Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2025-12-29 @ 10:02 PM
Study NCT ID:
NCT02417961
Status:
COMPLETED
Last Update Posted:
2018-05-23
First Post:
2015-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}], 'ancestors': [{'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571386', 'term': 'benralizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Mitchell.Goldman@astrazeneca.com', 'phone': '+1 301 398 0323', 'title': 'Mitchell Goldman, Global Clinical Lead Benralizumab', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': "≥ 60 days prior to submission of material for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ's Confidential Information without AZ's written approval. AZ can request Inst. and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication or presentation.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Benra 30 mg', 'description': 'Benralizumab administered subcutaneously every 4 weeks', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 43, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Benra 30 mg', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}]}]}, {'title': 'Weeks 12 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciPctValue': '95', 'paramValue': '98.2', 'ciLowerLimit': '93.81', 'ciUpperLimit': '99.79', 'estimateComment': 'Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12)', 'statisticalMethod': 'Clopper-pearson Exact CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'One sample Confidence Interval (Week 12)'}, {'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.1', 'ciLowerLimit': '94.99', 'ciUpperLimit': '99.98', 'estimateComment': 'Percentage of patients who successfully administered benralizumab with an APFS at home (Week 16)', 'statisticalMethod': 'Clopper-pearson Exact CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'One sample Confidence Interval (Week 16)'}, {'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '93.0', 'ciLowerLimit': '86.64', 'ciUpperLimit': '96.92', 'estimateComment': 'Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12 and 16)', 'statisticalMethod': 'Clopper-pearson Exact CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'One sample Confidence Interval (Week 12 and 16)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12, Week 16, and Weeks 12 and 16', 'description': 'Number (%) of patients/caregivers who successfully administered benralizumab with an APFS at home among those who have been deemed by the Principal Investigator to be suitable for at-home administration and are still in the study. A successful administration is defined as an injection completed, an answer of "Yes" to all 5 questions in the Functioning Device Return Questionnaire for the GREGALE Clinical Study (Appendix to the Clinical Study Protocol), and adequately passed the visual inspection and function tests. The percentage is calculated among all patients/caregivers who had been deemed by the Principal Investigator to be suitable for at home administration and were still in the study at the time point.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all patients who were administered for at least one dose of Benralizumab.'}, {'type': 'PRIMARY', 'title': 'Number and Percentage of Returned APFS Used to Administer Benralizumab at Home That Have Been Evaluated as Functional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Benra 30 mg', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.1', 'ciLowerLimit': '95.21', 'ciUpperLimit': '99.98', 'estimateComment': 'Percentage of patients returned functional APFS administered at home (Week 12)', 'statisticalMethod': 'Clopper-pearson Exact CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'One sample Confidence Interval (Week 12)'}, {'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '99.1', 'ciLowerLimit': '94.99', 'ciUpperLimit': '99.98', 'estimateComment': 'Percentage of patients returned functional APFS administered at home (Week 16)', 'statisticalMethod': 'Clopper Pearson Exact CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'One sample confidence interval (Week 16)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12, Week 16', 'description': 'Number (%) of returned APFS used to administer benralizumab at home that have been evaluated as functional among all returned APFS used to administer benralizumab at home. A functional APFS is defined as an answer of "Yes" to all the questions in the visual inspection and function tests. The percentage is calculated among all returned APFS at the specified time point.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all patients who were administered for at least one dose of Benralizumab.'}, {'type': 'PRIMARY', 'title': 'Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}, {'units': 'Accessorized Pre-filled Syringe', 'counts': [{'value': '573', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Benra 30 mg', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}, {'units': 'Accessorized Pre-filled Syringe', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}, {'units': 'Accessorized Pre-filled Syringe', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}, {'units': 'Accessorized Pre-filled Syringe', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}, {'units': 'Accessorized Pre-filled Syringe', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}, {'units': 'Accessorized Pre-filled Syringe', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 0 to 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}, {'units': 'Accessorized Pre-filled Syringe', 'counts': [{'value': '348', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 to 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}, {'units': 'Accessorized Pre-filled Syringe', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 0 to 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}, {'units': 'Accessorized Pre-filled Syringe', 'counts': [{'value': '573', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.00', 'ciUpperLimit': '3.13', 'estimateComment': 'Percentage of mulfunctioning APFS used to administer benralizumab at home or clinic (Week 0)', 'statisticalMethod': 'Clopper-pearson Exact CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'One sample Confidence Interval (Week 0)'}, {'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.02', 'ciUpperLimit': '4.67', 'estimateComment': 'Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 4)', 'statisticalMethod': 'Clopper-pearson Exact CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'One sample Confidence Interval (Week 4)'}, {'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.00', 'ciUpperLimit': '3.16', 'estimateComment': 'Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 8)', 'statisticalMethod': 'Clopper-pearson Exact CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'One sample Confidence Interval (Week 8)'}, {'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.00', 'ciUpperLimit': '3.13', 'estimateComment': 'Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12)', 'statisticalMethod': 'Clopper-pearson Exact CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'One sample Confidence Interval (Week 12)'}, {'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '3.33', 'estimateComment': 'Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 16)', 'statisticalMethod': 'Clopper-Pearson Exact CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'One sample Confidence Interval (Week 16)'}, {'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.01', 'ciUpperLimit': '1.59', 'estimateComment': 'Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 8)', 'statisticalMethod': 'Clopper-pearson Exact CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'One sample Confidence Interval (Week 0 to 8)'}, {'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.00', 'ciUpperLimit': '1.63', 'estimateComment': 'Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12 to 16)', 'statisticalMethod': 'Clopper-pearson Exact CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'One sample Confidence Interval (Week 12 to 16)'}, {'groupIds': ['OG000'], 'paramType': 'Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.97', 'estimateComment': 'Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 16)', 'statisticalMethod': 'Clopper-pearson Exact CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'One sample Confidence Interval (Week 0 to 16)'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16', 'description': 'Number (%) of APFS used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on APFS dispensed and used for the specified time point.', 'unitOfMeasure': 'Accessorized Pre-filled Syringe', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Accessorized Pre-filled Syringe', 'denomUnitsSelected': 'Accessorized Pre-filled Syringe', 'populationDescription': 'Number of Units analyzed per row represents number of accessorized pre-filled syringes used at each time point.'}, {'type': 'SECONDARY', 'title': 'The Effect of Benralizumab on Asthma Control Metrics in Terms of Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Benra 30 mg', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.80', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.72', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.73', 'spread': '0.93', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 (baseline) and weeks 4, 8, 12, 16, 20', 'description': 'The effect of benralizumab on asthma control metrics in terms of change from baseline in mean Asthma Control Questionnaire-6 (ACQ-6) score. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations, and rescue medication. Baseline is defined as the last non-missing observation prior to the first dose of study treatment. ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Smaller score indicates better controlled asthma.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all patients who were administered for at least one dose of Benralizumab.'}, {'type': 'SECONDARY', 'title': 'The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Benra 30 mg', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Value is less than lower limit of quantification', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1031.644', 'spread': '53.547', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '802.197', 'spread': '267.033', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.330', 'spread': '499.728', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Week 8, Week 20, and Week 28', 'description': 'Mean PK Concentration at each visit', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set - include all patients who had at least one quantifiable serum PK observation post first dose of Benralizumab.'}, {'type': 'SECONDARY', 'title': 'The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Benra 30 mg', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '362.2', 'spread': '322.01', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.0', 'spread': '56.33', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.1', 'spread': '141.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 20, and Week 28', 'description': 'Blood eosinophil counts by timepoint', 'unitOfMeasure': 'cells/ uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all patients who were administered for at least one dose of Benralizumab.'}, {'type': 'SECONDARY', 'title': 'The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Benra 30 mg', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}], 'classes': [{'title': 'Positive at any visit', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Base- and Post-baseline Positive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Only post-baseline positive', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Only baseline positive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Persistently Positive', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Transiently Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until Week 28', 'description': 'Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at \\>=2 post-baseline assessments (with \\>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - all patients who were administered for at least one dose of Benralizumab.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Benra 30 mg', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '162 participants signed informed consent, 116 participants receive treatment with benralizumab 30 mg at every 4 weeks schedule.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Benra 30 mg', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'spread': '13.19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-27', 'studyFirstSubmitDate': '2015-03-12', 'resultsFirstSubmitDate': '2017-03-13', 'studyFirstSubmitQcDate': '2015-04-13', 'lastUpdatePostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-12', 'studyFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home', 'timeFrame': 'Week 12, Week 16, and Weeks 12 and 16', 'description': 'Number (%) of patients/caregivers who successfully administered benralizumab with an APFS at home among those who have been deemed by the Principal Investigator to be suitable for at-home administration and are still in the study. A successful administration is defined as an injection completed, an answer of "Yes" to all 5 questions in the Functioning Device Return Questionnaire for the GREGALE Clinical Study (Appendix to the Clinical Study Protocol), and adequately passed the visual inspection and function tests. The percentage is calculated among all patients/caregivers who had been deemed by the Principal Investigator to be suitable for at home administration and were still in the study at the time point.'}, {'measure': 'Number and Percentage of Returned APFS Used to Administer Benralizumab at Home That Have Been Evaluated as Functional', 'timeFrame': 'Week 12, Week 16', 'description': 'Number (%) of returned APFS used to administer benralizumab at home that have been evaluated as functional among all returned APFS used to administer benralizumab at home. A functional APFS is defined as an answer of "Yes" to all the questions in the visual inspection and function tests. The percentage is calculated among all returned APFS at the specified time point.'