'OG000'}, {'value': '38.7', 'spread': '11.52', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=19, 33)', 'categories': [{'measurements': [{'value': '34.0', 'spread': '11.30', 'groupId': 'OG000'}, {'value': '39.6', 'spread': '11.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Stable State in Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Week 1 (n=25, 35)', 'categories': [{'measurements': [{'value': '6.182', 'spread': '3.271', 'groupId': 'OG000'}, {'value': '4.753', 'spread': '2.385', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=28, 36)', 'categories': [{'measurements': [{'value': '4.423', 'spread': '2.538', 'groupId': 'OG000'}, {'value': '1.558', 'spread': '1.864', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3 (n=24, 38)', 'categories': [{'measurements': [{'value': '2.080', 'spread': '2.041', 'groupId': 'OG000'}, {'value': '0.317', 'spread': '1.494', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=23, 38)', 'categories': [{'measurements': [{'value': '0.002', 'spread': '2.003', 'groupId': 'OG000'}, {'value': '0.657', 'spread': '1.459', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 5 (n=21, 37)', 'categories': [{'measurements': [{'value': '-1.058', 'spread': '1.748', 'groupId': 'OG000'}, {'value': '-0.307', 'spread': '1.276', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6 (n=19, 37)', 'categories': [{'measurements': [{'value': '-1.688', 'spread': '1.015', 'groupId': 'OG000'}, {'value': '-0.002', 'spread': '0.738', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 7 (n=20, 34)', 'categories': [{'measurements': [{'value': '-0.773', 'spread': '0.698', 'groupId': 'OG000'}, {'value': '0.002', 'spread': '0.514', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=18, 32)', 'categories': [{'measurements': [{'value': '-0.190', 'spread': '0.259', 'groupId': 'OG000'}, {'value': '-0.154', 'spread': '0.191', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, time point, treatment by time point and baseline by time point interaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Stable State in Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Week 1 (n=35, 39)', 'categories': [{'measurements': [{'value': '7.163', 'spread': '2.859', 'groupId': 'OG000'}, {'value': '4.697', 'spread': '2.077', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=37, 40)', 'categories': [{'measurements': [{'value': '4.839', 'spread': '2.259', 'groupId': 'OG000'}, {'value': '1.433', 'spread': '1.652', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=29, 42)', 'categories': [{'measurements': [{'value': '2.988', 'spread': '1.870', 'groupId': 'OG000'}, {'value': '0.179', 'spread': '1.363', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=27, 42)', 'categories': [{'measurements': [{'value': '0.909', 'spread': '1.861', 'groupId': 'OG000'}, {'value': '0.743', 'spread': '1.344', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=25, 41)', 'categories': [{'measurements': [{'value': '-0.657', 'spread': '1.554', 'groupId': 'OG000'}, {'value': '-0.318', 'spread': '1.129', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=23, 41)', 'categories': [{'measurements': [{'value': '-0.889', 'spread': '0.976', 'groupId': 'OG000'}, {'value': '-0.140', 'spread': '0.706', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 (n=24, 38)', 'categories': [{'measurements': [{'value': '-0.311', 'spread': '0.654', 'groupId': 'OG000'}, {'value': '-0.075', 'spread': '0.479', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 9n=19, 33)', 'categories': [{'measurements': [{'value': '-0.240', 'spread': '0.244', 'groupId': 'OG000'}, {'value': '-0.115', 'spread': '0.178', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, time point, treatment by time point and baseline by time point interaction.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Stable State in Diaries Peak Expiratory Flow (PEF) Weekly Average (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Week 1 (n=37, 38)', 'categories': [{'measurements': [{'value': '-16.551', 'spread': '5.144', 'groupId': 'OG000'}, {'value': '-9.915', 'spread': '4.442', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=35, 40)', 'categories': [{'measurements': [{'value': '-6.067', 'spread': '4.564', 'groupId': 'OG000'}, {'value': '-0.304', 'spread': '3.899', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3 (n=35, 40)', 'categories': [{'measurements': [{'value': '-4.996', 'spread': '3.914', 'groupId': 'OG000'}, {'value': '0.687', 'spread': '3.360', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=29, 39)', 'categories': [{'measurements': [{'value': '-4.595', 'spread': '3.421', 'groupId': 'OG000'}, {'value': '-0.420', 'spread': '2.737', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 5 (n=28, 38)', 'categories': [{'measurements': [{'value': '-3.557', 'spread': '4.061', 'groupId': 'OG000'}, {'value': '-1.224', 'spread': '3.287', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6 (n=27, 37)', 'categories': [{'measurements': [{'value': '-3.795', 'spread': '4.546', 'groupId': 'OG000'}, {'value': '-5.559', 'spread': '3.680', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 7 (n=27, 36)', 'categories': [{'measurements': [{'value': '-7.178', 'spread': '5.212', 'groupId': 'OG000'}, {'value': '-4.186', 