Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
Study NCT ID:
NCT04158050
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2019-11-03
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Biologicals in Treatment of Severe Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069444', 'term': 'Omalizumab'}], 'ancestors': [{'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'paula.kauppi@hus.fi', 'phone': '+358504286802', 'title': 'Dr Paula Kauppi', 'organization': 'Helsinki University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3).', 'description': 'Adverse events information was collected in the medical records.', 'eventGroups': [{'id': 'EG000', 'title': 'Anti-IL5/IL5R-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 7, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Anti-IgE-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 4, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatique', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rise in transaminases', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb or joint pain or oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumopleuritis and pericarditis', 'notes': 'Pneumopleuritis and pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Number of Exacerbations of the Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-IL5/IL5R-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma'}, {'id': 'OG001', 'title': 'Anti-IgE-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma'}], 'classes': [{'categories': [{'measurements': [{'value': '2.77', 'spread': '7.91', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '2.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)', 'description': 'Change from the baseline in the number of courses of oral corticosteroids. Exacerbations of asthma estimated as number of courses of oral corticosteroids.', 'unitOfMeasure': 'Change in number of courses of oral c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Oral Corticosteroid Dose in Milligrams', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-IL5/IL5R-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma'}, {'id': 'OG001', 'title': 'Anti-IgE-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '7.91', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '5.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The baseline (at the time of the last outpatient before starting biologicals) and up to approximately 12 months for Anti-IL5/IL5R Therapy and approximately 44 months for the Anti-IgE Therapy"', 'description': 'Change in oral corticosteroid dose in milligrams', 'unitOfMeasure': 'Milligrams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in the Number of Courses of Antimicrobics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-IL5/IL5R-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma'}, {'id': 'OG001', 'title': 'Anti-IgE-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma'}], 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '1.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals', 'description': 'Change in the number of courses of antimicrobics', 'unitOfMeasure': 'Change in antimicrobial courses/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in the Number of Emergency Room Visits of the Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-IL5/IL5R-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma'}, {'id': 'OG001', 'title': 'Anti-IgE-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '1.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals', 'description': 'Change in the number of emergency room visits of the participants', 'unitOfMeasure': 'Change in number of emergency visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Number of Polypectomy, FESS and Ethmoidectomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-IL5/IL5R-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma'}, {'id': 'OG001', 'title': 'Anti-IgE-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma'}], 'classes': [{'title': 'Polypectomy', 'categories': [{'measurements': [{'value': '1.24', 'spread': '3.03', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '4.69', 'groupId': 'OG001'}]}]}, {'title': 'FESS', 'categories': [{'measurements': [{'value': '0.95', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Ethmoidectomy', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The baseline (before biologicals) and the latest 12 months after initiation of biologicals', 'description': 'Change in number of Polypectomy, FESS and ethmoidectomy', 'unitOfMeasure': 'Procedures', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anti-IL5/IL5R-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma'}, {'id': 'FG001', 'title': 'Anti-IgE-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'comment': 'This is a retrospective evaluation of clinical data', 'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Anti-IL5/IL5R-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma'}, {'id': 'BG001', 'title': 'Anti-IgE-therapy Group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy\n\nIL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '9.75', 'groupId': 'BG000'}, {'value': '48', 'spread': '10.67', 'groupId': 'BG001'}, {'value': '52', 'spread': '11.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Finland', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-04', 'size': 292683, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-28T12:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2019-11-03', 'resultsFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-28', 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Number of Polypectomy, FESS and Ethmoidectomy', 'timeFrame': 'The baseline (before biologicals) and the latest 12 months after initiation of biologicals', 'description': 'Change in number of Polypectomy, FESS and ethmoidectomy'}], 'primaryOutcomes': [{'measure': 'Change in Number of Exacerbations of the Participants', 'timeFrame': 'baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)', 'description': 'Change from the baseline in the number of courses of oral corticosteroids. Exacerbations of asthma estimated as number of courses of oral corticosteroids.'}], 'secondaryOutcomes': [{'measure': 'Change in Oral Corticosteroid Dose in Milligrams', 'timeFrame': 'The baseline (at the time of the last outpatient before starting biologicals) and up to approximately 12 months for Anti-IL5/IL5R Therapy and approximately 44 months for the Anti-IgE Therapy"', 'description': 'Change in oral corticosteroid dose in milligrams'}, {'measure': 'Change in the Number of Courses of Antimicrobics', 'timeFrame': 'The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals', 'description': 'Change in the number of courses of antimicrobics'}, {'measure': 'Change in the Number of Emergency Room Visits of the Participants', 'timeFrame': 'The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals', 'description': 'Change in the number of emergency room visits of the participants'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '32467765', 'type': 'DERIVED', 'citation': 'Kotisalmi E, Hakulinen A, Makela M, Toppila-Salmi S, Kauppi P. A comparison of biologicals in the treatment of adults with severe asthma - real-life experiences. Asthma Res Pract. 2020 May 13;6:2. doi: 10.1186/s40733-020-00055-9. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This is a retrospective clinical study on adult patients (18 years or more) with biological therapy for severe asthma at the Helsinki University Central Hospital (HUCH). This is a real-life study with a broader patient population than in a randomized controlled trial. Omalizumab has been used for treatment of asthma in HUCH since January 2009, anti-IL5 therapies starting with mepolizumab since April 2016.', 'detailedDescription': 'The investigators collect and analyse results of anti-IL5/IL5R and anti-IgE therapies in asthma until October 2019.The investigators compare number of exacerbations, number of glucocorticoid courses, dose of per oral glucocorticoid, number of antibiotic courses, need of emergency care and hospitalizations because of asthma before use of biologicals and at the latest visits of the participants when using biologicals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Asthma patients that have received biologicals (anti-IL5/IL5R or anti-IgE) for asthma with or without chronic rhinitis and nasal polyps.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* asthma that remains uncontrolled despite moderate to high dose inhaled corticosteroid and additional therapy with at least one other controller medication and need for continuous per oral corticosteroids (OCS) or contraindications (or clinically significant side effects of OCS) against OCS and/or frequent courses (two or more per year) of OCS\n\nExclusion Criteria:\n\n* patients without asthma'}, 'identificationModule': {'nctId': 'NCT04158050', 'acronym': 'BiSA', 'briefTitle': 'Comparison of Biologicals in Treatment of Severe Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Comparison of Biologicals in Treatment of Severe Asthma - Real Life Experiences', 'orgStudyIdInfo': {'id': 'HUS/25/2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'anti-IL5/IL5R-therapy group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R', 'interventionNames': ['Drug: IL5 Antagonist or anti-IL5R-antibody or Omalizumab']}, {'label': 'anti-IgE-therapy group', 'description': 'Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy', 'interventionNames': ['Drug: IL5 Antagonist or anti-IL5R-antibody or Omalizumab']}], 'interventions': [{'name': 'IL5 Antagonist or anti-IL5R-antibody or Omalizumab', 'type': 'DRUG', 'description': 'mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma', 'armGroupLabels': ['anti-IL5/IL5R-therapy group', 'anti-IgE-therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Paula Kauppi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ida Montini Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Specialist of Allergy Department, Principal Investigator, Adj Prof.', 'investigatorFullName': 'Paula Kauppi, MD, PhD', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}