Viewing Study NCT04631016

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Ignite Creation Date: 2025-12-26 @ 11:46 AM
Ignite Modification Date: 2025-12-26 @ 11:46 AM
Study NCT ID: NCT04631016
Status: COMPLETED
Last Update Posted: 2025-02-27
First Post: 2020-10-20
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '+1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca Clinical Study Information Center'}, 'certainAgreement': {'otherDetails': 'MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 through 253 days (maximum observed duration)', 'description': 'As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.', 'eventGroups': [{'id': 'EG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 40, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 39, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 53, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 56, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 25, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}], 'seriousEvents': [{'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Pneumonia pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.019', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '-0.005', 'spread': '0.025', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.216', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.024', 'ciLowerLimit': '-0.015', 'ciUpperLimit': '0.063', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -35 to Day -28) through Week 12', 'description': 'The mean change from baseline in Pre-BD FEV1 at Week 12 (tozorakimab - placebo) estimated using a repeated measures mixed effects analysis of covariance measures was estimated. Data available from all visits up to and including Week 12, irrespective of whether the participant discontinued study drug or received reliever therapy was considered. FEV1 was measured by spirometry at clinic.', 'unitOfMeasure': 'Litre', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population included all participants who received any study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Serum Tozorakimab Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24604.70', 'spread': '43934.55', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8041.59', 'spread': '22355.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7548.78', 'spread': '6416.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10789.81', 'spread': '31903.70', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6410.05', 'spread': '4123.46', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7289.36', 'spread': '5331.35', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1483.19', 'spread': '1779.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '420.13', 'spread': '701.12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-dose at Study Weeks 2, 4, 12, 20, 24, 28, 32, and 36', 'description': 'Serum concentration of tozorakimab collected over time are reported. The lower limit of quantification (LLOQ) for tozorakimab was considered to be 10 μg/L.', 'unitOfMeasure': 'μg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) evaluable population included participants who received at least 1 dose of tozorakimab and had at least 1 detectable post-treatment sample available. Number of participants analyzed (N) denotes the number of participants evaluated for this outcome measure. Number analyzed (n) denotes those participants who had adequate PK sample available at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-drug Antibodies (ADA) to Tozorakimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'title': 'Treatment-induced ADA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-boosted ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Persistently positive ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Transiently positive ADA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-dose at Study Weeks 0 (baseline) and post-dose at Study Weeks 2, 4, 12, 20, 24, 28, 32, and 36', 'description': 'Number of participants with positive ADA to tozorakimab are reported. Treatment-induced ADA positive is defined as ADA negative at baseline and positive at post-baseline assessment. Treatment-boosted ADA positive is defined as ADA positive at baseline and boosted (\\>= 4 fold) the pre-existing titre during the study period. Persistent positive is defined as ADA negative at baseline and positive at \\>= 2 post-baseline assessments (with \\>= 16 weeks between first and last positive) or ADA positive at last post-baseline assessment. Transiently positive is defined as ADA negative at baseline and at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who had at least one post-baseline ADA assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing First Chronic Obstructive Pulmonary Disease Composite Exacerbations (COPDCompEx) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.186', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.79', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.11', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day -35 to Day -28) through Week 28', 'description': 'The COPDCompEx combines exacerbations with events defined from participant e-Diaries and peak expiratory flow (PEF). COPDCompEx defined exacerbations included episodes leading to one or more of the following: hospitalization, emergency room visit, treatment with systemic corticosteroids (injected and/or oral), or treatment with antibiotics. Diary COPDCompEx events are defined by threshold and slope criteria being met for \\>= 2 consecutive days using the following diary and home spirometry variables: overall symptom rating, night-time awakenings due to symptoms, reliever medication use, PEF.