'spread': '4.264', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=27, 35)', 'categories': [{'measurements': [{'value': '-2.877', 'spread': '5.388', 'groupId': 'OG000'}, {'value': '-0.956', 'spread': '4.418', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'Morning post-medication PEF (the best of 3 attempts measured with a mini-Wright peak-flow meter) was recorded in a daily diary. A positive change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.', 'unitOfMeasure': 'liters/minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Stable State in Diaries Peak Expiratory Flow (PEF) Weekly Average (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Week 1 (n=46, 42)', 'categories': [{'measurements': [{'value': '-13.958', 'spread': '4.147', 'groupId': 'OG000'}, {'value': '-8.447', 'spread': '3.865', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=44, 44)', 'categories': [{'measurements': [{'value': '-5.776', 'spread': '3.772', 'groupId': 'OG000'}, {'value': '1.029', 'spread': '3.488', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3 (n=44, 44)', 'categories': [{'measurements': [{'value': '-5.360', 'spread': '3.676', 'groupId': 'OG000'}, {'value': '2.038', 'spread': '3.421', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=37, 43)', 'categories': [{'measurements': [{'value': '-6.660', 'spread': '3.546', 'groupId': 'OG000'}, {'value': '1.133', 'spread': '3.126', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 5 (n=33, 42)', 'categories': [{'measurements': [{'value': '-5.568', 'spread': '3.847', 'groupId': 'OG000'}, {'value': '0.269', 'spread': '3.396', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6 (n=32, 41)', 'categories': [{'measurements': [{'value': '-2.186', 'spread': '3.515', 'groupId': 'OG000'}, {'value': '-4.596', 'spread': '3.076', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 7 (n=31, 40)', 'categories': [{'measurements': [{'value': '-8.513', 'spread': '4.544', 'groupId': 'OG000'}, {'value': '-1.974', 'spread': '3.952', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=31, 39)', 'categories': [{'measurements': [{'value': '-4.563', 'spread': '4.741', 'groupId': 'OG000'}, {'value': '0.950', 'spread': '4.091', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'Morning post-medication PEF (the best of 3 attempts measured with a mini-Wright peak-flow meter) was recorded in a daily diary. 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Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Stable State in Diaries Symptom Score Weekly Average (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Week 1 (n=38, 42)', 'categories': [{'measurements': [{'value': '2.930', 'spread': '0.286', 'groupId': 'OG000'}, {'value': '2.587', 'spread': '0.254', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=37, 42)', 'categories': [{'measurements': [{'value': '1.130', 'spread': '0.314', 'groupId': 'OG000'}, {'value': '1.331', 'spread': '0.272', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3 (n=35, 42)', 'categories': [{'measurements': [{'value': '0.906', 'spread': '0.299', 'groupId': 'OG000'}, {'value': '0.790', 'spread': '0.258', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=30, 40)', 'categories': [{'measurements': [{'value': '0.552', 'spread': '0.298', 'groupId': 'OG000'}, {'value': '0.922', 'spread': '0.248', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 5 (n=29, 39)', 'categories': [{'measurements': [{'value': '0.413', 'spread': '0.305', 'groupId': 'OG000'}, {'value': '0.882', 'spread': '0.254', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6 (n=28, 39)', 'categories': [{'measurements': [{'value': '0.141', 'spread': '0.310', 'groupId': 'OG000'}, {'value': '0.681', 'spread': '0.258', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 7 (n=27, 37)', 'categories': [{'measurements': [{'value': '0.442', 'spread': '0.294', 'groupId': 'OG000'}, {'value': '0.673', 'spread': '0.243', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=27, 36)', 'categories': [{'measurements': [{'value': '0.626', 'spread': '0.361', 'groupId': 'OG000'}, {'value': '0.612', 'spread': '0.297', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'Any increase in the following respiratory symptoms: dyspnea, sputum purulence, sputum amount, wheeze, sore throat, cough, fever, symptoms of a common cold, ie, nasal congestion and discharge over the previous 24 hours were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Stable State in Diaries Symptom Score Weekly Average (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Week 1 (n=48, 46)', 'categories': [{'measurements': [{'value': '3.110', 'spread': '0.257', 'groupId': 'OG000'}, {'value': '2.593', 'spread': '0.246', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=47, 46)', 'categories': [{'measurements': [{'value': '1.171', 'spread': '0.285', 'groupId': 'OG000'}, {'value': '1.402', 'spread': '0.267', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3 (n=44, 46)', 'categories': [{'measurements': [{'value': '0.850', 'spread': '0.267', 'groupId': 'OG000'}, {'value': '0.802', 'spread': '0.250', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=38, 44)', 'categories': [{'measurements': [{'value': '0.751', 'spread': '0.312', 'groupId': 'OG000'}, {'value': '0.924', 