Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT00252135
Status:
COMPLETED
Last Update Posted:
2017-05-12
First Post:
2005-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8023}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-11', 'studyFirstSubmitDate': '2005-11-09', 'studyFirstSubmitQcDate': '2005-11-09', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Moderate to severe asthma'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '39309477', 'type': 'DERIVED', 'citation': 'Fiocchi A, Chinthrajah RS, Ansotegui IJ, Sriaroon P, Mustafa SS, Raut P, Cameron B, Gupta S, Fleischer DM. Does Comorbid Food Allergy Affect Response to Omalizumab in Patients with Asthma? J Asthma Allergy. 2024 Sep 17;17:889-900. doi: 10.2147/JAA.S475517. eCollection 2024.'}, {'pmid': '21885725', 'type': 'DERIVED', 'citation': 'Eisner MD, Yegin A, Trzaskoma B. Severity of asthma score predicts clinical outcomes in patients with moderate to severe persistent asthma. Chest. 2012 Jan;141(1):58-65. doi: 10.1378/chest.11-0020. Epub 2011 Sep 1.'}, {'pmid': '19788018', 'type': 'DERIVED', 'citation': 'Long AA, Fish JE, Rahmaoui A, Miller MK, Bradley MS, Taki HN, Demeo AN, Tilles SA, Szefler SJ. Baseline characteristics of patients enrolled in EXCELS: a cohort study. Ann Allergy Asthma Immunol. 2009 Sep;103(3):212-9. doi: 10.1016/S1081-1206(10)60184-6.'}, {'pmid': '19411292', 'type': 'DERIVED', 'citation': 'Wechsler ME, Wong DA, Miller MK, Lawrence-Miyasaki L. Churg-strauss syndrome in patients treated with omalizumab. Chest. 2009 Aug;136(2):507-518. doi: 10.1378/chest.08-2990. Epub 2009 May 1.'}]}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, prospective, observational cohort study of \\~5000 Xolair-treated and \\~2500 non-Xolair-treated patients with moderate to severe persistent asthma and a positive skin test or in vitro reactivity to an aeroallergen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited from a variety of practice settings, including managed care organizations, community physicians, and academic centers.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative)\n* ≥12 years of age\n* Physician diagnosis of moderate to severe persistent asthma\n* Evidence or history of positive skin test or in vitro reactivity to an aeroallergen\n* Willingness to participate fully for the duration of the study (5 years)\n* For patients in the Xolair-treated cohort, have received at least one dose of Xolair therapy at the time of enrollment\n\nExclusion Criteria:\n\n* Contraindication to Xolair therapy (e.g., patients who experienced a severe hypersensitivity reaction to Xolair)\n* Acute asthma exacerbation within the previous 2 weeks of screening requiring any of the following: initiation of systemic corticosteroids, increased doses of systemic corticosteroids from baseline, doubling of inhaled corticosteroids, emergency room visit, or hospitalization\n* Acute flare of significant systemic disease (e.g., infection, hematologic, renal, hepatic, cardiovascular diseases, or gastrointestinal diseases), or a recent hospitalization because of their disease within the previous 2 months\n* Use of an experimental drug within 30 days prior to study screening\n* Diagnosis of cystic fibrosis\n* For patients in the non-Xolair-treated cohort, any prior treatment with Xolair"}, 'identificationModule': {'nctId': 'NCT00252135', 'briefTitle': 'A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'An Epidemiologic Study of Xolair (Omalizumab): Evaluating Clinical Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma (EXCELS)', 'orgStudyIdInfo': {'id': 'Q2948g'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dennis Wong, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}