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in 4-weekly Mean Evaluating Respiratory Symptoms of COPD (E-RS:COPD) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.09', 'spread': '1.004', 'groupId': 'OG000'}, {'value': '-6.06', 'spread': '0.962', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12', 'description': 'Change from baseline to Week 12 in 4-weekly mean E-RS:COPD total score is reported. The E-RS™:COPD is an 11-item electronic patient reported outcome (ePRO) questionnaires developed to evaluate the severity of respiratory symptoms of COPD including breathlessness (5 items; score range: 0 to 17), cough and sputum (3 items; score range: 0 to 11), and chest symptoms (3 items; score range: 0 to 12). The ePRO was completed every day at home and at site visits. Summation of E-RS:COPD item responses produced a total score ranging from 0 to 40, with higher scores indicating greater severity. The 4-weekly mean will be calculated as the sum of all non-missing daily scores over the 28-day evaluation period, divided by the number of non-missing daily scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Mean Breathlessness, Cough and Sputum Scale (BCSS) Score (Over the Previous 4 Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.18', 'spread': '0.313', 'groupId': 'OG000'}, {'value': '-2.18', 'spread': '0.298', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12', 'description': 'Change from baseline to Week 12 in mean BCSS score (over the previous 4 weeks) is reported. The BCSS was a 3-item daily diary that assesses the severity of the 3 symptoms: breathlessness, sputum, and cough, each on a 5-point Likert scale ranging from 0 (no symptoms) to 4 (severe symptoms). Item scores were summed to yield a total score ranging from 0 to 12; wherein higher total score indicated more severe symptoms. The BCSS was captured each evening via eDiary. The 4-weekly mean BCSS score was calculated as the sum of all non-missing daily scores over the 28-dayevaluation period, divided by the number of non-missing daily scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Cough Visual Analogue Scale (VAS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.21', 'spread': '3.639', 'groupId': 'OG000'}, {'value': '-17.70', 'spread': '3.483', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12', 'description': 'Change from baseline to Week 12 in cough VAS score is reported. Participants were asked to complete a cough severity VAS (100 mm linear scale marked with a horizontal line by the participant, with 0 mm representing \'\'no cough\'\' and 100 mm representing "worst cough") that measured subjective assessment by the participant of the prior 24 hrs for severity of cough symptoms. It was completed each evening in the eDiary. The 4-weekly mean cough VAS score was calculated as the sum of all non-missing daily scores over the 28-day evaluation period, divided by the number of non-missing daily scores.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': "Change From Baseline to Week 12 in Saint George's Respiratory Questionnaire (SGRQ) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.177', 'spread': '2.116', 'groupId': 'OG000'}, {'value': '-8.273', 'spread': '2.029', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12', 'description': "Change from baseline to Week 12 in SGRQ total score is reported. The SGRQ was a 50-item electronic PRO instrument developed to measure the health status of participants with airway obstruction diseases and is divided into 2 parts. Part 1 consisted 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; Part 2 consisted 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yielded a total score and three domain scores (symptoms, activity, and impacts). The total score indicated the impact of disease on overall health status, which was expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status. The domain scores range from 0 to 100, with higher scores indicative of greater impairment.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable at Week 12.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Decrease in SGRQ Total Score of >= 4 Points From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '1.58'}, {'value': '61.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12', 'description': "Percentage of participants with a decrease in SGRQ total score of \\>= 4 points from baseline to Week 12 is reported. The SGRQ was a 50-item electronic PRO instrument developed to measure the health status of participants with airway obstruction diseases and is divided into 2 parts. Part 1 consisted 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; Part 2 consisted 42 items related to the daily activity and psychosocial impacts of individual's respiratory condition. SGRQ yielded a total score and three domain scores (symptoms, activity, and impacts). Total score indicated the impact of disease on overall health status, which was expressed as a percentage of overall impairment, in which 100 represents worst possible health status and 0 indicates best possible health status. The domain scores range from 0 to 100, with higher scores indicative of greater impairment. A change of 4 units/points is associated with a minimum clinically important difference.