Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2026-01-09 @ 4:13 PM
Study NCT ID:
NCT00242359
Status:
WITHDRAWN
Last Update Posted:
2019-07-10
First Post:
2005-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'could not find subject population', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2005-10-17', 'studyFirstSubmitQcDate': '2005-10-17', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergy Induced Asthma']}, 'descriptionModule': {'briefSummary': 'Management of animal induced occupational asthma is mainly avoidance, but this is not feasible for many occupations. Treatment with avoidance and conventional treatment is also not always successful. Omalizumab is FDA approved for the treatment of allergic asthma and may be effective at reducing symptoms and disease progression in the animal handlers population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ages 18-65\n2. occupation that involves close contact with animals\n3. stable dose of ICS for 30 days\n4. Skin test positive to one or more animals\n5. evidence of asthma on spirometry\n6. demonstrate PEFR variability-\n\nExclusion Criteria:\n\n1. on allergen immunotherapy\n2. on prohibited medications\n3. unstable asthma\n4. recent URI\n5. known hypersensitivity to omalizumab-'}, 'identificationModule': {'nctId': 'NCT00242359', 'briefTitle': 'A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Bernstein Clinical Research Center'}, 'officialTitle': 'A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma', 'orgStudyIdInfo': {'id': '2085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'omalizumab', 'description': 'open-label', 'interventionNames': ['Drug: omalizumab']}], 'interventions': [{'name': 'omalizumab', 'type': 'DRUG', 'armGroupLabels': ['omalizumab']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bernstein Clinical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Jonathan A. Bernstein, MD', 'investigatorAffiliation': 'Bernstein Clinical Research Center'}}}}