'spread': '0.282', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 5 (n=34, 43)', 'categories': [{'measurements': [{'value': '0.437', 'spread': '0.287', 'groupId': 'OG000'}, {'value': '0.907', 'spread': '0.259', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6 (n=33, 43)', 'categories': [{'measurements': [{'value': '0.041', 'spread': '0.257', 'groupId': 'OG000'}, {'value': '0.661', 'spread': '0.231', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 7 (n=31, 41)', 'categories': [{'measurements': [{'value': '0.503', 'spread': '0.247', 'groupId': 'OG000'}, {'value': '0.533', 'spread': '0.216', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=31, 40)', 'categories': [{'measurements': [{'value': '0.451', 'spread': '0.274', 'groupId': 'OG000'}, {'value': '0.530', 'spread': '0.237', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'Any increase in the following respiratory symptoms: dyspnea, sputum purulence, sputum amount, wheeze, sore throat, cough, fever, symptoms of a common cold, ie, nasal congestion and discharge over the previous 24 hours were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Stable State in Diaries Treatment Score Weekly Average (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Week 1 (n=38, 42)', 'categories': [{'measurements': [{'value': '0.849', 'spread': '0.194', 'groupId': 'OG000'}, {'value': '0.769', 'spread': '0.174', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=37, 42)', 'categories': [{'measurements': [{'value': '0.682', 'spread': '0.190', 'groupId': 'OG000'}, {'value': '0.804', 'spread': '0.167', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3 (n=35, 42)', 'categories': [{'measurements': [{'value': '0.281', 'spread': '0.115', 'groupId': 'OG000'}, {'value': '0.188', 'spread': '0.099', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=30, 40)', 'categories': [{'measurements': [{'value': '0.185', 'spread': '0.118', 'groupId': 'OG000'}, {'value': '0.217', 'spread': '0.099', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 5 (n=29, 39)', 'categories': [{'measurements': [{'value': '0.130', 'spread': '0.123', 'groupId': 'OG000'}, {'value': '0.263', 'spread': '0.103', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6 (n=28, 39)', 'categories': [{'measurements': [{'value': '0.128', 'spread': '0.130', 'groupId': 'OG000'}, {'value': '0.204', 'spread': '0.108', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 7 (n=27, 37)', 'categories': [{'measurements': [{'value': '0.112', 'spread': '0.117', 'groupId': 'OG000'}, {'value': '0.135', 'spread': '0.097', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=27, 36)', 'categories': [{'measurements': [{'value': '0.122', 'spread': '0.101', 'groupId': 'OG000'}, {'value': '0.127', 'spread': '0.084', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': "Any changes in the participant's usual treatment were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Stable State in Diaries Treatment Score Weekly Average (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Week 1 (n=48, 46)', 'categories': [{'measurements': [{'value': '0.787', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '0.730', 'spread': '0.162', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=47, 46)', 'categories': [{'measurements': [{'value': '0.767', 'spread': '0.172', 'groupId': 'OG000'}, {'value': '0.780', 'spread': '0.161', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3 (n=44, 46)', 'categories': [{'measurements': [{'value': '0.338', 'spread': '0.103', 'groupId': 'OG000'}, {'value': '0.177', 'spread': '0.095', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=38, 44)', 'categories': [{'measurements': [{'value': '0.379', 'spread': '0.144', 'groupId': 'OG000'}, {'value': '0.206', 'spread': '0.129', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 5 (n=34, 43)', 'categories': [{'measurements': [{'value': '0.191', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '0.244', 'spread': '0.096', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6 (n=33, 43)', 'categories': [{'measurements': [{'value': '0.127', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '0.196', 'spread': '0.096', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 7 (n=31, 41)', 'categories': [{'measurements': [{'value': '0.179', 'spread': '0.116', 'groupId': 'OG000'}, {'value': '0.156', 'spread': '0.103', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=31, 40)', 'categories': [{'measurements': [{'value': '0.084', 'spread': '0.086', 'groupId': 'OG000'}, {'value': '0.171', 'spread': '0.075', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': "Any changes in the participant's usual treatment were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Stable State in Diaries Hours Out of the Home Weekly Average (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Week 1 (n=34, 34)', 'categories': [{'measurements': [{'value': '-1.313', 'spread': '0.416', 'groupId': 'OG000'}, {'value': '-0.105', 'spread': '0.391', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=34, 38)', 'categories': [{'measurements': [{'value': '-0.974', 'spread': '0.359', 'groupId': 'OG000'}, {'value': '-0.328', 'spread': '0.333', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3 (n=34, 40)', 