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable at Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Airwave Oscillometry (AO) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'title': 'R5-R20', 'categories': [{'measurements': [{'value': '0.008', 'spread': '0.013', 'groupId': 'OG000'}, {'value': '-0.014', 'spread': '0.013', 'groupId': 'OG001'}]}]}, {'title': 'R5', 'categories': [{'measurements': [{'value': '0.015', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '-0.030', 'spread': '0.030', 'groupId': 'OG001'}]}]}, {'title': 'R20', 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '-0.017', 'spread': '0.023', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Study Day 1) and Week 12', 'description': "Change from baseline to Week 12 in AO parameters including frequency dependence of resistance at 5-20 Hz (R5-R20) and respiratory resistance at 5 Hz (R5; total airway resistance) and 20 Hz (R20; resistance of large airways) is reported. AO is a non-invasive lung function test assessed using an AO device. It is assessed during quiet, tidal breathing with no participant effort required, by superimposing a multi-frequency oscillation onto the participant's natural breathing. AO device uses a vibrating mesh to generate a multifrequency sinusoidal pseudorandom noise (PRN) signal. The AO markers; respiratory resistance at 5 Hz (R5) and 20 Hz (R20) and difference between resistance at 5 and 20Hz (R5-R20; resistance in small airways) are recorded. These markers measure peripheral airway resistance.", 'unitOfMeasure': 'kPa*s/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable at Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in AO Parameter-Area Under the Reactance Curve (AX)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.081', 'spread': '0.375', 'groupId': 'OG000'}, {'value': '-0.267', 'spread': '0.360', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Study Day 1) and Week 12', 'description': "Change from baseline to Week 12 in AO Parameter-Area Under the Reactance Curve (AX) is reported. AO is a non-invasive lung function test assessed using an AO device. It is assessed during quiet, tidal breathing with no participant effort required, by superimposing a multi-frequency oscillation onto the participant's natural breathing.", 'unitOfMeasure': 'kPa/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable at Week 12.'}, {'type': 'SECONDARY', 'title': 'Ratio to Baseline in Daily, Night-time, and Awake Time Cough Frequency at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'title': 'Daily cough frequency', 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '1.07'}, {'value': '0.83', 'groupId': 'OG001', 'lowerLimit': '0.70', 'upperLimit': '0.99'}]}]}, {'title': 'Night-time cough frequency', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '1.70'}, {'value': '0.61', 'groupId': 'OG001', 'lowerLimit': '0.38', 'upperLimit': '0.98'}]}]}, {'title': 'Awake time cough frequency', 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '1.07'}, {'value': '0.84', 'groupId': 'OG001', 'lowerLimit': '0.71', 'upperLimit': '0.99'}]}]}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -21 to Day -7) and Week 12', 'description': 'Ratio to baseline in daily, night-time, and awake time cough frequency at Week 12 is reported. Objective cough frequency was measured using an ambulatory cough monitoring (ACM) which was fitted and worn by the participants for approximately 24 hours after the visits. Daily cough frequency as full average hourly cough of the full duration of recording, night time cough frequency as sleep average hourly cough of the duration of recording at night, and awake time cough frequency as awake average hourly cough of the full duration of recording minus sleep recording will be derived from the recording.', 'unitOfMeasure': 'Ratio to baseline', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable at Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-BD FEV1 and Post-BD FEV1 Through Week 28 in Participants With Extent of Emphysema < 10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'title': 'Pre-BD FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.031', 'spread': '0.057', 'groupId': 'OG000'}, {'value': '0.006', 'spread': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Post-BD FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.039', 'spread': '0.071', 'groupId': 'OG000'}, {'value': '-0.018', 'spread': '0.059', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week -5 to -4) through Week 28 post-dose', 'description': 'Change from baseline in pre-BD FEV1 and post-BD FEV1 through Week 28 in participants with extent of emphysema \\< 10% is reported.', 'unitOfMeasure': 'Litre', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable at Week 28.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-BD FEV1 and Post-BD FEV1 Through Week 28 in Participants With Extent of Emphysema >= 10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'title': 'Pre-BD FEV1 Week 28', 'categories': [{'measurements': [{'value': '-0.015', 'spread': '0.036', 'groupId': 'OG000'}, {'value': '-0.068', 'spread': '0.034', 'groupId': 'OG001'}]}]}, {'title': 'Post-BD FEV1 Week 28', 'categories': [{'measurements': [{'value': '0.074', 'spread': '0.044', 'groupId': 'OG000'}, {'value': '-0.053', 'spread': '0.042', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week -5 to -4) through Week 28 post-dose', 'description': 'Change from baseline in pre-BD FEV1 and post-BD FEV1 through Week 28 in participants with extent of emphysema \\>= 10% is reported.', 'unitOfMeasure': 'Litre', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable at Week 28.