Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT00590720
Status:
TERMINATED
Last Update Posted:
2014-03-21
First Post:
2007-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001991', 'term': 'Bronchitis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542276', 'term': 'enokizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'parkerj@medimmune.com', 'phone': '301-398-0000', 'title': 'Joseph Parker, MD', 'organization': 'MedImmune'}, '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. The PIs also agree for data to be presented first as a joint, multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PLACEBO', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MEDI528 50 mg', 'otherNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Injection site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Post-traumatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Blood bicarbonate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hyposmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nerve root compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Nuclear magnetic resonance imaging abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 150', 'description': 'Number of participants experiencing adverse events (includes both adverse events and serious adverse events)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of investigational product (MEDI-528 or placebo).'}, {'type': 'PRIMARY', 'title': 'Incidence of Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 150', 'description': 'Number of participants experiencing serious adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of investigational product (MEDI-528 or placebo).'}, {'type': 'SECONDARY', 'title': 'Incidence of Anti-drug Antibodies (ADA) to MEDI-528', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 28, 56, 119, and 150', 'description': 'Number of participants with ADA to MEDI-528', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of MEDI-528.'}, {'type': 'SECONDARY', 'title': 'Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.43', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Two-sample t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 measured before and after exercising on Day 28.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and performed acceptable spirometry (n=9, with 2 placebo and 7 MEDI-528).'}, {'type': 'SECONDARY', 'title': 'Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Two-sample t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 56.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).'}, {'type': 'SECONDARY', 'title': 'Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Two-sample t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 150.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).'}, {'type': 'SECONDARY', 'title': 'Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.6', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '-6.49', 'spread': '11.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Two-sample t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 28.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and performed acceptable spirometry (n=9, 2 placebo and 7 MEDI-528).'}, {'type': 'SECONDARY', 'title': 'Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.1', 'spread': '7.41', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '2.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Two-sample t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 56.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).'}, {'type': 'SECONDARY', 'title': 'Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.2', 'spread': '15.48', 'groupId': 'OG000'}, {'value': '-5.04', 'spread': '3.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Two-sample t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 150.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '92.69', 'spread': '41.14', 'groupId': 'OG000'}, {'value': '86.04', 'spread': '15.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'AUC of FEV1 at Day 28', 'unitOfMeasure': 'Liter x min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '85.38', 'spread': '44.72', 'groupId': 'OG000'}, {'value': '83.35', 'spread': '22.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'AUC of FEV1 at Day 56', 'unitOfMeasure': 'Liter x min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=7, 2 placebo and 5 MEDI-528).'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '82.53', 'spread': '18.31', 'groupId': 'OG000'}, {'value': '81.37', 'spread': '19.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'AUC of FEV1 at Day 150', 'unitOfMeasure': 'Liter x min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=7, 2 placebo and 5 MEDI-528).'}, {'type': 'SECONDARY', 'title': 'Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '10.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '5.71', 'spread': '1.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after 30 minues of exercise on Day 28', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=9, 2 placebo and 7 MEDI-528).'}, {'type': 'SECONDARY', 'title': 'Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '10.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 56', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).'}, {'type': 'SECONDARY', 'title': 'Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7.50', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 150', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).'}, {'type': 'SECONDARY', 'title': 'Mean Trough Concentration (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.207', 'spread': '1.694', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150', 'description': 'Cmin of MEDI-528', 'unitOfMeasure': 'Microgram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of MEDI-528.'}, {'type': 'SECONDARY', 'title': 'Mean Trough Concentration at Last Measurable Time Point (Cmin_last)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '18.123', 'spread': '10.456', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150', 'description': 'Cmin\\_last of MEDI-528', 'unitOfMeasure': 'Microgram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of MEDI-528.'