Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-25 @ 11:26 AM
Study NCT ID:
NCT00527566
Status:
COMPLETED
Last Update Posted:
2017-03-22
First Post:
2007-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015267', 'term': 'Churg-Strauss Syndrome'}], 'ancestors': [{'id': 'D056648', 'term': 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis'}, {'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006099', 'term': 'Granuloma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C434107', 'term': 'mepolizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wechslerm@NJHealth.org', 'phone': '617-285-4987', 'title': 'Michael Wechsler', 'organization': 'National Jewish Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mepolizumab', 'description': 'Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.', 'otherNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Digestive System Issues', 'notes': 'Abdominal pain/diarrhea, gastroenteritis, gastroesophageal reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Churg-Strauss Syndrome Flair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wheezing and Shortness of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fractured Hip', 'notes': 'Subject fell and broke hip. Event classified as serious, unexpected, and unrelated.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Indicated Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mepolizumab', 'description': 'Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.'}], 'classes': [{'title': 'Mild transient headaches', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Mild pruritus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urticaria, allergic reaction, worsening symptoms', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Loose stool', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed for the duration of the study, approximately 44 weeks', 'description': 'Side effects experienced by participants 1 to 2 days after Mepolizumab infusion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Steroid Dosing During Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mepolizumab', 'description': 'Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.'}], 'classes': [{'title': 'Baseline (Week 0)', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '20'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '12.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '20'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 weeks', 'unitOfMeasure': 'Prednisone mg/day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mepolizumab', 'description': 'Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.'}], 'classes': [{'title': 'Week 0, baseline', 'categories': [{'measurements': [{'value': '1.40', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.86'}]}]}, {'title': 'Week 12, Treatment phase', 'categories': [{'measurements': [{'value': '1.76', 'groupId': 'OG000', 'lowerLimit': '0.29', 'upperLimit': '7'}]}]}, {'title': 'Week 20, end of washout phase', 'categories': [{'measurements': [{'value': '1.30', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 weeks', 'description': 'The Asthma Control Questionnaire (ACQ) was one measure used to assess the prevalence of asthma symptoms the participant was having during the study. It is a series of 7 questions assessing how often, over the past two weeks, the participant wakes up from their asthma, how bad their symptoms were, etc. The greater the prevalence of symptoms, the higher the score. Each of the 7 questions is scored 0-6. The total score is calculated by adding the individual question scores and dividing the sum by 7.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Specific Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mepolizumab', 'description': 'Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.'}], 'classes': [{'title': 'Wheeze or cough', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Sore throat', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Nausea or abdominal discomfort', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Sinusitis', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Arthritis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '44 weeks', 'description': 'Number of participants who experienced specific symptoms during the trial.