Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-05 @ 6:29 PM
Study NCT ID:
NCT00734292
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2008-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect of FlutiForm HFA pMDI in Adult Subjects With Mild to Moderate Asthma
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': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'C586520', 'term': 'fluticasone-formoterol'}], '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'dispFirstSubmitDate': '2010-08-24', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-24', 'studyFirstSubmitDate': '2008-08-04', 'dispFirstSubmitQcDate': '2010-08-24', 'studyFirstSubmitQcDate': '2008-08-13', 'dispFirstPostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline FEV1 to post study drug dosing FEV1', 'timeFrame': '3 minutes'}], 'secondaryOutcomes': [{'measure': 'Change from baseline FEV1 to post study drug dosing FEV1', 'timeFrame': '8, 15, 30, and 60 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Asthma Mild to Moderate'], 'conditions': ['Mild to Moderate Asthma']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the early bronchodilating effect of SKP FlutiForm HFA pMDI compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid\n\nExclusion Criteria:\n\n* Participation in a prior FlutiForm study\n* Smoking history within the last 12 months,\n* Significant, non-reversible, pulmonary disease\n* Life-threatening asthma within the last year'}, 'identificationModule': {'nctId': 'NCT00734292', 'briefTitle': 'Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect of FlutiForm HFA pMDI in Adult Subjects With Mild to Moderate Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'SkyePharma AG'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-blind, Crossover, Single-dose Exposure Study to Evaluate the Early Bronchodilating Effect of FlutiForm 100/10 µg HFA pMDI and FlutiForm 250/10 µg HFA pMDI, Compared to Placebo in Adult Subjects With Mild to Moderate Asthma', 'orgStudyIdInfo': {'id': 'SKY2028-2-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'I', 'description': '* Period 1 Treatment Regimen A: FlutiForm 250/10 ug\n* Period 2 Treatment Regimen B: FlutiForm 100/10 ug\n* Period 3 Treatment Regimen C: placebo', 'interventionNames': ['Drug: fluticasone propionate, formoterol fumarate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'II', 'description': '* Period 1 Treatment Regimen B: FlutiForm 100/10 ug\n* Period 2 Treatment Regimen C: placebo\n* Period 3 Treatment Regimen A: FlutiForm 250/10 ug', 'interventionNames': ['Other: fluticasone propionate, formoterol fumarate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'III', 'description': '* Period 1 Treatment Regimen C: placebo\n* Period 2 Treatment Regimen A: FlutiForm 250/10 ug\n* Period 3 Treatment Regimen B: FlutiForm 100/10 ug', 'interventionNames': ['Other: fluticasone propionate, formoterol fumarate']}], 'interventions': [{'name': 'fluticasone propionate, formoterol fumarate', 'type': 'DRUG', 'otherNames': ['FlutiForm'], 'description': '● Period 1 Treatment Regimen A: FlutiForm 250/10 ug\n\nFlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation)\n\n● Period 2 Treatment Regimen B: FlutiForm 100/10 ug\n\nFlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation)\n\n● Period 3 Treatment Regimen C: placebo\n\nSKP placebo; (two actuations)', 'armGroupLabels': ['I']}, {'name': 'fluticasone propionate, formoterol fumarate', 'type': 'OTHER', 'otherNames': ['FlutiForm'], 'description': '● Period 1 Treatment Regimen B: FlutiForm 100/10 ug\n\nFlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation)\n\n● Period 2 Treatment Regimen C: placebo\n\nSKP placebo; (two actuations)\n\n● Period 3 Treatment Regimen A: FlutiForm 250/10 ug\n\nFlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation)', 'armGroupLabels': ['II']}, {'name': 'fluticasone propionate, formoterol fumarate', 'type': 'OTHER', 'otherNames': ['FlutiForm'], 'description': '● Period 1 Treatment Regimen C: placebo\n\nSKP placebo; (two actuations)\n\n● Period 2 Treatment Regimen A: FlutiForm 250/10 ug\n\nFlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation)\n\n● Period 3 Treatment Regimen B: FlutiForm 100/10 ug\n\nFlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation)', 'armGroupLabels': ['III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33594', 'city': 'Valrico', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 27.93789, 'lon': -82.23644}}, {'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': '23229', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53227', 'city': 'West Allis', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 43.01668, 'lon': -88.00703}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SkyePharma AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'SkyePharma AG', 'oldOrganization': 'SkyePharma AG'}}}}