}, {'type': 'SECONDARY', 'title': 'Half-life (T1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '34.708', 'spread': '7.891', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150', 'description': 'T1/2 of MEDI-528', 'unitOfMeasure': 'Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of MEDI-528.'}, {'type': 'SECONDARY', 'title': 'Accumulation Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'OG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7.615', 'spread': '5.215', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0 and 24', 'description': 'Ratio of trough concentrations after first (Day 0) and last (Day 24) dose of MEDI-528', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of MEDI-528 (n=7) and had available data (n=5).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'FG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 11 subjects participated in this study from 26Feb2008 to 27Dec2008 at 4 sites in the United States of America.', 'preAssignmentDetails': 'Treatment assignments were determined using a block randomization procedure with a 2:1 ratio (MEDI-528:placebo) via an interactive voice response system on Day 0 before study drug administration.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'BG001', 'title': 'MEDI528 50 mg', 'description': 'MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '32.1', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '32.0', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Study is replaced by MI-CP198 per CPM.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-04', 'studyFirstSubmitDate': '2007-12-26', 'resultsFirstSubmitDate': '2013-10-22', 'studyFirstSubmitQcDate': '2007-12-27', 'lastUpdatePostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-04', 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'Days 0 - 150', 'description': 'Number of participants experiencing adverse events (includes both adverse events and serious adverse events)'}, {'measure': 'Incidence of Serious Adverse Events', 'timeFrame': 'Days 0 - 150', 'description': 'Number of participants experiencing serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Incidence of Anti-drug Antibodies (ADA) to MEDI-528', 'timeFrame': 'Days 0, 28, 56, 119, and 150', 'description': 'Number of participants with ADA to MEDI-528'}, {'measure': 'Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 measured before and after exercising on Day 28.'}, {'measure': 'Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 56.'}, {'measure': 'Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 150.'}, {'measure': 'Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 28.'}, {'measure': 'Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 56.'}, {'measure': 'Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 150.'}, {'measure': 'Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'AUC of FEV1 at Day 28'}, {'measure': 'Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'AUC of FEV1 at Day 56'}, {'measure': 'Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'AUC of FEV1 at Day 150'}, {'measure': 'Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after 30 minues of exercise on Day 28'}, {'measure': 'Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 56'}, {'measure': 'Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)', 'description': 'Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 150'}, {'measure': 'Mean Trough Concentration (Cmin)', 'timeFrame': 'Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150', 'description': 'Cmin of MEDI-528'}, {'measure': 'Mean Trough Concentration at Last Measurable Time Point (Cmin_last)', 'timeFrame': 'Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150', 'description': 'Cmin\\_last of MEDI-528'}, {'measure': 'Half-life (T1/2)', 'timeFrame': 'Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150', 'description': 'T1/2 of MEDI-528'}, {'measure': 'Accumulation Index', 'timeFrame': 'Days 0 and 24', 'description': 'Ratio of trough concentrations after first (Day 0) and last (Day 24) dose of MEDI-528'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Asthma', 'Bronchitis'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '21356110', 'type': 'DERIVED', 'citation': 'Parker JM, Oh CK, LaForce C, Miller SD, Pearlman DS, Le C, Robbie GJ, White WI, White B, Molfino NA; MEDI-528 Clinical Trials Group. Safety profile and clinical activity of multiple subcutaneous doses of MEDI-528, a humanized anti-interleukin-9 monoclonal antibody, in two randomized phase 2a studies in subjects with asthma. BMC Pulm Med. 2011 Feb 28;11:14. doi: 10.1186/1471-2466-11-14.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the safety and tolerability of multiple fixed doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).', 'detailedDescription': 'The primary objective of this study is to evaluate the safety and tolerability of multiple fixed escalating SC doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must meet all of the following criteria:\n\n* Male or female adults, age 18 through 50 years at the time of screening;\n* Weight 50-100 kg and body mass index ≤ 35;\n* Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;\n* Documented clinical history of asthma and receiving stable treatment for ≥ 1 month prior to Study Day 0;\n* Airway hyperresponsiveness (AHR) on methacholine inhalation challenge testing at screening (or a documented history within the past 6 months), with provoking concentration of methacholine to cause a 20% fall in FEV1(subscript) (PC20) ≤ 8 mg/mL (Crapo, 2000);\n* Exercise-induced bronchoconstriction (EIB) with a decrease in FEV1 (subscript) of ≥ 15% from pre-exercise challenge testing level at screening;\n* Able to provide spirometry readings that meet American Thoracic Society (ATS) and European Respiratory Society (ERS) standards (Miller, 2005);\n* Women of childbearing potential, unless surgically sterile or at least 1 year post-menopausal, must use two effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom, spermicide, diaphragm, cervical cap, abstinence, contraceptive foam, or use of a condom by the sexual partner or sterile sexual partner) from screening through Study Day 0, and must agree to continue using such precautions through Study Day 150. Cessation of birth control after this point should be discussed with a responsible physician. Men, unless surgically sterile, must likewise use an effective method of birth control (condom with spermicide) and must agree to continue using such precautions from screening through Study Day 150;\n* Able to complete the study period, including follow-up period, of up to approximately 150 days; and\n* Willing to forego other forms of experimental treatment and study procedures during the study and for 30 days after the follow-up period is completed.