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Efficacy- Exacerbation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mepolizumab (Treatment Phase)', 'description': 'Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.'}, {'id': 'OG001', 'title': 'Non-treatment Phase', 'description': 'The non-treatment phase consists of the wash-out phase and the safety monitoring phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000'}, {'value': '0.69', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment period (12 weeks)', 'description': 'Quantified the exacerbation rate (total number of exacerbations per day) of the participants during treatment with mepolizumab and without treatment. Exacerbations were characterized as any worsening of clinical disease requiring an increase of systemic corticosteroid therapy (e.g. prednisone) for asthma, respiratory symptoms, or underlying vasculitis.', 'unitOfMeasure': 'Exacerbation rate (Exacerbations/day)', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mepolizumab', 'description': 'Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Mepolizumab', 'description': 'Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Participants', 'categories': [{'title': '# White Participants', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-01', 'studyFirstSubmitDate': '2007-09-07', 'resultsFirstSubmitDate': '2011-06-22', 'studyFirstSubmitQcDate': '2007-09-07', 'lastUpdatePostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-01', 'studyFirstPostDateStruct': {'date': '2007-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Indicated Side Effects', 'timeFrame': 'Participants were followed for the duration of the study, approximately 44 weeks', 'description': 'Side effects experienced by participants 1 to 2 days after Mepolizumab infusion.'}, {'measure': 'Number of Participants Who Experienced Specific Symptoms', 'timeFrame': '44 weeks', 'description': 'Number of participants who experienced specific symptoms during the trial.'}], 'secondaryOutcomes': [{'measure': 'Steroid Dosing During Trial', 'timeFrame': '20 weeks'}, {'measure': 'Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims', 'timeFrame': '20 weeks', 'description': 'The Asthma Control Questionnaire (ACQ) was one measure used to assess the prevalence of asthma symptoms the participant was having during the study. It is a series of 7 questions assessing how often, over the past two weeks, the participant wakes up from their asthma, how bad their symptoms were, etc. The greater the prevalence of symptoms, the higher the score. Each of the 7 questions is scored 0-6. The total score is calculated by adding the individual question scores and dividing the sum by 7.'}, {'measure': 'Efficacy- Exacerbation Rate', 'timeFrame': 'Treatment period (12 weeks)', 'description': 'Quantified the exacerbation rate (total number of exacerbations per day) of the participants during treatment with mepolizumab and without treatment. Exacerbations were characterized as any worsening of clinical disease requiring an increase of systemic corticosteroid therapy (e.g. prednisone) for asthma, respiratory symptoms, or underlying vasculitis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Churg Strauss Syndrome'], 'conditions': ['Churg Strauss Syndrome']}, 'referencesModule': {'availIpds': [{'id': 'PubMed ID: 20513524', 'url': 'http://www.ncbi.nlm.nih.gov/pubmed/20513524', 'type': 'Publication', 'comment': 'Mepolizumab as a steroid-sparing treatment option in patients with Churg-Strauss syndrome.\n\nKim S, Marigowda G, Oren E, Israel E, Wechsler ME. J Allergy Clin Immunol. 2010 Jun;125(6):1336-43. doi:10.1016/j.jaci.2010.03.028.'}], 'references': [{'pmid': '15073927', 'type': 'BACKGROUND', 'citation': 'Martin RM, Wilton LV, Mann RD. Prevalence of Churg-Strauss syndrome, vasculitis, eosinophilia and associated conditions: retrospective analysis of 58 prescription-event monitoring cohort studies. Pharmacoepidemiol Drug Saf. 1999 May;8(3):179-89. doi: 10.1002/(SICI)1099-1557(199905/06)8:33.0.CO;2-K.'}, {'pmid': '15940771', 'type': 'BACKGROUND', 'citation': 'Harrold LR, Andrade SE, Go AS, Buist AS, Eisner M, Vollmer WM, Chan KA, Frazier EA, Weller PF, Wechsler ME, Yood RA, Davis KJ, Platt R. Incidence of Churg-Strauss syndrome in asthma drug users: a population-based perspective. J Rheumatol. 2005 Jun;32(6):1076-80.'}, {'pmid': '16126951', 'type': 'BACKGROUND', 'citation': 'Hellmich B, Csernok E, Gross WL. Proinflammatory cytokines and autoimmunity in Churg-Strauss syndrome. Ann N Y Acad Sci. 2005 Jun;1051:121-31. doi: 10.1196/annals.1361.053.'