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-BD and Post-BD Forced Vital Capacity (FVC) Through Week 28 in Participants With Extent of Emphysema < 10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'title': 'Pre-BD FVC Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.143', 'spread': '0.105', 'groupId': 'OG000'}, {'value': '-0.056', 'spread': '0.093', 'groupId': 'OG001'}]}]}, {'title': 'Post-BD FVC Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.121', 'spread': '0.114', 'groupId': 'OG000'}, {'value': '0.046', 'spread': '0.096', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week -5 to -4) through Week 28 post-dose', 'description': 'Change from baseline in pre-BD and post-BD FVC through Week 28 in participants with extent of emphysema \\< 10% is reported.', 'unitOfMeasure': 'Litre', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable at Week 28.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pre-BD and Post-BD FVC Through Week 28 in Participants With Extent of Emphysema >= 10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'title': 'Pre-BD FVC Week 28', 'categories': [{'measurements': [{'value': '0.089', 'spread': '0.086', 'groupId': 'OG000'}, {'value': '-0.121', 'spread': '0.084', 'groupId': 'OG001'}]}]}, {'title': 'Post-BD FVC Week 28', 'categories': [{'measurements': [{'value': '0.081', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '-0.094', 'spread': '0.077', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week -5 to -4) through Week 28 post-dose', 'description': 'Change from baseline in pre-BD and post-BD FVC through Week 28 in participants with extent of emphysema \\>= 10% is reported.', 'unitOfMeasure': 'Litre', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable at Week 28.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Any TESAEs', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAESIs', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 253 days (maximum observed duration)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse event of special interest (AESI) are AEs of scientific and medical interest specific to understanding of tozorakimab and requires close monitoring. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Vital Signs Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 253 days (maximum observed duration)', 'description': 'Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (oral or tympanic temperature, diastolic blood pressure, systolic blood pressure, heart \\[pulse\\] rate, and respiratory rate).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'title': 'Anaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypercholesterolaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hyperuricaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypertransaminasaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Haematuria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SARS-CoV-2 test positive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperthyroidism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypothyroidism', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary tract infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 253 days (maximum observed duration)', 'description': 'Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of clinical chemistry, hematology, endocrinology, and urinalysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 253 days (maximum observed duration)', 'description': 'Number of participants with abnormal ECGs reported as TEAEs are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '5.78', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '4.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week -3 to -1) through Week 28', 'description': 'Change from baseline in LVEF as measured by echocardiogram is reported.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable at Week 28.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.051', 'spread': '17.937', 'groupId': 'OG000'}, {'value': '1.948', 'spread': '14.280', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -35 to Day -28) through Week 28', 'description': 'Change in NT-proBNP Level from baseline is reported.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable at Week 28.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Coronavirus Disease 2019 (COVID-19) Related AEs and SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'title': 'COVID-19 related AEs', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'COVID-19 related SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 253 days (maximum observed duration)', 'description': 'The number of participants with COVID-19 related AEs and SAEs are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Seropositive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Week 0) through Week 28', 'description': 'Number of participants who were seronegative at baseline and who had positive SARS-Cov-2 serology result at the end of study is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes the number of participants who were SARS-CoV-2 serum negative at baseline and had at least one post-baseline result.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Post-BD FEV1 To Weeks 12 and 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.041', 'spread': '0.036', 'groupId': 'OG000'}, {'value': '-0.025', 'spread': '0.033', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '0.021', 'spread': '0.036', 'groupId': 'OG000'}, {'value': '-0.049', 'spread': '0.033', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.067', 'ciLowerLimit': '0.017', 'ciUpperLimit': '0.116', 'pValueComment': 'One-sided p-value', 'groupDescription': 'Results are based on the mixed model for repeated measures (MMRM) analysis at Week 12.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Kenward-Roger correction has been used for degrees of freedom approximation in the generation of model.'