Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT00747318
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2008-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005
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': 'C586520', 'term': 'fluticasone-formoterol'}, {'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'dispFirstSubmitDate': '2011-06-08', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-08', 'studyFirstSubmitDate': '2008-09-04', 'dispFirstSubmitQcDate': '2011-06-08', 'studyFirstSubmitQcDate': '2008-09-04', 'dispFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005', 'timeFrame': 'week 60'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Moderate to Severe'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Documented use of an inhaled corticosteroid for at least 4 weeks prior to the Day 1 (Baseline) visit and at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids). Subjects who enroll in this study SKY2028-3-006 immediately upon completion of study SKY2028-3-005 have automatically satisfied this criterion. Subjects who enroll in this study SKY2028-3-006 after completion of study SKY2028-3-005 within 24 weeks must use inhaled corticosteroid therapy at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids) for at least 4 weeks prior to the Day 1 (Baseline) visit.\n* 2\\. Females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test at the Day 1 Visit\n* 3\\. Subject is judged to be in good general health as determined by the investigator.\n* 4\\. Demonstrate satisfactory technique in the use of pMDI.\n\nExclusion Criteria:\n\n* 1\\. Subjects who prematurely discontinued from the study SKY2028-3-005.\n* 2\\. Life-threatening asthma within the past year.\n* 3\\. History of systemic (oral or injectable) corticosteroid use within the past 12 weeks,\n* 4\\. An upper or lower respiratory infection within 4 weeks prior to the Day 1 (Baseline) visit.\n* 5\\. Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis).\n* 6\\. Recent history of smoking, alcohol, substance abuse and/or psychiatric illness,\n* 7\\. Subjects who have taken beta-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past 1 week.'}, 'identificationModule': {'nctId': 'NCT00747318', 'briefTitle': 'A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005', 'organization': {'class': 'INDUSTRY', 'fullName': 'SkyePharma AG'}, 'officialTitle': 'A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005, Incorporating Amendment 1 and 2', 'orgStudyIdInfo': {'id': 'SKY2028-3-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: SKP FlutiForm HFA pMDI']}], 'interventions': [{'name': 'SKP FlutiForm HFA pMDI', 'type': 'DRUG', 'otherNames': ['FlutiForm', 'fluticasone propionate/formoterol fumarate'], 'description': 'Each subject will receive SKP FlutiForm HFA pMDI 250/10 microgram twice daily for 60 weeks (two actuations of SKP FlutiForm HFA pMDI 125/5 microgram/actuation) for a total daily dose of 500 microgram fluticasone propionate and 20 microgram formoterol fumarate.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92868', 'city': 'Orange County', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site'}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33596', 'city': 'Valrico', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 27.93789, 'lon': -82.23644}}, {'zip': '27909', 'city': 'Elizabeth City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 36.2946, 'lon': -76.25105}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '02914', 'city': 'East Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 41.81371, 'lon': -71.37005}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '53227', 'city': 'West Allis', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 43.01668, 'lon': -88.00703}}, {'zip': '44100', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Investigational Site', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '14050', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Investigational site', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '50080', 'city': 'Toluca', 'state': 'State of Mexico', 'country': 'Mexico', 'facility': 'Investigational Site', 'geoPoint': {'lat': 19.28786, 'lon': -99.65324}}, {'zip': '86100', 'city': 'Villahermosa', 'state': 'Tabasco Mexico', 'country': 'Mexico', 'facility': 'Investigational Site', 'geoPoint': {'lat': 17.98625, 'lon': -92.93928}}, {'zip': '45200', 'city': 'Zapopan', 'state': 'Zapopan Jalisco', 'country': 'Mexico', 'facility': 'Investigational Site', 'geoPoint': {'lat': 20.72111, 'lon': -103.38742}}, {'zip': 'Lima-01', 'city': 'Lima', 'state': 'Lima Province', 'country': 'Peru', 'facility': 'Investigational site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima-27', 'city': 'Lima', 'state': 'Lima Province', 'country': 'Peru', 'facility': 'Investigational site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima-29', 'city': 'Lima', 'state': 'Lima Province', 'country': 'Peru', 'facility': 'Investigational site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima-31', 'city': 'Lima', 'state': 'Lima Province', 'country': 'Peru', 'facility': 'Investigational site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima-32', 'city': 'Lima', 'state': 'Lima Province', 'country': 'Peru', 'facility': 'Investigational site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima-33', 'city': 'Lima', 'state': 'Lima Province', 'country': 'Peru', 'facility': 'Investigational site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '900002', 'city': 'Constanța', 'state': 'Jud. 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