Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2026-02-05 @ 9:39 PM
Study NCT ID:
NCT00530166
Status:
TERMINATED
Last Update Posted:
2014-06-18
First Post:
2007-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety Study for JNJ-18054478 in Asthma Patients.
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'Lack of efficacy following an interim analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'dispFirstSubmitDate': '2011-06-01', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-03', 'studyFirstSubmitDate': '2007-09-13', 'dispFirstSubmitQcDate': '2011-06-01', 'studyFirstSubmitQcDate': '2007-09-13', 'dispFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percent change from the beginning of the study in Forced Expiratory Volume in one Second (FEV1) after 12 weeks on study drug.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'The change in FEV1 after 1, 2, 4, 6, 8 and 10 weeks therapy. The change in symptoms and use of asthma rescue medication. The number of asthma attacks compared to placebo. The safety, tolerability, and blood and urine levels of JNJ-18054478', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Asthma', 'persistant asthma', 'controller medications', 'FEV1'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness of JNJ-18054478 measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy in patients with persistent asthma.', 'detailedDescription': 'Asthma is one of the most common chronic diseases worldwide. This is a randomized (study medication assigned by chance), double-blind study (neither the physician or the patient knows which drug they are receiving, active or placebo) to Investigate the effectiveness and safety of 12 weeks of dosing with JNJ-18054478 (300 mg taken orally once daily) compared with placebo in patients with persistent asthma. The hypothesis is that the study drug will be more effective in treatment of asthma than placebo as measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy, without any significant adverse events. Safety evaluations will include, monitoring for adverse reactions, clinical laboratory tests of blood and urine, ECGs to monitor the cardiovascular system, vital signs and physical examinations. Patients will take three capsules (100 mg) of JNJ-18054478 orally once daily for 12 weeks or placebo for the same period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically confirmed diagnosis of persistent asthma\n* Able to demonstrate reversibility of at least 12% with albuterol inhalation\n* Use of short-acting b-2 agonists for rescue \\>= 5 times within 2 weeks prior\n* Able to produce an FEV1 between 45 and 85% of predicted\n* Willing to perform study procedures for about 14 weeks.\n\nExclusion Criteria:\n\n* Use of inhaled corticosteroids within 4 weeks\n* Use of oral/parenteral corticosteroids within 8 weeks\n* Use of long-acting beta-2 agonists or montelukast within 2 weeks\n* History of life-threatening asthma attack within 3 months\n* Female of child bearing potential.'}, 'identificationModule': {'nctId': 'NCT00530166', 'briefTitle': 'Effectiveness and Safety Study for JNJ-18054478 in Asthma Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of JNJ-18054478 in Subjects With Asthma', 'orgStudyIdInfo': {'id': 'CR013087'}, 'secondaryIdInfos': [{'id': '18054478NAP2002'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '002', 'description': 'sham comparator 3(100 mg) tablets once daily for 12 weeks', 'interventionNames': ['Drug: sham comparator']}, {'type': 'EXPERIMENTAL', 'label': '001', 'description': 'JNJ-18054478 3(100 mg) tablets once daily for 12 weeks', 'interventionNames': ['Drug: JNJ-18054478']}], 'interventions': [{'name': 'JNJ-18054478', 'type': 'DRUG', 'description': '3(100 mg) tablets once daily for 12 weeks', 'armGroupLabels': ['001']}, {'name': 'sham comparator', 'type': 'DRUG', 'description': '3(100 mg) tablets once daily for 12 weeks', 'armGroupLabels': ['002']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Paramount', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.88946, 'lon': -118.15979}}, {'city': 'San Jose', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'city': 'Pueblo', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 38.25445, 'lon': -104.60914}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'city': 'River Forest', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.89781, 'lon': -87.81395}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'North Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 41.63899, 'lon': -70.97032}}, {'city': 'Plymouth', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 45.01052, 'lon': -93.45551}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Skillman', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.42011, 'lon': -74.7146}}, {'city': 'North Syracuse', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.13479, 'lon': -76.12992}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'city': 'Lake Oswego', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.42067, 'lon': -122.67065}}, {'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Chester', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.84753, 'lon': -75.35785}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'city': 'San José', 'country': 'Costa Rica', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}, {'city': 'Bangalore', 'country': 'India', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Chennai', 'country': 'India', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Hyderabad', 'country': 'India', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Mumbai', 'country': 'India', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Mysore', 'country': 'India', 'geoPoint': {'lat': 12.29791, 'lon': 76.63925}}, {'city': 'Vellore', 'country': 'India', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}], 'overallOfficials': [{'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}