}, {'pmid': '14699394', 'type': 'BACKGROUND', 'citation': "Garrett JK, Jameson SC, Thomson B, Collins MH, Wagoner LE, Freese DK, Beck LA, Boyce JA, Filipovich AH, Villanueva JM, Sutton SA, Assa'ad AH, Rothenberg ME. Anti-interleukin-5 (mepolizumab) therapy for hypereosinophilic syndromes. J Allergy Clin Immunol. 2004 Jan;113(1):115-9. doi: 10.1016/j.jaci.2003.10.049. Epub 2003 Dec 12."}, {'pmid': '17157662', 'type': 'BACKGROUND', 'citation': "Stein ML, Collins MH, Villanueva JM, Kushner JP, Putnam PE, Buckmeier BK, Filipovich AH, Assa'ad AH, Rothenberg ME. Anti-IL-5 (mepolizumab) therapy for eosinophilic esophagitis. J Allergy Clin Immunol. 2006 Dec;118(6):1312-9. doi: 10.1016/j.jaci.2006.09.007. Epub 2006 Nov 7."}, {'pmid': '14668459', 'type': 'BACKGROUND', 'citation': 'Plotz SG, Simon HU, Darsow U, Simon D, Vassina E, Yousefi S, Hein R, Smith T, Behrendt H, Ring J. Use of an anti-interleukin-5 antibody in the hypereosinophilic syndrome with eosinophilic dermatitis. N Engl J Med. 2003 Dec 11;349(24):2334-9. doi: 10.1056/NEJMoa031261. No abstract available.'}, {'pmid': '12704348', 'type': 'BACKGROUND', 'citation': 'Menzies-Gow A, Flood-Page P, Sehmi R, Burman J, Hamid Q, Robinson DS, Kay AB, Denburg J. Anti-IL-5 (mepolizumab) therapy induces bone marrow eosinophil maturational arrest and decreases eosinophil progenitors in the bronchial mucosa of atopic asthmatics. J Allergy Clin Immunol. 2003 Apr;111(4):714-9. doi: 10.1067/mai.2003.1382.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Mepolizumab (a monoclonal antibody against interleukin-5) is a safe and well-tolerated therapy that will allow for steroid tapering in patients with steroid-dependent Churg-Strauss Syndrome (CSS).', 'detailedDescription': 'Specific Aims:\n\n1. Document the safety of mepolizumab therapy in patients with CSS.\n2. Demonstrate the steroid sparing effect of mepolizumab therapy by decreasing corticosteroid dosage while using this anti-IL5 therapy.\n3. Demonstrate the efficacy of anti-IL5 therapy in improving the signs and symptoms of CSS by:\n\n 1. Measuring serum markers of CSS disease activity, including: peripheral eosinophilia, erythrocyte sedimentation rate, anti- neutrophil cytoplasmic antigen, C-reactive protein and IgE levels.\n 2. Assessing the activity level of vasculitis via the Birmingham Vasculitis Activity Score\n 3. Evaluating asthmatic response via serial peak flow and FEV1 measurements as well as asthma symptom scores using the Juniper scale.\n 4. Assessing changes in novel parameters such as fractional excretion of nitric oxide and IL-5 levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>18 years old\n* Diagnosis of Churg Strauss Syndrome\n* Maintained on stable corticosteroid dose of at least prednisone 10mg daily (or equivalent) prior to enrollment in study\n* If on cyclophosphamide, azathioprine or methotrexate, must be on a stable dose and be able to maintain that dose for the duration of the study\n\nExclusion Criteria:\n\n* Hypereosinophilic Syndrome\n* Wegener's Granulomatosis\n* Malignancy\n* Parasitic Disease\n* Pregnant or nursing\n* If female and of child-bearing potential, must have negative pregnancy test prior to each infusion of study medication and must adhere to acceptable method of contraception (with \\<1% failure rate)\n* Any other medical illness that precludes study involvement"}, 'identificationModule': {'nctId': 'NCT00527566', 'acronym': 'MATOCSS', 'briefTitle': 'Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Mepolizumab As a Steroid Sparing Treatment Option in the Churg Strauss Syndrome', 'orgStudyIdInfo': {'id': '2007-P-000012/1;BWH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mepolizumab', 'description': 'Subjects will receive open-label mepolizumab', 'interventionNames': ['Biological: Mepolizumab']}], 'interventions': [{'name': 'Mepolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['Anti IL-5'], 'description': 'IV mepolizumab, 750 mg', 'armGroupLabels': ['Mepolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Michael Wechsler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Assistant Professor of Medicine at Harvard Medical School and Brigham and Women's Hospital", 'investigatorFullName': 'Michael Wechsler, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}