}, {'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.070', 'ciLowerLimit': '0.020', 'ciUpperLimit': '0.120', 'pValueComment': 'One-sided p-value', 'groupDescription': 'Results are based on the MMRM analysis at Week 28.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Kenward-Roger correction has been used for degrees of freedom approximation in the generation of model.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week -5 to -4) to Weeks 12 and 28 post-dose', 'description': 'Change from baseline in post-BD FEV1 to Weeks 12 and 28 is reported.', 'unitOfMeasure': 'Litre', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received any study drug and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Reason unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Failure to meet randomization criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 47 centers in 12 countries (Australia, Canada, Czech Republic, Denmark, Germany, United Kingdom, Hungary, Israel, Poland, South Africa, Spain, and USA).', 'preAssignmentDetails': 'A total of 137 participants were randomized, of which 135 participants received at least one dose of study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '64.3', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '64.4', 'spread': '7.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-16', 'size': 17037959, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-07T08:48', 'hasProtocol': True}, {'date': '2023-05-11', 'size': 5002482, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-07T08:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigational product only will be prepared and administrated by unmasked personnel.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomised to recieve either MEDI3506 or placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'dispFirstSubmitDate': '2024-04-12', 'completionDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2020-10-20', 'resultsFirstSubmitDate': '2024-11-07', 'studyFirstSubmitQcDate': '2020-11-10', 'dispFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-07', 'studyFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Post-BD FEV1 To Weeks 12 and 28', 'timeFrame': 'Baseline (Week -5 to -4) to Weeks 12 and 28 post-dose', 'description': 'Change from baseline in post-BD FEV1 to Weeks 12 and 28 is reported.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic', 'timeFrame': 'Baseline (Day -35 to Day -28) through Week 12', 'description': 'The mean change from baseline in Pre-BD FEV1 at Week 12 (tozorakimab - placebo) estimated using a repeated measures mixed effects analysis of covariance measures was estimated. Data available from all visits up to and including Week 12, irrespective of whether the participant discontinued study drug or received reliever therapy was considered. FEV1 was measured by spirometry at clinic.'}], 'secondaryOutcomes': [{'measure': 'Serum Tozorakimab Concentration', 'timeFrame': 'Post-dose at Study Weeks 2, 4, 12, 20, 24, 28, 32, and 36', 'description': 'Serum concentration of tozorakimab collected over time are reported. The lower limit of quantification (LLOQ) for tozorakimab was considered to be 10 μg/L.'}, {'measure': 'Number of Participants With Positive Anti-drug Antibodies (ADA) to Tozorakimab', 'timeFrame': 'Pre-dose at Study Weeks 0 (baseline) and post-dose at Study Weeks 2, 4, 12, 20, 24, 28, 32, and 36', 'description': 'Number of participants with positive ADA to tozorakimab are reported. Treatment-induced ADA positive is defined as ADA negative at baseline and positive at post-baseline assessment. Treatment-boosted ADA positive is defined as ADA positive at baseline and boosted (\\>= 4 fold) the pre-existing titre during the study period. Persistent positive is defined as ADA negative at baseline and positive at \\>= 2 post-baseline assessments (with \\>= 16 weeks between first and last positive) or ADA positive at last post-baseline assessment. Transiently positive is defined as ADA negative at baseline and at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.'}, {'measure': 'Number of Participants Experiencing First Chronic Obstructive Pulmonary Disease Composite Exacerbations (COPDCompEx) Event', 'timeFrame': 'Baseline (Day -35 to Day -28) through Week 28', 'description': 'The COPDCompEx combines exacerbations with events defined from participant e-Diaries and peak expiratory flow (PEF). COPDCompEx defined exacerbations included episodes leading to one or more of the following: hospitalization, emergency room visit, treatment with systemic corticosteroids (injected and/or oral), or treatment with antibiotics. Diary COPDCompEx events are defined by threshold and slope criteria being met for \\>= 2 consecutive days using the following diary and home spirometry variables: overall symptom rating, night-time awakenings due to symptoms, reliever medication use, PEF.'}, {'measure': 'Change From Baseline to Week 12 in 4-weekly Mean Evaluating Respiratory Symptoms of COPD (E-RS:COPD) Total Score', 'timeFrame': 'Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12', 'description': 'Change from baseline to Week 12 in 4-weekly mean E-RS:COPD total score is reported. The E-RS™:COPD is an 11-item electronic patient reported outcome (ePRO) questionnaires developed to evaluate the severity of respiratory symptoms of COPD including breathlessness (5 items; score range: 0 to 17), cough and sputum (3 items; score range: 0 to 11), and chest symptoms (3 items; score range: 0 to 12). The ePRO was completed every day at home and at site visits. Summation of E-RS:COPD item responses produced a total score ranging from 0 to 40, with higher scores indicating greater severity. The 4-weekly mean will be calculated as the sum of all non-missing daily scores over the 28-day evaluation period, divided by the number of non-missing daily scores.'