'categories': [{'measurements': [{'value': '-1.077', 'spread': '0.374', 'groupId': 'OG000'}, {'value': '0.226', 'spread': '0.335', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=28, 39)', 'categories': [{'measurements': [{'value': '-1.131', 'spread': '0.414', 'groupId': 'OG000'}, {'value': '-0.306', 'spread': '0.354', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 5 (n=26, 38)', 'categories': [{'measurements': [{'value': '-0.826', 'spread': '0.465', 'groupId': 'OG000'}, {'value': '0.280', 'spread': '0.407', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6 (n=25, 35)', 'categories': [{'measurements': [{'value': '-1.154', 'spread': '0.448', 'groupId': 'OG000'}, {'value': '-0.062', 'spread': '0.386', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 7 (n=26, 35)', 'categories': [{'measurements': [{'value': '-1.194', 'spread': '0.449', 'groupId': 'OG000'}, {'value': '-0.340', 'spread': '0.394', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=26, 34)', 'categories': [{'measurements': [{'value': '-0.812', 'spread': '0.532', 'groupId': 'OG000'}, {'value': '0.037', 'spread': '0.458', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'Estimates of the length of time the participants were out of their own home on the previous day were recorded in a daily diary. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Stable State in Diaries Hours Out of the Home Weekly Average (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Week 1 (n=42, 38)', 'categories': [{'measurements': [{'value': '-1.472', 'spread': '0.353', 'groupId': 'OG000'}, {'value': '-0.276', 'spread': '0.344', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=43, 42)', 'categories': [{'measurements': [{'value': '-1.305', 'spread': '0.319', 'groupId': 'OG000'}, {'value': '-0.472', 'spread': '0.307', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3 (n=42, 44)', 'categories': [{'measurements': [{'value': '-1.314', 'spread': '0.343', 'groupId': 'OG000'}, {'value': '0.099', 'spread': '0.324', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=35, 43)', 'categories': [{'measurements': [{'value': '-1.328', 'spread': '0.357', 'groupId': 'OG000'}, {'value': '-0.266', 'spread': '0.325', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 5 (n=31, 42)', 'categories': [{'measurements': [{'value': '-0.833', 'spread': '0.402', 'groupId': 'OG000'}, {'value': '0.158', 'spread': '0.369', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6 (n=30, 39)', 'categories': [{'measurements': [{'value': '-1.271', 'spread': '0.372', 'groupId': 'OG000'}, {'value': '-0.247', 'spread': '0.344', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 7 (n=30, 39)', 'categories': [{'measurements': [{'value': '-1.144', 'spread': '0.363', 'groupId': 'OG000'}, {'value': '-0.478', 'spread': '0.333', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=30, 38)', 'categories': [{'measurements': [{'value': '-0.714', 'spread': '0.443', 'groupId': 'OG000'}, {'value': '-0.068', 'spread': '0.401', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'Estimates of the length of time the participants were out of their own home on the previous day were recorded in a daily diary. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Exacerbation Length (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '18.0'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '17.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 Weeks', 'description': 'Exacerbation length is the period from start of increased symptoms to end of increased symptoms; the last day of an exacerbation was to be followed by 2 days without symptom entries in the diary.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Exacerbation Length (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '19.0'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '17.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 Weeks', 'description': 'Exacerbation length is the period from start of increased symptoms to end of increased symptoms; the last day of an exacerbation was to be followed by 2 days without symptom entries in the diary.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Aortic Pulse Wave Velocity in a Subset of Participants (Initial Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 14 (n=18, 24)', 'categories': [{'measurements': [{'value': '-0.047', 'spread': '0.337', 'groupId': 'OG000'}, {'value': '-0.343', 'spread': '0.290', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=14, 24)', 'categories': [{'measurements': [{'value': '-0.380', 'spread': '0.413', 'groupId': 'OG000'}, {'value': '-0.474', 'spread': '0.321', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Days 14 and 28', 'description': 'Carotid-femoral aortic pulse wave velocity (aPWV) will be measured in a subset of participants to determine changes in arterial stiffness. A negative change from Baseline indicates improvement. Covariates for MMRM are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'meters/second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Aortic Pulse Wave Velocity in a Subset of Participants (Extended Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}], 'classes': [{'title': 'Change at Day 14 (n=28, 28)', 'categories': [{'measurements': [{'value': '-0.128', 'spread': '0.247', 