Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-09 @ 12:17 PM
Study NCT ID:
NCT00232050
Status:
COMPLETED
Last Update Posted:
2011-10-25
First Post:
2005-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Omalizumab in Moderate to Severe Bronchial Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'C562694', 'term': 'Epilepsy, Idiopathic Generalized'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 327}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-24', 'studyFirstSubmitDate': '2005-10-03', 'studyFirstSubmitQcDate': '2005-10-03', 'lastUpdatePostDateStruct': {'date': '2011-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morning peak expiratory flow (PEF) at baseline and end of treatment.'}], 'secondaryOutcomes': [{'measure': 'Pulmonary function parameters measured by spirometer'}, {'measure': 'Frequency of rescue medication use'}, {'measure': 'Symptom score'}, {'measure': 'Activities of daily living score'}, {'measure': 'Nighttime sleep score'}]}, 'conditionsModule': {'keywords': ['Asthma, IgE, Omalizumab'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult patients with moderate to severe bronchial asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Allergic asthma patients\n* Inadequately controlled patients\n\nExclusion Criteria:\n\n* \\- History of severe anaphylactoid or anaphylactic reactions\n* Previous treatment with omalizumab\n* History of cancer or cancer\n\nOther protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00232050', 'briefTitle': 'Study of Omalizumab in Moderate to Severe Bronchial Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Study of Omalizumab in Moderate to Severe Bronchial Asthma', 'orgStudyIdInfo': {'id': 'CIGE025A1304'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Omalizumab', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis Pharmaceuticals Japan', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Pharmaceuticals Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Daiichi Sankyo Co., Ltd.', 'class': 'INDUSTRY'}]}}}