}, {'measure': 'Change From Baseline to Week 12 in Mean Breathlessness, Cough and Sputum Scale (BCSS) Score (Over the Previous 4 Weeks)', 'timeFrame': 'Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12', 'description': 'Change from baseline to Week 12 in mean BCSS score (over the previous 4 weeks) is reported. The BCSS was a 3-item daily diary that assesses the severity of the 3 symptoms: breathlessness, sputum, and cough, each on a 5-point Likert scale ranging from 0 (no symptoms) to 4 (severe symptoms). Item scores were summed to yield a total score ranging from 0 to 12; wherein higher total score indicated more severe symptoms. The BCSS was captured each evening via eDiary. The 4-weekly mean BCSS score was calculated as the sum of all non-missing daily scores over the 28-dayevaluation period, divided by the number of non-missing daily scores.'}, {'measure': 'Change From Baseline to Week 12 in Cough Visual Analogue Scale (VAS) Score', 'timeFrame': 'Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12', 'description': 'Change from baseline to Week 12 in cough VAS score is reported. Participants were asked to complete a cough severity VAS (100 mm linear scale marked with a horizontal line by the participant, with 0 mm representing \'\'no cough\'\' and 100 mm representing "worst cough") that measured subjective assessment by the participant of the prior 24 hrs for severity of cough symptoms. It was completed each evening in the eDiary. The 4-weekly mean cough VAS score was calculated as the sum of all non-missing daily scores over the 28-day evaluation period, divided by the number of non-missing daily scores.'}, {'measure': "Change From Baseline to Week 12 in Saint George's Respiratory Questionnaire (SGRQ) Total Score", 'timeFrame': 'Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12', 'description': "Change from baseline to Week 12 in SGRQ total score is reported. The SGRQ was a 50-item electronic PRO instrument developed to measure the health status of participants with airway obstruction diseases and is divided into 2 parts. Part 1 consisted 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; Part 2 consisted 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yielded a total score and three domain scores (symptoms, activity, and impacts). The total score indicated the impact of disease on overall health status, which was expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status. The domain scores range from 0 to 100, with higher scores indicative of greater impairment."}, {'measure': 'Percentage of Participants With a Decrease in SGRQ Total Score of >= 4 Points From Baseline to Week 12', 'timeFrame': 'Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12', 'description': "Percentage of participants with a decrease in SGRQ total score of \\>= 4 points from baseline to Week 12 is reported. The SGRQ was a 50-item electronic PRO instrument developed to measure the health status of participants with airway obstruction diseases and is divided into 2 parts. Part 1 consisted 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; Part 2 consisted 42 items related to the daily activity and psychosocial impacts of individual's respiratory condition. SGRQ yielded a total score and three domain scores (symptoms, activity, and impacts). Total score indicated the impact of disease on overall health status, which was expressed as a percentage of overall impairment, in which 100 represents worst possible health status and 0 indicates best possible health status. The domain scores range from 0 to 100, with higher scores indicative of greater impairment. A change of 4 units/points is associated with a minimum clinically important difference."}, {'measure': 'Change From Baseline to Week 12 in Airwave Oscillometry (AO) Parameters', 'timeFrame': 'Baseline (Study Day 1) and Week 12', 'description': "Change from baseline to Week 12 in AO parameters including frequency dependence of resistance at 5-20 Hz (R5-R20) and respiratory resistance at 5 Hz (R5; total airway resistance) and 20 Hz (R20; resistance of large airways) is reported. AO is a non-invasive lung function test assessed using an AO device. It is assessed during quiet, tidal breathing with no participant effort required, by superimposing a multi-frequency oscillation onto the participant's natural breathing. AO device uses a vibrating mesh to generate a multifrequency sinusoidal pseudorandom noise (PRN) signal. The AO markers; respiratory resistance at 5 Hz (R5) and 20 Hz (R20) and difference between resistance at 5 and 20Hz (R5-R20; resistance in small airways) are recorded. These markers measure peripheral airway resistance."}, {'measure': 'Change From Baseline to Week 12 in AO Parameter-Area Under the Reactance Curve (AX)', 'timeFrame': 'Baseline (Study Day 1) and Week 12', 'description': "Change from baseline to Week 12 in AO Parameter-Area Under the Reactance Curve (AX) is reported. AO is a non-invasive lung function test assessed using an AO device. It is assessed during quiet, tidal breathing with no participant effort required, by superimposing a multi-frequency oscillation onto the participant's natural breathing."