'groupId': 'OG000'}, {'value': '-0.326', 'spread': '0.245', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=19, 28)', 'categories': [{'measurements': [{'value': '-0.316', 'spread': '0.323', 'groupId': 'OG000'}, {'value': '-0.511', 'spread': '0.273', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Days 14 and 28', 'description': 'Carotid-femoral aortic pulse wave velocity (aPWV) will be measured in a subset of participants to determine changes in arterial stiffness. A negative change from Baseline indicates improvement. Covariates for MMRM are baseline value, treatment, visit, and treatment by visit interaction.', 'unitOfMeasure': 'meters/second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations. Eligible participants were re-randomized to receive either roflumilast 500 μg or placebo for 4 weeks in Cycle 2.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Eligible participants were re-randomized to receive either roflumilast 500 μg or placebo for 4 weeks in Cycle 2.'}, {'id': 'FG002', 'title': 'Roflumilast 500 µg (Cycle 2)', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations in Cycle 2.'}, {'id': 'FG003', 'title': 'Placebo (Cycle 2)', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations in Cycle 2.'}], 'periods': [{'title': 'Cycle 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Cycle 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 1 investigative site in the United Kingdom from 16 February 2012 to 25 March 2014.', 'preAssignmentDetails': 'Participants with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) were enrolled equally in 1 of 2 treatment groups, once a day placebo or roflumilast 500 µg in Cycle 1. Participants were re-randomized in Cycle 2 to once a day placebo or roflumilast 500 µg and are counted as new participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Roflumilast 500 μg', 'description': 'Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '≤ 65 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': '> 65 years', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking status', 'classes': [{'title': 'Non-smoker', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Current smoker', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Former smoker', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline COPD Assessment Test (CAT) Total Score', 'classes': [{'title': '< 10', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': '≥ 10', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst).", 'unitOfMeasure': 'participants'}, {'title': 'Weight Category by Body Mass Index (BMI)', 'classes': [{'title': 'Underweight', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Normal Weight', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Overweight', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Obese', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Chronic Bronchitis', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Historical Chronic Obstructive Pulmonary Disease (COPD) Exacerbations', 'classes': [{'title': '< 2', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': '≥ 2', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Full Analysis set consisted of all randomized patients who received at least 1 dose of investigational medicinal product (IMP)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'whyStopped': 'Company decision: No Safety or Efficacy Concerns', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'dispFirstSubmitDate': '2015-02-20', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-22', 'studyFirstSubmitDate': '2011-10-31', 'dispFirstSubmitQcDate': '2015-02-20', 'resultsFirstSubmitDate': '2015-07-23', 'studyFirstSubmitQcDate': '2011-11-14', 'dispFirstPostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-31', 'studyFirstPostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Sputum Neutrophil Counts at Day 14 Post Exacerbation (Initial Approach)', 'timeFrame': 'Baseline and Day 14', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used with neutrophil count at Baseline and treatment as independent variables, fixed effects.'}, {'measure': 'Change From Baseline in Sputum Neutrophil Counts at Day 14 Post Exacerbation (Extended Approach)', 'timeFrame': 'Baseline and Day 14', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used with neutrophil count at Baseline and treatment as independent variables, fixed effects.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Whose Sputum Neutrophil Counts Returned to Stable State at Day 14 (Initial Approach)', 'timeFrame': 'Day 14', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) and were determined with a Neubauer hemocytometer.'}, {'measure': 'Percentage of Participants Whose Sputum Neutrophil Counts Returned to Stable State at Day 14 (Extended Approach)', 'timeFrame': 'Day 14', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) and were determined with a Neubauer hemocytometer.'