\n\nExclusion Criteria:\n\nPatients must have none of the following criteria:\n\n* Receipt of MEDI-528 in any previous clinical study;\n* History of allergy or reaction to any component of the study drug formulation;\n* Lung disease other than asthma (eg, chronic obstructive pulmonary disease, cystic fibrosis);\n* Forced expiratory volume in 1 second (FEV1-subscript) \\< 70% of predicted values at screening;\n* Use of systemic immunosuppressive drugs including systemic corticosteroids, ICS with doses \\> 800 μg/day budesonide (or another ICS of equivalent dose), long-acting β2 agonists, cromolyn sodium, nedocromil sodium, leukotriene receptor antagonists, theophylline, or omalizumab from screening through Study Day 150;\n* Current use of any β-adrenergic antagonist (eg, propranolol);\n* Any disease or illness, other than asthma, that is likely to require the use of systemic corticosteroids during the study period;\n* Acute illnesses or evidence of significant active infection, such as fever ≥ 38.0°C (100.5°F) from screening through Study Day 0;\n* Current allergy vaccination therapy (desensitization immunotherapy);\n* Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to screening;\n* Pregnancy (women of child bearing potential, unless surgically sterile or at least 1 year postmenopausal, must have a negative serum and urine pregnancy test at screening before methacholine inhalation challenge testing and a negative urine pregnancy test prior to study drug administration on Study Day 0);\n* Breastfeeding or lactating woman;\n* Evidence of infection with hepatitis B or C virus or HIV-1 or HIV-2, or active infection with hepatitis A; must have negative HIV-1, HIV-2, hepatitis A, B, and C tests at screening;\n* History of cancer other than basal cell carcinoma of the skin or cervical carcinoma-in-situ treated with apparent success with curative therapy more than 1 year prior to Study Day 0;\n* History of primary immunodeficiency\n* History of pancreatitis or currently active gastroduodenal ulcer;\n* Current use of tobacco products or a history of use of tobacco products of more than one cigarette per month or equivalent within 1 year prior to randomization or history of smoking of ≥ 10 pack-years;\n* History of life-long urinary retention;\n* History of anaphylaxis (defined as immediate life-threatening event requiring medical invention);\n* Elective surgery planned from screening through Study Day 150;\n* Clinically significant abnormality, as determined by the investigator, on 12-lead ECG or chest radiograph at screening;\n* History of any disease, evidence of any current disease (other than asthma), any finding upon physical examination, or any laboratory abnormality, that, in the opinion of the investigator or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study; or\n* Any employee of the research site who is involved with the conduct of the study.'}, 'identificationModule': {'nctId': 'NCT00590720', 'briefTitle': 'A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Effect on Exercise Challenge Testing of Multiple Fixed Subcutaneous Doses of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody, in Adults With Stable Asthma and Exercise-Induced Bronchoconstriction', 'orgStudyIdInfo': {'id': 'MI-CP143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEDI528 50 mg', 'description': 'MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks', 'interventionNames': ['Biological: MEDI528 50 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks', 'interventionNames': ['Other: PLACEBO']}], 'interventions': [{'name': 'MEDI528 50 mg', 'type': 'BIOLOGICAL', 'description': 'MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks', 'armGroupLabels': ['MEDI528 50 mg']}, {'name': 'PLACEBO', 'type': 'OTHER', 'description': 'Placebo administered as a subcutaneous injection twice weekly for 4 weeks', 'armGroupLabels': ['PLACEBO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Institute of Healthcare Assessment, Inc', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Medical and Research Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Waterbury Pulmonary Associates', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ. of South Florida, Asthma, Allergy & Immunology Clinical Research Unit', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Sneeze,Wheeze & Itch Associates, LLC', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '02747', 'city': 'No. Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Northeast Medical Research Associates, Inc'}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Clinical Research Center, LLC', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton University', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '45231', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bernstein Clinical Research Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': 'T2N4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Calgary COPD & Asthma Program', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'M5T2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'UHN- Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G1V4M6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Recherche Appliquee en Allergie de Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Joseph Parker, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}