}, {'measure': 'Ratio to Baseline in Daily, Night-time, and Awake Time Cough Frequency at Week 12', 'timeFrame': 'Baseline (Day -21 to Day -7) and Week 12', 'description': 'Ratio to baseline in daily, night-time, and awake time cough frequency at Week 12 is reported. Objective cough frequency was measured using an ambulatory cough monitoring (ACM) which was fitted and worn by the participants for approximately 24 hours after the visits. Daily cough frequency as full average hourly cough of the full duration of recording, night time cough frequency as sleep average hourly cough of the duration of recording at night, and awake time cough frequency as awake average hourly cough of the full duration of recording minus sleep recording will be derived from the recording.'}, {'measure': 'Change From Baseline in Pre-BD FEV1 and Post-BD FEV1 Through Week 28 in Participants With Extent of Emphysema < 10%', 'timeFrame': 'Baseline (Week -5 to -4) through Week 28 post-dose', 'description': 'Change from baseline in pre-BD FEV1 and post-BD FEV1 through Week 28 in participants with extent of emphysema \\< 10% is reported.'}, {'measure': 'Change From Baseline in Pre-BD FEV1 and Post-BD FEV1 Through Week 28 in Participants With Extent of Emphysema >= 10%', 'timeFrame': 'Baseline (Week -5 to -4) through Week 28 post-dose', 'description': 'Change from baseline in pre-BD FEV1 and post-BD FEV1 through Week 28 in participants with extent of emphysema \\>= 10% is reported.'}, {'measure': 'Change From Baseline in Pre-BD and Post-BD Forced Vital Capacity (FVC) Through Week 28 in Participants With Extent of Emphysema < 10%', 'timeFrame': 'Baseline (Week -5 to -4) through Week 28 post-dose', 'description': 'Change from baseline in pre-BD and post-BD FVC through Week 28 in participants with extent of emphysema \\< 10% is reported.'}, {'measure': 'Change From Baseline in Pre-BD and Post-BD FVC Through Week 28 in Participants With Extent of Emphysema >= 10%', 'timeFrame': 'Baseline (Week -5 to -4) through Week 28 post-dose', 'description': 'Change from baseline in pre-BD and post-BD FVC through Week 28 in participants with extent of emphysema \\>= 10% is reported.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs)', 'timeFrame': 'Day 1 through 253 days (maximum observed duration)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse event of special interest (AESI) are AEs of scientific and medical interest specific to understanding of tozorakimab and requires close monitoring. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.'}, {'measure': 'Number of Participants With Abnormal Vital Signs Reported as TEAEs', 'timeFrame': 'Day 1 through 253 days (maximum observed duration)', 'description': 'Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (oral or tympanic temperature, diastolic blood pressure, systolic blood pressure, heart \\[pulse\\] rate, and respiratory rate).'}, {'measure': 'Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs', 'timeFrame': 'Day 1 through 253 days (maximum observed duration)', 'description': 'Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of clinical chemistry, hematology, endocrinology, and urinalysis.'}, {'measure': 'Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs', 'timeFrame': 'Day 1 through 253 days (maximum observed duration)', 'description': 'Number of participants with abnormal ECGs reported as TEAEs are reported.'}, {'measure': 'Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram', 'timeFrame': 'Baseline (Week -3 to -1) through Week 28', 'description': 'Change from baseline in LVEF as measured by echocardiogram is reported.'}, {'measure': 'Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level', 'timeFrame': 'Baseline (Day -35 to Day -28) through Week 28', 'description': 'Change in NT-proBNP Level from baseline is reported.'}, {'measure': 'Number of Participants With Coronavirus Disease 2019 (COVID-19) Related AEs and SAEs', 'timeFrame': 'Day 1 through 253 days (maximum observed duration)', 'description': 'The number of participants with COVID-19 related AEs and SAEs are reported.'}, {'measure': 'Number of Participants Seropositive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)', 'timeFrame': 'Baseline (Week 0) through Week 28', 'description': 'Number of participants who were seronegative at baseline and who had positive SARS-Cov-2 serology result at the end of study is reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MEDI3506', 'IL-33', 'COPD', 'Chronic Bronchitis', 'Lung function', 'Inflammation'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)', 'Chronic Bronchitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D9180C00002&amp;attachmentIdentifier=8cec254d-22b5-4324-a9c7-3a1c85961135&amp;fileName=d9180c00002-study-CSR-synopsis-Redacted.pdf&amp;versionIdentifier=', 'label': 'Redacted CSR synopsis'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D9180C00002&amp;attachmentIdentifier=e07af4eb-a32b-4902-be1c-366581ef5363&amp;fileName=D9180C00002_-_Statistical_Analysis_Plan-Redacted.pdf&amp;versionIdentifier=', 'label': 'Redacted SAP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D9180C00002&amp;attachmentIdentifier=0b28d766-11db-42c1-a3d3-a43b0d7d053c&amp;fileName=D9180C00002_-_Protocol_Amendment-Redacted.pdf&amp;versionIdentifier=', 'label': 'Redacted CSP'}]}, 'descriptionModule': {'briefSummary': 'This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult participants with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.', 'detailedDescription': 'Study D9180C00002 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy and safety of MEDI3506 in adult participants with moderate to severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.\n\nApproximately 85 sites globally will participate in this study. Approximately 144 participants will be randomized to 2 treatment groups in a 1:1 ratio to receive MEDI3506 or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of informed consent.