}, {'measure': 'Change From Baseline in Sputum Marker Total Cells (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Total Cells (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Percentage of Neutrophils (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of neutrophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Percentage of Neutrophils (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of neutrophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Sputum Marker Percentage of Macrophages (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of macrophages was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Percentage of Macrophages (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of macrophages was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Percentage of Eosinophils (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of eosinophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Percentage of Eosinophils (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of eosinophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Percentage of Lymphocyte (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of lymphocytes was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Percentage of Lymphocytes (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of lymphocytes was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-6 (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-6 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-6 (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-6 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-8 (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-8 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-8 (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-8 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Concentration of Myeloperoxidase (MPO) (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker MPO was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Concentration of Myeloperoxidase (MPO) (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker MPO was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Concentration of Neutrophil Elastase (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker Neutrophil Elastase was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Sputum Marker Concentration of Neutrophil Elastase (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker Neutrophil Elastase was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Blood Biomarker Interleukin (IL)-6 (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and serum biomarker IL-6 was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Blood Biomarker Interleukin (IL)-6 (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and serum biomarker IL-6 was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Blood Biomarker Interleukin-1 Beta (IL-1β) (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and serum biomarker IL-1β was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Blood Biomarker IL-1β (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and serum biomarker IL-1β was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Blood Biomarker C-reactive Protein (CRP) (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and serum biomarker CRP was measured using Roche Modular Analytics E 170 Module. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Blood Biomarker C-reactive Protein (CRP) (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and serum biomarker CRP was measured using Roche Modular Analytics E 170 Module. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Blood Biomarker Fibrinogen (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Biomarker Plasma fibrinogen was determined using the method described by Clauss. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Blood Biomarker Fibrinogen (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Biomarker Plasma fibrinogen was determined using the method described by Clauss. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Blood Biomarker Glucose (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and analyzed for serum glucose levels. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Blood Biomarker Glucose (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Blood was collected and analyzed for serum glucose levels. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Forced Expiratory Volume (FEV1) (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.'}, {'measure': 'Change From Baseline in Forced Expiratory Volume (FEV1) (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.'}, {'measure': 'Change From Baseline in Forced Vital Capacity (FVC) (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.'}, {'measure': 'Change From Baseline in Forced Vital Capacity (FVC) (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.'}, {'measure': 'Change From Baseline in FEV1/FVC (Initial Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'FEV1/FVC is the percentage of the vital capacity which is expired in the first second of maximal expiration. In healthy patients the FEV1/FVC is usually around 70%. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.'}, {'measure': 'Change From Baseline in FEV1/FVC (Extended Approach)', 'timeFrame': 'Baseline and Day 7, Day 14, Day 28 and Day 56', 'description': 'FEV1/FVC is the percentage of the vital capacity which is expired in the first second of maximal expiration. In healthy patients the FEV1/FVC is usually around 70%. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.'