}, {'measure': 'Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16', 'description': 'Number (%) of APFS used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on APFS dispensed and used for the specified time point.'}], 'secondaryOutcomes': [{'measure': 'The Effect of Benralizumab on Asthma Control Metrics in Terms of Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score', 'timeFrame': 'Week 0 (baseline) and weeks 4, 8, 12, 16, 20', 'description': 'The effect of benralizumab on asthma control metrics in terms of change from baseline in mean Asthma Control Questionnaire-6 (ACQ-6) score. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations, and rescue medication. Baseline is defined as the last non-missing observation prior to the first dose of study treatment. ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Smaller score indicates better controlled asthma.'}, {'measure': 'The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab', 'timeFrame': 'Baseline, Week 8, Week 20, and Week 28', 'description': 'Mean PK Concentration at each visit'}, {'measure': 'The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels', 'timeFrame': 'Baseline, Week 20, and Week 28', 'description': 'Blood eosinophil counts by timepoint'}, {'measure': 'The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA)', 'timeFrame': 'Baseline until Week 28', 'description': 'Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at \\>=2 post-baseline assessments (with \\>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Asthma,', 'Bronchial Diseases,', 'Respiratory Tract Diseases,', 'Lung Diseases,', 'Obstructive Lung Diseases,', 'Benralizumab'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '29670379', 'type': 'BACKGROUND', 'citation': 'Ferguson GT, Mansur AH, Jacobs JS, Hebert J, Clawson C, Tao W, Wu Y, Goldman M. Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma. J Asthma Allergy. 2018 Apr 5;11:63-72. doi: 10.2147/JAA.S157762. eCollection 2018.'}], 'seeAlsoLinks': [{'url': 'http://doi.org/10.2147/JAA.S157762', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3529&filename=D3250C00029_Clinical%20Study%20Protocol_GREGALE%20-%20Redacted.pdf', 'label': 'Redacted CSP'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess functionality, performance, and reliability of an accessorized pre-filled syringe (APFS) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or caregiver, and to confirm the safety and clinical benefit of benralizumab administration in asthma patients with severe asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n* Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union (EU) guidelines\n* Male and female patients aged 18 to 75 years of age at the time of Visit 1\n* Patient or caregiver must be willing and able to self-administer the IP (Investigational product). Caregiver must be age of consent or older at the time of Visit 1, if applicable\n* Weight of ≥40 kg\n* Evidence of asthma as documented by either: Airway reversibility (FEV1 ≥12% and 200 ml) demonstrated at Visit 1 or 2 OR documented in the previous 12 months OR; Airflow variability in FEV1 ≥20% between pulmonary function testing documented in the 12 months prior to V2 OR; Airflow variability shown by \\>20% diurnal variability in peak flow observed in the patient's asthma action plan\n* Documented history of current treatment with ICS (Inhaled corticosteroids) and LABA (Long-acting β2 agonists). The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, both the mid- and high-strength maintenance doses approved in the local country will meet this ICS criterion. Additional asthma controller medications (e.g., LTRAs (Leukotriene receptor antagonists), tiotropium, theophylline, oral corticosteroids) are allowed\n* Morning pre-bronchodilator (pre-BD) FEV1 of \\>50% predicted at Visit 1 or Visit 2\n* Not well controlled asthma as documented by either: An ACQ6 (Asthma Control Questionnaire 6) ≥1.5 OR; A peak flow of 60-80% predicted OR; An exacerbation, one or more, that required oral or systemic corticosteroids in the previous year OR; Any one of the following assessed by patient recall over the previous 2-4 weeks: Asthma symptoms \\>2 days/week; OR / Nighttime awakenings 1 or more/week; OR / Short acting beta2-agonist use for symptom control (not for prevention of exercise induced asthma) \\>2 days/week\n\nExclusion criteria:\n\n* Clinically important pulmonary disease other than asthma (eg, active lung infection, COPD (Chronic obstructive pulmonary disease), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome)\n* Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: Affect the safety of the patient throughout the study; Influence the findings of the studies or their interpretations; Impede the patient's ability to complete the entire duration of study\n* Known history of allergy or reaction to the IP formulation\n* History of anaphylaxis to any biologic therapy\n* History of Guillain-Barré syndrome\n* A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy\n* Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening period\n* Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study"}, 'identificationModule': {'nctId': 'NCT02417961', 'briefTitle': 'Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multicenter, Open-Label, Functionality, Reliability, and Performance Study of an Accessorized Pre-filled Syringe With Home-administered Subcutaneous Benralizumab in Adult Patients With Severe Asthma (GREGALE)', 'orgStudyIdInfo': {'id': 'D3250C00029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Benralizumab 30 mg', 'description': 'Benralizumab administered subcutaneously every 4 weeks', 'interventionNames': ['Biological: Benralizumab']}], 'interventions': [{'name': 'Benralizumab', 'type': 'BIOLOGICAL', 'description': 'Benralizumab administered subcutaneously every 4 weeks', 'armGroupLabels': ['Benralizumab 30 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'city': 'Celebration', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}, {'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'city': 'Albany', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.57851, 'lon': -84.15574}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Bellevue', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.13667, 'lon': -95.89084}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Ajax', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.85012, 'lon': -79.03288}}, {'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Pointe-Claire', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.44868, 'lon': -73.81669}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Saint-Charles-Borromée', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.05007, 'lon': -73.46586}}, {'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}], 'overallOfficials': [{'name': 'Gary T. Ferguson, MD, PC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pulmonary Research Institute of Southeast Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}