\n* Participant must be 40 to 80 years of age inclusive, at the time of signing the informed consent form (ICF).\n* Participants who are current or ex-smokers with a tobacco history of \\>= 10 pack-years.\n* Participants who have a documented history of COPD for at least 1 year.\n* Participants who have a post-BD FEV1/FVC \\< 0.70 and a post-BD FEV1 \\>= 20% and \\< 80% predicted normal value at screening. Centralized spirometry will be used for this criteria assessment.\n* Participants who have a physician confirmed participant history of chronic bronchitis as defined as presence of cough and sputum on most days for \\>= 3 months/year in at least the 2 year period immediately prior to study visit 1 (SV1) (Screening).\n* Participants who have an average BCSS score of \\>= 2 in cough and \\>= 2 in sputum domains assessed over 14 days preceding SV3.\n* Participants who have a documented stable regimen of dual therapy or triple therapy for \\>= 3 months prior to enrolment; there should have been no change in treatment after the previous exacerbation prior to entering into the study. Where dual therapy consists of inhaled corticosteroids (ICS) + long-acting beta 2 agonist (LABA) or LABA + long-acting muscarinic receptor antagonist (LAMA), and triple therapy consists of ICS + LABA + LAMA.\n* Participants who have a documented history of \\>= 1 moderate or severe AECOPD requiring systemic corticosteroids and/or antibiotics for at least 3 days duration (or 1 injection of depot formulation), or hospitalization for reason of AECOPD in the previous 24 months.\n* Body mass index within the range 18 to 40 kg/m\\^2 (inclusive).\n* Female participants of childbearing potential, must have negative pregnancy tests.\n* Male and female participants must follow protocol contraceptive guidance.\n\nExclusion Criteria:\n\n* Participants with a positive diagnostic nucleic acid test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening. Participants with mild or asymptomatic disease could be rescreened.\n* Participants with a significant coronavirus disease 2019 (COVID-19) illness within 6 months of enrolment.\n* As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason which in the investigator's opinion makes it undesirable for the participant to participate in the study.\n* Current or past diagnosis of asthma which persisted beyond age of 25 years.\n* Clinically important pulmonary disease other than COPD, radiological findings, and/or laboratory findings suggestive of a respiratory disease other than COPD that is contributing to the participant's respiratory symptoms.\n* Increased pre-BD FEV1 at randomization visit (SV3) compared to Screening SV1 of \\>= 400 mL or \\>= 25% of SV1 FEV1.\n* Any other clinically relevant abnormal findings on physical examination, laboratory testing; or chest CT scan, which in the opinion of the investigator or medical monitor may compromise the safety of the participant in the study or interfere with evaluation of the study intervention or reduce the participant's ability to participate in the study.\n\nChest CT scan findings requiring further investigation or repeat CT surveillance before SV14.\n\n* A family history of heart failure.\n* A LVEF \\< 45% measured by echocardiogram.\n* History of a clinically significant infection (viral, bacterial, or fungal) within 4 weeks.\n* History of, or a reason to believe a participant has a history of, drug or alcohol abuse within the past 2 years prior to screening.\n* Participants with a recent history of, or who have a positive test for, infective hepatitis or unexplained jaundice, or participants who have been treated for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).\n* Evidence of active or untreated latent tuberculosis (TB).\n* Change in smoking status in 12 weeks prior to enrolment or intention to change smoking status between enrolment and end of follow-up.\n* Participants currently receiving background therapy that is not approved by regulatory authorities in the country of study for COPD are not eligible for the study.\n* History of treatment with cardiotoxic medications (eg, as part of cancer therapy) including thiazolidinedione's.\n* Treatment with broad spectrum antibiotic within 4 weeks prior to randomization (Day 1).\n* Receiving any of the prohibited concomitant medications as specified in the clinical study protocol (CSP).\n* Inability to perform technically acceptable spirometry.\n\nAdditional inclusion and exclusion criteria's applies."}, 'identificationModule': {'nctId': 'NCT04631016', 'acronym': 'FRONTIER-4', 'briefTitle': 'A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of MEDI3506 in Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis (FRONTIER 4)', 'orgStudyIdInfo': {'id': 'D9180C00002'}, 'secondaryIdInfos': [{'id': '2020-000571-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tozorakimab', 'description': 'Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).', 'interventionNames': ['Drug: Tozorakimab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tozorakimab', 'type': 'DRUG', 'otherNames': ['MEDI3506'], 'description': 'Participants will receive SC injection of tozorakimab as stated in arm description.', 'armGroupLabels': ['Tozorakimab']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants will receive SC injection of placebo as stated in arm description.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '34746', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.28581, 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For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.\n\nAll request will be evaluated as per the AZ disclosure commitment:\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}