}, {'measure': 'Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Initial Approach)', 'timeFrame': 'Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': "The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst)."}, {'measure': 'Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Extended Approach)', 'timeFrame': 'Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': "The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst)."}, {'measure': 'Change From Stable State in Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Initial Approach)', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': "The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst). A negative change from Baseline indicates improvement. Covariates for MMRM are stable state value, treatment, time point, and treatment by time point interaction."}, {'measure': 'Change From Stable State in Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Extended Approach)', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': "The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst). A negative change from Baseline indicates improvement. Covariates for MMRM are stable state value, treatment, time point, and treatment by time point interaction."}, {'measure': 'Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Initial Approach)', 'timeFrame': 'Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status.'}, {'measure': 'Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Extended Approach)', 'timeFrame': 'Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status.'}, {'measure': 'Change From Stable State in Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Initial Approach)', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, time point, treatment by time point and baseline by time point interaction.'}, {'measure': 'Change From Stable State in Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Extended Approach)', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, time point, treatment by time point and baseline by time point interaction.'}, {'measure': 'Change From Stable State in Diaries Peak Expiratory Flow (PEF) Weekly Average (Initial Approach)', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'Morning post-medication PEF (the best of 3 attempts measured with a mini-Wright peak-flow meter) was recorded in a daily diary. A positive change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.'}, {'measure': 'Change From Stable State in Diaries Peak Expiratory Flow (PEF) Weekly Average (Extended Approach)', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'Morning post-medication PEF (the best of 3 attempts measured with a mini-Wright peak-flow meter) was recorded in a daily diary. A positive change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.'}, {'measure': 'Change From Stable State in Diaries Symptom Score Weekly Average (Initial Approach)', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'Any increase in the following respiratory symptoms: dyspnea, sputum purulence, sputum amount, wheeze, sore throat, cough, fever, symptoms of a common cold, ie, nasal congestion and discharge over the previous 24 hours were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.'}, {'measure': 'Change From Stable State in Diaries Symptom Score Weekly Average (Extended Approach)', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'Any increase in the following respiratory symptoms: dyspnea, sputum purulence, sputum amount, wheeze, sore throat, cough, fever, symptoms of a common cold, ie, nasal congestion and discharge over the previous 24 hours were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.'}, {'measure': 'Change From Stable State in Diaries Treatment Score Weekly Average (Initial Approach)', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': "Any changes in the participant's usual treatment were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction."}, {'measure': 'Change From Stable State in Diaries Treatment Score Weekly Average (Extended Approach)', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': "Any changes in the participant's usual treatment were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction."}, {'measure': 'Change From Stable State in Diaries Hours Out of the Home Weekly Average (Initial Approach)', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'Estimates of the length of time the participants were out of their own home on the previous day were recorded in a daily diary. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.'}, {'measure': 'Change From Stable State in Diaries Hours Out of the Home Weekly Average (Extended Approach)', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8', 'description': 'Estimates of the length of time the participants were out of their own home on the previous day were recorded in a daily diary. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.'}, {'measure': 'Exacerbation Length (Initial Approach)', 'timeFrame': '8 Weeks', 'description': 'Exacerbation length is the period from start of increased symptoms to end of increased symptoms; the last day of an exacerbation was to be followed by 2 days without symptom entries in the diary.'