Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT00575861
Status:
COMPLETED
Last Update Posted:
2007-12-20
First Post:
2007-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zileuton and Exhaled Nitric Oxide in Asthmatics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C063449', 'term': 'zileuton'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-18', 'studyFirstSubmitDate': '2007-12-15', 'studyFirstSubmitQcDate': '2007-12-17', 'lastUpdatePostDateStruct': {'date': '2007-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide', 'timeFrame': '2 hr to 1 month'}], 'secondaryOutcomes': [{'measure': 'expiratory spirometry and asthma symptom Juniper score', 'timeFrame': '2 hr to 1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['asthma', 'nitric oxide gas exchange', 'lung function'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Gelb AF, Flynn Taylor C, Shinar C, et al. Additive role of zileuton on total exhaled, bronchial, alveolar nitric oxide in non-atopic moderate to severe persistent asthmatics on fluticasone 250/salmeterol 50. Chest 2006;130:163S'}, {'pmid': '16778266', 'type': 'BACKGROUND', 'citation': 'Gelb AF, Flynn Taylor C, Shinar CM, Gutierrez C, Zamel N. Role of spirometry and exhaled nitric oxide to predict exacerbations in treated asthmatics. Chest. 2006 Jun;129(6):1492-9. doi: 10.1378/chest.129.6.1492.'}, {'pmid': '15229098', 'type': 'BACKGROUND', 'citation': 'Gelb AF, Taylor CF, Nussbaum E, Gutierrez C, Schein A, Shinar CM, Schein MJ, Epstein JD, Zamel N. Alveolar and airway sites of nitric oxide inflammation in treated asthma. Am J Respir Crit Care Med. 2004 Oct 1;170(7):737-41. doi: 10.1164/rccm.200403-408OC. Epub 2004 Jun 30.'}, {'pmid': '19467341', 'type': 'DERIVED', 'citation': 'Gelb AF, Taylor CF, Simmons M, Shinar C. Role of add-on zileuton on total exhaled, large airway, and small airway/alveolar nitric oxide in moderate-severe persistent adult asthmatics on fluticasone 250 microg/Salmeterol 50 microg. Pulm Pharmacol Ther. 2009 Dec;22(6):516-21. doi: 10.1016/j.pupt.2009.05.003. Epub 2009 May 23.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on Advair 250/50 bid. Since asthma is an endogenous inflammatory disease there usually is increased total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven pathways of inflammation. The addition of zileuton which is a leukotriene synthesis inhibitor by itself or together with inhaled corticosteroids should reduce nitric oxide gas exchange.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smoking\n* Moderate to severe persistent asthmatics\n* Clinically stable X 6 weeks on Advair 250/50 bid for at least 12 months\n\nExclusion Criteria:\n\n* No leukotriene synthesis inhibitors or receptor antagonists for 6 weeks'}, 'identificationModule': {'nctId': 'NCT00575861', 'briefTitle': 'Zileuton and Exhaled Nitric Oxide in Asthmatics', 'organization': {'class': 'INDIV', 'fullName': 'Gelb, Arthur F., M.D.'}, 'officialTitle': 'Evaluation of Additive Effects of Zileuton to Advair on Total Exhaled, Bronchial, and Alveolar Nitric Oxide in Asthmatics', 'orgStudyIdInfo': {'id': '2000'}, 'secondaryIdInfos': [{'id': 'Critical Therapeutics, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Advair 250/50 (baseline) fluticasone/salmeterol 250/50', 'interventionNames': ['Drug: zileuton']}], 'interventions': [{'name': 'zileuton', 'type': 'DRUG', 'otherNames': ['zyflo'], 'description': 'zileuton (Zyflo) 600mg qid for 2hr and for 30 days', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90712', 'city': 'Lakewood', 'state': 'California', 'country': 'United States', 'facility': 'Arthur F Gelb Medical Corporation', 'geoPoint': {'lat': 33.85363, 'lon': -118.13396}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gelb, Arthur F., M.D.', 'class': 'INDIV'}, 'responsibleParty': {'oldNameTitle': 'Arthur F. Gelb MD', 'oldOrganization': 'Arthur F. Gelb Medical Corporation'}}}}