Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 5:51 PM
Study NCT ID:
NCT00507234
Status:
COMPLETED
Last Update Posted:
2010-11-11
First Post:
2007-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study in Subjects Greater Than 40 Years of Age With COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-10', 'studyFirstSubmitDate': '2007-07-24', 'studyFirstSubmitQcDate': '2007-07-24', 'lastUpdatePostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy endpoint will be the standardized area under the curve for FEV1 (FEV1 AUC0-3) over the 3-hour assessment period at End Study (Week 6/ET).', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '19537837', 'type': 'RESULT', 'citation': 'Hanania NA, Boota A, Kerwin E, Tomlinson L, Denis-Mize K. Efficacy and safety of nebulized formoterol as add-on therapy in COPD patients receiving maintenance tiotropium bromide: Results from a 6-week, randomized, placebo-controlled, clinical trial. Drugs. 2009 Jun 18;69(9):1205-16. doi: 10.2165/00003495-200969090-00005.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled, parallel-group, comparative study.\n\nThe objectives of this study are:\n\n1. To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.\n2. To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice daily compared to tiotropium 18 mcg once daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical diagnosis of COPD\n* Current or prior history of cigarette smoking\n\nExclusion Criteria:\n\n* Medical diagnosis of asthma\n* Significant condition or disease other than COPD'}, 'identificationModule': {'nctId': 'NCT00507234', 'briefTitle': 'Study in Subjects Greater Than 40 Years of Age With COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dey'}, 'officialTitle': 'A 6-Week Trial to Compare the Efficacy and Safety of Concomitant Treatment With Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '201-080'}}, 'armsInterventionsModule': {'interventions': [{'name': 'formoterol fumarate inhalation solution', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36695', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '30330', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48152', 'city': 'Livonia', 'state': 'Michigan', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 42.36837, 'lon': -83.35271}}, {'zip': '63301', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '12205', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '13212', 'city': 'North Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 43.13479, 'lon': -76.12992}}, {'zip': '14221', 'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}, {'zip': '45560', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '24210', 'city': 'Abingdon', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 36.70983, 'lon': -81.97735}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53209', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Nicola A Hanania, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dey', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Affairs', 'oldOrganization': 'Dey'}}}}