}, {'measure': 'Exacerbation Length (Extended Approach)', 'timeFrame': '8 Weeks', 'description': 'Exacerbation length is the period from start of increased symptoms to end of increased symptoms; the last day of an exacerbation was to be followed by 2 days without symptom entries in the diary.'}, {'measure': 'Change From Baseline in Aortic Pulse Wave Velocity in a Subset of Participants (Initial Approach)', 'timeFrame': 'Baseline and Days 14 and 28', 'description': 'Carotid-femoral aortic pulse wave velocity (aPWV) will be measured in a subset of participants to determine changes in arterial stiffness. A negative change from Baseline indicates improvement. Covariates for MMRM are baseline value, treatment, visit, and treatment by visit interaction.'}, {'measure': 'Change From Baseline in Aortic Pulse Wave Velocity in a Subset of Participants (Extended Approach)', 'timeFrame': 'Baseline and Days 14 and 28', 'description': 'Carotid-femoral aortic pulse wave velocity (aPWV) will be measured in a subset of participants to determine changes in arterial stiffness. A negative change from Baseline indicates improvement. Covariates for MMRM are baseline value, treatment, visit, and treatment by visit interaction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Chronic obstructive pulmonary disease', 'Roflumilast'], 'conditions': ['Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation']}, 'referencesModule': {'references': [{'pmid': '28146642', 'type': 'DERIVED', 'citation': 'Mackay AJ, Patel ARC, Singh R, Sapsford RJ, Donaldson GC, Prasad N, Goehring UM, Nip TK, Wedzicha JA. Randomized Double-Blind Controlled Trial of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Sep 1;196(5):656-659. doi: 10.1164/rccm.201612-2518LE. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to investigate if roflumilast can reduce the neutrophilic inflammation at acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). In addition, the potential benefit of roflumilast on severity and recovery periods of acute COPD exacerbations will be assessed using patient diaries and questionnaires.', 'detailedDescription': 'Participants will be asked whether they agree to participate in the measurements of arterial stiffness. Participants who agree will be included in the substudy, with the target of 60 patients with arterial stiffness measurements to complete the trial.\n\nStudy was terminated due to difficulty in identifying further eligible patients for this exploratory study within a reasonable time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent (IC)\n* Age ≥ 40 years\n* History of COPD for at least 12 months prior to enrollment (Visit V0)\n* Chronic productive cough for 3 months in each of the 2 years prior to enrollment (if other causes of productive cough have been excluded) and/or an exacerbation with predominantly bronchitic symptoms at enrollment\n* Presentation of an acute exacerbation of COPD that will be associated with increased sputum volume or change in sputum colour\n* Documented fixed airway obstruction determined by an FEV1/FVC ratio (post-bronchodilator) \\< 70% (if a pulmonary function test is not possible at Visit V0 a previous measurement can be taken which must not be older than 6 months)\n* Former smoker (defined as: smoking cessation at least 1 year ago) or current smoker both with a smoking history of at least 10 pack years\n\nMain Exclusion Criteria:\n\n* Diagnosis of asthma and/or other relevant lung disease\n* Known alpha-1-antitrypsin deficiency\n* Recurrent exacerbations (within 8 weeks of a preceding exacerbation)\n* Treatment of current exacerbation with oral corticosteroids and/or antibiotics already started at enrollment\n* Treatment with PDE4 inhibitors within 3 months prior to Visit V0\n* Other protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01473758', 'acronym': 'TREAT', 'briefTitle': 'Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Effect of Roflumilast 500 μg Tablets Once Daily at Acute COPD Exacerbations Treated With Standard Therapy of Oral Steroids and Antibiotics. A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial', 'orgStudyIdInfo': {'id': 'RO-2455-405-RD'}, 'secondaryIdInfos': [{'id': '2011-002905-31', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1137-4023', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': '11/SC/0494', 'type': 'REGISTRY', 'domain': 'NRES'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Roflumilast', 'description': 'added on to standard therapy for acute COPD exacerbations', 'interventionNames': ['Drug: Roflumilast']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'added on to standard therapy for acute COPD exacerbations', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Roflumilast', 'type': 'DRUG', 'description': '500 µg tablet, od, oral administration in the morning after breakfast', 'armGroupLabels': ['Roflumilast']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'tablet, od, oral administration in the morning after breakfast', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW3 2PF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Academic Unit of Respiratory Medicine, Royal Free Hospital, Jadwiga A. Wedzicha', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Medical Director Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}